chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: She had a little bit of a sore arm on the first one; This is a spontaneous report received from a contactable consumer (patient). A 74-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL8982, EL9262and Expiration date: 20May2021), via intramuscular route of administration in the Arm Left on 22Jan2021 12:30 as single dose for COVID-19 immunization. Patient medical history: Provide other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity included: She is overweight. This past year, started in Jun2020, she lost 30 pounds, but she is still overweight. Prior Vaccinations (within 4 weeks) was none. AE following prior vaccinations was none. No previous history of immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). No additional Vaccines Administered on Same Date of the Pfizer Suspect. Family medical history was none. The patient's concomitant medications included Thyroid and Cholesterol medication. On 22Jan2021, the patient had left arm soreness. It was reported that on 22Jan2021 17:00, the patient had a little bit of a sore arm on the first one. It was just a little bit that night and day, but not at all on the second dose. She takes Thyroid and Cholesterol medication and they don't have anything to do with it. No further details provided. She received her second dose on 12Feb2021 at 10:00 am (expiration date: 21May2021). She has had no reaction whatsoever and the site this time around was not even sore. A friend said that she read somewhere if you had no reaction it means the first shot did not give you any antigens. The patient would like to know if that was why she didn't have any reaction to the second shot. No ER or physician's office visit required. No Investigation Assessment. No relevant tests were done. The outcome of the event was recovering.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia
Clinical narrative: Chills; muscular pain; tiredness; This is a spontaneous report from a contactable consumer. This 40-year-old female consumer reported that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EL3247) via an unspecified route of administration from 12Feb2021 at 01:15 pm to 12Feb2021 at 01:15 pm at single dose (dose number; 2) on left arm for covid-19 immunisation. Patient was 40 years old and not pregnant at the time of vaccination. Patient's medical history was not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EL3247) via an unspecified route of administration from 22Jan2021 at 12:00 pm to 22Jan2021 at 12:00 pm at single dose (dose number; 1) on left arm for covid-19 immunisation. Facility type vaccine was reported as workplace clinic. Patient's concomitant medications were not reported. If other vaccine in four weeks was reported as no facility type vaccine was administered. Patient experienced chills, muscular pain, tiredness on 12Feb2021 at 06:00 pm. Treatment for adverse event was reported as no. If COVID prior vaccination; no, If COVID tested post vaccination; no. The outcome of events was recovered on an unknown date.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Had a little small node that was kind of like below my shoulder; First it was kind of little soft but I noticed it is firm; This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 04Feb2021 (Batch/Lot Number: EN9581, Expiration Date: May2021) as SINGLE DOSE, dose 2 via an unspecified route of administration on 25Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included blood cholesterol and ocular hypertension. Concomitant medications included atorvastatin (ATORVASTATIN) taken for blood cholesterol, start and stop date were not reported; latanoprost (LATANOPROST) taken for ocular hypertension, start and stop date were not reported; hydrochlorothiazide (HYDROCHLOROTHIAZIDE) taken for an unspecified indication, start and stop date were not reported. On an unspecfied date it was reported that the patient received the Pfizer vaccine on 04Feb2021 and she donot have any side effect when she received the vaccine and she guessed probably about 5 may be 6, 7 days after she received it, after she got out of the shower she noticed that she had a little small node that was kind of like below her shoulder and it's really tiny probably the size of a pea and she looked back for information sheet and she noticed that it had some of the minor side effects which would be swelling of lymph nodes so was this the possibility of what that could be." When paraphrased the above concern, consumer stated, yes the first dose of COVID vaccine was 04Feb2021, and expires at May2021. She thought it's a slash, she touched it and it feel little. At first it was kind of little soft but she noticed it is firm and it's kind of going down just a little."Outcome of the event was unknown.
