chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: Slept all day; very tired; This is a spontaneous report from a contactable consumer (patient). A 77-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6199), via an unspecified route of administration, administered in Arm Left on 07Mar2021 08:00 as dose 1, single, and via an unspecified route of administration, administered in Arm Left on 28Mar2021 (Lot Number: EP6955) as dose 2, single for Covid-19 immunisation (Vaccinated at 77years of age). Medical history and concomitant medications were not reported. No family medical history relevant to adverse events reported. The patient slept all day, very tired on 09Mar2021. Patient reported that she received her first dose on a Sunday(07Mar2021) and was tired on Tuesday(09Mar2021) and just slept all day and by the 3rd day(10Mar2021) she was up and fine. The patient said that the tiredness was with her first dose. She stated that the tiredness was just for 1 day. Her vaccines were received 2 weeks apart and thought they were in May. Patient clarified that they were actually 3 weeks apart and she received them in Mar2021. NDC number of Pfizer Covid-19 Vaccine was Unknown. AE(s) did not required a visit to Emergency Room or Physician Office. There was no Prior Vaccinations within 4 weeks. There was no AE(s) following prior vaccinations. No relevant tests. The outcome of events were resolved on 10Mar2021.   Follow-Up (14Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Laboratory test, Palpitations, Tremor
Clinical narrative: tremors; thought it was sugar dropping and had been tested; voice changes; heart palpitations; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 73-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9266, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 17Feb2021 (age at vaccination was 73 years) as dose 1, single for COVID-19 immunization. The patient's medical history included heart surgery/triple bypass surgery (The patient had open heart surgery at age 70, 2 years prior to getting the COVID vaccines, she was 70 and it was a triple bypass surgery and she has not had any problems until she got the vaccines). The patient did not have family medical history relevant to the adverse event. The patient's concomitant medications were not reported. The patient previously took a flu shot that last fall and a month before the COVID vaccine had a pneumonia shot. There was no history of any previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines were administered on same date of the Pfizer Suspect. The patient did not receive any other vaccines the same day of either COVID vaccine. The facility where the most recent COVID-19 vaccine was administered was Pharmacy/Drug Store. The vaccine was not administered at Military Facility. The patient did have a reaction with the vaccine and still had side effects from the Pfizer shot. On an unspecified date in 2021, after the first dose, the patient experienced tremors, voice changes and heart palpitations. She stated that after the first shot she started with the tremors and voice changes, now she knows what it was like when people stutter. The heart palpitations happened the first two days of getting the first shot. The tremors were still with her and sometimes were better than other times. She thought it was her sugar dropping and had been tested and it had nothing to do with it. She saw a heart specialist because she was very concerned whether something had happened. The heart surgeon/specialist did do some tests and he didn't see anything that would have indicated any trauma to her heart. The adverse events required a visit to Physician Office. The adverse events did not require a visit to the Emergency Room. The patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6202, Expiration date: unknown) via an unspecified route of administration, administered in right arm on 10Mar2021 (age at vaccination was 73 years) as dose 2, single for COVID-19 immunization. The outcome of the events was not resolved.  Follow-up attempts are completed. No further information is expected.  Follow-up (16Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: She mentioned that she had no issues with her 1st dose other than a sore arm; This is a spontaneous report from a contactable consumer or other non hcp. A 35-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) via an unspecified route of administration on 18Jun2021 (at the age of 35 years old) (Batch/Lot Number: EW0167) as single dose for COVID-19 immunisation. Medical history included migraine, anaphylactic reaction due to selfish, 3 months postpartum. Concomitant medications included vitamin d3; ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS). On an unspecified date the patient experienced sore arm. She mentioned that she had no issues with her 1st dose other than a sore arm but had problems with her 2nd dose. The patient was asked if her side effects from the vaccine would affect her baby as she was breast feeding. The outcome of the event was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Sensory loss
