chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Lymphadenopathy, Menstrual disorder, Myalgia, Pyrexia
Clinical narrative: High fever; muscle aches; extreme lethargy continuing a month; early menstrual cycle (two weeks early); swollen lymph nodes in my armpit; ringing that comes and goes in my left ear; This is a spontaneous report from a contactable consumer or other non-hcp (patient). A 30-years-old non-pregnant female patient second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0183), via an unspecified route of administration, in left arm on 19May2021 12:00 (age at the time of vaccination 30-years-old), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0175), via an unspecified route of administration, in left arm on 28Apr2021 12:00 (age at the time of vaccination 30-years-old), as a single dose for COVID-19 immunization. The patient had no known allergies. No other vaccine in four weeks. No other medications in two weeks. No covid prior vaccination. No covid tested post vaccination. No treatment required. On 19May2021 12:00, patient experienced High fever, muscle aches, extreme lethargy continuing a month, early menstrual cycle (two weeks early), swollen lymph nodes in my armpit, and ringing that comes and goes in my left ear. Adverse event resulted in doctor or other healthcare professional office/clinic visit. No treatment required. The outcome for all the events was not recovered.  Follow-up (19Jul2021): Follow-up attempts completed. No further information expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: High fever; muscle aches; extreme lethargy continuing a month; early menstrual cycle (two weeks early); swollen lymph nodes in my armpit; ringing that comes and goes in my left ear; This is a spontaneous report from a contactable consumer or other non-hcp (patient). A 30-years-old non-pregnant female patient second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0183), via an unspecified route of administration, in left arm on 19May2021 12:00 (age at the time of vaccination 30-years-old), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0175), via an unspecified route of administration, in left arm on 28Apr2021 12:00 (age at the time of vaccination 30-years-old), as a single dose for COVID-19 immunization. The patient had no known allergies. No other vaccine in four weeks. No other medications in two weeks. No covid prior vaccination. No covid tested post vaccination. No treatment required. On 19May2021 12:00, patient experienced High fever, muscle aches, extreme lethargy continuing a month, early menstrual cycle (two weeks early), swollen lymph nodes in my armpit, and ringing that comes and goes in my left ear. Adverse event resulted in doctor or other healthcare professional office/clinic visit. No treatment required. The outcome for all the events was not recovered.  Follow-up (19Jul2021): Follow-up attempts completed. No further information expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Gait inability, Headache, Vertigo, Vision blurred
Clinical narrative: SEVERE vertigo for 3 weeks; Extreme vomiting; headache; blurry vision; dizzy - couldn't walk; dizzy - couldn't walk; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 60-year-old male patient received second dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: ew0153), via an unspecified route in the left arm on 19Apr2021 at 11:00 (age at vaccination: 60-year-old), as a single dose for covid-19 immunization. Medical history included known allergies to penicillin and high blood pressure. Concomitant medications included lisinopril 10mg. Historical vaccine included first dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: er8727), via an unspecified route in the right arm on 29Mar2021 at 11:00, as a single dose for covid-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 21Apr2021 at 02:00, patient experienced severe vertigo for 3 weeks, extreme vomiting, headache, blurry vision, dizzy - couldn't walk for a couple weeks. Adverse events resulted in emergency room/department or urgent care. Therapeutic measures taken as a result of the events included steroids, anti-vertigo, anti-nausea and antibiotics. The clinical outcome of the events was recovered with lasting effects.  Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: SEVERE vertigo for 3 weeks; Extreme vomiting; headache; blurry vision; dizzy - couldn't walk; dizzy - couldn't walk; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 60-year-old male patient received second dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: ew0153), via an unspecified route in the left arm on 19Apr2021 at 11:00 (age at vaccination: 60-year-old), as a single dose for covid-19 immunization. Medical history included known allergies to penicillin and high blood pressure. Concomitant medications included lisinopril 10mg. Historical vaccine included first dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: er8727), via an unspecified route in the right arm on 29Mar2021 at 11:00, as a single dose for covid-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 21Apr2021 at 02:00, patient experienced severe vertigo for 3 weeks, extreme vomiting, headache, blurry vision, dizzy - couldn't walk for a couple weeks. Adverse events resulted in emergency room/department or urgent care. Therapeutic measures taken as a result of the events included steroids, anti-vertigo, anti-nausea and antibiotics. The clinical outcome of the events was recovered with lasting effects.  Follow-up attempts are completed. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Fatigue, Poor quality product administered
Clinical narrative: fatigue; States there was a pharmacist in from a temp agency and that pharmacist took an expired vial(expired one week prior) and diluted and gave to 6 patients; States there was a pharmacist in from a temp agency and that pharmacist took an expired vial(expired one week prior) and diluted and gave to 6 patients; This is a spontaneous report from a contactable pharmacist. A 38-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EW0170, Expiration Date was not reported), via Intramuscular route of administration in left arm on 14Jun2021 at 09:22 (at the age of 36-year-old) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EW0178, Expiration Date was not reported), via Intramuscular route of administration in left arm on 22May2021 at 09:37 (at the age of 36-year-old) as dose 1, single for covid-19 immunisation and no reaction on previous exposure to Vaccine. It was unknown if patient received prior vaccinations within 4 weeks. The reporter states that she was a pharmacist speaking about the Pfizer COVID-19 vaccine. States there was a pharmacist in from a temp agency and that pharmacist took an expired vial (expired one week prior) and diluted and gave to 6 patients. Caller states the vaccine had no other excursions while being stored. She would like to know if the patients need to be revaccinated. Tried to warm transfer to Safety but no agents were available. Upon follow-up (23Jul2021), it was reported that pharmacists removed expired (clearly marked so) reconstituted & administered to 6 separate people. Vaccine was sequestered to destroy pending approval/acknowledgement Patients reported no adverse effects but did experience normal side effects in this case fatigue. Patient elected to not get another dose of vaccine. The outcomes of the events were unknown.  Follow-up (02Jul2021): 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 have been completed and no further information is expected.  Follow-up(23Jul2021): new information received from a contactable pharmacist in response to HCP letter sent via follow-up which included that: age at vaccination was updated. First dose date and time was updated, route of administration was updated, lot number was added. New event was added (fatigue).  Follow up attempts are complete. No further information is expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021716440 same drug/reporter /events different patient
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Dysgeusia, Hypoaesthesia oral, Pain, Taste disorder
Clinical narrative: Metallic taste; numbness on left side of mouth; loss of taste completely; everything tasted like soap; Soreness up side of neck to base of skull and down back of arm to elbow; This is a spontaneous report from a contactable consumer. This 45-year-old female consumer (Patient) reported for herself. A 45-year-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: FW0186, Expiration Date: not reported), via an unspecified route of administration in left arm on 16Jun2021 08:00 as single dose for COVID-19 immunization (At the age of 45-year-old, non-pregnant). Medical history included thyroid disorder and had allergies with just Sulfa and Vicodin. Concomitant medications included (Other medications in two weeks) ketoconazole (KETONE); colecalciferol (VITAMIN D) taken for an unspecified indication and thyroid medications. Patient did not receive any other vaccine in four weeks. The patient previously took vicodin and experienced drug hypersensitivity. Patient did not tested for covid prior and post vaccination. The patient experienced metallic taste, numbness on left side of mouth, loss of taste completely, everything tasted like soap, soreness up side of neck to base of skull and down back of arm to elbow on 16Jun2021 08:15. It was reported that, metallic taste followed by numbness on left side of mouth and loss of taste completely. When taste returned everything tasted like soap and numbness wore off. Soreness up side of neck to base of skull and down back of arm to elbow. Patient did not received any treatment. The outcome of the events recovering.  Information on the lot/batch number has been requested. Follow-up attempts have been completed and no further information is expected
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Breast pain, Cardiac stress test, Chest pain, Electrocardiogram
Clinical narrative: Shoulder, chest, underarm and left breast pain on my left side.; Shoulder, chest, underarm and left breast pain on my left side.; Shoulder, chest, underarm and left breast pain on my left side.; Shoulder, chest, underarm and left breast pain on my left side.; This is a spontaneous report from a contactable consumer(patient). A 59-year-old non pregnant female patient received first dose of bnt162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EWO151), via an unspecified route of administration on 19Apr2021 at 10:30 ( at the age of 59 year old) into left arm as a single dose for COVID-19 immunization. Medical history included high blood pressure, cancerous cyst removed, covid-19, Cholesterol. The concomitant medications included blood pressure and cholesterol medication. The patient did not receive any other vaccine in four weeks. Prior to the vaccination, the patient was diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. The patient did not have any allergies. On 20Apr2021 at 08:30 AM, the patient experienced Shoulder, chest, underarm and left breast pain on my left side. The patient was performed EKG and scheduled stress test for heart precaution. The adverse event did result Doctor or other healthcare professional office/clinic visit. The outcome of the events was recovering.