chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: never had any problems with flu until I took a flu shot. Had it twice in 3 weeks; Initial information regarding an unsolicited valid non-serious case received from a patient via social media on 11-Dec-2020.  This case involved patient with unknown demographic who experienced flu (Influenza) (I never had any problems with flu until I took a flu shot in 1965 with football team. Had it twice in 3 weeks), while he/she received influenza vaccine.  The patient's medical history, medical treatment(s), vaccination(s), family history and concomitants 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  On an unknown date, following the administration of influenza vaccine, patient developed flu (Influenza).  No laboratory data was provided.  It was not reported if the patient received any corrective treatment.  The event outcome was reported as unknown for influenza.  There will be no information about batch number.  No further relevant information was provided.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: really sick; Initial information received on 15-Dec-2020 regarding an unsolicited valid non-serious case received from a consumer via social media.  This case involved an unknown age patient who reported really sick (Illness), while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) 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 at an unknown administration site.  On an unknown date, (latency unknown) the patient developed a non-serious event of being really sick (illness) after administration of INFLUENZA VACCINE.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: Headache, Tiredness, arm soreness
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: Headache, Tiredness, arm soreness
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure abnormal, Dizziness, Heart rate abnormal, Tachycardia
Clinical narrative: Patient became slightly tachycardic (HR 145, BP 140/75) and light-headed.  Described as anxiety attack.  Patient laid down and feet were elevated and heart rate and blood pressure returned to normal.  Patient was observed for another 30 minutes and released
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Pain in extremity, Rhinorrhoea
Clinical narrative: Caller stated on 12/18/20 and on 12/19/20  she had some arm pain and nasal drainage. Caller stated that she went to doctor on 12/21/20  and was diagnosis with Cellulitis and was prescribed steroids and cefalexin for 7days x three times daily. Caller stated that physician does not recommend second injection. Vaers report completed over the phone.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Patient get really sick; Initial information was received on 15-Dec-2020 regarding an unsolicited valid non-serious case from a social media via consumer or non-health care professional (Patient).  This case involves patient [age and gender unspecified] who got really sick (illness), while patient received vaccine INFLUENZA VACCINE [Flu shot].  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 an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got really sick (illness) (non-serious) unknown latency following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for event.  There will be no information available on the batch number for this case.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Injection site pain
Clinical narrative: Headache, injection site soreness
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Nausea, Vomiting
Clinical narrative: Stomach pain, nausea, vomiting, diarrhea
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Nausea
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Flushing, Headache, Hyperhidrosis
Clinical narrative: Employee reported headache, flushing, and a sweaty feeling. He was taken to ED for evaluation and treatment.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Erythema, Flushing, Headache, Hyperhidrosis
Clinical narrative: Employee reported headache, flushing, and a sweaty feeling. He was taken to ED for evaluation and treatment.
Sex: U
Vaccine: FLUX
Symptoms: Fatigue, Pain
Clinical narrative: felt tired; achy; Initial information received on 16-Dec-2020 regarding an unsolicited valid non-serious social media case received from a consumer (patient).  This case involves a patient with an unknown demography who felt tired (fatigue) and achy (pain), while he/she received INFLUENZA VACCINE.  The patient's medical treatments, vaccinations, concomitant medications and family history were not provided.  At the time of the event, the patient had ongoing medical history of arthritis.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, (unknown latency) after administration of INFLUENZA VACCINE, patient felt tired (fatigue) and achy (pain).  The patient did not experienced these events this year when he/she had flu shot.   No laboratory data was provided.  It was not reported if the patient received any corrective treatment.  The events outcome was unknown, at the time of reporting.  There would be no information available on batch number for this case.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain lower, Chills, Headache, Nausea, Pain in extremity
Clinical narrative: 12/21/2020 3:00PM Abdominal  l quad pain, nausea sore arm, headache, fever 101.9 with chills -- tylenol, ibuprofen some relief. 12/22/20 tylenol in  AM-- low grade fever persists with headache, some nausea.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 12/21/2020 3:00PM Abdominal  l quad pain, nausea sore arm, headache, fever 101.9 with chills -- tylenol, ibuprofen some relief. 12/22/20 tylenol in  AM-- low grade fever persists with headache, some nausea.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Histamine intolerance, Pruritus, Rhinorrhoea, Upper-airway cough syndrome
Clinical narrative: Histamine reaction 2 hours after injection and still present at 15 hours from injection: itchy runny nose, post-nasal drip, mild itchiness around body (torso, arms, ears, head), Left ear pain on side of injection . Took 50mg benadryl at bedtime and this morning took 10mg claritin and 10mg syngulair.
Sex: U
Vaccine: FLUX, PPV
Symptoms: Influenza, Pneumonia
Clinical narrative: Took a pneumonia shot and spent 10 days in the hospital with pneumonia; patient got the flu.; Initial information received on 17-Dec-2020 regarding an unsolicited valid serious social media case received from a consumer.  This case involves a patient with unknown demographics who spent 10 days in the hospital with pneumonia (pneumonia) and patient got the flu (influenza), while he/she received PNEUMOCOCCAL VACCINE and INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE and PNEUMOCOCCAL 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 spent 10 days in the hospital with pneumonia (pneumonia) and patient got the flu (influenza) (Unknown latency) following the administration of INFLUENZA VACCINE and PNEUMOCOCCAL VACCINE.  Pneumonia event was assessed as medically significant as per important medical event list. The patient was hospitalized. (hospitalization during 10 days).  Relevant laboratory data was not reported.   It was not reported if the patient received any corrective treatment.  The event outcome was Unknown.  There will be no information available on the batch number for this case.; Sender's Comments: This case involves a patient who had pneumonia and influenza, while he/she received PNEUMOCOCCAL VACCINE and INFLUENZA VACCINE produced by unknown manufacturer. Time to onset is unknown. Moreover, additional information on patients medical condition at the time of vaccination, concomitant medication and investigations ruling out other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Heart rate increased, Injection site erythema
Clinical narrative: Evening following receiving vaccine: Severe Dizziness, Chills, Body Ache, Increased Heart Rate (racing sensation). Following day: Minor/Noticeable Joint Pain throughout body (knees, shoulders, spine). Continuing symptoms: Minor Redness/Itchiness around injection site.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Pain
Clinical narrative: Evening following receiving vaccine: Severe Dizziness, Chills, Body Ache, Increased Heart Rate (racing sensation). Following day: Minor/Noticeable Joint Pain throughout body (knees, shoulders, spine). Continuing symptoms: Minor Redness/Itchiness around injection site.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Flu; Initial information was received on 18-Dec-2020 regarding an unsolicited valid non-serious case from a social media via consumer or non-health care professional (Patient).    This case involves patient [age and gender unspecified] who experienced flu (influenza), while patient received vaccine INFLUENZA VACCINE.  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 an unknown route at an unknown administration site.    On an unknown date, the patient developed a non-serious flu (influenza) unknown latency following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for event.  There will be no information available on the batch number for this case.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Na
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Palpitations, BP 113/78, HR 115 - treated with prone position, resolved at BP 122/91, HR 111
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Neuropathy peripheral
Clinical narrative: worsening peripheral neuropathy feet/legs/hands/arms
Age: 11.0
Sex: M
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received a dose of Ipol on 18th of November that had expired on the 9th of November 2020, No AE; Initial information received on 20-Nov-2020 regarding an unsolicited valid non-serious case from a physician.  This case involves a 11 years old male patient who was administered with 0.5 ml expired first dose of IPV POLIOMYELITIS VACCINE (INACTIVATED) (VERO)  [IPOL] (lot number- P1E701M and expiration date: 09-Nov-2020) via intramuscular route in right deltoid for prophylactic vaccination on 18th of November 2020 (Expired product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  This was an actual medication error due to expired vaccine used [latency was same day].  No laboratory data reported.  At the time of reporting, no adverse event was reported to the patient.  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: FLU4
Symptoms: Feeling abnormal, Malaise, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: he had malaise; had a fever of 103.6; Initial information regarding an unsolicited valid non-serious case was received from a consumer (patient) via Medical Information (Reference number- 00369207) and transmitted to Sanofi on 23-Nov-2020.  This case involves a 72 year old male patient who had a fever of 103.6 (pyrexia) and he had malaise (malaise), while he received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, medical treatments, vaccinations, concomitant medication and family history were not provided.   On an unknown date Thursday about a month and a half ago, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number unknown) via an unknown route in the left arm for prophylactic vaccinations.  On an unknown date, the patient felt bad, no cough and had a fever of 103.6 "for a day or two" (pyrexia) and the fourth day patient was fine. Patient wondered if he had Covid so had he had done 2 test that resulted as negative. Patient also mentioned that he had malaise but it was "financial".   It was not reported if the patient received any corrective treatment.  Event outcome was reported as Unknown for pyrexia.  There will be no information regarding the batch number for the case.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: the patient was administered ActHIB with sterile water instead of ActHIB diluent with no adverse event; Initial information regarding this unsolicited valid non-serious case received from the other health professional (medical assistant) via Global Medical Information (GMI) (Reference number- 00369951) and transmitted to Sanofi on 24-Nov-2020.  This case involves a patient with unknown demographics who received a dose of suspect HIB (PRP/T) VACCINE [ACT-HIB] (batch number: UJ351AA, expiry date: 09-Aug-2021) with sterile water instead of ACT-HIB diluent (product preparation issue), via an unknown route in unknown administration site for prophylactic vaccination on an unknown date.  Relevant medical history, past medical treatment, vaccination details, concomitant medications and family history were not provided.   It was a case of an actual medication error case due to wrong solution used in drug reconstitution (latency: same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report was 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 was 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 had contributed to or is to be held liable for the occurrence of this medication error.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a 58 year old patient was administered Fluzone Quadrivalent High Dose by a staff / No AE; a 58 years old patient was administered Fluzone Quadrivalent High Dose by a staff due to not paying attention/ No AE; Initial information regarding this unsolicited valid non-serious case received from the nurse via Medical Information (Reference number- 00370461) on 24-Nov-2020.  This case involves a 58-year-old male patient who received a 0.7 ml dose of FLUZONE HIGH-DOSE QUADRIVALENT (batch number and expiry date not reported) via an intramuscular route in an unknown administration site on 11-NOV-2020.    Medical history, past medical treatment, vaccination details and family history were not provided.  No other concomitant vaccines given.   It was a case of an actual medication error case due to inappropriate age at vaccine administration and it was a case of overdose (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.    There will be no information on the batch number for this case.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Pentacel was not reconstituted with HIB powder and only the liquid was administered DTap-IPV portion, No AE; Initial information regarding an unsolicited valid non-serious case was received from the Other Health Care Professional via Global Medical Information (GMI) (Reference number- 00370490) via phone via call center and transmitted to Sanofi on 24-Nov-2020.   This case involves a 6 months old female patient who received a 0.5 ml DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] which was not reconstituted with Haemophilus influenzae type B (HIB) powder and only the liquid was administered Diphtheria, Tetanus, Pertussis, Polio (DTAP-IPV) portion (batch number and expiry date not reported) via intramuscular route in unknown administration site for prophylactic vaccination on 09-Nov-2020 (product preparation issue).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE, PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR), INFLUENZA VACCINE (FLU SHOT) and HEPATITIS B VACCINE for prophylactic vaccination.  This was an actual medication error case due to inappropriate reconstitution technique (latency same day).   The caller is needing to know how to proceed since the HIB component was not given at this time. The caller was made aware of the Pentacel.com site and video.  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.   There will be no information on the batch number for this case.
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, Medication error, No adverse event
Clinical narrative: a patient has accidently administered a 2nd dose of vaccine without adverse event; Initial information regarding an unsolicited valid non-serious case was received from a consumer via Medical Information (Reference number- 00372235) and transmitted to Sanofi on 25-Nov-2020.  This case involves a 65 years old male patient who received QUADRIVALENT INFLUENZA VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT], (Extra dose administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication included pneumococcal vaccine polysacch 23V (Pneumovax 23).  The patient was given two doses of QUADRIVALENT INFLUENZA VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (Lot numbers: UJ500AA, UJ555AA) via an unknown route for prophylactic vaccination on two separate occasions. On the first visit on 30-Sep-2020, the patient was given 0.7 ml of the product in the left deltoid. No other vaccinations or medications were given on that visit. On 19-Nov-2020, the same patient was given 0.7 ml of the product in the right deltoid. It was reported that the patient had accidently administered a 2nd dose of vaccine (Extra dose administered).   It was a case of actual medication error due to Extra dose administered.  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.
Sex: M
Vaccine: BCG, FLU3
Symptoms: Myalgia, Pain
Clinical narrative: patient developed moderately severe myalgias out of the blue; Very mild soreness for a day; Initial information received on 27-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 77 years old male patient who moderately developed severe myalgias out of the blue (myalgia) and very mild soreness for a day (pain), while he received vaccines BCG VACCINE and INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE].  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were unknown.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient received a dose of suspect BCG 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 developed moderately severe myalgias out of the blue (myalgia) and very mild soreness for a day (pain) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED and BCG VACCINE.  Relevant laboratory data was not reported.  It was not reported if the patient received a corrective treatment.  The outcome was reported as Unknown for both events.  There will be no information available on the batch number for this case.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: 4 year old female patient inadvertently administered expired dose of QUADRACEL, no AE; Initial information received on 01-Dec-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a four year old female patient who was inadvertently vaccinated with an expired dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation.  On 30-Nov-2020, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot C5532AA and expiry date: 31-Oct-2020) via an intramuscular route for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency on same day).  Product used: used  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: 13.0
Sex: F
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: 13 year old female patient inadvertently administered expired dose of IPOL, no AE; Initial information received on 01-Dec-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 13 year old female patient who was inadvertently vaccinated with an expired dose of IPV (VERO) [IPOL] (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included INFLUENZA VACCINE INACT SPLIT 4V (FLUZONE QUADRIVALENT) for Immunisation; HEPATITIS A VACCINE (HEPATITIS A) for Immunisation; and HPV VACCINE (HPV VACCINE) for Immunisation.  On 01-Dec-2020, the patient received a 0.5 ml first dose of suspect IPV (VERO) (lot P1F491M and expiry date: 30-Nov-2020) via an intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency on same day).  Reporter relationship: HCP (health care professional), product used: used, first time product used: no and still using product: no  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: 50.0
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: a temperature excursion for GARDASIL 9, RECCOMBIV AX HB, PEDVAX HIB, ROTATEQ, and PNEUMOVAX 23 syringes,; This spontaneous report was received from a registered nurse and refers to a 50-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 02-DEC-2020, the patient was vaccinated with a one time dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) syringe (lot# was reported as T022297 but upon internal validation was established as not valid for pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), expiration date was reported as 26-MAR-2022; site and route of injection were not reported) for prophylaxis. Administered dose of vaccine underwent a temperature excursion of above 9 degrees Celsius (113.5 degrees Celsius) for 3 hours. There was no previous temperature excursion. Data logger was involved.
Sex: F
Vaccine: PPV
Symptoms: Chills, Influenza like illness
Clinical narrative: This spontaneous report was received from a female patient of unknown age, who was referring to herself. The patient had not medical history, concurrent conditions or concomitant medications. On 09-DEC-2020 at 4:00 pm, the patient was vaccinated with a 0.5 ml dose of PNEUMOVAX23 injection, once or as needed (site and route of administration, lot# and expiration date were not reported) for prevention of pneumococcal disease. On 11-DEC-2020, 26 hours after getting the vaccination, the patient woke up in the morning with chills and flu-like symptoms. She had no fever, fatigue and headache. The patient wanted to know if that was attributable to PNEUMOVAX23. No treatment was given for the event. No lab diagnostic tests were performed. The patient sought medical attention. The outcome of the event was not recovered. The relatedness between the event and PNEUMOVAX23 was
Sex: F
Vaccine: VARZOS
Symptoms: Adverse event, Injection site pain
Clinical narrative: That one hurt; Adverse event; This case was reported by a consumer and described the occurrence of injection site pain in a adult female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On 20th October 2017, the patient received the 1st dose of Shingles vaccine. On 21st October 2017, 1 days after receiving Shingles vaccine, the patient experienced injection site pain and adverse event. On an unknown date, the outcome of the injection site pain and adverse event were recovered/resolved.   The reporter considered the injection site pain and adverse event to be possibly related to Shingles vaccine.  Additional details were reported as follows: The age at the vaccination was not reported. The patient mentioned that once she had shingles and had to wait a couple of months before getting the vaccine. The patient told everyone else to get it but now it had been a year. The patient received vaccine in the other arm and she felt like ow, and that one hurt and hit her with a few side effects the next day but said that she had done her part.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Pyrexia
Clinical narrative: light headache; low fever; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th November 2020, the patient received the 2nd dose of Shingrix. On 25th November 2020, less than a day after receiving Shingrix, the patient experienced headache and fever. On an unknown date, the outcome of the headache and fever were unknown.   It was unknown if the reporter considered the headache and fever to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as an adult as per the vaccine indication. The patient did not have these reactions after the first shot. The patient received Shingrix shot yesterday morning from the day of reporting. By evening, the patient had a light headache, and later a low fever.  The reporter wanted to know do have to worry about having Covid, or are these side effects common after shot two.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Gastrointestinal disorder, Headache, Myalgia
Clinical narrative: Myalgia; Fatigue; Shivering; Headache; GI symptoms; This case was reported by a other health professional via interactive digital media and described the occurrence of myalgia in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th November 2020, the patient received Shingrix. In November 2020, less than a day after receiving Shingrix, the patient experienced myalgia, fatigue, shivering, headache and gastrointestinal symptom nos. On an unknown date, the outcome of the myalgia, fatigue, shivering, headache and gastrointestinal symptom nos were not recovered/not resolved.   It was unknown if the reporter considered the myalgia, fatigue, shivering, headache and gastrointestinal symptom nos to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as an adult as per the vaccine indication. The patient complained of myalgia, fatigue, shivering, headache, and gastrointestinal symptoms and now persisting 9 days. The reporter wanted to know how long do these side effects last.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site mass, Injection site pain, Pain in extremity
Clinical narrative: injection site Soreness/ left arm continues to be sore; initially had a lump at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 48-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number 5P499, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th November 2020, the patient received Fluarix Tetra 2020-2021 season (intramuscular) and Fluarix Tetra Pre-Filled Syringe Device. In November 2020, less than 2 weeks after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced injection site pain and injection site lump. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the injection site lump was recovered/resolved.   It was unknown if the reporter considered the injection site pain and injection site lump to be related to Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received Fluarix Quadrivalent 2020-2021 season vaccine approximately two weeks before the time of reporting in left arm. The patient reported injection site soreness and she stated that she initially had a lump at the injection site, but it had dissipated. The patient's left arm continued to be sore. The patient was referred to her physician. The reporter consented to follow up.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: everytime I got a Flu Shot I got sicker; Initial information received on 22-Nov-2020 regarding an unsolicited valid non-serious case from a patient.  This case involves a patient of an unknown demographics who got sicker everytime after getting a flu shot (illness), while being treated with vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medication was not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE [lot number: unknown and expiration date: unknown] at an unknown dose and frequency via unknown route and unknown site for prophylactic vaccination.  On an unknown date (unknown latency), after starting the suspect vaccine therapy, the patient got sicker everytime after getting a flu shot (illness).  No laboratory data was not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.
Sex: F
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: after getting the flu shot I was so sick with the flu; Initial information received on 23-Nov-2020 regarding an unsolicited valid non-serious case from a patient.  This case involves a female patient of an unknown age who after getting the flu shot was so sick with the flu (influenza), while she received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medication was not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE [lot number: unknown and expiration date: unknown] at an unknown dose and frequency via unknown route and unknown site for prophylactic vaccination.  On an unknown date in 2014 (6 years ago) (unknown latency), after starting the suspect vaccine therapy, the patient got the flu shot just one time. She was in home health and they had the medical personnel in the office giving it out for free to whoever wanted it. The very next day after getting the flu shot the patient was so sick with the flu (influenza). That was the sickest she ever had been in her life. She would never get the flu shot again. Never been sick like that before or since.  No laboratory data was not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu 3 times in a row; Initial information received on 27-Nov-2020 regarding an unsolicited valid non-serious case from a patient.  This case involves a patient of an unknown demographics who had flu 3 times in a row (influenza), while being treated with vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medication was not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE [lot number: unknown and expiration date: unknown] at an unknown dose and frequency via unknown route and unknown site for prophylactic vaccination.  On an unknown date (unknown latency), after starting the suspect vaccine therapy, the patient had flu 3 times in a row (influenza).  No laboratory data was not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Malaise
Clinical narrative: I got so sick; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 04-Dec-2020.  This case involves a patient of unknown demographics reported got so sick as got the flu shot and got the flu (influenza), while the patient received Influenza Vaccine.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was unknown.  On an unknown date, the patients received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date, the patient reported got vaccine two times and got so sick (Illness), stayed in bed three days in misery, both times (influenza) unknown period of time after the administration of influenza vaccine.  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown, at the time of reporting.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 07-Dec-2020 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (patient) via social media.  This case involves Adult patient who experienced flu (influenza), while he/she received vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) 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.  On an unknown date, unknown latency after vaccination, the patient developed a non-serious flu (influenza).  Final diagnosis was flu.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown.  No further information was reported.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Flu; Initial information regarding an unsolicited valid non-serious case received from a patient via social media and transmitted to Sanofi on 08-DEC-2020.  This case involved patient with unknown demographic who experienced flu (Influenza), while he/she received influenza vaccine.  The patient's medical history, medical treatment(s), vaccination(s), family history and concomitants 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, following the administration of influenza vaccine, patient developed flu (Influenza).  No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown for influenza.  There will be no information available on the batch number for this case.  No further relevant information was provided.
Sex: U
Vaccine: FLUX
Symptoms: Bronchitis chronic, Sinusitis
Clinical narrative: use to get chronic bronchitis and sinus infections every year too. No more....not even a cold since stopping the flu vaccine; use to get chronic bronchitis and sinus infections every year too. No more....not even a cold since stopping the flu vaccine; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 13-Dec-2020.  This case involves a patient of unknown demographics who used to get chronic bronchitis (bronchitis  chronic) and sinus infections (sinusitis) every year too, while the patient received Influenza Vaccine.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was unknown.  On an unknown date, the patients received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date, the patient stated that he/she used to get chronic bronchitis (bronchitis  chronic) and sinus infections (sinusitis) unspecified days after the patient got the shot.  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown, at the time of reporting.  There will be no information available on the batch number for this case.  The reporter assessed the causal relationship with suspect vaccine as related.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Incorrect dose administered, No adverse event, Wrong product administered
Clinical narrative: Tubersol was given in error instead of Adacel/ no AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse via Medical Information (Reference number- 00378506) and transmitted to Sanofi on 02-Dec-2020 .    This case involves a 63 year old female patient who received a TUBERCULIN TEST (TUBERSOL) (lot number C5736AA, expiry date 22-Aug-2022, Multidose vial, standard) via intramuscular route in left deltoid for tuberculin test instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (ADACEL) on 02-Dec-2020 (Wrong product administered).    The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   No other vaccine was administered concomitantly.  This was an actual medication error case due to Wrong product administered (latency same day).   Case details- Reporter stated that she had a vial of Adacel and mutidose vial of Tubersol and she accidentally drew up the Tubersol as 0.5mL and injected it into the patient (also reported as TUBERSOL was mistakenly administered  instead of flu shot). Reporter realized the error after the Tubersol was administered. Reporter asked if there could be any effects of overdose and intramuscular (IM) injection of the Tubersol. Reporter was unable to locate any information on this other than not to inject IM  At the time of reporting, no adverse event was reported.   Patient was administered another dose of Tubersol 0.1mL intradermal and a dose of Adacel 0.5mL IM.  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: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received expired TENIVAC vaccine/ NO AE; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via Medical Information (Reference number- 00383301) and transmitted to Sanofi 07-Dec-2020.   This case involves patient (unknown demographics) who received 0.5 mL expired dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (batch number not reported and expiry date: 23-Oct-2020 via an unknown route at an unknown administration site) (expired product administered) on 03-Dec-2020 for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error case due to expired vaccine used (latency: same day).  Pharmacist wants to know if there will be any side effects or if the patient needs revaccination.  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 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.  There will be no information available on the batch number for this case.
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong product administered
Clinical narrative: MENACTRA was given to a 17 year old by mistake/no adverse event; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via Medical Information (Reference number- 00387387) and transmitted to Sanofi on 09-Dec-2020.    This case involves a 17-year old male patient who received MENACTRA vaccine old by mistake of  suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U67878AA via intramuscular route in the left arm. The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   Concomitant medications included INFLUENZA VACCINE (FLU VACCINE VII).  This was an actual medication error case due to 3rd dose of Menactra after only a year after receiving the 2nd dose (Wrong vaccine administered). (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.