Age: 77.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Condition aggravated, Diarrhoea
Clinical narrative: diarrhea; COVID shot made the diarrhea worse.; This is a spontaneous report from a contactable consumer. A 78-Year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 27Jan2021 (Batch/Lot number: Unknown) as single dose for covid-19 immunisation, hyaluronic acid (GEL ONE), via an unspecified route of administration from 21Jan2021 (Batch/Lot number: Unknown) at 2 DF (he got two shots in his knees) for his bones.The patient medical history was not reported. Concomitant medication included paracetamol (TYLENOL) taken for an unspecified indication. In Jan2021 the patient experinced diarrhea and In Jan2021 the patient stated covid shot made the diarrhea worse. It was reported that he later added that he got two gel shots, clarified as, Gil 1, he got two shots in his knees on 21Jan2021. After he got these shots in his knees he a little diarrhea about 3-4 days after that. He got the shots in his knees for his bones. He then got the shot, the COVID shot on 27Jan2021 and he thinks the COVID shot made the diarrhea worse. He reinforced he does not go like 5-6 times a day. However, sometimes it is twice a day and it is loose. It is a lot worse than before, not normal. He stated he only took one Tylenol before the shot and now it's out saying should not take it before the COVID shot. He stated they have not taken any Tylenol since the COVID shot. The outcome of the event diarrhea was not recovered and outcome of the other event was unknown.  Information on the lot/batch number has been requested.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Nausea, Salivary hypersecretion, Vomiting
Clinical narrative: Large influx of saliva in mouth; Nauseated; Thrown Up; stomach cramping; This is a spontaneous report from a contactable 78-Years old male consumer reported for himself that he received bnt162b2 second dose of (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL0739), via an unspecified route of administration on 09Feb2021 at single dose in left arm for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 on 18Jan2021 (First dose lot number: EL8982, received both COVID-19 Vaccines in his left arm). On 12Feb2021, the patient experienced stomach cramping and on 15Feb2021, Large influx of saliva in mouth and he felt nauseated and thrown up. The outcome of the events was unknown.  Information on the lot batch number has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Lymphadenopathy
Clinical narrative: High Fever (103); chills; body aches; headache; nausea; fatigue; pain at injection site; injection site swelling and redness; lymphadenopathy; injection site swelling and redness; This is a spontaneous report from a contactable consumer(patient). A 54-year-old female (non-pregnant) patient received second dose of BNT162B2 (Solution for injection, Lot number: EL9269, Expiration date: unknown), in left arm on 11Feb2021 at 03:30 PM, at single dose for COVID-19 immunization. The patient historical vaccine included first dose BNT162B2 (lot number: EL8982) left arm on 21Jan2021, at single Covid-19 immunization. Patient medical history and concomitant medications were not reported. After second shot Patient experienced High Fever (103), chills, body aches, headache, nausea, fatigue, pain at injection site, injection site swelling and redness, lymphadenopathy on 12Feb2021 at 09:00. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the event was recovered.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, Vaccination site erythema, Vaccination site pain
Clinical narrative: High Fever (103); chills; body aches; headache; nausea; fatigue; pain at injection site; injection site swelling and redness; lymphadenopathy; injection site swelling and redness; This is a spontaneous report from a contactable consumer(patient). A 54-year-old female (non-pregnant) patient received second dose of BNT162B2 (Solution for injection, Lot number: EL9269, Expiration date: unknown), in left arm on 11Feb2021 at 03:30 PM, at single dose for COVID-19 immunization. The patient historical vaccine included first dose BNT162B2 (lot number: EL8982) left arm on 21Jan2021, at single Covid-19 immunization. Patient medical history and concomitant medications were not reported. After second shot Patient experienced High Fever (103), chills, body aches, headache, nausea, fatigue, pain at injection site, injection site swelling and redness, lymphadenopathy on 12Feb2021 at 09:00. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the event was recovered.