chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Lymph node pain, Lymphadenopathy, Off label use, Pain
Clinical narrative: Start Date/Time: 8-MAR-2021 11:30 AM/15-JAN-2021 02:00 PM; Start Date/Time: 8-MAR-2021 11:30 AM/15-JAN-2021 02:00 PM; Fever; Arm Pain; Body Aches; Left Under Arm Lymph Node Swelling and Pain; Left Under Arm Lymph Node Swelling and Pain; This is a spontaneous report from a non-contactable consumer (patient). This 35-year-old male patient received dose 2 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number EL9264) via an unspecified route of administration on 08Mar2021 at 11:30 (at the age of 35-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient had not been diagnosed with COVID-19 prior to vaccination. The patient previously received dose 1 of BNT162B2 (lot number EL9263) on 15Jan2021 at 14:00 (at the age of 34-years-old) as a single dose in the left arm for COVID-19 immunization. On 09Mar2021 after dose 2 of BNT162B2, the patient experienced fever, arm pain, body aches, and left underarm lymph node swelling and pain. The events were reported as non-serious. The patient was not hospitalized for the events. The patient was treated for the events with acetaminophen (TYLENOL) from an unspecified date. The outcomes of fever, arm pain, body aches, and left underarm lymph node swelling and pain were recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Start Date/Time: 8-MAR-2021 11:30 AM/15-JAN-2021 02:00 PM; Start Date/Time: 8-MAR-2021 11:30 AM/15-JAN-2021 02:00 PM; Fever; Arm Pain; Body Aches; Left Under Arm Lymph Node Swelling and Pain; Left Under Arm Lymph Node Swelling and Pain; This is a spontaneous report from a non-contactable consumer (patient). This 35-year-old male patient received dose 2 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number EL9264) via an unspecified route of administration on 08Mar2021 at 11:30 (at the age of 35-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient had not been diagnosed with COVID-19 prior to vaccination. The patient previously received dose 1 of BNT162B2 (lot number EL9263) on 15Jan2021 at 14:00 (at the age of 34-years-old) as a single dose in the left arm for COVID-19 immunization. On 09Mar2021 after dose 2 of BNT162B2, the patient experienced fever, arm pain, body aches, and left underarm lymph node swelling and pain. The events were reported as non-serious. The patient was not hospitalized for the events. The patient was treated for the events with acetaminophen (TYLENOL) from an unspecified date. The outcomes of fever, arm pain, body aches, and left underarm lymph node swelling and pain were recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash is from her elbow down to her arm and is not itchy/skin irritation on arm of vaccination; This is a spontaneous report from a contactable consumer reporting for his wife. A female patient of an unspecified age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 04Mar2021 as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 on 11Feb2021 (Lot Number: Unknown) via an unspecified route of administration for COVID-19 immunisation. In Mar2021, the patient experienced skin irritation on the arm that she received the vaccination, and rash is from her elbow down to her arm and is not itchy. The husband reported it has been 5 days since she had the second dose of BNT162b2 (given on 04Mar2021) and she had skin irritation on the arm that she received the vaccination. The rash is from her elbow down to her arm and is not itchy. She has applied hydrocortisone cream and it worked a little bit. The patient is not in pain, and it is not really irritating her. The outcome of the event, rash is from her elbow down to her arm and is not itchy/skin irritation on arm of vaccination was unknown.   Information on the lot/batch number is requested
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: My husband tested positive; My husband tested positive; This is a spontaneous report from a contactable consumer (patient's wife). This reporter reported similar events for 2 patients (herself and her husband), this report refers to the reporter's husband. A male patient of unspecified age received dose 1 of 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. On an unspecified date, the patient tested positive for COVID-19. The patient's wife believed symptoms she had after she received BNT162B2 were due to COVID-19 because as about 8 days later the patient tested positive. The patient received dose 2 of BNT162B2 on an unspecified date and was feeling fine. The outcome of tested postiive for COVID-19 was unknown.  No follow up attempts are possible.  Information about lot number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021014336 Same product, different AE/patient
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Headache, Hypersomnia
Clinical narrative: runny nose; Chills; fatigue; weakness; sore arm; slept for 14 hrs/slept a lot; Headache; Body ache; Injection site pain; This is a spontaneous report from a contactable nurse (patient). This 77-year-old female patient received dose 2 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number EN6201) intramuscularly on 24Feb2021 at 13:00 (at the age of 77-years-old) as a single dose in the left deltoid for COVID-19 immunization. Medical history included type 2 diabetes mellitus (DM II), hypothyroid for over 20 years, glaucoma in right (R) eye, and hypertension (HTN), all ongoing. The patient was not pregnant at the time of vaccination. Concomitant medications included metformin; levothyroxine sodium (SYNTHROID); lisinopril; atorvastatin; amlodipine; "HOPZ 25 mg;" multiminerals, multivitamins (CENTRUM SILVER); brimonidine tartrate (BRIMOT); and dorzolamide, timolol (COSOPT) from unspecified dates for unspecified indications. The patient previously received acetaminophen (TYLENOL EXTRA STRENGTH) from 04Feb2021 to 09Feb2021 for pain (severe headache). The patient previously received dose 1 of BNT162B2 (lot number EL9261) intramuscularly on 03Feb2021 as a single dose in the left deltoid for COVID-19 immunization and experienced pain, unable to think clearly, headache, aching body, and feeling out of sorts. On 25Feb2021 after dose 2 of BNT162B2, the patient experienced chills, fatigue, weakness, sore arm, slept for 14 hours, headache, injection site pain, body ache. On an unspecified date the patient experienced runny nose. The patient was treated with acetaminophen (TYLENOL) at "3 per day" from 24Feb2021 to 27Feb2021. The outcomes of chills, fatigue, weakness, sore arm, slept for 14 hours, headache, injection site pain, and body ache were recovered on 27Feb2021. The outcome of runny nose was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Rhinorrhoea, Vaccination site pain
Clinical narrative: runny nose; Chills; fatigue; weakness; sore arm; slept for 14 hrs/slept a lot; Headache; Body ache; Injection site pain; This is a spontaneous report from a contactable nurse (patient). This 77-year-old female patient received dose 2 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number EN6201) intramuscularly on 24Feb2021 at 13:00 (at the age of 77-years-old) as a single dose in the left deltoid for COVID-19 immunization. Medical history included type 2 diabetes mellitus (DM II), hypothyroid for over 20 years, glaucoma in right (R) eye, and hypertension (HTN), all ongoing. The patient was not pregnant at the time of vaccination. Concomitant medications included metformin; levothyroxine sodium (SYNTHROID); lisinopril; atorvastatin; amlodipine; "HOPZ 25 mg;" multiminerals, multivitamins (CENTRUM SILVER); brimonidine tartrate (BRIMOT); and dorzolamide, timolol (COSOPT) from unspecified dates for unspecified indications. The patient previously received acetaminophen (TYLENOL EXTRA STRENGTH) from 04Feb2021 to 09Feb2021 for pain (severe headache). The patient previously received dose 1 of BNT162B2 (lot number EL9261) intramuscularly on 03Feb2021 as a single dose in the left deltoid for COVID-19 immunization and experienced pain, unable to think clearly, headache, aching body, and feeling out of sorts. On 25Feb2021 after dose 2 of BNT162B2, the patient experienced chills, fatigue, weakness, sore arm, slept for 14 hours, headache, injection site pain, body ache. On an unspecified date the patient experienced runny nose. The patient was treated with acetaminophen (TYLENOL) at "3 per day" from 24Feb2021 to 27Feb2021. The outcomes of chills, fatigue, weakness, sore arm, slept for 14 hours, headache, injection site pain, and body ache were recovered on 27Feb2021. The outcome of runny nose was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: She feels like she has the flu; This is a spontaneous report from a contactable consumer (patient). This female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on an unspecified date, reported as Monday (as of 10Mar2021), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient reported she had her first shot on Monday, and today as of 10Mar2021, she felt like she had the flu. She inquired if she could take acetaminophen (TYLENOL) or any pain reliever. The clinical outcome of she felt like she had the flu was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: left shoulder was still sore where he got the shot; Headache; This is a spontaneous report received from a contactable consumer, the patient. A 64-years-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE),via an unspecified route of administration in the left arm on 09Mar2021 11:00 (Batch/Lot Number: unknown; expiration date: unknown; NDC number: unknown) (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included the patient had occasionally headaches and took acetaminophen, aspirin and caffeine off and on as needed for headaches. Concomitant medications were not reported. On 09Mar2021, shortly after when he was leaving and driving, he started getting a headache and he took two acetaminophen, aspirin and caffeine (EXCEDRIN) at lunch time. His head started hurting about half an hour after the vaccination. The headache kind of went away after the lunch. On an unspecified date, the patient stated that left shoulder was still sore where he got the shot. The outcome of event, headache was recovered on 09Mar2021 as the headache was gone and the outcome of event, left shoulder was still sore where he got the shot was not recovered.   The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Rash
Clinical narrative: rash is on her face and down onto her neck and her left shoulder; This is a spontaneous report from a contactable consumer (patient). This 85-year-old female patient received dose 1 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number EL9262  on 02Feb2021 (at the age of 85-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On an unspecified date, the patient experienced a rash on the face down onto the  neck and left shoulder. The rash started a little before dose 2 of BNT162B2 but it was not going to stop the patient from getting the second dose of BNT162B2. It was a little big. The event was reported as nonserious. The patient sawa doctor on 03Mar2021 who thought the rash would go away. The patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included bloodwork on an unspecified date in Feb2021 a week prior to seeing her doctor with results of "okay." The outcome of rash on the face down onto the neck and left shoulder was unknown.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) :-PFIZER INC-2021263595 same report/patient, different dose/AE
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Blood test, Fatigue, Headache, Lymph node pain
Clinical narrative: Stiff neck; Lymph node pain; persistent pain on both sides of her back; Mild headache; Fatigue extreme; body was sore; bump at injection site that is sore; bump at injection site that is sore; Sleepiness; This is a spontaneous report received from a contactable consumer (patient). This 50-year-old female patient received dose 1 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number EN6198) via an unspecified route of administration on 08Mar2021 at about 21:00 (at the age of 50-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included vitamin D deficiency and hypothyroidism from about 4 years ago as of 2021, and morbidly obese. The patient had not had any other recent vaccinations. Concomitant medications included levothyroxine sodium (SYNTHROID) from at least 4 years ago or more as of 2021. On 09Mar2021, the patient experienced extreme fatigue,  body was sore, at the place where the injection was there was a bump there that was sore, sleepy, and mild headache. On 10Mar2021, the patient experienced soreness, pain, and fatigue which were worse; everywhere on her body hurt, lymph nodes on the side and back of her head and down to her ear on both sides of her neck were hurting so bad; persistent pain on her back where her chest is, she didn't know what that was called, it was like someone punched her there on both sides. On an unspecified date the patient experienced sometimes she had a stiff neck that was new.  The patient wanted to know if she should go to a doctor. The patient had blood work on an unspecified date with results of okay.  The patient did not receive any treatment for the events. The outcomes of extreme fatigue, body was sore, at the place where the injection was there was a bump there that was sore, sleepy, mild headache, pain, lymph node pain, back pain, and stiff neck were unknown.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain, Somnolence, Vaccination site mass, Vaccination site pain
Clinical narrative: Stiff neck; Lymph node pain; persistent pain on both sides of her back; Mild headache; Fatigue extreme; body was sore; bump at injection site that is sore; bump at injection site that is sore; Sleepiness; This is a spontaneous report received from a contactable consumer (patient). This 50-year-old female patient received dose 1 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number EN6198) via an unspecified route of administration on 08Mar2021 at about 21:00 (at the age of 50-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included vitamin D deficiency and hypothyroidism from about 4 years ago as of 2021, and morbidly obese. The patient had not had any other recent vaccinations. Concomitant medications included levothyroxine sodium (SYNTHROID) from at least 4 years ago or more as of 2021. On 09Mar2021, the patient experienced extreme fatigue,  body was sore, at the place where the injection was there was a bump there that was sore, sleepy, and mild headache. On 10Mar2021, the patient experienced soreness, pain, and fatigue which were worse; everywhere on her body hurt, lymph nodes on the side and back of her head and down to her ear on both sides of her neck were hurting so bad; persistent pain on her back where her chest is, she didn't know what that was called, it was like someone punched her there on both sides. On an unspecified date the patient experienced sometimes she had a stiff neck that was new.  The patient wanted to know if she should go to a doctor. The patient had blood work on an unspecified date with results of okay.  The patient did not receive any treatment for the events. The outcomes of extreme fatigue, body was sore, at the place where the injection was there was a bump there that was sore, sleepy, mild headache, pain, lymph node pain, back pain, and stiff neck were unknown.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: UNK
Symptoms: Dizziness, Headache
Clinical narrative: drug interaction with this vaccine; feeling extremely dizzy; head feels like it's on fire; This is a spontaneous report from a contactable consumer (patient's friend). A male patient of an unspecified age received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE solution for injection; Batch/Lot Number and Expiry date were unknown), via an unspecified route of administration on 08Mar2021, Monday, at a single dose for covid-19 immunization; atorvastatin calcium (Batch/Lot Number and Expiry date were unknown), via an unspecified route of administration from an unspecified date to an unspecified date, at 20 mg for blood cholesterol abnormal (cholesterol problem); phenoxymethylpenicillin potassium (PENICILLIN VK; Batch/Lot Number and Expiry date were unknown), via an unspecified route of administration from an unspecified date to an unspecified date, at 500 mg for dental problem (tooth disorder); chlorthalidone (Batch/Lot Number and Expiry date were unknown), via an unspecified route of administration from an unspecified date to an unspecified date, at 25 mg for blood pressure abnormal (blood pressure problem). Medical history included dental problem (tooth disorder), blood pressure abnormal, blood cholesterol abnormal (blood pressure problem and cholesterol problem); all from an unknown date. The patient's concomitant medications were not reported. It was reported that patient seemed to have a quite severe reaction after he got the vaccine. On 10Mar2021, two days after vaccination, the patient experienced drug interaction with the vaccine. The reporter was sure about drug interaction with this vaccine as the patient also took blood pressure and cholesterol medicine along with Penicillin. Patient now felt extremely dizzy and felt like his head is on fire, all on 10Mar2021. The events were reported as non-serious. 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: Feeling cold
Clinical narrative: Got very cold; This is a spontaneous report from a contactable consumer (patient's daughter). This consumer reported similar events for three patients; this is the second of three reports. A 92-year-old female patient received a dose of 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 reporter stated that last night her husband, her mom and herself all got very cold. The reporter stated that her mom was actually doing better than she was. The clinical outcome of got very cold was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: chills; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer sponsored program, . This male patient of unspecified age received the first dose of BNT162B2 (TRADE NAME UNSPECIFIED; lot number unknown) via an unspecified route of administration on 06Mar2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 10Mar2021, 4 days after vaccination, the patient experienced chills. The patient inquired if this was normal. The clinical outcome of chills was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This is a spontaneous report from a Pfizer sponsored study  from a contactable consumer. The patient was the reporter's daughter. A female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) dose 2, via an unspecified route of administration, on 09Mar2021 as a single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received dose 1 of BNT162b2 on an unspecified date, for COVID-19 immunization. The patient experienced fever on an unspecified date. The clinical outcome of the event fever was unknown.   The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
Age: 72.0
Sex: U
Vaccine: COVID19
Symptoms: Joint swelling
Clinical narrative: shoulders started to swell; This is a spontaneous report received from a contactable consumer (patient). This 72-year-old patient of unspecified gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 19Feb2021 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number unknown) on an unspecified date for COVID-19 immunisation. The patient reported they had received the second dose on 19Feb (2021) and their shoulders started to swell; they inquired how long that was supposed to last, further stating they would call their doctor. The clinical outcome of shoulders started to swell was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blood iron, Fatigue, Feeling abnormal, Gastric disorder, Illness
Clinical narrative: Event woke her up; feeling really bad; kind of sick at her stomach; fatigue, tired; really nauseous; Really, really sick; This is a spontaneous report received from a contactable consumer (patient). This contactable 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6198) via an unspecified route of administration in the right upper arm on 06Mar2021 at 13:30, reported as about 13:30 to 14:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes mellitus from 2001 and ongoing, high blood pressure from 2001 and ongoing, and chronic obstructive pulmonary disease from 2001 and ongoing. Concomitant medications were not reported; the patient stated she'd been taking them for years and they were not relevant to these events. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient received her first dose of BNT162B2 on 06Mar2021 around 13:30-14:00. She reported being really, really sick later that day on 06Mar2021 and called to inquire if this event could be related to the vaccine and asked if she had to get the same type of COVID-19 vaccine for both doses, or if she could get a different manufacturer's COVID-19 vaccine for the second dose. She reported really, really sick initially onset around 19:00-20:00 on 06Mar2021 and continued for 2 days, until around 08Mar2021 then she felt better. Starting 09Mar2021 around 19:00-20:00 she started feeling really, really sick again like she was on 06Mar2021. She was feeling really bad, kind of sick at her stomach, really nauseous, fatigued, and tired. The event woke her up around 06:30 on 11Mar2021. She further reported the ongoing event is about the same as initial onset, persistent. Regarding bloodwork performed about a month or so before being administered BNT162B2, approximately Feb2021, she reported that they had corrected her low iron and low B12. The events did not require hospitalization. The clinical outcomes of really, really sick, feeling really bad, kind of sick at her stomach, fatigue, tired, nauseous and event woke her up were not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Middle insomnia, Nausea, Vitamin B12
Clinical narrative: Event woke her up; feeling really bad; kind of sick at her stomach; fatigue, tired; really nauseous; Really, really sick; This is a spontaneous report received from a contactable consumer (patient). This contactable 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6198) via an unspecified route of administration in the right upper arm on 06Mar2021 at 13:30, reported as about 13:30 to 14:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes mellitus from 2001 and ongoing, high blood pressure from 2001 and ongoing, and chronic obstructive pulmonary disease from 2001 and ongoing. Concomitant medications were not reported; the patient stated she'd been taking them for years and they were not relevant to these events. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient received her first dose of BNT162B2 on 06Mar2021 around 13:30-14:00. She reported being really, really sick later that day on 06Mar2021 and called to inquire if this event could be related to the vaccine and asked if she had to get the same type of COVID-19 vaccine for both doses, or if she could get a different manufacturer's COVID-19 vaccine for the second dose. She reported really, really sick initially onset around 19:00-20:00 on 06Mar2021 and continued for 2 days, until around 08Mar2021 then she felt better. Starting 09Mar2021 around 19:00-20:00 she started feeling really, really sick again like she was on 06Mar2021. She was feeling really bad, kind of sick at her stomach, really nauseous, fatigued, and tired. The event woke her up around 06:30 on 11Mar2021. She further reported the ongoing event is about the same as initial onset, persistent. Regarding bloodwork performed about a month or so before being administered BNT162B2, approximately Feb2021, she reported that they had corrected her low iron and low B12. The events did not require hospitalization. The clinical outcomes of really, really sick, feeling really bad, kind of sick at her stomach, fatigue, tired, nauseous and event woke her up were not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Influenza like illness, Pain
Clinical narrative: weakness; aching flu like symptoms; Aching flu like symptoms; Headache; general tiredness; This is a spontaneous report from a contactable consumer (patient herself). A 32-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on an unspecified date (Batch/Lot Number: EL3248) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced weakness, aching flu like symptoms, headache and general tiredness on 09Mar2021. No treatment was received for the adverse event. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. The outcome of the events was recovering.  Information about lot/batch no. has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Myalgia
Clinical narrative: sore muscle pain; dizziness; This is a spontaneous report from a contactable consumer (patient). The consumer reported similar events for two patients, this is the first of two reports. This 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6200) via an unspecified route of administration in the right arm on 07Mar2021 at 16:00 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure (BP) from an unknown date and unknown if ongoing, and cholesterol from an unknown date and unknown if ongoing. The patient had no allergies to medications, food or other products, and was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included losartan from an unknown date for an unknown indication; atorvastatin from an unknown date for an unknown indication; and fish oil from an unknown date for an unknown indication. The patient had not received any other vaccines in the 4 weeks prior to vaccination. The patient experienced sore muscle pain and dizziness on 08Mar2021 at 8:00. The patient reported she knew that sore muscle pain was normal but three days after vaccination and dizziness continue. The events were reported as non-serious and did not require hospitalization. No treatment was provided for the events. The outcomes of the events were not recovered. It was also reported that since vaccination the patient had not been tested for COVID-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021285640 same reporter/drug/event, different patients
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: diagnosed with Shingles; This is a spontaneous report received from Salelytics from a contactable consumer or other non hcp.  A female patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced diagnosed with shingles on an unspecified date. Clinical outcome of the event shingles was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: some mild arm tenderness as typical with vaccines; This is a spontaneous report from a contactable consumer (the patient). A patient of an unspecified age and gender 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 (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the first dose of the COVID-19 vaccine earlier today and had some mild arm tenderness as is typical with vaccines (unspecified date). The outcome of the event was unknown.    Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: lymph node in her throat looks swollen; This is a spontaneous report received from a Pfizer-Sponsored Program, . A contactable consumer reported a female patient of an unspecified age received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 on unspecified date (lot number not provided) for COVID-19 immunization. The caller's daughter got first vaccine her arm was swollen and went away. The consumer reported it's been a week since the patient had the second one and a lymph node in her throat looks swollen. The clinical outcome of lymph node in her throat looks swollen was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: she looked at her arm with a band aid on it, then it hurt; This is a spontaneous report from a contactable consumer (the patient) from a Pfizer-sponsored program .A female 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 (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the COVID vaccine and had no side effects and didn't even feel the vaccine until she looked at her arm with a band aid on it, then it hurt. She was wondering if the first and second dose of the vaccine were the same. The outcome of the 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: Rhinitis allergic
Clinical narrative: nasal allergies; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program.This male patient of unspecified age received the second 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 previously received the first dose of BNT162B2 (lot number unknown) on an unspecified date for COVID-19 immunisation. On an unspecified date the patient experienced nasal allergies. The patient inquired if he could take fluticasone propionate (FLONASE) allergy nasal spray because he was experiencing nasal allergies. The clinical outcome of nasal allergies was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Chills, Cold sweat, Drug ineffective
Clinical narrative: States so he doesn't get Covid again, caller states patient said he feels like he has it again; States so he doesn't get Covid again, caller states patient said he feels like he has it again; cold sweat; Body Aches; fever/99.3 last night/100.2 last night; sore arm/Right Arm Hurting; muscle pain/Muscle and Body Aches; Chills and Shaking; Chills and Shaking; This is a spontaneous report from a contactable consumer (patient's spouse). A 74-year-old male patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), 1st dose on 01Mar2021 (Lot Number: EN6205) and 2nd dose on 21Mar2021 10:35 (Lot Number: EP7534); both via unspecified routes of administration, administered in right arm, as single doses for COVID-19 immunisation. Medical history included ongoing atrial fibrillation (A-Fib, diagnosed around 5 years ago) and ongoing high blood pressure - had it since he was 30 years old. Concomitant medication included apixaban (ELIQUIS) taken for A-Fib from an unspecified start date (started years ago, probably 5 years ago) and ongoing. No additional vaccines administered on same date of the Pfizer vaccines. The patient received the second dose of the Pfizer covid vaccine on 21Mar2021 and had fever, chills and shaking, sore arm, muscle pain. The patient received 2 Tylenol at 7:40 at the time of report and his temp was 98.6. The reporter stated her husband had the vaccine and he has been having fever, chills, and muscle aches. Clarifies that he had chills with shaking that are gone now, and just cold sweat morning (day of reporting). Muscle and body aches: achy all over. Fever: 99.3 on 21Mar2021 and morning of reporting got it down but got up to 100.2 on 21Mar2021, still having a slight fever at time of report. Right arm hurting: states it started as soon as they were in the parking lot after the vaccine. Treatment was Tylenol. Arm started hurting in parking lot 14:00, body aches and fever at 21:00. Events did not require a visit to emergency room or physician office. When asked for the indication of 2nd dose, the reporter stated "so he doesn't get Covid again, caller states patient said he feels like he has it again." Outcome of events fever, muscle and body aches, right arm hurting was not recovered, events chills and shaking recovered on 22Mar2021, other events was unknown. The events were reported as non-serious.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pain in extremity, Pyrexia, Tremor
Clinical narrative: States so he doesn't get Covid again, caller states patient said he feels like he has it again; States so he doesn't get Covid again, caller states patient said he feels like he has it again; cold sweat; Body Aches; fever/99.3 last night/100.2 last night; sore arm/Right Arm Hurting; muscle pain/Muscle and Body Aches; Chills and Shaking; Chills and Shaking; This is a spontaneous report from a contactable consumer (patient's spouse). A 74-year-old male patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), 1st dose on 01Mar2021 (Lot Number: EN6205) and 2nd dose on 21Mar2021 10:35 (Lot Number: EP7534); both via unspecified routes of administration, administered in right arm, as single doses for COVID-19 immunisation. Medical history included ongoing atrial fibrillation (A-Fib, diagnosed around 5 years ago) and ongoing high blood pressure - had it since he was 30 years old. Concomitant medication included apixaban (ELIQUIS) taken for A-Fib from an unspecified start date (started years ago, probably 5 years ago) and ongoing. No additional vaccines administered on same date of the Pfizer vaccines. The patient received the second dose of the Pfizer covid vaccine on 21Mar2021 and had fever, chills and shaking, sore arm, muscle pain. The patient received 2 Tylenol at 7:40 at the time of report and his temp was 98.6. The reporter stated her husband had the vaccine and he has been having fever, chills, and muscle aches. Clarifies that he had chills with shaking that are gone now, and just cold sweat morning (day of reporting). Muscle and body aches: achy all over. Fever: 99.3 on 21Mar2021 and morning of reporting got it down but got up to 100.2 on 21Mar2021, still having a slight fever at time of report. Right arm hurting: states it started as soon as they were in the parking lot after the vaccine. Treatment was Tylenol. Arm started hurting in parking lot 14:00, body aches and fever at 21:00. Events did not require a visit to emergency room or physician office. When asked for the indication of 2nd dose, the reporter stated "so he doesn't get Covid again, caller states patient said he feels like he has it again." Outcome of events fever, muscle and body aches, right arm hurting was not recovered, events chills and shaking recovered on 22Mar2021, other events was unknown. The events were reported as non-serious.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombophlebitis superficial
Clinical narrative: Superficial blood clot in right upper thigh; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on arm left on 14Mar2021 12:00 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization at the Pharmacy or Drug Store. Medical history included ongoing birth control.  Concomitant medications included unspecified birth control pills and vitamins.  The patient was not pregnant (including the time of vaccination). On 15Mar2021 12:00, the patient experienced superficial blood clot in right upper thigh. The patient had no COVID-19 prior vaccination and not tested for COVID-19 post vaccination. The patient was treated with apixaban (ELIQUIS) 10 mg. The patient was recovering from the event.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement, Discomfort, Dizziness, Heart rate
Clinical narrative: Upon standing, she felt an extreme heaviness along with feelings like she was going to pass out; heart began racing; felt like she was going to be sick; Upon standing, she felt an extreme heaviness; thinks her blood pressure dropped; shaky; her face was completely pale; This is a spontaneous report from a contactable consumer (the patient). A 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EP7534), via an unspecified route of administration on 18Mar2021 16:45 (at the age of 43-years-old) as a single dose for COVID-19 immunization. The patient's medical history included: epilepsy, asthma, environmental allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications included: lamotrigine, montelukast sodium (SINGULAIR), colecalciferol (VITAMIN D), and antihistamine all taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of COVID-19 vaccine (UNSPECIFIED TRADE NAME), via an unspecified route of administration on an unspecified date for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Mar2021 03:00, also reported as 8 hours after vaccine, the patient's heart began racing, she felt like she was going to be sick. Upon standing, she felt an extreme heaviness along with feelings like she was going to pass out (she thinks her blood pressure dropped). She was shaky. Her husband confirmed that her face was completely pale. The patient's heart raced on and off for another half hour before she felt more normal. No treatment was received for the events. The outcome of the events was recovered on an unspecified date in Mar2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pallor, Palpitations, Tremor
Clinical narrative: Upon standing, she felt an extreme heaviness along with feelings like she was going to pass out; heart began racing; felt like she was going to be sick; Upon standing, she felt an extreme heaviness; thinks her blood pressure dropped; shaky; her face was completely pale; This is a spontaneous report from a contactable consumer (the patient). A 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EP7534), via an unspecified route of administration on 18Mar2021 16:45 (at the age of 43-years-old) as a single dose for COVID-19 immunization. The patient's medical history included: epilepsy, asthma, environmental allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications included: lamotrigine, montelukast sodium (SINGULAIR), colecalciferol (VITAMIN D), and antihistamine all taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of COVID-19 vaccine (UNSPECIFIED TRADE NAME), via an unspecified route of administration on an unspecified date for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Mar2021 03:00, also reported as 8 hours after vaccine, the patient's heart began racing, she felt like she was going to be sick. Upon standing, she felt an extreme heaviness along with feelings like she was going to pass out (she thinks her blood pressure dropped). She was shaky. Her husband confirmed that her face was completely pale. The patient's heart raced on and off for another half hour before she felt more normal. No treatment was received for the events. The outcome of the events was recovered on an unspecified date in Mar2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Initial insomnia, Therapeutic response unexpected
Clinical narrative: pain and inflammation was greatly reduced on left knee (osteoarthritis); difficulty falling asleep.; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: ER2613), via an unspecified route of administration in the left arm on 20Mar2021 at 14:30 (at the age of 71-years-old) as a single dose for COVID-19 immunization. Medical history included osteoarthritis of both knees, and aortic stenosis. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included apixaban (ELIQUIS), metoprolol, losartan, loratadine (LORTADINE), calcium. The patient did not receive any other vaccine within 4 weeks of the vaccination. The patient previously took erythromycin and experienced allergies, and previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN6198) in the left arm on 27Feb2021 at 14:30 for COVID-19 immunization. On 20Mar2021 at 20:15, the patient had difficulty falling asleep (that night only). It was also reported that on 20Mar2021 at 20:30, 6 hours after vaccination, the patient's pain and inflammation of the left knee (osteoarthritis) was greatly reduced, and 48 hours later, still greatly reduced pain. The patient was not treated for the event difficulty falling asleep. Since the vaccination, the patient was not tested for COVID-19. The clinical outcome of difficulty falling asleep was resolved on 21Mar2021, while of "pain and inflammation was greatly reduced on left knee (osteoarthritis)" was unknown.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Diagnosed with COVID-19; Diagnosed with COVID-19; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (reported as 51; unspecified unit) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 04Mar2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Last Monday (Mar2021; pending clarification), the patient was diagnosed with COVID-19. The patient was surprised that Pfizer didn't have additional information and asked if the company was doing any trials on people like her as she was sure there are more people than just her. The outcome of the events was unknown.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.