Clinical narrative: Caller received his second dose of the Pfizer COVID vaccine and is experiencing numbness in his legs / numbness in his feet / numbness in his knees; when he pinches his skin in his left leg and some parts of his body, he doesn't feel the pinch; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number: EW0196, Expiration Date was not reported), via an unspecified route of administration on an unspecified date (at the age of 78-years-old) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 (Lot number: EW0196) received on an unspecified date (at the age of 78-years-old) for COVID-19 immunization. Patient states that, the person at the pharmacy told him to mention that he was calling in regards to the Pfizer BioNTech COVID vaccine EUA although his card after both doses has EW0196. Patient received his second dose of the Pfizer COVID vaccine and is experiencing numbness in his legs, feet, and knees. Patient states when pinching his left leg and other parts of his body he doesn't feel the pinch. Patient would like to know if this is a common side effect, if there have been any other reports of this side effect, if this side effect will go away in a couple weeks on its own without having to go get medication for it. No information in PI regarding numbness in legs, feet, and knees being reported as a side effect, when pinching the left leg and other parts of the body not feeling the pinch. Patient confirms he received the Pfizer Covid 19 Vaccine.  Additonal information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Erythema, Joint swelling, Peripheral swelling
Clinical narrative: Has swelling of the arm where the second dose vaccine was administered; Further down in the fold of arm at elbow joint is redness and swelling; Further down in the fold of arm at elbow joint is redness and swelling; Further down in the fold of arm at elbow joint is redness and swelling was reported as worsened/11Jul2021 and is worsening; This is a spontaneous report from a contactable consumer. A female 74-year-old received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection; Batch/Lot Number: EW0173), dose 2 via an unspecified route of administration, administered in Arm Left on 08Jul2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection; Batch/Lot Number: EW0172) on 17Jun2021 via an unspecified route of administration, administered in Arm Left for covid-19 immunisation. On 11Jul2021 the consumer calling for her sister. The caller sister received the second dose Pfizer BIONTECH Vaccine on 08Jul2021. The caller was calling to report her sister side effects that the patient was showing today and see what the caller can do. The caller wanted to know how to treat the side effects the patient was having Reporter details: The caller did not wish to provide an email address. The patient had swelling of the arm that the second dose Pfizer BIONTECH Vaccine was administered in. Further down in the fold of arm, at elbow joint, was redness and swelling was reported as worsened. Has swelling of the arm that the second dose Vaccine was administered in: The caller states apparently this began yesterday, 11Jul2021 and was worsening. Further down in the fold of arm, at elbow joint, was redness and swelling this began yesterday, 11Jul2021 and was persisting. The caller does not wish to provide HCP name, address, telephone number or email. The caller states she was calling the primary care physician when she hangs up with the DSU Agent. When asked to complete an additional questionnaire the caller replies no, no not really. The caller states she really wanted recommendations on treating the patient redness and swelling. The caller appreciates the DSU Agent telling the caller to consult the doctor for treatment and documenting the side effects. The outcome of the event further down in the fold of arm, at elbow joint, was redness and swelling was reported as worsened was unknown and not resolved for other events.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Diarrhoea, Musculoskeletal stiffness, Pain, Pyrexia
Clinical narrative: Cough; Pain in her body; She couldn't close her hand; Diarrhea; Vomit; She had a fever for 3 days; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6201) via an unspecified route of administration on 07Apr2021 in left arm as dose 1 single (at the age of 53-year-old) for COVID-19 immunization. Medical history included Covid-19, issue with immunology. Concomitant medications were not reported. Confirmed the immunology condition was prior to vaccine. Patient clarified she had Covid twice prior to vaccine, had symptoms for 5 months, off and on, reason she went to immunology doctor, studied why she had Covid so many times. Patient stated that after first dose of the vaccine she had a fever for 3 days, cough, pain in her body, states she had no pain in her arm, states she couldn't close her hand, she had diarrhea and vomit for 3-4 days, exact dates unknown, states this lasted a few days. Patient was scheduled to receive the second dose on 28Apr2021, stated she was unable to take it due to immunology problem, wanted to know if it is it okay to get 2nd dose even though it has been 90 days since taking first dose. Patient had been advised by HCP to receive the second dose >90 days from first dose of Pfizer Covid-19 vaccine Patient was asking if that is okay to receive the second dose within that time frame.  Patient was asking if she can restart the vaccination series. Stated she does have antibodies for Covid, stated her doctor told her she had great antibodies right now. The outcome of the events was recovered on an unspecified date.