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: High Fever (103); chills; body aches; headache; nausea; fatigue; pain at injection site; injection site swelling and redness; lymphadenopathy; injection site swelling and redness; This is a spontaneous report from a contactable consumer(patient). A 54-year-old female (non-pregnant) patient received second dose of BNT162B2 (Solution for injection, Lot number: EL9269, Expiration date: unknown), in left arm on 11Feb2021 at 03:30 PM, at single dose for COVID-19 immunization. The patient historical vaccine included first dose BNT162B2 (lot number: EL8982) left arm on 21Jan2021, at single Covid-19 immunization. Patient medical history and concomitant medications were not reported. After second shot Patient experienced High Fever (103), chills, body aches, headache, nausea, fatigue, pain at injection site, injection site swelling and redness, lymphadenopathy on 12Feb2021 at 09:00. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the event was recovered.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue
Clinical narrative: pain in shoulder; chills; fatigue; This is a spontaneous report from a sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: UNKNOWN), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation.The patient medical history and concomitant medications were not reported. It was reported that caller wondering how long virus lives outside of the body airborn/surfaces. Caller stated that he had pain in shoulder, chills and fatigue after receiving vaccine. Outcome of the events were unknown.  Information on the Lot/Batch number has been requested.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Vaccination site pain
Clinical narrative: Muscle soreness/aches; headache; injection site pain; fatigue; This is a spontaneous report from a contactable consumer. A 36-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection; Lot number: En9581), via an un-specified route of administration, administered in Arm Left on 15Feb2021 17:00 (at the age of 36-years-old) at a single dose for COVID-19 immunization. Medical history included colitis ulcerative, blood pressure increased. Concomitant medication included sertraline hydrochloride (ZOLOFT) 50 mg; losartan potassium (LOSARTAN POTASSIUM) 25 mg, lansoprazole (LANSOPRAZOLE) taken for an unspecified indication, start and stop date were not reported. Patient took other_medications_in_two weeks: Zoloft -50mg, losartan pot -25mg, lansoprazole. On 16Feb2021 10:00 Muscle soreness/aches, headache, injection site pain, fatigue; The patient not received treatment, Patient not had Covid prior vaccination; covid not tested post vaccination; The outcome of the events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 antibody test positive, SARS-CoV-2 test
Clinical narrative: tested positive with COVID-19 on 04Feb; tested positive with COVID-19 on 04Feb; This is a spontaneous report from a sponsored program. A contactable pharmacist reported for a female patient. A female patient of an unspecified age received BNT162B2 (BNT162B2, Formulation: solution for injection, Batch/Lot number was not reported) first dose via an unspecified route of administration as a single dose for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. On 04Feb2021 The patient experienced tested positive with covid-19 on 04feb (sars-cov-2 antibody test positive). The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 04Feb2021. the HCP wants to know if she can still give the 2nd dose to the patient. The outcome of the event was unknown  Information about lot/batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: sore arm; severe headache; This is a spontaneous report from a contactable physician (self-Reported). A 65-years-old non pregnant female patient received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Lot number: EL9262) via an unspecified route of administration in Arm Left on 25Jan2021 09:30 as single dose for covid-19 immunisation. Medical history included atrial tachycardia and asthmatic bronchitis. Concomitant medications were not reported. On an unspecified date in 2021, the patient experienced sore arm and severe headache. The outcome of the event was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Weight
Clinical narrative: had little sore arm; This is a spontaneous report from a contactable consumer (patient). A 71-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 26Jan2021 09:00 (Batch/Lot Number: EK4176) as single dose for covid-19 immunisation. Medical history included High Blood pressure, arthritis and heart problems (Both of her parents had heart problems) from an unknown date and unknown if ongoing. The patient received unknown concomitant medications. The patient experienced had little sore arm on an unspecified date and used ice on it. The patient underwent lab tests and procedures which included weight: 46 lbs on it was intentional. The outcome of the event was unknown.
