chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: 3 days after vaccine I developed shingles on the back of my left thigh; This is a spontaneous report from a contactable consumer (patient) via COVAES. This 28-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER8734) via an unspecified route of administration in the left arm on 09Apr2021 at 11:15 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included ankylosing spondylitis, Sjogren's syndrome, fibromyalgia and interstitial cystitis, all from unknown dates and unknown if ongoing. The patient reported no allergies to medications, food or other products. Concomitant medications included ixekizumab (TALTZ), baclofen, and docusate sodium "plus," all from unspecified dates for unspecified indications. The patient had not received any other vaccines in the four weeks prior to the COVID vaccine. The patient reported that on 13Apr2021, 3 days after vaccination she developed shingles on the back of her left thigh. The event resulted in a doctor or other healthcare professional office/clinic visit. Treatment was received for the event and the treatment was reported as ongoing. The clinical outcome of 3 days after vaccine I developed shingles on the back of my left thigh was recovering. It was also reported that since vaccination the patient had not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: numbness in left side; pins and needles in left hand and back of left shoulder; This is a spontaneous report from a contactable consumer (patient). A 59-year-old patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EP6955; Expiration Date: 30Jun2021) via unspecified route single dose for COVID-19 immunization on 31Mar2021, at 58-year-old. The patient medical history was not reported. The patient's concomitant medications were not reported. In the last couple of days (Apr2021), she had been getting numbness in her left side. She reported this could be due to other medical issues. The patient described tingling that felt like pins and needles in her hand, only in her left hand, and a little bit in the back of her shoulder, behind edge of left shoulder. She ran her hand under warm water to try to make it go away.  She explained it's almost as if she slept on her arm and it was asleep. Outcome of the events was not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Vaccination site pain
Clinical narrative: Measured a 101 Fever; Severely sore arm around injection site upon waking up; Chills; This is a spontaneous report from a contactable consumer (patient). This 31-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER8733) via unspecified route on left arm single dose for COVID-19 immunization on 19Apr2021 01:15 PM, at 31-year-old. Medical history included: Metabolic syndrome/Moderate obesity. Concomitant medication included: lovastatin from 09Apr2021. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER8733) on right arm for COVID-19 immunization on 29Mar2021 12:30 PM, at 31-year-old. On 20Apr2021 04:30 AM, the patient had severely sore arm around injection site upon waking up, could not lift arm to put on jacket without significant pain, began taking ibuprofen (ADVIL). Chills set in during the day. Measured a 101 Fever with ibuprofen in system just after 5:00 PM. Outcome of the events was not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Feeling abnormal
Clinical narrative: strong menstrual cramps; Very bad; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route single dose for COVID-19 immunization on unknown date, at 55-year-old. Medical history and concomitant medication were not reported. The patient was very bad and had strong menstrual cramps. Outcome of the events was unknown.  No Follow-up attempts are needed. Information on lot/batch number cannot be obtained.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed
Clinical narrative: Delayed menstrual Cycle by 12 days; This is a spontaneous report from a non-contactable consumer (patient). A 31-year-old female patient received the first dose of BNT162B2 (lot number: EW0158), via an unspecified route of administration in left arm, on 13Apr2021 10:30 AM at single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient was not tested for COVID-19. No allergies to medications, food, or other products. No other medical history. No other vaccines were received within 4 weeks prior to the COVID vaccine. No list of any other medications the patient received within 2 weeks of vaccination. The patient's medical history was none. Concomitant medications were not reported. The patient experienced delayed menstrual Cycle by 12 days on 13Apr2021. No treatment was received. The outcome of the event was recovered.  No follow-up attempts are possible. No further information is expected
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Headache, Malaise, Pain, Pyrexia
