chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hyperhidrosis, Muscular weakness, Myalgia, Pain
Clinical narrative: Difficulty breathing; Pain at the injection site; Tired; Muscle pain; Chills; Joint pain; feeling very weak; At the injection site she had swelling and redness that went down her arm that lasted 2 weeks.; At the injection site she had swelling and redness that went down her arm that lasted 2 weeks.; She felt a little pain; rash or redness; Got the sweats after the chills; having weakness in her legs, the muscles and joints.; Having weakness in her legs, the muscles and joints.; This is a spontaneous report from a contactable consumer (patient). A 86-years-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EWO162), dose 1 via an unspecified route of administration,  on 22Apr2021 13:00 as 1st dose, single (at the age of 86-years-old) dose on left arm for COVID-19 immunization. Medical history included prosthesis on the right arm 7-8 years ago, that is why she gets everything done on the left arm. And got COVID-19 virus, then she got the antibodies intravenously applied. The patient's concomitant medications were not reported and she would rather not give her list of medications. On 22Apr2021, after vaccination, the  patient had reaction. The  patient also had pain at the injection site injection, site swelling and redness that went down her arm, was tired, had muscle pain, chills, joint pain, difficulty breathing and weakness in joint. After getting the shot she felt a little pain, then a rash or redness that kept growing and growing; she felt it was little swollen. The patient stated that she got so chilled she had to put on 4 layers of clothing and 2 blankets. Then she got the sweats after the chills, so much that you could wring it out of her clothing. She reports feeling very weak and had the chills, then she went to bed and woke up with the sweats. The patient also having weakness in her legs, the muscles and joints. It was reported that everything went away after about a week, gently. At the injection site she had swelling and redness that went down her arm that lasted 2 weeks and went away. The patient furthermore stated that  "she is not going bald but, losing her hair a little and the color of her hair changed from dark brown to all white now, it happens when one gets old they shrink, go bald or lose your hair". The patient was  scheduled to receive second shot on 12May2021 at 11:00. She went to her pulmonary doctor due to having trouble breathing. They increased her medication for her breathing which helped a lot. Therapeutic measures were taken with medications for dyspnea. The patient recovered from all the events.  No follow-up attempts are needed. No further information is expected.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Difficulty breathing; Pain at the injection site; Tired; Muscle pain; Chills; Joint pain; feeling very weak; At the injection site she had swelling and redness that went down her arm that lasted 2 weeks.; At the injection site she had swelling and redness that went down her arm that lasted 2 weeks.; She felt a little pain; rash or redness; Got the sweats after the chills; having weakness in her legs, the muscles and joints.; Having weakness in her legs, the muscles and joints.; This is a spontaneous report from a contactable consumer (patient). A 86-years-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EWO162), dose 1 via an unspecified route of administration,  on 22Apr2021 13:00 as 1st dose, single (at the age of 86-years-old) dose on left arm for COVID-19 immunization. Medical history included prosthesis on the right arm 7-8 years ago, that is why she gets everything done on the left arm. And got COVID-19 virus, then she got the antibodies intravenously applied. The patient's concomitant medications were not reported and she would rather not give her list of medications. On 22Apr2021, after vaccination, the  patient had reaction. The  patient also had pain at the injection site injection, site swelling and redness that went down her arm, was tired, had muscle pain, chills, joint pain, difficulty breathing and weakness in joint. After getting the shot she felt a little pain, then a rash or redness that kept growing and growing; she felt it was little swollen. The patient stated that she got so chilled she had to put on 4 layers of clothing and 2 blankets. Then she got the sweats after the chills, so much that you could wring it out of her clothing. She reports feeling very weak and had the chills, then she went to bed and woke up with the sweats. The patient also having weakness in her legs, the muscles and joints. It was reported that everything went away after about a week, gently. At the injection site she had swelling and redness that went down her arm that lasted 2 weeks and went away. The patient furthermore stated that  "she is not going bald but, losing her hair a little and the color of her hair changed from dark brown to all white now, it happens when one gets old they shrink, go bald or lose your hair". The patient was  scheduled to receive second shot on 12May2021 at 11:00. She went to her pulmonary doctor due to having trouble breathing. They increased her medication for her breathing which helped a lot. Therapeutic measures were taken with medications for dyspnea. The patient recovered from all the events.  No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Heart rate increased, Hypersensitivity, Hypoaesthesia
Clinical narrative: half of her body she is feeling numb; Dizzy; cannot see well from the right side of her right eye; heart is beating faster; can barely talk; throat closing; Allergic reaction; her throat clogged; difficulty breathing; Face swell; This is a spontaneous report from a contactable consumer. This consumer reported for a 37-year-old female patient (reporter's sister) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in arm left on 08May2021 12:15 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included allergy to penicillin. Concomitant medications included paracetamol (TYLENOL) taken for stomach hurt from 07May2021 to an unspecified stop date. The reporter called on behalf of the patient, that the patient got the vaccine on Saturday, 08May2021 at 12:15, so right after the administration of the first dose, the patient had allergic reaction, her throat clogged, throat was getting closed, had difficulty breathing and then her face started to swell, and the patient was administered or took an anti-allergic medicine and was sent to emergency room and they said it was an allergic reaction. The patient was still feeling bad. The reporter provided the important safety information, and the reporter were also asking why the common side effects was not advised before the administration. The reporter and patient went to the emergency room and was there until 1:00 am on Sunday, 09May2021. The caller was never admitted as a patient into the hospital. On 09May2021, when the patient left the emergency room, patient started that she was feeling numb on half of her body, started feeling dizzy, couldn't see well from her right-side eye, her heart was beating faster, and she can barely talk. The patient being able to barely talk comes and goes. The patient received the treatment in the emergency room. Reporter stated, "It's for side effects for vaccine she had allergies to the vaccine." The outcome of the events was allergic reaction, her throat clogged, difficulty breathing, face swell, can barely talk, throat closing unknown. The outcome of the events was half of her body she is feeling numb, dizzy, cannot see well from the right side of her right eye, heart is beating faster was not resolved.   No follow-up attempts are needed. information about lot/batch number cannot be obtained.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Mutism, Swelling face, Throat tightness, Upper respiratory tract congestion, Visual impairment
Clinical narrative: half of her body she is feeling numb; Dizzy; cannot see well from the right side of her right eye; heart is beating faster; can barely talk; throat closing; Allergic reaction; her throat clogged; difficulty breathing; Face swell; This is a spontaneous report from a contactable consumer. This consumer reported for a 37-year-old female patient (reporter's sister) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in arm left on 08May2021 12:15 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included allergy to penicillin. Concomitant medications included paracetamol (TYLENOL) taken for stomach hurt from 07May2021 to an unspecified stop date. The reporter called on behalf of the patient, that the patient got the vaccine on Saturday, 08May2021 at 12:15, so right after the administration of the first dose, the patient had allergic reaction, her throat clogged, throat was getting closed, had difficulty breathing and then her face started to swell, and the patient was administered or took an anti-allergic medicine and was sent to emergency room and they said it was an allergic reaction. The patient was still feeling bad. The reporter provided the important safety information, and the reporter were also asking why the common side effects was not advised before the administration. The reporter and patient went to the emergency room and was there until 1:00 am on Sunday, 09May2021. The caller was never admitted as a patient into the hospital. On 09May2021, when the patient left the emergency room, patient started that she was feeling numb on half of her body, started feeling dizzy, couldn't see well from her right-side eye, her heart was beating faster, and she can barely talk. The patient being able to barely talk comes and goes. The patient received the treatment in the emergency room. Reporter stated, "It's for side effects for vaccine she had allergies to the vaccine." The outcome of the events was allergic reaction, her throat clogged, difficulty breathing, face swell, can barely talk, throat closing unknown. The outcome of the events was half of her body she is feeling numb, dizzy, cannot see well from the right side of her right eye, heart is beating faster was not resolved.   No follow-up attempts are needed. information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (age at the time of vaccination was 62-year-old) as single dose for COVID-19 immunization. Medical history included asthma. Concomitant medications included Singulair. The patient stated that she got the COVID-19 shot a couple weeks ago, had a 102.3 fever on an unspecified date. The patient stated she was concerned about shortness of breath that she experienced for 12 hours after. Wanted to know if she could do anything else besides her inhalers. Wanted to know if she could take an extra Singulair pill that has to do with the lungs, or she should take other drugs such as Pulmicort and Levalbuterol tartrate. Therapeutic measures were taken as a result of shortness of breath. The outcome of the events was reported as unknown. Follow-up attempts are completed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness, Urticaria
