chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: Her fiance who has been tested positive; Her fiance who has been tested positive; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 31Jan2021 this case now contains all required information to be considered valid:   This is a spontaneous report from a non-contactable consumer (Patient's fiance) and a contactable consumer (Patient). An elderly male patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 18Dec2020 at single dose, second dose via an unspecified route of administration on 13Jan2021 at single dose for covid-19 immunisation. Medical history included back pain before receiving the vaccine; later described as a Spinal pain. The patient's concomitant medications were not reported. Caller said she got the 1st dose of Covid vaccine on the 18Dec. But she is living with her fiance who has been tested positive. Caller would like to know if there is any reason why she should take the 2nd dose of the vaccine. Caller stated receiving the first dose of the COVID-19 vaccine yesterday (18Dec2020), And receiving a drug prescription for "Medol" today. He explained that his appointment with the doctor was scheduled a month ago, due to his "back pain", which he later described as a "Spinal pain". He specified that "everything is fine" and that his pain is not due to the inoculation. He asked if the Medol would interact with the vaccine. patients second dose was scheduled for Wednesday and he got a call on Saturday saying the spot was not available now. They want me to get his second dose tomorrow instead. he had heart problems and he was over 65 years old. he was thinking perhaps he should wait because he wanted the maximum beneficial effect of the inoculation. Will he get as much protection if he got the vaccine at 19 days instead of 21 days, patient questioned. Reporter said (patients fiance) she got the 1st dose of Covid vaccine on the 18Dec2020. But she was living with her fiance who had been tested positive. Caller would like to know if there is any reason why she should take the 2nd dose of the vaccine she questioned. The relevant laboratory tests includes SARS-CoV-2 Antibody test with result was positive. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative
Clinical narrative: antibody test came back negative; This is a spontaneous report from a contactable consumer.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration first dose on 17Dec2020 and second dose on 07Jan2021, both at single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  It was reported that the patient received both doses of Pfizer COVID vaccine, antibody test came back negative. 1st dose 17Dec 2nd dose 07Jan, antibody test 12Jan2021. The outcome of the event was unknown.   Information on lot/batch number has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a contactable consumer (reported for herself). A 36-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot no: EL3247), on right arm via an unspecified route of administration on 27Jan2021 10:15 at single dose for covid-19 immunisation. The patient's Medical history and concomitant drug was not reported. The patient experienced sore arm on 28Jan2021 06:00. Prior to vaccination, patient was not diagnosed with COVID-19, Prior to vaccination, patient was not diagnosed with COVID-19, patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received within 2 weeks of vaccination. Outcome of the event was not recovered
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Paraesthesia oral
Clinical narrative: Within 3 minutes of injection I developed a medicinal, metallic taste in my mouth; tingling in my tongue and on my lips; This is a spontaneous report from a contactable consumer herself. A 76-years-old female patient received first dose bnt162b2 (Solution for injection, Pfizer, Lot number:EL3249) via an unspecified route of administration arm left from 27Jan2021 09:30 at single dose for Covid-19 immunization. Medical history included rheumatoid arthritis, and Hypothyroid. Concomitant medication included adalimumab (HUMIRA), levothyroxine sodium (SYNTHROID), montelukast sodium (SINGULAIR), ezetimibe (ZETIA), rosuvastatin calcium (CRESTOR) and calcium. The patient previously took metronidazole (FLAGYL) and experienced allergy. On 27Jan2021, 09:30 AM, within 3 minutes of injection I developed a medicinal, metallic taste in my mouth. In a few more minutes, tingling in my tongue and on my lips and for both events received treatment Benadryl and extra waiting. The outcome o the events recovered in 2021
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: Chills; body aches; This is a spontaneous report from a contactable consumer (patient parent). A 17-year-old (17-year-old age at vaccination) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on 27Jan2021 01:00 PM at single dose in left arm for COVID-19 immunization at  clinic. Medical history was none. The patient was not pregnant at time of vaccination. No other vaccines received by patient within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. No Allergies to medications, food, or other products. Concomitant medication was not reported. The patient previously took (at age 17-year-old) first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: E1014D) on 06Jan2021 in left arm for COVID-19 immunization. The patient experienced chills, body aches on 28Jan2021 01:15 AM. No treatment received for the adverse events. Since the vaccination, it was unknown whether the patient been tested for COVID-19. The outcome of events was recovering.  