chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Ear pain, Herpes zoster, Neuralgia, Otitis media
Clinical narrative: I got shingles on the right side of my scalp around my ear, in the hairline, and in my inner ear and outer ear, as well as a few patches on the right jaw and anterior neck, and right hairline of posterior neck. It first started off with sensitivity to the touch of my right ear and around my ear, then it began itching, then the severe nerve pain on right side of my head, inner ear, right side jaw and down my medial arm and right side chest. I had sever blisters in my right side hairline and in back of my outer ear, face and anterior and posterior neck. currently they are in the scabbed phase and the nerve pain is more tolerable. also, before the blisters showed up, I went to the ER with inner ear pain and was told i had otitis media and was given antibiotics, however, once the blisters showed up, I went to minute clinic and was told it was shingles.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Scab, Tenderness
Clinical narrative: I got shingles on the right side of my scalp around my ear, in the hairline, and in my inner ear and outer ear, as well as a few patches on the right jaw and anterior neck, and right hairline of posterior neck. It first started off with sensitivity to the touch of my right ear and around my ear, then it began itching, then the severe nerve pain on right side of my head, inner ear, right side jaw and down my medial arm and right side chest. I had sever blisters in my right side hairline and in back of my outer ear, face and anterior and posterior neck. currently they are in the scabbed phase and the nerve pain is more tolerable. also, before the blisters showed up, I went to the ER with inner ear pain and was told i had otitis media and was given antibiotics, however, once the blisters showed up, I went to minute clinic and was told it was shingles.
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; patients received improperly stored vaccines; This spontaneous report was received from a licensed practical nurse (LPN)referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 14-MAR-2022, the patient was vaccinated with improperly stored doses of the vaccines vaccine, live, oral, pentavalent (ROTATEQ) 1 dose (exact dose, route of administration, vaccination scheme frequency, and anatomical location were not reported; lot number u026664 with expiration date 24-FEB-2023 or lot number 1741817 with expiration date 30-JUL-2022) and of the vaccine haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 1 dose (exact dose, route of administration, vaccination scheme frequency, and anatomical location were not reported; lot number u026217 with expiration date 02-NOV-2023); both as prophylaxis (product storage error). The administered doses of the vaccines experienced a temperature excursion of 34.3 degrees Fahrenheit for 55 minutes. There was no previous temperature excursion. No additional adverse events (AEs) were reported.  This is one of several reports received from the same reporter.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: soreness 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 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 18th December 2021 and experienced injection site erythema and swelling, refer case US2022058853).   On 1st April 2022, the patient received the 2nd dose of Shingrix. On 1st April 2022, less than a day after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.     Linked case(s) involving the same patient:  US2022058853   Additional Information: GSK Receipt Date: 01-APR-2022 Reporter's Comments: The patient experienced soreness at the injection site on her left arm. The information provided to the reporter as per content and package insert and gave medical disclaimer and referred to health care professional (HCP). The reporter consented to follow up.  Additional Supportive Information:  This case was linked with case US2022058855, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022058855:Husband's case US-GLAXOSMITHKLINE-US2022058853:Same patient and reporter US-GLAXOSMITHKLINE-US2022058855:Same patient and reporter
Age: 16.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Expired product administered
Clinical narrative: Expired Product Used; Expired Product Used; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA95AA, expiry date 28th February 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, Men B NVS (Bexsero) (batch number ABXA95AA, expiry date 28th February 2022) for prophylaxis and meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st April 2022, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 1st March 2022, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 1st March 2022, not applicable after receiving Bexsero and Bexsero Pre-Filled Syringe Device and unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On 1st April 2022, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used and expired vaccine used were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-Apr-2022 Reporter's Comments: The patient was administered 1st and 2nd dose of Bexsero, both the dosed were expired. At the time of reporting, repeat dosing had not been performed. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional Supportive Information: The patient received 1st and 2nd dose of Bexsero, which were expired on 28th February 2022, which led to expired vaccine used and expired vaccine used.