Clinical narrative: my throat started to feel constricted; hives/rash developed on the left side of my neck, and across my chest; This is a spontaneous report from a contactable consumer ((the patient, reported for self).  A 28-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot/Batch number: ER8736, Expiration date: UNKNOWN) via an unspecified route of administration, administered in Arm Left on 11May2021 17:15 (at the age of 28-year-old) as single for covid-19 immunisation.   The patient Medical history included food allergy to Peanuts, soy, shellfish, fish, sesame, legumes, coconut, nuts, stone fruit; Drug allergy to penicillin; Anaphylaxis allergic reaction from an unspecified date an unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient concomitant medications were not reported. The patient did not receive any other vaccine within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination.   On 11May2021 17:15 within two minutes of getting the shot patient stated that her throat started to feel constricted, within five minutes of getting the shot "hives/rash developed on the left side of my neck, and across my chest." She stated that throat continued to get constricted. She had a history of Anaphylaxis allergic reactions to various food, so she had felt her throat tighten due to food before, but this was different. Patient had visited Doctor or other healthcare professional office/clinic. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken because of throat continued to feel tight as she took Benadryl on the ride to the (ER) Emergency room/department or urgent care. No epi was taken before arriving at the hospital. Patient received steroids and Antihistamines at the ER. The outcome of the events were unknown.  Device Date : 12May2021  Information on Lot/Batch number was available. Additional information has been requested
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Muscle twitching
Clinical narrative: I developed shingles; muscle twitching; This is a spontaneous report from a contactable Pharmacist (patient herself). A 69-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6199) via an unspecified route of administration in left arm on 04Mar2021 08:30 as 2nd dose, single dose for COVID-19 immunization. Patient was 69-years-old and was not pregnant at the time of vaccination. Patient did not had COVID-19 prior to vaccination. Patient was not tested for COVID-19 post vaccination. Vaccination facility type was reported as Health Clinic/Administration facility. Patient did not receive any vaccines within 4 weeks. Patient medical history included diabetic arthritis, heart problems, fibromyalgia and known allergies to versed, hydrocodone. Concomitant medications included atorvastatin calcium, losartan, metformin, ASA, dexamethasone sodium phosphate (DEXALAB [DEXAMETHASONE SODIUM PHOSPHATE]), metoprolol succinate (TOPROL). Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- Pfizer 6199) via an unspecified route of administration on 04Mar2020 08:30 (as reported) as 1st dose single dose for COVID-19 immunization. On 26Mar2021, patient developed shingles and had muscle twitching. Adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care visit. Patient did not receive any treatments for the adverse events. The outcome of the events was not resolved.   No follow-up attempts are possible. No further information is expected.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiovascular disorder, Dehydration, Muscle spasms, Pain in extremity, Sensation of blood flow
Clinical narrative: Sleepy; She couldn't get up, she had a horrible and "very strong" pain in her leg, soon it started in the other leg, like a "very strong cramp,"; She couldn't get up, she had a horrible and "very strong" pain in her leg, soon it started in the other leg, like a "very strong cramp,"; She felt the blood flow at a tremendous speed, from the waist down; It could be a circulation problem because of her varicose veins; It could be a circulation problem because of her varicose veins; she felt in her legs as if they had uncovered a sewer pipe and the water was squirting, she thinks she was probably dehydrated; This is a spontaneous report from Medical Information Team. A contactable consumer (patient) reported that a 82-year-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection) via unspecified route of administration on 20Apr2021 as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. as per reported, She received the first dose on 20Apr2021, then went home and was very sleepy, she took a nap. When she woke up, she couldnt get up, she had a horrible and "very strong" pain in her leg, soon it started in the other leg, like a "very strong cramp," so she had to massage herself. She lived alone and when she got up, she felt the blood flow at a tremendous speed, from the waist down. After that she drank water and the feeling disappeared. She thought it could be a circulation problem because of her varicose veins, she takes aspirin. She thought her reaction the first time might have been vaccine-related, it was "horrifying, very strong," she felt in her legs as if they had uncovered a sewer pipe and the water was squirting, she thought she was probably dehydrated, so she was a little afraid to receive the second dose. However, now "I feel very good". Outcome of event Blood flow sensation was recovered on an unspecified date in 2021 and for remaining events its was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Varicose vein