Age: 75.0
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Peripheral swelling
Clinical narrative: hands are very swollen right now; This is a spontaneous report from a sponsored program . A contactable consumer (patient) reported that a 75-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation; methotrexate sodium (manufacturer unknown) at an unspecified dose and tofacitinib citrate (XELJANZ) at 5 mg both via an unspecified route of administration from an unspecified date for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 in Jan2021 (mid-January) for COVID-19 immunization (went off Xeljanz 5mg for three days and things got very bad very quickly). The patient took Xeljanz 5mg and Methotrexate who stated her hands were very swollen right now. Stated that she got the Covid vaccine and stopped Methotrexate a week before the vaccine. Stated that it has been a week since the vaccine she and was hoping that she can go back on Methotrexate so that things can go back to normal. Stated that this was her second dose of the Covid vaccine. The action taken in response to the event for methotrexate sodium was post-therapy and tofacitinib citrate was unknown. Outcome of the events was not recovered.   This product is a marketing authorization holder of methotrexate sodium in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of methotrexate sodium has submitted the same report to the regulatory authorities.  Information about lot/batch number has been requested.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Oropharyngeal pain, Palpitations
Clinical narrative: heart palpitations; chest pressure; mild sore throat; This is a spontaneous report from a contactable consumer reported for a 62-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL9266), via an unspecified route of administration on 16Feb2021 14:00 at single dose in left arm for covid-19 immunization.  The patient's medical history included hypertension and peanuts allergy. Historical vaccine included bnt162b2 on 22Jan2021 (Lot number: EL3247, Administration time: 04:00 PM, vaccine location: Left arm, dose number: 1). Concomitant medications included hydrochlorothiazide, ergocalciferol (VITAMIN D). Past drugs included ACE inhibitors for known allergies, tetracycline for known allergies. On 17Feb2021 at 16:00, the patient experienced heart palpitations, chest pressure and mild sore throat. The patient did not take any treatment for the events. The outcome of the events was not resolved.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Pain, Rash
Clinical narrative: chills; body aches; under arm/neck/torso/inner thigh rash; diarrhea; This is a spontaneous report from a contactable consumer (patient reported herself) reported in response to non-HCP letter sent in cross-referenced case. A 60-Year-old female patient received second dose of BNT162B2 (COVID 19, Pfizer/BioNTech, Formulation: Solution for injection, Lot number: EL3247, Expiration Date: May2021) via an unspecified route of administration on 16Feb2021 02:45 PM at single dose to her left arm for Covid-19 immunization. Facility type vaccine: Workplace clinic. The patient's medical history was not reported. Known allergies included gluten intolerant. Historical vaccine details included: product: COVID Pfizer, vaccine date: 26Jan2021, lot number: EL3247, vaccine location: arm left, Expiration Date: May2021, time the vaccination was given: 14:24 (24hour clock), anatomical location of administration of Pfizer vaccine considered as suspect: arm left, events: soreness at site of injection and loose bowels; fine now; did not receive any treatment. Concomitant medications included lisinopril, MULTIVITAMIN, ongoing ergocalciferol (VIT D), ongoing calcium and ibuprofen (ADVIL) from an unspecified date to an unspecified date. Covid was not tested prior or post vaccination. On 17Feb2021 01:45 PM, the patient experienced chills, body aches, under arm/neck/torso/inner thigh rash and diarrhea. Outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive after 1st dose.; Tested positive after 1st dose.; This is a spontaneous report from a contactable consumer (patient) reported that a female patient of an unspecified age received bnt162b2 (BNT162B2) dose 1, via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient reported, tested positive after 1st dose. The outcome of the events was unknown.  Information about lot/ batch number has been requested.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Rash
Clinical narrative: This is a spontaneous report from a contactable physician reported that: A 29-years-old female patient received BNT162B2 (BNT162B2), dose 2 intramuscular, administered in deltoid Left (Arm left) on 08Jan2021 17:00 (Batch/Lot Number: EL3249) as 1Mx2 single dose for COVID-19 immunization. Medical history included, drug hypersensitivity (allergic to penicillin). The patient's concomitant medications were unknown. The patient provide information to you regarding the reported adverse events with the use of the product, considering. the Pfizer product had a causal effect to the adverse event. On an unspecified date, the patient experienced extreme fever, rash, body aches. Outcome of the events were unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 30Jan2021 (Batch/Lot number: unknown) as single dose for covid-19 immunisation. Medical history included several allergies with food and hay fever from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The reporter stated that the second dose will be on 20Feb2021at 4:30PM, she was asking if it's okay to take it earlier than 4:30 because she doesn't want to sit for too long due to an allergy (though she did not elaborate about the allergy). She said that she has several allergies with food and hay fever. She said she got a sore arm and took Tylenol after the first dose. The outcome of the event was reported as unknown.   Information about lot/Batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure measurement, Fatigue, Injection site pain, Photopsia