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Cough; Pain in her body; She couldn't close her hand; Diarrhea; Vomit; She had a fever for 3 days; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6201) via an unspecified route of administration on 07Apr2021 in left arm as dose 1 single (at the age of 53-year-old) for COVID-19 immunization. Medical history included Covid-19, issue with immunology. Concomitant medications were not reported. Confirmed the immunology condition was prior to vaccine. Patient clarified she had Covid twice prior to vaccine, had symptoms for 5 months, off and on, reason she went to immunology doctor, studied why she had Covid so many times. Patient stated that after first dose of the vaccine she had a fever for 3 days, cough, pain in her body, states she had no pain in her arm, states she couldn't close her hand, she had diarrhea and vomit for 3-4 days, exact dates unknown, states this lasted a few days. Patient was scheduled to receive the second dose on 28Apr2021, stated she was unable to take it due to immunology problem, wanted to know if it is it okay to get 2nd dose even though it has been 90 days since taking first dose. Patient had been advised by HCP to receive the second dose >90 days from first dose of Pfizer Covid-19 vaccine Patient was asking if that is okay to receive the second dose within that time frame.  Patient was asking if she can restart the vaccination series. Stated she does have antibodies for Covid, stated her doctor told her she had great antibodies right now. The outcome of the events was recovered on an unspecified date.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Head discomfort, Headache, Illness, Influenza
Clinical narrative: Sick since getting first dose; I came down with flu symptoms in the middle of the night.; Body aches; headache; throat swollen and scratchy.  Voice.; throat swollen and scratchy.  Voice.; My head is pumped up.; Sore throat; Throat swollen scratchy and hardly talk.; This is a spontaneous report received from a contactable consumer (patient). A 55-Year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on 03Jul2021 as dose 1 single (at the age of 55-Year-old) for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient stated that she was sick since getting first dose on 03Jul2021. On an unspecified date in 2021, She came down with flu symptoms in the middle of the night.  Body aches, headache around Thursday mild throat swollen and scratchy  Voice.  Her head was pumped up. Taking Mucinex D, Aleve, Alternating Tylenol, and Night Quil. Barely Blood Boogers. Symptomatic when the medication wears out. Sore throat started third day. All of this triggered by that vaccine. Throat swollen scratchy and hardly talk. Got worse over the days. Patient was asking so you have the sore throat as a reported. Patient indicates she does not have a HCP. Patient previously gal went day by day. The outcome of the events was unknown.  Information about batch/lot number has been requested
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort, Oropharyngeal pain, Pain, Pharyngeal swelling
Clinical narrative: Sick since getting first dose; I came down with flu symptoms in the middle of the night.; Body aches; headache; throat swollen and scratchy.  Voice.; throat swollen and scratchy.  Voice.; My head is pumped up.; Sore throat; Throat swollen scratchy and hardly talk.; This is a spontaneous report received from a contactable consumer (patient). A 55-Year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on 03Jul2021 as dose 1 single (at the age of 55-Year-old) for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient stated that she was sick since getting first dose on 03Jul2021. On an unspecified date in 2021, She came down with flu symptoms in the middle of the night.  Body aches, headache around Thursday mild throat swollen and scratchy  Voice.  Her head was pumped up. Taking Mucinex D, Aleve, Alternating Tylenol, and Night Quil. Barely Blood Boogers. Symptomatic when the medication wears out. Sore throat started third day. All of this triggered by that vaccine. Throat swollen scratchy and hardly talk. Got worse over the days. Patient was asking so you have the sore throat as a reported. Patient indicates she does not have a HCP. Patient previously gal went day by day. The outcome of the events was unknown.  Information about batch/lot number has been requested
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash; onset of rash on 06Jul2021 that has worsened; This is a spontaneous report from a contactable consumer or other non-HCP (patient).   A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8737), dose 1 via an unspecified route of administration, administered in Arm Right on 18Jun2021 (around 13:30-14:00, around 15:00) (at the age of 67-years-old) as single dose for covid-19 immunisation. The patient's medical history included ongoing arthritis, ongoing prior to any doses of Pfizer-BioNTech Covid-19 Vaccine, ongoing diabetes, ongoing cholesterol, bronchitis, sinus infection, rash, diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities and obesity (start date was unknown, and unknown if ongoing). She thinks they said she has Bronchitis, but it's not really bad; she has an inhaler, but she never has to use it. She thinks she has had maybe a sinus infection or something like that. She has history of having had a rash that comes up on her hand and sometimes on legs but went to dermatologist gave her some cream that cleared it up. The patient had no family medical history