Clinical narrative: Sleepy; She couldn't get up, she had a horrible and "very strong" pain in her leg, soon it started in the other leg, like a "very strong cramp,"; She couldn't get up, she had a horrible and "very strong" pain in her leg, soon it started in the other leg, like a "very strong cramp,"; She felt the blood flow at a tremendous speed, from the waist down; It could be a circulation problem because of her varicose veins; It could be a circulation problem because of her varicose veins; she felt in her legs as if they had uncovered a sewer pipe and the water was squirting, she thinks she was probably dehydrated; This is a spontaneous report from Medical Information Team. A contactable consumer (patient) reported that a 82-year-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection) via unspecified route of administration on 20Apr2021 as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. as per reported, She received the first dose on 20Apr2021, then went home and was very sleepy, she took a nap. When she woke up, she couldnt get up, she had a horrible and "very strong" pain in her leg, soon it started in the other leg, like a "very strong cramp," so she had to massage herself. She lived alone and when she got up, she felt the blood flow at a tremendous speed, from the waist down. After that she drank water and the feeling disappeared. She thought it could be a circulation problem because of her varicose veins, she takes aspirin. She thought her reaction the first time might have been vaccine-related, it was "horrifying, very strong," she felt in her legs as if they had uncovered a sewer pipe and the water was squirting, she thought she was probably dehydrated, so she was a little afraid to receive the second dose. However, now "I feel very good". Outcome of event Blood flow sensation was recovered on an unspecified date in 2021 and for remaining events its was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Pain, Pain in extremity, Pyrexia
Clinical narrative: The dizziness was incapacitating; Had 100.6 temp and body aches; Had 100.6 temp and body aches; Sore arm; Temporary shortness of breath; This is a spontaneous report from a contactable other hcp. A 60-years-old female patient received BNT162B2 (COMIRNATY) (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, (Lot Number: EL3248 expiry date was not reported) dose 1 via intramuscularly administered at Arm Right on 13Jan2021 11:30 as 1st Dose, Single for Covid-19 immunization.The patient's procedural history included tonsillectomy and adenoidectomy, total abdominal hysterectomy, salpingo-oopherectomy and cholesytectomy (01Jan2004). The patient's medical history included mononucleosis (from 01Jun2020 to 01Mar2021). The patient's concurrent conditions noted hypertension (from 01Jan2013) and hot flashes. The patient family history included hypertension for maternal grandmother.Concomitant medications included . The patient had reaction  immediately after 1st vaccine and she felt short of breath that evening on 13Jan2021. The patient had a sore arm 14Jan2021 (the next day).  On an unspecified date, the patient had dizziness which was incapacitating and could not drive and also had 100.6 temp and body aches. The patient unable to stand without passing out.The patient received Dramamine for dizziness and Nyquil for fever and body aches and temperature.The patient received Nyquil (doxylamine-DM-acetaminophen) and went to bed. The patient reported that she was okay. The outcome of all the events was resolved on an unspecified date in 2021.     Causal relationship:Is there a reasonable possibility that the event is related to suspect product: Yes  No follow-up attempts are possible. No further information is expected.  Comments/narrative: Reaction immediately after 1st vaccine. Felt short of breath that evening, took Nyquil went to bed. Besides a sore arm the next day, I was okay. Approximately 12 hours after second vaccine, I was achy, dizzy and had temperature of 100.6. Did go to walk but by the afternoon, felt bad enough and went home. The next day, was still dizzy, achy and was vasovagal with standing.Stayed home from work. The 3rd day, I felt ok, went to work.