chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Hyperaesthesia teeth
Clinical narrative: they've also experienced teeth sensitivity to hot and cold temperatures; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A female patient received bnt162b2 (COMIRNATY), administration date 27Nov2021 (Batch/Lot number: unknown) as dose 1 , single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERAESTHESIA TEETH (non-serious), outcome "unknown", described as "they've also experienced teeth sensitivity to hot and cold temperatures".  Additional information: Caller asked any information on menstrual irregularities following vaccination with the Pfizer BioNTech COVID-19 vaccine adult formulation (purple cap) Caller states: She was a premenopausal 53 year old woman, very healthy, active, not a smoker, don't drink alcohol and  exercise regularly. On 01Dec2021 had COVID-19 infection that lasted from 6 to 7 weeks, within weeks  ended up getting a cycle again and experienced 1 or 2 cycles,  had all the premenstrual symptoms: she broke out [pimples], she was irritable, experienced nausea, felt bloated, experienced premenstrual cramps and overall felt miserable . On 27Nov2021 she received first dose on the Pfizer BioNTech COVID-19 vaccine adult formulation (purple cap) and since the she has not felt right since then: her teeth hurt, they are extremely sensitive to temperature (hot or cold). She even have tooth pain in a tooth that does not even have a root anymore, she did not change paste or any other factors that may be causing this situation. She had chills, cough and feel fatigued, she had experienced fever as well, had a bullseye headache that has not gone away since then and sinus pressure since  got the vaccine. Some hours are worse than others. She has not had a menstrual cycle for over a year now (since my COVID-19 infection), but experiencing all the premenstrual symptoms she asked if any information on teeth pain reports after receiving the first dose of the Pfizer BioNTech COVID-19 vaccine adult formulation (purple cap)  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101767836 ame reporter/drug, different patients.;US-PFIZER INC-202101771852 Same reporter/drug, different patients.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, SARS-CoV-2 test, Somnolence
Clinical narrative: very tired/tiredness; had a need to sleep it off /went to bed earlier; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (172250). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 09Mar2021 (Batch/Lot number: unknown) as dose 1, single and administration date 28Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: her experience with testing positive from COVID-19. The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "very tired/tiredness"; SOMNOLENCE (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "had a need to sleep it off /went to bed earlier". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient was not pregnant at the time of vaccination. It was reported that, the patient had Pfizer COVID-19 vaccine-both doses-experienced mild symptoms; both times only lasted for 24 hrs and the symptoms reminded patient of her experience with testing positive from COVID-19 as she was very tired and had a need to sleep it off. Stated that, second dose was supposed to wait until the 30th, but patient had conflict and asked nurses whether she could take the second dose two days earlier. Stated that, mild symptoms consisted of tiredness and went to bed earlier.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Gastrointestinal disorder
Clinical narrative: had a heart and upper gastrointestinal reaction to the purple cap Pfizer Covid-19 vaccine; had a heart and upper gastrointestinal reaction to the purple cap Pfizer Covid-19 vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GASTROINTESTINAL DISORDER (non-serious), CARDIAC DISORDER (non-serious), outcome "unknown" and all described as "had a heart and upper gastrointestinal reaction to the purple cap Pfizer Covid-19 vaccine". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: hair loss; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 40 year-old female patient received bnt162b2 (COMIRNATY), administration date Oct2021 (Batch/Lot number: unknown) at the age of 40 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: ALOPECIA (non-serious) with onset 2021, outcome "not recovered", described as "hair loss".  Additional information:Reporter wanted to report hair loss in herself, her husband, and her daughter. Reported states they all noticed this adverse event around the same time as one another. They all got their shots in Oct and had hair loss. Patient: Declines height and weight. Reporter doesn't have the patients vaccination card with her. Expiry Date of COVID-19 vaccine: Unknown. Batch/lot number: Unknown.  Follow-up (28Jan2022): 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: Linked Report(s) : US-PFIZER INC-202101799475 same reporter/drug/event, different pt;US-PFIZER INC-202101797400 same reporter/drug/event, different pt
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 36 year-old female patient received bnt162b2 (BNT162B2), administered in arm right (Batch/Lot number: unknown) at the age of 36 years as dose 1, single and administered in arm right (Batch/Lot number: unknown) as dose 2, single for Covid-19 immunisation. Relevant medical history included: "She is disabled and has been disabled since birth" (unspecified if ongoing). Family history included: "3 of her grandparents died of cancer" (unspecified if ongoing). There were no concomitant medications. The following information was reported: TASTE DISORDER (non-serious) with onset Mar2021, outcome "not recovered", described as "Messed up taste buds". Additional information: The patient stated after vaccination next day in the evening she messed up her taste buds. It is like food she was used to eating, she can't even eat it. She can still taste, but it doesn't taste good. The patient stated that she works with over 200 kids. No any other product received. No any additional Vaccines administered on Same Date of the Pfizer Suspect. No any vaccine received prior Vaccinations (within 4 weeks). No any AE following prior vaccinations. No relevant Tests was performed. The event did not cause Emergency Room or Physician Office visit. The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Tremor
