chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product storage error
Clinical narrative: Menactra was administered after being exposed to frozen temperatures several times, with a minimum of minus 1.25 Celsius, no AE; Initial information received on 03-Aug-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case is linked to cases 2020SA203233, 2020SA203126 and 2020SA203423 (same reporter).  This case involves a 11 years old female patient who received a 0.5 mL dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number not reported) via unknown route in the left arm for prophylactic vaccination on 03-Jul-2020 after being exposed to frozen temperatures several times, with a minimum of minus 1.25 Celsius (product storage error).  The patient's medical history, past medical treatment, past vaccination and family history were not provided. The patient did not receive any other medications or vaccines on that visit.  It was an actual medication error due to product storage error temperature too low.  It was reported that the refrigerator got too cold many times due to possible batteries issues and it happened on and off on several days.  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 lot number for this case.
Sex: F
Vaccine: TDAP
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylactic reaction; Initial information was received on 05-Aug-2020 regarding an unsolicited valid serious case (via GMIPROD) from the pharmacist.  This case involves a female patient (age was not reported) who experienced anaphylactic reaction, while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient received Adacel vaccine on an unknown date of 2006 with batch number C2454AA for prophylactic vaccination and no adverse event was reported post vaccination.  The patient's medical history, past medical treatment and family history were not provided.  At time of reporting, the patient's allergy was under investigation at allergy clinic.  The patient's concomitant medication was not reported.  In May-2020, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U6539AA and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, the patient developed serious anaphylactic reaction, (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. This event was assessed as medically significant.  Details of laboratory data were not reported.   It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome was unknown.; Sender's Comments: This case concerns a female patient of unknown age who presented with anaphylactic reaction after vaccination with ADACEL. The time to onset is unknown. Also the patient received same vaccine in the past and had no adverse event post vaccination.  Moreover, patient's medical condition at the time of vaccination and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Chills, Heart rate increased, Pyrexia
Clinical narrative: high heart rate; fever; chills; weak; Initial information was received on 07-Aug-2020 regarding an unsolicited valid non-serious case received from a non-health care professional.  This case involves a 70 year old male patient who experienced fever (pyrexia), high heart rate (heart rate increased), chills and was weak (asthenia), while he received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient in the past was vaccinated with a dose of regular quadrivalent influenza vaccine on an unknown date, a dose of  Fluzone HD (high dose) on 26-OCT-2017 for prophylactic vaccination and  visited emergency room on 09-Nov-2017 also a dose of Fluzone HD on 09-OCT-2018 for prophylactic vaccination and visited emergency room on 14-Oct-2018 with events of fever, chills, weakness and high hear rate.  The patient's past medical treatment, concomitant therapy and family history were not provided.   On 18-Sep-2019, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, the patient developed non-serious fever (pyrexia), high heart rate (heart rate increased), chills and was weak (asthenia), (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  The patient was visited to emergency room on 24-Sep-2019.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  On an unknown date, the patient had recovered from the events.  There will be no information available on the batch number for this case.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness (3 inch diameter), swelling, warmth, and pain at injection site.
Age: 4.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient got the tetanus shot Tuesday morning by Wednesday morning is got red and swollen.. Thursday it grew and was about 5 - 6 inches  by 4-5 inches and warm to the touch.
Age: 29.0
Sex: F
Vaccine: PPV
Symptoms: Arthritis, Arthroscopy, Hypokinesia, Magnetic resonance imaging, Musculoskeletal pain
Clinical narrative: Shoulder pain and decreased movement treatment with pain medications, rest then physical therapy. Once pain persisted and worsened over six months underwent shoulder arthroscopy on 7/16/2020. Intra-operative diagnosis of right shoulder rotator cuff tear, AC joint arthritis, impingement
Age: 29.0
Sex: F
Vaccine: PPV
Symptoms: Rotator cuff syndrome, X-ray limb
Clinical narrative: Shoulder pain and decreased movement treatment with pain medications, rest then physical therapy. Once pain persisted and worsened over six months underwent shoulder arthroscopy on 7/16/2020. Intra-operative diagnosis of right shoulder rotator cuff tear, AC joint arthritis, impingement
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site bruising
Clinical narrative: 15 days post vaccination states he developed a large bruise, approx. 2.5" x 2.5" on the anterior aspect of his L upper arm. Denies pain, no swelling noted, area non tender and soft to touch. States he takes "blood thinners". Referred him to his PCP.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional adverse events.; a pediatric VAQTA administered to an adult patient; This spontaneous report was received from a pharmacist and refers to an adult patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided. The case concerns 1 patient and 1 combination product. On 20-JUL-2020, the patient was vaccinated with a pediatric hepatitis a vaccine, inactivated (VAQTA) lot # S020241, expiration date 23-AUG-2020, (exact dose, injection site and route of administration were not reported) for prophylaxis. There was no adverse events reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: S020241; expirationdate: 23-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Heart rate increased
Clinical narrative: have a headache; how long does the increased heart rate last; I was shivering a bit; This case was reported by a consumer via call center representative and described the occurrence of heart rate increased in a 60-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On 5th August 2020, the patient received the 2nd dose of Shingrix. On 6th August 2020, 1 days after receiving Shingrix, the patient experienced headache. In August 2020, the patient experienced heart rate increased and chills. On an unknown date, the outcome of the heart rate increased, chills and headache were unknown.   It was unknown if the reporter considered the heart rate increased, chills and headache to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was captured as adult as per the vaccine indication. The age at vaccination was not reported. After receiving Shingrix, the patient's heart was beating at about 100 bpm and the patient was shivering a bit and had headache.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: rash also has blisters; This case was reported by a pharmacist via call center representative and described the occurrence of blistery rash in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th February 2020, the patient received the 1st dose of Shingrix .5 ml. In February 2020, 2 weeks after receiving Shingrix, the patient experienced blistery rash. On an unknown date, the outcome of the blistery rash was not recovered/not resolved.   It was unknown if the reporter considered the blistery rash to be related to Shingrix.  Additional details were reported as follows: The patient received a Shingrix and 2 weeks after her first dose presented rash on the patient's back The rash also had blisters.  The blisters resolved but presented again and were present at the time of reporting. The reporter consented to follow up. This case has been linked with case US2020152656, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020152656:same reporter
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of product administration
Clinical narrative: 1 of Shingrix on September 7, 2018 / dose 2 on April 18, 2019; shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included non-hodgkin's lymphoma. Previously administered products included Shingrix (received 1st dose on 7th September 2018). Concomitant products included rituximab.   On 18th April 2019, the patient received the 2nd dose of Shingrix. In April 2019, less than 2 weeks after receiving Shingrix, the patient experienced shingles. On 18th April 2019, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The patient received dose 1 of Shingrix in 7th September 2018, and 2nd dose in 18th April 2019, which led to drug dose administration interval too long. The patient developed shingles in late April 2019, and till the time of reporting patient was not recovered for shingles The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: rash  on injection site; redness at injection site; This case was reported by a other health professional via call center representative and described the occurrence of injection site rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site rash and injection site erythema. On an unknown date, the outcome of the injection site rash and injection site erythema were unknown.   It was unknown if the reporter considered the injection site rash and injection site erythema to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix and experienced rash and redness on injection site  The patient was not received second dose because after the first dose experienced rash and redness on injection site which led to   The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient was over the age of 65 and had a prior history of shingles outbreaks.  The patient received the first dose of Shingrix and experienced shingles and never went back for the second dose. This case is one of the 3 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020153380:same reporter US-GLAXOSMITHKLINE-US2020153378:same reporter
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Muscular weakness, Neuritis, Radial nerve palsy
Clinical narrative: Vaccinated 7/30/20 Woke 8/2/20  weakness left hand;worse second digit Referred to neurology. No pain or paresthesia.  Dx: incomplete radial nerve palsy; suspect neuritis secondary to autoimmune response and not due to administration trauma. Undergoing  PT and OT with some improvement
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Peripheral swelling, Pyrexia
Clinical narrative: Patient reports 100 F fever, redness and swelling of arm from elbow to neck, fatigue
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Ear pain, Facial pain, Headache, Herpes zoster, Rash erythematous
Clinical narrative: Severe pain in the right side of his head, chin, right ear and right cheek associated with red rash consistent with shingles.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site joint pain, Pain, Product administered at inappropriate site
Clinical narrative: I do not have the information for the vaccine lot, it was given at the pharmacy.  Patient states she was given the vaccination "slightly higher" on the deltoid than she is used to, by the evening after she received her vaccination, her left shoulder joint ached. It has not stopped aching since she had her vaccination.  If she reaches too fast with that arm, she will get a sharp pain, otherwise it is a bit better in the am and worse as the day goes on, becoming more achy and painful by the end of the day.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Flushing, Hyperhidrosis, Syncope
Clinical narrative: syncope onset within minutes of vaccination. no injuries. patient recovered within 20 minutes with no treatment needed beyond monitoring symptoms and BP. Also experienced Flushing, sweating
Age: 12.0
Sex: F
Vaccine: DTAPIPV, MMRV, MNQ
Symptoms: Wrong product administered
Clinical narrative: Needed Tdap. Was accidentally given Dtap-IPV (Kinrix) instead, as well as MMRV. These 2 vaccines were drawn up for the patient's sibling and they got switched. The mistake was realized prior to administration of MCV4 and the sibling has not been given any vaccines yet at that time. The patient and parent were made aware of the mistake and instructed that the DTAP would take the place of the intended Tdap.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Paraesthesia oral, Throat irritation, Tremor
Clinical narrative: After administering the Shingrix vaccine the patient developed tingling sensation in her mouth, shaking, sense of ill at ease, and eventually an odd sensation in her throat. 50 mg Benadryl given at 1458. NS bolus started at 1500. her symptoms progressed so called the rapid response team and transferred her to the emergency room as a precaution.  She was given the EpiPen given the progression of her symptoms and the likelihood of development to angioedema.  She should not likely receive another Shingrix vaccine given this
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Vaccination error
Clinical narrative: Vaccine  administration error.  Patient was mistakenly given the  MenCYW only. With out the  Men A Lyophilized.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Headache, Nausea, Neck pain, Pyrexia
Clinical narrative: Patient got extreme headches, neck pain , lower back pin nausea fever within 24-36 hours of shot. Pt is ok now
Age: 26.0
Sex: F
Vaccine: RAB
Symptoms: Pyrexia
Clinical narrative: PT RECEIVED #2 POST-EXPOSURE VACCINE IN OUR OFFICE ON 8/6/20- REPORTED TO US ON 8/11/20 THAT AFTER EACH VACCINE SHE HAS EXPERIENCED FEVER ON THE DAY OF, UP TO 101F- STATES SYMPTOM IS RESOLVED THE FOLLOWING DAY-
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Headache, Nausea, Pain
Clinical narrative: Fever, shivering, headache, body aches, nausea, stomach pain
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever, shivering, headache, body aches, nausea, stomach pain
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional adverese effect reported; one patient was administered a dose of improperly stored VARIVAX; This spontaneous report has been received from a physician, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions and previous drug reactions and allergies was not provided.  On 07-JUL-2020, the patient received an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot number S038701 and expiration date 01-DEC-2021)(strength, exact dose, frequency, route of administration and anatomical location were not provided) for prophylaxis. The varicella virus vaccine live (oka/merck)(VARIVAX) was reconstituted with properly stored sterile diluent (one of the following lots: S033779 and expiration date: 16-JUN-2022, S030249 and expiration date: 02-JUN-2022, S036204 and expiration date: 03-JUL-2022).  The vaccine was stored at  in between 15 to 46 degrees Fahrenheit (F) 32.9 F: for 5 hours, with no previous temperature excursion. The storage was recorded by Digital Data Logger.  No additional adverse effects were reported.; Sender's Comments:  US-009507513-2007USA005592:
Sex: U