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: spasms; her arms "tightens up" during the night; having trouble sleeping/she barely sleeps 3-4 hours per night; muscle in her arm tightens up so tight it wakes her; both arms hurt from her elbows to shoulders and it is terrible at night.; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 78-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, #lot: ER8737, expiration date: 31Jul2021) via an unspecified route of administration administered in Arm Left on 03Apr2021 (at the age of 78-years-old) as single dose for COVID-19 immunization. Medical history included ongoing breast cancer diagnosed 2.5 years ago and still being followed for it, ongoing irritable bowel syndrome diagnosed 5-6 years ago and had muscle aches in her legs from cholesterol medicines in the past. Concomitant medications included acetylsalicylic acid (ASPRIN, strength: 81 mg) at 81 mg once daily, bumetanide (strength: 1 mg) at 1 mg tables, 2 tablets on Monday, Wednesday and Friday and one tablet the rest of the week, glucosamine, methylsulfonylmethane (GLUCOSAMINE & MSM) one in the morning and one at night, 2x/day), letrozole (strength: 2.5 mg) at 2.5 mg once daily, levothyroxine (strength: 25 mg) at 25 mg, alternate day, lisinopril (strength: 5 mg) at 5 mg one at night, loratadine (CLARITINE), lorazepam, omeprazole (strength: 20 mg) at 20 mg, alternate day, probiotics once daily, calcium (strength: 600 mg) at 600 mg twice daily, vitamin c (ASCORBIC ACID, strength: 500 mg) at 500 mg once daily, vitamin d3 (strength: 500 mg) at 500 mg once daily, simethicone (strength: 125 mg) at 125 mg once daily. It was reported that within 2 days after vaccination, on 05Apr2021, the patient right arm started hurting from elbow to shoulder along with left arm then started hurting also but doesn't recall at what point it started. Patient thought that pain was due to the vaccine since in her left arm was also in pain. Further patient described pain as excruciating at night, in the evenings or when lays down, and tolerable during the day. On an unspecified date, the patient specified about the spasms and arms that tightens up during the night, which keep her up. On an unspecified date, the patient added she barely sleeps 3-4 hours per night, despite the muscle relaxant she takes. Patient further explained she cannot lift her arms as high in the morning and provided the following example: she couldn't open her venetian blind or put her coat without help. She specified the pain eases up during the day and can't move her arms as it hurts, the pain on a scale of 1-10 was a 15. Reporter assessed the event as non-serious. On unspecified date the patient underwent lab tests and procedures which included left arm x-ray and left arm x-ray found to be negative. The outcome of the events both arms hurt from her elbows to shoulders and it is terrible at night was not recovered while the outcome of the rest of events was unknown.  Follow up attempts needed. Further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Gout, Rash, Vaccination site pain
Clinical narrative: Gout flared up; he had pain in his arm at the injection site; has a rash on the back of his arm and around his neck; This is a spontaneous report from a contactable consumer reporting for himself. A 56-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: first dose of EW0176 and expiry date not reported) via an unspecified route of administration, administered in Left arm on 10May2021 (at age of 56-years old) as SINGLE DOSE for covid-19 immunization. Medical history included hypertension (he was diagnosed with high blood pressure over 10 years ago), ongoing gout (he was diagnosed with gout 5-6 years ago), Acid reflux (diagnosed with acid reflux well over 10 years ago), sinusitis (Sinuses), blood cholesterol (Pravastatin has been maintaining his cholesterol levels). Concomitant medication(s) included mometasone furoate (NASONEX) taken for sinusitis he has been using it for about 10 years; lisinopril taken for hypertension, he has been taking Lisinopril for over 10 years now; pravastatin taken for blood cholesterol, he has been taking Pravastatin for 10 years now; omeprazole (PROTONIX) taken for gastrooesophageal reflux disease he has been taking Protonix for well over 10 years; and colchicine (COLCHICINE A) taken for gout, start and stop date were not reported. Caller reported that he had pain in his arm at the injection site the next day after the Covid-19 vaccine, 11May2021 and the pain at the site went away on day 2, 12May2021, or day 3, 13May2021. His gout flared up the night of Thursday, 13May2021. Caller reported that he took some medication for his gout flare up so it's going away. Also reported that, the gout flares up got better the afternoon of Saturday, 15May2021 when he took his gout medication. Caller reported that he has been taking his medication for gout, so he doesn't feel the gout flare up as much now as he did. On unknown date in May2021, he had a rash on the back of his arm and around his neck that wasn't there before he got the Covid-19 vaccine. Caller reported that the rash began a couple of days ago. Caller reported that he has been taking one pill of Colchicine daily for his gout flare up. Caller reported that he only takes the colchicine as needed and that he normally avoids the foods that cause his gout to flare up. Caller stated that he needed to leave the house. Caller unable to complete vaccine supplemental form with agent. Therapeutic measures were taken as a result of gout flared up: treatment included Colchicine. The outcome of the events pain in his arm at the injection site and gout flared up was resolved on unknown date in May2021. The outcome of the event rash on the back of his arm and around his neck was not resolved.   Information on lot/batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Muscle spasms
Clinical narrative: diarrhea; cramping; This is a spontaneous report from a contactable consumer (Patient). A 65-year-old female patient received second dose of BNT162B2(COVID-19 VACCINE, Solution for injection, Lot number& Expiry date not reported) via unspecified route of administration on unspecified date as second dose, single for COVID-19 Immunization. Patient medical history was not reported. Concomitant medication included secukinumab (COSENTYX) used for unspecified indication from unknown date and unknown if ongoing. Patient stated that she had diarrhea and cramping for the last 4 days after second Covid vaccine on unspecified date. The outcome of events was unknown.   Information on the lot/batch number has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis contact
Clinical narrative: Contact Dermatitis in left eye; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA COVID-19 VACCINE; Lot number: ew0185), via an unspecified route of administration in her left arm on 23Apr2021 (at the age of 55-years) at 12:00 as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication includes spironolactone (MANUFACTURER UNKNOWN), sottopelle and progesterin (MANUFACTURER UNKNOWN), all for unknown indications. On 14May2021, at 12:00 (at the age of 56-years), the patient received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA COVID-19 VACCINE; Lot number: Unknown), via an unspecified route of administration in her left arm as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to COVID-19 vaccine. The patient received the most recent COVID-19 vaccine at pharmacy or drug Store. The patient was diagnosed with COVID-19 prior to vaccination on an unknown date. The patient was not tested for COVID-19 since the vaccination. On 24Apr2021, the patient experienced contact dermatitis in her left eye. The patient experienced contact dermatitis in left eye after both vaccines. The patient received an ointment for the event contact dermatitis in left eye. The clinical outcome of the event contact dermatitis in left eye was resolved on an unknown date. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Sneezing
Clinical narrative: runny nose; sneezing; This is a spontaneous report from Medical Information Team. A contactable consumer (patient) reported that a 41-year-olf female received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot: EW0185) via unspecified route of administration on 13May2021 on 14:30 as single dose in left arm for COVID-19 immunization in Hospital. Medical history and concomitant medications were not reported. the patient previously took first dose of bnt162b2 (Lot Number: EW0169) on 22Apr2021 13:00 in left arm and experienced smell and taste it feels weird, I can't taste food, food taste like something different and smell you know feels something different. She felt like she was having an allergic reaction, clarified she wakes up with a runny nose and sneezing and has never had this before. The runny nose and sneezing started third or fourth day after the second dose of the vaccine, it was a little better. No treatment was received in response to the events. Outcome of the events was recovering.  Follow up needed, further information has been requested.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Chills, Erythema, Fatigue, Palpitations
Clinical narrative: Redness; Heart palpitations; Chills; Fever; heart issue; Fatigue; This is a spontaneous report from a contactable consumer (patient) via COVAES. This 71-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER8736) via an unspecified route of administration in the left arm on 18May2021 at 12:00 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. Medical history included non-ST elevated myocardial infarction (NSTEMI), aortic valve replacement, dye contrast allergy, and 4 stents placed, all from unknown dates and unknown if ongoing. Concomitant medications included acetylsalicylic acid (ASPIRIN), apixaban (ELIQUIS), lisinopril, and metoprolol, all from unknown dates for unknown indications. Prior to vaccination the patient had not been diagnosed with COVID-19 and had not received any other vaccine in four weeks. The patient previously received ciprofloxacin, metformin, and simvastatin, all from unknown dates for unknown indications and experienced drug allergy. On 21May2021 at 12:00 the patient experienced redness, and heart palpitations. The patient stated he was having heart issues before vaccination which he stated could be verified by records. He also had chills, fever, and fatigue, but not severe, "only heart issue" stating he had been having heart issues but reaction to vaccine had not been severe. The events resulted in an emergency department visit; no treatment was received for the events. The clinical outcomes of redness, heart palpitations, chills, fever, fatigue, and heart issues were recovering. It was also reported that since vaccination the patient had not been tested for COVID-19.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Redness; Heart palpitations; Chills; Fever; heart issue; Fatigue; This is a spontaneous report from a contactable consumer (patient) via COVAES. This 71-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER8736) via an unspecified route of administration in the left arm on 18May2021 at 12:00 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. Medical history included non-ST elevated myocardial infarction (NSTEMI), aortic valve replacement, dye contrast allergy, and 4 stents placed, all from unknown dates and unknown if ongoing. Concomitant medications included acetylsalicylic acid (ASPIRIN), apixaban (ELIQUIS), lisinopril, and metoprolol, all from unknown dates for unknown indications. Prior to vaccination the patient had not been diagnosed with COVID-19 and had not received any other vaccine in four weeks. The patient previously received ciprofloxacin, metformin, and simvastatin, all from unknown dates for unknown indications and experienced drug allergy. On 21May2021 at 12:00 the patient experienced redness, and heart palpitations. The patient stated he was having heart issues before vaccination which he stated could be verified by records. He also had chills, fever, and fatigue, but not severe, "only heart issue" stating he had been having heart issues but reaction to vaccine had not been severe. The events resulted in an emergency department visit; no treatment was received for the events. The clinical outcomes of redness, heart palpitations, chills, fever, fatigue, and heart issues were recovering. It was also reported that since vaccination the patient had not been tested for COVID-19.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Periorbital swelling, Toothache
Clinical narrative: Tired/fatigue; Headachy; a puffy corner on the side of her eye; toothache; This is a spontaneous report from a contactable consumer (patient). This 57-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 21May2021 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number unknown) on an unspecified date for COVID-19 immunisation. The patient reported she received the second dose of BNT162B2 on 21May2021 and she was still feeling tired and "headachy." She also had a puffy corner on the side of her eye and a toothache that developed right after the vaccine. The patient had a video appointment with her doctor, and they were unable to see the puffiness but gave the patient a referral. The patient reported she was now (as of 25May2021) experiencing headache and fatigue even a few days after the vaccine. She inquired if it was common to last this long, if she could call out of work, and if tooth pain was a reported side effect. The clinical outcomes of tired/fatigue, "headachy," puffy corner on the side of her eye, and toothache were not recovered.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal chest pain, Pain in extremity, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Rib cage area is sore; pains throughout arm; redness and swelling at the injection site; redness and swelling at the injection site; This is a spontaneous report from a contactable consumer (patient). This 34-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0173) via an unspecified route of administration on 23May2021 at 14:15 (at the age of 34-years-old as a single dose in the left arm for COVID-19 immunization. Medical history included high cholesterol and borderline diabetic. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included pantoprazole (PROTONIX); ethinyl estradiol, ferrous fumarate, norethisterone acetate (TAYTULLA); rosuvastatin; buproprion XL, and "noreth" from unknown dates for unknown indications. The patient previously received hydrocodone from an unknown date for an unknown indication and experienced allergy. On 24May2021 the patient experienced rib case area was sore, pains throughout arm, and redness and swelling at the injection site. The patient did not receive any treatment for the events. The outcomes of rib case area was sore, pains throughout arm, and redness and swelling at the injection site were unknown. It was also reported that since the vaccine the patient was not tested for COVID-19.   No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation, Hypoaesthesia, Limb discomfort, Paraesthesia
Clinical narrative: weird numbing, tingling, burning, freezing sensations in my thighs; weird numbing, tingling, burning, freezing sensations in my thighs; weird numbing, tingling, burning, freezing sensations in my thighs; weird numbing, tingling, burning, freezing sensations in my thighs; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A patient of unspecified age and gender received bnt162b2 (BNT162B2 Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Lot number: unknown, Expiration date: unknown), dose 1 via an unspecified route of administration on 30Mar2021 (Batch/Lot Number: Unknown) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. After the first one, on an unspecified date in 2021 had weird numbing, tingling, burning, freezing sensations in my thighs. Reporter seriousness for all the events was unspecified.  The outcome for all the events was not recovered.   Additional Context: Consumer stated, "I had my first shot on like 30Mar and my second one on 20Apr and after the first one, I was getting these weird numbing, tingling, burning, freezing sensations in my thighs. I didn't think anything for a while and then after I had my second one, it got like a little worse and it is like my legs are (sentence incomplete) and it is every day and even right now, I am trying to scratch my thighs because they itch, they burn, they freeze and they are numb. I don't know if (sentence incomplete), I don't know what is going on. I lost my job in September and I don't have insurance anymore. So, I do not have a primary care physician and I didn't inject myself with the shot, I was told to have it. So, what do I do now?"  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Musculoskeletal stiffness