Clinical narrative: sore injection site; fatigue; flashing irregular light; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 16Feb2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced sore injection site, fatigue and flashing irregular light. Patient reported just received my first dose of your covid vaccine on the 16Feb. Patient had typical side effects of sore injection site and fatigue the day after. The unusual affect was what appeared to be flashing irregular light in the lateral aspect of patient's right eye. This symptom was new to patient. Track if others have had similar experiences. It subsided on the 2nd day after the vaccine. The patient underwent lab tests and procedures which included blood pressure measurement was 136/64. The outcome of event was unknown and for event flashing irregular light was recovered.  Information on the Lot/Batch number has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives on both upper and lower arms; This is a spontaneous report from a contactable consumer (patient). A 46-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VAC-CINE, Formulation: Solution for injection, Lot number: EL9265), via an unspecified route of administration in the right arm on 11Feb2021 10:00 (at the age of 46-years-old) as single dose for COVID-19 immunization. Medical history included asthma, basedow's disease and nut allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR) and salbutamol (ALBUTEROL HFA). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Feb2021, patient experienced hives on both upper and lower arms. Comes and goes but breakouts everyday since vaccination. Patient did not receive any treatment for the event. The outcome of the event was not recovered.
Sex: F
Vaccine: PPV
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report from a contactable consumer (patient herself). A 76-year-old female patient received first dose of pneumococcal 13-val conj vac (Dipht CRM197 Protein) (Unspecified trade name, Formulation: Solution for injection in pre-filled syringe), via an unspecified route of administration on an unspecified date as a single dose for immunization. The patient's medical history included obesity, endocrine abnormalities (including diabetes), genetic / chromosomal abnormalities, respiratory illness, compromised immune status, allergic to an unknown preservatives (unknown preservatives allergy gives her headaches), stress related to work. They used to be stress related to work and she retired. Concomitant medications were not reported. No previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). The patient did not receive additional vaccines on same date of the Pfizer suspect. No emergency room or physician's office required. The patient did not have prior vaccinations (within 4 weeks). Family medical history was none. She has had headache with Pneumonia vaccine, fast foods, and foods with sauces etc. They have never been able to determine the point of origin. She did not have the manufacturer for the Pneumonia vaccine she received and did not have a lot or expiration. It was 4 years ago. She never received the second Pneumonia 13 because of the reaction with the first one. Pneumonia shot first one and she had bad reactions, so she did not get the Pneumonia 13 since she had that. No manufacturer, lot, or expiration. It occurred around 4 years ago. They are telling her they are changing the Pneumonia vaccine so she has to talk to her doctor to see if she should try it again. The patient experienced headache on an unspecified date. She has not had a headache in a long time and that was why she feels it was the shot. No relevant tests included. The outcome of the event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: she later tested positive for the coronavirus infection; This is a spontaneous report from a contactable consumer via Medical information Team. A female (wife) patient of an unspecified age received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as a SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced she later tested positive for the coronavirus infection (non-serious) on an unspecified date. Caller would like to know if he should get his second dose of the covid vaccine tomorrow as scheduled since he has been in contact with his family (wife and child) who tested positive for the coronavirus. Will there be an interaction between myself and the vaccine. The caller stated that his wife spoke to somebody already. Caller and his wife both received their 1st dose of the covid vaccine however she later tested positive for the coronavirus infection. Caller was advised to quarantine for 17 days, however since he is quarantining at home with people who have tested positive for coronavirus, can he be in contact with the HCPs for his 2nd dose of the covid vaccine. he patient underwent lab tests and procedures which included coronavirus: positive on an unspecified date. The outcome of event was unknown.  Information on the Lot/Batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp. A 52-year-old male patient received BNT162B2 (BNT162B2, solution for injection), dose 1 via an unspecified route of administration on 02Mar2021 as SINGLE DOSE for COVID-19 immunization. Medical history included COVID-19 from 2020 to an unknown date had COVID-19 a year ago. His antibody went down. The patient's concomitant medications were not reported. On 03Mar2021, the patient experienced body aches, fatigue, high temperature, headache. The patient underwent lab tests and procedures which included body temperature: high on 03Mar2021 high. The action taken in response to the event for BNT162B2 was not applicable. The outcome of high temperature outcome was recovered and rest events outcome was unknown. Information on the lot/batch number has been requested.