Vaccine: PPV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events.; a patient was administered an improperly stored PNEUMOVAX 23; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided. The case concerns 1 patient and 1 combination product. On 15-JUL-2020, the patient was vaccinated with an improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S033516, expiration date 29-JUN-2021, (exact dose, injection site and route of administration were not reported)for prophylaxis. Administered dose of vaccine experienced the temperature excursion of below 32 degrees Fahrenheit/ 0 degrees Celsius (-0.2 degrees Celsius) for 4 hours and 48 minutes, 1 cycle. The digital data logger was not involved in recording the temperature excursion details. Administered dose of vaccine experienced the previous temperature excursion of below 2 degrees Celsius (0.5 degrees Celsius) for 23 minutes, above 9 degrees Celsius (8.9 degrees Celsius) for 14 minutes, below 32 degrees Fahrenheit/ 0 degrees Celsius (-0.4 degrees Celsius) for 11 hours and 2 minutes, 1 cycle, below 32 degrees Fahrenheit/ 0 degrees Celsius (-0.7 degrees Celsius) for 11 hours and 20 minutes, 1 cycle. There was no adverse events reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp; devicelotnumber: S033516; expirationdate: 29-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Product storage error
Clinical narrative: Improperly stored administered vaccines; This spontaneous report was received from a physician referring to a patient of unknown age and gender. Information regarding the patient's  concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.   On 05-AUG-2020, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) lot # S020160, expiration date 30-JUN-2021 for prophylaxis.  Other suspect therapies included varicella virus vaccine live (oka/merck)(VARIVAX) s038175, expiration date 30-JUN-2021 for prophylaxis (dose, frequency and route of administration were not reported for any of the vaccines involved) (Product storage error).  The improperly stored suspect vaccines experienced all a temperature of - 6 fahrenheit degrees (°F) to 14°F (average 10°F) for 1 hour and 15 minutes; 15°F to 46°F ( average 44.8 °F )  for 1 hour and 30 minutes; 47°F to 77°F (average 50°F ) for 2 hours and 30 minutes.  The call was made due to a digital data logger. No previous temperature excursion was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain of skin, Vaccination failure
Clinical narrative: Suspected vaccination failure; herpes zoster; I seem to have zoster sine herpete; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included immune system disorder and cancer (patient was immune compromised due to cancer treatment).   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), herpes zoster and skin pain. On an unknown date, the outcome of the vaccination failure, herpes zoster and skin pain were unknown.   It was unknown if the reporter considered the vaccination failure, herpes zoster and skin pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient stated that he or she was immune compromised due to cancer treatment. The patient received shingrix vaccine and experienced zoster sine herpete. The patient asked whether this event was due to vaccine and whether it lower chances of long term pain. No other information was reported. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: Adverse drug reaction, Incorrect route of product administration, Wrong technique in product usage process
Clinical narrative: ADR's were MUCH less this second time; were given subQ; divided the 2nd shot into multiple smaller injections; This case was reported by a pharmacist via call center representative and described the occurrence of adverse drug reaction in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix (subcutaneous). On an unknown date, unknown after receiving Shingrix, the patient experienced adverse drug reaction, intramuscular formulation administered by other route and wrong technique in product usage process. On an unknown date, the outcome of the adverse drug reaction, intramuscular formulation administered by other route and wrong technique in product usage process were unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of the patient was not reported, but selected as an adult as per vaccine indication. The reporter stated that, the patient received 2nd dose of Shingrix divided into multiple smaller injections that were given subcutaneously, which led to intramuscular formulation administered by other route and wrong technique in product usage process. The reporter stated that, the patient had much less adverse drug reaction after 2nd dose of Shingrix vaccination. This was 1 of 2 linked cases, reported by same reporter for same patient. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020151914:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Heart rate increased
Clinical narrative: Headache; Heart was beating me at about 100 bpm; Shivering; This case was reported by a consumer via interactive digital media and described the occurrence of heart rate increased in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th August 2020, the patient received the 2nd dose of Shingrix. On 6th August 2020, 1 days after receiving Shingrix, the patient experienced headache. In August 2020, the patient experienced heart rate increased and shivering. On an unknown date, the outcome of the heart rate increased, shivering and headache were unknown.   It was unknown if the reporter considered the heart rate increased, shivering and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and heart was beating at about 100 bpm, shivering a bit and did had headache. The reporter asked how long would those last or was that it just a day before date of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain
Clinical narrative: I have injection site pain; fatigue.; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th August 2020, the patient received Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced injection site pain and fatigue. On an unknown date, the outcome of the injection site pain and fatigue were unknown.   It was unknown if the reporter considered the injection site pain and fatigue to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient received the Shingrix vaccine on Wednesday and In August 2020, and had injection site pain and fatigue.  The patient asked how long do the side effects last
Sex: U
Vaccine: VARZOS
Symptoms: Nerve injury
Clinical narrative: Terrible reaction; Nerve damage; This case was reported by a consumer via interactive digital media and described the occurrence of adverse reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse reaction and nerve damage. On an unknown date, the outcome of the adverse reaction and nerve damage were unknown.   It was unknown if the reporter considered the adverse reaction and nerve damage to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had terrible reaction and nerve damage.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Injection site "started getting a little red, itchy, and hot or warm; Injection site "started getting a little red, itchy; Injection site "started getting a little red; This case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included mesothelioma (The patient receives chemotherapy for mesothelioma). Concomitant products included chemotherapy, nos (Chemotherapy).   On 27th April 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 29th April 2020, 2 days after receiving Shingrix, the patient experienced injection site warmth, injection site itching and injection site erythema. The patient was treated with sulfamethoxazole + trimethoprim (Bactrim). On an unknown date, the outcome of the injection site warmth, injection site itching and injection site erythema were not recovered/not resolved.   It was unknown if the reporter considered the injection site warmth, injection site itching and injection site erythema to be related to Shingrix.  Additional details were reported as follows: The patient received first dose of Shingrix on left arm and following the vaccination the injection site started getting a little red, itchy, and hot or warm. The patient also reports that she receives chemotherapy for mesothelioma.  The patient was prescribed generic bactrim by her HCP for the injection site.  The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Headache, Lethargy, Myalgia, Weight decreased
Clinical narrative: Diarrhea; lethargy; headache; muscle aches; patient lost 9 pounds; This case was reported by a pharmacist via call center representative and described the occurrence of diarrhea in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd August 2020, the patient received the 2nd dose of Shingrix. In August 2020, less than a week after receiving Shingrix, the patient experienced diarrhea, lethargy, headache, muscle pain and weight loss. On an unknown date, the outcome of the diarrhea, lethargy, headache, muscle pain and weight loss were unknown.   The reporter considered the diarrhea, lethargy, headache, muscle pain and weight loss to be unrelated to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and reported some unrelated side effects including diarrhea, lethargy, headache, muscle aches and the patient lost 9 pounds. The patient felt like a normal human being. The reporter consented to follow up and could follow up directly with the pharmacist. This case linked with US2020156555, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020156555:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Headache, Lethargy, Myalgia, Weight decreased
Clinical narrative: diarrhea; lethargy; headache; muscle ache; patient lost 13 pounds; This case was reported by a pharmacist via call center representative and described the occurrence of diarrhea in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd August 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced diarrhea, lethargy, headache, muscle pain and weight loss. On an unknown date, the outcome of the diarrhea, lethargy, headache, muscle pain and weight loss were unknown.   The reporter considered the diarrhea, lethargy, headache, muscle pain and weight loss to be unrelated to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and reported some unrelated side effects including diarrhea, lethargy, headache, muscle aches and the patient lost 9 pounds. The patient felt like a normal human being. The reporter consented to follow up and could follow up directly with the pharmacist. This case linked with US2020156554, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020156554:same reporter
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Immediate post-injection reaction, Lymphadenopathy, Pain