Clinical narrative: Chills; cold feeling; Shaking; This is a spontaneous report received from a contactable reporter(s) (Physician).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "Chills"; FEELING COLD (non-serious), outcome "unknown", described as "cold feeling"; TREMOR (non-serious), outcome "unknown", described as "Shaking".  Additional information: Patient had shaking and chills that she had never had in her life. Reporter says he doesn't know enough about the relative, she was just one of his relatives and she had the cold feeling and shaking. Reporter seriousness was unspecified.  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.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Heart rate, Palpitations, Tremor
Clinical narrative: about 12 hours later she woke up out of a sound sleep with her whole body shaking; Her heart was jumping out of her chest; she was very uncomfortable for 8-10 hours; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single and administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TREMOR (non-serious) with onset Mar2021, outcome "unknown", described as "about 12 hours later she woke up out of a sound sleep with her whole body shaking"; PALPITATIONS (non-serious) with onset Mar2021, outcome "recovered", described as "Her heart was jumping out of her chest"; DISCOMFORT (non-serious) with onset Mar2021, outcome "recovered", described as "she was very uncomfortable for 8-10 hours". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Warm transfer from (name) with Support CEP159558. Caller is calling to ask about her nasty reaction to the COVID 19 vaccine. She is worried about it and it is not listed on the side effect sheet. She didn't specify what kind of reaction it was. The caller confirmed the details provided by the transferring agent. She got both of her first two shots three weeks apart in Mar2021. She would like to get the booster with Omicron and everything, but she had such a nasty reaction. She is worried about it. She has tried talking to her doctor and pharmacist, and no one will tell her anything. The pharmacist said to contact Pfizer directly. She is looking for information to see if anyone else has had this reaction. She has talked to dozens of people who have had all three shot with no issues. Caller declined email. She got her shot at 130 pm both times, and about 12 hours later she woke up out of a sound sleep with her whole body shaking. Her heart was jumping out of her chest, and she was very uncomfortable for 8-10 hours. It was worse with the second vaccine. Caller felt like the questions were to personal and declined to continue report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: trouble sleeping; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization. The following information was reported: INSOMNIA (non-serious), outcome "unknown", described as "trouble sleeping".  Additional information: The reporter mentioned he has not been sleeping at all since he got the booster dose. He went to the doctor and the doctor said this was not a side effect. He has not been having any problems until he got the vaccine. He is not sure if this is a reported side effect or not. However, if it is, he wants to know how long it will last.   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.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in her arm.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary series, manufacturer unknown), for covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "pain in her arm."  Additional Information: It was reported that the caller was a consumer who asked how many milligrams were in the booster shot what were the ingredients. Asked about the percentage of people calling reporting side effects due to the booster shoot in the last 2 weeks. The caller mentioned that the next date after the vaccine she presented pain in her arm.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pericardial cyst
Clinical narrative: Have a pericardial cyst as it is; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERICARDIAL CYST (non-serious), outcome "unknown", described as "Have a pericardial cyst as it is".  Additional information: It was reported I am 42 and have a pericardial cyst as it is.  Follow-up (03Feb2022): 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.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: The second shot was fairly bad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A 52 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single, Pfizer Covid vaccine series), for Covid-19 Immunization, reaction(s): "I had the first shot with mild symptoms".  The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "The second shot was fairly bad".  Additonal Information: The patient wanted to share her experience with my Pfizer Covid vaccine series for research. She was normally healthy 52 year old woman. She had the first shot with mild symptoms. The second shot was fairly bad.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  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.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Neck pain, X-ray
Clinical narrative: upper back and neck pain; upper back and neck pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 15 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03Dec2021 (Batch/Lot number: unknown) at the age of 14 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: NECK PAIN (non-serious), BACK PAIN (non-serious) all with onset 13Dec2021, outcome "unknown" and all described as "upper back and neck pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of neck pain, back pain.  Additional information: The adverse events were treated with Ibuprofen 400mg, 1 every 4 to 6 hours, maybe twice a day. The patient underwent the following laboratory tests and procedures: x-ray: (21Dec2021) negative.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: her second shot was pretty sick for 2 or 3 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the parent.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (1st dose, Manufacturer: Unknown), for COVID-19 Immunization. The following information was reported: ILLNESS (non-serious), outcome "recovered", described as "her second shot was pretty sick for 2 or 3 days".  Additional information: Patients second shot was pretty sick for 2 or 3 days so mother guess it effects everybody differently.  The follow-up was 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.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headaches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the parent. Other Case identifier(s): US-PFIZER INC-202101863336 (Pfizer).  A 6 year-old female patient received bnt162b2 (BNT162B2), administration date 04Dec2021 08:30 (Batch/Lot number: unknown) at the age of 6 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1, single), for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 04Dec2021, outcome "not recovered", described as "headaches". The event "headaches" was evaluated at the physician office visit.  Additional Information: The patient started developing headaches in in afternoon of vaccination. Based on the information it is a common side effect that should have been gone in 2-3 days. However she was still had frequent episodes of the headache. She had visited her primary doctor and seems okay.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: After each dose of the vaccine, her daughter experienced dizziness within 8-10 minutes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 20 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU VACCINE VII. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "After each dose of the vaccine, her daughter experienced dizziness within 8-10 minutes".  Additional Information: After each dose of the vaccine, her daughter experienced dizziness within 8-10 minutes. Reporter stated, patient received a flu shot around the same time and did not experience dizziness.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Fatigue". Additional information: Patient reported that they experienced fatigue after each dose of the Pfizer Covid-19 vaccine Comirnaty. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Diplopia, Strabismus
Clinical narrative: double vision; cross-eyed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIPLOPIA (non-serious), outcome "not recovered", described as "double vision"; STRABISMUS (non-serious), outcome "not recovered", described as "cross-eyed".  Additional information: Patient asked if there was any information regarding how many people have reported having vision problems after getting the Comirnaty vaccine and stated he has double vision and is cross-eyed after getting the vaccine. Also reported that patient has been having vision problems for a few weeks after taking the vaccine like double vision and eyes are crossed. Patient states his vision problems would come and go, but now they are permanent. Patient also wanted to know if any of those symptoms and side effects are reversed. Patient asks what can he do to prevent further damage from the vaccine and asks if there is any statistics on how many people have reported vision problems after taking the vaccine.  Follow-up attempts completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Anosmia
Clinical narrative: lost their smell; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the parent.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANOSMIA (non-serious), outcome "unknown", described as "lost their smell".  Additional Information: just need to let you guys know that both of my kids got their vaccination the 5 to 11:00 and they lost their smell I didn't know if you guys was aware that that was probably a side effect of it I didn't know if you needed to let the FDA know about it  Follow-up attempts completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101883364 for Same reporter / drug / event, different patients.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: complications since my second Pfizer Covid Vaccination in Aug2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Aug2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01), for COVID-19 Immunization. The following information was reported: VACCINATION COMPLICATION (non-serious) with onset Aug2021, outcome "unknown", described as "complications since my second Pfizer Covid Vaccination in Aug2021". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Skin disorder
Clinical narrative: my skin is full of red docs; my skin is full of red docs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "HIV" (unspecified if ongoing), notes: one year ago I discovered that I have HIV. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer unknown), for COVID-19 immunization. The following information was reported: SKIN DISORDER (non-serious), ERYTHEMA (non-serious), outcome "unknown" and all described as "my skin is full of red docs".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Allergy test, Hyperhidrosis
Clinical narrative: sweating profusely; This is a spontaneous report received from contactable reporter(s) (Physician and Other HCP).  A 49-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 17Dec2021 (Batch/Lot number: unknown) at the age of 49 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was none. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose: 01, Route of administration: Intramuscular, Lot not available), administration date: 26Nov2021, when the patient was 49 years old, for COVID-19 Immunization, reaction(s): "patient reported lip swelling", "patient woke up with burning sensation of the skin". The following information was reported: HYPERHIDROSIS (non-serious) with onset 17Dec2021, outcome "recovered" (Dec2021), described as "sweating profusely". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: 12-hour post vaccine. patient reported sweating profusely but no fever. This symptom lasted 12 hours then subsided. Prior vaccinations was none.  Follow-up attempts completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Mass, Pruritus
Clinical narrative: My right hand was itchy; raised bumps; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 2021 (Batch/Lot number: unknown) at the age of 61 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "known allergies: Yes" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: PRURITUS (non-serious) with onset 2021, outcome "not recovered", described as "My right hand was itchy"; MASS (non-serious) with onset 2021, outcome "not recovered", described as "raised bumps". Therapeutic measures were not taken as a result of pruritus, mass.  Additional information: No covid prior vaccination and no covid tested post vaccination. There was other medical history. There was other medications in two weeks and no other vaccine in four weeks.  Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Gastritis, Gastrooesophageal reflux disease, Inappropriate schedule of product administration, X-ray
Clinical narrative: Gerd and gastritis I have been in treatment since Apr2021. I saw the D1 & D2 earlier-no improvement after the second shot Jan2022 I had another flare up of the issue I was in treatment for; It is now one year later and the caller is wondering if she can have her second shot; Gerd and gastritis I have been in treatment since Apr2021. I saw the D1 & D2 earlier-no improvement after the second shot Jan2022 I had another flare up of the issue I was in treatment for; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 77 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 17Jan2022 17:00 (Lot number: FJ1614) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid all over again /I had Covid", start date: 26Dec2020 (unspecified if ongoing); "Stomach problem" (unspecified if ongoing); "Gastritis", start date: Apr2021 (ongoing); "Gerd", start date: Apr2021 (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Lot no: EL1283, Anatomical site of injection: arm, Route: Intramuscular), administration date: 24Jan2021, for Covid-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 17Jan2022 17:00, outcome "unknown", described as "It is now one year later and the caller is wondering if she can have her second shot"; GASTRITIS (non-serious), outcome "not recovered", GASTROOESOPHAGEAL REFLUX DISEASE (non-serious) with onset Jan2022, outcome "not recovered" and all described as "Gerd and gastritis I have been in treatment since Apr2021. I saw the D1 & D2 earlier-no improvement after the second shot Jan2022 I had another flare up of the issue I was in treatment for". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of gastritis, gastrooesophageal reflux disease.  Additional information: Patient had stomach issues and was dealing with that since a year.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vomiting
Clinical narrative: vomiting; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 35 year-old female patient received bnt162b2 (BNT162B2), administration date 04Jan2022 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VOMITING (non-serious) with onset 05Jan2022, outcome "unknown", described as "vomiting"; HEADACHE (non-serious) with onset 05Jan2022, outcome "recovering", described as "headache".  Additional information: Reporter stated that her daughter, who was 35 years old, took her first dose of the Pfizer Covid Vaccine and then went out drinking and now had been vomiting all day. Reporter asked if vomiting was a reported side effect and if alcohol had any effect on the efficacy of the vaccine. Reporter also stated that her daughter had a headache but seems to be calming down now.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, COVID-19, Oxygen saturation, Pain in extremity
Clinical narrative: His wife had a sore arm after the Comirnaty. It was sore in the arm and the armpit.; His wife had a sore arm after the Comirnaty. It was sore in the arm and the armpit.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 73 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Flu shots (Caller and the patient both had their Flu shots), administration date: 21Oct2021, when the patient was 72 years old, for immunisation, reaction(s): "No reaction". The following information was reported: AXILLARY PAIN (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "His wife had a sore arm after the Comirnaty. It was sore in the arm and the armpit.". The event "his wife had a sore arm after the comirnaty. it was sore in the arm and the armpit." and "his wife had a sore arm after the comirnaty. it was sore in the arm and the armpit." was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  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.
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: Following the second dose I had a very bad cold for two months; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 80 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for Covid-19 immunization. The following information was reported: NASOPHARYNGITIS (non-serious), outcome "not recovered", described as "Following the second dose I had a very bad cold for two months".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Prostatic specific antigen, Prostatic specific antigen increased
Clinical narrative: PSA levels were detected to be 3 times the level it was before the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 Immunization. The following information was reported: PROSTATIC SPECIFIC ANTIGEN INCREASED (non-serious), outcome "unknown", described as "PSA levels were detected to be 3 times the level it was before the vaccine". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller stated he was calling on behalf of his patient. Caller stated his patient was vaccinated twice with the Pfizer COVID-19 vaccine and within two months of being vaccinated twice his PSA levels were detected to be 3 times the level it was before the vaccine. Caller stated the level was only 6 at the beginning of the year noting (name) pays for yearly checks and now is 18. Caller stated he reported this finding to agent. Caller stated the CDC shows 44 ongoing studies on the effect of the vaccine on PSA levels. Caller stated his personal HCP found information on the internet about the vaccine increasing PSA levels. Caller stated the vaccines are destroying cancer markers. Caller disconnected before survey could be offered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick".  Additional information: The patient was calling to make recommendations on Pfizer booster shots. She mentioned that she already had her 2 doses of vaccines and she recently had her Pfizer booster shot. She said as well that before getting the booster shot she was sick and she had a cough now when she had her booster shot she had her Pneumonia together she claims that she got well. She wants to see if Pfizer can have a correlation between the Booster shots and Pneumonia shots/vaccine. Unable to gather 1st and 2nd dose dates  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: hair loss and hair thinning shortly after receiving the vaccine; hair loss and hair thinning shortly after receiving the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALOPECIA (non-serious), ALOPECIA (non-serious), outcome "unknown" and all described as "hair loss and hair thinning shortly after receiving the vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200055983 same reporter/drug/event, different patient
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Headache, Hypoaesthesia, Paraesthesia, Spinal pain
Clinical narrative: headache; bilateral burning of ears; spinal pain from mid back to neck; numbness and tingling in the injection arm; numbness and tingling in the injection arm; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 12Feb2021 (Lot number: EM9810) at the age of 37 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies: latex" (unspecified if ongoing); "Known allergies: PCN" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing); "Known allergies: seasonal allergies" (unspecified if ongoing); "Known allergies: bee venom" (unspecified if ongoing); "Known allergies: almonds" (unspecified if ongoing); "Asthma" (unspecified if ongoing). Concomitant medication(s) included: FLUCONAZOLE; ZYRTEC ALLERGY; LO LOESTRIN FE. Past drug history included: Cefazolin, reaction(s): "Known allergies"; Midrin, reaction(s): "Known allergies". Vaccination history included: Bnt162b2 (Dose 1, Lot number EL3249), administration date: 22Jan2021, for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headache"; EAR DISCOMFORT (non-serious), outcome "unknown", described as "bilateral burning of ears"; SPINAL PAIN (non-serious), outcome "unknown", described as "spinal pain from mid back to neck"; HYPOAESTHESIA (non-serious), PARAESTHESIA (non-serious), outcome "unknown" and all described as "numbness and tingling in the injection arm". It was unknown if therapeutic measures were taken as a result of headache, ear discomfort, spinal pain, hypoaesthesia, paraesthesia.  Additional information:The patient did not received any other vaccine in last 4 month and received multivitamin. The patient did not tested for covid post vaccination and it was unknown if the patient had covid prior to vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Nausea, Pain, Pallor
