chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Biopsy skin, Rash erythematous, Rash pruritic
Clinical narrative: red itchy skin rash; red itchy skin rash; This is a spontaneous report from a contactable consumer based on information received by Pfizer from program (manufacturer control number US-AMGEN-USASP2021069724). This case was split from master case 2021537545 for an elderly patient taking bnt162b2 and experienced red itchy skin rash.  An elderly male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. Medical history included ongoing rheumatoid arthritis with rheumatoid factor, unspecified. Concomitant medication(s) included etanercept (ENBREL) taken for rheumatoid arthritis from Sep2020 and ongoing; allopurinol (ALLOPURINOL); atorvastatin (ATORVASTATIN); fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA); ferrous sulfate (FERROUS SULFATE); prednisone (PREDNISONE); valsartan (VALSARTAN). The patient experienced red itchy skin rash on an unspecified date. The patient underwent lab tests and procedures which included biopsy skin: unknown results on 04May2021 to determine cause of rash whose result were not provided. No treatment information was received. Outcome of events was not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Nausea, Off label use, Pyrexia
Clinical narrative: nauseous; My son started feeling badly 5-6 hours after the 2nd shot./feeling overall very bad; this morning he had 103.5 fever; The patient was less  than 12 years old; This is a spontaneous report from a contactable consumer (parent). A 10-year-old male patient received bnt162b2 (COMIRNATY, solution for injection, Lot Number: not reported), via an unspecified route of administration, administered in Arm Left on 09Jun2021 00:30 (at the age of 10-years-old) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was allergic to Penicillin's and Sulfa. The patient previously received bnt162b2 (COMIRNATY, solution for injection, Lot Number: not reported), via an unspecified route of administration, administered in Arm Left on 19May2021, 12:00 (at the age of 10-years-old) as dose 1, single for COVID-19 immunisation. There were no other vaccine in four weeks and no other medications in two weeks. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not having COVID prior vaccination and has not been COVID tested post vaccination. On 09Jun2021 00:30 The patient who was less than 12 years old took the vaccination and on 10Jun2021 07:30 the patient had 103.5 fever, nauseous and started feeling badly 5-6 hours after the 2nd shot feeling overall very bad. The patient started feeling badly 5-6 hours after the 2nd shot. At 7:30am morning he had 103.5 fever, nauseous and feeling overall very bad. Event treatment included Advil Tylenol swap every 4 hours so far. Laboratory data include fever 103.5. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on back from the belt line to under arm; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8727), via an unspecified route of administration, administered in left arm on 15Apr2021 13:00 (at the age of 65 years old) as dose 1, single for COVID-19 immunisation. Medical history included chronic pain in back and penicillin allergy/cholesterol drugs allergy. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. Concomitant medication included steroids. The patient experienced rash on back from the belt line to under arm on 16Apr2021 12:00. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of rash on back from the belt line to under arm and included treatment with cream. Outcome of the event was recovered on 2021.  No follow-up attempts are needed. No further information is expected.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Rash macular
Clinical narrative: red spots on my chest and overtime they started to spread throughout my body, to my stomach, arms, hands, and now on my thighs; it's an allergic reaction; This is a spontaneous report from a contactable consumer (patient).    A 20-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 22May2021 12:00 (Lot Number: EW0182) as single dose (at the age of 20 years old) for COVID-19 immunisation. The vaccine was administered at Pharmacy or Drug Store. Medical history none. Concomitant medication included vitamin C [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), Vital protein collagen and protein powder, all taken for an unspecified indication, start and stop date were not reported. On 26May2021, the patient experienced: red spots on my chest and overtime they started to spread throughout my body, to my stomach, arms, hands, and now on my thighs; it's an allergic reaction. The outcome of the events was not recovered. No treatment was performed. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The clinical course was reported as follows: Within 4-5 days after I got the PfizerBioNTech vaccine, I started seeing red spots on my chest and overtime they started to spread throughout my body, to my stomach, arms, hands, and now on my thighs. It does not itch or anything, the most it does is get more red than usual and that happens whenever I am exercising or working out. As of now this is starting to spread more and more and I'm assuming it's an allergic reaction.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Irregular menstrual cycle; This is a spontaneous report from a contactable Health Care Professional (patient).   A 28-year-old non-pregnant female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine), the first dose, on an unspecified date, at single dose, in the left arm and the second dose on an unspecified date (Lot. 59267-1000-03) at single dose, in the left arm, for COVID-19 immunisation. Relevant medical history and concomitant medications were none. The patient had not experienced Covid-19 prior vaccination. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient had not received any other medications within 2 weeks of vaccination. No known allergies were reported. On 17May2021, the patient had irregular menstrual cycle. No treatment received. Clinical outcome of the adverse event was unknown at time of this report. Post the vaccination, the patient has not been tested for COVID-19.  Follow-up attempt have been completed and no further information is expected. The lot number is not available despite follow-up attempts made.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pyrexia
Clinical narrative: chills; headache; fever; This is a spontaneous report from a contactable physician (parent). A 12-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 intramuscular, administered in arm left on 09Jun2021 07:30 (Batch/Lot Number: EW0186) (at the age of 12-year-old) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history was none. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 dose 1, intramuscular (lot number: EW0179) on 18May2021 07:30 AM for COVID-19 immunisation. The patient had no other vaccines within four weeks. The patient had no covid prior vaccination. He had not tested with covid post vaccination. The patient experienced chills, headache and fever on 09Jun2021 19:30 with outcome of recovered on 10Jun2021 14:00. It was reported that 12 hours after receiving the vaccine, the patient started having chills, headache and fever (38.5 degrees Celsius). Ibuprofen 300 mg was taken once. The following morning (June-10) around 9 am another dose of Ibuprofen 300 mg was taken. The events resolved by 2 pm the same day. Therapeutic measures were taken as a result of chills, headache and fever.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: Menstruation abnormal; This is a spontaneous report form a non-contactable consumer (patient). A 43-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 31Mar2021 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing. Patient did not have COVID-19 prior to vaccination. Patient did not receive other vaccine in four weeks. Concomitant medications included birth control pill, multivitamin. The patient experienced menstruation abnormal (non-serious) on 01Apr2021 with outcome of unknown. The patient reported period cycle changes. First month period did not come. 2nd month lots if cramping and only spotting. Her periods normally were very consistent. Patient was not tested for COVID-19 after vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow-up.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Fatigue, Headache, Lymphadenopathy
Clinical narrative: racy feeling; extreme headache; fatigue; lymph node swelling; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew 0180), via an unspecified route of administration, administered in right arm on 14May2021 at 10:00 (at the age of 61-years-old) as dose 1, single for COVID-19 immunisation.  Medical history included allergy to medications (some past prescription medications). The patient stated that she was sensitive person and had the uncommon side effects. She had no chronic conditions, no illnesses. She was a healthy person. Concomitant medications included unspecified multivitamins and unspecified magnesium supplements. On 14May2021 in the evening the patient experienced experienced a racy feeling and a bit of needing to take deep breaths. She had an extreme headache for 3 days along with fatigue, along with the lymph node swelling. The event resulted in Doctor or other healthcare professional office/clinic visit. The patient did not received treatment for events. The patient did not have COVID prior vaccination and she was not tested post vaccination. The outcome of events was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Fatigue, Pyrexia
Clinical narrative: extreme fatigue; slight fever; cough; This is a spontaneous report from a non-contactable consumer (patient). A 49-year-old male patient received bnt162b2 (BNT162B2, Lot Number: ER8735), dose 1 via an unspecified route of administration, administered in left arm on 20May2021 17:30 (at the age of 49-year-old) as dose 1, single for COVID-19 immunization. Medical history included Covid-19. There were no concomitant medications. No other vaccine in four weeks. No other medications in two weeks. On 20May2021, the patient experienced extreme fatigue, slight fever and cough. The events lasted for about 32 hours. The patient received no treatment for the events. The outcome of the events recovered in May2021.    No follow-up attempts are possible. No further information is expected.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pyrexia
Clinical narrative: fever (38.5 degrees Celsius); chills; headache; This is a spontaneous report from a contactable physician (patient's parent). A 12-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), intramuscular, administered in the left arm on 09Jun2021 at 07:30 (Lot Number: EW0186) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient did not receive any other vaccines in four weeks. The patient did not receive other medications in two weeks. The patient did not have COVID prior to vaccination. The patient was not tested for COVID post vaccination. The patient previously received the first dose of BNT162B2 (lot number: EW0179), intramuscular on 18May2021 at 07:30 on the left arm for COVID-19 immunization. On 09Jun2021 at 19:30, 12 hours after receiving the vaccine, the patient started having chills, headache and fever (38.5 degrees Celsius). Ibuprofen 300 mg was taken once. The following morning, 10Jun2021 around 9:00, another dose of Ibuprofen 300 mg was taken. The events resolved 14:00 on 10Jun2021.   No follow-up attempts are possible.  No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Swelling, Vomiting
Clinical narrative: 48 hrs after 2nd shot  woke up to lemon size swelling in armpit of arm that was vacinated; 24 hrs after 2nd shot, vomiting; fever (102); This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Jun2021 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. Medical history included sulfonamide allergy. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 16May2021 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 07Jun2021 the patient experienced vomiting and 102 fever 24 hrs after 2nd shot, on 08Jun2021, 48 hrs after 2nd shot woke up to lemon size swelling in armpit of arm that was vaccinated. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. The clinical outcome of the events vomiting and 102 fever 24 hrs after 2nd shot, on 08Jun2021, 48 hrs after 2nd shot woke up to lemon size swelling in armpit of arm that was vaccinated were not resolved at this time of report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: needle was very short hence very uncomfortable/felt the needle was not long enough; needle was very short hence very uncomfortable for her; burning; This is a spontaneous report from a non-contactable consumer (patient) via Pfizer-sponsored program. A female patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for immunization. The patient's medical history and concomitant medications were not reported. It was reported that regarding PREVNAR 13, the patient complained that the needle was very short hence very uncomfortable for her and burning. The patient felt the needle was not long enough. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Acne cystic, Breast pain, Fungal infection, Menstruation irregular, Migraine
Clinical narrative: A week of migraines; many painful acne cysts on face; yeast infections; sore breasts for 2 weeks and counting; multiple periods, 2 week early periods; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A 37-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration, administered in Arm Left on 05Jun2021 at 15:45 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization (at the age of 37-years-old). Medical history included patient had known allergies to dilantin and penicillin from an unknown date and unknown if ongoing. There were no concomitant medications. Patient had not received any other vaccine in four weeks and other medications in two weeks. Patient had no covid prior vaccination and not tested for covid post vaccination. It was reported that after receiving the dose of vaccine on 06Jun2021 at 12:00 the patient experienced a week of migraines, many painful acne cysts on face, yeast infections, sore breasts for 2 weeks and counting, multiple periods, 2 week early periods. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Patient had not received any treatment for the events. The patient was not recovered from the events.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Epistaxis, Erythema, Flushing, Hot flush, Pruritus
Clinical narrative: blood (thick) running from my nose; tongue had splits on it; sight became dark red, swollen and hard; hot flashes; face flushing; itchy neck; Ears ringing; bit wheezy; sight became dark red; sight became dark red, swollen; This is a spontaneous report from a contactable consumer (unspecified relationship with patient) reported for patient. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0164, and Expiration date: Unknown), intramuscular, administered in deltoid left on 05May2021 15:40 as dose 1, single for COVID-19 immunization, at hospital. Medical history included none. There were no concomitant medications. There was no prior vaccination. The patient initially had an itchy neck and a bit wheezy, hot flashes, face flushing. Took a Benadryl, ears ringing, on an unspecified date in 2021. Then after 3 days the sight became dark red, swollen and hard, continued for 1 week. Then on 11Jun2021, while sleeping the patient awoke to "blood (thick) running from my nose (about 2 ounces). The patient's "tongue had splits on it". The outcome of the event "sight became dark red, swollen" (swelling), "sight became dark red" (erythema) and "sight became dark red, swollen and hard" (skin hypertrophy) reported as resolved on an unspecified date in 2021. The investigation assessment was not provided. No relevant tests were performed. The outcome of other events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Skin hypertrophy, Swelling, Tinnitus, Tongue disorder, Wheezing
Clinical narrative: blood (thick) running from my nose; tongue had splits on it; sight became dark red, swollen and hard; hot flashes; face flushing; itchy neck; Ears ringing; bit wheezy; sight became dark red; sight became dark red, swollen; This is a spontaneous report from a contactable consumer (unspecified relationship with patient) reported for patient. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0164, and Expiration date: Unknown), intramuscular, administered in deltoid left on 05May2021 15:40 as dose 1, single for COVID-19 immunization, at hospital. Medical history included none. There were no concomitant medications. There was no prior vaccination. The patient initially had an itchy neck and a bit wheezy, hot flashes, face flushing. Took a Benadryl, ears ringing, on an unspecified date in 2021. Then after 3 days the sight became dark red, swollen and hard, continued for 1 week. Then on 11Jun2021, while sleeping the patient awoke to "blood (thick) running from my nose (about 2 ounces). The patient's "tongue had splits on it". The outcome of the event "sight became dark red, swollen" (swelling), "sight became dark red" (erythema) and "sight became dark red, swollen and hard" (skin hypertrophy) reported as resolved on an unspecified date in 2021. The investigation assessment was not provided. No relevant tests were performed. The outcome of other events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding
Clinical narrative: Heavier spotting after the second administered dose while still on the pill; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 41 year old non pregnant female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 29May2021 (Batch/Lot Number: EW0187) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE) taken for an unspecified indication, start and stop date were not reported. The patient previously took oxycodone, albuterol. The patient experienced Light spotting for a week after the first dose administration while still on the contraceptive pill and heavier spotting after the second administered dose while still on the pill for intermenstrual bleeding on 30May2021 with outcome of recovered.    Follow-up (23Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Developed chest pain.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 37-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: Ep6955, Expiry date was not reported) via an unspecified route of administration in arm left (at the age of 37-year-old) on 07Apr2021 10:30 as single dose for COVID-19 immunization. The patient medical history was not reported, no known allergy. Concomitant medication(s) included terbinafine (LAMISIL) taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: En6208, Expiry date was not reported) via an unspecified route of administration at arm left (at the age of 37-year-old) on 17Mar2021 10:30 (Lot Number: En6208) as single dose for COVID-19 immunisation. The patient did not have COVID prior vaccination. The patient had not tested COVID post vaccination. On 27Apr2021 the patient experienced developed chest pain. Patient received treatment for the event in the form of pills. The adverse event resulted in consultation in Doctor or other healthcare professional office/clinic visit. The outcome for the event was not recovered.  No follow-up attempts are possible. No further information is expected.  Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Dizziness, Dyspnoea, Dysstasia
Clinical narrative: Tired; Starting from around 2:00 pm, I started having high fever, peaking at 102 (then I took some Tylenol pills).; felt very dizzy and weak, having headache and wanting to vomit (but didn't); felt very dizzy and weak, having headache and wanting to vomit (but didn't); wanting to vomit (but didn't).; I realized that my heart beat rate was very high, at around 120 per minute; also felt hard to breath for at least couple of hours; felt very dizzy and weak, having headache and wanting to vomit (but didn't); extremely hard to standup on my feet because of above symptoms; Everything was good on the day when I got the second vaccine shot, except for some pain on my left arm; This is a spontaneous report from a contactable consumer (patient). This 31-year-old non-pregnant female consumer was reported for herself that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0196, Expiry Date: not reported), via an unspecified route of administration, administered in left arm on 25Jun2021 at 15:15 (at the age of 31 years) as dose 2, single for covid-19 immunisation. The patient medical history included known allergy to Cephalosporin. Concomitant medications were not reported. The patient previously received first dose of bnt162b2 PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0187, Expiry Date: not reported), via an unspecified route of administration, administered in left arm on 04Jun2021 at 14:30 (at the age of 31 years) as dose 1, single for covid-19 immunisation. Facility type vaccine was pharmacy or drug store. No other vaccine given in four weeks. No other medications in two weeks. No Covid prior and post vaccination. It was reported that everything was good on the day when she got the second vaccine shot, except for some pain on her left arm on 25Jun2021. Things got much worse on the second day (26Jun2021) when she woke at around 11:00 am. She felt very dizzy and weak, had headache and wanting to vomit (but didn't). She realized that her heart beat rate was very high, at around 120 per minute. She also felt hard to breath for at least couple of hours and extremely hard to standup on her feet because of above symptoms. But at that time, there was no fever. Starting from around 2:00 pm, she started having high fever, peaking at 102 (then she took some Tylenol pills). During the whole day, her heart beat was around 120 and felt very dizzy. From the third day to fifth day, heart beat rate became normal but still felt dizzy, headache and tired with low fever. The patient underwent lab tests and procedures which included body temperature: 102 f on 26Jun2021. Therapeutic measures were taken as a result of all events. The outcome of all events was recovered in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Heart rate, Heart rate increased, Nausea