relevant to adverse event. The patient's concomitant medications included simvastatin taken for cholesterol started years ago, enalapril taken for diabetes mellitus started years ago. No additional vaccines administered on same date of the Pfizer suspect. No prior Vaccinations (within 4 weeks) or any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No adverse events following prior vaccinations. The patient previously took flu shot, she just always gets the flu shot every year and never had any reaction with those. The patient took vaccine to help prevent the Covid, where she wouldn't be so sick if she got it. The patient received the first dose of the Pfizer Covid 19 vaccine on 18Jun2021. On 06Jul2021, Tuesday, developed a rash. She asked could it be related to the first dose. She initially reported having had no reaction to the first dose of the Pfizer-BioNTech Covid-19 Vaccine shot but later reported having onset of rash on 06Jul2021 that has worsened. She asked for further information on side effects, rash, and if she should go to her doctor about this. The rash started out small on 06Jul2021, now rash has worsened and keeps spreading. She does not know what the rash was, but it was irritating, going all across her back and all up under her breast. She does not know if rash was from the first dose of Pfizer-BioNTech Covid-19 Vaccine and just didn't show up until later. The adverse event not required emergency room and physician office visit. No relevant tests were done. Last Friday (09Jul2021), the patient received the second dose (of bnt162b2). The patient has been administered both doses of the Pfizer-BioNTech Covid-19 Vaccine. The outcome of the event was not recovered.  Follow up information has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Product administered at inappropriate site
Clinical narrative: numbness; tingling in her arm which radiated to her hand.; The injection was maybe 3 inches down from her left shoulder.  She is not sure if given in the muscle.; This is a spontaneous report from a contactable consumer or other non-hcp (Patient).  A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EW0196) via an unspecified route of administration (age at vaccination 45-year) in Left Arm on 21Jun2021 around 17:00-17:30 or 17:15 as dose 1, single for COVID-19 immunization.Medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities, diabetes, obesity, upper respiratory tract infection from Nov2019.The patient's concomitant medications were not reported.The patient previously took omega XL and fish oil (6-7 years ago).There was no prior Vaccinations within 4 weeks.On 27Jun2021 the patient experienced numbness and tingling in her arm which radiated to her hand. It was reported that the injection was maybe 3 inches down from her left shoulder. she was not sure if given in the muscle. The reporter was at the pharmacy seeking guidance whether she should receive the second of the Pfizer COVID-19 vaccine or not. She got first shot on 21Jun2021 and on 27Jun2021, her arm and hand in the side it was given became numb and tingly. It was not as bad as it was. Her hand was still tingly. She came to get second shot and pharmacist said she needs to find out if it was ok to receive second dose. The reporter mentioned she doesn't have an HCP and can't afford to go the emergency room because she does not have insurance. She was a CNA. She does not have a primary care provider. She called where she got the shot last Friday past. The pharmacist said they probably hit a nerve or something. Her whole left arm in the beginning was numb for 3-4 days and then just her hand. If she touches fingers together with thumb, she can still feel tingly sensation, but it was not as bad. It felt like when you lay on your hand like when falling asleep. It was not as aggravating as it was. The injection was maybe 3 inches down from her left shoulder. She was not sure if given in the muscle. She thinks she had COVID in Nov2019, and at the time they did not know if it was COVID and called it an upper respiratory infection. On 06Jun2021, she thought she got the new strand and after she got well, she went ahead and got the vaccine because she did not want to get it again. She does not take other medication unless it may be an Advil or Ibuprofen and was not taking any when she got the vaccine. Therapeutic measures were taken as a result of the adverse events. The patient was recovering from numbness and tingling in her arm which radiated to her hand, while the outcome of another event was unknown.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Blood pressure measurement, Dizziness, Feeling abnormal, Headache
Clinical narrative: Random headaches on daily basis; my cycle is back in full swing day after my second dose; Bottom number of BP rising; Swelling in feet and legs.; Lightheartedness; I really feel that something is just not right; This is a spontaneous report from a contactable consumer (patient). A 52-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot umber: EV0164, patient was 51-year-old and not pregnant at the time of vaccination) via an unspecified route of administration, administered in arm left on 23Mar2021 as dose 2, single for COVID-19 immunization. Medical history included ADHD, bipolar, depression, anxiety, colon cancer, migraines, bananas tree nuts, premenopausal. Concomitant medications included amlodipine besilate (5mg); ascorbic acid, ferrous fumarate (VITRON C) both was taken within 2 weeks of vaccination. The patient previously took dilantin [phenytoin] and experienced Allergies. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot umber: EN6208) via an unspecified route of administration, administered in arm left on an unspecified date as dose 1, single for COVID-19 immunization. Patient does not receive other vaccine in four weeks. Reported that never had an issue with bottom number before only top. No COVID prior vaccination. Patient was not tested COVID post vaccination. On 16Apr2021 at 12:00, the patient experienced random headaches on daily basis, my cycle is back in full swing day after my second dose, bottom number of bp rising, swelling in feet and legs, lightheartedness, I really feel that something is just not right. The patient underwent lab tests and procedures which included blood pressure measurement resulted as bp rising on 16Apr2021 as bottom number of BP rising. Patient received treatment for events and increased BP medication. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Peripheral swelling
Clinical narrative: Random headaches on daily basis; my cycle is back in full swing day after my second dose; Bottom number of BP rising; Swelling in feet and legs.; Lightheartedness; I really feel that something is just not right; This is a spontaneous report from a contactable consumer (patient). A 52-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot umber: EV0164, patient was 51-year-old and not pregnant at the time of vaccination) via an unspecified route of administration, administered in arm left on 23Mar2021 as dose 2, single for COVID-19 immunization. Medical history included ADHD, bipolar, depression, anxiety, colon cancer, migraines, bananas tree nuts, premenopausal. Concomitant medications included amlodipine besilate (5mg); ascorbic acid, ferrous fumarate (VITRON C) both was taken within 2 weeks of vaccination. The patient previously took dilantin [phenytoin] and experienced Allergies. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot umber: EN6208) via an unspecified route of administration, administered in arm left on an unspecified date as dose 1, single for COVID-19 immunization. Patient does not receive other vaccine in four weeks. Reported that never had an issue with bottom number before only top. No COVID prior vaccination. Patient was not tested COVID post vaccination. On 16Apr2021 at 12:00, the patient experienced random headaches on daily basis, my cycle is back in full swing day after my second dose, bottom number of bp rising, swelling in feet and legs, lightheartedness, I really feel that something is just not right. The patient underwent lab tests and procedures which included blood pressure measurement resulted as bp rising on 16Apr2021 as bottom number of BP rising. Patient received treatment for events and increased BP medication. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Asthenia, Balance disorder, Blood blister, Dyspnoea
Clinical narrative: I got a blood blisters on my mouth and it is after 6 week I still have a spot on my lips where blood blister; I had loss of balance; I could not walk; I was short of breath/Trouble breathing; I had blotting stomach; I had pain in my head; I had trouble sleeping; I was very weak; I have a problem with my memory; I was so ill; I feared I would die I was so sick; This is a spontaneous report from a contactable consumer or other non hcp. A 89-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: ER8733) via an unspecified route of administration on 06Apr2021 at the age of (89-years-old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient experienced that she had loss of balance, could not walk, short of breath, blotting stomach and trouble breathing, pains in my head and trouble sleeping and she got a blood blisters on her mouth and it was after 6 week she still had a spot on her lips where blood blister was it was not painful, but she was very weak. She had a problem with her memory. She took Benadryl first and it did not really help after 3 or 4 weeks and then did not help she visited the emergency room for two times and later she went to doctor cabin for several times. This was how ill she was and eventually she had problems with Prednisone (Not clear and not clarified). She informed that she was so ill and did not take the second shot. The patient stated that she was very very ill, and she and her husband went to cemetery, a place where she could be buried because she feared she would die she was so sick, and her husband had a shot, and he was absolutely fine. The patient reported that there were people like who did not help and actually made her very ill maybe it was her age maybe it was her chemistry but it was definitely not for every single person. The patient finished taking drugs as she took them for a period of time (completed the course). She was not taking any drug and she was recovered, and she was doing better and her health was better. The patient took treatment for all the events. The outcome of the event the problem with her memory was not resolved whereas other events were resolved on an unknown date.  Follow-up attempts are completed. No further information is expected.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Fear of death, Gait disturbance, Headache, Illness, Insomnia
Clinical narrative: I got a blood blisters on my mouth and it is after 6 week I still have a spot on my lips where blood blister; I had loss of balance; I could not walk; I was short of breath/Trouble breathing; I had blotting stomach; I had pain in my head; I had trouble sleeping; I was very weak; I have a problem with my memory; I was so ill; I feared I would die I was so sick; This is a spontaneous report from a contactable consumer or other non hcp. A 89-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: ER8733) via an unspecified route of administration on 06Apr2021 at the age of (89-years-old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient experienced that she had loss of balance, could not walk, short of breath, blotting stomach and trouble breathing, pains in my head and trouble sleeping and she got a blood blisters on her mouth and it was after 6 week she still had a spot on her lips where blood blister was it was not painful, but she was very weak. She had a problem with her memory. She took Benadryl first and it did not really help after 3 or 4 weeks and then did not help she visited the emergency room for two times and later she went to doctor cabin for several times. This was how ill she was and eventually she had problems with Prednisone (Not clear and not clarified). She informed that she was so ill and did not take the second shot. The patient stated that she was very very ill, and she and her husband went to cemetery, a place where she could be buried because she feared she would die she was so sick, and her husband had a shot, and he was absolutely fine. The patient reported that there were people like who did not help and actually made her very ill maybe it was her age maybe it was her chemistry but it was definitely not for every single person. The patient finished taking drugs as she took them for a period of time (completed the course). She was not taking any drug and she was recovered, and she was doing better and her health was better. The patient took treatment for all the events. The outcome of the event the problem with her memory was not resolved whereas other events were resolved on an unknown date.  Follow-up attempts are completed. No further information is expected.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Memory impairment
Clinical narrative: I got a blood blisters on my mouth and it is after 6 week I still have a spot on my lips where blood blister; I had loss of balance; I could not walk; I was short of breath/Trouble breathing; I had blotting stomach; I had pain in my head; I had trouble sleeping; I was very weak; I have a problem with my memory; I was so ill; I feared I would die I was so sick; This is a spontaneous report from a contactable consumer or other non hcp. A 89-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: ER8733) via an unspecified route of administration on 06Apr2021 at the age of (89-years-old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient experienced that she had loss of balance, could not walk, short of breath, blotting stomach and trouble breathing, pains in my head and trouble sleeping and she got a blood blisters on her mouth and it was after 6 week she still had a spot on her lips where blood blister was it was not painful, but she was very weak. She had a problem with her memory. She took Benadryl first and it did not really help after 3 or 4 weeks and then did not help she visited the emergency room for two times and later she went to doctor cabin for several times. This was how ill she was and eventually she had problems with Prednisone (Not clear and not clarified). She informed that she was so ill and did not take the second shot. The patient stated that she was very very ill, and she and her husband went to cemetery, a place where she could be buried because she feared she would die she was so sick, and her husband had a shot, and he was absolutely fine. The patient reported that there were people like who did not help and actually made her very ill maybe it was her age maybe it was her chemistry but it was definitely not for every single person. The patient finished taking drugs as she took them for a period of time (completed the course). She was not taking any drug and she was recovered, and she was doing better and her health was better. The patient took treatment for all the events. The outcome of the event the problem with her memory was not resolved whereas other events were resolved on an unknown date.  Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Illness, Pityriasis rosea, Pyrexia, Rash
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 43-years-old non-pregnant female patient second dose received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0164, Expiry date: not reported), via an unspecified route of administration on 28May2021(age at vaccination: 43-year-old) as dose 2, single for covid-19 immunization. Medical history was none. The patient had no known allergies. The patient's concomitant medications were not reported. Previously the patient received first dose of bnt162b2 (Lot number EW0171), on 07May2021 for covid-19 immunization. The patient was not diagnosed with covid prior to vaccination and was not tested for covid-19 post vaccination. The patient did not receive any other vaccine within four weeks and did not receive any other medications in two weeks after the vaccination. On 29May2021 (following day after vaccine), the patient had chills and fever which subsided on 30May2021. And around 3 weeks later on 14Jun2021, the patient had noticed an oval rash on her chest with some discoloration, resembled ring worm. A few weeks after that her body developed little rashes on chest, trunk and legs. So she went to the dermatologist on Friday 09Jul2021 and was diagnosed with Pityriasis Roses. She was asked if she recently had a fever or was sick, she didn't remember that she had recently received the covid 19 vaccine and had a fever after until she got home. The patient did not receive any treatment for the events. The patient visited doctor or other healthcare professional office/clinic visit due to adverse events. The events were non-serious. The outcome of the events was recovering.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 43-years-old non-pregnant female patient second dose received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0164, Expiry date: not reported), via an unspecified route of administration on 28May2021(age at vaccination: 43-year-old) as dose 2, single for covid-19 immunization. Medical history was none. The patient had no known allergies. The patient's concomitant medications were not reported. Previously the patient received first dose of bnt162b2 (Lot number EW0171), on 07May2021 for covid-19 immunization. The patient was not diagnosed with covid prior to vaccination and was not tested for covid-19 post vaccination. The patient did not receive any other vaccine within four weeks and did not receive any other medications in two weeks after the vaccination. On 29May2021 (following day after vaccine), the patient had chills and fever which subsided on 30May2021. And around 3 weeks later on 14Jun2021, the patient had noticed an oval rash on her chest with some discoloration, resembled ring worm. A few weeks after that her body developed little rashes on chest, trunk and legs. So she went to the dermatologist on Friday 09Jul2021 and was diagnosed with Pityriasis Roses. She was asked if she recently had a fever or was sick, she didn't remember that she had recently received the covid 19 vaccine and had a fever after until she got home. The patient did not receive any treatment for the events. The patient visited doctor or other healthcare professional office/clinic visit due to adverse events. The events were non-serious. The outcome of the events was recovering.
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: might be something in that vaccine that treat pruritus; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that: A 78-years-old male patient received first dose of bnt162b2 (BNT162B2, Solution injection; Batch/Lot Number: EW0162), via an unspecified route of administration, administered in Arm Right on an unspecified date as single dose and received the second dose of bnt162b2 (BNT162B2, Solution injection; Batch/Lot Number: EW0196), via an unspecified route of administration, administered in Arm Right on 10Jun2021 at 15:00 as single dose for covid-19 immunisation.  Medical history included pruritus for several years, erythema and redness for 3 or 4 years.  The patient's concomitant medications were not reported. The patient reported that when he got his vaccine my first vaccine shot around 04Jun it was on his left arm, it basically was to get his shot up and then using Calamine lotion (Treatment) because of the itch and redness and it had been there for 3 or 4 years, ok when he got his first vaccine which was 3 or 4 days the itch started disappearing and the redness disappeared and by the time he got his second vaccine it totally left out of his arm and no itch all he have is a little tissue scar. There has to be something in that vaccine to treat pruritus. He stated that he don't know if Pfizer is aware of this or not. Like he was saying it 3 or 4 days it started disappearing and he have been treating it for 3 or 4 years and he had it years ago and it came back to same spot and when he got that vaccine the first vaccine like a say it, it started disappearing in 3 or 4 days and by the time he got his second shot it totally disappeared, and all is there is a tissue scar on his arm. He stated it cleared up and it went all the way now and all you can see is you have to take a magnifying glass it was a spot as big as a eye glass on his arm and its been there for 3 or 4 years and like he said when he got his first shot within 3 or 4 days, the itch started leaving and the redness started leaving it like sand paper, its like a a raw meat in a steak and by the time he think what 10 days or 14 days after his second shot, when he got his second shot it totally disappeared that was he think 19Jun of he think and its totally gone. So, you may want to do some research on that might be something in that vaccine that treats pruritus because pruritus is a battle. So this was something people told him that he need to report this to Pfizer, might be something in that vaccine that treat pruritus. The outcome of the event was unknown.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Decreased appetite, Eye pruritus, Headache, Hypoaesthesia