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Shoulder, chest, underarm and left breast pain on my left side.; Shoulder, chest, underarm and left breast pain on my left side.; Shoulder, chest, underarm and left breast pain on my left side.; Shoulder, chest, underarm and left breast pain on my left side.; This is a spontaneous report from a contactable consumer(patient). A 59-year-old non pregnant female patient received first dose of bnt162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EWO151), via an unspecified route of administration on 19Apr2021 at 10:30 ( at the age of 59 year old) into left arm as a single dose for COVID-19 immunization. Medical history included high blood pressure, cancerous cyst removed, covid-19, Cholesterol. The concomitant medications included blood pressure and cholesterol medication. The patient did not receive any other vaccine in four weeks. Prior to the vaccination, the patient was diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. The patient did not have any allergies. On 20Apr2021 at 08:30 AM, the patient experienced Shoulder, chest, underarm and left breast pain on my left side. The patient was performed EKG and scheduled stress test for heart precaution. The adverse event did result Doctor or other healthcare professional office/clinic visit. The outcome of the events was recovering.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Echocardiogram, Electrocardiogram, Heart rate, Investigation
Clinical narrative: tachycardia; chest pain; This is a follow-up spontaneous report from a contactable consumer. This contactable consumer (Patients parent/guardian) reported in response to Non-HCP letter via follow-up letter which included that:  A 12-year-old consumer (patient) of unspecified gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0173) via intramuscular route of administration on 14May2021 at 14:00 hours in left arm as dose 1, single for COVID-19 immunization. Medical history of the patient and prior vaccinations was reported as none. Concomitant medication included lisdexamfetamine mesilate (Vyvanse) taken for attention deficit hyperactivity disorder. On 05Jun2021 at 12:00 hours patient complained of chest pain and rapid heartbeat. Symptoms subsided before confirmation by parent/guardian. On 07Jun2021 patient complained of chest pain and rapid heart rate. Confirmed with oximeter device (171 beats/min) which subsided after 5-10min. Urgent care visit did not result in any findings and heartrate was normal. On 08Jun2021 patient underwent EKG for which results were normal. On 12Jun patient complained of rapid heart rate confirmed with oximeter (130 beats/min). The events required emergency room visit. Patient received follow-up visit with pediatrician. On 14Jun2021 echocardiogram was normal. On an unknown date in 2021 tachycardia recovered. The outcome of chest pain was unknown.  Follow-Up (21Jul2021): Follow-up attempts are completed. No further information was expected.
Sex: U
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: tachycardia; chest pain; This is a follow-up spontaneous report from a contactable consumer. This contactable consumer (Patients parent/guardian) reported in response to Non-HCP letter via follow-up letter which included that:  A 12-year-old consumer (patient) of unspecified gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0173) via intramuscular route of administration on 14May2021 at 14:00 hours in left arm as dose 1, single for COVID-19 immunization. Medical history of the patient and prior vaccinations was reported as none. Concomitant medication included lisdexamfetamine mesilate (Vyvanse) taken for attention deficit hyperactivity disorder. On 05Jun2021 at 12:00 hours patient complained of chest pain and rapid heartbeat. Symptoms subsided before confirmation by parent/guardian. On 07Jun2021 patient complained of chest pain and rapid heart rate. Confirmed with oximeter device (171 beats/min) which subsided after 5-10min. Urgent care visit did not result in any findings and heartrate was normal. On 08Jun2021 patient underwent EKG for which results were normal. On 12Jun patient complained of rapid heart rate confirmed with oximeter (130 beats/min). The events required emergency room visit. Patient received follow-up visit with pediatrician. On 14Jun2021 echocardiogram was normal. On an unknown date in 2021 tachycardia recovered. The outcome of chest pain was unknown.  Follow-Up (21Jul2021): Follow-up attempts are completed. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: tachycardia; This is a spontaneous report from a contactable nurse via medical information team. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on unspecified date as dose number unknown single for COVID-19 immunization. Medical history and Concomitant medications were not reported. Reporter was a nurse who was calling looking for information regarding side effect of tachycardia after wife received the Pfizer Covid vaccine. The outcome of event was unknown.  Information on the lot/batch number has been requested
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, SARS-CoV-2 test, Wheezing
Clinical narrative: Shortness of breath; Unusual wheezing; This is a spontaneous report from a contactable other healthcare professional, the patient. A 47-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9261), dose 1 via an unspecified route of administration, administered in Arm Left on 22Jan2021 (at the age of 47-years-old) as a single dose for covid-19 immunization. Medical history included asthma, cancer in remission, hypothyroidism, atrial fibrillation, hypersensitivity, drug hypersensitivity. The patient had allergies with penicillin. The patient had no other vaccine within four weeks and had other medications received within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 25Jan2021, the patient experienced shortness of breath and unusual wheezing a few days-week later after both shots. Since the vaccination, the patient had been tested for COVID-19 and resulted was negative. The patient did not receive any treatment. Outcome of the event was recovered with sequelae.  Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: That swelled up immediately and was very painful; That swelled up immediately and was very painful; This is a spontaneous report received from a contactable consumer (patient herself). A 57-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: unknown), via an unspecified route of administration, at arm right (at the age of 57-year-old) on 13Mar2021 12:15 as single dose for COVID-19 immunisation. Medical history included: COVID-19 (at New Year but was not tested, spent a few days in bed and was exhausted for all of January). The patient had not tested COVID post vaccination. The patient's concomitant medications were not reported. The patient previously took shingles (Shingrix) as second shot at via an unspecified route of administration at left (at the age of 57-year-old) on 09Feb2021. The patient took some unspecified antibiotics and experienced allergy. The patient had the first Covid shot in right arm. That swelled up immediately and was very painful but started feeling better the next day on an unspecified date in Mar2021. My doctors said she had seen another patient who had a long term reaction to the vaccine like me. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Overdose, Pain in extremity, Product preparation error
Clinical narrative: the vaccine administered to his son was not diluted/undiluted vaccine administered is equivalent to 3 shots or 3 doses; the vaccine administered to his son was not diluted/undiluted vaccine administered is equivalent to 3 shots or 3 doses; arm is a little sore; This is a spontaneous report from a Pfizer sponsored program . A contactable consumer (mother) reported that a 12-year-old male patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 25Jun2021 (age at vaccination: 12 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 27Jun2021, patient experienced the vaccine administered to his son was not diluted/undiluted vaccine administered is equivalent to 3 shots or 3 doses, arm is a little sore on Jun2021. Caller is a mother of a (withheld) year old male who received 1st dose of Pfizer BioNTech Covid19 Vaccine on Friday 25Jun2021. 1 hour after the vaccine was administered, they got a call from the vaccination site informing them that the vaccine administered to his son was not diluted and the woman who called said that the undiluted vaccine administered is equivalent to 3 shots or 3 doses. The people working on the vaccination site had been calling them since 27Jun2021 and 28Jun2021 to check the boy how's he's doing. As per the mother, his son's arm is a little sore. She talked already to the pharmacist and reported this event and she called the health department and they are already in the process of reporting it. Their doctor recommends not to get the second dose of the vaccine, but she wants to know Pfizer's recommendation, if his son should get the 2nd dose of the vaccine. The outcome for the events was unknown. Information about batch/lot number has been requested.  Follow-up (19Jul2021): Follow-up attempts completed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Added event Product concentrate not diluted.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Product administered at inappropriate site, Somnolence
Clinical narrative: Fatigue/extremely tired; Wants to fall over and cannot stay awake; She gets the vaccine in her hip; Nauseous; Headache; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 10Apr2021 as dose 2, single for covid-19 immunisation. Medical history included mastectomy (she has had a double mastectomy). The concomitant medications of patient were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unspecified date as dose 1, single for covid-19 immunisation, patient received vaccine in her hip (Product administered at inappropriate site). Caller stated she had no side effects immediately following either dose of the vaccine, and she got the vaccine in her hip because she has had a double mastectomy and could not get shots in her arms. Since late May she was having instantaneous fatigue, can be all of the sudden and wanted to fall over and cannot stay awake. And it most recently happened this past Saturday and it can last all day once it has happened and can get a headache with it. She was seeing a physician today (unspecified date) to talk about the issues, but the doctors do not know anything about this, she has already asked her primary care, and no one knows what she was talking about. Caller would like to speak with someone who could answer side effect questions for her. One second she will be fine and the next is extremely tired. This was the fourth time this has happened to her. However, this was happening before getting the vaccine but at that time the fatigue would only last 1-2 hours but since the vaccine it lasts longer and was getting a headache with it and because of the headache she was getting nauseous as well. The outcome of events was unknown.   Information about lot/batch number cannot be obtained. No further information expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, General physical health deterioration, Headache, Illness
Clinical narrative: Headache, caused him to be dizzy and throw up, couldn't function,; Headache, caused him to be dizzy and throw up, couldn't function,  captured together, after first vaccine; Headache, caused him to be dizzy and throw up, couldn't function,; He got sick; Massive headache, constant, after first vaccine; Joint pain, after first vaccine; This is a spontaneous report from a contactable consumer or other non hcp.  A 56-years-old male patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 20May2021 18:00 (Age at vaccination 56 years old) (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included ongoing hypertension (High Blood Pressure Caller states he was diagnosed in the late 1990's) , ongoing back pain (Low back pain Caller states he was diagnosed originally in 1995 or 1996) , spinal operation from an unknown date and unknown if ongoing (adds that he has had 4 back surgeries). Concomitant medications included metoprolol taken for hypertension and loratadine taken for back pain from an unspecified start date and ongoing. Caller states, the day after (21May2021, early in the morning when he woke up, at 5 AM. ), the patient woke up with a massive headache and joint pain that his headache got so bad, he was dizzy and threw up. he has had both effects, ever since that time. his doctor told him to take Aleve and Advil, but the medications, did not relieve the headache. his headache was constant, and his joint pain was terrible. he has no idea what to do, was there anything that he can do, for his effects? his doctor said the effects will wear off, but they have been constant. Headache and the patient got sick. The patient missed second dose, afraid of what the effects will be: 47 days from first dose, 20May2021. Outcome of events was not recovered.  Information on lot/batch number has been requested.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Headache, caused him to be dizzy and throw up, couldn't function,; Headache, caused him to be dizzy and throw up, couldn't function,  captured together, after first vaccine; Headache, caused him to be dizzy and throw up, couldn't function,; He got sick; Massive headache, constant, after first vaccine; Joint pain, after first vaccine; This is a spontaneous report from a contactable consumer or other non hcp.  A 56-years-old male patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 20May2021 18:00 (Age at vaccination 56 years old) (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included ongoing hypertension (High Blood Pressure Caller states he was diagnosed in the late 1990's) , ongoing back pain (Low back pain Caller states he was diagnosed originally in 1995 or 1996) , spinal operation from an unknown date and unknown if ongoing (adds that he has had 4 back surgeries). Concomitant medications included metoprolol taken for hypertension and loratadine taken for back pain from an unspecified start date and ongoing. Caller states, the day after (21May2021, early in the morning when he woke up, at 5 AM. ), the patient woke up with a massive headache and joint pain that his headache got so bad, he was dizzy and threw up. he has had both effects, ever since that time. his doctor told him to take Aleve and Advil, but the medications, did not relieve the headache. his headache was constant, and his joint pain was terrible. he has no idea what to do, was there anything that he can do, for his effects? his doctor said the effects will wear off, but they have been constant. Headache and the patient got sick. The patient missed second dose, afraid of what the effects will be: 47 days from first dose, 20May2021. Outcome of events was not recovered.  Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Burning sensation, Headache, Hypoaesthesia, Musculoskeletal disorder
Clinical narrative: Could not lift her arm; blood pressure went up; headaches; right hand went numb and burns off and on; right hand went numb and burns off and on; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient (reporter's girlfriend's daughter) that:  A 75-year-old female patient received bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine; solution for injection; Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient shared she received both doses of the vaccine. She said she has talked with a pharmacist who recommended calling Pfizer and that she has experienced her symptoms for five months. The patient stated that after the first vaccine she felt like she could not lift her arm. After the second shot, she felt like she had a problem with reaching, with lifting things. She said also that she felt "the muscles behind my things, same thing. It hurts. She was given Mobic, took that for six days then my blood pressure went up and I started getting headaches and then my right hand went numb and burns off and on. She has been to physical therapy, but is unsure if that is helping, and was told to see a rheumatologist and a neurologist. She hasn't "slept for nights", that she is a side sleeper and keeps turning from one side to the other. Patient was asking if her symptoms have been reported and wanted to know length of time of the symptoms and what she should do. Patient also shared her girlfriend's daughter is much younger, in her forties, but is having the same things. Her daughter told her to ride it out for six months and was also told that skinny people had a harder time after the vaccine. Patient said she had never heard of such a thing and asked if weight affected symptoms.  Response: Spoke from PI, referencing table 3.0 in section 6.1, LAB-1457-10.0 Revised: 25 June 2021, when sharing about those experiencing muscle pain. Informed caller that weights were not in the reporting data gathered in the PI.  Informed caller, when asking about if others had reported length of symptoms, that there is not information gathered that I can speak to regarding that information but that data is still being collected from callers such as herself and is being monitored by Pfizer and many other regulatory agencies.  Informed caller that Pfizer is unable to make treatment recommendations and she should continue following her HCP recommendations.  Lot/batch number is not available despite of follow-up attempts made. Follow up attempts have been completed and no fruther information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: pretty sore arm; fatigue; This is a spontaneous report received from a Pfizer sponsored program. A 51-years-old male patient (Reporter husband) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm on Mar2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced pretty sore arm, and fatigue on Mar2021. It was reported that Caller also mentioned that her husband, (1 year older than caller) had the Pfizer BioNTech COVID-19 vaccine last March and her husband had a pretty sore arm and experienced maybe about half and hour of fatigue on second dose. The outcome of events was unknown.  Information about batch/lot number has been requested
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: very tired and fatigue; Very sleepy; This is a spontaneous report from a contactable consumer (Patient) or other non health care professional. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration on Mar2021 as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced very tired and fatigue, very sleepy Just needing to sleep more in 2021. Patient was enquiring about a lot of people or any people calling saying that they have been having this kind of symptoms. The outcome of the events was unknown.  Information about Lot/Batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Feeling abnormal, Nausea, Tremor, Vomiting
Clinical narrative: horrible chest pain; feels like he's dying; hurts so bad he feels like he's going to throw up; nauseous; shaky; feels bad; This is a spontaneous report from a contactable consumer reported for a male patient (reporter's husband). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration from 14Jul2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter was calling for her husband, he's at work and got the vaccine yesterday and her husband just called her and he doesn't know if he's having a reaction or if it's normal or if he needs to go to the hospital. He called saying that he feels bad, horrible chest pain, feels like he's dying, it hurts so bad he feels like he's going to throw up, he's nauseous, and shaky on 15Jul2021. The reporter does not want to file a safety report. She thinks her husband was having more symptoms than what he is telling her. She was asking if he needs to go to the doctor. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: she is also experiencing headache with the first shot; This is a spontaneous report from two contactable consumers. A female consumer (patient) and another consumer (patient's husband) reported that a 42-year-old female patient (consumer) received bnt162b2 (BNT162B2, formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient and her husband stated that, the patient experienced headache with the first shot as well so we were expecting that on an unspecified date. The patient passed phone to her husband because, she no longer felt like talking on the phone. The outcome of the event was reported as unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Myalgia, Pyrexia
Clinical narrative: Muscle pain; Fever; This is a spontaneous report from a Pfizer-sponsored program. A contactable male consumer (patient) of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot number: unknown), via an unspecified route of administration on 12Jul2021 as single for COVID-19 immunization. Consumer stated about lot number, EW01-83, 0183 looks like a 0. No medical and concomitant medication history were reported. Transferring agent stated, I have a caller on the other line and he said that he was vaccinated last 12Jul2021 for the first dose of the Pfizer Covid-19 vaccine and in Jul2021, he experienced a little bit of muscle pain and fever which was on and off and patient was asking that how long will it last. Date scheduled for 2nd shot of Vaccine on 01Aug2021. The patient underwent lab tests and procedures which included body temperature with unknown result. The outcome of both events was unknown.  Batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Pain in extremity
Clinical narrative: Arm ached; massive headache; extremely tired; weak; This is the second of two reports. This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received bnt162b2 (Pfizer covid vaccine), via an unspecified route of administration on May2021 (Batch/Lot number was not reported) as dose number unknown, single dose at the age of 59-year-old for covid-19 immunization. Patient's past medical history included: mumps, bladder Issues. Patient's concurrent condition included: type 2 diabetes, loss of hearing, tired, relapsing remitting multiple sclerosis, hypothyroidism, hiatal hernia, depression, anxiety, tremors. Concomitant medications included ocrelizumab (OCREVUS); metformin; diphenhydramine hydrochloride (BENADRYL); paracetamol (TYLENOL); omeprazole, all taken for an unspecified indication, start and stop date were not reported. On May2021, it was reported that patient experienced: arm ached, massive headache; was extremely tired, weak. The outcome of the reported events was recovered in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: arm pain; fatigue; This is a spontaneous report from a contactable consumer or other non Healthcare Professional (patient, reported for self). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on unspecified date in Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient reported that with her first dose of the vaccine, she just had arm pain and fatigue which they (doctor) said was normal.The clinical outcome of the events was unknown.  Follow-up attempts are completed. Information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100912728 same patient/drug, different event/dose
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product preparation issue
Clinical narrative: ACTHIB was mixed with sterile water instead of ACTHIB diluent and administered to a patient with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other Health Professional via Medical Information (MI) (Reference number- 00700661) and transmitted to Sanofi on 28-Jul-2021.  This case involves a one-year-old male patient who was administered with HIB (PRP/T) VACCINE [ACT-HIB] which was mixed with sterile water instead of Act-Hib diluent (wrong diluent used).  The patient's medical history, past medical treatments, vaccinations and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for prophylactic vaccination.  On 27-Jul-2021, the patient received third dose of 0.5ml suspect HIB (PRP/T) VACCINE (lot UJ399AA and expiry date: 02-Oct-2021) via an intramuscular route in the left thigh for prophylactic vaccination.  The reporter "asking for further guidance."  It was a case of an actual medication error due to wrong diluent used (latency: same day).  At time of reporting no adverse event was reported.  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.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired QUADRACEL was administered to a patient with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health care professional via Agency (Reference number- 00701102) and transmitted to Sanofi on 28-Jul-2021.  This case involves a five-year-old female patient who was vaccinated with the expired DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On 28-Jul-2021, the patient received a fifth dose of 0.5 ml suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot C5635AA, expiry date-18-Jun-2021) via intramuscular route in the right deltoid for prophylactic vaccination (expired product administered).  It was a case of actual medication error due to expired vaccine used (same day).  At the time of report, no adverse event was reported.  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.
Sex: M
Vaccine: MNQ
Symptoms: Accidental exposure to product, Needle issue, No adverse event
Clinical narrative: MENACTRA shot into the medical assistant's eye with no adverse event; administering Menactra, as she was pushing down on the plunger the needle popped off syringe with no adverse event; Initial information with live follow up regarding an unsolicited valid non-serious case from other health care professional and physician via Medical Information (MI) (Reference number- 00702860) and transmitted to Sanofi on 29-Jul-2021.  This case involves a 17-year old male patient for whom it was reported that MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] shot into the medical assistant's eye (accidental exposure to product) and administering the suspect vaccine, as she was pushing down on the plunger the needle popped off syringe (device issue) (lot number: U6951AB and expiration date: 06-Jun-2022) at a dose of 0.5 ml via intramuscular route in the unknown site for prophylactic vaccination.  Medical history, past medical treatments, past vaccinations and family history were not provided.  Concomitant medications were not reported, and concomitant vaccination included HPV VACCINE.  It was an actual medication error case due to Accidental occupational exposure to product and device issue (latency: same day).  At the time of reporting, the patient experienced no adverse event.  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.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Device deployment issue, No adverse event, Underdose
Clinical narrative: patient received Menactra 0.4 mL (instead of 0.5 mL) with no reported adverse event; when patient retracted the syringe 0.1mL came back into the syringe with no reported adverse event; Initial information was received on 29-Jul-2021 regarding an unsolicited valid non-serious case received from a physician via Agency under reference number-0702910). This case involves a 11 year-old male patient who was vaccinated with 0.4 mL dose (instead of 0.5 mL) of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] due to while retracting the syringe 0.1 mL came back into the syringe (underdose) (Device deployment issue).  The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.   On 29-Jul-2021, the patient received 0.4 mL first dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6952AB  and expiry date 06-Sep-2022) via  an intramuscular route at the left deltoid for prophylactic vaccination.  It was reported that "The caller would like to know if the injection was valid. Caller asking if the MENACTRA dose would need to be re-administered since the patient will be receiving a booster as well. Caller states that the provider thinks that the patient will be fine since it was such a small volume that the patient did not receive".  It was a case of an actual medication error due to  vaccine underdose (latency was on same day).   It was also a case of device retraction issue.  At the time of report, no adverse event reported.   Outcome of event was 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.