Sex: U
Vaccine: COVID19
Symptoms: Injury
Clinical narrative: HIGH INJURIES POST VACCINATION; This spontaneous report received from a health care professional concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 expiry: 21-NOV-2021) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced high injuries post vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of high injuries post vaccination was not reported. This report was non-serious. This case, from the same reporter is linked to 20220415256.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-533734, MOD-2022-534186, MOD-2022-534194, MOD-2022-534279, MOD-2022-534307, MOD-2022-534308, MOD-2022-534309, MOD-2022-534377, MOD-2022-534378, MOD-2022-534379, MOD-2022-534400 (Patient Link).
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered to patient post expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patient post expiry date) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patient post expiry date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patient post expiry date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported.  It was reported that patient had received the additional dose.  Date the vial was initially stored in refrigerator was 31 Aug 2021 and the vial did not undergone any temperature excursions.  No treatment medications was reported   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2022: Follow-up document received includes no new information.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received expired doses; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired doses) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received expired doses) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that patient took additional dose. Vial was initially stored in the refrigerator on 31 Aug 2021 and it was reported that the vial did not undergo ay temperature excursion. No treatment medications were provided.   This case was linked to MOD-2022-534284 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2022: Follow up received does not contain any new information.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was also beyond the 30 day use by date (initially placed in the refrigerator on 13Dec2021); administered with an expired vaccine which was beyond 30 day use by date per manufacturer; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine which was beyond 30 day use by date per manufacturer) and PRODUCT STORAGE ERROR (Vaccine was also beyond the 30 day use by date (initially placed in the refrigerator on 13Dec2021)) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2022 at 11:30 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2022 at 11:30 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine which was beyond 30 day use by date per manufacturer). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was also beyond the 30 day use by date (initially placed in the refrigerator on 13Dec2021)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine which was beyond 30 day use by date per manufacturer) and PRODUCT STORAGE ERROR (Vaccine was also beyond the 30 day use by date (initially placed in the refrigerator on 13Dec2021)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that this was the patient's 1st booster dose.  It was reported that the vaccine was also beyond the 30 day use by date and was initially placed in the refrigerator on 13-Dec-2021. Vail did not undergo any temperature excursions. No concomitant medications were reported. No treatment information were reported. Safety follow up was not obtained by the agent.   Reporter did not allow further contact
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) in a 51-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 013H21B) for COVID-19 vaccination.     Patient was not tested positive for COVID-19.     On 30-Mar-2022 at 10:30 AM, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 30-Mar-2022 at 10:30 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.   For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (expired vaccine used) to be not related.    No concomitant medication was reported by the reporter.  No treatment medication was reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Experiencing really weird side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Experiencing really weird side effects) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Experiencing really weird side effects). At the time of the report, VACCINATION COMPLICATION (Experiencing really weird side effects) had not resolved.            No concomitant medications were provided by the reporter.  It was reported they did not really have much of a reaction to any of the others, may be patient did not felt it on the first day, but it was very different and it was the same thing for both husband and wife.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-535478 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Malaise, Pain, SARS-CoV-2 test positive
Clinical narrative: After the 2nd booster patient started feeling unwell; Achy/Achy basically; chills; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (After the 2nd booster patient started feeling unwell), PAIN (Achy/Achy basically) and CHILLS (chills) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002M21A, 051F21A, 043LC0A and 010M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (COVID 19 a couple months ago.) in February 2022. Concurrent medical conditions included Drug allergy (minocycline tetracycline) and Drug allergy (Procainamide).   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Apr-2022, the patient experienced PAIN (Achy/Achy basically) and CHILLS (chills). On an unknown date, the patient experienced MALAISE (After the 2nd booster patient started feeling unwell). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse reaction, at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse reaction, at an unspecified dose and frequency. At the time of the report, MALAISE (After the 2nd booster patient started feeling unwell), PAIN (Achy/Achy basically) and CHILLS (chills) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2022, SARS-CoV-2 test positive: positive (Positive) Positive.         No concomitant medications was reported. No chronic illnesses medical history was reported relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination. Other vaccines given within 1 month prior to moderna COVID-19 vaccine included whopping cough shot. Patient had not experienced the similar events with previous 3 shots and not in past.   This case was linked to MOD-2022-535513 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2022: Follow up received contains no new clinical information.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: After the 2nd booster patient started feeling unwell; Achy/Achy basically; chills; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (After the 2nd booster patient started feeling unwell), PAIN (Achy/Achy basically) and CHILLS (chills) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002M21A, 051F21A, 043LC0A and 010M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (COVID 19 a couple months ago.) in February 2022. Concurrent medical conditions included Drug allergy (minocycline tetracycline) and Drug allergy (Procainamide).   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Apr-2022, the patient experienced PAIN (Achy/Achy basically) and CHILLS (chills). On an unknown date, the patient experienced MALAISE (After the 2nd booster patient started feeling unwell). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse reaction, at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse reaction, at an unspecified dose and frequency. At the time of the report, MALAISE (After the 2nd booster patient started feeling unwell), PAIN (Achy/Achy basically) and CHILLS (chills) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2022, SARS-CoV-2 test positive: positive (Positive) Positive.         No concomitant medications was reported. No chronic illnesses medical history was reported relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination. Other vaccines given within 1 month prior to moderna COVID-19 vaccine included whopping cough shot. Patient had not experienced the similar events with previous 3 shots and not in past.   This case was linked to MOD-2022-535513 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2022: Follow up received contains no new clinical information.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was stored in refrigerator post expiry; Administered vaccine to patient post expiry; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator post expiry) and EXPIRED PRODUCT ADMINISTERED (Administered vaccine to patient post expiry) in a 31-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 013H21B) for COVID-19 vaccination.     Patient was not diagnosed or tested positive for COVID-19. Diagnosis for acute illness at the time of vaccination and up to one month before was unknown. Chronic or long standing conditions was unknown. Patient had no known drug allergies.     On 30-Mar-2022 at 10:45 AM, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 30-Mar-2022 at 10:45 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine to patient post expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator post expiry). At the time of the report, PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator post expiry) and EXPIRED PRODUCT ADMINISTERED (Administered vaccine to patient post expiry) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications was reported. Date the vials was initial stored in refrigerator was 01 Mar 2022. Vial had not undergone any temperature excursions.  At the time of report none of the patient had reported adverse reaction. Treatment information was not provided.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vials were initially stored in refrigerator on 01-Mar-2022, and administered on 30-Mar-2022, which was expired on 19-Mar-2022; Inadvertently administered an expired Moderna Covid-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Inadvertently administered an expired Moderna Covid-19 vaccine) and PRODUCT STORAGE ERROR (Vials were initially stored in refrigerator on 01-Mar-2022, and administered on 30-Mar-2022, which was expired on 19-Mar-2022) in a 42-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 013H21B) for COVID-19 vaccination.     The patient had no known drug allergies. The patient was not diagnosed with or tested positive for COVID-19. Acute illness at the time of vaccination and up to one month before was reported as unknown. Chronic or long-standing health condition was reported as none.     On 30-Mar-2022 at 10:48 AM, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 30-Mar-2022 at 10:48 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Inadvertently administered an expired Moderna Covid-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vials were initially stored in refrigerator on 01-Mar-2022, and administered on 30-Mar-2022, which was expired on 19-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Inadvertently administered an expired Moderna Covid-19 vaccine) and PRODUCT STORAGE ERROR (Vials were initially stored in refrigerator on 01-Mar-2022, and administered on 30-Mar-2022, which was expired on 19-Mar-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   It was unknown whether the patient took any prescriptions, over-the-counter medications, dietary supplements or herbal medicines at the time of vaccination or at the time of adverse event. The vial was initially stored in the refrigerator on 01-Mar-2022. The vial did not undergo any temperature excursions. The patient did not reported any adverse event. The potential cause was reported as expired moderna vaccine. No treatment information was reported.