Information on the lot/batch number for 2nd dose has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: bad front of the head headache; injection site is slightly sore when touched; This is a spontaneous report from a contactable consumer (patient herself). A 47-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration in left arm on 28Jan2021 13:45 at single dose for COVID-19 immunization in workplace clinic. The patient's medical history included asthma, chronic sinusitis with nasal polyps. The patient have allergies to medications, food, or other products. Concomitant medications included other medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient received other medications within 2 weeks of vaccination. It was reported that, woke up the next morning on 29Jan2021 07:00 AM with a bad front of the head headache and injection site was slightly sore when touched. The events were considered as non-serious by the consumer. No treatment received for the adverse events. The outcome of the events was not recovered.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Lipids, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: When he raises his left arm where the vaccine was given, he feels a twinge of pain/lifts his arm over his head he feels the twinge of pain; When he raises his left arm where the vaccine was given he feels a twinge of pain where that was, and a kind of numbness; when he exercises it and swings his left arm, then he feels a bit tightness; This is a spontaneous report received from a contactable consumer (patient). A 79-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiry date: unknown), via an unspecified route of administration in the left arm, on 19Jan2021, at single dose, to prevent COVID, at a hospital. Medical history included lung cancer (19-year lung cancer survivor), mild heart attack in 2011, aortic valve replacement in 2013 and a heart issue. Concomitant medications were not reported. Historical vaccine included influenza vaccine received on 06Nov2020 for immunization. The patient reported that on he had the first vaccine shot on 19Jan2021 (10 days ago) and on 20Jan2021, when he raised his left arm where the vaccine was given, he felt a twinge of pain where that was, and a kind of numbness, it was nothing that restricts him in any way, but when he exercised in the morning and lifted his arm over his head he felt the twinge of pain, which was something he never experienced with the flu vaccine or any other vaccines. He wondered if it had something to do with this vaccine. He has not treated it, it has not bothered him much. He stated he feels it when he exercises it and swings his left arm, then he feels a bit tightness or a twinge of pain. He says it does not restrict him or cause him to cry out or anything. The patient also reported that he is scheduled for the second dose on 09Feb2021 and stated that he needs to get a dental procedure done on 04Feb2021 and needs to take amoxicillin for it due to past heart issue. The patient wanted to know if it is okay to take amoxicillin and was wondering if this medication will interfere with the second dose. He also asked if he should cancel the dental procedure. The patient mentioned that he had his annual wellness visit on an unspecified date and they did a lipid profile (unknown results) but it was not relevant in his opinion. The outcome of the events was unknown.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness
Clinical narrative: Stiff arm; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231), via an unspecified route of administration in the right arm on 26Jan2021 08:30 at a single dose for COVID-19 immunisation. The patient's medical history included hyperactive thyroid, psoriasis, and prostate disorder. Concomitant medications included methimazole (tablet) for hyperactive thyroid, apremilast (OTEZLA, tablet, lot number: 1121523) for psoriasis, and tamsulosin (capsule, lot number: KP7571, expiration date: Apr2022) for his prostate to help him urinate. The patient experienced stiff arm on 27Jan2021. Day 4 after he had the first dose of the vaccine, he has had no side effects. He wants to double check his medications since he is taking three different medications. He wants to check his meds so he will not have adverse effects on the vaccine's ability to work for him. Outcome of the event was unknown.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Rhinorrhoea, Vaccination site pain
Clinical narrative: also developed a minor runny nose/occasional nasal congestion that has persisted for at least 3 days (this might also be due to extreme cold weather in my area currently); also developed a minor runny nose/occasional nasal congestion that has persisted for at least 3 days (this might also be due to extreme cold weather in my area currently); mild pain/soreness at the site of injection evening and following day post vaccination; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration (at the age of 53-years-old) on 27Jan2021 11:30 at a single dose in left arm for COVID-19 immunization. Medical history type 2 diabetes. Concomitant medication included metformin (METFORMIN), colecalciferol (VITAMIN D), omega-3 fatty acids (OMEGA-3 FATTY ACIDS), multivitamins with minerals [umbrella term] (CENTRUM) and ''tumeric". The patient previously took azithromycin and experienced drug allergies. The patient experienced mild pain/soreness at the site of injection evening and following day post vaccination, on 27Jan2021 23:00, also developed a minor runny nose/occasional nasal congestion that has persisted for at least 3 days (this might also be due to extreme cold weather in my area currently) on 28Jan2021. No treatment received for the adverse events. The outcome of the events was recovered. The events were assessed as non-serious. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was at Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Dyspnoea, Fatigue, Headache