Clinical narrative: I was partially blind in both eyes; extreme headache; fever; pain; malaise; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 19-year-old female patient received BNT162B2(Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 via an unspecified route of administration, administered in left arm, at age 19 years, on 12Apr2021 14:00 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for COVID-19 immunisation. Medical history included seasonal asthma from an unknown date and unknown if ongoing and taking birth control medications in 2 weeks. Patient had no known allergies. Patient did not have COVID prior to vaccination. The patient's concomitant medications were not reported. Patient had not had other vaccine in 4 weeks. Patient received vaccine on 12Apr2021 14:00. Six hours later (12Apr2021 20:00), she experienced extreme headache, fever, pain, malaise that lasted through Monday night, Tuesday, and early Wednesday morning (14Apr2021). Fever broke early Wednesday morning and when she woke up later in the morning, She was partially blind in both eyes. All other symptoms were gone. COVID was not tested post vaccination. Treatment was received for the events by ER, personal physician, opthamologist. AE resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. Patient had not recovered from partially blind; while recovered for all other events on 14Apr2021.  Information on the lot/batch number has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Anger, Blood test, Cerebral disorder, Flushing, Hallucination, auditory
Clinical narrative: No sleep for two weeks straight; hostile; Angry; could not turn off her brain; whispering to herself all day/all night; monkey chatter in head; had a flushed face; This is a spontaneous report from a contactable consumer. A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose at the age of 46-years-old via an unspecified route of administration, administered in arm left on 25Feb2021 (Batch/Lot Number: EL 9264) as 2nd dose, single for covid-19 immunisation. Medical history included Pervasive Developmental Delay (on the autism spectrum), penicillin allergy, shellfish allergy from an unknown date and unknown if ongoing. Concomitant medication included fexofenadine hydrochloride (ALLEGRA) taken for an unspecified indication, start and stop date were not reported and multivitamins. The patient previously took ceftin and ceclor and experienced allergies. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 46-years-old on 04Feb2021 (lot number EL 3302) administered in left arm for covid-19 immunisation and no adverse effect was experienced. It was reported that after Pfizer vaccine #2, the patient immediately had a flushed face on 25Feb2021 which disappeared by the next day. The following week on 04Mar2021, the patient was hostile/angry/and could not turn off her brain; she was whispering to herself all day/all night called it "monkey chatter" in her head. There was no sleep for two weeks straight. The reporter called their gynecologist for bloodwork, thinking it could be hormonal, perimenopause; it was not. They called the psychiatrist and counselor for guidance and was recommended Seroquel, to stop the chatter in her head, and to help her sleep. They visited their family physician, who prescribed the medication, 25 mg for bedtime. The patient is finally becoming more like herself, pleasant, no whispering to herself, no monkey chatter in her head, and able to sleep at night with the support of the Seroquel. The patient underwent lab tests and procedures which included blood test: unknown results on an unspecified date. The patient recovered from flushed face on 26Feb2021, and was recovering from the other events.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Hostility, Insomnia, Soliloquy
Clinical narrative: No sleep for two weeks straight; hostile; Angry; could not turn off her brain; whispering to herself all day/all night; monkey chatter in head; had a flushed face; This is a spontaneous report from a contactable consumer. A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose at the age of 46-years-old via an unspecified route of administration, administered in arm left on 25Feb2021 (Batch/Lot Number: EL 9264) as 2nd dose, single for covid-19 immunisation. Medical history included Pervasive Developmental Delay (on the autism spectrum), penicillin allergy, shellfish allergy from an unknown date and unknown if ongoing. Concomitant medication included fexofenadine hydrochloride (ALLEGRA) taken for an unspecified indication, start and stop date were not reported and multivitamins. The patient previously took ceftin and ceclor and experienced allergies. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 46-years-old on 04Feb2021 (lot number EL 3302) administered in left arm for covid-19 immunisation and no adverse effect was experienced. It was reported that after Pfizer vaccine #2, the patient immediately had a flushed face on 25Feb2021 which disappeared by the next day. The following week on 04Mar2021, the patient was hostile/angry/and could not turn off her brain; she was whispering to herself all day/all night called it "monkey chatter" in her head. There was no sleep for two weeks straight. The reporter called their gynecologist for bloodwork, thinking it could be hormonal, perimenopause; it was not. They called the psychiatrist and counselor for guidance and was recommended Seroquel, to stop the chatter in her head, and to help her sleep. They visited their family physician, who prescribed the medication, 25 mg for bedtime. The patient is finally becoming more like herself, pleasant, no whispering to herself, no monkey chatter in her head, and able to sleep at night with the support of the Seroquel. The patient underwent lab tests and procedures which included blood test: unknown results on an unspecified date. The patient recovered from flushed face on 26Feb2021, and was recovering from the other events.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pneumonia, Product supply issue
Clinical narrative: a touch of Pneumonia; still trying to get the second shot, and it's been 8 weeks and 3 days; still trying to get the second shot, and it's been 8 weeks and 3 days; This is a spontaneous report from a non-contactable consumer (patient's daughter) via Medical Information team. An 88-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 02Mar2021 at the age of 87 years old (Batch/Lot number was not reported) as the 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient had a touch of pneumonia, used inhalers, and cleared up. The patient was hospitalized for the event "a touch of pneumonia" on an unspecified date. The reporter stated that they were still trying to get the second shot, and it's been 8 weeks and 3 days. The reporter was asking if there would be worse side effects after getting 3 doses, if they did get the second dose as a first dose. The reporter was referred to their doctor or health care provider for further guidance, since they were the most familiar with their medical condition. The patient recovered from the event "a touch of pneumonia" on an unspecified date in 2021. The reporter stated that the pneumonia did not have anything to do with the shot she got, but it was after the first dose of the Pfizer vaccine.  No follow-up attempts are possible, information about batch/lot number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the event of pneumonia.  The reported event likely represent intercurrent medical condition. There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Sudden hearing loss
Clinical narrative: Sudden hearing loss in both ears 5 days after 2nd vaccination.; inflammation; This is a spontaneous report from a non-contactable consumer (patient). A 46-year-old non-pregnant female patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), dose 2 at vaccination age of 46-year-old via an unspecified route of administration in the right arm on 29Apr2021 09:30 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. Medical history included meniere's disease. The patient has no known allergies. The patient was not diagnosed with Covid-19 prior to vaccination. The patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE) at vaccination age of 46-year-old on 09Apr2021 at 10:30 AM in the left arm for Covid-19 immunisation. Concomitant medications included cetirizine hydrochloride (ZYRTEC); and ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE), both indications and therapy dates were not reported. The patient did not have other vaccine in four weeks. The patient received the vaccine in a doctor's office/urgent care. On 04May2021 07:30 AM, the patient experienced sudden hearing loss in both ears 5 days after 2nd vaccination. The event resulted in doctor or other healthcare professional office/clinic visit and received the treatment of steroid to relieve inflammation (04May2021 07:30 AM). The patient has not been tested post vaccination. The outcome of the event sudden hearing loss was recovering while the outcome of the other event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: they got second shot on 16Mar2021. 5 days later, on 21Mar2021, they both tested positive for Covid-19/came down with symptoms on 21Mar2021; tested positive for Covid-19/came down with symptoms on 21Mar2021; This is a spontaneous report from a contactable consumer (patient). This consumer reported same events for him and his wife. This is the first of two reports.  An 84-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 23Feb2021 (Batch/Lot Number: EN6203) as 1st dose, single and via an unspecified route of administration, administered in Arm Left on 16Mar2021 (Batch/Lot Number: EN6204) as 2nd dose, single for covid-19 immunization. The patient has no medical history and concomitant medications. The patient and his wife both received the first dose of the Pfizer Covid 19 shot on 23Feb2021 and they got the second shot on 16Mar2021. 5 days later, on 21Mar2021, they both tested positive for Covid-19. The patient clarified that they came down with symptoms on 21Mar2021, then tested positive on 22Mar2021. The patient did not get over the Covid symptoms for a good solid 4 weeks, but thinks he is mostly recovered. The outcome of the events was recovering.  Information about Lot/Batch number can be obtained. Additional information has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021505937 Same reporter/drug/AE, different patient
