chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Muscle spasms
Clinical narrative: Severe cramping to chest/My toes and calves are cramping/my right side of the chest was starting to cramp/ hands, fingers and his right ankle severe cramping.; Rght wrist has locked up; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number was not reported; manufacturer: Unspecified; NDC number and Expiry Date of Pfizer COVID 19 vaccine: Unknown) via an unspecified route of administration, administered in deltoid left on 27Mar2021 at 17:30 as dose 1, single (at the age of 59 years old) for covid-19 immunisation. Patient medical history and concomitant medications were not reported. No other products were reported. History of all previous immunization with the Pfizer vaccine considered as suspect and Additional Vaccines Administered on Same Date of the Pfizer Suspect was none, family history was none. The patient experienced severe cramping to chest/my toes and calves are cramping/my right side of the chest was starting to cramp/ hands, fingers and his right ankle severe cramping and right wrist has locked up on 29Mar2021. No emergency room or physician office visit. Prior vaccinations within 4 weeks were none. Relevant test was none. Patient questioned that I had my 1st Pfizer vaccine on 27Mar2021 5:30pm. Patient reported that he had severe cramping to chest, his right wrist has locked up. His toes and calves were cramping, and he woke up this morning and his right side of the chest was starting to cramp but he rubbed it before it got started. He called to report this to make sure this was a symptom of the vaccine. He not sure it is causing it but this is the only thing that has changed. His other medications have not. Disclaimer provided: Side effects that have been reported with the Pfizer-BioNTech COVID-19 Vaccine include: muscle pain. These may not be all the possible side effects of the Pfizer-BioNTech COVID-19 Vaccine. Serious and unexpected side effects may occur. Pfizer-BioNTech COVID-19. Vaccine was still being studied in clinical trials.1. Consumer reporting on side effects; states he got the first dose of the Pfizer COVID 19 vaccine 27Mar2021 at 17:30PM in the left shoulder. Reports last night he had in both hands, fingers and his right ankle severe cramping. He was asking that was it normal. Adds normally cramps just last a minute and then they are gone but these were coming and not stopping. It happened twice and it was painful enough to bring tears to your eyes. Adds today he was fine. He is planning to get the second dose on 17Apr2021. Adds the shot is the only thing new and he is thinking that is the cause of the cramps. The outcome of the events was recovered on 30Mar2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: needed an EpiPen after receiving the Pfizer Covid vaccine; This is a spontaneous report from a contactable consumer or other non hcp.  A female patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 2021 as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, Caller states that her 32 y/o son has a histamine allergy. When he drinks wine "his face turns beet red." He is scheduled to get the Pfizer Covid vaccine soon. She is worried because she heard from a friend who' s daughter needed an EpiPen after receiving the Pfizer Covid vaccine ,the patient experienced needed an EpiPen after receiving the Pfizer covid vaccine on 2021 with outcome of unknown.    No follow-up attempts are possible; information about lot/batch cannot be obtained.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dysgeusia, Feeling abnormal, Nausea, Swelling
Clinical narrative: Existing Tinnitus made significantly worse beginning one day after vaccination; Bad taste in mouth; nausea; General spacey feeling in head; weakness; slight swelling in face/neck on the side the vaccine was given, lasting for about 6 hours after the vaccination was initially administered; This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and Expiration Date: not reported) via an unspecified route of administration, administered in right arm on 29Mar2021 at 09:45 (at the age of 38 years old) as dose number unknown, single for COVID-19 immunisation in a hospital. Medical history included eczema, prostatitis, childhood asthma, shellfish allergy- all from an unknown date; and ongoing tinnitus from 2016 (began about 5 years ago after a procedure to remove earwax with water pressure at a urgent card clinic). Prior to vaccination the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient did not receive any other vaccines in 4 weeks and has no medications received in 2 weeks. On 29Mar2021, the patient experienced slight swelling in face/neck on the side the vaccine was given, lasting for about 6 hours after the vaccination was initially administered. Then on 30Mar2021 at 23:00, the patient reported that existing tinnitus became significantly worse beginning one day after vaccination. If base line was 25/100 annoying, it is now 50/100 annoying (as reported). The patient did not suffer from general hearing loss. Furthermore, on 30Mar2021 at 23:00, the patient experienced bad taste in mouth, nausea, general spacey feeling in head, and weakness. No treatment was received for the adverse events. Since vaccination, the patient has not been tested for COVID-19. The patient recovered from slight swelling in face/neck on the side the vaccine was given on an unspecified date in Mar2021 but has not recovered from the rest of the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Existing Tinnitus made significantly worse beginning one day after vaccination; Bad taste in mouth; nausea; General spacey feeling in head; weakness; slight swelling in face/neck on the side the vaccine was given, lasting for about 6 hours after the vaccination was initially administered; This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and Expiration Date: not reported) via an unspecified route of administration, administered in right arm on 29Mar2021 at 09:45 (at the age of 38 years old) as dose number unknown, single for COVID-19 immunisation in a hospital. Medical history included eczema, prostatitis, childhood asthma, shellfish allergy- all from an unknown date; and ongoing tinnitus from 2016 (began about 5 years ago after a procedure to remove earwax with water pressure at a urgent card clinic). Prior to vaccination the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient did not receive any other vaccines in 4 weeks and has no medications received in 2 weeks. On 29Mar2021, the patient experienced slight swelling in face/neck on the side the vaccine was given, lasting for about 6 hours after the vaccination was initially administered. Then on 30Mar2021 at 23:00, the patient reported that existing tinnitus became significantly worse beginning one day after vaccination. If base line was 25/100 annoying, it is now 50/100 annoying (as reported). The patient did not suffer from general hearing loss. Furthermore, on 30Mar2021 at 23:00, the patient experienced bad taste in mouth, nausea, general spacey feeling in head, and weakness. No treatment was received for the adverse events. Since vaccination, the patient has not been tested for COVID-19. The patient recovered from slight swelling in face/neck on the side the vaccine was given on an unspecified date in Mar2021 but has not recovered from the rest of the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Anosmia, Fatigue, Nausea, Pain in extremity
Clinical narrative: arm was sore, tired and nauseous; cannot take the smell; arm was sore, tired and nauseous; arm was sore, tired and nauseous; This is a spontaneous report from a contactable consumer (patient). This consumer reported about herself that: A patient of an unspecified age and gender received dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported, NDC/UPC number and Expiry Date: Unknown) via an unspecified route of administration on 22Mar2021 11:40, as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced arm was sore, tired and nauseous and cannot take the smell. The patient stated that on last Monday 22Mar2021, received the Pfizer COVID Vaccine at 11:40 and had no problems, but at night arm was sore and was talking about the side effects now was tired and nauseous. But the real call was that cannot take the smell, the consumer asked if it was that part one of the side effects. The consumer also asked some questions about the vaccine that did you know anything about this vaccine side effects. Consumer was informed about Pfizer Medical information department and was provided with the number. Product details (LOT#, NDC#, UPC# and Expiration date) and Pharmacy details were not available over the call as the consumer hung up the call abruptly. The clinical outcome of all the events was reported as unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be requested.
Sex: M
Vaccine: COVID19
Symptoms: Swelling, Vaccination site pain
Clinical narrative: swelling under the armpit; muscle pain at the site of injection; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 2 patients. This is the second of 2 reports. A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced swelling under the armpit and muscle pain at the site of injection after receiving the second dose of the Pfizer covid-19 vaccine. There was no swelling at the site of the injection, only swelling under the armpit on the same arm the injection was given. The swelling under the armpit was continuing. The outcome of the event swelling under the armpit was not recovered (reported as continuing) and outcome of event some muscle pain at the site of injection was unknown. The reporter was querying if these were anything serious to be concerned about, how long could it last, what should be done about it and should the doctor be notified if it does not go away.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021361736 Same reporter and drug, similar event, different patient.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: headaches; chills; little bit of a temperature; body ache/pain; This is a spontaneous report from a contactable consumer (patient).   A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EP7534), via an unspecified route of administration, administered in Left arm on 25Mar2021 19:00 (at the age of 54 year old) as dose 2, single for COVID-19 immunisation.  The patient medical history, family history and concomitant medications were reported as none. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number EN6205 , via an unspecified route of administration in left hand on 04Mar2021, as single dose for COVID-19 immunization. On 25Mar2021, she got the second shot of the vaccine. The first day and a half after the vaccine, on 26Mar2021, she was having chills, a little bit of a temperature, body aches and she was kind of okay but had pains here and there. On 28Mar2021 she had headache, where it was not bad, as the day went on, it got worse. For the past 2 days (29Mar2021, 30Mar2021), she has been having bad headaches. Last night (on 30Mar2021 night) she took two Advil (strength 200mg, Lot Number: 3532417, expiry: Feb 2022) at 1:00 and woke up at 5:00. Even though she slept four hours, her head was still hurting. At 7:00, in the morning on 31Mar2021, she took two extra strength Tylenol (500mg each, Lot Number: SBA051, expiry: Dec 2021) and still has headache at the time of report. No relevant test had done. The outcome of the event headache was not recovered and of other events was unknown.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: achiness; low grade fever  (97.3°F to 99.4°F); headaches; tiredness; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and Expiration Date: not reported) via an unspecified route of administration on 29Mar2021 as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced achiness, low grade fever (97.3°F to 99.4°F), headaches and tiredness. The patient mentioned she would be having a dinner with some kids and was seeking information on whether she should be around kids or to just cancel. Outcome of all events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Urticaria, Vaccination site pain
Clinical narrative: pain and soreness at the site of injection in his left arm; break out in hives; This is a spontaneous report from a contactable consumer (patient). A 31-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EN6206, Expiration date was not reported), via an unspecified route of administration (administered on the left arm) on 24Mar2021 at 12:15 (at the age of 31-years-old) as dose 1, single for COVID-19 immunisation. The patient's medical history was not reported. The patient has no concomitant medications since the patient didn't receive any medications in two weeks. The patient previously took CODINE and experienced allergy. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient has not been diagnosed with COVID-19. On 27Mar2021 at 12:00, the patient experienced pain and soreness at the site of injection in his left arm and break out in hives. It was further reported that the hives have gotten progressively worse, and the outbreaks happen at random. The patient believed that the events were reaction to the vaccine. The events resulted in emergency room visit. Therapeutic measures were taken as a result of the events which included Prednisone and diphenhydramine hydrochloride (BENADRYL). The patient underwent lab tests and procedures which included Polymerase chain reaction (PCR) with pending results on 31Mar2021. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Pain, Pyrexia
Clinical narrative: body aches; joint pain; fever; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age (Age: 32; unit: Unknown) and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration Date was not reported), via an unspecified route of administration on 28Mar2021 15:00, as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced fever on 30Mar2021, body aches, joint pain on an unspecified date. Patient was asking if paracetamol (TYLENOL) can be taken for cold-like symptoms. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone disorder, Exposure to SARS-CoV-2, Gait disturbance, Impaired driving ability
Clinical narrative: her knee was in "out of control pain"; joint stiffness in this knee for a while now; she has to wear a brace and walk with crutches/ Having to use brace and crutches/Leg giving her lots of problems, couldn't hardly walk; hasn't been able to drive or work for the past 2 weeks; hasn't been able to drive or work for the past 2 weeks; X-rays show she has bone touching bone in her knee; she and her husband were around an asymptomatic covid patient; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) via an unspecified route of administration, in left arm, on 19Mar2021 (at the age of 64-years-old), at dose 1, single for covid-19 immunization. Medical history included preexisting issue with her knee, like arthritis, wasn't bothering her before, just stiff.  The patient's concomitant medications were not reported. On 20Mar2021, the patient experienced her knee was in out-of-control pain, joint stiffness in this knee for a while now, she has to wear a brace and walk with crutches; leg giving her lots of problems. The patient couldn't hardly walk, hasn't been able to drive or work for the past 2 weeks, her x-rays showed bone touching bone in her knee on Mar2021. It was also reported that she and her husband were around an asymptomatic covid patient after first vaccination in Mar2021. The patient underwent orthopedic office twice for the events leg was giving her a lot of problems. The patient underwent lab tests and procedures which included x-ray showed bone touching bone in her knee on Mar2021. Therapeutic measures included: treating her pain with anti-inflammatories, Tylenol and ice, and the pain is improving. The outcome of the event knee pain was recovering, and outcome of other events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Joint stiffness, Loss of personal independence in daily activities, X-ray
Clinical narrative: her knee was in "out of control pain"; joint stiffness in this knee for a while now; she has to wear a brace and walk with crutches/ Having to use brace and crutches/Leg giving her lots of problems, couldn't hardly walk; hasn't been able to drive or work for the past 2 weeks; hasn't been able to drive or work for the past 2 weeks; X-rays show she has bone touching bone in her knee; she and her husband were around an asymptomatic covid patient; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) via an unspecified route of administration, in left arm, on 19Mar2021 (at the age of 64-years-old), at dose 1, single for covid-19 immunization. Medical history included preexisting issue with her knee, like arthritis, wasn't bothering her before, just stiff.  The patient's concomitant medications were not reported. On 20Mar2021, the patient experienced her knee was in out-of-control pain, joint stiffness in this knee for a while now, she has to wear a brace and walk with crutches; leg giving her lots of problems. The patient couldn't hardly walk, hasn't been able to drive or work for the past 2 weeks, her x-rays showed bone touching bone in her knee on Mar2021. It was also reported that she and her husband were around an asymptomatic covid patient after first vaccination in Mar2021. The patient underwent orthopedic office twice for the events leg was giving her a lot of problems. The patient underwent lab tests and procedures which included x-ray showed bone touching bone in her knee on Mar2021. Therapeutic measures included: treating her pain with anti-inflammatories, Tylenol and ice, and the pain is improving. The outcome of the event knee pain was recovering, and outcome of other events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash macular
Clinical narrative: fixed drug eruption of the left wrist which she describes as a small circular rash spot; This is a spontaneous report from a contactable nurse received via Medical Information Team. A "20" (age unit not specified) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced a fixed drug eruption of the left wrist which she describes as a small circular rash spot on the patient's left wrist, with no other symptoms. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: swelling to the right side of her face/right sided facial swelling; This is a spontaneous report from a contactable consumer (parent) and another consumer via medical information team and a Pfizer Sponsored program. A 16-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: ER8733, expiration date was not reported) via an unspecified route of administration, in left arm, on 29Mar2021 09:45 (at the age of 16-years-old), at dose 1, single for covid-19 immunization. Medical history included ongoing medullary sponge kidney from Feb2005; she was born with it, ongoing celiac disease from Feb2017, ongoing urinary tract infection (still has the infection, it didn't go away) and heavy periods. Concomitant medications included ethinyl estradiol, etonogestrel (NUVARING) taken for heavy periods from 20Mar2021 and ongoing; cefalexin taken for urinary tract infection from 20Mar2021 to 28Mar2021 and she took supplements (unspecified). The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. The patient had no additional vaccines administered on same date of vaccination and no history of previous immunization with bnt162b2. On 30Mar2021 09:45, 24 hours after vaccination, the patient experienced swelling to the right side of her face/right sided facial swelling. The reporter assessed the event as non-serious. There were no investigation assessments. Therapeutic measures were taken included Benadryl and it did not make any difference to her. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Increased upper airway secretion
Clinical narrative: her throat had mucus or phelgm; her teeth were shivering; her arm was a little bit red; This is a spontaneous report from a non-contactable consumer (parent). A 16-year-old female patient received BNT162B2 (PFZIER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. Medical history included anaphylactic allergy to treenuts. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced her throat had mucus or phlegm, her teeth were shivering, and her arm was a little bit red. Benadryl was given as a treatment for the events. The patient is scheduled to take the second dose of the vaccine. The parent wanted to know if the first and second dose of the vaccine is identical in composition and in strength. The parent of the patient wanted to know if they should expect the same type of reaction for the second dose of the vaccine. He wanted to know if there would be exponentially worse reactions or less reactions because the body is already familiar with the vaccine with the second dose of the vaccine. Is it better to eat before and after getting vaccinated to dilute the vaccine out in the body? He wanted to know if it is ok to give Benadryl or Zyrtec before vaccination and what is the percentage in immunity after the first dose of the vaccine. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Feeling hot, Flushing, Hyperhidrosis
Clinical narrative: I started perspiring in the forehead; I am very hot; I had dark pink flushing on my right cheek and neck; I started perspiring in the forehead; I am very hot; This is a spontaneous report from a contactable other HCP (nurse, the patient) reported. A patient of an unknown age and gender received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, batch/lot number: unknown, expiry date: unknown), via an unknown route of administration on 24Mar2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medication was not reported. On 24Mar2021, the patient started perspiring in the forehead, the patient was very hot; patient had dark pink flushing on patient's right cheek and neck; irritation with lot of medications like antibiotics (Unspecified medications). Nurse stated, had the first dose of the vaccine (Covid Vaccine) last Wednesday just this past Wednesday and while the patient was in the waiting room like 20 minutes after the immunization the patient started perspiring in the forehead. The nurse manager came over and asked nurse if I am okay and I said no I am very hot so they took me into a room and I had dark pink flushing on my right cheek and neck'. The patient was so hot they prepare half an hours and they gave me Benadryl 25 mg. The patient do have a history of some kind of irritation with lot of medications like antibiotics (Unspecified medications). The patient never had an allergic reaction to the vaccine, the patient did not experience anaphylaxis at this time or breathing problem. The patient received treatment for events. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch cannot be obtained.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine, Nausea
Clinical narrative: Migraine that was very faint before had the COVID-19 vaccine, just got worst; Feelings of nausea; Headache again; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 30Mar2021 at 14:45 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included sleep apnea and migraine headache. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included acetylsalicylic acid/ caffeine/ paracetamol (EXCEDRIN) for migraine headache and from unknown start date. The patient previously received codeine (MANUFACTURER UNKNOWN) and experienced drug allergy. On 30Mar2021 at 17:30, the patient experienced migraine that was very faint before had the COVID-19 vaccine which just got worst along with feelings of nausea that got worst throughout the evening & into the morning of 31Mar2021 and headache again occurred. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events migraine that was very faint before had the COVID-19 vaccine, just got worst, feelings of nausea and headache again were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Paraesthesia, Paraesthesia oral, Rash
Clinical narrative: Tingling on face and lips; Tingling on face and lips; Redness; Rash; This is a spontaneous report from a contactable consumer (patient) via medical information team. A female patient of an unspecified age (also reported as aged 61) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) via an unspecified route of administration, on 29Mar2021 15:00, at dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced a little face tingling with a little redness and rash on the day before the time of report (30Mar2021) and then had some lip tingling on the day of report (31Mar2021). The outcome of the events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Eye disorder, Fatigue, Headache
Clinical narrative: Chills; Vomiting and dry heaves; Vomiting and dry heaves; Pounding headache; Joint pains; Eyes (saw crazy designs on walls) felt very shakey inside; Wanted to was sleep; fatigue; nausea; This is a spontaneous report from a contactable consumer (patient).  A 79-years-old non-pregnant female patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Lot number: POD 30) via an unspecified route of administration, administered in arm right on 26Mar2021 10:45 AM (age at vaccination: 79 years and non-pregnant at the time of vaccination) as dose 2, single and first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number: unknown) via an unspecified route of administration, administered in arm right on 05Mar2021 10:00 AM (age at vaccination: 79 years non-pregnant at the time of vaccination) as dose 1, single for covid-19 immunisation. The patient's medical history included rheumatoid arthritis, osteoarthritis, renal disorder, emphysema, calcification metastatic, lung disorder, hypothyroidism, gastroesophageal reflux disease, hypersensitivity. Allergies to medications, food, or other products included Sulfur, Staydol nasal spray anesthetic. Prior to vaccination, patient was diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Other facility where the most recent COVID-19 vaccine was administered. Concomitant or list of other medications the patient received within 2 weeks of vaccination included hydroxychloroquine, famotidine, albendazole (Morezole), folic acid. On 26Mar2021 19:00 the patient experienced chills, nausea, vomiting & dry heaves, pounding headache, joint pains, fatigue, eyes (saw crazy designs on walls) felt very shakey inside. Eye doctor said what was happening with her eyes was a result of having gotten the COVID vaccine. Patient had the COVID-19 virus in late October. After quarantine, patient was tested and found to have antibodies in her system. Told to wait 90 days before patient got COVID vaccine - which patient did. Doctor said the antibodies were probably still in her body and that's why patient got such a bad reaction. Patient was never so sick. All patient wanted to was sleep. Adverse event results Doctor or other healthcare professional office/clinic visit. Patient was received treatment for the adverse event nausea. The outcome of events was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Retching, Somnolence, Vomiting
Clinical narrative: Chills; Vomiting and dry heaves; Vomiting and dry heaves; Pounding headache; Joint pains; Eyes (saw crazy designs on walls) felt very shakey inside; Wanted to was sleep; fatigue; nausea; This is a spontaneous report from a contactable consumer (patient).  A 79-years-old non-pregnant female patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Lot number: POD 30) via an unspecified route of administration, administered in arm right on 26Mar2021 10:45 AM (age at vaccination: 79 years and non-pregnant at the time of vaccination) as dose 2, single and first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number: unknown) via an unspecified route of administration, administered in arm right on 05Mar2021 10:00 AM (age at vaccination: 79 years non-pregnant at the time of vaccination) as dose 1, single for covid-19 immunisation. The patient's medical history included rheumatoid arthritis, osteoarthritis, renal disorder, emphysema, calcification metastatic, lung disorder, hypothyroidism, gastroesophageal reflux disease, hypersensitivity. Allergies to medications, food, or other products included Sulfur, Staydol nasal spray anesthetic. Prior to vaccination, patient was diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Other facility where the most recent COVID-19 vaccine was administered. Concomitant or list of other medications the patient received within 2 weeks of vaccination included hydroxychloroquine, famotidine, albendazole (Morezole), folic acid. On 26Mar2021 19:00 the patient experienced chills, nausea, vomiting & dry heaves, pounding headache, joint pains, fatigue, eyes (saw crazy designs on walls) felt very shakey inside. Eye doctor said what was happening with her eyes was a result of having gotten the COVID vaccine. Patient had the COVID-19 virus in late October. After quarantine, patient was tested and found to have antibodies in her system. Told to wait 90 days before patient got COVID vaccine - which patient did. Doctor said the antibodies were probably still in her body and that's why patient got such a bad reaction. Patient was never so sick. All patient wanted to was sleep. Adverse event results Doctor or other healthcare professional office/clinic visit. Patient was received treatment for the adverse event nausea. The outcome of events was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Lymphadenopathy, Myalgia, Pain, Pyrexia
Clinical narrative: Muscle pain; fever (up to 102 F); Pain and swelling in left axillary lymph node; Pain and swelling in left axillary lymph node; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EN6199 and expiration date: not reported), via an unspecified route of administration, in Left Arm, on 30Mar2021 at 13:45 (at the age of 46-year-old) as DOSE 2, SINGLE for covid-19 immunization.  Medical history included hypothyroidism, hay fever, migraine and penicillin allergy. The patient's concomitant medications included unspecified medication. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL3248 and expiration date: not reported), via an unspecified route of administration, in Left Arm, on 09Mar2021 at 13:45 (at the age of 46-year-old) as DOSE 1, SINGLE for covid-19 immunization. The patient was not pregnant at time of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID -19 vaccine. The patient received other medications (unspecified) within 2 weeks of vaccination.  The Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.  The patient experienced Muscle pain, Pain and swelling in left axillary lymph node, fever (up to 102 F) on 30Mar2021 at 18:00. No treatment was received for the events. The outcome of the events was recovering at time of report.   No follow-up attempts are needed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Feeling abnormal
Clinical narrative: extreme fatigue; headache; nausea; joint & muscle pain; joint & muscle pain; chills; slight 1 degree temp; slight sore throat; tender glands; feeling very unwell; foggy brain.; tender site for 1 day; This is a spontaneous report from a contactable consumer (patient). A 74-year-old non pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot number: EN6208), via an unspecified route of administration in the right arm on 11Mar2021 (at the age of 74-years-old) as dose 2, single for COVID-19 immunization. Medical history and concomitant medication reported as yes.  The patient previously received flu vaccine but never had a flu. The patient had allergies to medications, food, or other products. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot number: EL9266), via an unspecified route of administration in the right arm on 18Feb2021 at 11:30 and experienced very tired and slept for about 10-12 hours each day. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not been tested for COVID-19. The patient had not received any other vaccines within four weeks prior to the vaccination. The patient underwent body temperature test and result was reported as slight 1 degree temp. The patient experienced tender site for 1 day on 11Mar2021 and the patient experienced extreme fatigue, headache, nausea, joint and muscle pain, chills, slight fever, slight sore throat, tender glands, feeling very unwell, had very foggy brain on 15Mar2021 at 16:00 (Reported as Day 3). Therapeutic measures were not taken for the events. The clinical outcome of the events site tender, extreme fatigue, headache, nausea, joint and muscle pain, chills, slight fever, slight sore throat, tender glands, feeling very unwell, had very foggy brain was resolved in Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Myalgia, Nausea, Oropharyngeal pain
Clinical narrative: extreme fatigue; headache; nausea; joint & muscle pain; joint & muscle pain; chills; slight 1 degree temp; slight sore throat; tender glands; feeling very unwell; foggy brain.; tender site for 1 day; This is a spontaneous report from a contactable consumer (patient). A 74-year-old non pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot number: EN6208), via an unspecified route of administration in the right arm on 11Mar2021 (at the age of 74-years-old) as dose 2, single for COVID-19 immunization. Medical history and concomitant medication reported as yes.  The patient previously received flu vaccine but never had a flu. The patient had allergies to medications, food, or other products. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot number: EL9266), via an unspecified route of administration in the right arm on 18Feb2021 at 11:30 and experienced very tired and slept for about 10-12 hours each day. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not been tested for COVID-19. The patient had not received any other vaccines within four weeks prior to the vaccination. The patient underwent body temperature test and result was reported as slight 1 degree temp. The patient experienced tender site for 1 day on 11Mar2021 and the patient experienced extreme fatigue, headache, nausea, joint and muscle pain, chills, slight fever, slight sore throat, tender glands, feeling very unwell, had very foggy brain on 15Mar2021 at 16:00 (Reported as Day 3). Therapeutic measures were not taken for the events. The clinical outcome of the events site tender, extreme fatigue, headache, nausea, joint and muscle pain, chills, slight fever, slight sore throat, tender glands, feeling very unwell, had very foggy brain was resolved in Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tenderness, Vaccination site pain
Clinical narrative: extreme fatigue; headache; nausea; joint & muscle pain; joint & muscle pain; chills; slight 1 degree temp; slight sore throat; tender glands; feeling very unwell; foggy brain.; tender site for 1 day; This is a spontaneous report from a contactable consumer (patient). A 74-year-old non pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot number: EN6208), via an unspecified route of administration in the right arm on 11Mar2021 (at the age of 74-years-old) as dose 2, single for COVID-19 immunization. Medical history and concomitant medication reported as yes.  The patient previously received flu vaccine but never had a flu. The patient had allergies to medications, food, or other products. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot number: EL9266), via an unspecified route of administration in the right arm on 18Feb2021 at 11:30 and experienced very tired and slept for about 10-12 hours each day. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not been tested for COVID-19. The patient had not received any other vaccines within four weeks prior to the vaccination. The patient underwent body temperature test and result was reported as slight 1 degree temp. The patient experienced tender site for 1 day on 11Mar2021 and the patient experienced extreme fatigue, headache, nausea, joint and muscle pain, chills, slight fever, slight sore throat, tender glands, feeling very unwell, had very foggy brain on 15Mar2021 at 16:00 (Reported as Day 3). Therapeutic measures were not taken for the events. The clinical outcome of the events site tender, extreme fatigue, headache, nausea, joint and muscle pain, chills, slight fever, slight sore throat, tender glands, feeling very unwell, had very foggy brain was resolved in Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Ear swelling, Miliaria, Rash, Rash erythematous, Rash macular
Clinical narrative: she had a couple spots on the back of her thigh; her ears are swollen red and itchy; there is a heat to the rash; she started getting a hot, red, swollen, itchy rash on the palm of her hands; itchy rash/her ears are swollen red and itchy/the other hand is still red swollen and itchy; she had a rash in one palm of the hand and the next day had it on the other hand and then her knee, ear/it has worsened because it is in a lot more areas now; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EP6955; Expiration Date: 30Jun2021), via an unspecified route of administration on 22Mar2021 (at the age of 41 year old) as dose 1, single for COVID-19 immunisation. Medical history and concomitant medications were reported as none. On 22Mar2021, she got the first dose of the vaccine. On 24Mar2021, she started getting a hot, red, swollen, itchy rash on the palm of one hand, then next day (25Mar2021), found on other hand, then it spread to one of her knees, she had a couple spots on the back of her thigh, also her ears were swollen red and itchy. She has been to the urgent care, dermatologist, and pharmacy, where they told her to call Pfizer. Patient confirmed that she has not been in contact with anything, has been staying in home, has not had any new soaps or doesn't had anything that were linking the reaction to the vaccine. The biggest thing she worries about is getting the second dose. She was asking, should she get the second dose and it had been a week and a half since she got the first vaccination. At the time of report, the first side it started on, where her left had not started, so the initial side it started on is much better but that took a week. Patient would say rash has worsened, because it is in a lot more areas at the time of report.  Her both ears were red, swollen and itchy and the other hand is still red swollen and itchy and there is a heat to the rash. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: she had a couple spots on the back of her thigh; her ears are swollen red and itchy; there is a heat to the rash; she started getting a hot, red, swollen, itchy rash on the palm of her hands; itchy rash/her ears are swollen red and itchy/the other hand is still red swollen and itchy; she had a rash in one palm of the hand and the next day had it on the other hand and then her knee, ear/it has worsened because it is in a lot more areas now; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EP6955; Expiration Date: 30Jun2021), via an unspecified route of administration on 22Mar2021 (at the age of 41 year old) as dose 1, single for COVID-19 immunisation. Medical history and concomitant medications were reported as none. On 22Mar2021, she got the first dose of the vaccine. On 24Mar2021, she started getting a hot, red, swollen, itchy rash on the palm of one hand, then next day (25Mar2021), found on other hand, then it spread to one of her knees, she had a couple spots on the back of her thigh, also her ears were swollen red and itchy. She has been to the urgent care, dermatologist, and pharmacy, where they told her to call Pfizer. Patient confirmed that she has not been in contact with anything, has been staying in home, has not had any new soaps or doesn't had anything that were linking the reaction to the vaccine. The biggest thing she worries about is getting the second dose. She was asking, should she get the second dose and it had been a week and a half since she got the first vaccination. At the time of report, the first side it started on, where her left had not started, so the initial side it started on is much better but that took a week. Patient would say rash has worsened, because it is in a lot more areas at the time of report.  Her both ears were red, swollen and itchy and the other hand is still red swollen and itchy and there is a heat to the rash. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.