Clinical narrative: the minute she shot me there was pain; swollen lymph nodes; side of head hurts; This case was reported by a consumer via call center representative and described the occurrence of pain in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th August 2020, the patient received the 2nd dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced pain, enlargement of lymph nodes and headache. On an unknown date, the outcome of the pain was recovered/resolved and the outcome of the enlargement of lymph nodes and headache were unknown.   It was unknown if the reporter considered the pain, enlargement of lymph nodes and headache to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and was told she was too early, pharmacist was not ready, but administered the shot anyway.  The reporter stated that the minute the pharmacist shot patient there was pain and was resolved.  The patient also had swollen lymph node and side of head hurts. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: injection site arm is Red; injection site is Sore; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 6 days after receiving Shingrix, the patient experienced injection site erythema and injection site pain. The patient was treated with immunosuppressants nos (Immunosuppressant Drug (Nos)). On an unknown date, the outcome of the injection site erythema and injection site pain were recovering/resolving.   It was unknown if the reporter considered the injection site erythema and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix on an unknown arm. After receiving Shingrix, the patient's injection site arm was red and sore. The patient planned to show his physician. The reporter did not consent to follow up. All information was not available.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site warmth
Clinical narrative: Inflammation characteristics; Left arm was tender, red and warm at the injection site / Tender, pain; Left arm was tender, red and warm at the injection site; left arm was tender, red and warm at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site inflammation in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th August 2020, the patient received the 2nd dose of Shingrix. In August 2020, less than a week after receiving Shingrix, the patient experienced injection site inflammation, injection site pain, injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site inflammation, injection site pain, injection site erythema and injection site warmth were recovering/resolving.   It was unknown if the reporter considered the injection site inflammation, injection site pain, injection site erythema and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and noticed after the injection, that her left arm was tender, red and warm at the injection site, but she reported that it looks better every day.  The tender, pain, warm and red, inflammation characteristics.  The reporter did not know HCP information. The reporter did not consent to follow up.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Tinnitus
Clinical narrative: started to experience tinnitus; This case was reported by a consumer via call center representative and described the occurrence of tinnitus in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included tinnitus (had a history of tinnitus which had resolved).   On 11th March 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced tinnitus. On an unknown date, the outcome of the tinnitus was unknown.   It was unknown if the reporter considered the tinnitus to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in right arm and within a week he started to experience tinnitus.  The tinnitus was affecting both the ears and thougth got the Shingrix vaccine in his right arm. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Heart rate decreased, Myalgia
Clinical narrative: Tiredness; Muscle pain; Low pulse rate; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced tiredness, muscle pain and low pulse rate. On an unknown date, the outcome of the tiredness, muscle pain and low pulse rate were unknown.   It was unknown if the reporter considered the tiredness, muscle pain and low pulse rate to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had low pulse rate, muscle pain, and tiredness. The reporter declined to provide contact information or details.  No additional information was provided. The reporter did not consent to follow up.
Age: 3.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Injection site warmth
Clinical narrative: Left thigh with reaction. Firm, hot to touch, red, large area covering anterior thigh from hip to approximately 3 inches proximal to knee.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Vaccination site erythema
Clinical narrative: Localized erythema at site of vaccination. Discussed monitoring closely. Apply cool compress PRN. May use Benadryl q8h for the next several days. Advised to follow-up if area becomes increasingly red, swollen or hard, or if other symptoms of concern develop (including but not limited to persistent fever, urticaria).
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Skin warm, Urticaria
Clinical narrative: Hives (diffuse urticarial rash) started mid-morning day after vaccine - no wheezing or respiratory compromise reported. Child is warm to touch but temperature not taken
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Headache, Nausea, Pyrexia, Sinus disorder
Clinical narrative: fever, headache, sinus problems, diarrhea, nausea
Age: 14.0
Sex: F
Vaccine: MENB
Symptoms: No adverse event
Clinical narrative: No adverse event noted.
Age: 37.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Exposure during pregnancy, Injection site erythema, Injection site rash, Limb mass
Clinical narrative: 29 weeks pregnant.   Painful lump in arm that felt warm to touch.  Bump was red.  Small red bumps on entire right arm, including wrists.