Clinical narrative: Tired; Starting from around 2:00 pm, I started having high fever, peaking at 102 (then I took some Tylenol pills).; felt very dizzy and weak, having headache and wanting to vomit (but didn't); felt very dizzy and weak, having headache and wanting to vomit (but didn't); wanting to vomit (but didn't).; I realized that my heart beat rate was very high, at around 120 per minute; also felt hard to breath for at least couple of hours; felt very dizzy and weak, having headache and wanting to vomit (but didn't); extremely hard to standup on my feet because of above symptoms; Everything was good on the day when I got the second vaccine shot, except for some pain on my left arm; This is a spontaneous report from a contactable consumer (patient). This 31-year-old non-pregnant female consumer was reported for herself that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0196, Expiry Date: not reported), via an unspecified route of administration, administered in left arm on 25Jun2021 at 15:15 (at the age of 31 years) as dose 2, single for covid-19 immunisation. The patient medical history included known allergy to Cephalosporin. Concomitant medications were not reported. The patient previously received first dose of bnt162b2 PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0187, Expiry Date: not reported), via an unspecified route of administration, administered in left arm on 04Jun2021 at 14:30 (at the age of 31 years) as dose 1, single for covid-19 immunisation. Facility type vaccine was pharmacy or drug store. No other vaccine given in four weeks. No other medications in two weeks. No Covid prior and post vaccination. It was reported that everything was good on the day when she got the second vaccine shot, except for some pain on her left arm on 25Jun2021. Things got much worse on the second day (26Jun2021) when she woke at around 11:00 am. She felt very dizzy and weak, had headache and wanting to vomit (but didn't). She realized that her heart beat rate was very high, at around 120 per minute. She also felt hard to breath for at least couple of hours and extremely hard to standup on her feet because of above symptoms. But at that time, there was no fever. Starting from around 2:00 pm, she started having high fever, peaking at 102 (then she took some Tylenol pills). During the whole day, her heart beat was around 120 and felt very dizzy. From the third day to fifth day, heart beat rate became normal but still felt dizzy, headache and tired with low fever. The patient underwent lab tests and procedures which included body temperature: 102 f on 26Jun2021. Therapeutic measures were taken as a result of all events. The outcome of all events was recovered in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Tired; Starting from around 2:00 pm, I started having high fever, peaking at 102 (then I took some Tylenol pills).; felt very dizzy and weak, having headache and wanting to vomit (but didn't); felt very dizzy and weak, having headache and wanting to vomit (but didn't); wanting to vomit (but didn't).; I realized that my heart beat rate was very high, at around 120 per minute; also felt hard to breath for at least couple of hours; felt very dizzy and weak, having headache and wanting to vomit (but didn't); extremely hard to standup on my feet because of above symptoms; Everything was good on the day when I got the second vaccine shot, except for some pain on my left arm; This is a spontaneous report from a contactable consumer (patient). This 31-year-old non-pregnant female consumer was reported for herself that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0196, Expiry Date: not reported), via an unspecified route of administration, administered in left arm on 25Jun2021 at 15:15 (at the age of 31 years) as dose 2, single for covid-19 immunisation. The patient medical history included known allergy to Cephalosporin. Concomitant medications were not reported. The patient previously received first dose of bnt162b2 PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0187, Expiry Date: not reported), via an unspecified route of administration, administered in left arm on 04Jun2021 at 14:30 (at the age of 31 years) as dose 1, single for covid-19 immunisation. Facility type vaccine was pharmacy or drug store. No other vaccine given in four weeks. No other medications in two weeks. No Covid prior and post vaccination. It was reported that everything was good on the day when she got the second vaccine shot, except for some pain on her left arm on 25Jun2021. Things got much worse on the second day (26Jun2021) when she woke at around 11:00 am. She felt very dizzy and weak, had headache and wanting to vomit (but didn't). She realized that her heart beat rate was very high, at around 120 per minute. She also felt hard to breath for at least couple of hours and extremely hard to standup on her feet because of above symptoms. But at that time, there was no fever. Starting from around 2:00 pm, she started having high fever, peaking at 102 (then she took some Tylenol pills). During the whole day, her heart beat was around 120 and felt very dizzy. From the third day to fifth day, heart beat rate became normal but still felt dizzy, headache and tired with low fever. The patient underwent lab tests and procedures which included body temperature: 102 f on 26Jun2021. Therapeutic measures were taken as a result of all events. The outcome of all events was recovered in 2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pneumonitis
Clinical narrative: Shortness of breath (left lung inflammation; side closest to injection site); Shortness of breath (left lung inflammation; side closest to injection site); This is a spontaneous report from a non-contactable other hcp (Patient).  A 31-years-old non pregnant female patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIOTEH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8735), via an unspecified route of administration, administered in Arm Left on 02Jul2021 10:00 as single dose for covid-19 immunization. (Vaccination facility: Hospital). Medical history included allergies to sulfa from an unknown date and unknown if ongoing, patient had Never smoked. There were no concomitant medications. Historical vaccine included first dose of BNT162B2 (Lot number= ER8735) in left arm on 11Jun2021 09:00 for covid-19 immunization. Patient did not receive any other vaccine in four weeks. Patient did not receive any other medications in two weeks. Patient was not diagnosed with Covid prior vaccination. It was reported that on 04Jul2021 Shortness of breath (left lung inflammation: side closest to injection site), no previous medical concerns with her lungs. Highly physically active individual (especially cardiovascular) consuming a healthy diet. Patient did not receive any treatment for the events. Patient was not tested for covid post vaccination. The outcome for the events was reported as resolving at the time of this report.   No follow-up attempts are possible. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: runny nose; sore throat; trouble breathing; headaches; This is a spontaneous report from a contactable consumer (Patient). A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 23Mar2021 (Batch/Lot number was not reported) AND dose 1 via an unspecified route of administration on 03Mar2021 (Batch/Lot number was not reported) both as single dose for covid-19 immunisation. Medical history included ongoing COPD. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced runny nose, sore throat, trouble breathing and headaches. Therapeutic measures were taken as a result of adverse event. Patient received the first dose of the Pfizer COVID-19 vaccine on 03March2021 and the second dose on 23Mar2021 and had recently developed a runny nose, sore throat, trouble breathing and headaches, she does have COPD and was under a doctors care. Stated her doctor/Nurse PR actioner had given her medication and inhalers and would like her to go to the emergency room because of her breathing but she does not want to do that, she was wondering if she can get test of the COVID-19 virus. The outcome of event was unknown.   The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
Sex: U
Vaccine: 6VAX-F, DTAPIPVHIB
Symptoms: Off label use
Clinical narrative: Doctor using a combination schedule of Pentacel and Vaxelis. 2 doses of each in the 4 dose DTaP series with no AE; Initial information was received on 31-Aug-2021 regarding an unsolicited valid non-serious case from a consumer/non-hcp (healthcare professional).  This case involves a patient with unknown demography who experienced "doctor using a combination schedule of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), HIB VACCINE CONJ (MENIGOCOCCAL PROTEIN), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID [VAXELIS]. 2 doses of each in the 4 dose dtap series" (off label use).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE and VAXELIS (not produced by Sanofi Pasteur) (lot number and expiry dates were not reported) via unknown route at an unknown administration site for prophylactic vaccination (off label use).  It was a case of actual medication error due to off label use (latency: same day).  It was reported "however, vaccination should not be deferred if the specific vaccine product previously administered is unavailable or unknown".  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information on the batch number for this case.
Sex: F
Vaccine: TDAP
Symptoms: Hypoacusis
Clinical narrative: hearing impaired; Initial information received on 30-Aug-2021 regarding an unsolicited valid serious case received from a consumer/non-health care professional.  This case involves an 8-month-old female patient who experienced hearing impaired (hypoacusis) after receiving DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient past medical treatment included Noctec.  The patient past vaccination(s), concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [lot number and expiry date not reported] via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious hearing impaired (hypoacusis) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. This event was assessed as medically significant.  Caller states she almost died when she was 8 months from a medication called Adacel. It caused hearing loss as well.  It was reported it was spoke from attached document who should not get the vaccine to emphasize the contraindications. Encouraged caller to reach out to HCP (health care professional) with ingredient list for the comimaty vaccine so they can help compare ingredients.   It was unknown if there were lab data/results available.  It was unknown if the patient experienced any additional symptoms/events.  It was not reported if the patient received any corrective treatment for the event (hearing impaired).  At time of reporting, the outcome was unknown for the event hearing impaired.  Information on the batch number was requested.; Sender's Comments: This case involves an 8-month-old female patient who experienced hypoacusis after vaccination with ADACEL. The time to onset is unknown. There is no further information regarding patient's medical condition at time of vaccination, history and laboratory tests ruling out alternate etiologies. Based upon the reported information, the role of a vaccine cannot be assessed.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy
Clinical narrative: Fluzone exposure during pregnancy with no adverse event; Initial information received on 01-Sep-2021 regarding an unsolicited valid non-serious case from an other health professional and consumer/non healthcare professional.  This case involves a 29 years old female pregnant patient who was vaccinated with QUADRIVALENT INFLUENZA VACCINE (FLUZONE QUADRIVALENT) [exposure during pregnancy].   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported event occurred at 45 weeks of pregnancy and the patient was exposed to QUADRIVALENT INFLUENZA VACCINE (FLUZONE QUADRIVALENT) at 45 weeks of pregnancy, during unknown pregnancy trimester for the vaccine.  The date of last menstrual period was reported as 26-Feb-2020.  The estimated delivery due date was 02-Oct-2021.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 09-Jan-2021, the patient received first dose of suspect FLUZONE QUADRIVALENT (suspension for injection, lot UT7325JA and expiration date 30-Jun-2022) via intramuscular route in an unknown administration site for prophylactic vaccination.  It was an actual medication error case due to vaccine exposure during pregnancy (same day latency).  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were laboratory data/results available.  At time of reporting, the outcome was unknown for the reported event.  Additionally, at time of reporting, the outcome of the pregnancy was unknown.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy
Clinical narrative: pregnant female patient received FLUZONE vaccine/ NO AE; Initial information received on 01-Sep-2021 regarding an unsolicited valid non-serious case received from a other health professional and physician.  This case involves 24-year-old female pregnant patient who was exposed to vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] (exposure during pregnancy).  Data regarding this pregnancy were received prospectively.  Patient was exposed to the vaccine at gestation period of 20 weeks.  The date of last menstrual period was reported as 20-Apr-2021.  The estimated due date is 25-Jan-2022.  The patient past medical treatment, family history and concomitant medication were not provided.  Patient had any medical history, concomitant disease or risk factor  On 01-Sep-2021, the patient received a first dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [lot 477325SA, expiry date: 30-Jun-2022] via an intramuscular route at an unknown administration site for prophylactic vaccination.  It was the case of vaccine exposure during pregnancy (latency same day). The patient was pregnant when she received FLUZONE vaccine.   It was not reported if the patient received a corrective treatment for the events.  It was not reported whether patient experienced any adverse reaction after the injection.  Pregnancy outcome was unknown at the time of report.
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: other symptoms as well; fainted twice within the first hour; Initial information was received on 31-Aug-2021 regarding an unsolicited valid serious case received from a consumer/non-healthcare professional.  This case involves an adult female patient who fainted twice within the first hour (syncope) and had other symptoms as well (unevaluable event) after receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s) and family history were not provided.  Information of concomitant medications was not reported.  On 14-Aug-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination.  On 14-Aug-2020 the patient developed a serious event reported as fainted twice within the first hour (syncope) on the same day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. This event was assessed as medically significant.  On an unknown date the patient, developed non-serious other symptoms as well (unevaluable event) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. Also, it was reported that sometimes that happens.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the events.  At the time of this report, the outcome of both the events was unknown.  Information on lot/batch number was requested for this case.; Sender's Comments: This case concerns an adult female patient who had syncope and unevaluable event after vaccination with  FLUZONE HIGH-DOSE QUADRIVALENT. The time to onset is compatible with the role of the vaccines for the event syncope. The time to onset is unknown for the event unevaluable event. Additional information regarding medical history, condition at the time of vaccination and lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant woman recieved Fluzone QIV with no reported adverse event; Initial information was received on 01-Sep-2021 regarding an unsolicited valid non-serious case from other health professional.  This case involves a 26-year-old pregnant female patient who was vaccinated with INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] on 09-Feb-2021 (exposure during pregnancy).  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported Pregnant woman received Fluzone QIV with no reported adverse event occurred at unknown gestation period.  The date of last menstrual period was not reported.  The estimated due date is 02-Oct-2021.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s) concomitant medications and family history were not provided.  On 09-Feb-2021, the patient received a dose 1 of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number: UT7325JA; expiry date: 30-Jun-2022; form: suspension for injection) via intramuscular route in unknown administration site for prophylactic vaccination.  It was the case of vaccine exposure during pregnancy (same day latency).  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were laboratory data/results available.  At time of reporting, the outcome was unknown for the reported event.  Additionally, at time of reporting, the outcome of the pregnancy was unknown.