Clinical narrative: sore arm/arms were quite sore; injection site pain; extreme fatigue/exhaustion; a little headache; chills; muscle pains which makes them a little achy overall; feel like they have Covid all over again; achy; feel lousy; sleepy all afternoon and stated that she sat down and just passed out, caller clarified that she went to sleep/very drowsy; issues with breathing and shortness of breath; This is a spontaneous report from a contactable consumer (patient herself) via Medical information team. A 77-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3248) intramuscularly on 28Jan2021 at single dose in left arm for COVID-19 immunization. Medical history included Covid (she had Covid already). Concomitant medication was none. Patient received the 1st dose of the vaccine yesterday afternoon. Today patient experienced a sore arm, injection site pain, extreme fatigue, a little headache, chills, and muscle pains which makes them a little achy overall on 29Jan2021. she received the vaccine yesterday and stated that she felt like she has Covid all over again on 29Jan2021. She stated that she had Covid already and stated that they have chills and are achy in 2021. Caller said that she was also having issues with breathing and shortness of breath in 2021. Caller said that she was also having that Covid exhaustion. Their arms were quite sore too from the shot, but she did not expect to feel lousy in 2021. patient have been sleepy all afternoon and stated that she sat down and just passed out, caller clarified that she went to sleep in 2021. Yesterday they were ok, but she felt sleepy. She started feeling very drowsy after the shot and they were fine all night. Caller said that since they have slept all afternoon they have perked up a little bit. She does not feel the chills anymore, she turned the furnace up a little bit. Achy: She said that it has improved as her back does not hurt as badly. patient said that this was her first dose of the Covid-19 vaccine. The outcome of event chills was recovered on 29Jan2021, for fatigue, COVID-19 and ache was recovering and for other events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Malaise, Myalgia, Pain, Pain in extremity
Clinical narrative: sore arm/arms were quite sore; injection site pain; extreme fatigue/exhaustion; a little headache; chills; muscle pains which makes them a little achy overall; feel like they have Covid all over again; achy; feel lousy; sleepy all afternoon and stated that she sat down and just passed out, caller clarified that she went to sleep/very drowsy; issues with breathing and shortness of breath; This is a spontaneous report from a contactable consumer (patient herself) via Medical information team. A 77-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3248) intramuscularly on 28Jan2021 at single dose in left arm for COVID-19 immunization. Medical history included Covid (she had Covid already). Concomitant medication was none. Patient received the 1st dose of the vaccine yesterday afternoon. Today patient experienced a sore arm, injection site pain, extreme fatigue, a little headache, chills, and muscle pains which makes them a little achy overall on 29Jan2021. she received the vaccine yesterday and stated that she felt like she has Covid all over again on 29Jan2021. She stated that she had Covid already and stated that they have chills and are achy in 2021. Caller said that she was also having issues with breathing and shortness of breath in 2021. Caller said that she was also having that Covid exhaustion. Their arms were quite sore too from the shot, but she did not expect to feel lousy in 2021. patient have been sleepy all afternoon and stated that she sat down and just passed out, caller clarified that she went to sleep in 2021. Yesterday they were ok, but she felt sleepy. She started feeling very drowsy after the shot and they were fine all night. Caller said that since they have slept all afternoon they have perked up a little bit. She does not feel the chills anymore, she turned the furnace up a little bit. Achy: She said that it has improved as her back does not hurt as badly. patient said that this was her first dose of the Covid-19 vaccine. The outcome of event chills was recovered on 29Jan2021, for fatigue, COVID-19 and ache was recovering and for other events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: sore arm/arms were quite sore; injection site pain; extreme fatigue/exhaustion; a little headache; chills; muscle pains which makes them a little achy overall; feel like they have Covid all over again; achy; feel lousy; sleepy all afternoon and stated that she sat down and just passed out, caller clarified that she went to sleep/very drowsy; issues with breathing and shortness of breath; This is a spontaneous report from a contactable consumer (patient herself) via Medical information team. A 77-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3248) intramuscularly on 28Jan2021 at single dose in left arm for COVID-19 immunization. Medical history included Covid (she had Covid already). Concomitant medication was none. Patient received the 1st dose of the vaccine yesterday afternoon. Today patient experienced a sore arm, injection site pain, extreme fatigue, a little headache, chills, and muscle pains which makes them a little achy overall on 29Jan2021. she received the vaccine yesterday and stated that she felt like she has Covid all over again on 29Jan2021. She stated that she had Covid already and stated that they have chills and are achy in 2021. Caller said that she was also having issues with breathing and shortness of breath in 2021. Caller said that she was also having that Covid exhaustion. Their arms were quite sore too from the shot, but she did not expect to feel lousy in 2021. patient have been sleepy all afternoon and stated that she sat down and just passed out, caller clarified that she went to sleep in 2021. Yesterday they were ok, but she felt sleepy. She started feeling very drowsy after the shot and they were fine all night. Caller said that since they have slept all afternoon they have perked up a little bit. She does not feel the chills anymore, she turned the furnace up a little bit. Achy: She said that it has improved as her back does not hurt as badly. patient said that this was her first dose of the Covid-19 vaccine. The outcome of event chills was recovered on 29Jan2021, for fatigue, COVID-19 and ache was recovering and for other events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Computerised tomogram, Headache, Nausea, Neck pain
Clinical narrative: had flush feeling (much like injection during CT scan); Within hour my ears felt hot and turned bright red Subsided within hour.; Ate supper, Went to bed, upon waking in nite experienced imbalance; vertigo; Neck pain; headache; nausea; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female non-pregnant patient received first dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264, Solution for injection), via an unspecified route of administration in the left arm on 29Jan2021 (at the age of 64-years-old) as a single dose for COVID-19 vaccination. Medical history included CAD (coronary artery disease), Irregular heart rhythm, BPPV, degenerative disc disease, anxiety, ptsd (post-traumatic stress disorder), pre diabetic, Allergies to food, chemical and sensitivities and med and sensitivites. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had not received any other vaccine within 4 weeks prior to the vaccine. Concomitant medications were not reported. Upon receiving injection, on 30Jan2021, patient had flush feeling (much like injection during CT scan). Within hour her ears felt hot and turned bright red Subsided within hour. After supper, went to bed, upon waking in night experienced imbalance. Laying back down experieced vertigo (what she thought was a BPPV episode, a prior cond) but she couldnt figure out which side to treat, she performed maneuver. But did not resolve. She was remaining off balance and spinny even being upright with movement of head or eyes. Neck pain and headache residual nausea. About 12 hours after injection. Upside, her arm doesnt hurt. The patient did not receive any treatment for the events. No seriousness criteria was reported. The patient underwent lab tests and procedures which included computerised tomogram and results are unknown. The outcome of events was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: had flush feeling (much like injection during CT scan); Within hour my ears felt hot and turned bright red Subsided within hour.; Ate supper, Went to bed, upon waking in nite experienced imbalance; vertigo; Neck pain; headache; nausea; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female non-pregnant patient received first dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264, Solution for injection), via an unspecified route of administration in the left arm on 29Jan2021 (at the age of 64-years-old) as a single dose for COVID-19 vaccination. Medical history included CAD (coronary artery disease), Irregular heart rhythm, BPPV, degenerative disc disease, anxiety, ptsd (post-traumatic stress disorder), pre diabetic, Allergies to food, chemical and sensitivities and med and sensitivites. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had not received any other vaccine within 4 weeks prior to the vaccine. Concomitant medications were not reported. Upon receiving injection, on 30Jan2021, patient had flush feeling (much like injection during CT scan). Within hour her ears felt hot and turned bright red Subsided within hour. After supper, went to bed, upon waking in night experienced imbalance. Laying back down experieced vertigo (what she thought was a BPPV episode, a prior cond) but she couldnt figure out which side to treat, she performed maneuver. But did not resolve. She was remaining off balance and spinny even being upright with movement of head or eyes. Neck pain and headache residual nausea. About 12 hours after injection. Upside, her arm doesnt hurt. The patient did not receive any treatment for the events. No seriousness criteria was reported. The patient underwent lab tests and procedures which included computerised tomogram and results are unknown. The outcome of events was unknown.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Eye inflammation, Eye pain, Eye swelling, Insomnia, Ocular hyperaemia
Clinical narrative: Had a hard time getting sleep; My left eye got seriously inflamed/ left eye became extremely red, inflamed; Eye was red, and still swollen/ left eye became extremely red, inflamed; Eye was red, and still swollen; Painful/ Eye is still sore/still having the pain in it but not intense; This is a spontaneous report from a contactable consumer (patient). An 85-years-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN5318), via an unspecified route of administration on 29Jan2021 at 01:15 at single dose for to protect me against COVID. Medical history included blood pressure and muscular degeneration in eye. Concomitant medication included hydrocodone (trade name not reported) for blood pressure. The patient experienced my left eye got seriously inflamed/ left eye became extremely red, inflamed, eye was red, and still swollen/ left eye became extremely red, inflamed, eye was red, and still swollen, painful/ eye is still sore/still having the pain in it but not intense on 29Jan2021 and had a hard time getting sleep on an unspecified date. Outcome of the events eye was red, and still swollen and painful/ eye is still sore/still having the pain in it but not intense was not recovered and other events were unknown.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Insomnia, Pain
Clinical narrative: restless; tired; head hurt; arm hurts; body aches; cold chills; couldnot sleep; tongue burning; This is a spontaneous report from a contactable consumer (Patient's daughter).  A 84-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 28Jan2021 19:00 (at the age of 84-years-old) as a single dose for COVID-19 immunization). Medical history included diabetes mellitus and arthritis from 20 years. Concomitant medication included ibuprofen (ADVIL [IBUPROFEN]) at a dose of 200 mg as needed. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unspecifie date consumer stated her mom got the first shot of the Pfizer COVID 19 vaccine 28Jan2021 at 19:00PM in the right arm. After the shot she was fine but during the night her head hurt, she had body aches and cold chills, she was tired but she couldnot sleep because she was so restless and her tongue was burning up and she couldnot feel it. Clarified she can feel her tongue and it feels really hot. It was questioned that this a side effect of the vaccine. She was scheduled to receive the second dose of the vaccine on 18Feb2021. Added her mother took two Advil before the shot getting the shot because she was anxious and worried about the side effects. It was reported that the events couldnot sleep, tongue burning and tired were worsened. Outcome of the event cold chills was recovering and not recovered for other events.  Information on the lot/batch number has been requested.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Restlessness, Tongue discomfort
Clinical narrative: restless; tired; head hurt; arm hurts; body aches; cold chills; couldnot sleep; tongue burning; This is a spontaneous report from a contactable consumer (Patient's daughter).  A 84-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 28Jan2021 19:00 (at the age of 84-years-old) as a single dose for COVID-19 immunization). Medical history included diabetes mellitus and arthritis from 20 years. Concomitant medication included ibuprofen (ADVIL [IBUPROFEN]) at a dose of 200 mg as needed. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unspecifie date consumer stated her mom got the first shot of the Pfizer COVID 19 vaccine 28Jan2021 at 19:00PM in the right arm. After the shot she was fine but during the night her head hurt, she had body aches and cold chills, she was tired but she couldnot sleep because she was so restless and her tongue was burning up and she couldnot feel it. Clarified she can feel her tongue and it feels really hot. It was questioned that this a side effect of the vaccine. She was scheduled to receive the second dose of the vaccine on 18Feb2021. Added her mother took two Advil before the shot getting the shot because she was anxious and worried about the side effects. It was reported that the events couldnot sleep, tongue burning and tired were worsened. Outcome of the event cold chills was recovering and not recovered for other events.  Information on the lot/batch number has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Erythema, Feeling hot, Flushing
Clinical narrative: Face and Neck red, swollen and hot to the touch.; Face and Neck red, swollen and hot to the touch.; Face and Neck red, swollen and hot to the touch.; Face and Neck red, swollen and hot to the touch.; Face and neck red, swollen and hot to the touch.; Similar to a Cortisone flush.; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old female non-pregnant patient started to received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/lot number: EL3246), via an unspecified route of administration in the left arm on 29Jan2021 at 16:00 (at the age of 66-years-old) as a single dose for covid-19 immunisation. Medical history included diabetes mellitus, renal disorder fibromyalgia and hypersensitivity (allergies to medications, food, or other products). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received multiple concomitant medication (unspecified). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Jan2021 at 14:00 the patient expereinced face and neck red, swollen and hot to the touch, similar to a cortisone flush. On 31Jan2021 the patient underwent lab tests and procedures which included blood pressure measurement: normal and body temperature: 97.3 (normal). The patient was treated for face and neck red, face and neck red, swollen and hot to the touch similar to a cortisone flush with 50mg of benadryl (MANUFACTURER UNKNOWN). The outcome of the events was recovering.   No follow-up attempts are possible. No further information was expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Swelling face
Clinical narrative: Face and Neck red, swollen and hot to the touch.; Face and Neck red, swollen and hot to the touch.; Face and Neck red, swollen and hot to the touch.; Face and Neck red, swollen and hot to the touch.; Face and neck red, swollen and hot to the touch.; Similar to a Cortisone flush.; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old female non-pregnant patient started to received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/lot number: EL3246), via an unspecified route of administration in the left arm on 29Jan2021 at 16:00 (at the age of 66-years-old) as a single dose for covid-19 immunisation. Medical history included diabetes mellitus, renal disorder fibromyalgia and hypersensitivity (allergies to medications, food, or other products). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received multiple concomitant medication (unspecified). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Jan2021 at 14:00 the patient expereinced face and neck red, swollen and hot to the touch, similar to a cortisone flush. On 31Jan2021 the patient underwent lab tests and procedures which included blood pressure measurement: normal and body temperature: 97.3 (normal). The patient was treated for face and neck red, face and neck red, swollen and hot to the touch similar to a cortisone flush with 50mg of benadryl (MANUFACTURER UNKNOWN). The outcome of the events was recovering.   No follow-up attempts are possible. No further information was expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Fever; severe body aches and pain; This is a spontaneous report from a contactable Other Health Professional (patient herself). A 44-years-old non-pregnant female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot: Number: Unknown) via an unspecified route of administration from 29Jan2021 10:00 (at the age of 44-years-old) at single dose for covid-19 immunisation. Medical history included high blood pressure from an unknown date and unknown if ongoing. Concomitant medication included lurasidone hydrochloride (LATUDA), lisinopril and metoprolol. The patient experienced fever and severe body aches and pain on 30Jan2021 at 12:00 AM. No treatment was received for the adverse events. The outcome of the events was reported as recovered. The events were assessed non-serious.  Information on the lot/batch number has been requested.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Dizziness, Fatigue, Feeling hot, Head discomfort
Clinical narrative: hard to fall asleep; felt like she was going to pass out/vasovagal reaction; heartbeat was high; Fatigue; Woozy/Dizzy; hard to concentrate; feeling hot; he also felt as though was on the verge of a headache but never got one/she felt like the blood was rushing to her head; This is a spontaneous report from a contactable consumer (patient). A 21-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL3249), via an unspecified route of administration on 16Jan2021 09:00 at SINGLE DOSE for covid-19 immunisation. The patient medical history was none. No prior vaccinations within 4 weeks. No family history relevant to adverse events. Patient has no concomitant medications. On 16Jan2021 09:20, 20 minutes after vaccination, the patient felt like she was going to pass out reported as vasovagal reaction, and experienced heart beat was high, fatigue, woozy/dizzy, hard to concentrate, feeling hot, and felt as though she was on the verge of a headache but never got one/she felt like the blood was rushing to her head. On 16Jan2021 10:00, 1 hour after vaccination, the patient experienced had to fall asleep. On the day she got the shot she sat for a full hour with the nurse to be monitored. Then she went home. The events lasted from 09:20 until 18:00 on that day. 13 days after vaccination on 29Jan2021, 12:00 and ongoing until reporting time, the symptoms recurred about the same when they started. The patient was wondering if this could be a side effect 2 weeks after getting the shot or if she should look elsewhere on what could be causing these events. She is supposed to get the second dose on Friday and was wondering about getting the second dose after her experience. Patient wanted to know it is safer for her to have the 2nd dose. No physician office visit and emergency room visit. No prior vaccinations within 4 weeks. Outcome of the events was recovered on 16Jan2021 18:00.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Insomnia, Presyncope