Clinical narrative: During these holds the inflammation and stiffness came back; During these holds the inflammation and stiffness came back; This is a spontaneous report from a contactable other health professional and a contactable consumer. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 1st dose via an unspecified route of administration in Apr2021 (Batch/Lot number was not reported) as a single dose, 2nd dose via an unspecified route of administration in 2021 (Batch/Lot number was not reported) as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient experienced  the inflammation and stiffness came back during these holds on an unspecified date.  The outcome of the events was unknown. Clinical course: patient reported after start of therapy she missed 7 days of medication for her first covid-19 vaccine at the end of April 2021and another 7 days for her second covid-19 vaccine two weeks ago. patient reported during these holds the inflammation and stiffness came back.  Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Feeling cold, Presyncope
Clinical narrative: felt like was going to pass out; became very cold; she didnt eat today; This is a spontaneous report from a contactable consume reported for a female friend from a mass vaccination event. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on an unspecified date, as unknown single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient felt like she was going to pass out and became very cold on an unspecified date, after the vaccination at a mass vaccination event. She had to lay down after 10 minutes and EMTs were called and was not sure of result or any other information except she did not eat for the day. The outcome of the events was unknown at the time of this report.  Information on the batch/lot number has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Pyrexia
Clinical narrative: Burning up and severe chills: States these were like she never had before. Used four blankets and bed pillows trying to warm up; she felt so hot/ she figured it was about 104/ burning up/ Temperature around 100 and 101; she is exhausted; Pains in toes and finger joints; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number: EP7534), via an unspecified route of administration, administered in arm left on 30Mar2021 12:30 PM (at the age of 64-year-old) as single dose for COVID-19 immunization. The patient medical history included inflammatory eye problem (patient had this 10 year. Does not think this is anything related), ileostomy for 50 years. The patient took no concomitant medications. No family medical history. The patient did not receive any other vaccines prior vaccinations within 4 weeks. No additional vaccines administered on same date. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number: ED6203), via an unspecified route of administration on 09Mar2021 (at the age of 64-year-old) for COVID-19 immunization and experienced pain in extremity, injection site mass, injection site swelling, injection site erythema, rash. Patient stated she was reporting side effects again. Stated that she reported after the first dose, where she had problems with her arm, reported having a big lump and rash. Patient stated that she got the shot on Tuesday, was fine all afternoon and evening. On an unspecified date in 2021 during the night she felt so hot, wouldn't even take her temp because she figured it was about 104. Burning up and severe chills: Stated these were like she never had before. Used four blankets and bed pillows trying to warm up. Temperature around 100 and 101: Stated that this started the next day, which was yesterday that it has been staying between 100 and 101. Stated she was exhausted. Pains in toes and finger joints: Stated that this was going on now and has no muscle soreness or aching. The patient received Motrin as a treatment. Outcome of the events was unknown.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Periodontitis
Clinical narrative: Gum Periodontitis; This is a spontaneous report from a contactable consumer (patient). A 77-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on 19Feb2021 as a single dose for covid-19 immunization. Medical history included ache in upper left gum (molar area) from 20Jan2021, patient had Teeth Periodontitis on 20Jan2021 (Admission to the hospital due to the event: No, Any treatment received: Yes, Still experiencing: Fine Now). The patient's concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine) on 29Jan2021for COVID-19 immunization and fistula was developed on her gum on 06Feb2021. The patient received the second dose of vaccine on 19Feb2021 and on the same day she experienced gum periodontitis. She waited until 05Mar2021 for procedure to clean around and under her tooth. Her next appointment was on 29Mar2021 and it appeared better. Treatment medication included antibiotic for 5 days. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.