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Seizure, Syncope, Tremor, Vital signs measurement
Clinical narrative: Fainted; Didn't know if it was a convulsion or a seizure; Shaking; was very anxious; This is a spontaneous report from two contactable pharmacists. A 16-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0167, expiry date: Aug2021), via an unspecified route of administration, administered in the left deltoid, on 30Apr2021 15:30, as 1st dose, single, for COVID-19 immunisation, at a pharmacy/drug store. There were no medical history and concomitant medications. On 30Apr2021 15:30, the patient received the first dose of the COVID-19 vaccine and was very anxious. She wanted her mom to be present. On the same day, 30Apr2021 15:35, five minutes later, the patient was shaking, and she fainted. The reporter did not know if she was having a convulsion or a seizure. A few minutes later, the patient was sitting and becoming more alert. The patient was given water and one dose of Benadryl. The patient's vital signs were checked (unknown result). The reporter talked to the patient's mother and contacted the patient's pediatrician. The events resulted to emergency room and physician's office visits. Later in the evening, the reporter followed up with the mother and she confirmed that the patient was doing well and better. The mother asked the reporter if the patient should get the second dose of the COVID-19 vaccine. The outcome of the events fainted, shaking,  "didn't know if it was a convulsion or a seizure" and "was very anxious" was recovering. The reporter assessed the events fainted, shaking,  "didn't know if it was a convulsion or a seizure" as serious (medically significant). The reporter considered that BNT162B2 has a causal effect to the adverse events.  Follow-up (18May2021: New information received from a contactable pharmacist includes: reporter information, lab data, suspect drug details (vaccination site and vaccination time), event details (onset time provided, outcome updated to recovering, causality and seriousness assessment provided).  Follow up attempts are completed. No further information is expected.; Sender's Comments: Based on the available information, and on a reportedly closed temporal association, the company assessed that a reasonable possibility could not be excluded that the reported events (fainted;  didn't know if it was a convulsion or a seizure) were related to the suspect product BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE). The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Rash pruritic
Clinical narrative: rash all over the upper body and upper leg, its very itchy; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EN 6293) via an unspecified route of administration on 02Mar2021 (at the age of 69-years-old) as a single dose for COVID-19 immunization. Medical history included blood pressure and cholesterol. Concomitant medications included losartan for blood pressure and atorvastatin for cholesterol. On an unspecified date in Mar2021, about a week after the second vaccination, the patient experienced a rash all over the upper body and upper leg, which was very itchy. The patient went to four doctors and a dermatologist and nobody knew what it was. The patient was treated for the event with a steroid, prednisone, for a month and a steroid cream, mometasone. The event was not getting better, not going away. The patient had blood work "last week", with pending results. The clinical outcome of "rash all over the upper body and upper leg, its very itchy" was not resolved.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blister, Rash pruritic
Clinical narrative: rash all over the upper body and upper leg, its very itchy; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EN 6293) via an unspecified route of administration on 02Mar2021 (at the age of 69-years-old) as a single dose for COVID-19 immunization. Medical history included blood pressure and cholesterol. Concomitant medications included losartan for blood pressure and atorvastatin for cholesterol. On an unspecified date in Mar2021, about a week after the second vaccination, the patient experienced a rash all over the upper body and upper leg, which was very itchy. The patient went to four doctors and a dermatologist and nobody knew what it was. The patient was treated for the event with a steroid, prednisone, for a month and a steroid cream, mometasone. The event was not getting better, not going away. The patient had blood work "last week", with pending results. The clinical outcome of "rash all over the upper body and upper leg, its very itchy" was not resolved.
Sex: M
Vaccine: COVID19
Symptoms: Ankylosing spondylitis
Clinical narrative: the patient had had been having flares. He experiences it in his wrists, shoulders, GI, and spine; This is a spontaneous report from a contactable consumer. A 49-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history included ongoing ankylosing spondylitis. Concomitant medication included etanercept (ENBREL, Solution for injection in pre-filled pen) taken for ankylosing spondylitis. On an unknown date, the patient took covid vaccine, since he had the covid vaccine, the patient had had been having flares (ankylosing spondylitis). He experienced it in his wrists, shoulders, GI, and spine. The action taken in response to the event for concomitant drug etanercept was unknown. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: sick; Based on information previously received, the case was classified as valid as suspect was coded to Influenza vaccine  Initial information was received on 12-Oct-2020 regarding an unsolicited non-valid non-serious case from a consumer/non-health care professional (patient) via social media.  This case involves a male patient (age unspecified) who was sick (illness), after receiving INFLUENZA VACCINE  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination  On an unknown date, the patient was sick (illness) (unknown latency, non-serious event) following the administration of INFLUENZA VACCINE. Every time he was ordered to get the shot, he got sick. Since he stopped getting it, he did not get sick from flu. He was not going to get the shot again.  No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case
Age: 0.25
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: The patient was administered expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse via Medical Information (Reference number-00578878) and transmitted to Sanofi on 27-Apr-2021.  This case involves a three month old female patient who was administered a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Lot Number:U6395AA, Expiration Date: 24-Apr-2021; Lot Number: UJ162AB, Expiration Date : 24-Apr-2021) via intramuscular route in unknown administration site for prophylactic vaccination on 27-Apr-2021 (expired product administered).  Medical history, medical treatment(s), past vaccination(s), concomitant medications and family history were not provided.  It was a case of an actual medication error due to expired vaccine used (latency same day).  The reporter stated the expiration date was read incorrectly. The reporter wanted to know if the vaccine was still valid and what needed to be done going forward. Also, the reporter mentioned they came to the health department for the vaccines and this was the only one she has had.  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 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: 18.0
Sex: M
Vaccine: TYP
Symptoms: Expired product administered
Clinical narrative: received an expired Typhim vaccine with no reported adverse event; Initial information received on 05-May-2021 regarding an unsolicited valid non-serious case received from a other Healthcare Professional.  This case involves an 18 year old male patient who received an expired dose of 0.5 ml of TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] (lot R1B743M and expiry date: 23-Mar-2021) (Injection) (Frequency: Once) via an intramuscular route in the right arm for prophylactic vaccination on 24-Apr-2021 (expired product administered).   Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included INFLUENZA VACCINE (INFLUENZA VACCINE) and TETANUS VACCINE (TETANUS VACCINE).  It was a case of actual medication error due to expired vaccine used (latency on 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.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered, Medication error
Clinical narrative: A patient received an expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00592591) and transmitted to Sanofi on 07-May-2021.  This case involves a 12-year-old female patient who received an expired 0.5 mL dose of  DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot C5577AA and expiry date: 20-Feb-2021) via an intramuscular route in the deltoid for prophylactic vaccination on 07-May-2021 (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) for prophylactic vaccination and ALTHAEA OFFICINALIS ROOT, CINNAMOMUM CAMPHORA ESSENTIAL OIL, CITRUS AURANTIUM OIL, EUCALYPTUS GLOBULUS LEAF ESSENTIAL OIL, MENTHA X PIPERITA ESSENTIAL OIL (GARDISIL).  The medical assistant (MA) would like to know the efficacy of ADACEL past the expiration date.  This was a case of actual medication error due to expired vaccine used (latency same day).  At the 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 holders compliance with the requirements set out in 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: 0.58
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: 07 month old female patient administered expired dose of Pentacel, no AE; Initial information received on 11-May-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 7 months old female patient (reported that 7 months, 1 week, and 3 days) who was administered expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (expired product administered).  Past vaccination included PEDIARIX.  Medical history, medical treatment and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation.  On 04-May-2021, the patient received a 0.5 ml first dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ163AA and expiry date: 03-May-2021) (Frequency once) via an  intramuscular route in the left thigh for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency on same day).  It was also reported that the caller stated that PENTACEL was administered to a patient 1 day after the expiration date. The caller would like to know what the protocol is for this issue. Caller asking how to proceed if an expired Pentacel was given to a patient.  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.
Age: 2.0
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, Medication error
Clinical narrative: A patient received an expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00596556) and transmitted to Sanofi on 11-May-2021.  This case involves a two-year-old female patient who received an expired 0.5 mL dose of HIB (PRP/T) VACCINE [ACT-HIB] (lot UJ178AA and expiry date: 04-May-2021) via an intramuscular route in the left thigh for prophylactic vaccination on 11-May-2021 (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   This was a case of actual medication error due to expired vaccine used (latency same day).  At the time of reporting, no adverse event was reported.  The reporter requested guidance on how to proceed.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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: U
Vaccine: MNQ
Symptoms: Expired product administered, Medication error
Clinical narrative: patient inadvertently received an expired dose of MENACTRA, with no AE; Initial information received on 11-May-2021 regarding an unsolicited valid non-serious case from a pharmacist via Media Information (reference number ).  This case involves a patient (unknown gender and age) who inadvertently received an expired dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (total, 1x, lot number not reported and expiration date: 23-Feb-2021) via unknown route in an unknown administration site for prophylactic vaccination on 04-May-2021 (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   It was an actual medication error due to expired vaccine used (same day latency).  It was also reported that smart scripts was not completed as caller had limited data available to report. Caller was advised to call back to provide patient and vaccine data. Caller was with the question on the safety and efficacy of the expired dose.   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: M
Vaccine: DT
Symptoms: Medication error, No adverse event, Product storage error
Clinical narrative: DT went down to 31F and after going down the temperature was turned up for the refrigerator documented as being in range at 39 degrees F and at 35 degrees F but was then administered with no reported adverse event; Initial information received on 12-May-2021 regarding an unsolicited valid non-serious case from other health professional (Inquiry number: 00598066).  It was reported that an unknown age male patient received DIPHTHERIA AND TETANUS TOXOIDS produced by unknown manufacturer (lot number: C5733AA, expiry date not reported) which  went down to 31 Fahrenheit and after going down the temperature was turned up for the refrigerator documented as being in range at 39 degrees Fahrenheit and at 35 degrees Fahrenheit but was then administered on 09-Apr-2021 via an unknown route at an unknown administration site for prophylactic vaccination (product storage error temperature too low).  It was a case of actual medication error due to product storage error temperature too low.  At the time of report, no adverse event 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 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: 1.67
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: the liquid portion was not used; the powder portion was mixed with sterile water; aside from the patient not receiving the DTaP-IPV portion with no AE; Initial information received on 12-May-2021 regarding an unsolicited valid non-serious case from other health professional (Inquiry number: 00598239).  It was reported that a 20 month old female patient received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number: lot UJ339AAA, expiry date: 07-May-2021) (Suspension For Injection) where the liquid portion was not used, the powder portion was mixed with sterile water; aside from the patient not receiving the dtap-ipv portion on 04-May-2021 via intramuscular route at an unknown administration site for prophylactic vaccination (product preparation issue).  It was a case of actual medication error due to Inappropriate reconstitution technique.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR).  At the time of report, no adverse event 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 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: FLUX
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case from was retrieved on 13-May-2021 from other non-health professional (consumer) via Communication (reference number: SEQW21-01316) and concerned unknown age, male patient.  The patient's medical history and concomitant medications were not reported.   On an unknown date, the patient was vaccinated with influenza virus vaccines polyvalent (brand not specified; dose, anatomical location, indication and route of administration: not reported). The batch number was not reported.  On an unknown date, unknown amount of time after receiving influenza virus vaccines polyvalent, the patient experienced sore arm, reported as no issues other than a sore arm.  The outcome of the event was not reported.  The reporter did not provide causality assessment.   The case is linked to case 202102436 (the same patient).  Company comment: A male patient of an unspecified age was vaccinated with influenza virus vaccines polyvalent. An unknown amount of time after receiving influenza virus vaccines polyvalent, the patient experienced sore arm. Causal role of the suspect vaccine is assessed as possibly related.; Sender's Comments: A male patient of an unspecified age was vaccinated with influenza virus vaccines polyvalent. An unknown amount of time after receiving influenza virus vaccines polyvalent, the patient experienced sore arm. Causal role of the suspect vaccine is assessed as possibly related.
Age: 39.0
Sex: M
Vaccine: FLU4
Symptoms: Facial pain, Hypoaesthesia, Pain in extremity, Tenderness
Clinical narrative: Face on the side of the injection was noticeably numb with a dull ache feeling; Face on the side of the injection was noticeably numb with a dull ache feeling; Face on the side of the injection was noticeably numb with a dull ache feeling; Cheek and jaw feeling tight and numb; Sensitivity to touch; This spontaneous case was received on 13-May-2021 from other non-health professional (consumer)(reference number: SEQW21-01316) and concerned 39-year-old, male patient.  The patient's medical history and concomitant medications were not reported. The patient received flu vaccines in the past with no issues other than a sore arm (see case 202102435).   On 28-Sep-2020 at 03:00 p.m., the patient was vaccinated with Afluria Quadrivalent (influenza vaccine; dose: 0.5 ml, anatomical location and route of administration: not reported) for influenza prophylaxis. The batch number reported was P100229091 and expiry date 25-May-2021.  On the same day, within an hour after receiving Afluria Quadrivalent, the patient's face on the side of the injection was noticeably numb with a dull ache feeling. The feeling was similar to getting Novacaine (procaine) at the dentist office with his cheek and jaw feeling tight and numb. Also, he had sensitivity to touch and did not experience a rash or any swelling. Nurses recommended the patient to monitor and contact medical attention if symptoms got worse. This same feeling continued until the patient woke up the next morning.   On 29-Sep-2020, the patient recovered from the events and had been fine since then.  The reporter did not provide causality assessment.   The case was assessed as non-serious.   The case is linked to case 202102435 (the same patient).  Company comment: A 39-year-old, male patient was vaccinated with Afluria Quadrivalent. On the same day, within an hour after receiving Afluria Quadrivalent, the patient's face on the side of the injection was noticeably numb with a dull ache feeling. Reportedly, the feeling was similar to getting Novacaine (procaine) at the dentist office with his cheek and jaw feeling tight and numb. The patient had sensitivity to touch. Based on plausible chronology and no alternative aetiology provided, causality is assessed as possibly related for all events.; Sender's Comments: A 39-year-old, male patient was vaccinated with Afluria Quadrivalent. On the same day, within an hour after receiving Afluria Quadrivalent, the patient's face on the side of the injection was noticeably numb with a dull ache feeling. Reportedly, the feeling was similar to getting Novacaine (procaine) at the dentist office with his cheek and jaw feeling tight and numb. The patient had sensitivity to touch. Based on plausible chronology and no alternative aetiology provided, causality is assessed as possibly related for all events.
Sex: U
Vaccine: HEPA, VARCEL
Symptoms: Product storage error
Clinical narrative: No signs or symptoms reported.; temperature excursion on VARlVAX - VAQTA that was administered; Information has been received from a medical assistant reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On 22-APR-2021, the patient was vaccinated with an improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) lot#T017687, expiration date 21-MAY-2022 (dose and route of administration were not reported) and with hepatitis A vaccine, inactivated (VAQTA) lot#T023913, expiration date 31-MAR-2022 (dose and route of administration were not reported). Both vaccines for prophylaxis.   On an unknown date, varicella virus vaccine live (Oka/Merck) (VARIVAX) underwent a temperature excursion between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 1 hour and 45 minutes; between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 2 hours and 30 minutes. On an unknown date, hepatitis A vaccine, inactivated (VAQTA) underwent a temperature excursion above 47 degrees Fahrenheit for 2 hours. No previous temperature excursion. The call was not placed due to a digital data logger.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA007341: US-009507513-2105USA004334:
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events reported; Caller reporting the administration of expired ROTATEQ; This spontaneous report as received from a other referring to a patient of unknown age and gender. The patient's medical history, previous drug reactions or allergies, and concomitant medications were not reported.     On 18-MAY-2021, the patient was vaccinated with ran expired dose (expired product administered) of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at a dose of 2 milliliter (mL) for prophylaxis (strength, route of administration, and anatomical location were not reported; lot # 1661000 had been verified to be a valid number; expiration date 13-MAY-2021). No additional adverse events reported.
Sex: U
Vaccine: HEPA, VARCEL
Symptoms: Product storage error
Clinical narrative: No signs or symptoms reported.; temperature excursion on VARlVAX - VAQTA that was administered; Information has been received from a medical assistant reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On 22-APR-2021, the patient was vaccinated with an improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) lot#T017687, expiration date 21-MAY-2022 (dose and route of administration were not reported) and with hepatitis A vaccine, inactivated (VAQTA) lot#T023913, expiration date 31-MAR-2022 (dose and route of administration were not reported). Both vaccines for prophylaxis.   On an unknown date, varicella virus vaccine live (Oka/Merck) (VARIVAX) underwent a temperature excursion between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 1 hour and 45 minutes; between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 2 hours and 30 minutes. On an unknown date, hepatitis A vaccine, inactivated (VAQTA) underwent a temperature excursion above 47 degrees Fahrenheit for 2 hours. No previous temperature excursion. The call was not placed due to a digital data logger.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.  deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA007341: US-009507513-2104USA007215: