chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Chromaturia, Urinary tract infection, Vaccination site pain
Clinical narrative: URINARY TRACT INFECTION; pink in my urine; Little bit of Pain after injection in left arm; A spontaneous report  was received from a 71 years old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced urinary tract infection (urinary tract infection), pink in my urine (chromaturia) and little bit of pain in arm of injection (pain in extremity).  The patient's medical history was not provided. The relevant concomitant medications were also not provided.  On 02 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA (Lot number:013M20A ) through intramuscular route of administration in the left arm for prophylaxis of COVID-19 infection.  On 02 Feb 2021, patient experienced little bit of pain in arm of injection.   On 23 Feb 2021, patient experienced pink in urine. The patient subsequently visited the urgent care on 26-Feb-2021 and was diagnosed with  a urinary tract infection. Treatment for urinary tract infection included ciprofloxacin 500 mg twice daily for 7days.  No laboratory data was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The event little bit of pain in arm of injection was resolved 03 Feb 2021. The event pink in urine was resolved on 01 Mar 2021. The outcome of the event urinary tract infection was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event (vaccination site pain) a causal relationship cannot be excluded. However, for the events - chromaturia and UTI, a very limited information has been provided at this time. Further information has been requested.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Rash
Clinical narrative: Very red face; Broke out in rash that eventually covered my whole body; This is a spontaneous report from a contactable consumer (patient). A 76-years-old male patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: El3248), via an unspecified route of administration from 29Jan2021 11:00 to an unspecified date at single dose for covid-19 immunization. Medical history included 2 knee replacement, diabetic, high blood pressure, anemic and allergies to penicillin. Concomitant medication included insulin, paracetamol (TYLENOL) and metformin. The patient previously took Benadryl and experienced drug hypersensitivity. The patient experienced very red face and broke out in rash that eventually covered my whole body on 29Jan2021 at 18:15. The outcome of the event was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Malaise, Pain, Pneumonia
Clinical narrative: pneumonia; sick; chills; headache; body aches; rash; This is a spontaneous report from a contactable consumer (patient's wife). An 82-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration on unspecified date at a single dose for COVID-19 immunization. Medical history included rash which he gets anytime of the year. Concomitant medications were not reported. The patient had the first shot and got sick eight days later. He was in the hospital for two days and saw his primary doctor when he got out. The doctor told them that everything with the blood tests was good, and also with his kidneys, then he prescribed medication for pneumonia. With the first dose of the vaccine, the patient also experienced chills, headache and a little body aches without fever. When he came home from the hospital, the patient had a rash. Outcome of the events was not reported.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: pneumonia; sick; chills; headache; body aches; rash; This is a spontaneous report from a contactable consumer (patient's wife). An 82-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration on unspecified date at a single dose for COVID-19 immunization. Medical history included rash which he gets anytime of the year. Concomitant medications were not reported. The patient had the first shot and got sick eight days later. He was in the hospital for two days and saw his primary doctor when he got out. The doctor told them that everything with the blood tests was good, and also with his kidneys, then he prescribed medication for pneumonia. With the first dose of the vaccine, the patient also experienced chills, headache and a little body aches without fever. When he came home from the hospital, the patient had a rash. Outcome of the events was not reported.   Information on the lot/batch number has been requested.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain in extremity, Weight
Clinical narrative: Then by tuesday nerves in his left heal was jumping all over the place and it was really uncomfortable/Bottom of left foot bothering him; Since the second shot, his arm is still a little sore/Arm soreness; his foot hurt and he didn't feel right so he took Advil /Took Advil for left foot nerve pain in heel; This is a spontaneous report from a contactable consumer (patient). A 88-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9264), via an unspecified route of administration on left arm on 31Jan2021 11:00 at single dose for covid-19 immunisation. Medical history included ongoing Arthritis. The patient's concomitant medications were not reported. His first dose was 10Jan2021. Lot number for the first dose was EJ1686. The first one was 3 weeks before on a Sunday at 9:30 am.On 02Feb2021, patient stated that his nerves in his left heal was jumping all over the place and it was really uncomfortable (Bottom of left foot bothering him he doesn't know what it was).His foot hurt and he didn't feel right so he took Advil (Took Advil for left foot nerve pain in heel).The first shot didn't bother him at all. Since the second shot, his arm is still a little sore (his left arm bothered him a little/ Arm soreness). So Monday and Tuesday, he took two Advil for two days. The foot pain was like a nerve was jumping in his foot. The bottom of his foot was hurting. He is a father and a grandfather, and he wanted to get the vaccine to be safe. He doesn't get to go anywhere right now, and he doesn't want to live the rest of his life this way.It was reported that when he was in the job, he fell down in a hatch, and jammed his left foot. Then, 10 years ago, he got diagnosed with spinal stenosis. Ever since then, his left leg isn't the same diameter as his right leg. Since then, he has lost 15 lbs. He used to be 170lbs.He is now 150lbs, and not as strong. He lost circumference in his left leg up and down.He had a flu shot a couple months ago. The patient received treatment for the events.The events were considered as non-serious. The outcome of the event his nerves in his left heal was jumping all over the place and it was really uncomfortable (Bottom of left foot bothering him) was recovered and the event his arm is still a little sore (his left arm bothered him a little/ Arm soreness) was recovering and outcome of other event was unknown.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling hot, Hyperhidrosis, Magnetic resonance imaging, Malaise
Clinical narrative: nausea; She was just not quite herself; feeling hot and sweaty; feeling hot and sweaty; not feeling well; shaky; nervous; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9265), via an unspecified route of administration, on 02Feb2021 12:00 at a single dose on the right arm for COVID-19 immunization. Medical history included asthma, knee surgery, and bulging disc.  The patient had an MRI on an unspecified date in Jan2021 (a week and a half prior to the date of initial report) with result of bulging disc. Concomitant medications included fluticasone furoate (ARNUITY ELLIPTA) for asthma; She was supposed to take 1 puff a day. However, being in the house, she had no problems, she had maybe used it twice a week since she hasn't had any problems, she last took 1 puff on 01Feb2021). She was also taking vitamin pills concomitantly. On 04Feb2021 23:00, 2 days after the vaccine, the patient had sweats, was wringing wet, and was not feeling well. Her hair was wet, and she was sweating. She was okay on the morning of 05Feb2021 but not herself. She had a little nausea on 05Feb2021. She was just not quite herself on 05Feb2021 but doesn't have the sweats. She further reported that she had her first shot on 02Feb2021 12:00. She was fine and had no problems. However, on night of 04Feb2021, before bed, she started getting hot and sweaty, like she was wringing wet. She didn't feel good, but 2 days had gone by and she was fine. She also went to bed with something like chills (later clarified as not chills), she went to sleep on the morning of 05Feb2021 and felt okay but not that great. When queried when the chills started, she said that it was not really chills, she was just very sweaty, wringing wet. She stated that she never sweats, and in this case her whole hair was wet. Being older, she was wondering what was going. Her feeling hot and sweaty subsided during the night. She did start to feel nausea, or she thought maybe she hasn't had anything to eat and so had a half banana and then she was okay. She thought she was hungry and felt funny, she had the half banana and was okay. She also felt a little shaky and nervous on 04Feb2021; however, it all subsided after going to bed. At the date of report, 05Feb2021, she felt okay but she didn't feel completely herself. Her second dose is scheduled on 26Feb2021 at 9:15 AM. Outcome of events feeling hot and sweaty was recovered with sequel on 05Feb2021. Outcome of event not feeling well was unknown. Outcome of event nausea was recovered on 05Feb2021. Outcome of the events shaky and nervous was recovered on 04Feb2021. Outcome of she was just not quite herself was not recovered.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Nervousness, Tremor
Clinical narrative: nausea; She was just not quite herself; feeling hot and sweaty; feeling hot and sweaty; not feeling well; shaky; nervous; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9265), via an unspecified route of administration, on 02Feb2021 12:00 at a single dose on the right arm for COVID-19 immunization. Medical history included asthma, knee surgery, and bulging disc.  The patient had an MRI on an unspecified date in Jan2021 (a week and a half prior to the date of initial report) with result of bulging disc. Concomitant medications included fluticasone furoate (ARNUITY ELLIPTA) for asthma; She was supposed to take 1 puff a day. However, being in the house, she had no problems, she had maybe used it twice a week since she hasn't had any problems, she last took 1 puff on 01Feb2021). She was also taking vitamin pills concomitantly. On 04Feb2021 23:00, 2 days after the vaccine, the patient had sweats, was wringing wet, and was not feeling well. Her hair was wet, and she was sweating. She was okay on the morning of 05Feb2021 but not herself. She had a little nausea on 05Feb2021. She was just not quite herself on 05Feb2021 but doesn't have the sweats. She further reported that she had her first shot on 02Feb2021 12:00. She was fine and had no problems. However, on night of 04Feb2021, before bed, she started getting hot and sweaty, like she was wringing wet. She didn't feel good, but 2 days had gone by and she was fine. She also went to bed with something like chills (later clarified as not chills), she went to sleep on the morning of 05Feb2021 and felt okay but not that great. When queried when the chills started, she said that it was not really chills, she was just very sweaty, wringing wet. She stated that she never sweats, and in this case her whole hair was wet. Being older, she was wondering what was going. Her feeling hot and sweaty subsided during the night. She did start to feel nausea, or she thought maybe she hasn't had anything to eat and so had a half banana and then she was okay. She thought she was hungry and felt funny, she had the half banana and was okay. She also felt a little shaky and nervous on 04Feb2021; however, it all subsided after going to bed. At the date of report, 05Feb2021, she felt okay but she didn't feel completely herself. Her second dose is scheduled on 26Feb2021 at 9:15 AM. Outcome of events feeling hot and sweaty was recovered with sequel on 05Feb2021. Outcome of event not feeling well was unknown. Outcome of event nausea was recovered on 05Feb2021. Outcome of the events shaky and nervous was recovered on 04Feb2021. Outcome of she was just not quite herself was not recovered.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: I am wondering different parts and areas of my body itching/itchiness; This is a spontaneous report from a contactable consumer (Patient). A 65-years-old female patient  received first dose of  (BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL1283, NDC number; UPC number; Expiry Date: unknown) via an unspecified route of administration on 19Jan2021 at single dose for COVID-19 immunisation. Covid-19 vaccine was a Pfizer product. Covid-19 vaccine manufacturer was unspecified. The patient's medical history included high blood pressure. Concomitant medication included valsartan for High blood pressure. The patient stated "I had my first vaccine, Pfizer Covid vaccine on the 19th of Jan (19Jan2021) and on the 12th day (12 days after) on Monday (01Feb2021) she began to feel itchiness, she wondering different parts and areas of her body were itching." She stated, "I have no idea if it's related, I haven't used any other detergents or anything that would have caused and so I thought it may be related to the vaccine." No investigation assessment. The second dose was due on 16Feb2021. No laboratory test was reported, she would go next week. No treatment was received for the events. The outcome of event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement, Dizziness
Clinical narrative: dizzy; BP dropped to 117/79.; This is a spontaneous report from a   consumer.  A 75-years-old male patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number:  EL9265, via an unspecified route of administration in left arm,from 03Feb2021 as a single doseE for COVID-19 immunization .  Medical history included  a stroke and high blood pressure .  Concomitant medication included oral clopidogrel (CLOPIDOGREL), 75 mg once a day for a storkeand  apixaban (ELIQUIS) 5 mg 2x/day oral for blood clots.  On 03Feb2021Patient had a reaction with the first dose of the Pfizer vaccine. He got a little dizzy and his BP dropped to 117/79. He wants to know if it is safe to take the second dose.. Patient states that he had a mild reaction to the COVID shot on 03Feb2021. Patient states that he got kind of dizzy, and his blood pressure dropped to 117. Patient states that his reaction lasted about an hour, and he had no other problems. Patient is wondering if he should get the second dose, or if he should not take some of his blood thinning medications on the same day as his second dose. Patient got his first dose of the product on 03Feb2021, and the side effects occurred that same day, just after the patient left the clinic, about 15 minutes later. Patient reports that he got kind of dizzy and he checked his blood pressure which was 117/79. Patient states that the dizziness lasted about an hour, and he did not check his blood pressure again after that. The outcome of the events was not reported.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pyrexia
Clinical narrative: headache/headache at temples radiating to base of skull; Chills; Fever of 100.0; This is a spontaneous report from a non-contactable consumer (patient). A 34-year-old female patient received (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EL3247), via an unspecified route of administration on right arm on 05Feb2021 09:00 AM at single dose for Covid-19 immunisation. Patient was not pregnant. Medical history was not reported. No other vaccine was received by the patient in four weeks. Other medications in two weeks included birth control. Past drug event included neosporin allergy. 12 hours after injection on 05Feb2021 at 21:00 PM, the patient experienced headache at temples radiating to base of skull, chills, fever of 100.0. No treatment received for events. Patient didn't have Covid prior vaccination. No Covid tested was done post vaccination. Outcome of the events was recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: Cold; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient's husband) reported a female patient of an unspecified age received first dose bnt162b2 (Solution for injection) via an unspecified route of administration from unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Caller stated that he and his wife are scheduled for their second dose tomorrow morning. Stated that his wife has a cold but no temperature. Clarified that this is for Pfizer Covid.
Sex: M
Vaccine: COVID19
Symptoms: Memory impairment
Clinical narrative: caller can't remember if he took tylenol or ibuprofen during the vaccination series; This is a spontaneous report from a Pfizer-sponsored. A contactable male consumer (patient) reported that: A contactable male consumer (patient) of an unspecified age received his second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date  single dose for COVID-19 immunization. The patient's medical history and concomitant medicines were not reported. The patient previously had first doseof covid-19 vaccine. Caller is done with the 2 doses of Pfizer vaccine but the caller can't remember if he took Tylenol or ibuprofen during the vaccination series. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: she tested positive with Covid after the first dose; She tested positive with Covid after the first dose; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A non-contactable consumer (patient) reported that that a female patient of unspecified age received the first dose of BNT162B2 (BNT162B2, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient reported she tested positive with COVID after the first dose on an unspecified date. Outcome of the events was unknown.  No follow up attempts are possible; information regarding Lot/Batch cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for covid; This is a spontaneous report from a contactable consumer.  A female consumer of an unknown age reported that received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EL9269) on 03Feb2021 at 0.3 ml single for COVID-19 immunization. Medical history and concomitant drugs were unknown. The consumer reported she got her first covid vaccine and she tested positive for Covid on 10Feb2021. She had minor covid symptoms. Caller thought she probably got covid from the OR since she worked in a hospital. Asking what manufacturer recommendation is for getting the second dose. Caller wanted to know if she should delay her vaccination.
Sex: M
Vaccine: COVID19
Symptoms: Skin haemorrhage
Clinical narrative: as he was rubbing, blood came out; This is a spontaneous report from a non-contactable consumer (patient friend). A male patient of an unspecified age received BNT162B2 (lot/batch number and expiration date were unknown) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was rubbing his arm vigorously after getting BNT162B2 and as he was rubbing, blood came out. The outcome of event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Pain in extremity
Clinical narrative: Sore Arm; Nausea; Light Headedness; This is a spontaneous report received from a contactable consumer (patient herself). A 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number EN5318) via an unspecified route of administration to left arm on 04Feb2021 at single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. It was reported as patient experienced with Sore Arm, Nausea, Light Headedness on 04Feb2021. Patient did not receive any treatment for events. Outcome of events was recovered on an unspecified date.  No follow-up attempts are possible. No further information was provided.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: not feeling good/sick/Covid-19 positive; not feeling good/sick/Covid-19 positive; This is a spontaneous report from a contactable consumer (the patient). A patient of an unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided), via an unspecified route of administration on 24Jan2021 (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had an appointment next Tuesday (16Feb2021) for their second dose, but they were not feeling good. The doctor said the patient was COVID-19 positive, so the patient wanted to cancel that and reschedule the appointment for next time. The patient got sick and took a COVID test, and the doctor said the patient was positive (on an unspecified date). The patient asked if they could get the second dose since they were sick. The clinical outcome of not feeling good/ sick/ Covid-19 positive was not recovered.  Information about lot number was requested.
Age: 78.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Haemorrhage urinary tract
Clinical narrative: He has had a friable capillaries, so sometimes when he urinate, he urinate blood or little blood clots; This is a spontaneous report from a contactable consumer. A 78-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6198), via an unspecified route of administration on 24Feb2021 at a single dose for COVID-19 immunization and apixaban (ELIQUIS), via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose for Atrial Fib (atrial fibrillation). Medical history included prostate cancer from about 10 years ago and was treated by radiation, the radiation has caused capillaries in the penis to be fragile (friable capillaries) and there were times when he bleeds and has some clots and it usually resolves itself; and bloody urine in the past. The patient's concomitant medications were not reported.. Radiation has caused capillaries in the penis to be fragile and there are times when he bleeds and has some clots. The patient has had a friable capillaries, so sometimes when he urinates, he urinate blood or little blood clots. The patient was on Eliquis, so yesterday when they came home after he got the vaccine, he was bleeding with the clots which he has done in the past. The reporter asked if it is possible that the vaccine can precipitate a bleeding episode in someone that is on Eliquis and had on and off had bloody urine in the past. After the shot, he was bleeding with the clots and with the bloody urine. The patient got the first dose of the Pfizer COVID-19 vaccine on Wednesday. He had radiation for prostate cancer 10 years ago. He had a bloody urine periodically and the doctors were aware. He had a blood urine one hour post vaccination in 24Feb2021. It would take at least a few hours for the medication to get in the system before having any kind of reaction. It resolved on its own he doesn't have a blood urine anymore. The second dose of the vaccine is due on 16Mar2021. The action taken in response to the events for apixaban was unknown. The outcome of the events was recovered on unspecified date in Feb2021.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Nausea, Pain
Clinical narrative: Body aches; joint pain; intermittent nausea; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3247), via an unspecified route of administration on Left arm on 04Feb2021 10:15 at single dose for covid-19 immunisation administered at workplace clinic. Medical history included none. The patient's concomitant medications were not reported in two weeks. On 04Feb2021 07:30, patient had Body aches, joint pain, and intermittent nausea. These symptoms started approximately 8 hours after the shot and persisted for 48 hours. The patient not received treatment for the event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19 was unknown; Since the vaccination, the patient not been tested for COVID-19. The seriousness was reported as non-serious. The outcome of the events resolved.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021232169 same reporter/patient/drug, different time/event
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dry mouth, Fatigue, Headache, Myalgia
Clinical narrative: Diarrhea; headache; muscle soreness; body aches; nasal congestion; fatigue; dry mouth; This is a spontaneous report from a contactable consumer (patient herself). A 42-year-old female patient received the first dose of BNT162B2, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization.  The patient's illness at vaccine included asthma and took Breo inhaler on day of vaccine injection. Concomitant medication included fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA) for asthma. The patient experienced diarrhea, headache, muscle soreness, body aches, nasal congestion, fatigue, and dry mouth on an unspecified date. Events took place after use of product. The  outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Pain
Clinical narrative: Diarrhea; headache; muscle soreness; body aches; nasal congestion; fatigue; dry mouth; This is a spontaneous report from a contactable consumer (patient herself). A 42-year-old female patient received the first dose of BNT162B2, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization.  The patient's illness at vaccine included asthma and took Breo inhaler on day of vaccine injection. Concomitant medication included fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA) for asthma. The patient experienced diarrhea, headache, muscle soreness, body aches, nasal congestion, fatigue, and dry mouth on an unspecified date. Events took place after use of product. The  outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: Pneumonia; A spontaneous report (United States) was received from a consumer concerning about a 70 years old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pneumonia.  The patient's medical history included smoking.  Concomitant medications were not reported.  On 04 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 013M20A) via intramuscular for prophylaxis of COVID-19 infection.   On 28 Feb 2021 the patient had pneumonia and she hospitalized for that. But the reporter states that pneumonia was not related to the vaccine, but it might be due to cold temperatures and the patient smokes too.  Laboratory tests was not reported.  Treatment information was unknown.  All the events occurred after first dose of vaccination.  Action taken with mRNA-1273 in response to the events are unknown.  The outcomes of all the events remain unknown.; Reporter's Comments: The events were consistent with increased risk of infections associated in pandemic set up confounded by elderly age of patient. Company assessed the events to be unlikely related to company product.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Severe nausea 4-6 hours, fever (101.1), chills, body aches, and headache 24 hours.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Muscular weakness, Pain, X-ray
Clinical narrative: On the day after my vaccine, my back started hurting me.  I went to an orthopedist, who prescribed Tylenol. That night, my back was so painful I could not bend over to pick something up.  Transitioning from sitting to standing and vice versa was excruciating pain. The next day, the back pain was no longer there.  It was definitely a side effect to the Moderna vaccine I had the day before.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood magnesium, Flushing, Full blood count, Malaise
Clinical narrative: Pt developed palpitations 3.5 hrs after dose (along w/nausea, malaise, fatigue). She did not require ED or office eval, just monitored on her own. Then 3/13 pt had a presyncopal episode w/profound weakness sensation, flushing and nausea
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Metabolic function test, Nausea, Palpitations, Presyncope, Thyroid function test
Clinical narrative: Pt developed palpitations 3.5 hrs after dose (along w/nausea, malaise, fatigue). She did not require ED or office eval, just monitored on her own. Then 3/13 pt had a presyncopal episode w/profound weakness sensation, flushing and nausea