Clinical narrative: hard to fall asleep; felt like she was going to pass out/vasovagal reaction; heartbeat was high; Fatigue; Woozy/Dizzy; hard to concentrate; feeling hot; he also felt as though was on the verge of a headache but never got one/she felt like the blood was rushing to her head; This is a spontaneous report from a contactable consumer (patient). A 21-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL3249), via an unspecified route of administration on 16Jan2021 09:00 at SINGLE DOSE for covid-19 immunisation. The patient medical history was none. No prior vaccinations within 4 weeks. No family history relevant to adverse events. Patient has no concomitant medications. On 16Jan2021 09:20, 20 minutes after vaccination, the patient felt like she was going to pass out reported as vasovagal reaction, and experienced heart beat was high, fatigue, woozy/dizzy, hard to concentrate, feeling hot, and felt as though she was on the verge of a headache but never got one/she felt like the blood was rushing to her head. On 16Jan2021 10:00, 1 hour after vaccination, the patient experienced had to fall asleep. On the day she got the shot she sat for a full hour with the nurse to be monitored. Then she went home. The events lasted from 09:20 until 18:00 on that day. 13 days after vaccination on 29Jan2021, 12:00 and ongoing until reporting time, the symptoms recurred about the same when they started. The patient was wondering if this could be a side effect 2 weeks after getting the shot or if she should look elsewhere on what could be causing these events. She is supposed to get the second dose on Friday and was wondering about getting the second dose after her experience. Patient wanted to know it is safer for her to have the 2nd dose. No physician office visit and emergency room visit. No prior vaccinations within 4 weeks. Outcome of the events was recovered on 16Jan2021 18:00.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: After the injection, she started experiencing headache and dizziness; After the injection, she started experiencing headache and dizziness; This is a spontaneous report from a contactable consumer (patient). A 66-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot: Number: Unknown) via an unspecified route of administration from 31Jan2021 at single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The reporter stated that after the injection, she started experiencing headache and dizziness on an unspecified date in 2021. She reports the dizziness started 6 hours after the covid-19 vaccine injection and was really bad, like vertigo. She reports the dizziness is improving and not as bad today. She treated the headache with Tylenol. The outcome of the events dizziness was reported as recovering and headache was reported as unknown. The events were assessed non-serious.  Information on the Lot/Batch number has been requested.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Swelling; Redness; minor Pain; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3247, vaccine location: left arm), via an unspecified route of administration from 29Jan2021 12:45 PM to 29Jan2021 12:45 PM at a single dose for COVID-19 immunisation. The patient medical history included COVID-19 (if covid prior vaccination: Yes). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications (received within 2 weeks of vaccination) included nortriptyline, levothyroxine and celecoxib (CELEXA) and other vaccine same date product (Pfizer product, lot number=EL3247), on 29Jan2021 (dose number= 01, vaccine location=left arm). Patient previously took allopurinol, Bactrim and experienced Allergies. Since the vaccination, Patient has not been tested for COVID-19. Location of injection information is available for all vaccines received on the same date. The patient experienced Swelling, Redness, minor Pain (non-serious) on 31Jan2021. The outcome of events was not-recovered. Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Leg hurt; This is a spontaneous report from a contactable consumer (patient herself), received from a Pfizer-sponsored program. A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; batch/lot/NDC/UPC number and expiration date were unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient's leg hurt due to baby sitting and not because of the COVID-19 vaccine. The patient wanted to know if she could take paracetamol (TYLENOL) or ibuprofen (ADVIL). The outcome of the event was unknown.  Information on the batch/lot number has been requested.; Sender's Comments: Based on the information provided, the reported leg pain is an intercurrent medical condition and unrelated to BNT162B2.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report from a Pfizer-sponsored program. Two contactable consumers reported for a female patient (one of the reporter was reporter's mom) of an unspecified age received first dose BNT162B2 (Solution for injection) via an unspecified route of administration on an unspecified date at single dose for COVID-19 Immunisation. Patient medical history and concomitant medications were not reported. It was told her mom got the vaccine on an unspecified date and reported last she was asking if her mom could take Tylenol, penitent experienced headache on an unspecified date. Outcome of event was unknown.  Information on Lot/Batch has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Facial pain, Rash
Clinical narrative: A rash on my forehead and that spread around the right eye for next two days; Developed pain on right side of face; This is a spontaneous report from a contactable consumer (patient). A 67-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EK9231), via an unspecified route of administration on Right arm on 21Jan2021 11:45 at single dose for covid-19 immunisation. Medical history included Allergies to Sulfa and Osteopenia/osteoarthritis. The patient's concomitant medications were not reported. The patient reported, On 28Jan2021, one week after receiving the Covid vaccine, I developed pain on right side of face. On 31Jan2021 I developed a rash on my forehead and that spread around the right eye for next two days. The Dr was contacted on 02Feb2021 and I started on Valtrex (Valacyclovir HCL, 1 Gm, 3 times a day on 28Jan2021 13:00 upon Doctor or other healthcare professional office/clinic visit). The patient received treatment for the event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient not been tested for COVID-19. The seriousness was reported as non-serious. The outcome of the events recovering.  Information on the lot/batch number has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster
Clinical narrative: A rash on my forehead and that spread around the right eye for next two days; Developed pain on right side of face; This is a spontaneous report from a contactable consumer (patient). A 67-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EK9231), via an unspecified route of administration on Right arm on 21Jan2021 11:45 at single dose for covid-19 immunisation. Medical history included Allergies to Sulfa and Osteopenia/osteoarthritis. The patient's concomitant medications were not reported. The patient reported, On 28Jan2021, one week after receiving the Covid vaccine, I developed pain on right side of face. On 31Jan2021 I developed a rash on my forehead and that spread around the right eye for next two days. The Dr was contacted on 02Feb2021 and I started on Valtrex (Valacyclovir HCL, 1 Gm, 3 times a day on 28Jan2021 13:00 upon Doctor or other healthcare professional office/clinic visit). The patient received treatment for the event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient not been tested for COVID-19. The seriousness was reported as non-serious. The outcome of the events recovering.  Information on the lot/batch number has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, SARS-CoV-2 test
Clinical narrative: small rash on left side of chest; This is a spontaneous report from other Health Professional (reported for herself). A 36-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot no: EJ1685), on arm left via an unspecified route of administration on 31Dec2020 08:00 at single dose for covid-19 immunisation . Medical history included none. Concomitant medication included levothyroxine sodium (EUTHYROX, strength: 150mcg), drospirenone, ethinylestradiol (NIKKI, strength: 3mg/0.02mg). It was reported that after first shot (31Dec2020) developed small rash on left side of chest. Persisted for three weeks and was starting to fade when patient got second dose. Grew 4-5 times larger, raised, painful, red itched and tender. Now reaches my neck and breasts and shoulders. White normal skin in center, edge is now scaly and dry, itches very badly. Dr won't prescribe steroid fears it will dampen immune response. Taking Allegra, Benadryl and hydrocortisone cream did not help. Never had a reaction to a vaccine before. Prior to vaccination, patient was not diagnosed with COVID-19, Since the vaccination, patient has not been tested for COVID-19. Post vaccination Covid test done on 29Jan2021, Covid test type post vaccination was nasal Swab, covid test result was negative. Outcome of the event was not recovered.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, SARS-CoV-2 antibody test negative
Clinical narrative: her husband dose not; This is spontaneous report from a contactable consumer (spouse). An 80-year-old male patient (husband) received second dose BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 28Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medication were not reported. It was reported herself and spouse received their second dose of Pfizer COVID vaccine on 28Jan2021. They have both been subsequently tested for antibodies, stated that she has antibodies present but her husband does not in 2021. The outcome of event was unknown.  Information on the Lot/Batch number has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Injection site pain, Myalgia
Clinical narrative: Head ache; Fever; Chills; Muscle soreness; Soreness at injection site; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received BNT162B2 (formulation: Solution for injection), via an unspecified route of administration in the Left arm on 01Feb2021 16:00 at single dose for covid-19 immunization. Medical history included asthma and Allergy to penicillin. Concomitant medication included drospirenone (SLYND), fish oil, vitamin D and berberine. On 01Feb2021, the patient experienced head ache, fever, chills, muscle soreness and soreness at injection site. On 01Feb2021, the patient underwent lab tests and procedures which included body temperature: fever. The outcome of the events was recovering.  Information on the lot/batch number has been requested.