chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report from a contactable consumer or other non hcp.    A male patient of an unspecified age received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number and expiration date were not reported), via an unspecified route of administration on an 29May2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced headache on an unspecified date. Outcome of the event was unknown.  No follow up attempts are needed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Pain in extremity, Vaccination site bruising
Clinical narrative: arm got real sore; a little blood bruising dots all over her arm from the shot; red dots from the shot on her upper arm (bruise); This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in arm on 02Apr2021 (at the age of 73 years old; Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received first dose of Pfizer COVID vaccine on 02Apr2021. The patient mentioned that later that evening her arm got real sore and she developed a little blood bruising dots all over her arm from the shot and red dots from the shot on her upper arm (bruise) on 02Apr2021. The patient wondered if these has been reported and if these are possible side effects and was concerned about taking the 2nd dose. Outcome of the events was unknown.   Information on lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Medical device site pain, Neck pain
Clinical narrative: headache; nape pain; chills; 2 days later he felt pain in screws and other instrumentation instaled in his body due to a hip surgery; This is a spontaneous report received from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient called in to report the symptoms experienced after first dose of Pfizer's COVID-19 vaccine. Patient reports that the same day of vaccination patient had headache, nape pain and chills. The patient reports that 2 days later he felt pain in screws and other instrumentation installed in his body due to a hip surgery, the pain was gone after this time. Outcome of the event Medical device site pain was recovered on an unknown date and for remaining events outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Pneumonia
Clinical narrative: Pneumonia; This is a solicited report from a contactable consumer, based on information received by Pfizer (Mfr. Control Number: 21K-163-3826688-00), from a non-Pfizer marketing program (marketing program name not available). A 78-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a 1st dose, single for COVID-19 immunisation and ibrutinib (IMBRUVICA), oral from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 420 mg daily for chronic lymphocytic leukaemia.  Medical history included diabetes mellitus and allergies IV-dye, both from unknown dates. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Concomitant medications included apixaban (ELIQUIS); lisinopril (LISINOPRIL); loperamide hydrochloride (LOPERAMIDE HYDROCHLORIDE); pantoprazole sodium anhydrous (PANTOPRAZOLE SODIUM ANHYDROUS); tamsulosin hydrochloride (TAMSULOSIN HYDROCHLORIDE); colecalciferol (VITAMIN D3); all taken from unknown dates for unspecified indications.  On 11Mar2021 the patient experienced pneumonia. The patient was hospitalized for pneumonia from 11Mar2021 to 19Mar2021.  The action taken in response to the event for ibrutinib was temporarily withdrawn on an unspecified date. The outcome of the event pneumonia was recovering. The causality assessment for BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) and the event pneumonia was not provided by the reporter.  The reporter's assessment of the causal relationship of the pneumonia with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible: information about lot/batch number cannot be obtained.  Follow-up (18May2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.; Sender's Comments: Based on the current available information, the event Pneumonia is most likely related to an intercurrent or underlying condition which is not related to the suspected drug.  The case will be reassessed if additional information becomes available.
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, Disturbance in attention, Fatigue, Headache
Clinical narrative: Headaches bother her the most; Sensitivity to light\computer screen; Lost of appetite; Diarrhea; Sleeping a lot I'm tired; Hard to concentrate; Sleeping a lot I'm tired; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: Not reported), via an unspecified route of administration on 02Apr2021 as a 1st dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 02Apr2021, the patient stated she had the Pfizer-BioNTech COVID-19 Vaccine on Friday afternoon (First dose 02Apr2021) and experienced a lot of the side effects, none of the allergic reaction, but she still experiencing them (since Friday through Tuesday) and asked how much time does it take to become normal, headaches bother me the most, she have sensitivity to light\computer screen, she don't want to go outside, she had lost of appetite, diarrhea, hard to concentrate, sleeping a lot , she was tired. On unknown date (Monday), the patient underwent lab test and procedure included Covid-19 test: Negative but, she was worried what was wrong with her. She stated that, she had not reported to safety because she did want to give them all her information without having an answer. The reporter was concerned about her second dose which was scheduled on 23Apr2021. She wants to know whether people who had first dose had similar side effects and they are presented separately. She wants to know risks of pfizer-Biontech covid-19 Vaccine. 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: Photophobia, SARS-CoV-2 test, Somnolence
Clinical narrative: Headaches bother her the most; Sensitivity to light\computer screen; Lost of appetite; Diarrhea; Sleeping a lot I'm tired; Hard to concentrate; Sleeping a lot I'm tired; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: Not reported), via an unspecified route of administration on 02Apr2021 as a 1st dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 02Apr2021, the patient stated she had the Pfizer-BioNTech COVID-19 Vaccine on Friday afternoon (First dose 02Apr2021) and experienced a lot of the side effects, none of the allergic reaction, but she still experiencing them (since Friday through Tuesday) and asked how much time does it take to become normal, headaches bother me the most, she have sensitivity to light\computer screen, she don't want to go outside, she had lost of appetite, diarrhea, hard to concentrate, sleeping a lot , she was tired. On unknown date (Monday), the patient underwent lab test and procedure included Covid-19 test: Negative but, she was worried what was wrong with her. She stated that, she had not reported to safety because she did want to give them all her information without having an answer. The reporter was concerned about her second dose which was scheduled on 23Apr2021. She wants to know whether people who had first dose had similar side effects and they are presented separately. She wants to know risks of pfizer-Biontech covid-19 Vaccine. The outcome of the events was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Gastric disorder, Headache
Clinical narrative: headaches; stomach issues; This is a spontaneous report from a contactable consumer or other non hcp as reporter (patient). A patient of unknown age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, (lot number, expiry date was unknown), via an unspecified route of administration (lot number and expiry date was unknown) as a Unknown dose, single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. On unknown date, patient experienced headaches and stomach issues after the covid vaccine. The outcome of the events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report from a contactable consumer (patient) received from a Pfizer sponsored program . A female 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 31Mar2021 as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had a scheduled appointment for a second dose due on 21Apr2021. This past Sunday, her granddaughter tested positive for COVID. On an unspecified date in Apr2021, the patient experienced headache. The patient asked whether it will affect her second dose of the vaccine. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: A little headache; Achy arm; little tired; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number, NDC number and Expiry Date are not provided), via an unspecified route of administration on 29Mar2021 as 2ND DOSE, SINGLE for covid-19 immunisation. The patient medical history included first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on 08Mar2021 for covid-19 immunisation. The patient previously took lamisil [terbinafine hydrochloride] and experienced horrible reaction she had with Lamisil a few years ago on an unspecified date. While calling to report on her husband, caller reported that she experienced what she stated to be the normal, classic reaction. Caller reported that after taking Lamisil, she lost her sense of taste for 6 months. Caller reported that after losing her sense of taste, she had to put hot sauce on everything just to be able to taste anything. Caller reported that she followed up with her physician and that her physician looked through all of the side effects of Lamisil. Caller stated that she understands that there has to be a certain percentage of patients that experience side effects before the side effects are listed on the prescribing information. Caller reported that losing the sense of taste after taking Lamisil was a reaction, but it had not occurred enough to put on the prescribing information and that the experience of her husband was kind of a bingo thing. Caller reported that she was one of the fortunate people that had no taste after taking Lamisil. Caller reported that she survived that, but she can no longer take Lamisil. The patients concomitant medications were not reported. It was reported that, she had her first dose of the Pfizer Covid-19 vaccine on 08Mar2021 and the second dose on 29Mar2021. Caller reported earlier in the call that she had experienced a little bit of a headache, an achy arm, and was a little tired on an unspecified date in Mar2021 after receiving the Covid-19 vaccine. Investigation assessment was not provided. The reporter assessed events as non-serious. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Cough, Feeling cold, Headache, Malaise, Migraine
Clinical narrative: headache; migraine; feeling cold; not feeling good; coughing; This is a spontaneous report from a Pfizer-sponsored Program via contactable consumer (patient) reported for herself that.   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. The patient experienced headache, migraine, feeling cold, not feeling good and coughing on an unspecified date. Patient received treatment in response to the events. It was reported that, Caller had headache and was tried to look for her card. Was supposed to get her second dose on the 14Apr2021 but couldn't find it. caller now had migraine from looking for it. Caller would like to change the appointment from 14Apr2021 to 20Apr2021 or 21Apr2021. Was feeling cold and was not feeling good and coughing and 10 days later still felt the same way. Tried taking Zyr-tec and that wasn't working. Transferred to Pfizer DSU but due to long hold times transferred to queue from CoVax US Support CEP 159558. The outcome of the events was not recovered.  Medical Information: Were any unaddressed medical questions referred or forwarded to Medical Information? No.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headaches; This is a spontaneous report received from a contactable consumer (reporting on herself). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and Expiration Date was not reported) via an unspecified route of administration on an unspecified date, as 1st dose, single dose and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and Expiration Date was not reported) via an unspecified route of administration on 31Mar2021, as 2nd dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that patient had her second shot, clarifies Pfizer Covid vaccine, last Wednesday, 31 Mar2021, states she has had headaches off and on since then and wants to know if this was natural. Patient had first shot, had headache but it went away, states this time it was on and off. The outcome of the event was unknow.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Decreased appetite, Diarrhoea, Fatigue
Clinical narrative: Headache; chills; began vomiting what meal eaten that evening; diarrhea; very, very tired; GI distress; no urge to eat; This is a spontaneous report from  contactable consumer (patient) and Health Professional Registered Nurse reported via Pfizer Sponsored Program COVAX US Support. A 62-years-old female patient received of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch no: ER8734, Expiration date: 31 Jul 2021) via an unspecified route of administration on 05 Apr 2021 as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the Patient is a Registered Nurse reporting the Pfizer Covid Vaccine was administered to her yesterday, 05APR2021 and is reporting side effects. Caller had the Pfizer Covid Vaccine at 13:00 yesterday and by 21:00 last night had a headache, chills and began vomiting what meal she had eaten that evening, then diarrhea began. The diarrhea has continued through today 06Apr2021, Headache has also continued through today 06Apr2021. Patient is very, very tired. Treatment received as has been drinking fluids and took Tylenol for headache and says it helped began Vomiting what meal eaten that evening, vomiting stopped last night but patient is still nauseous.  Reports a wave of nausea on and off. Chills:Reports the chills went away this morning, but patient had them on and off throughout last night. Onset of symptoms: Symptoms began last night about 9 o'clock, that's what started it all. GI distress: GI distress throughout the night and this morning. Its not as severe as it was overnight. No urge to eat: patient still hasn't really eaten anything today. Says she nibbled an English muffin to get something down. Reports no urge to eat but is drinking water. Outcome of the events was recovering.  No Follow-up attempts are required. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vomiting
Clinical narrative: Headache; chills; began vomiting what meal eaten that evening; diarrhea; very, very tired; GI distress; no urge to eat; This is a spontaneous report from  contactable consumer (patient) and Health Professional Registered Nurse reported via Pfizer Sponsored Program COVAX US Support. A 62-years-old female patient received of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch no: ER8734, Expiration date: 31 Jul 2021) via an unspecified route of administration on 05 Apr 2021 as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the Patient is a Registered Nurse reporting the Pfizer Covid Vaccine was administered to her yesterday, 05APR2021 and is reporting side effects. Caller had the Pfizer Covid Vaccine at 13:00 yesterday and by 21:00 last night had a headache, chills and began vomiting what meal she had eaten that evening, then diarrhea began. The diarrhea has continued through today 06Apr2021, Headache has also continued through today 06Apr2021. Patient is very, very tired. Treatment received as has been drinking fluids and took Tylenol for headache and says it helped began Vomiting what meal eaten that evening, vomiting stopped last night but patient is still nauseous.  Reports a wave of nausea on and off. Chills:Reports the chills went away this morning, but patient had them on and off throughout last night. Onset of symptoms: Symptoms began last night about 9 o'clock, that's what started it all. GI distress: GI distress throughout the night and this morning. Its not as severe as it was overnight. No urge to eat: patient still hasn't really eaten anything today. Says she nibbled an English muffin to get something down. Reports no urge to eat but is drinking water. Outcome of the events was recovering.  No Follow-up attempts are required. No further information is expected.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: experienced a headache; This is a spontaneous report from a contactable consumer (Patient's wife).   A 81-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 05Apr2021 as 1ST DOSE, SINGLE for a covid-19 immunisation (Age at the vaccination 81-years). The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced headache. Reporter wanted to know if her husband can take any pain reliever. It was reported that she called doctor's office and they said it was ok. It was also mentioned she went to have her second Pfizer vaccine today and they told her to wait 24 hours before taking any Advil/Aleve/Tylenol. It was reported that patient took Motrin 5 hours after he had the vaccine. The outcome of event was unknown.  No follow up attempts are possible. Information on lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Hyperhidrosis, Nausea
Clinical narrative: Severe headache lasting approx 24 hrs; fever; Chills; Sweats; Nausea; Severe Body ache; Rhinorrhea; This is a spontaneous report from a contactable consumer (patient) via Pfizer Company Representative. A male patient of unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced severe headache lasting approximately 24 hours, fever/chills/sweats/nausea lasting approximately 24 hours, severe body ache lasting approximately 48 hours. The patient also experienced significant rhinorrhea on day 2 and 3 after shot. Event took place after use of product. Outcome of the events was recovered on an unspecified date.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Rhinorrhoea
Clinical narrative: Severe headache lasting approx 24 hrs; fever; Chills; Sweats; Nausea; Severe Body ache; Rhinorrhea; This is a spontaneous report from a contactable consumer (patient) via Pfizer Company Representative. A male patient of unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced severe headache lasting approximately 24 hours, fever/chills/sweats/nausea lasting approximately 24 hours, severe body ache lasting approximately 48 hours. The patient also experienced significant rhinorrhea on day 2 and 3 after shot. Event took place after use of product. Outcome of the events was recovered on an unspecified date.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: she has had severe headaches since; This is a Spontaneous report from a contactable consumer (patient herself). A 63-year-old female patient received of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: Unknown, Expiry date: unknown), via unspecified route of administration on 18Feb2021 as 2nd dose, single dose for COVID-19 immunisation. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE for COVID-19 Immunisation. Medical history included brain neoplasm from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 18Feb2021, since the evening of her vaccine, she experienced severe headaches. Caller states she was healthy prior to receiving the vaccine and she has accumulated a lot of medical bills since receiving the vaccine. Unable to offer survey caller disconnected call. States she was taking Tylenol regularly but it didn't really help so she stopped, and 3 days later she had a tremendous headache. States she has gone to the doctor, urgent care, and the ER. States they also did tests to rule out a brain tumour because even with meds, she gets very little relief. Therapeutic measures were taken as a result of adverse event. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache
Clinical narrative: instant headache; dizziness; fatigue; chills; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A 65-years-old female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, solution for injection, Batch/Lot Number and expiration date were unknown), dose 2 via an unspecified route of administration on 06Apr2021 as 2nd DOSE, SINGLE for covid-19 immunization. The patient previously received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, solution for injection, Batch/Lot Number and expiration date were unspecified), dose 1 via an unspecified route of administration for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 06Apr2021, the patient experienced instant headache after the vaccine was administered and dizziness. The patient also reported the dizziness has resolved but she now has fatigue and chills. The patient also shows concern about if this is all normal and how long could it last. The outcome of the events headache, dizziness and chills were reported as unknown, whereas for dizziness it was recovered.  No follow up attempts are needed. No Information on lot/batch number cannot be obtained.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Migraine
Clinical narrative: headache; had a little migraine; This is a spontaneous report from a contactable consumer or other non hcp. A 37-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number EW0IS) via an unspecified route of administration, administered in left arm on 08Apr2021 as single dose for COVID -19 immunisation. The patient medical history and concomitant medications were not reported. On 08Apr2021 the patient experienced headache, had a little migraine. Caller stated he had the first dose of the Pfizer COVID vaccine today and had a little migraine; stated he did not eat a lot today and had a headache that occurred after the vaccine; caller stated he was calling to see if he could take Aspirin BC powder or Tylenol or something and known once he taken something like Tylenol, he will feel better. Caller aware that we could not provide treatment recommendations or medical advice and was referred to his HCP. Caller stated he did not think the headache had to do with the vaccine, but he did not eat and did not know but the headache just up and started. HCP information: Caller declined HCP information and stated he did not have HCP. Caller stated he had the Pfizer COVID Vaccine about 10:25 am and the headache began after that. Stated the headache was not like it was earlier and he got something to eat so he was 80 percent feeling a little better. Caller stated he had not required treatment for the reported event at this time. No follow-up attempts are possible; information about lot/batch number cannot be obtained. The outcome of all events was recovering.  Communication: Caller stated the lot number for the Pfizer COVID vaccine was handwritten on his patient card and he thought it was EW0IS; captured as stated by the caller; stated his card did not have the NDC or expiry date written on it.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Influenza like illness
Clinical narrative: This is a spontaneous report received from contactable consumer. An adult non pregnant female patient of unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EP6955), via an unspecified route of administration on 07Apr2021 as 2ND DOSE, SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were unknown. The patient's vaccination history included BNT162B2 (Lot number: EP655) on 17Mar2021. The patient was not allergic to medications, food, or other products. On 08Apr2021, the patient experienced headache, fatigue and flu like symptoms. The patient did not receive any treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. There were no other medications the patient received within 2 weeks of vaccination. The patient was not been diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pruritus, Rash
Clinical narrative: Headaches on and off; Itchy; Rash on my abdomen, back, legs and arms.; This is a spontaneous report from a contactable consumer (patient).  A 63-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation solution for injection; Lot number: EP7533), via an unspecified route of administration on 31Mar2021 10:00, as single in Arm Left, for covid-19 immunization. Prior to vaccination, the patient was not diagnosed with covid-19 and since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient's medical history was not reported. The patient's concomitant medications included loratadine, pseudoephedrine sulfate (CLARITIN-D) and vitamins. Past drug events included Celebrex and Doxycycline with known allergies. On 04Apr2021 14:00, the patient experienced headaches on and off; itchy; and rash on my abdomen, back, legs and arms. The patient did not receive treatment for the reported events. The outcome of the events was not resolved.   No follow attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache just like the day after but a little less severe since 09Mar (last dose); This is a spontaneous report from a contactable consumer or other non hcp (patient).  A 67-year-old (non-pregnant) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm right on 09Mar2021 14:00 (at the age of 67-year-old) at a 2nd dose, single dose, for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included vitamins (List of any other medications the patient received within 2 weeks of vaccination). Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm right on an unspecified date (at the age of 67-year-old) at a 1st dose, single dose, for covid-19 immunization. On 10Mar2021 at 02:00, the patient experienced headache just like the day after but a little less severe since 09mar2021 (last dose). Patient did not receive treatment for the adverse event. Since the vaccination, patient has not been tested for COVID-19. Outcome of the event was recovered with sequelae.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: received first vaccine and now tested positive for Covid; received first vaccine and now tested positive for Covid; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of vaccine and now  (unspecified date) tested positive for COVID. She wanted to know how long would she have to wait after testing positive to get the 2nd dose. Outcome of events was unknown.  Information on the lot/batch number has been requested.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: Chills, body ache, headache; Chills, body ache, headache; Chills, body ache, headache; This is a spontaneous report from a contactable consumer. A 41-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown) via an unspecified route of administration, administered in Arm Left on 05Apr2021 at 11:00 (at the age of 41-years) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162B2 (Lot Number: EN6208) via an unspecified route of administration, administered in Arm right on 14Mar2021 at 15:30 (at the age of 41-years) as single dose for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. On 06Apr2021, the patient experienced chills, body ache and headache. The patient did not receive any treatment for the events. Since the vaccination, the patient was not tested for COVID-19. The outcome of events was resolved on an unspecified date in Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Decreased appetite, Dyspnoea, Fatigue, Headache
Clinical narrative: severe headache, between the eyes, worsened; very bad cough, she woke up with it, its hard to breathe with the cough, worsened; very bad cough, she woke up with it, its hard to breathe with the cough, worsened; yesterday she was tired when she got her shot, yesterday morning she slept all day; she was not really hungry; yesterday she was tired when she got her shot, yesterday morning she slept all day; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration, administered in left arm on 07Apr2021 at 11:00 hours, as single dose (at the age of 63-years-old) for covid-19 immunisation. Patient had no medical history. Patient stated that she had no problems, no medications, no heart problems, no diabetes, she was free and clear of medication. Patient had no family medical history relevant to events. Patient stated that a couple family member been vaccinated, and they did not had a problem. The patient's concomitant medications were not reported. Patient had no prior vaccinations (within 4 weeks). On 07Apr2021, patient got her shot at 11:00 hours and patient were tired when she got her shot and in morning patient slept all day, she did not eat because she was not really hungry, she had a headache between the eyes and it was odd for her to not be hungry. Patient stated that it happened after the first shot. Patient had severe headache and cough happened in the middle of the night, and can't breathe (on 07Apr2021). Patient had a bad cough, she woke up with it and it was hard to breathe with the cough (on 07Apr2021). Patient asked if she could take ibuprofen for headache and she was wondering if the cough was normal and can she take cough syrup. She stated that she needs something, she was coughing and hacking. Patient stated that every time she coughs her head was pounding. She could not eat and she was an eater. Patient said that she tried to get coffee down this morning and forget it, she was not really feeling hungry (on 07Apr2021) which was unusual for her, normally she would eat whatever you put in front of her. She didn't eat anything right now. As far as tiredness she was ok, not tired right now. Patient stated that she did feel tired (on 07Apr2021) yesterday but feels uncomfortable with headache and cough. Patient had no emergency room and physician office visit.  Event severe headache, between the eyes and very bad cough, she woke up with it, it was hard to breathe with the cough was worsened. The outcome was recovered for yesterday she was tired when she got her shot, yesterday morning she slept all day (tired) on 08Apr2021, not recovered for (very bad cough, she woke up with it, it was hard to breathe with the cough, worsened), (severe headache, between the eyes, worsened) and unknown for rest of the events.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia
Clinical narrative: severe headache, between the eyes, worsened; very bad cough, she woke up with it, its hard to breathe with the cough, worsened; very bad cough, she woke up with it, its hard to breathe with the cough, worsened; yesterday she was tired when she got her shot, yesterday morning she slept all day; she was not really hungry; yesterday she was tired when she got her shot, yesterday morning she slept all day; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration, administered in left arm on 07Apr2021 at 11:00 hours, as single dose (at the age of 63-years-old) for covid-19 immunisation. Patient had no medical history. Patient stated that she had no problems, no medications, no heart problems, no diabetes, she was free and clear of medication. Patient had no family medical history relevant to events. Patient stated that a couple family member been vaccinated, and they did not had a problem. The patient's concomitant medications were not reported. Patient had no prior vaccinations (within 4 weeks). On 07Apr2021, patient got her shot at 11:00 hours and patient were tired when she got her shot and in morning patient slept all day, she did not eat because she was not really hungry, she had a headache between the eyes and it was odd for her to not be hungry. Patient stated that it happened after the first shot. Patient had severe headache and cough happened in the middle of the night, and can't breathe (on 07Apr2021). Patient had a bad cough, she woke up with it and it was hard to breathe with the cough (on 07Apr2021). Patient asked if she could take ibuprofen for headache and she was wondering if the cough was normal and can she take cough syrup. She stated that she needs something, she was coughing and hacking. Patient stated that every time she coughs her head was pounding. She could not eat and she was an eater. Patient said that she tried to get coffee down this morning and forget it, she was not really feeling hungry (on 07Apr2021) which was unusual for her, normally she would eat whatever you put in front of her. She didn't eat anything right now. As far as tiredness she was ok, not tired right now. Patient stated that she did feel tired (on 07Apr2021) yesterday but feels uncomfortable with headache and cough. Patient had no emergency room and physician office visit.  Event severe headache, between the eyes and very bad cough, she woke up with it, it was hard to breathe with the cough was worsened. The outcome was recovered for yesterday she was tired when she got her shot, yesterday morning she slept all day (tired) on 08Apr2021, not recovered for (very bad cough, she woke up with it, it was hard to breathe with the cough, worsened), (severe headache, between the eyes, worsened) and unknown for rest of the events.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: she had minor headaches after the 1st dose; This is a spontaneous report from a Pfizer-sponsored program. A Contactable female consumer (patient) reported for herself. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) dose 1 via an unspecified route of administration on 28Feb2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 28Feb2021, patient experienced minor headaches.The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: horrendous headache; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on Apr2021 as unknown, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On Apr2021, patient experienced horrendous headache. Stated received their Pfizer covid19 shot 2 days ago and came down with a horrendous headache. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Pyrexia, Restless legs syndrome
Clinical narrative: Restless legs; Sweat; headache; Low grade fever; Chills; This is a spontaneous report from a contactable consumer or other non hcp received by Pfizer. Reference ID: NUS2021US049295_NC. A 44-years-old female patient started to receive unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: Not reported) via an unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, patient experienced headache, restless legs, low grade fever, sweat and chills. The reporter considered the events as non-serious. The patient received treatment for headache with Tylenol and for about 12 hours after event resolved. The outcome of event headache was recovered on an unspecified date while for the restless legs, low grade fever, sweat and chills was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Fatigue, Headache
Clinical narrative: mild headache; fatigue; This is a spontaneous report from a contactable consumer (patient). A 67-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6199) via an unspecified route of administration, administered in left arm on 03Mar2021 at 11:50 (at the age of 67years) as 2nd single dose for COVID-19 immunisation. Medical history included systemic lupus erythematosus from 1974 ongoing, asthma from 2016 ongoing, heart disease from 2002 ongoing, rheumatoid arthritis from 1975 ongoing and joint surgery from 1975 ongoing. The patient's concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number:Unknown) via an unspecified route of administration on 10-FEB-2021 as single dose for COVID-19 immunisation. On 03Mar2021 the patient experienced mild headache and fatigue recovered 8 hours after injection. Reporter seriousness reported as not serious. Patient received no treatment for the events. The patient underwent lab tests and procedures which included regular blood drawn for SLE and normal- abnormal results depending on flare ups. The outcome of the events was recovered on 03Mar2021.  No follow-up attempts are possible; information about lot/batch number available.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Vertigo
Clinical narrative: intermittent headache; vertigo; This is a spontaneous report from a contactable consumer, the patient. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number unknown), via unspecified route of administration on 20Mar2021 as single dose for COVID-19 immunization. No medical history was reported. The concomitant medications were not reported. Since the vaccination, patient experienced intermittent headache and vertigo on an unspecified date. The reporter assessed the events as non-serious. The outcome of the event was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: An on and off headache; Had fever on and off; Tiredness; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: Unknown, Expiration date: Unknown), via an unspecified route on 06Apr2021 (reported as last Tuesday) (at the age of 58-year-old) as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date in Apr2021, patient experienced fever on and off, tiredness and an on and off headache. Patient wanted to know for how long this expected to last and would like to enquire if the vaccine can cause a positive test result for covid. It was unknown if the patient received any treatment for the events. The clinical outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Oral disorder, Pain
Clinical narrative: headache; body aches; hurts to eat and chew food.; This is a spontaneous report received from a contactable consumer or other non hcp via Pfizer. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number was not reported) via an unspecified route of administration on an unspecified date as single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The reporter called on behalf of mother who had 1st Pfizer vaccine last week. The patient experienced headache, body aches, hurts to eat and chew food on an unspecified date. Outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: painful headache; This is a spontaneous report from a contactable consumer (patient) reported for himself. A male patient of an unspecified age received an unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unknown date (age at vaccination was unknown) as UNKNOWN, SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The caller stated he had called regarding the Pfizer Covid 19 vaccine. The caller only wanted to ask simple question whether he could take Advil if he was experiencing a headache. Stated that it was a painful headache. He asked whether taking Advil or Tylenol would reverse the effects of the vaccine. Mentioned he would just figure out and take it himself. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.