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antinuclear antibody negative, Biopsy skin abnormal, Blood folate normal, Blood thyroid stimulating hormone decreased, Complement factor C3
Clinical narrative: Pt developed palpitations 3.5 hrs after dose (along w/nausea, malaise, fatigue). She did not require ED or office eval, just monitored on her own. Then 3/13 pt had a presyncopal episode w/profound weakness sensation, flushing and nausea
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Complement factor C4, Electrophoresis protein normal, Glycosylated haemoglobin normal, Small fibre neuropathy, Vitamin B12 normal
Clinical narrative: Pt developed palpitations 3.5 hrs after dose (along w/nausea, malaise, fatigue). She did not require ED or office eval, just monitored on her own. Then 3/13 pt had a presyncopal episode w/profound weakness sensation, flushing and nausea
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vitamin B6 normal
Clinical narrative: Pt developed palpitations 3.5 hrs after dose (along w/nausea, malaise, fatigue). She did not require ED or office eval, just monitored on her own. Then 3/13 pt had a presyncopal episode w/profound weakness sensation, flushing and nausea
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives skin reaction only
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: Covid arm: itchy, hard, red raised 2-3 inch diameter circle at injection site.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cough, Dizziness, Dyspnoea, Headache, Heart rate irregular
Clinical narrative: 102 degree fever starting about 10 hours after vaccination. The fever lasted the night of the injection, and the next two days. I was unable to sit up in bed without getting dizzy, had a headache, after walking 25 steps in my house I had to sit down due to shortness of breath and rapid heartbeat. Now, two weeks after vaccination I am experiencing a cough, syncope and occasional irregular heartbeat.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Syncope
Clinical narrative: 102 degree fever starting about 10 hours after vaccination. The fever lasted the night of the injection, and the next two days. I was unable to sit up in bed without getting dizzy, had a headache, after walking 25 steps in my house I had to sit down due to shortness of breath and rapid heartbeat. Now, two weeks after vaccination I am experiencing a cough, syncope and occasional irregular heartbeat.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Autoimmune disorder, Computerised tomogram, Confusional state, Delusion, Encephalopathy
Clinical narrative: After severe confusion, delusion, and paranoia, he was taken to the er.  Encephalopathy, autoimmune and antibody disorders
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Paranoia
Clinical narrative: After severe confusion, delusion, and paranoia, he was taken to the er.  Encephalopathy, autoimmune and antibody disorders
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cold sweat, Discomfort, Dyspnoea, Dysstasia
Clinical narrative: Injection site became pink, 3X5 inches, the day following the shot.  On 2.11.2021, about 55 hours after vaccination #2, pt developed generalized weakness, nausea, and then vomited.  She was taken to bed, where she rested poorly and only dozed off for 1-2 minutes at a time and was mumbling words.  She  continued with generalized weakness, nausea with dry heaves, a sensation of marked shortness of breath, and inability to stand without support.  Complained of feeling hot and then cold.  Appeared pale and lethargic, skin clammy and complained of difficulty breathing and was irritable. Lung sounds -clear, no wheezing despite being unable to speak more than a few words at time. Vitals at 10:00pm:  HR 62, pulse weak, O2 sat 92% (normal for her), temp 101.7F (her normal temp is 95-96).  Given a Tylenol extra strength 500mg, 2.5 mg Prednisone, increased O2 nasal canula to 3-4 L/min, and cold compresses to reduce fever and discomfort.   Vitals at 10:15p:  HR 93, O2 sat 92%, BP 131/59. Discussed going to the ER, but decided to wait until the morning if not better. Symptoms continued until ~ 2am, when she was able to fall deep asleep for 4 hours.  Awoke and felt better, able to walk, but still a bit weak and short of breath.  By noon Feb 12 she felt mostly back to normal.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling of body temperature change, Irritability, Lethargy, Nausea, Pallor
Clinical narrative: Injection site became pink, 3X5 inches, the day following the shot.  On 2.11.2021, about 55 hours after vaccination #2, pt developed generalized weakness, nausea, and then vomited.  She was taken to bed, where she rested poorly and only dozed off for 1-2 minutes at a time and was mumbling words.  She  continued with generalized weakness, nausea with dry heaves, a sensation of marked shortness of breath, and inability to stand without support.  Complained of feeling hot and then cold.  Appeared pale and lethargic, skin clammy and complained of difficulty breathing and was irritable. Lung sounds -clear, no wheezing despite being unable to speak more than a few words at time. Vitals at 10:00pm:  HR 62, pulse weak, O2 sat 92% (normal for her), temp 101.7F (her normal temp is 95-96).  Given a Tylenol extra strength 500mg, 2.5 mg Prednisone, increased O2 nasal canula to 3-4 L/min, and cold compresses to reduce fever and discomfort.   Vitals at 10:15p:  HR 93, O2 sat 92%, BP 131/59. Discussed going to the ER, but decided to wait until the morning if not better. Symptoms continued until ~ 2am, when she was able to fall deep asleep for 4 hours.  Awoke and felt better, able to walk, but still a bit weak and short of breath.  By noon Feb 12 she felt mostly back to normal.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Pulse abnormal, Pyrexia, Retching, Sleep disorder, Speech disorder
Clinical narrative: Injection site became pink, 3X5 inches, the day following the shot.  On 2.11.2021, about 55 hours after vaccination #2, pt developed generalized weakness, nausea, and then vomited.  She was taken to bed, where she rested poorly and only dozed off for 1-2 minutes at a time and was mumbling words.  She  continued with generalized weakness, nausea with dry heaves, a sensation of marked shortness of breath, and inability to stand without support.  Complained of feeling hot and then cold.  Appeared pale and lethargic, skin clammy and complained of difficulty breathing and was irritable. Lung sounds -clear, no wheezing despite being unable to speak more than a few words at time. Vitals at 10:00pm:  HR 62, pulse weak, O2 sat 92% (normal for her), temp 101.7F (her normal temp is 95-96).  Given a Tylenol extra strength 500mg, 2.5 mg Prednisone, increased O2 nasal canula to 3-4 L/min, and cold compresses to reduce fever and discomfort.   Vitals at 10:15p:  HR 93, O2 sat 92%, BP 131/59. Discussed going to the ER, but decided to wait until the morning if not better. Symptoms continued until ~ 2am, when she was able to fall deep asleep for 4 hours.  Awoke and felt better, able to walk, but still a bit weak and short of breath.  By noon Feb 12 she felt mostly back to normal.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Injection site became pink, 3X5 inches, the day following the shot.  On 2.11.2021, about 55 hours after vaccination #2, pt developed generalized weakness, nausea, and then vomited.  She was taken to bed, where she rested poorly and only dozed off for 1-2 minutes at a time and was mumbling words.  She  continued with generalized weakness, nausea with dry heaves, a sensation of marked shortness of breath, and inability to stand without support.  Complained of feeling hot and then cold.  Appeared pale and lethargic, skin clammy and complained of difficulty breathing and was irritable. Lung sounds -clear, no wheezing despite being unable to speak more than a few words at time. Vitals at 10:00pm:  HR 62, pulse weak, O2 sat 92% (normal for her), temp 101.7F (her normal temp is 95-96).  Given a Tylenol extra strength 500mg, 2.5 mg Prednisone, increased O2 nasal canula to 3-4 L/min, and cold compresses to reduce fever and discomfort.   Vitals at 10:15p:  HR 93, O2 sat 92%, BP 131/59. Discussed going to the ER, but decided to wait until the morning if not better. Symptoms continued until ~ 2am, when she was able to fall deep asleep for 4 hours.  Awoke and felt better, able to walk, but still a bit weak and short of breath.  By noon Feb 12 she felt mostly back to normal.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Injection site pain
Clinical narrative: After both vaccinations, the next day had a fever of 99.5 or higher, chills, body aches, injection site soreness, pain and swelling, dizziness, nauseated, fatigued, extreme headaches.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Nausea, Pain, Pyrexia, Reaction to previous exposure to any vaccine
Clinical narrative: After both vaccinations, the next day had a fever of 99.5 or higher, chills, body aches, injection site soreness, pain and swelling, dizziness, nauseated, fatigued, extreme headaches.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: After both vaccinations, the next day had a fever of 99.5 or higher, chills, body aches, injection site soreness, pain and swelling, dizziness, nauseated, fatigued, extreme headaches.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus.  Low humming in head.  Progressively got louder.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue the day after injection.  I had to go back to bed and sleep for 3-4 hours.  After that I was fine.  The news said to report anything so I did
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Lip swelling, Oral herpes, Peripheral swelling
Clinical narrative: ?Pfizer-BioNTech COVID-19 Vaccine    My upper lip began to swell  about 5 hours after the injection and after a while turned into a terrible cold sore. I haven't had a cold sore in many, many years and have only gotten one if I have been in the sun too long or have a high fever.  I called the doctor on call the following morning  and asked for a prescription of acyclovir. Starting it that late resulted in not stopping the progression of the cold sore. Also had runny nose (haven't had a cold since masking started last year), and a red swollen arm..still red and swollen two days later and a terrible headache (started the day after injection and still bad today which is two days after).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: ?Pfizer-BioNTech COVID-19 Vaccine    My upper lip began to swell  about 5 hours after the injection and after a while turned into a terrible cold sore. I haven't had a cold sore in many, many years and have only gotten one if I have been in the sun too long or have a high fever.  I called the doctor on call the following morning  and asked for a prescription of acyclovir. Starting it that late resulted in not stopping the progression of the cold sore. Also had runny nose (haven't had a cold since masking started last year), and a red swollen arm..still red and swollen two days later and a terrible headache (started the day after injection and still bad today which is two days after).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Sleep paralysis
Clinical narrative: Brain fog, fatigue increasing over 3 days resulting in 2 episodes of sleep paralysis. First lasting about 2 minutes, second lasting about 15 minutes
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Rash maculo-papular
Clinical narrative: fine maculopapular rash on right side of face, onset ~4-6 hours after vaccination, not painful or pruritic
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Hypoaesthesia, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Swelling, redness, pain, and itching from approximately 1 inch below the injection site (upper deltoid) to  just above the elbow,  distal and proximal of bicep and swollen lymph nodes under the arm.  INTERMITTENT Numbness also noted in the wrist and fingers.  Swelling, redness, and pain did not abate with administration of 600mg every 6 hours x 2 days. Symptoms still persisting. Managing with ice to take heat out of swelling, which has maintained a localized temperature between 101-102 degrees F.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Joint swelling, Lymphadenopathy
Clinical narrative: Swelling, redness, pain, and itching from approximately 1 inch below the injection site (upper deltoid) to  just above the elbow,  distal and proximal of bicep and swollen lymph nodes under the arm.  INTERMITTENT Numbness also noted in the wrist and fingers.  Swelling, redness, and pain did not abate with administration of 600mg every 6 hours x 2 days. Symptoms still persisting. Managing with ice to take heat out of swelling, which has maintained a localized temperature between 101-102 degrees F.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Arthralgia, Feeling abnormal, Headache, Nausea
Clinical narrative: Started with nausea. Then omitting (without GI disturbances). Around noon, symptoms included severe body pain, feet swelling, headache, light and noise sensitivity, foggy thought process, and facial rash with noticeable hair loss comparable to a Lupus flare prior to treatment several years ago. Low grade temperature of 99 for a few days. The symptoms have improved, however, thinking is very foggy. Physician ordered Phenergan for nausea and vomiting; as well as: hydration and rest. Ibuprofen for headache and joint and body pain. Ambien to sleep. This has been going on for four days.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Oversensing, Pain, Peripheral swelling, Photophobia, Rash
Clinical narrative: Started with nausea. Then omitting (without GI disturbances). Around noon, symptoms included severe body pain, feet swelling, headache, light and noise sensitivity, foggy thought process, and facial rash with noticeable hair loss comparable to a Lupus flare prior to treatment several years ago. Low grade temperature of 99 for a few days. The symptoms have improved, however, thinking is very foggy. Physician ordered Phenergan for nausea and vomiting; as well as: hydration and rest. Ibuprofen for headache and joint and body pain. Ambien to sleep. This has been going on for four days.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder, Vomiting
Clinical narrative: Started with nausea. Then omitting (without GI disturbances). Around noon, symptoms included severe body pain, feet swelling, headache, light and noise sensitivity, foggy thought process, and facial rash with noticeable hair loss comparable to a Lupus flare prior to treatment several years ago. Low grade temperature of 99 for a few days. The symptoms have improved, however, thinking is very foggy. Physician ordered Phenergan for nausea and vomiting; as well as: hydration and rest. Ibuprofen for headache and joint and body pain. Ambien to sleep. This has been going on for four days.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Eczema, Hand dermatitis
Clinical narrative: Discoid eczema outbreak started 1 week post shot and has continued (currently at 3 weeks post first shot). No other changes were made regarding clothing, lifestyle, diet, travel, etc. mainly has appeared on legs, hands, and wrists.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Rash, soreness, swelling, and itchiness at injection site
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Nausea
Clinical narrative: 4:45pm nausea, acute fatigue, headache  5:55pm vomiting x2, low fever, chills x 3.5 hours 9:25pm fatigue and flu-like aches only, acute symptoms lessening
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: 4:45pm nausea, acute fatigue, headache  5:55pm vomiting x2, low fever, chills x 3.5 hours 9:25pm fatigue and flu-like aches only, acute symptoms lessening
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Breast tenderness, Cough, Headache, Productive cough
Clinical narrative: This is day 6 of my 2nd Moderna vaccine.  I began coughing around 10 pm tonight. I noticed  3 days after  my 2nd vaccine that my breast are tender. And they still are. My 2nd vaccine was March 9, 2021.   Slight headache still persist.  All other body pains are gone. The cough is new. Seems like phlegm is trying to come up .
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Rash
Clinical narrative: Rash near injection site that appears approximately one week after injection. First day rash appeared with small bumps, then following days transitioned to look like a weld approximately 4 inches long and 2 inches wide around the injection site. No iching or pain.   Rash barely visible 4 days later.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Facial paralysis
Clinical narrative: Bell's Palsy; got the shot around 9 am and facial paralysis began around 9 pm.