Clinical narrative: Shortness of breath; Dizziness; Nausea; Fever; Shakiness; Pale to the face; Body aches; Vomiting; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 13Jan2022 16:15 (Batch/Lot number: unknown) at the age of 27 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: HYDROCODONE; GABAPENTIN; IBUPROFEN. The following information was reported: DYSPNOEA (non-serious) with onset 13Jan2022 19:00, outcome "not recovered", described as "Shortness of breath"; DIZZINESS (non-serious) with onset 13Jan2022 19:00, outcome "not recovered", described as "Dizziness"; NAUSEA (non-serious) with onset 13Jan2022 19:00, outcome "not recovered", described as "Nausea"; PYREXIA (non-serious) with onset 13Jan2022 19:00, outcome "not recovered", described as "Fever"; TREMOR (non-serious) with onset 13Jan2022 19:00, outcome "not recovered", described as "Shakiness"; PALLOR (non-serious) with onset 13Jan2022 19:00, outcome "not recovered", described as "Pale to the face"; PAIN (non-serious) with onset 13Jan2022 19:00, outcome "not recovered", described as "Body aches"; VOMITING (non-serious) with onset 13Jan2022 19:00, outcome "not recovered", described as "Vomiting". The events "shortness of breath", "dizziness", "nausea", "fever", "shakiness", "pale to the face", "body aches" and "vomiting" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of dyspnoea, dizziness, nausea, pyrexia, tremor, pallor, pain, vomiting.  Additional Information: The patient did not received other vaccines within 4 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tremor, Vomiting
Clinical narrative: Shortness of breath; Dizziness; Nausea; Fever; Shakiness; Pale to the face; Body aches; Vomiting; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 13Jan2022 16:15 (Batch/Lot number: unknown) at the age of 27 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: HYDROCODONE; GABAPENTIN; IBUPROFEN. The following information was reported: DYSPNOEA (non-serious) with onset 13Jan2022 19:00, outcome "not recovered", described as "Shortness of breath"; DIZZINESS (non-serious) with onset 13Jan2022 19:00, outcome "not recovered", described as "Dizziness"; NAUSEA (non-serious) with onset 13Jan2022 19:00, outcome "not recovered", described as "Nausea"; PYREXIA (non-serious) with onset 13Jan2022 19:00, outcome "not recovered", described as "Fever"; TREMOR (non-serious) with onset 13Jan2022 19:00, outcome "not recovered", described as "Shakiness"; PALLOR (non-serious) with onset 13Jan2022 19:00, outcome "not recovered", described as "Pale to the face"; PAIN (non-serious) with onset 13Jan2022 19:00, outcome "not recovered", described as "Body aches"; VOMITING (non-serious) with onset 13Jan2022 19:00, outcome "not recovered", described as "Vomiting". The events "shortness of breath", "dizziness", "nausea", "fever", "shakiness", "pale to the face", "body aches" and "vomiting" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of dyspnoea, dizziness, nausea, pyrexia, tremor, pallor, pain, vomiting.  Additional Information: The patient did not received other vaccines within 4 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: temperature excursion; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer sponsored program (159558).  A patient (no qualifiers provided) received bnt162b2 (Pfizer Covid 19 Vaccine-Solution for injection), (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), outcome "unknown", described as "temperature excursion". Additional information: Verbatim and Event Description: (Name withheld) is a HCP who wants to know if the vaccine they have received can be replaced because these pediatric vaccines are already on a temperature excursion. Caller is a HCP as per representative but was not able to verify from the caller itself. Cap color not confirmed.  Follow-up attempts completed. No further information is expected.  Follow up(13Jan2022): New information received from a Pfizer sponsored program (159558). A contactable Other-HCP reported that included reporter details, suspect product details verbatim and events description.  Follow-up (07Feb2022): 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.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Hive looking rash all over body and face; Hive looking rash all over body and face; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 5 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 13Jan2022 15:15 (Batch/Lot number: unknown) at the age of 5 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: URTICARIA (non-serious), RASH (non-serious) all with onset 14Jan2022 12:00, outcome "not recovered" and all described as "Hive looking rash all over body and face". Therapeutic measures were not taken as a result of urticaria, rash.  Additional information: The patient not received other vaccine in four weeks. The patient not had covid prior vaccination. The was not tested for covid post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.