chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Drowsiness; This is a spontaneous report from a contactable consumer or other non hcp (patient himself). A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247, expiration date not reported), via an unspecified route of administration, administered on the left arm on 11Mar2021 12:00 (at the age of 44-years-old), as first dose, single dose for COVID-19 immunisation. There were no pertinent medical history and concomitant medications. Patient has no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient experienced drowsiness on 11Mar2021 14:00. No treatment was received as a result of the event. Event did not result to physician office visit or urgent care. The outcome of event was recovered on an unspecified date.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Limb mass
Clinical narrative: aches and pain in left shoulder, pain in left thumb joint; little bubble on her left forefinger by the tip; This is a spontaneous report from a contactable consumer (patient).  An 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Mar2021 (Batch/Lot number was not reported) as 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced aches and pain in left shoulder, pain in left thumb joint that she had to tape up, a little bubble on her left forefinger by the tip. She took 2 paracetamol (TYLENOL). All these symptoms appeared on the left side which was also the side she received the injection. The aches have subsided, gotten better; however, she can't lay on her left shoulder. Her 2nd dose is scheduled for 29Mar2021. Outcome of event "aches and pain in left shoulder, pain in left thumb joint" was recovering, while other event was unknown.  Follow-up attempts have been completed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Injection site sore; Intense headache; This is a spontaneous report from a contactable consumer (patient). A 28-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 11Mar2021 15:30 (Lot Number: EN6204) (at the age of 28-years-old) as 1st dose, single dose for Covid-19 immunisation.  Medical history included allergies: latex, tree nuts, shellfish, environmental allergens. The patient did not receive other vaccines in four weeks. Concomitant medication(s) included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); diphenhydramine hydrochloride (BENADRYL); colecalciferol (D3); lamotrigine (LAMICTAL); cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and zinc, all taken for an unspecified indication, start and stop date were not reported.  The patient experienced injection site sore and intense headache on 12Mar2021. No treatment was received for the adverse events. The patient was not tested for COVID post vaccination. Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hair disorder
Clinical narrative: A person was having clumps of her hair were coming out after having the COVID-19 vaccine; This is a spontaneous report from a contactable nurse via medical information team. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter stated that she had heard other people who are having this adverse event. Her friend saw on TV that a person was having clumps of her hair were coming out on an unspecified date after having the COVID-19 vaccine but she isn't sure which vaccine the news is pertaining to. The outcome of the evet was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis, Rash pruritic
Clinical narrative: She's developed an itchy rash, like dermatitis, "on my upper arms and from my kneecaps down to my ankle; She's developed an itchy rash, like dermatitis, "on my upper arms and from my kneecaps down to my ankle; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not reported), via an unspecified route of administration on an unspecified date (at an unspecified age) at 2nd dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took paracetamol (TYLENOL) for small rash that didn't itch, feeling tired, and headache. Historical vaccine included first dose of BNT162B2 received on an unspecified date for COVID-19 immunization, where the patient experienced small rash that didn't itch, feeling tired, and headache. The patient treated her symptoms by taking 2 paracetamol (TYLENOL), and symptoms resolved. The patient reported of receiving both doses of Pfizer COVID-19 vaccine. But after the second dose, the patient developed an itchy rash, like dermatitis, on the patient's upper arms and from her kneecaps down to her ankle. The patient received a steroid cream as a treatment for the events. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Vomiting
Clinical narrative: nausea; vomit; fatigue; This is a spontaneous case received from a contactable consumer (patient). A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient reported that she experienced side effects 5 days after the administration of the second dose of the Pfizer's COVID-19 vaccine, she started with nausea and vomit for 24 hours and fatigue for several days. It was reported that now she feels fine. The outcome of events was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: he had a little bit of a funny taste which tasted like metal; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program COVAX US Support. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient was concerned about the minor reaction that he experienced with the first dose of the Pfizer COVID-19 vaccine. After 20 minutes or so while patient was walking back to his car, he had a little bit of a funny taste which tasted like metal. It was funky. It lasted 30 seconds and went away. Outcome of event was recovered on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Pain in extremity, Peripheral coldness
Clinical narrative: cold feeling in her arms; after the second dose it has become more painful; after the second dose it has become more painful; This is a spontaneous report from a contactable consumer (patient herself). An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration, on 27Jan2021, as 2nd dose, single dose, for COVID -19 immunisation. The patient's medical history included pain in her arm before receiving the vaccine.  The patient's concomitant medications were not reported. On unspecified date in 2021, it was reported that since the last two weeks or 10 days or so, the patient experienced a cold feeling in her arms almost everyday once a day in both arms. She stated that before receiving the vaccine she would get pain in her arms but after the second dose it has become more painful and then went away. The patient queried if that was going to be a long-term effect of the vaccine. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Coronavirus test, Disease recurrence, Feeling jittery, Restless legs syndrome
Clinical narrative: feet restless and jittery; feet restless and jittery; Increased high anxiety, difficulty calming down; legs jittery/feet jittery; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration administered in left arm on 13Mar2021 at 14:30 (at 72 years old) as single dose for COVID-19 immunization. There were no other vaccinations within 4 weeks prior to the first dose of BNT162B2. Medical history included diabetic, hypothyroid, high blood pressure, gastroesophageal reflux disease (GERD), chronic kidney disease, and restless legs; all from unspecified date. Concomitant medications included dioxybenzone/padimate o (SUNGARD) 12.5 mg x2/day and glimepiride 2 mg x2/day, both from unspecified date for unspecified indication. It was unknown if the patent had COVID prior to vaccination. The patient was tested for COVID post vaccination (results unknown). The patient increased high anxiety, legs jittery, feet restless and jittery. The patient had difficulty calming down. All events were non-serious on 13Mar2021 at 17:00. The patient took muscle relaxant, tizanidine 4 mg, but had very little help. No treatment received for other events. Outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch no cannot be obtained.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Nausea, Pain, Pyrexia
Clinical narrative: body aches; headaches; fever reaching as high as 102.2; Severe nausea; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscular route, administered in left arm on 16Jan2021 (at 26 years old) as single dose for COVID-19 immunization. There were no other vaccinations within 4 weeks prior to the first dose of BNT162B2. Medical history included seasonal allergies and asthma both from unspecified date. Concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (Lot number: EJ16851) via intramuscular route, administered in left arm on 26Dec2020 at 16:45 (at 26 years old) as single dose for COVID-19 immunization. The patient did not have COVID prior to vaccination. The patient was tested for COVID post vaccination. Nasal swab for COVID was negative. On 17Jan2021 at 02:00, approximately 12-16 hours after the second dose, the patient experienced body aches, headaches, fever reaching as high as 102.2 lasting for 3 days, and severe nausea for 6 days; all non-serious. No treatment received for the events. Outcome of the events was recovered on unspecified date in Jan2021.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: body aches; headaches; fever reaching as high as 102.2; Severe nausea; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscular route, administered in left arm on 16Jan2021 (at 26 years old) as single dose for COVID-19 immunization. There were no other vaccinations within 4 weeks prior to the first dose of BNT162B2. Medical history included seasonal allergies and asthma both from unspecified date. Concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (Lot number: EJ16851) via intramuscular route, administered in left arm on 26Dec2020 at 16:45 (at 26 years old) as single dose for COVID-19 immunization. The patient did not have COVID prior to vaccination. The patient was tested for COVID post vaccination. Nasal swab for COVID was negative. On 17Jan2021 at 02:00, approximately 12-16 hours after the second dose, the patient experienced body aches, headaches, fever reaching as high as 102.2 lasting for 3 days, and severe nausea for 6 days; all non-serious. No treatment received for the events. Outcome of the events was recovered on unspecified date in Jan2021.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness
Clinical narrative: Dizziness; Weakness; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6202, Expiry Date: unknown) via an unspecified route of administration administered in upper left arm on 23Feb2021 11:00 (at the age of 75-years) as single dose for covid-19 immunization. The patient medical history included ongoing chronic obstructive pulmonary disease she was diagnosed years ago and she was just now receiving since Jun2020 oxygen at night, ongoing cardiac disorder states it was years ago. There was no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient previously received the first dose of bnt162b2 (Lot Number: EM9810) via an unspecified route of administration administered in upper left arm on 02Feb2021 11:00 (at the age of 75-year-old) as single dose for COVID-19 immunization. Patient stated that she had no side effects with the first shot. On 23Feb2021 13:30 after the second dose of vaccination, the patient experienced dizziness and weakness started after that on same day for 24hours. Patient stated the dizziness hit her first and then the weakness came after but started that same day. Patient not sure if she should even report the weakness as when you're dizzy you usually feel week. Patient clarified that the weakness and dizziness stopped on 24Feb2021. Patient stated she had the vaccine card and it said COVID 19 PFIZER BIONTECH. Patient stated she did not see a dose listed for either shot. There was no any relevant tests performed. AE's dose not resulted in physician office and emergency room visit. As for treatment she sat down, pretty much moved from chair to chair and couldn't do much of anything. Outcome of events was recovered on 24Feb2021.  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Insomnia, Myalgia
Clinical narrative: red rash on my inner thighs; pain in the injection site; couldn't go back to sleep; chills; my throat hurt; tired; muscle pain; my arm hurt; pain in my shoulder is much improved though; This is a spontaneous report from a contactable consumer (patient). A 72-year-old non pregnant female patient received second dose of BNT162B2 (Solution for injection, lot number: EN6199 expiry date: unknown) via an unspecified route of administration in Right arm on 08Mar2021 10:45 as a single dose for Covid-19 immunization. Medical history included high blood pressure and cholesterol, she had diverticulosis, but it was not active at the time of this report. She did not have any known allergies. Concomitant medications in two weeks included Amlodepine, Rosuvastatin and unspecified prescription medicine for high blood pressure and cholesterol. The patient previously received first dose of BNT162B2 (Solution for injection, lot number: EN6201 expiry date: unknown) via an unspecified route of administration in Left arm on 15Feb2021 14:00, as a single dose for Covid-19 immunization. The patient did not receive any other vac-cine in four weeks of suspect vaccine. It was stated that the first shot caused soreness in her arm where the injection was made, which went away after about three days. After about 10 days, she developed a rash on both inner thighs. It cleared up in about three days. The patient also had a rash on the left side of face about the same time. She received second shot two days prior to this report, on 08Mar2021, the day of vaccination, the patient experienced that her arm hurt, and she woke up about 4:30 am and could not go back to sleep because it hurt so. She had chills that day, her throat hurt, she felt so tired, and had muscle pain. On 10Mar2021 the day of this report, two days after the shot, she had the red rash on inner thighs again, but the other symptoms (except for the pain in the injection site) were gone. The pain in her shoulder was much improved though. She did take one acetaminophen a day prior to this report in afternoon. The patient did not have Covid prior to vaccination and was not tested for it post vaccination. The outcome of the events of was resolving.  No follow-up attempts were Possible. No further information was expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain in extremity, Rash erythematous, Vaccination site pain
Clinical narrative: red rash on my inner thighs; pain in the injection site; couldn't go back to sleep; chills; my throat hurt; tired; muscle pain; my arm hurt; pain in my shoulder is much improved though; This is a spontaneous report from a contactable consumer (patient). A 72-year-old non pregnant female patient received second dose of BNT162B2 (Solution for injection, lot number: EN6199 expiry date: unknown) via an unspecified route of administration in Right arm on 08Mar2021 10:45 as a single dose for Covid-19 immunization. Medical history included high blood pressure and cholesterol, she had diverticulosis, but it was not active at the time of this report. She did not have any known allergies. Concomitant medications in two weeks included Amlodepine, Rosuvastatin and unspecified prescription medicine for high blood pressure and cholesterol. The patient previously received first dose of BNT162B2 (Solution for injection, lot number: EN6201 expiry date: unknown) via an unspecified route of administration in Left arm on 15Feb2021 14:00, as a single dose for Covid-19 immunization. The patient did not receive any other vac-cine in four weeks of suspect vaccine. It was stated that the first shot caused soreness in her arm where the injection was made, which went away after about three days. After about 10 days, she developed a rash on both inner thighs. It cleared up in about three days. The patient also had a rash on the left side of face about the same time. She received second shot two days prior to this report, on 08Mar2021, the day of vaccination, the patient experienced that her arm hurt, and she woke up about 4:30 am and could not go back to sleep because it hurt so. She had chills that day, her throat hurt, she felt so tired, and had muscle pain. On 10Mar2021 the day of this report, two days after the shot, she had the red rash on inner thighs again, but the other symptoms (except for the pain in the injection site) were gone. The pain in her shoulder was much improved though. She did take one acetaminophen a day prior to this report in afternoon. The patient did not have Covid prior to vaccination and was not tested for it post vaccination. The outcome of the events of was resolving.  No follow-up attempts were Possible. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes; This is a spontaneous report from a contactable Consumer or other non-health professional (reported for daughter). A female patient of unknown age (Age:18; unit: Unknown) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number and expiration date: not reported) via an unknown route of administration on an unknown date in 2021 (reported as a week ago) as single dose for COVID-19 immunization. Patient received first dose of BNT162B2 (solution for injection, Batch/Lot number and expiration date: not reported) via an unknown route of administration on an unknown date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, the caller was calling regarding the covid vaccine. The caller's daughter was 18, the whole family got vaccinated, when the caller's daughter got the first shot her armpit lymph nodes were swollen and then it went away on an unknown date. Now the caller's daughter noticed that, underneath her jaw her lymph nodes were swollen. The caller made an appointment to go to the doctor a little bit later. The caller wants to know this could be a side effect even though she took the second vaccine a week ago. The first time the lymph nodes were inflamed under the caller's daughter's arms, but the caller's daughter just noticed this swelling under her neck/jaw area, so the reporter was unsure how long it has been like this. The outcome of the event was unknown.   No follow-up attempts were possible; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Body height, Ocular hyperaemia
Clinical narrative: blood shot spot in her eye; This is spontaneous report from a contactable consumer (Patient). This 65-year-old female consumer (patient) reported that she received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, 0.3mL, Formulation: Solution for injection, Batch/Lot number: EN6198) via an unspecified route of administration into the right arm on 09Mar2021 09:30 (at the age of 65-year-old) as single dose for COVID-19 immunization. The patient medical history included high blood pressure. Concomitant medication included unspecified high blood pressure medicine, vitamins. On 09Mar2021, the patient reported of blood shot spot in her eye which worsened. The patient got her Pfizer Covid vaccine, she got done with her first shot. Yesterday(09Mar2021) the patient came home and nothing was wrong then at 6:00 in the evening her right eye, initially stated like where she got the shot at, it had blood shot in it, she put some eye drops in it for the redness of the eye.  She clarified she received the vaccine on the right side. She wanted to know what she needs to do about her eye, should she go to the emergency room or see an eye doctor. Patient height may be a little shorter than 5'2." No investigation assessment. Outcome for the event was not resolved.  No follow up attempts are needed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fungal infection
Clinical narrative: She was having female health issues/yeast infection; This is a spontaneous report from a contactable consumer or other non-HCP. A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6201), via an unspecified route of administration on 25Feb2021 as single dose (at the age of 65-year-old) for covid-19 immunization.  Medical history included thyroid disorder included Thyroid medication. Concomitant medication(s) included budesonide, formoterol fumarate (SYMBICORT). On an unspecified date the patient experienced she was having female health issues/yeast infection. Therapeutic measures were taken as a result of she was having female health issues/yeast infection. The outcome of event was unknown.    No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: very dizzied; headache; This is a spontaneous report from a contactable consumer (Patient, self-reported). A 72-years-old patient of an unspecified gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 16Jan2021 11:30 as first dose, single dose for COVID-19 immunization. Medical history included Cholesterol, blood Irregular heartbeat and acid reflux (all ongoing). Concomitant medications included ezetimibe (ZETIA) taking for Cholesterol since 5 years and ongoing, amlodipine besilate (NORVAS) taking for blood pressure since 5 years and ongoing; omeprazole (PROTONIX [OMEPRAZOLE]) taking 2 twice a day for acid reflux since 8 years and ongoing and metoprolol succinate (TOPROL XL) taking 2 twice a day for Irregular heartbeat since 5 years and ongoing. On 16Jan2021, the patient experienced very dizzied and headache. Outcome of the events was unknown (stop in 30 minutes, as reported).  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Cardioversion, Heart rate, Heart rate increased
Clinical narrative: This is a spontaneous report from non-contactable consumer via Pfizer Sales Representative. A 74-year-old male patient received BNT162B2 (Pfizer COVID-19 Vaccine, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunisation. Medical history included cardiovascular issues and has pacemaker. The patient concomitant medications were not reported. On an unknown date, the patient experienced rapid heart rate and had cardioversion to alleviate. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: left arm is completely numb; This is a spontaneous report from a PFIZER-sponsored program. A contactable female consumer reported for herself that on an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Batch/Lot number was not reported, NDC number and expiry date of was not provided) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced left arm is completely numb. It was reported that warm transfer from a PFIZER-sponsored program. patient was calling for an adverse event felt after the first dose of PFIZER COVID vaccine. The left arm was completely numb. She confirmed contact details upon transfer. Patient was calling to find out what she was going to do about it since her arm was not like this before. She went to the Hospital, clarified she went to the ER. She was told by the hospital that PFIZER would be scheduling nerve test to be done. She stated if the vaccine was what caused this to her arm, then she was asking for help from the manufacturer. Stated this was a new year and her deductible was starting out all over. She had to go to ER since her hands was so swelled out. She did not have a left arm to use since it was completely numb. She went to her doctor and the ER and nobody has been able to help her. Her arm was fine before the vaccine and now she has no arm, clarified her arm is completely numb. Describes that it was like when your leg gone to sleep and felt. It's coming out of sleep and it hurts that was what her arm felt like and it has been ten days. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Nodule, Pain
Clinical narrative: It is like a little sore; Under his arm there is a big swollen knot under his arm; This is a spontaneous report from a contactable consumer. The 46-year-old Male consumer reported for himself. A 46-years-old male patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number may be EN6205, expiry date: unknown) via an unspecified route of administration in Arm Left on 07Mar2021 09:00 as SINGLE DOSE for covid-19 immunization at primary care. 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. Medical history and no concomitant medications were reported. He is a Veteran and got the vaccine on Sunday (07mar2021). On 08Mar2021 at 10:00 patient felt there is a big swollen knot under his arm. He felt like there is pressure on it when he puts his arm down. It's like on top and squeezes it. It is like a little sore. It is not hard. That is why he is thinking it is lymph nodes/glands. He does not think it is a cyst or anything and this occurred with left arm. No relevant test reported. The clinical outcome of the events were recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a contactable other health care Professional (HCP). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection) via an unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to vaccination patient diagnosed with COVID-19 was unknown. Since the vaccination the patient tested for COVID-19 was unknown. The patient received any vaccines within four weeks prior to the vaccination was unknown. On an unspecified date the developed shingles. The outcome of the event was unknown.  No follow up attempts are possible; information about Lot/batch number cannot be obtained.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Headache, Insomnia, Muscle contractions involuntary, Pyrexia
Clinical narrative: Fever; Muscle contractions; couldn't sleep; Major headache; This is a spontaneous report received from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the right arm on 12Mar2021 at 15:30 (at the age of 47-year-old), as single dose for COVID-19 immunisation. The patient previously received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the right arm on 19Feb2021 at 15:15 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not have any allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Mar2021, the patient experienced high fever(39C) for more than 24 hours, muscle contractions which were painful, could not sleep and major headaches. The patient did not receive any treatment for the reported adverse event. The clinical outcome of the event high fever(37C), muscle contraction, sleeplessness and major headaches were recovered.    Information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm at injection site; This is spontaneous report from a non-contactable consumer, the patient. A 60-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch number: Unknown), via an unspecified route of administration and in unspecified anatomical site on 10Mar2021 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history and Concomitant medications were not reported. Patient was not allergic to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unspecified date in Mar2021, the patient experienced sore arm at injection site. The patient did not receive treatment for the event. The clinical outcome of the event sore arm at injection site was resolving at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Insomnia
Clinical narrative: made her sick; couldn't sleep; This is a spontaneous report from a contactable consumer (patient). A 72-year-old 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  2nd dose, single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medication included pregabalin (LYRICA) for fibromyalgia. On an unspecified date, the patient stated that the 2nd vaccine shot made her sick and couldn't sleep. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Gout
Clinical narrative: Gout flare; This is a spontaneous report from a contactable consumer, the patient. A 62-years-old patient of unknown gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown, Dose number: 1) via an unspecified route of administration in the left arm on 25Feb2021 at 13:30 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Since the vaccination, the patient had not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. The patient's medical history and concomitant medications were not reported. On 26Feb2021 at 14:30 (start day after vaccination), the patient had gout flare. The patient was treated for the event gout flare with Indomethacin (INDOCIN). The clinical outcome of the gout flare was unknown. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in ears; This is a spontaneous report received from a contactable consumer. A 65-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) as a single dose via unspecified route in the right arm on 25Feb2021 at 10:00 for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient had no allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that the patient did not receive any other vaccines or medications within 4 weeks prior to the COVID-19 vaccination. On 03Mar2021 at 08:00, the patient experienced ringing in ears. No treatment was received for the event. The clinical outcome of ringing in ears was not resolved at the time of report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Patient's detail contact information was added per reporter since reporting for self.  2. Patient's "Age at Vaccination" captured as 65 years per vaccination date=25Feb2021 and DoB.  3. "Relevant Med History" captured as "None" per source reported "other medical history: None" and also no allergy and "if covid prior vaccination: No". 4. "Unknown" removed from Lot# field for suspect vaccine.  5. For event: "Treatment Received?" captured as "No" per source reported "if treatment ae: No".  6. Final sentence "Information about Lot number cannot be obtained. No further information is expected." updated as "No follow-up attempts are needed; information about lot/batch number cannot be obtained." 7. "Concomitant Therapy" captured as None per source "if_other_vaccine_in_fourweeks: No" and "other_medications_in_twoweeks: No".  8. Initial information need be reviewed: covid_vaccine_details: product=COVID 19, brand=Pfizer, lot_unknown=True, lot_unknown_reason=Other, lot_unknown_reason_other=Don't know , administration_date=25Feb2021, administration_time=10:00 AM, vaccine_location=Right arm, dose_number=1, other_vaccine_same_date_details: other_vaccine_same_date_vaccine_date=25Feb2021, facility_type_vaccine: Other, if_other_vaccine_in_four weeks: No, other_medications_in_two weeks: No, other_medical_history: None
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: migraine; This is a spontaneous report from a non-contactable consumer reporting for his wife. A female patient of an unspecified age received BNT162B2 (Lot number was not reported), via an unspecified route of administration on 11Mar2021 as 2nd dose, single for COVID-19 immunization; eletriptan hbr (RELPAX, strength: 40 mg, Lot number was not reported), via an unspecified route of administration from an unspecified date and ongoing, at 40 mg for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient started experiencing migraine in the morning of 12Mar2021 after taking the final dose of the Covid-19 vaccine on 11Mar2021. The patient felt the event was related to use of RELPAX (eletriptan HBr) 40 mg. As of 12Mar2021, the event subsided, and use of eletriptan HBr 40 mg continues. The action taken in response to the event for eletriptan hbr was dose not changed. The patient recovered from the event on 12Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Lymph Node swelling under armpit - same arm as injection, this began 2 days after the injection and has persisted.; This is a spontaneous report from a contactable non-health care professional.  A 59-year-old non-pregnant female patient received first dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202), via an unspecified route of administration, on left arm on 12Mar2021 at 11:00 (at the age of 59-years-old) as single dose for COVID-19 immunisation. Medical history included hyper tension, occasional migraines, depression. Concomitant medications included MD-cholesterol( MANUFACTURER UNKNOWN) ,curcumin( MANUFACTURER UNKNOWN), fluoxetine(PROZAC) , tekturna( MANUFACTURER UNKNOWN), amlodipine besylate( MANUFACTURER UNKNOWN), baby aspirin (MANUFACTURER UNKNOWN), losartan-hctz 100 ( MANUFACTURER UNKNOWN), magnesium ( MANUFACTURER UNKNOWN)and tylenol (MANUFACTURER UNKNOWN) . The patient had not received any other vaccines within four weeks prior to the COVID vaccine and  was not been diagnosed with COVID-19. Patient experienced Lymph Node swelling  under armpit - same arm as injection on 14Mar2021 at 13:00. The patient did not receive any treatment for reported events. The clinical outcome of event Lymph Node swelling was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Fatigue; Headache; This is a spontaneous report from a contactable consumer, the patient. A 47-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number- UNKNOWN) via an unspecified route of administration in left arm on 16Mar2021 at 09:30 (at an age of 47-years-old) as  single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. The patient didn't 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. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number- UNKNOWN) via an unspecified route of administration  on 23Feb2021 at 09:30 (at an age of 47-years-old) as single dose for COVID-19 immunisation. On 17Mar2021, the patient experienced fatigue and headache. The patient didn't receive treatment for the events. The clinical outcome of fatigue and headache were recovered on an unknown date in Mar2021. Information about lot/batch number cannot be obtained. No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Vomiting
Clinical narrative: Severe gastrointestinal upset. Vomiting and diarrhea; Severe gastrointestinal upset. Vomiting and diarrhea; Severe gastrointestinal upset. Vomiting and diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6207), via an unspecified route of administration in the left arm on 17Mar2021 at 13:30 (at the age of 26-years-old), as a single dose for COVID-19 immunisation. The patients medical history included anxiety and depression. The patient had allergies to medications menthol (MANUFACTURER UNKNOWN) and doxycycline (MANUFACTURER UNKNOWN). Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included PROZAC and PRILOSEC for unknown indications within 2 weeks of vaccination from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 28Jan2021, the patient experienced severe gastrointestinal upset, vomiting and diarrhoea. The clinical outcome of the events severe gastrointestinal upset, vomiting and diarrhoea was recovering. No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm soreness at injection site; This is a spontaneous report received from a contactable consumer, the patient. A 58-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 17Mar2021 at 15:00 (at the age of 58-year-old), as single dose for COVID-19 immunisation. The patient medical history included asthma. Concomitant medications included Allegra, vitamin D (MANUFACTURER UNKNOWN), Afrin decongestant nose spray for unspecified indications. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Mar2021 at 15:15, the patient experienced arm soreness at injection site. The clinical outcome of event arm soreness at injection site was recovering.   Information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Back pain, Hunger, Lymphadenopathy, Nausea
Clinical narrative: upper back pain; neck pain; Thirsty; hungry; Nausea and feeling of vomit; Wrist /Hip/ joint pain; Swollen throat; Left under arm lymph node swollen, swollen lymph node behind ears near jaw and below chin; This is a spontaneous report from a non-contactable consumer, the patient. A 46-year-old non-pregnant female patient received a first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199) as single dose via an unspecified route of administration on left arm on 11Mar2021 at 18:30 (at the age of 46-years-old) for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was reported that none other medications received by the patient within 2 weeks of vaccination. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to and since vaccination, the patient was not been diagnosed with COVID-19. On 11Mar2021 at 20:30, the patient experienced hungry, nausea and feeling of vomit, neck pain, swollen throat, thirsty, upper back pain, wrist /hip/ joint pain and also reported left under arm lymph node swollen, swollen lymph node behind ears near jaw and below chin. The patient says no fever and it was a week after 1st dose and symptoms still existed and she felt like she was overdosed. The patient visited Doctor or other healthcare professional office/clinic and she reported the same to physician and waiting for response. Therapeutic measures taken was unknown. The clinical outcome of events hungry, nausea and feeling of vomit, neck pain, swollen throat, thirsty, upper back pain, wrist /hip/ joint pain, left under arm lymph node swollen, swollen lymph node behind ears near jaw and below chin were not recovered. No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neck pain, Pharyngeal swelling, Thirst
Clinical narrative: upper back pain; neck pain; Thirsty; hungry; Nausea and feeling of vomit; Wrist /Hip/ joint pain; Swollen throat; Left under arm lymph node swollen, swollen lymph node behind ears near jaw and below chin; This is a spontaneous report from a non-contactable consumer, the patient. A 46-year-old non-pregnant female patient received a first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199) as single dose via an unspecified route of administration on left arm on 11Mar2021 at 18:30 (at the age of 46-years-old) for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was reported that none other medications received by the patient within 2 weeks of vaccination. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to and since vaccination, the patient was not been diagnosed with COVID-19. On 11Mar2021 at 20:30, the patient experienced hungry, nausea and feeling of vomit, neck pain, swollen throat, thirsty, upper back pain, wrist /hip/ joint pain and also reported left under arm lymph node swollen, swollen lymph node behind ears near jaw and below chin. The patient says no fever and it was a week after 1st dose and symptoms still existed and she felt like she was overdosed. The patient visited Doctor or other healthcare professional office/clinic and she reported the same to physician and waiting for response. Therapeutic measures taken was unknown. The clinical outcome of events hungry, nausea and feeling of vomit, neck pain, swollen throat, thirsty, upper back pain, wrist /hip/ joint pain, left under arm lymph node swollen, swollen lymph node behind ears near jaw and below chin were not recovered. No follow-up attempts are needed. No further information is expected.