Clinical narrative: Body was itching; Headache; Body is aching; Body pain; Numbness; Rash is still on my face and my chest; Eyes are red and itchy; Eyes are red and itchy; I have to be shaking shaking my self something; Joints are hurting me; Face is little bit swollen; Throat, I can't even eat anything; Loose appetite; This is a spontaneous report from a contactable consumer (Patient reported for herself). A 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EW0187) via an unspecified route of administration, administered in arm left on 08Jul2021 at 12:10 pm (at the age of 51-year-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient had no medical history related to event. The patient had no Family medical history related to event. There were no concomitant medications. No vaccination received 4 weeks prior to COVID 19 Vaccine. On 08Jul2021, at night after the vaccination, the patient experienced body was itching, headache and body was aching, body pain. On an unspecified date in Jul2021, it would be 10 to 12 hours time after the vaccination, the patient experienced, joints hurting, face was little bit swollen, throat she cannot even eat anything, loose appetite, numbness, rash still on her face and her chest, eyes are red and itchy. The clinical course of the events as follows: she stated she took the first dose of Pfizer Vaccine on Thursday on 8thJul. The very day she took it, and she waited there for 15 minutes and then she went to home in the night. She could believe it would be 10 to 12 hours time, I was (incomplete sentence). She felt that her body was itching and the whole night she felt headache and her body started aching. She continued having headache, body ache, and even her joints were hurting, it came to a point, her thigh, the leg to the bottom of her buttock was trying to be numb and she had to be shaking herself something. She stated that she put alcohol to stop the itching and then she takes Tylenol for headache almost every 4 hours, she said that she put alcohol on her face, the part which was itching the most and because of that alcohol she put it, her skin turned black. Her face was little bit swollen and her throat, she cannot even eat anything and she loose appetite. She stated the numbness would not stay for long but the itchy and rash was still on her face and her chest. She stated that she does not know if she is supposed to go to the ER. She stated that her second dose is supposed to be on 29thJul. She reported basically, it stays the same as the first time she experienced the rashes, it was the same and not going away and it was not getting worst either. No Investigation Assessment was provided. The outcome of the events body was itching, and rash was still on her face and chest was not resolved and the outcome of the other events was unknown at the time of this report.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular hyperaemia, Pain, Pharyngeal swelling, Pruritus, Rash
Clinical narrative: Body was itching; Headache; Body is aching; Body pain; Numbness; Rash is still on my face and my chest; Eyes are red and itchy; Eyes are red and itchy; I have to be shaking shaking my self something; Joints are hurting me; Face is little bit swollen; Throat, I can't even eat anything; Loose appetite; This is a spontaneous report from a contactable consumer (Patient reported for herself). A 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EW0187) via an unspecified route of administration, administered in arm left on 08Jul2021 at 12:10 pm (at the age of 51-year-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient had no medical history related to event. The patient had no Family medical history related to event. There were no concomitant medications. No vaccination received 4 weeks prior to COVID 19 Vaccine. On 08Jul2021, at night after the vaccination, the patient experienced body was itching, headache and body was aching, body pain. On an unspecified date in Jul2021, it would be 10 to 12 hours time after the vaccination, the patient experienced, joints hurting, face was little bit swollen, throat she cannot even eat anything, loose appetite, numbness, rash still on her face and her chest, eyes are red and itchy. The clinical course of the events as follows: she stated she took the first dose of Pfizer Vaccine on Thursday on 8thJul. The very day she took it, and she waited there for 15 minutes and then she went to home in the night. She could believe it would be 10 to 12 hours time, I was (incomplete sentence). She felt that her body was itching and the whole night she felt headache and her body started aching. She continued having headache, body ache, and even her joints were hurting, it came to a point, her thigh, the leg to the bottom of her buttock was trying to be numb and she had to be shaking herself something. She stated that she put alcohol to stop the itching and then she takes Tylenol for headache almost every 4 hours, she said that she put alcohol on her face, the part which was itching the most and because of that alcohol she put it, her skin turned black. Her face was little bit swollen and her throat, she cannot even eat anything and she loose appetite. She stated the numbness would not stay for long but the itchy and rash was still on her face and her chest. She stated that she does not know if she is supposed to go to the ER. She stated that her second dose is supposed to be on 29thJul. She reported basically, it stays the same as the first time she experienced the rashes, it was the same and not going away and it was not getting worst either. No Investigation Assessment was provided. The outcome of the events body was itching, and rash was still on her face and chest was not resolved and the outcome of the other events was unknown at the time of this report.