Age: 74.0
Sex: M
Vaccine: COVID19, UNK, UNK, UNK, UNK, UNK
Symptoms: Rash
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 74-years-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in right arm on 08Mar2021 at 14:15 (Batch/Lot Number: EN6204) (at the age of 74-years-old) as a single dose for COVID-19 immunization; donepezil hcl (DONEPEZIL HCL), 10mg tablet, via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 10 mg, 1x/day for an unspecified indication; clonazepam (CLONAZEPAM), 2mg tablet, via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 2 mg for an unspecified indication; pioglitazone (PIOGLITAZONE), 45mg tablet, via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 45 mg for an unspecified indication; lisinopril (LISINOPRIL), 10mg tablet, via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 10 mg for an unspecified indication; vitamin d3 (VITAMIN D3), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 2000 iU for an unspecified indication; multivitamin, via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at an unspecified dose for an unspecified indication. Medical history included Parkinson's, diabetes type 2, hypertension and rapid eye movement (REM) sleep disorder, all from an unknown date and unknown if ongoing. The patient had no known allergies. Concomitant medications included carbidopa, levodopa (CARBIDOPA LEVODOPA), at 25-100 mg, taken for an unspecified indication, start and stop date were not reported; lovastatin (LOVASTATIN), 20mg tablet, at 20mg taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to BNT162b2. 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 experienced rashes on different parts of the body, whole left arm, upper back, both hands, trunk on 08Mar2021 at 14:30. No treatment was received for the event, rashes on different parts of the body, whole left arm, upper back, both hands, trunk. The action taken in response to the event for donepezil hcl, clonazepam, pioglitazone, lisinopril, vitamin D3 and multivitamin was unknown. The outcome of event, rashes on different parts of the body, whole left arm, upper back, both hands, trunk was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Platelet count, Platelet count decreased
Clinical narrative: platelets went down / her palettes went down; she immediately got sick; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age 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 an unspecified date at a single dose for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient's platelets went down (reported as "her palettes went down")  and immediately got sick on an unspecified date.  The patient underwent lab tests and procedures which included platelet count: went down on an unspecified date. Events resulted to patient ending in the emergency room.  The outcome of the events reported was unknown.  Information about lot/batch number has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blood test, Culture stool, Diarrhoea, Haemoglobin
Clinical narrative: upper gastric pain/terrible stomach pain; continuous diarrhea; experienced cramping; This is a spontaneous report from a contactable Nurse, the patient.   A 71-year-old female patient received the first dose of bnt162b2 (BNT162B2, Lot number unknown), via an unspecified route of administration on 18Feb2021 as a single dose in the arm (reported as "deltoid") for COVID-19 immunization. Medical history included multiple sclerosis from an unknown date. The patient responded "yes" when asked if she had been diagnosed with COVID-19 prior to the vaccination but also provided no details about this. The patient's concomitant medications were not reported. The patient experienced upper gastric pain/terrible stomach pain on an unspecified date with outcome of unknown, continuous diarrhea on an unspecified date with outcome of unknown and cramping on an unspecified date with outcome of unknown. The patient provided further details in that she reported that she woke the following morning after receiving the COVID-19 vaccine feeling as if she was having a heart attack, which was determined to be a result of upper gastric pain. She reported that she has experienced cramping and continuous diarrhea and she has been unable to leave the house except to receive medical treatment. She stated that she had had lab work (blood and stool samples) and everything has returned negative. She believes that the gastric pain and other symptoms are a result of her receiving the vaccine.  She remarked that she works in healthcare and has been tested every week for COVID-19 prior to receiving the vaccine, and has not had any gastric pain issues prior to receiving the vaccine, never had any problem with her stomach, pain, diarrhea or anything related to diarrhea and stomach pain. The patient underwent lab tests and procedures which included stool culture negative on an unspecified date and "BMP, CMP and Hemoglobin - things like that" on an unspecified date the results of which were reported as "good" and SARS COV 2 test: negative on an unspecified date prior to this vaccine. Unspecified therapeutic measures were taken as a result of the events. Treatment for the events was reported as  "just Tylenol."
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, SARS-CoV-2 test
Clinical narrative: upper gastric pain/terrible stomach pain; continuous diarrhea; experienced cramping; This is a spontaneous report from a contactable Nurse, the patient.   A 71-year-old female patient received the first dose of bnt162b2 (BNT162B2, Lot number unknown), via an unspecified route of administration on 18Feb2021 as a single dose in the arm (reported as "deltoid") for COVID-19 immunization. Medical history included multiple sclerosis from an unknown date. The patient responded "yes" when asked if she had been diagnosed with COVID-19 prior to the vaccination but also provided no details about this. The patient's concomitant medications were not reported. The patient experienced upper gastric pain/terrible stomach pain on an unspecified date with outcome of unknown, continuous diarrhea on an unspecified date with outcome of unknown and cramping on an unspecified date with outcome of unknown. The patient provided further details in that she reported that she woke the following morning after receiving the COVID-19 vaccine feeling as if she was having a heart attack, which was determined to be a result of upper gastric pain. She reported that she has experienced cramping and continuous diarrhea and she has been unable to leave the house except to receive medical treatment. She stated that she had had lab work (blood and stool samples) and everything has returned negative. She believes that the gastric pain and other symptoms are a result of her receiving the vaccine.  She remarked that she works in healthcare and has been tested every week for COVID-19 prior to receiving the vaccine, and has not had any gastric pain issues prior to receiving the vaccine, never had any problem with her stomach, pain, diarrhea or anything related to diarrhea and stomach pain. The patient underwent lab tests and procedures which included stool culture negative on an unspecified date and "BMP, CMP and Hemoglobin - things like that" on an unspecified date the results of which were reported as "good" and SARS COV 2 test: negative on an unspecified date prior to this vaccine. Unspecified therapeutic measures were taken as a result of the events. Treatment for the events was reported as  "just Tylenol."
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: After the first, the arm was sore for a day or two; This is a spontaneous report from a non-contactable physician (the patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that after the first (dose), the arm was sore for a day or two. The outcome of the event was unknown.      No Follow-up attempts are possible; information about lot number cannot be obtained.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain in the site of infection; This is a spontaneous report from a contactable consumer (patient). This 50-year-old female patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL3248) via an unspecified route of administration on an unknown date (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient had no allergies, medical history or concomitant medications. On an unspecified date 8 hours after receiving her shot, the patient experience pain in the site of "infection" that had been mild. It was unknown if treatment was received for the event. The clinical outcome of pain in the site of "infection" was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from contactable pharmacist. A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date the patient experienced sore arm. The clinical outcome of sore arm was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Headache, Pain in extremity, Vaccination site pain
Clinical narrative: sore arm; sore arm and injection site; slight headache; fatigue; feeling cold; This is a spontaneous report received from a contactable consumer (patient). This female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient reported she received the Pfizer COVID vaccine and on 03Mar2021 she experienced side effects including sore arm and injection site, slight headache, fatigue, and feeling cold. The clinical outcomes of sore arm and injection site, slight headache, fatigue, and feeling cold were unknown.                      No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Tenderness
Clinical narrative: tenderness; felt very fatigued; This is a spontaneous report from a contactable healthcare professional (patient). This 57-year-old female patient received dose 2 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number EL1284) intramuscularly on 03Feb2021 (at the age of 57-years-old) as a single dose in the right deltoid for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination.  The patient previously received dose 1 of BNT162B2 (lot number EK4176) on 09Jan2021 as a single dose in the left arm for COVID-19 immunization. On an unspecified date after dose 2 of BNT162B2 the patient experienced tenderness and felt very fatigued for about 24 hours. The patient was not hospitalized for the events. The patient did not receive any treatment for the events. The outcomes of tenderness and very fatigued were unknown.   No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Extreme fatigue; This is a spontaneous report from a contactable consumer (patient). This patient of unspecified age and gender received BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. After the vaccine on an unspecified date the patient experienced extreme fatigue. The outcome of extreme fatigue was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Feeling "really sick"; This is a spontaneous report from non-contactable consumer (patient) via a Pfizer-sponsored program, COVAX Support. This female patient of unspecified age received a dose of BNT162B2 (TRADE NAME UNSPECIFIED; lot number unknown) via an unspecified route of administration on 01Mar2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient reported feeling really sick on an unspecified date; the patient also asked about other side effects. The clinical outcome of feeling really sick was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Sluggishness
Clinical narrative: feeling sluggish; This is a spontaneous report from a non-contactable consumer (patient). This 30-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 03Mar2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date in Mar2021, the patient experienced feeling slugglsh after the vaccine. The outcome of feeling sluggish was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore at inj site for 3 days; This is a spontaneous report from a contactable Nurse (patient). A 49-year-old female patient received second dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration, in left deltoid on 01Feb2021 as single dose for covid-19 immunisation. Medical history included vestibular migraine from 24May2017 and ongoing, PCN allergy from 01Jun2012 and ongoing, ragweed allergy from 10Oct2017 and ongoing. Concomitant medications included allopurinol (ELAVIL) via oral from unknown date in 2017 and ongoing at 10 mg, daily for vestibular migraines and propranolol via oral from 12Aug2020 and ongoing at 60 mg, daily for Vestibular migraine. The patient historical medication included first dose of BNT162B2 (at the age of 49-year-old) Lot number: EL0142, (IM injection) time vaccination was given: 12:50 (24-hour clock) on 08Jan2021 for covid-19 immunisation and experienced Sore arm inj site, diarrhea (event onset date and time of onset (24 hr clock): 09Jan2021; 22:00), Migraine, vertigo (event onset date and time of onset (24 hr clock): 10Jan2021; 14:30) and dizziness (After vertigo attack, increase dizziness persisted resulting in EMLA/LOA from work) and acetaminophen (Most recent dose: x 1 dose 1000mg oral) for Premedicated before vaccine. The patient experienced sore at inj site for 3 days on Feb2021. The outcome of the event was unknown. Reporter considered that the Pfizer product had a casual effect to the adverse event.  Information on the lot/batch number has been requested.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Some fatigue; This is a spontaneous report received from a contactable consumer, the patient. This patient reported different events with two vaccine doses: This is the second of two doses. This 77-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN9810), via an unspecified route of administration in the left deltoid arm on 19Feb2021 from 08:15 to 08:30 (at the age of 77-year-old) as a single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient was not taking any concomitant medications. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318), via an unspecified route of administration on 26Jan2021 08:15 (at the age of 77-year-old) as a single dose for COVID-19 immunization, then on 31Jan2021 she became totally nauseous, light headed, very chilled, extremely tired, very cold and felt asleep under warm down quilt until 14:00 (total 13 hours) with recovery without any hospital admission and treatment received. On 25Feb2021, the patient experienced some fatigue for one day. The clinical outcome of some fatigue was resolved in Feb2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021093680 Same patient, different drug (first vaccine dose) and events.