Sex: M
Vaccine: DTAP
Symptoms: Bacterial disease carrier, Speech sound disorder, Unresponsive to stimuli
Clinical narrative: unresponsive; he may be a carrier and can pass Whooping cough; It was not crying but making a weird sounds/ made sounds like a space baby; Initial information received on 01-Apr-2022 regarding an unsolicited valid serious case received from a consumer/non-healthcare professional (hcp) via call center.  This case involves an unknown age male patient who reported it was not crying but making a weird sounds/ made sounds like a space baby, unresponsive and he may be a carrier and can pass whooping cough  while receiving vaccine Diphtheria, Tetanus and Acellular Pertussis Vaccine.  The patient's past medical history included Cardiac operation. The patient's past medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Heart disorder and Neonatal pneumonia.   On an unknown date, the patient received unknown dose of suspect Diphtheria, Tetanus and Acellular Pertussis Vaccine produced by unknown manufacturer (dose, formulation lot number  expiry date : unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed non-serious events it was not crying but making a weird sounds/ made sounds like a space baby (Unevaluable event ) (unknown latency) and serious events unresponsive (unresponsive to stimuli), he may be a carrier and can pass whooping cough (bacterial disease carrier) (unknown latency) following the administration of Diphtheria, Tetanus and Acellular Pertussis Vaccine. This event was assessed as medically significant.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the events.  Seriousness criteria: Medically significant for events unresponsive and he may be a carrier and can pass whooping cough.; Sender's Comments: Sanofi Company Comment dated 07-Apr-2022: This case involves an unknown age male patient who reported it was not crying but making a weird sounds/ made sounds like a space baby, unresponsive and he may be a carrier and can pass whooping cough  while receiving vaccine Diphtheria, Tetanus and Acellular Pertussis Vaccine. Further information regarding concurrent condition during vaccination, previous vaccination, concomitant medication and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information the role of the individual suspect vaccine cannot be assessed.
Sex: M
Vaccine: TDAP
Symptoms: Extra dose administered, Medication error, No adverse event
Clinical narrative: inadvertently administered an additional dose of adacel today with no adverse event; Initial information received on 28-Mar-2022 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 11-year-old male patient who experienced inadvertently administered an additional dose of Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel] today with no adverse event.   The patient's past vaccination(s) included Adacel in NOV-2021. The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included Meningococcal Vaccine A/C/Y/W CONJ (DIP TOX) (Menactra) for Immunization.  On 28-Mar-2022, the patient received a dose of suspect Adacel (lot U7276AA) 0.5 ml via intramuscular route in the left deltoid (formulation, strength, expiration date: unknown) as prophylactic vaccination.  On 28-MAR-2022, (latency same day) the patient reports inadvertent administration of an additional dose of adacel today with no adverse event (extra dose administered).  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 38.0
Sex: F
Vaccine: TYP
Symptoms: Expired product administered, No adverse event
Clinical narrative: received the expired vaccine with no reported adverse event; Initial information received on 06-Apr-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 38 years old female patient who had received the expired vaccine with no reported adverse event while receiving vaccine typhoid vi polysaccharide vaccine [Typhim VI].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 01-Mar-2022, the patient received a 0.5 ml dose of suspect typhoid vi polysaccharide vaccine frequency: once lot T1A671M: 17-feb-2022 via intramuscular route in the left deltoid (Unknown: strength, formulation) for immunization.  On 01-MAR-2022, the patient developed a non-serious event received the expired vaccine with no reported adverse event (expired product administered) (latency: same day) following the administration of typhoid vi polysaccharide vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (expired product administered).  At time of reporting, the outcome was Unknown for the event expired product administered. 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 guidelines. 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: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pneumonia, Sputum culture, Upper respiratory tract infection, X-ray
Clinical narrative: Woke up next day with sore arm and beginning of upper respiratory infection which turned into pneumonia.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash macular
Clinical narrative: Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Additional Details: Patient started having symptoms 4/6/2022 at 11:00pm, from wrist to shoulder on inner under arms and on torso, belly, ribs, chest, has a hives rash that is not responding to benadryl. There is also a 10-inch large splotch on upper inner thieghs. I told her to go to urgent care since the benadryl is not taking it down, and to rule out other causes of the rash since it was 5 days later and had no previous allergic reaction to other 3 doses of pfizer.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting/Unresponsive-Mild, Additional Details: Patient fainted few minutes after vaccination. He was responsive after a few seconds. EMT called, but patient declined care.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Expired Product Administered-
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: On 4/1/2022, patient given the vaccine for <12-year-old. The vaccine was not diluted. Patient and father left the office when the mistake was noticed. Physician was notified. Physician advised to call parents, inform them of mistake and watch patient for any severe reaction to the vaccine such as nausea, vomiting, fever and/or headache. If he had any of these symptoms, contact our office or seek medical attention. Patient's father said he was fine but he would watch and call if any changes. Follow-up call on Monday, 4/4/2022, spoke to father again, he reported patient was fine and at school.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Expired Product Administered.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation error
Clinical narrative: On 4/1, pt was given the vaccine that was not diluted.  Patient and father had left the office when the mistake was noticed, physician was notified.  Physician advised to call parents and inform them of mistake and advised to watch pt. for any severe reaction to the vaccine such as nausea, vomiting, fever, headache and if he had any of these symptoms to contact our office or seek medical attention.  Father stated pt. was fine but he would watch and call if any changes.  Follow up call on Monday, 4/4, spoke to father again, he reports that pt. was fine and at school.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Sudden onset of severe pain in the shoulder and upper arm a little over 48 hours after the vaccine was administered. As of this report pt. is unable to raise her left arm by the shoulder, but is able to bend the elbow and retains sensation in and use of the hand.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: High blood pressure. My blood pressure has always been perfect or even lower than normal, but when I went for cardiology check-up on Jan 6, 2022, it was 174/90, and continues to run high since then.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Condition aggravated, Extra dose administered, Fatigue, Headache
Clinical narrative: headache, body aches, chills, nausea, fatigue, soreness at injection site, lymph swelling
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Interchange of vaccine products, Lymphadenopathy, Nausea, Pain
Clinical narrative: headache, body aches, chills, nausea, fatigue, soreness at injection site, lymph swelling
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pain in extremity, Pyrexia
Clinical narrative: All over body soreness (since injection), Fever (nightly), Extreme Chills (nightly), Arm Pain (since injection)
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test positive
Clinical narrative: Moderna 2/5/21, 4/22/21, 9/15/21. Positive on 4/10/22
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: I have developed mild tinnitus in my right ear this winter. I have seen that scientists are investigating a possible link between the COVID vaccines and tinnitus, so I thought I should report it. It is sometimes annoying but not major. I did not have any adverse reactions after the first two shots; only after the booster. I'm not sure when it actually began. I thought it was some sort of strange electrical humming in my house, but when I couldn't locate the source, I realized it was my ear.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Immunisation reaction, Migraine, Palpitations, Urticaria
Clinical narrative: two weeks after getting my moderna booster shot, I started experiencing headaches/migraines, heart palpitations, chest pain, recent hives outbreak that is still ongoing as of today. Currently seeking treatment to see why I reacted to the vaccine negatively.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Epilepsy, Seizure
Clinical narrative: Being to have seizures and was diagnosed with epilepsy.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: hospitalized with covid; fully vaccinated with boosters
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Extra dose administered, Frequent bowel movements, Influenza like illness
Clinical narrative: this is the 2nd booster shot, i received in left arm, the next 2 1/2 days my hurt at a pain level of 8+, also had dizziness, constant bowel movement extreem  weakness flu like symptoms, very light headed. overall body aches never had this type of reaction with other 3 doses. was very weird, especially have the injection site hurting for 2 1/2 days had a hard time moving my arm, i am better now, just thought you would like to know this.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Mobility decreased, Pain, Pain in extremity
Clinical narrative: this is the 2nd booster shot, i received in left arm, the next 2 1/2 days my hurt at a pain level of 8+, also had dizziness, constant bowel movement extreem  weakness flu like symptoms, very light headed. overall body aches never had this type of reaction with other 3 doses. was very weird, especially have the injection site hurting for 2 1/2 days had a hard time moving my arm, i am better now, just thought you would like to know this.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Mechanical urticaria, Pruritus, Swelling
Clinical narrative: Extreme skin itching about 1 week post Moderna booster resulting in Urticaria Dermatographia. Itching skin results in raised hives upon scratching skin surface.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pneumonia
Clinical narrative: ER visit for acute headache - treated and released. 4 days later ED to hospital, Pneumonia of right lower lobe due to infectious organism - started on rocephin/azithromycin. Patient completed his 3-day azithromycin course on 05/28 and received 3 doses of rocephin, will discharge patient with 7 days of Augmentin. ED visits and hospital admission within 6 weeks of receiving the COVID vaccine.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Pain in extremity, Sick leave
Clinical narrative: In September I started having pain in my feet, I thought it was because I do between 10-20,000 steps a day. The balls of my feet started hurting. I took a medical leave of absence. The doctor diagnosed me with peripheral neuropathy.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal X-ray, Abdominal distension, Abdominal pain, Asthenia, Feeding disorder
Clinical narrative: Acute onset abdominal bloating and cramps, rapidly worsening. Inability to eat or drink for 6 days. Malaise, weakness.  Attempted visit to urgent care center, was turned away,   EMT came to the house to put in IV access, got several liters of saline. Had labs drawn at home. ABDOMINAL XR  done. After 6 days abdominal distension and cramps started getting better. Started drinking. Careful solid foods after 7 days Noticed for about 10 days after recovery that I was free of chronic pain from tendinitis (probably due to overwhelming immune response -  HAD EXTREMELY HIGH ANTIBODY TITERS AT THE TIME OF VACCINE WHICH WAS DISREGARDED BY MY EMPLOYER , QUOTING "MANDATE" TO VACCINATE)
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Fluid intake reduced, Ileus, Ileus paralytic, Malaise, Therapeutic response unexpected
Clinical narrative: Acute onset abdominal bloating and cramps, rapidly worsening. Inability to eat or drink for 6 days. Malaise, weakness.  Attempted visit to urgent care center, was turned away,   EMT came to the house to put in IV access, got several liters of saline. Had labs drawn at home. ABDOMINAL XR  done. After 6 days abdominal distension and cramps started getting better. Started drinking. Careful solid foods after 7 days Noticed for about 10 days after recovery that I was free of chronic pain from tendinitis (probably due to overwhelming immune response -  HAD EXTREMELY HIGH ANTIBODY TITERS AT THE TIME OF VACCINE WHICH WAS DISREGARDED BY MY EMPLOYER , QUOTING "MANDATE" TO VACCINATE)
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Delivery, Exposure during pregnancy, Normal labour
Clinical narrative: Normal labor and delivery on 12/27/2021. Hospital admission within 6 weeks of receiving the COVID vaccine.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein decreased, Cellulitis, Erythema, Lethargy, Scab
Clinical narrative: Cellulitis of right lower extremity - Placed on Zosyn.  Erythema resolved.  CRP was declining.  Check was oftentimes lethargic but would wake up and sit up in the chair.  Was seen by physical therapy and ambulated in the hall.  Family felt his level of alertness was baseline as it varies through the day and night.  Foot was looking better.  Can follow-up with podiatry as an outpatient for the scabs on his toes.  ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Eye pain, Facial pain, Feeling hot
Clinical narrative: On the way home I had a taste of blood in my mouth. Every day I've had problems since the vaccine. I had a sharp pain in my left kidney and eye. I've had light headedness, dizziness, nausea. I've also had itchy ears. The site of the vaccine was hot to the touch and the heat and pain traveled down my left arm. At that point I called the doctor and it ended up that I had an infection. I eventually began to have warmth, tingling and pain throughout the left side of my face and the entire left side of my body with chills that occurred off and on. Every time I thought it was getting better, things would flare up again. Eventually, it went away but because I was having such difficulty I was calling my doctor every day for advice on whether or not I should get the second dose of the vaccine. When I went to get my second shot, the person I believe to be the pharmacist was hesitant to give me a dose of any vaccine even though my doctor advised that I receive the Pfizer vaccine rather than Moderna. She stated that with all of the issues I've had, that she did not believe I should get a second shot.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Infection, Injection site warmth, Nausea, Pain, Pain in extremity
Clinical narrative: On the way home I had a taste of blood in my mouth. Every day I've had problems since the vaccine. I had a sharp pain in my left kidney and eye. I've had light headedness, dizziness, nausea. I've also had itchy ears. The site of the vaccine was hot to the touch and the heat and pain traveled down my left arm. At that point I called the doctor and it ended up that I had an infection. I eventually began to have warmth, tingling and pain throughout the left side of my face and the entire left side of my body with chills that occurred off and on. Every time I thought it was getting better, things would flare up again. Eventually, it went away but because I was having such difficulty I was calling my doctor every day for advice on whether or not I should get the second dose of the vaccine. When I went to get my second shot, the person I believe to be the pharmacist was hesitant to give me a dose of any vaccine even though my doctor advised that I receive the Pfizer vaccine rather than Moderna. She stated that with all of the issues I've had, that she did not believe I should get a second shot.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pruritus, Renal pain, Taste disorder
Clinical narrative: On the way home I had a taste of blood in my mouth. Every day I've had problems since the vaccine. I had a sharp pain in my left kidney and eye. I've had light headedness, dizziness, nausea. I've also had itchy ears. The site of the vaccine was hot to the touch and the heat and pain traveled down my left arm. At that point I called the doctor and it ended up that I had an infection. I eventually began to have warmth, tingling and pain throughout the left side of my face and the entire left side of my body with chills that occurred off and on. Every time I thought it was getting better, things would flare up again. Eventually, it went away but because I was having such difficulty I was calling my doctor every day for advice on whether or not I should get the second dose of the vaccine. When I went to get my second shot, the person I believe to be the pharmacist was hesitant to give me a dose of any vaccine even though my doctor advised that I receive the Pfizer vaccine rather than Moderna. She stated that with all of the issues I've had, that she did not believe I should get a second shot.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Suicide attempt
Clinical narrative: ED visit - Needs psychiatric admission for suicide attempt, COVID positive. Admitted to the hospital 2 days later from the ED. She was medically cleared for that ingestion and initially was to be admitted to medicine due to positive COVID-19, but was found to be no longer symptomatic and outside of the timeframe requiring quarantine, so she is admitted to psychiatry. Treated in behavioral health inpatient for 35 days and then placed at an outside facility.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Migraine, Vaccine positive rechallenge
Clinical narrative: Severe Migraine 12 hours later.  It has been on and off since booster (I had the same issues with the first dose)  This has been going on for 6 days.  Standard Migraine symptoms.  Unusual as I have had these under control with only 2 - 3 one day events until I got the injection.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Pain
Clinical narrative: I remember the pain on the side where the vaccine was administered took longer to subside. I began to have pain and weakness that continued but I am uncertain if it was in the area where the vaccine was administered. I am currently in physical therapy and still continuing to experience pain in this area.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Red circular raised rash noted at injection site a few hours after received Moderna booster shot. The injection site was hardened, raised, hot to touch, and sore. Currently, bring treated with bactrim.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash papular
Clinical narrative: Red circular raised rash noted at injection site a few hours after received Moderna booster shot. The injection site was hardened, raised, hot to touch, and sore. Currently, bring treated with bactrim.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Condition aggravated, Headache
Clinical narrative: The questions were about headache, etc.  I had these symptoms at some point after my vaccine, but not immediately after.  I think the "adverse event(s)" were unrelated to the vaccine since those conditions had occurred prior to any vaccine as well (that question wasn't asked).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Plantar fasciitis, Tendonitis
Clinical narrative: Plantar Fasciitis came in both feet and Achilles Tendinitis. Peroneal Tendonitis came in my right ankle.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Fever and achiness at 6 hours after vaccine.  Headache now at 48 hour mark. Headache will not subside despite multiple doses of Tylenol