Age: 37.0
Sex: F
Vaccine: TD
Symptoms: Pain, Rash erythematous, Skin warm
Clinical narrative: 29 weeks pregnant.   Painful lump in arm that felt warm to touch.  Bump was red.  Small red bumps on entire right arm, including wrists.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Blood glucose, Hypotonia, Immediate post-injection reaction, Syncope, Unresponsive to stimuli
Clinical narrative: 13 year old patient presented to the pharmacy with his mother to get needed back to school immunizations. Pt received Adacel (Tdap) and Menactra (meningitis) vaccines. Tdap administered to patient in R arm without issue. Pt requested meningitis to be administered in R arm as well. Upon administration of meningitis vaccine Pt immediately went limp. Mother initially thought PT was joking with her, Pharmacist recognized signs of syncope, summoned technician to help respond and retrieve ammonia and epi pen from the immunization supply cart. the patient remained unresponsive and the technician was instructed to call 911. The pharmacist utilized 1 ammonia smelling salt and the patient became partially responsive. EMS arrived shortly thereafter to evaluate the patient. Pt was evaluated by EMS and released into his mothers care after approx. 30 minutes.
Age: 8.0
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Fatigue, Headache, Injection site erythema, Injection site induration, Pain in extremity
Clinical narrative: Pt has had 2.5 inch by 2 inch redness surrounding injection site with slightly hard center. Pain in arm and headache, feeling tired 8-12-2020. Less pain today.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Patient presented to the pharmacy on 8/13/20 with potential cellulitis of the left arm- redness, heat of upper arm. She stated that it began on 8/11/20; the day that she received the vaccine. Patient was advised to use a cold compress, take a benadryl and to contact her PCP.
Age: 84.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Stomatitis, Urticaria
Clinical narrative: Pt reported hives/sores in the mouth
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Burning sensation, Chills, Erythema, Fatigue, Headache
Clinical narrative: I am a healthy and highly active/athletic 66 woman. I had the ppsv-23 injection two days ago. Within 2 hours I began to have severe side effects. These have included extreme pain, edema, redness, and burning in the entire upper arm. I have greatly decreased arm mobility making dressing and performing even the smallest of tasks painful and nearly impossible.  I cannot lie in bed on that side thus rendering sleep tortuous. Additional side effects from this shot have included a bad headache, fatigue, myalgia, and chills. I have been taking Benadryl and Advil and have been icing the upper arm, all of which have helped somewhat. I hope these symptoms/side-effects will dissipate. I will never take this vaccine again nor can I recommend it to anyone. Merck Pharmaceutical, maker of ppsv23 should remove this money-maker from the market.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Insomnia, Loss of personal independence in daily activities, Mobility decreased, Myalgia, Oedema peripheral
Clinical narrative: I am a healthy and highly active/athletic 66 woman. I had the ppsv-23 injection two days ago. Within 2 hours I began to have severe side effects. These have included extreme pain, edema, redness, and burning in the entire upper arm. I have greatly decreased arm mobility making dressing and performing even the smallest of tasks painful and nearly impossible.  I cannot lie in bed on that side thus rendering sleep tortuous. Additional side effects from this shot have included a bad headache, fatigue, myalgia, and chills. I have been taking Benadryl and Advil and have been icing the upper arm, all of which have helped somewhat. I hope these symptoms/side-effects will dissipate. I will never take this vaccine again nor can I recommend it to anyone. Merck Pharmaceutical, maker of ppsv23 should remove this money-maker from the market.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: I am a healthy and highly active/athletic 66 woman. I had the ppsv-23 injection two days ago. Within 2 hours I began to have severe side effects. These have included extreme pain, edema, redness, and burning in the entire upper arm. I have greatly decreased arm mobility making dressing and performing even the smallest of tasks painful and nearly impossible.  I cannot lie in bed on that side thus rendering sleep tortuous. Additional side effects from this shot have included a bad headache, fatigue, myalgia, and chills. I have been taking Benadryl and Advil and have been icing the upper arm, all of which have helped somewhat. I hope these symptoms/side-effects will dissipate. I will never take this vaccine again nor can I recommend it to anyone. Merck Pharmaceutical, maker of ppsv23 should remove this money-maker from the market.
Sex: U
Vaccine: HEPA, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse affects reported.; an expired dose of VAQTA was inadvertently administered to the patient on 7/20/2020; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided. The case concerns 1 patient and 1 combination product. On 20-JUL-2020, the patient was inadvertently vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) lot # S018772, expiration date 07-JUL-2020, (exact dose, injection site and route of administration were not reported) for prophylaxis. There was no adverse effects reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: S018772; expirationdate: 07-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability