chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Rash
Clinical narrative: her legs just ache; someone who had recently had the vaccine on 15Sep2021 and developed a rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 15Sep2021 (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: RASH (non-serious) with onset 2021, outcome "unknown", described as "someone who had recently had the vaccine on 15Sep2021 and developed a rash"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "her legs just ache".  Additional information: There are only AE for someone but not for caller herself, hence seems the gender female is not for the real patient someone. As per call recording, Caller mentioned that I broke out in a rash from them. By them, Caller was referring to a person that received a COVID Vaccine.   Follow-up attempts completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood test, Chest X-ray, Chest discomfort, Electrocardiogram
Clinical narrative: Very tight chest; Radiatiing pain in left side of jaw; Concerned about heart attack; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 02Oct2021 12:15 (Lot number: WAG 9048) at the age of 68 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Barrett's esophagus" (unspecified if ongoing); "High BP" (unspecified if ongoing), notes: Verbatim: High BP; "Anemia" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "known allergies : antibiotics" (unspecified if ongoing), notes: known allergies : antibiotics. Concomitant medication(s) included: IRON; SYNTHROID; HYZAAR; OMEPRAZOLE; LIPITOR. Past drug history included: Morphine, reaction(s): "known_allergies: Morphine". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Left, Route of administration: Intramuscular), administration date: 09Mar2021, when the patient was 67 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6200, Location of injection: Arm Left, Route of administration: Intramuscular), administration date: 16Feb2021, when the patient was 67 years old, for COVID-19 immunization. The following information was reported: CHEST DISCOMFORT (non-serious) with onset 04Oct2021, outcome "unknown", described as "Very tight chest"; PAIN IN JAW (non-serious) with onset 04Oct2021, outcome "unknown", described as "Radiatiing pain in left side of jaw"; ANXIETY (non-serious) with onset 04Oct2021, outcome "unknown", described as "Concerned about heart attack". The events "very tight chest" and "concerned about heart attack" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chest discomfort, pain in jaw, anxiety.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested positive for COVID-19. The patient did not receive other vaccine in four weeks. 2 days after 3rd dose patient had a very tight chest with some pain radiating her left jaw - after breakfast. She ate a 325 aspirin after 40 mints the pain started.  No follow-up attempts are possible. No further information is expected.  Follow-up PRD/SRD (15Nov2021) Follow-up attempts completed. No further information expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in jaw
Clinical narrative: Very tight chest; Radiatiing pain in left side of jaw; Concerned about heart attack; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 02Oct2021 12:15 (Lot number: WAG 9048) at the age of 68 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Barrett's esophagus" (unspecified if ongoing); "High BP" (unspecified if ongoing), notes: Verbatim: High BP; "Anemia" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "known allergies : antibiotics" (unspecified if ongoing), notes: known allergies : antibiotics. Concomitant medication(s) included: IRON; SYNTHROID; HYZAAR; OMEPRAZOLE; LIPITOR. Past drug history included: Morphine, reaction(s): "known_allergies: Morphine". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Left, Route of administration: Intramuscular), administration date: 09Mar2021, when the patient was 67 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6200, Location of injection: Arm Left, Route of administration: Intramuscular), administration date: 16Feb2021, when the patient was 67 years old, for COVID-19 immunization. The following information was reported: CHEST DISCOMFORT (non-serious) with onset 04Oct2021, outcome "unknown", described as "Very tight chest"; PAIN IN JAW (non-serious) with onset 04Oct2021, outcome "unknown", described as "Radiatiing pain in left side of jaw"; ANXIETY (non-serious) with onset 04Oct2021, outcome "unknown", described as "Concerned about heart attack". The events "very tight chest" and "concerned about heart attack" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chest discomfort, pain in jaw, anxiety.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested positive for COVID-19. The patient did not receive other vaccine in four weeks. 2 days after 3rd dose patient had a very tight chest with some pain radiating her left jaw - after breakfast. She ate a 325 aspirin after 40 mints the pain started.  No follow-up attempts are possible. No further information is expected.  Follow-up PRD/SRD (15Nov2021) Follow-up attempts completed. No further information expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Dizziness, Gait disturbance, Myalgia
Clinical narrative: she can hardly get around; joint pain; has pains in the muscles above knees on the thigh on both legs and arm from elbow to shoulders / pains in the arm; muscle pain/has pains in the muscles above knees on the thigh on both legs and arm from elbow to shoulders; weak; dizzy; This is a spontaneous report received from Pfizer medical information team from a contactable consumer (patient) that reported.  A 63 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 22Jul2021 (Batch/Lot number: unknown) at the age of 63 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Administration site: left arm), administration date: 30Jun2021, when the patient was 63 years old, for COVID-19 IMMUNIZATION, reaction(s): "nauseous", "left arm was hurting", "arm was red", "headaches", "hardly walk", "she was weak", "fatigue", "sleep all the time", "memory problems", "lymph nodes on the left side were swollen", "red streak down the middle of her cheek", "phlegm", "terrible tasting", "eyes hurt", "red ring around her eyes.", "hearing was gone", "thrush infection", "stomach was hurting"; Swine flu vaccine (when she was about 22 years old), when the patient was 22 years old, reaction(s): "vomiting". The following information was reported: DIZZINESS (non-serious) with onset Jul2021, outcome "not recovered", described as "dizzy"; GAIT DISTURBANCE (non-serious) with onset 22Jul2021, outcome "unknown", described as "she can hardly get around"; ARTHRALGIA (non-serious) with onset 22Jul2021, outcome "not recovered", described as "joint pain"; PAIN IN EXTREMITY (non-serious) with onset Jul2021, outcome "not recovered", described as "has pains in the muscles above knees on the thigh on both legs and arm from elbow to shoulders / pains in the arm"; MYALGIA (non-serious) with onset Jul2021, outcome "not recovered", described as "muscle pain/has pains in the muscles above knees on the thigh on both legs and arm from elbow to shoulders"; ASTHENIA (non-serious) with onset Jul2021, outcome "not recovered", described as "weak". Therapeutic measures were taken as a result of dizziness, gait disturbance, arthralgia, pain in extremity, myalgia, asthenia.  Additional information: Patient did not had any prior vaccination within 4 weeks. Patient did not had Emergency Room. Patient had Physician Office visit.  Follow-up (12Nov2021): 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: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: she can hardly get around; joint pain; has pains in the muscles above knees on the thigh on both legs and arm from elbow to shoulders / pains in the arm; muscle pain/has pains in the muscles above knees on the thigh on both legs and arm from elbow to shoulders; weak; dizzy; This is a spontaneous report received from Pfizer medical information team from a contactable consumer (patient) that reported.  A 63 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 22Jul2021 (Batch/Lot number: unknown) at the age of 63 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Administration site: left arm), administration date: 30Jun2021, when the patient was 63 years old, for COVID-19 IMMUNIZATION, reaction(s): "nauseous", "left arm was hurting", "arm was red", "headaches", "hardly walk", "she was weak", "fatigue", "sleep all the time", "memory problems", "lymph nodes on the left side were swollen", "red streak down the middle of her cheek", "phlegm", "terrible tasting", "eyes hurt", "red ring around her eyes.", "hearing was gone", "thrush infection", "stomach was hurting"; Swine flu vaccine (when she was about 22 years old), when the patient was 22 years old, reaction(s): "vomiting". The following information was reported: DIZZINESS (non-serious) with onset Jul2021, outcome "not recovered", described as "dizzy"; GAIT DISTURBANCE (non-serious) with onset 22Jul2021, outcome "unknown", described as "she can hardly get around"; ARTHRALGIA (non-serious) with onset 22Jul2021, outcome "not recovered", described as "joint pain"; PAIN IN EXTREMITY (non-serious) with onset Jul2021, outcome "not recovered", described as "has pains in the muscles above knees on the thigh on both legs and arm from elbow to shoulders / pains in the arm"; MYALGIA (non-serious) with onset Jul2021, outcome "not recovered", described as "muscle pain/has pains in the muscles above knees on the thigh on both legs and arm from elbow to shoulders"; ASTHENIA (non-serious) with onset Jul2021, outcome "not recovered", described as "weak". Therapeutic measures were taken as a result of dizziness, gait disturbance, arthralgia, pain in extremity, myalgia, asthenia.  Additional information: Patient did not had any prior vaccination within 4 weeks. Patient did not had Emergency Room. Patient had Physician Office visit.  Follow-up (12Nov2021): 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: Cough, Nasopharyngitis, Oropharyngeal pain, SARS-CoV-2 test, Sinus disorder
Clinical narrative: cold; sore throat; cough; sinus issues; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient) reported.  A female patient received bnt162b2 (BNT162B2) (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: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat"; COUGH (non-serious), outcome "unknown", described as "cough"; SINUS DISORDER (non-serious), outcome "unknown", described as "sinus issues". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The female consumer was over the age of 65. Patient states that she received her first dose of the Pfizer COVID 19 vaccine in Mar2021 and received the second dose as well. Patient is on day 18 of the cold and thinks that it is subsiding or "waning". She described a sore throat, cough, and sinus issues. Patient was told by the nurse that it was okay for her to receive the booster dose since her cold was going away. The pharmacist told her that she should wait at least a week after her cold is gone to get the booster dose. Patient would like to know how long she should wait or if she needs to wait for the cold to subside completely before getting the dose. Her appointment is this Thursday to receive the dose.  Follow-up (11Nov2021): 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: Chest pain, Chills, Epistaxis, Headache, Heart rate increased
Clinical narrative: rapid heart rate chest; nose bleeds; chills; night sweats; headache; chest pain; 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 patient.  A female patient received bnt162b2 (COMIRNATY), administration date 05Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "ASTHMA" (unspecified if ongoing) notes: controlled with an inhaler. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 IMMUNIZATION. The following information was reported: HEART RATE INCREASED (non-serious) with onset 2021, outcome "unknown", described as "rapid heart rate chest"; EPISTAXIS (non-serious) with onset 2021, outcome "unknown", described as "nose bleeds"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "chills"; NIGHT SWEATS (non-serious) with onset 2021, outcome "unknown", described as "night sweats"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache"; CHEST PAIN (non-serious) with onset 2021, outcome "unknown", described as "chest pain". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient had some questions regarding covid-19 antibodies. she had two vaccines Pfizer, had very adverse side effects reported, now upon recent testing with covid-19 exposures (she worked in Dental where colleagues and patients were covid-19 positive symptomatic), now have no covid-19 antibodies. She would like to provide my provider and blood test information for further study. Her medical provider is suggesting the third booster as I have asthma and no present antibodies. Caller added she had been exposed to co-workers, patients, and family members that were Covid positive but every PCR test she takes was negative, even thought she was symptomatic at one time, and her antibody tests had all been negative. She and her doctor think it is an anomaly. She received her second dose of Pfizer Covid 19 vaccine on 05Feb2021. Her doctor says she needs to get the booster even though she had a rapid heart rate, chest pain, nose bleeds, chills x48 hours, night sweats x2 months, and headache after a previous dose of the vaccine. She is also asthmatic controlled with an inhaler. She wants to be sure that is the correct protocol.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Night sweats, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: rapid heart rate chest; nose bleeds; chills; night sweats; headache; chest pain; 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 patient.  A female patient received bnt162b2 (COMIRNATY), administration date 05Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "ASTHMA" (unspecified if ongoing) notes: controlled with an inhaler. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 IMMUNIZATION. The following information was reported: HEART RATE INCREASED (non-serious) with onset 2021, outcome "unknown", described as "rapid heart rate chest"; EPISTAXIS (non-serious) with onset 2021, outcome "unknown", described as "nose bleeds"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "chills"; NIGHT SWEATS (non-serious) with onset 2021, outcome "unknown", described as "night sweats"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache"; CHEST PAIN (non-serious) with onset 2021, outcome "unknown", described as "chest pain". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient had some questions regarding covid-19 antibodies. she had two vaccines Pfizer, had very adverse side effects reported, now upon recent testing with covid-19 exposures (she worked in Dental where colleagues and patients were covid-19 positive symptomatic), now have no covid-19 antibodies. She would like to provide my provider and blood test information for further study. Her medical provider is suggesting the third booster as I have asthma and no present antibodies. Caller added she had been exposed to co-workers, patients, and family members that were Covid positive but every PCR test she takes was negative, even thought she was symptomatic at one time, and her antibody tests had all been negative. She and her doctor think it is an anomaly. She received her second dose of Pfizer Covid 19 vaccine on 05Feb2021. Her doctor says she needs to get the booster even though she had a rapid heart rate, chest pain, nose bleeds, chills x48 hours, night sweats x2 months, and headache after a previous dose of the vaccine. She is also asthmatic controlled with an inhaler. She wants to be sure that is the correct protocol.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information was expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hive reaction; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team for a Pfizer sponsored program (159558).  A 47 year-old female patient received bnt162b2 (BNT162B2), administration date 04Oct2021 (Batch/Lot number: unknown) at the age of 47 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: URTICARIA (non-serious) with onset 04Oct2021, outcome "recovering", described as "Hive reaction". The event "hive reaction" was evaluated at the physician office visit.  Additional information: The reporter stated the patient experienced hive reaction after receiving the first dose of the Pfizer Covid-19 vaccine. The reporter stated that this report was reported to VAERS. The reporter asked if the patient should get the second dose of the Pfizer Covid-19 vaccine and does Pfizer considered hives an allergic reaction. This report was not related to study or program. NDC number of Pfizer COVID-19 vaccine was unknown. The reason for no information about the batch/lot number of Pfizer COVID-19 vaccine was that reporter does not have the information available. Expiry date of Pfizer COVID-19 vaccine reported as unknown. The patient was not received other products. The reporter assessed the causality between the suspected drug and event was related. The reporter stated it is highly likely that the patient reaction was caused by the Pfizer COVID-19 vaccine. The patient has no medical history. There was no investigation assessment. The seriousness of the event was reported as unknown. The reporter denied any other medications, medical conditions, labs, testing, or treatments relevant to these events for the patient. Time of the vaccination was reported as unknown. Vaccination facility type reported as available. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) reported as none (this was the patient first dose). Additional Vaccines Administered on same date of the Pfizer suspect If applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect reported as none. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccines reported as none. Adverse event following prior vaccinations reported as none. Family medical history relevant to adverse event reported as none.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling hot, Headache, Hot flush
Clinical narrative: flush feeling; night sweats; lightheaded, dizzy; fever; body aches; felt heat on the outside/it's a weird, a weird type of heat; not felt well/ bad; headache; fatigue; 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 19 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date Sep2021 (Batch/Lot number: unknown) at the age of 19 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: HOT FLUSH (non-serious) with onset Sep2021, outcome "unknown", described as "flush feeling"; NIGHT SWEATS (non-serious) with onset Sep2021, outcome "unknown", described as "night sweats"; DIZZINESS (non-serious) with onset Sep2021, outcome "unknown", described as "lightheaded, dizzy"; PYREXIA (non-serious) with onset Sep2021, outcome "recovering", described as "fever"; PAIN (non-serious) with onset Sep2021, outcome "recovering", described as "body aches"; FEELING HOT (non-serious) with onset Sep2021, outcome "recovering", described as "felt heat on the outside/it's a weird, a weird type of heat"; MALAISE (non-serious) with onset Sep2021, outcome "recovering", described as "not felt well/ bad"; HEADACHE (non-serious) with onset Sep2021, outcome "recovering", described as "headache"; FATIGUE (non-serious) with onset Sep2021, outcome "recovering", described as "fatigue".  Additional information: No prior vaccinations within four weeks prior to the first administration date of the suspect vaccine. Patient had first dose of the Covid vaccine and was not due until the 17th or 18th this month for the second one. Had the first vaccine about 2 weeks ago. Time the vaccination was given: 10-11am. Seriousness of events was unspecified. Events were not resulted in visit to emergency room and physician office. No relevant tests reported. The events were improved, but still possibly may have the hot/heat, sweats, but caller was not really sure, unknown.  Follow-up attempts completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101340609 same reporter/drug, similar events, different patient
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Night sweats, Pain, Pyrexia
Clinical narrative: flush feeling; night sweats; lightheaded, dizzy; fever; body aches; felt heat on the outside/it's a weird, a weird type of heat; not felt well/ bad; headache; fatigue; 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 19 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date Sep2021 (Batch/Lot number: unknown) at the age of 19 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: HOT FLUSH (non-serious) with onset Sep2021, outcome "unknown", described as "flush feeling"; NIGHT SWEATS (non-serious) with onset Sep2021, outcome "unknown", described as "night sweats"; DIZZINESS (non-serious) with onset Sep2021, outcome "unknown", described as "lightheaded, dizzy"; PYREXIA (non-serious) with onset Sep2021, outcome "recovering", described as "fever"; PAIN (non-serious) with onset Sep2021, outcome "recovering", described as "body aches"; FEELING HOT (non-serious) with onset Sep2021, outcome "recovering", described as "felt heat on the outside/it's a weird, a weird type of heat"; MALAISE (non-serious) with onset Sep2021, outcome "recovering", described as "not felt well/ bad"; HEADACHE (non-serious) with onset Sep2021, outcome "recovering", described as "headache"; FATIGUE (non-serious) with onset Sep2021, outcome "recovering", described as "fatigue".  Additional information: No prior vaccinations within four weeks prior to the first administration date of the suspect vaccine. Patient had first dose of the Covid vaccine and was not due until the 17th or 18th this month for the second one. Had the first vaccine about 2 weeks ago. Time the vaccination was given: 10-11am. Seriousness of events was unspecified. Events were not resulted in visit to emergency room and physician office. No relevant tests reported. The events were improved, but still possibly may have the hot/heat, sweats, but caller was not really sure, unknown.  Follow-up attempts completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101340609 same reporter/drug, similar events, different patient
Sex: F
Vaccine: COVID19
Symptoms: Blister, Erythema, Hypersensitivity, Rash papular, Skin discolouration
Clinical narrative: an allergic skin reaction/ coworker had a very similar reaction; several red bumps on my arm and legs and 2 of them formed water blisters/ coworker had a very similar reaction; several red bumps on my arm and legs and 2 of them formed water blisters/ coworker had a very similar reaction; developed some type of outbreak with little, red marks that looked like water blisters or a bug bite/ coworker had a very similar reaction; allergic reaction/ coworker had a very similar reaction; turned jet black in color/ coworker had a very similar reaction; 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).  A female patient received bnt162b2 (BNT162B2) (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: SKIN REACTION (non-serious), outcome "unknown", described as "an allergic skin reaction/ coworker had a very similar reaction"; RASH PAPULAR (non-serious), BLISTER (non-serious), outcome "unknown" and all described as "several red bumps on my arm and legs and 2 of them formed water blisters/ coworker had a very similar reaction"; ERYTHEMA (non-serious), outcome "unknown", described as "developed some type of outbreak with little, red marks that looked like water blisters or a bug bite/ coworker had a very similar reaction"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "allergic reaction/ coworker had a very similar reaction"; SKIN DISCOLOURATION (non-serious), outcome "unknown", described as "turned jet black in color/ coworker had a very similar reaction".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Skin reaction
Clinical narrative: an allergic skin reaction/ coworker had a very similar reaction; several red bumps on my arm and legs and 2 of them formed water blisters/ coworker had a very similar reaction; several red bumps on my arm and legs and 2 of them formed water blisters/ coworker had a very similar reaction; developed some type of outbreak with little, red marks that looked like water blisters or a bug bite/ coworker had a very similar reaction; allergic reaction/ coworker had a very similar reaction; turned jet black in color/ coworker had a very similar reaction; 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).  A female patient received bnt162b2 (BNT162B2) (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: SKIN REACTION (non-serious), outcome "unknown", described as "an allergic skin reaction/ coworker had a very similar reaction"; RASH PAPULAR (non-serious), BLISTER (non-serious), outcome "unknown" and all described as "several red bumps on my arm and legs and 2 of them formed water blisters/ coworker had a very similar reaction"; ERYTHEMA (non-serious), outcome "unknown", described as "developed some type of outbreak with little, red marks that looked like water blisters or a bug bite/ coworker had a very similar reaction"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "allergic reaction/ coworker had a very similar reaction"; SKIN DISCOLOURATION (non-serious), outcome "unknown", described as "turned jet black in color/ coworker had a very similar reaction".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pruritus, Rash, Urticaria
Clinical narrative: it began to swell; rash; hives; itch; my arm was tender and painful; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Oct2021 11:30 (Lot number: FF2589) at the age of 70 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "CABG" (unspecified if ongoing), notes: CABG; "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin; "Hypothyroid" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6200, Location of injection: Right arm, Vaccine Administration Time: 03:00 PM, Route of administration: Intramuscular), administration date: 17Feb2021, when the patient was 70 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6200, Location of injection: Right arm, Vaccine Administration Time: 02:00 PM, Route of administration: Intramuscular), administration date: 10Mar2021, when the patient was 70 years old, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 05Oct2021, outcome "recovering", described as "my arm was tender and painful"; PERIPHERAL SWELLING (non-serious) with onset 06Oct2021, outcome "recovering", described as "it began to swell"; RASH (non-serious) with onset 06Oct2021, outcome "recovering", described as "rash"; URTICARIA (non-serious) with onset 06Oct2021, outcome "recovering", described as "hives"; PRURITUS (non-serious) with onset 06Oct2021, outcome "recovering", described as "itch". Therapeutic measures were not taken as a result of pain in extremity, peripheral swelling, rash, urticaria, pruritus.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Muscle spasms, Pyrexia
Clinical narrative: headache; fever; muscle cramps; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program (141003).  A 60 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "rheumatoid arthritis", start date: 2016 (ongoing); "chemotherapy", start date: 2018 (unspecified if ongoing); "radiation", start date: 2018 (unspecified if ongoing); "Lymph node removal", start date: 2018 (unspecified if ongoing); "breast cancer", start date: 2018 (unspecified if ongoing); "pulmonary embolism", start date: 2018 (unspecified if ongoing), notes: pulmonary embolism in 2018 and 2019.; "breathing issue", start date: 2011 (unspecified if ongoing), notes: Breathing issue due to lung nodules from 2011; "lung nodules" (unspecified if ongoing); "depression/discouragement" (unspecified if ongoing); "depression/discouragement due to medication (Unspecified) not working" (unspecified if ongoing); "disease progressing" (unspecified if ongoing); "depression/discouragement due to medication (Unspecified) not working" (unspecified if ongoing). Concomitant medication(s) included: XELJANZ taken for rheumatoid arthritis, start date: 2016 (ongoing). The following information was reported: HEADACHE (non-serious), outcome "recovered", described as "headache"; PYREXIA (non-serious), outcome "recovered", described as "fever"; MUSCLE SPASMS (non-serious), outcome "recovered", described as "muscle cramps".  Additional information: Patient reported to holding therapy per MD for 3 days before and after the COVID vaccine. No symptoms due to the missed doses. Experienced headache, fever and muscle cramps from the vaccine, which has since resolved. Forgot to order on time once due to miscounting pills, no missed doses. Strongly worried about the side effects of XELJANZ. Advised to notify MD. Underwent chemotherapy, radiation and lymph node removal for breast cancer in 2018 and pulmonary embolism in 2018 and 2019. Currently no signs of cancer in body. No mention of hospitalization. Prior to start of therapy and progressively worsening: Breathing issue due to lung nodules from 2011, and depression/discouragement due to medication (Unspecified) not working, disease progressing and "feeling that body is failing." Seeing therapist/psychologist.   Follow-up attempts completed. No further information is expected.
Sex: M
Vaccine: COVID19, UNK, UNK, UNK
Symptoms: Diarrhoea, Dyspnoea, Dyspnoea exertional, Fluid retention, Gait disturbance
Clinical narrative: Dyspnoea Exertional; Dyspnoea; Gait Disturbance; Diarrhoea; Fluid Retention; This is a spontaneous report received from contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: 19078300 (US FDA). Other Case identifier(s): US202103012733 (Eli Lilly And Company), 2021OCT19122306309 (United Therapeutics).  A 85 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; macitentan (OPSUMIT) (Batch/Lot number: unknown) for pulmonary arterial hypertension; tadalafil (ADCIRCA) (Batch/Lot number: unknown) for pulmonary arterial hypertension; treprostinil sodium (TYVASO) (Batch/Lot number: unknown) for pulmonary arterial hypertension. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DYSPNOEA EXERTIONAL (non-serious) with onset Jan2021, outcome "unknown", described as "Dyspnoea Exertional"; DYSPNOEA (non-serious) with onset Jan2021, outcome "unknown", described as "Dyspnoea"; GAIT DISTURBANCE (non-serious) with onset Jan2021, outcome "unknown", described as "Gait Disturbance"; DIARRHOEA (non-serious) with onset Jan2021, outcome "unknown", described as "Diarrhoea"; FLUID RETENTION (non-serious) with onset Jan2021, outcome "unknown", described as "Fluid Retention". The action taken for macitentan, tadalafil and treprostinil sodium was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Dizziness, Retinal migraine
Clinical narrative: ocular migraine; dizziness (which mainly happens when she looks down); light pressure between her eyebrows; 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), administration date 19May2021 (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, Anatomical location: Arm Left, lot/batch number: ER8729), administration date: 28Apr2021, for Covid-19 Immunization, reaction(s): "injection site pain", "injection site swelling/ swelling to her arm at the injection site", "lethargy", "tenderness/ she woke up and was getting dressed and noticed tenderness on her bra line on the opposite side of where she got the vaccine", "(black and blue) bruise on the right side of her bra line". The following information was reported: RETINAL MIGRAINE (non-serious), outcome "unknown", described as "ocular migraine"; DIZZINESS (non-serious), outcome "unknown", described as "dizziness (which mainly happens when she looks down)"; DISCOMFORT (non-serious), outcome "unknown", described as "light pressure between her eyebrows".  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: Arthralgia, Ear pain, Eye discharge, Fatigue, Illness
Clinical narrative: mucus on throat; stuffy nose; runny eyes; whole body pain; joint pain; feeling really sick; tired; sleepy; right sided ear aching; she got really sick and has been so sick; 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 female 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: INCREASED UPPER AIRWAY SECRETION (non-serious), outcome "unknown", described as "mucus on throat"; NASAL CONGESTION (non-serious), outcome "unknown", described as "stuffy nose"; EYE DISCHARGE (non-serious), outcome "unknown", described as "runny eyes"; PAIN (non-serious), outcome "unknown", described as "whole body pain"; ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain"; MALAISE (non-serious), outcome "unknown", described as "feeling really sick"; FATIGUE (non-serious), outcome "unknown", described as "tired"; SOMNOLENCE (non-serious), outcome "unknown", described as "sleepy"; EAR PAIN (non-serious), outcome "unknown", described as "right sided ear aching"; ILLNESS (non-serious), outcome "unknown", described as "she got really sick and has been so sick".  Additional Context: The caller was calling about the Pfizer covid vaccine. The caller took her second shot and after she took it she got really sick and has been so sick. The caller didn't know if this was normal. The caller has had a lot of mucus in her throat, a stuffy nose, runny eyes, whole body pain, joint pain, has been feeling really sick and tired and sleeping. It didn't happen with the first one, but it did with this one. The caller's right sided ear was aching. All of this started within 4-5 hours after the vaccines. The caller started feeling sleepy and laid down and couldn't hardly move because of the pain.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Increased upper airway secretion, Malaise, Nasal congestion, Pain, Somnolence
Clinical narrative: mucus on throat; stuffy nose; runny eyes; whole body pain; joint pain; feeling really sick; tired; sleepy; right sided ear aching; she got really sick and has been so sick; 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 female 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: INCREASED UPPER AIRWAY SECRETION (non-serious), outcome "unknown", described as "mucus on throat"; NASAL CONGESTION (non-serious), outcome "unknown", described as "stuffy nose"; EYE DISCHARGE (non-serious), outcome "unknown", described as "runny eyes"; PAIN (non-serious), outcome "unknown", described as "whole body pain"; ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain"; MALAISE (non-serious), outcome "unknown", described as "feeling really sick"; FATIGUE (non-serious), outcome "unknown", described as "tired"; SOMNOLENCE (non-serious), outcome "unknown", described as "sleepy"; EAR PAIN (non-serious), outcome "unknown", described as "right sided ear aching"; ILLNESS (non-serious), outcome "unknown", described as "she got really sick and has been so sick".  Additional Context: The caller was calling about the Pfizer covid vaccine. The caller took her second shot and after she took it she got really sick and has been so sick. The caller didn't know if this was normal. The caller has had a lot of mucus in her throat, a stuffy nose, runny eyes, whole body pain, joint pain, has been feeling really sick and tired and sleeping. It didn't happen with the first one, but it did with this one. The caller's right sided ear was aching. All of this started within 4-5 hours after the vaccines. The caller started feeling sleepy and laid down and couldn't hardly move because of the pain.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Vaccination site pruritus
Clinical narrative: felt itches at the injection site; a low grade fever after 24 hours; 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 80 year-old female 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: Yellow fever vaccine (She has had many vaccinations such as yellow fever, encephalitis,), for Immunization; Encephalitis vaccine (She has had many vaccinations such as yellow fever, encephalitis,), for Immunization; Bnt162b2 (Dose 1), for COVID-19 Immunization. The following information was reported: VACCINATION SITE PRURITUS (non-serious), outcome "unknown", described as "felt itches at the injection site"; PYREXIA (non-serious), outcome "recovered", described as "a low grade fever after 24 hours". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: PNC13
Symptoms: Pain
Clinical narrative: Pain; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from a sales representative.  A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) (Batch/Lot number: unknown) as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "Pain". Additional information: The patient felt pain compared to the flu vaccine. Pharmacist mentioned this was common adverse reactions. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Muscular weakness, Pain in extremity
Clinical narrative: Arm weakness/Weakness all over the hand; Arm pain/The pain is from her shoulders extending to her fingertips; The pain is from her shoulders extending to her fingertips.; 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 36 year-old female patient received bnt162b2 (BNT162B2), administration date 30Oct2021 11:30 (Lot number: FFZ588) at the age of 36 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing), notes: about 7 years ago. Concomitant medication(s) included: LEVOTHYROXINE taken for hypothyroidism. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization. The following information was reported: MUSCULAR WEAKNESS (non-serious) with onset 2021, outcome "not recovered", described as "Arm weakness/Weakness all over the hand"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "not recovered", described as "Arm pain/The pain is from her shoulders extending to her fingertips"; ARTHRALGIA (non-serious) with onset 2021, outcome "not recovered", described as "The pain is from her shoulders extending to her fingertips.". Therapeutic measures were taken as a result of muscular weakness, pain in extremity, arthralgia.   Additional information: The patient stated she received Ibuprofen for her pain. She said that the pain only goes away after taking Ibuprofen but comes back when it wears off. The patient received vaccine on the left.   No follow-up attempts are possible. No further information is expected.