chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Retching
Clinical narrative: dry heaves; felt tired; This is a spontaneous report received from a contactable reporter (Consumer) for a Pfizer sponsored program. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 03Mar2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RETCHING (non-serious), outcome "unknown", described as "dry heaves"; FATIGUE (non-serious), outcome "unknown", described as "felt tired". Additional information: The second dose is scheduled on 24Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: higher blood pressure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (first dose), for COVID-19 immunisation. The following information was reported: HYPERTENSION (non-serious), outcome "unknown", described as "higher blood pressure".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Gout
Clinical narrative: flare up of gout; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: GOUT (non-serious), outcome "unknown", described as "flare up of gout". Additional information: She wanted to know how to reschedule second appointment. She has a flare up of gout (severe form of arthritis). So she couldn't make it to her second appointment. Clarified she has had arthritis all her life.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03Mar2021 10:30 (Lot number: EN6198) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Type 2 diabetes mellitus" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (dose 1, single; time: 10:00am; site: left arm), administration date: 10Feb2021, for COVID-19 immunization, reaction(s): "Soreness". The following information was reported: HEADACHE (non-serious) with onset 05Mar2021 08:00, outcome "recovered" (Mar2021), described as "Headache". Therapeutic measures were not taken as a result of headache.  Additional information: The patient did not receive other vaccine within 4 weeks of the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient has no known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperaesthesia
Clinical narrative: sensation or sensitivity of the tenderness where he had shingles before, on the left side, left abdomen area; This is a spontaneous report received from contactable reporter (consumer, patient's wife).  A 75 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), administered in arm left, administration date 04Mar2021 at 10:15 (Batch/Lot number and Expiration date: unknown) at the age of 75 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Thyroid disorder" (unspecified if ongoing); "shingles", start date: 2019 (unspecified if ongoing). The patient took concomitant medications. There were no additional vaccines administered on same date of the Pfizer vaccine. The patient had no prior vaccinations (within 4 weeks) and no adverse events. The patient has no family medical history relevant to the event. The following information was reported: HYPERAESTHESIA (non-serious) with onset 05Mar2021, outcome "recovered" (06Mar2021), described as "sensation or sensitivity of the tenderness where he had shingles before, on the left side, left abdomen area ". Course of event: Patient's wife stated that her husband had a reaction from the vaccine that started on 05Mar2021. She stated that he had shingles 2 years ago. After the shot, he had the sensation or sensitivity of the tenderness where he had shingles before, on the left side, left abdomen area and it was gone by 06Mar2021. The event started in the evening. Reporter stated that the patient takes thyroid medication, but it doesn't have to do with this, no details provided. The event did not require a visit to the Emergency Room and physician office. The patient had no relevant tests.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, Increased insulin requirement
Clinical narrative: increased insulin needs (basal); decreased appetite; diarrhea; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 05Mar2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "T1D" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INCREASED INSULIN REQUIREMENT (non-serious), outcome "not recovered", described as "increased insulin needs (basal)"; DECREASED APPETITE (non-serious), outcome "unknown", described as "decreased appetite"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea". Additional information: Increased insulin needs lasted for approx 72 hours and has not subsided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: her arms little bit hurt when she touch it.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 93 year-old female patient received bnt162b2 (BNT162B2), administration date 09Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "her arms little bit hurt when she touch it.".  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, Headache, Nausea
Clinical narrative: Complete exhaustion/Tired; Headache; Nauseated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 93 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Complete exhaustion/Tired"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; NAUSEA (non-serious), outcome "unknown", described as "Nauseated". Therapeutic measures were taken as a result of headache.  Additional information: After her 2nd shot, the patient felt absolutely nothing. But on the 4th day after the 2nd shot, she had complete exhaustion for 15 mins. On the 6th day after the 2nd shot, the patient woke up with headache and was nauseated. She took medicine for headache and she woke up slightly tired. She just hopes that the vaccine worked, and she asked if she should get an antibody test.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: have a headache from the base of my neck up; felt nauseous; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "not recovered", described as "have a headache from the base of my neck up"; NAUSEA (non-serious), outcome "recovered", described as "felt nauseous". Additional information: nausea subsided at the end of the 15-minute wait at the vaccination clinic, but still has the headache.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: body aches pain; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Feb2021 08:00 (Lot number: EN6201) at the age of 44 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, lot number=EN9264, Administration time=3:00pm), administration date: 02Feb2021, when the patient was 44 years old, for COVID-19 immunization, reaction(s): "Blood pressure increased", "skin in the neck was burned", "Base BP: 105/110 over 65/70/ 85". The following information was reported: PAIN (non-serious) with onset Feb2021, outcome "recovered", described as "body aches pain"; FATIGUE (non-serious) with onset Feb2021, outcome "recovered", described as "fatigue". Therapeutic measures were taken as a result of pain, fatigue. Additional information: No reaction at the time of the second shot waited 1/2 hour post shot. Within 24-48 hrs., body aches pain, fatigue but no symptoms like for the 1st shot. Symptoms lasted 3days & took Tylenol/Motrin BID.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: Mild headache a day after receiving the Pfizer-BioNTech covid vaccine 2nd dose; nausea a day after receiving the Pfizer-BioNTech covid vaccine 2nd dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 45 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (first dose), for Covid-19 Immunisation. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Mild headache a day after receiving the Pfizer-BioNTech covid vaccine 2nd dose"; NAUSEA (non-serious), outcome "unknown", described as "nausea a day after receiving the Pfizer-BioNTech covid vaccine 2nd dose".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VITAMIN B12 [CYANOCOBALAMIN]. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm". Additional information: It was asked if it's okay to take the patient's monthly shot of vit b-12 or should she wait before taking it.  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 just hurt; She was tired; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 01882227.  A female patient received BNT162B2 (BNT162B2), administration date 02Mar2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm just hurt"; FATIGUE (non-serious), outcome "unknown", described as "She was tired". Additional information: The patient received her first dose of the Pfizer Covid-19 vaccine on 02Mar2021 and her arm "just hurt a little and she was tired, she took a nap at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 72.0
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Blood test, Fatigue, Mammogram, Pain
Clinical narrative: body ache; Very Tired; Upset Stomach; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 16Feb2021 18:00 (Lot number: EN9581) at the age of 72 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "IBS", start date: 2002 (ongoing), notes: ongoing; "Hysterectomy", start date: Jan1995, stop date: Jan1995; "Vertigo", start date: Feb2010 (ongoing), notes: Ongoing; "Seasonal Hay Fever", start date: 1968 (ongoing), notes: Ongoing; "Lumpectomy", start date: Sep1977, stop date: Dec1978. Concomitant medication(s) included: LACTAID taken for lactose intolerance; GAS X taken for irritable bowel syndrome, start date: 2005. Vaccination history included: Bnt162b2, administration date: 28Jan1202, for Covid-19 immunisation, reaction(s): "my upper arm began itching and was red and swollen/my arm where I had the shot swelled up and was red and was warm to the touch", "my upper arm began itching and was red and swollen/my arm where I had the shot swelled up and was red and was warm to the touch", "my upper arm began itching and was red and swollen/my arm where I had the shot swelled up and was red and was warm to the touch", "my upper arm began itching and was red and swollen/my arm where I had the shot swelled up and was red and was warm to the touch". The following information was reported: PAIN (non-serious) with onset 17Feb2021, outcome "recovered" (17Feb2021), described as "body ache"; FATIGUE (non-serious) with onset 17Feb2021, outcome "recovered" (17Feb2021), described as "Very Tired"; ABDOMINAL DISCOMFORT (non-serious) with onset 17Feb2021, outcome "recovered" (17Feb2021), described as "Upset Stomach". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm left, administration date 08Jan2021 at 14:15 (Batch/Lot number: unknown) at the age of 55 years as dose 1, single for COVID-19 immunisation. Family history included: "Allergies: Pollen", start date: 1996 (unspecified if ongoing); "Asthmatic", start date: 1996 (unspecified if ongoing); "Animal dander", start date: 1996 (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 08Jan2021 17:00, outcome "recovered" (29Jan2021), described as "Sore arm". Therapeutic measures were not taken as a result of pain in extremity.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache 5days following 1st vaccine; This is a spontaneous report from a contactable reporter (other healthcare professional). The reporter is the patient.  A 57-year-old female patient received the first dose of bnt162b2 ((PFIZER BIONTECH COVID-19 VACCINE)) intramuscular, administered in the left arm on 23Dec2020 (batch/lot number: EK5730) at the age of 57 years old, as DOSE 1, SINGLE for COVID-19 immunization. Relevant medical history included: "Endometrial PolyP", start date: 29Nov2012 (unspecified if ongoing), notes: with Laparoscopic Supracervical Hysterectomy; "Adenomyosis", start date: 29Nov2012 (unspecified if ongoing), notes: with Laparoscopic Supracervical Hysterectomy; "Laparoscopic Supracervical Hysterectomy" (unspecified if ongoing); "Intermittent A-Fib", stop date: 29Apr2014, notes: with successful A-Fib ablation; "A-Fib ablation" (unspecified if ongoing); "Hypothyroid", start date: 18Nov2019 (unspecified if ongoing), notes: Started oral Synthroid; "High blood pressure" (unspecified if ongoing). There was no family medical history relevant to the adverse event. Concomitant medication included: LISINOPRIL taken for hypertension. The following information was reported: HEADACHE (non-serious) with onset 28Dec2020, outcome "unknown" described as "headache 5days following 1st vaccine."  No follow-up attempts are possible. No further information is expected.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm the next day after the vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 83 year-old female patient received bnt162b2 (BNT162B2), administration date 31Jan2021 (Lot number: EL8982, Expiration Date: May2021) at the age of 83 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "slight heart problem" (unspecified if ongoing); "thyroid elevated" (unspecified if ongoing). There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 01Feb2021, outcome "unknown", described as "sore arm the next day after the vaccine".  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: She was just more tired than usual; Her arm wasn't very sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 04Mar2021 17:30 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Tylenol for headache. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunisation, reaction(s): "headache". The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "She was just more tired than usual"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Her arm wasn't very sore".  Additional information: Patient stated she read online that she shouldn't take TYLENOL before vaccine afterwards. But she did take TYLENOL before getting the vaccine. She wanted to know if that'll effect the vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: FLUX
Symptoms: COVID-19
Clinical narrative: fully vaccinated spent 5 days in the hospital with Covid; Initial information received on 16-Dec-2021 regarding an unsolicited valid serious case received from a consumer non health care professional (Under reference number: US-SA-SAC20211222000299).  This case involves Adult and unknown gender patient who experienced fully vaccinated spent 5 days in the hospital with covid (covid-19) after receiving INFLUENZA VACCINE. The patient's medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided.  It was unknown if the patient had any concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiry date not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a serious event fully vaccinated spent 5 days in the hospital with Covid (Covid-19) (unknown latency) following the administration of INFLUENZA VACCINE. The patient was hospitalized for this event.  It was unknown if the patient experienced any additional symptoms/ event.  It was unknown if there were lab data/results available  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome of the event was reported as unknown.  There was be no information on the batch number for this case; Sender's Comments: This case concerns a Adult and unknown gender patient who experienced covid-19 (Unknown latency) after vaccination with INFLUENZA VACCINE. The time to onset is Unknown. There is no further information regarding patient's medical condition at the time of vaccination and laboratory tests ruling out other alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Sex: M
Vaccine: FLUX
Symptoms: Sinusitis
Clinical narrative: This case is linked to case 2021SA425382(CLUSTER). This case involves adult male patient who experienced sinus infection (sinusitis) when received vaccine INFLUENZA VACCINE. The patient's medical history, past medical treatment, vaccination, concomitant medication 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 and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date the patient developed a non-serious sinus infection (sinusitis) (5 years) following the administration of INFLUENZA VACCINE. Laboratory details were not reported. It was not reported if the patient received a corrective treatment for the event. At the time of reporting, the outcome was unknown for the event (sinusitis). There will be no information available on the batch number for this case.
Sex: U
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Injection site pain, Pyrexia
Clinical narrative: This case involves child (an unknown age and gender) patient who had pain following injection (injection site pain) and fever (pyrexia), after receiving DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) [PREVNAR 13].  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number and expiry date: not reported) (suspension for injection) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient received a dose of suspect PREVNAR 13 not produced by Sanofi Pasteur (lot number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious pain following injection (injection site pain) and fever (pyrexia) (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE and PREVNAR 13.  It was reported that, Pentacel is generally given at the same time and is likely cause of fever.  The patient was treated with TYLENOL [PARACETAMOL] and ADVIL [IBUPROFEN] for fever.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At time of reporting, the outcome was unknown for all the reported events.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Flu; Initial information was received on 17-Dec-2021 regarding an unsolicited valid non-serious case from a Social Media via a consumer/non-health care professional.  This case involves a patient (unknown demographics) who had flu (influenza) after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "and so did I, yet a month later I got the flu!"  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, outcome of the event was unknown.  The reporter did not report the causality of event with suspect.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: know of people who have been sick for weeks for the flu shot; Initial information received on 19-Dec-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health care professional.  This case involves adult patient (unknown age and gender) who had know of people who have been sick for weeks for the flu shot (illness), after receiving INFLUENZA VACCINE.  The patient's medical history, medical treatment, vaccination, concomitant medication 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 and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious know of people who have been sick for weeks for the flu shot (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: MNQ
Symptoms: Medication error, Product storage error
Clinical narrative: The Highest temperature 72-73 Fahrenheit degrees. Total excursion time was for 5 1/2 hours with no AE; Initial information received on 13-Dec-2021 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves unknown gender patient for whom it was reported "the highest temperature 72-73 Fahrenheit degrees. total excursion time was for 5 1/2 hours" (product storage error) after receiving vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA]  The patient medical history, medical treatment(s), vaccination(s), concomitant medication, and family history were not provided.   On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [lot U7140BB, expiry date: 07-Nov-2022] via an unknown route in unknown administration site for prophylactic vaccination.  It was case of actual medication error due to product storage error [Latency: on the same day].  It was reported "Caller stated that she left the product out".  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: U
Vaccine: DTAP
Symptoms: Crying, Pyrexia
Clinical narrative: fever; crying for 3 hours; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional via Medical Information (MI) (Reference number- 00899754) and transmitted to Sanofi on 15-Dec-2021.  This case involves Child and unknown gender patient who had fever (pyrexia) and crying for 3 hours (crying) after receiving DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot C576b5A, expiry: 28-Aug-2022) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed non-serious fever (pyrexia) and crying for 3 hours (crying) (unknown latency) following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE.  It was reported "Secretary states that a child had a reaction and was crying for two hours and also had fever after receiving DAPTACEL. The doctor wanted to know what else can be given other than Daptacel. Caller states that she would have the doctor call back with adverse event (AE) information and receive recommendation."  No laboratory test was reported.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, outcome of the event was unknown.  The reporter did not report the causality of events with suspect.
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: the portion given was the diluent part of the vaccine with no reported adverse event; Initial information received on 17-Dec-2021 regarding an unsolicited valid non-serious case from a other health professional via Medical Information (MI) (Reference number- 00903542).  This case involves a six -month-old male patient who experienced the portion given was the diluent part of the vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (product preparation issue).  The patient past medical history, medical treatment, vaccination and family history were not provided.  On 17-Dec-2021, the patient received a third dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot U7013AA and expiry date: not reported, solution) (frequency: once) via intramuscular route in left leg for prophylactic vaccination.  It was reported "They would like to know what to do as the parents do not want to repeat the ActHib. The ActHIB was mixed with and caller states nothing. Clarified the portion given was the diluent part of the vaccine. Caller wanted to know if they could use the diluent for the COVID vaccine since she thinks it is 0.4 % sodium chloride to mix with the powder that is left?".  It was a case of actual medication error due to inappropriate reconstitution technique.  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: F
Vaccine: TYP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This case involves a 16 months old female patient whom TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] vaccine was inadvertently administered (product administered to patient of inappropriate age). The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 17-Dec-2021, the patient received a dose of suspect TYPHIM VI (0.5 ml, lot T1E371M and expiration date: 14-SEP-2022) via unknown route in an unknown administration site for prophylactic vaccination. It was an actual medication error due to Inappropriate age at vaccine administration 9same day latency). 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 the Directive 2001/83/EC and Module VI . 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: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Pentacel liquid portion administered without lyophilized component with no reported adverse event; Initial information received on 21-Dec-2021 regarding an unsolicited valid non-serious case from a other health professional via Agency (Reference number- 00907136).  This case involves an unknown age female patient who was vaccinated with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], (Product preparation issue).  The patient's past medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination.  It was an actual medication error case due to Product preparation issue (latency on same day).  It was reported Nurse practitioner reports patient was given Pentacel liquid portion without the lyophilized component.  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: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Client came to the facility to receive her 1st dose of the Covid19 Moderna vaccine. RN vaccinated the client in the left arm at 1424 with the Covid19 Moderna vaccine (Lot# 069H21A). However, RN inadvertently administered the incorrect dosage to the client. She administered a booster dose of 0.25 mL instead of a full dose of 0.5 mL. The error was discovered by RN while she was returning a participant form to the room, she noted that she had circled 1st Dose on the form specifically for Boosters. RN then notified Lead RN, immediately. Lead RN, spoke with RN and determined the client had only received 50% of the full dose required for dose 1 of the Covid19 Moderna series. After consulting, Clinical Nurse Lead, it was determined the client would need to return to the facility to receive another 0.25 mL injection of the Covid19 Moderna vaccine as soon as possible. Lead RN, called the client at 17:04 and left a message and attempted to call again at 1715. At 1819 the client's spouse, called  back. Lead RN, explained hat the client would need to return as soon as possible, then a medical consult with the County MD would dictate the amount of vaccine that the client would receive to be fully vaccinated. Client's spouse stated "I will bring my wife in first thing in the morning at 10:30 AM to be re-vaccinated". On 12/16/2021 at 10:30 the client had returned. Lead RN then called Clinical Nurse Lead to elevate case to MD, per the MD recommendation the client was to receive an addition 0.25 mL dose of Moderna to complete the first dose series. The client was taken to RN vaccination station, and RN administered 0.25 mL of the Covid19 Moderna vaccine (Lot# 069H21A) into the client's right arm at approximately 11:00 AM. Client was calm and well post vaccination. Afterward, the client was directed to the observation area to sit for 15 minutes. No issues were noted.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Muscular weakness, Myalgia
Clinical narrative: Reports myalgias, lower extremity weakness. Followed up with orthopaedics.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Lichen planus, Post herpetic neuralgia
Clinical narrative: Post herpetic neuralgia; Lichen Planus; Multiple outbreaks of herpes zoster; Information has been received from a lawyer regarding a case in litigation and refers to a male patient of unspecified age. Information about the patient's concurrent condition, concomitant medication and medical history was not provided. On an unknown date, the patient was inoculated with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date after vaccination, the patient suffered multiple outbreaks of herpes zoster, postherpetic neuralgia and lichen planus. As a result of these symptoms, he was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live(ZOSTAVAX) vaccine, the patient's symptoms had resulted in physical limitations not present prior to using this product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live(ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of this conduct, he suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of herpes zoster, postherpetic neuralgia and lichen planus was not recovered. The lawyer considered the events to be related to zoster vaccine live(ZOSTAVAX).   The events of herpes zoster, postherpetic neuralgia and lichen planus were assessed as disabled by the lawyer.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: had both shots Vax and still got them/Suspected vaccination failure; still got them, small area on back n chest; still in pain, extremely painful; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In September 2021, 3 months after receiving Shingles vaccine and unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: This case was reported by patient's wife. The age at vaccination was not reported. The patient had received Shingles shots and still got shingles and 3 months later patient was still in pain, since September 2021. The patient still had Shingles in small area on his back and chest and it was extremely painful. This case was considered as suspected vaccination failure since the details regarding completion of time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site nodule, Vaccination site warmth
Clinical narrative: Hugh knot the size of her hand at injection site; Feeling hot/feverish at injection site; Redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE NODULE (Hugh knot the size of her hand at injection site), VACCINATION SITE WARMTH (Feeling hot/feverish at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058H21A, 002C21A and 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced VACCINATION SITE NODULE (Hugh knot the size of her hand at injection site), VACCINATION SITE WARMTH (Feeling hot/feverish at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site). At the time of the report, VACCINATION SITE NODULE (Hugh knot the size of her hand at injection site), VACCINATION SITE WARMTH (Feeling hot/feverish at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided. No treatment medication was provided.
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: non-immunocompromised receiving full dose as third dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (non-immunocompromised receiving full dose as third dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included PREDNISOLONE SODIUM PHOSPHATE (PREDNISOLONE [PREDNISOLONE SODIUM PHOSPHATE]) for Rheumatoid arthritis.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (non-immunocompromised receiving full dose as third dose). At the time of the report, ACCIDENTAL OVERDOSE (non-immunocompromised receiving full dose as third dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient has taken prednisolone 7mg everyday for long time, greater than 3 months for rheumatoid arthritis.   No treatment medications were reported.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: they gave a 1st dose to a 16 years & 9 months old patient; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (they gave a 1st dose to a 16 years & 9 months old patient) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Dec-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (they gave a 1st dose to a 16 years & 9 months old patient). On 20-Dec-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (they gave a 1st dose to a 16 years & 9 months old patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported.
Sex: U
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: gave the patient a booster even though they just got a booster 2 weeks ago; This spontaneous case was reported by an other health care professional and describes the occurrence of EXTRA DOSE ADMINISTERED (gave the patient a booster even though they just got a booster 2 weeks ago) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In December 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Dec-2021, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Dec-2021, the patient experienced EXTRA DOSE ADMINISTERED (gave the patient a booster even though they just got a booster 2 weeks ago). On 22-Dec-2021, EXTRA DOSE ADMINISTERED (gave the patient a booster even though they just got a booster 2 weeks ago) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medications were provided.  The patient was administered with one half dose booster and one full dose booster of vaccine.