chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Insomnia, Muscular weakness, Myalgia
Clinical narrative: couldn't sleep and had to walk around the room; severe muscle problems and muscle weakness, muscle problems lasted for 10 to 12 hours; really bad body aches; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (couldn't sleep and had to walk around the room), MUSCULAR WEAKNESS (severe muscle problems and muscle weakness, muscle problems lasted for 10 to 12 hours) and MYALGIA (really bad body aches) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A, 011821A and 030620A) for COVID-19 vaccination.     It was reported that patient had no allergies. Patient was never diagnosed with COVID-19.  The patient's past medical history included Knee replacement (due to osteoarthritis) on 20-Aug-2021. Concurrent medical conditions included Osteoarthritis (10 to 12 years ago or longer,Recent change involving worsening.), Coronary artery disease (No recent change in status reported), Depression (No recent change in status reported), Eye disorder NOS (Age related eye disease, No recent change in status reported) and Immunosuppression (Immunologically suppressed, No recent change in status reported). Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR), EZETIMIBE (ZETIA), DULOXETINE HYDROCHLORIDE (CYMBALTA), ASCORBIC ACID, TOCOPHERYL ACETATE, XANTOFYL, ZEAXANTHIN, ZINC (AREDS), FISH OIL, VITAMIN D [VITAMIN D NOS] and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 27-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 27-Aug-2021, the patient experienced INSOMNIA (couldn't sleep and had to walk around the room), MUSCULAR WEAKNESS (severe muscle problems and muscle weakness, muscle problems lasted for 10 to 12 hours) and MYALGIA (really bad body aches). In August 2021, MUSCULAR WEAKNESS (severe muscle problems and muscle weakness, muscle problems lasted for 10 to 12 hours) had resolved. At the time of the report, INSOMNIA (couldn't sleep and had to walk around the room) and MYALGIA (really bad body aches) outcome was unknown.            Concomitant medications reported included Areds eye vitamins, two fish oils and Vitamin B + Folic for unknown indications.  Patient had no problems with her breathing and the muscle problems lasted for 10 to 12 hours. Patient had a hand surgery on 11-Jan-2022 at the base of the left thumb. She reported they removed the trapezium bone and did the tendon repair.  No treatment medications were reported.   This case was linked to MOD-2022-560464, MOD-2022-560454, MOD-2022-560457 (Patient Link).
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Chest discomfort, Cough, Dizziness, Dyspnoea
Clinical narrative: Immediately following the vaccine, I experienced shortness of breath and chest tightness. I felt well enough to drive home, and these dissipated. The next morning I had such a sore arm that I could not drive, and the pain radiated through my neck and down my left side to my buttocks and left thigh. This was debilitating pain. I also experienced bad covid-like symptoms. I had already had covid twice, and this felt as bad as covid, if not worse. I had a fever, sore throat, coughing, dizzy spells, difficulty breathing and regulating temperature, and extreme nausea. I laid in bed all day feeling sick. This continued for 5 days. These side effects were extreme, but I expected much lesser versions of them, so I wasn't too upset about it. That first night, however, was when the real side effects began. I woke up gasping for air, as if I hadn't breathed in a long time. I vaguely remembered dreaming that I couldn't breathe. I thought it was just a weird occurance. The next night it happened again, still feeling very sick all day, and again I woke up with a start gasping for air, like my brain had stopped my body's natural breathing. Since having the vaccine, this has happened 6 nights. It is absolutely terrifying. Each time I wake up so afraid and feeling like I am about to die.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Fear, Flank pain, Immediate post-injection reaction, Impaired driving ability, Malaise
Clinical narrative: Immediately following the vaccine, I experienced shortness of breath and chest tightness. I felt well enough to drive home, and these dissipated. The next morning I had such a sore arm that I could not drive, and the pain radiated through my neck and down my left side to my buttocks and left thigh. This was debilitating pain. I also experienced bad covid-like symptoms. I had already had covid twice, and this felt as bad as covid, if not worse. I had a fever, sore throat, coughing, dizzy spells, difficulty breathing and regulating temperature, and extreme nausea. I laid in bed all day feeling sick. This continued for 5 days. These side effects were extreme, but I expected much lesser versions of them, so I wasn't too upset about it. That first night, however, was when the real side effects began. I woke up gasping for air, as if I hadn't breathed in a long time. I vaguely remembered dreaming that I couldn't breathe. I thought it was just a weird occurance. The next night it happened again, still feeling very sick all day, and again I woke up with a start gasping for air, like my brain had stopped my body's natural breathing. Since having the vaccine, this has happened 6 nights. It is absolutely terrifying. Each time I wake up so afraid and feeling like I am about to die.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal pain, Nausea, Neck pain, Oropharyngeal pain, Pain
Clinical narrative: Immediately following the vaccine, I experienced shortness of breath and chest tightness. I felt well enough to drive home, and these dissipated. The next morning I had such a sore arm that I could not drive, and the pain radiated through my neck and down my left side to my buttocks and left thigh. This was debilitating pain. I also experienced bad covid-like symptoms. I had already had covid twice, and this felt as bad as covid, if not worse. I had a fever, sore throat, coughing, dizzy spells, difficulty breathing and regulating temperature, and extreme nausea. I laid in bed all day feeling sick. This continued for 5 days. These side effects were extreme, but I expected much lesser versions of them, so I wasn't too upset about it. That first night, however, was when the real side effects began. I woke up gasping for air, as if I hadn't breathed in a long time. I vaguely remembered dreaming that I couldn't breathe. I thought it was just a weird occurance. The next night it happened again, still feeling very sick all day, and again I woke up with a start gasping for air, like my brain had stopped my body's natural breathing. Since having the vaccine, this has happened 6 nights. It is absolutely terrifying. Each time I wake up so afraid and feeling like I am about to die.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Temperature regulation disorder
Clinical narrative: Immediately following the vaccine, I experienced shortness of breath and chest tightness. I felt well enough to drive home, and these dissipated. The next morning I had such a sore arm that I could not drive, and the pain radiated through my neck and down my left side to my buttocks and left thigh. This was debilitating pain. I also experienced bad covid-like symptoms. I had already had covid twice, and this felt as bad as covid, if not worse. I had a fever, sore throat, coughing, dizzy spells, difficulty breathing and regulating temperature, and extreme nausea. I laid in bed all day feeling sick. This continued for 5 days. These side effects were extreme, but I expected much lesser versions of them, so I wasn't too upset about it. That first night, however, was when the real side effects began. I woke up gasping for air, as if I hadn't breathed in a long time. I vaguely remembered dreaming that I couldn't breathe. I thought it was just a weird occurance. The next night it happened again, still feeling very sick all day, and again I woke up with a start gasping for air, like my brain had stopped my body's natural breathing. Since having the vaccine, this has happened 6 nights. It is absolutely terrifying. Each time I wake up so afraid and feeling like I am about to die.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Computerised tomogram abnormal, Magnetic resonance imaging
Clinical narrative: Within 48-72 hours after Moderna booster vaccine, patient developed an occipital stroke, confirmed with CT imagining in the ED.  MRI pending during hospital admission.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Chest pain, Pain, Painful respiration
Clinical narrative: Severe chest/heart pain and pain while breathing, aches in body
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site pain, Mechanical urticaria, Pruritus, Skin swelling
Clinical narrative: No adverse effect besides soreness on injection site right after the vaccine for the 2nd booster shot. Same reactions with the First two shots and 1st booster shot.   2 weeks after the second booster. Itching hands and feet. Scratching resulted in hives, welts, redness. Was able materials like handles of Tote bags that were scratchy would result in redness and or bumps/raised skin. Was able to scratch skin spelling out my name and I could write on my skin. Would disappear after about 30 min. Self diagnosed it to be Dermatographia. I?ve never been a person that experiences allergic reactions to foods or vaccines before. Went to see my GP and he agreed with my self diagnosis as Dermatographia appeared exactly two weeks after my second Pfizer booster shot.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: No adverse effect besides soreness on injection site right after the vaccine for the 2nd booster shot. Same reactions with the First two shots and 1st booster shot.   2 weeks after the second booster. Itching hands and feet. Scratching resulted in hives, welts, redness. Was able materials like handles of Tote bags that were scratchy would result in redness and or bumps/raised skin. Was able to scratch skin spelling out my name and I could write on my skin. Would disappear after about 30 min. Self diagnosed it to be Dermatographia. I?ve never been a person that experiences allergic reactions to foods or vaccines before. Went to see my GP and he agreed with my self diagnosis as Dermatographia appeared exactly two weeks after my second Pfizer booster shot.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness unilateral, Ear discomfort, Inappropriate schedule of product administration, Pain
Clinical narrative: I made a prior report regarding the total body aches but now I have lost hearing in my right ear
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Fever and chills - Fever of 102 F 10 hours after injection / reduced to 99.8 F 16 hours after injection Moderate pain in the injection arm Redness and swelling at the injection site Fatigue Muscle pain Headache
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Myalgia, Pyrexia
Clinical narrative: Fever and chills - Fever of 102 F 10 hours after injection / reduced to 99.8 F 16 hours after injection Moderate pain in the injection arm Redness and swelling at the injection site Fatigue Muscle pain Headache
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Eyelid ptosis, Pyrexia
Clinical narrative: Fever and chills - Fever of 102 F 10 hours after injection / reduced to 99.8 F 16 hours after injection Moderate pain in the injection arm Redness and swelling at the injection site Fatigue Muscle pain Headache
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pain
Clinical narrative: 5/11/2022: 5:00 am Chills, achy, fever 101.7, extreme fatigue, headache, nausea,  6:00 pm vomiting
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: 5/11/2022: 5:00 am Chills, achy, fever 101.7, extreme fatigue, headache, nausea,  6:00 pm vomiting
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site scar, Vaccination site vesicles
Clinical narrative: developed a large blister at the vaccine site day 2 it appears to be forming a keloid some itchiness
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Rheumatological examination, Therapeutic response unexpected
Clinical narrative: Maintained all the improvements with RA after first booster dose/Improvements in IL6 driven autoimmune disease after vaccination/Rheumatory Arthritis (RA) has gone away after 4 Moderna vaccination; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Maintained all the improvements with RA after first booster dose/Improvements in IL6 driven autoimmune disease after vaccination/Rheumatory Arthritis (RA) has gone away after 4 Moderna vaccination) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A, 033C21A, 007M20A and 030L20A) for COVID-19 vaccination.     Previously administered products included for RA: Methotrexate in 2018 and LEFLUNOMIDE until August 2020. Past adverse reactions to the above products included No adverse event with LEFLUNOMIDE and Methotrexate. Concurrent medical conditions included RA since 2014 and Cancer.   On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jan-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2022, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Maintained all the improvements with RA after first booster dose/Improvements in IL6 driven autoimmune disease after vaccination/Rheumatory Arthritis (RA) has gone away after 4 Moderna vaccination). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Maintained all the improvements with RA after first booster dose/Improvements in IL6 driven autoimmune disease after vaccination/Rheumatory Arthritis (RA) has gone away after 4 Moderna vaccination) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Rheumatological examination: normal (normal) zero positive RA.         No concomitant medication were reported. Patient stated that after vaccination all positive RA numbers went down. All RA manifestations went away. Lab test Predictors of RA are completely gone. The patient had minimal arthritis symptoms from time to time and it goes away without using any medications. No treatment information were provided.   This case was linked to MOD-2022-564583, MOD-2022-564650, MOD-2022-564648 (Patient Link).
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Overdose
Clinical narrative: A dose of PROQUAD was administered with VARIVAX for 8 different patients; This spontaneous report has been received from a pharmacy technician referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not provided.  On 29-APR-2022 the patient was vaccinated with one dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) as prophylactic vaccination ( dose, route of administration, anatomical location and vaccination scheme frequency were not provided) lot number U024221 has been verified to be a valid lot number, expiration date 04-AUG-2023, and with one dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (recombinant human albumin rHA) (PROQUAD) (dose, route of administration, anatomical location and vaccination scheme frequency were not provided) lot number U028179 has been verified to be a valid lot number, expiration date 08-MAR-2023 (vaccine overdose).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2204USA004990: US-009507513-2204USA005095: US-009507513-2204USA005731: US-009507513-2204USA005733: US-009507513-2204USA005079: US-009507513-2204USA005707:
Age: 37.0
Sex: F
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: HCP reported an adverse event for GARDASIL 9. Caller explained a patient was administered an expired dose of GARDASIL 9. Caller confirmed the GARDASIL 9 has not had a temperature excursions. No additional AE or PQC reported. No additional information; HCP reported an adverse event for GARDASIL 9. Caller explained a patient was administered an expired dose of GARDASIL 9. Caller confirmed the GARDASIL 9 has not had a temperature excursions. No additional AE or PQC reported. No additional information; This spontaneous report was received from a medical assistant and refers to a 37-year-old female. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 08-APR-2022, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) prefilled syringe, 0.5ml, lot #1637641, administered for prophylaxis (strength, and route of administration were not provided). The dose of the vaccine expired on 16-FEB-2022.  The vaccine had no temperature excursions. By the time of reporting the patient was okay. No adverse events were reported.
Age: 1.75
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional adverse events were reported; Patient received VARIVAX and PROQUAD together; This spontaneous report was received from a registered nurse referring to a 21-month-old, patient of unknown gender, whose medical history, concurrent conditions, and concomitant therapies were not provided.  On 31-MAR-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, dose reported as 1 dose, administered for prophylaxis (lot number: u024220, has been verified to be a valid lot number, and expiration date: 04-AUG-2023; exact dose, vaccination scheme frequency, route of administration, and anatomical location were not provided); it was administered together with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, for prophylaxis (exact dose, vaccination scheme frequency, route of administration, anatomical location, lot number, and expiration date were not provided) (overdose).   No additional adverse events were reported.
Sex: U
Vaccine: MMRV
Symptoms: Incomplete course of vaccination
Clinical narrative: The customer reported PROQUAD was administered after a temperature excursion; This spontaneous report was received from a patient of unknown gender and age referred to himself/herself.  The patient's medical history, concurrent condition, and concomitant therapy were not reported.  On 30-APR-2021, the patient was administered measles (+) mumps (+) rubella (+) varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) subcutaneous injection (lot #U028184 has been verified to be a valid lot number with expiration date 08-MAR-2023 (dose, and route of administration were not provided) for prophylaxis after four hours of temperature excursion under the temperature of -12.3 degree Celsius. (Product storage error).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2204USA006621: US-009507513-2204USA006030: US-009507513-2204USA006215: US-009507513-2204USA006070:
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: No adverse event, Product use issue
Clinical narrative: adverse reaction or side effects experienced: none; "pneumonia" vaccines administered on 04-AUG-2016 and 09-NOV-2017; This spontaneous report has been received from a lawyer, via a Plaintiff Fact Sheet from a case in litigation for zoster vaccine live (ZOSTAVAX) (original legal case: MARRS # 2105USA004394), concerning a 71-year-old male patient. The patient's historical conditions included coronary artery surgery and varicella. His concurrent conditions included deafness neurosensory, back injury, disability, myocardial ischaemia, obstructive sleep apnoea syndrome, pulmonary mass, blood cholesterol increased, hypersensitivity, hypertension, tobacco user and pain prophylaxis. Concomitant therapies included atorvastatin, isosorbide mononitrate, ranolazine, metoprolol succinate, albuterol sulfate, budesonide and fluticasone.  On 04-AUG-2016 and 09-NOV-2017, the patient was vaccinated by a healthcare provider at a medical center with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (referred to as an unspecified "pneumonia" vaccine; dose, route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis (drug use for unapproved schedule). The patient had none adverse reaction or side effects experienced with regard to the suspect vaccine (no adverse reaction).  This is one of three cases concerning the same patient.; Sender's Comments:  US-009507513-2105USA004394: US-009507513-2204USA006883:
Age: 23.0
Sex: F
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No additional AE reported; 23 year old patient was administered a dose of PROQUAD on 13-APR-2022; the patient should received MMR and Varicella separately and not the combined dose; This spontaneous report was received from a certified medical assistant and refers to a 23-year-old female patient. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient had viral titre measurement done, which showed that the patient was not fully immunized against measles, mumps, and rubella (MMR) and varicella. On 12-APR-2022, she received tuberculin PPD (purified protein derivative of tuberculin (TB-PPD)) as a part of PPD test. The patient's concomitant vaccination included unspecified hepatitis B (Hep B) adult vaccine (manufacturer reported as GlaxoSmithKline (GSK)).  On 13-APR-2022, the patient was vaccinated by a healthcare professional with measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant human albumin (rHA) (PROQUAD) at a dose of 0.5 ml, subcutaneously (SQ) in the left arm, lot # U026799, expiration date 26-FEB-2023 to repeat the immunization series as required by her grad school (prophylaxis). The vaccine was reconstituted with a sterile diluent (exact volume of the diluent, lot number and expiration date were not reported). The reporter stated, that according to the patient's age, she should be vaccinated with MMR and varicella vaccine separately instead of the combined dose (product administered to patient of inappropriate age, wrong vaccine administered). No adverse events were reported (described also as the patient had no response and no reactions). No prescription drug treatment was required for the reported experience.
Age: 57.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No additional AE reported; HCP reported that a adult patient received a pediatric dose of VAQTA. No additional AE reported. No PQC reported. No further information was provided.; This spontaneous report was received from healthcare professional (HCP) and refers to a 57-year-old female patient. Information regarding the patient's historical conditions, past drugs reactions or allergies, concurrent conditions or concomitant therapies was not provided. /was unknown by the reporter.  On 31-MAR-2022, the patient was vaccinated with a pediatric dose of hepatitis a vaccine, inactivated (VAQTA) injection at a dose of 0.5 milliliters (mL) (incorrect dose administered) administered for prophylaxis (lot #U012525 verified as valid, expiration date reported and stablished as 06-FEB-2023) (strength, and route of administration were not provided). No additional adverse events (AE) reported.
Age: 59.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional AE's; The pharmacist stated that a patient was administered a MMR II vaccine via the intramuscular route instead of the subcutaneous route.; This spontaneous report was received from a pharmacist and refers to a 59-year-old female patient (reported as 58-year-old patient, conflicting information). The patient's concurrent conditions, medical history and concomitant therapies were not reported. There was no information regarding the patient's allergies or drug reactions.  On 21-APR-2022, the patient was vaccinated with second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), intramuscularly instead subcutaneously (incorrect route of product administration), albumin status rHa, lot #U028163, expiration date: 09-SEP-2023, (strength, exact dose were not provided) for prophylaxis; and sterile diluent (MERCK STERILE DILUENT) solution for injection/infusion, (strength, exact dose, expiration date, were not reported). Lot #00006468200 is an invalid lot # for sterile diluent (MERCK STERILE DILUENT). Lot #00006468200 does not match any Company product as confirmed by Lot Verification team. No additional adverse events was reported (no adverse events).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Caller reports expired dose of MMR II was administered.  No additional information provided.  No additional AEs or PQC reported.; This spontaneous report was received from an unspecified reporter regarding to a patient of unknown age and gender. The patient's concurrent conditions, medical history, and  historical drugs, were not reported.  On 18-APR-2022, the patient was vaccinated with a expired dose of measles, mumps, and rubella (Wistar RA 27-3) Virus Vaccine, Live (recombinant human albumin) (M-M-R II)  0.5ml, subcutaneously (SQ)  (lot number T013003 has been verified to be valid, expiration date: 15-APR-2022), in addition with sterile diluent, 0.5 ml, SQ, (lot number U006619 has been verified to be valid, expiration date: 06-SEP-2023) (anatomical location was not provided) as prophylaxis.   At the time of reporting, no additional information was provided, furthermore no adverse events were reported.
Sex: F
Vaccine: PNC15, PPV
Symptoms: Drug hypersensitivity
Clinical narrative: Drug allergies to pneumococcal vaccine; This spontaneous report was received from a nurse and refers to a female patient who was 72-year-old at the time of reporting. Her concurrent conditions included breast cancer, papillary thyroid cancer, hyperlipidemia, Meniere's disease, hypertension, hypothyroidism and diverticulitis. Her drug allergies included allergy to ciprofloxacin, erythromycin, penicillin, metronidazole, rosuvastatin, tetracycline, dust and mold.  On an unknown date, the patient was vaccinated with pneumococcal vaccine (manufacturer unknown) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis. On an unknown date, she experienced drug hypersensitivity. Outcome of the event was unknown.  Causal relationship between suspect therapies and pneumococcal vaccine (manufacturer unknown) was assessed as related.  This is one of two reports received from the same reporter. ; Sender's Comments:  US-009507513-2204USA006002:
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: COVID-19, Herpes zoster
Clinical narrative: I had a light case of COVID; On 22APR2022 I got shingles again in a different spot.; I recently got shingles on 03APR2022; Caller is a consumer reporting an AE after being separately vaccinated with ZOSTAVAX and an additional unspecified shingles vaccine.; This spontaneous information has been received from a 81-year-old female patient, reporting on herself.  The patient's medical history was not reported, however she stated that had a pacemaker. Her concurrent conditions were not reported. She reported that was allergic to penicillin, clindamycin, and sulfa drugs. The concomitant medications were reported as ''I took a whole lot of medication''.  On an unknown date in 2016 (also reported as ''a few years ago'' and ''maybe five or six years''), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose lot #, expiry date, and route of administration were not provided); and then separately received another dose of an unspecified shingles vaccines  (manufacturer unknown) (extra dose administered) (strength, lot #, expiry date, and route of administration were not provided), both administered as ''protection to getting shingles''.   Moreover, on an unknown date, the patient stated that since being vaccinated with zoster vaccine live (ZOSTAVAX) she experienced ''light case of COVID'' and received unspecified treatment and sought medical attention. On 03-APR-2022, she had shingles, so she went to the emergency department (ER). There, she was placed on treatment with antiviral medication (valacyclovir) 1 gram three times (3x) daily, for ten days. On 22-APR-2022, she got shingles again in a different spot, and received another 10-day round of treatment with valacyclovir. No additional information was provided. At the reporting time, the status of the subject was not recovered.  The causal assessment between zoster vaccine live (ZOSTAVAX) and the events was unknown.  On 09-MAY-2022, additional information was requested.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Caller is an office manager who reports administration of vaccine following temperature excursion. No adverse effects of administration. No further information provided. No other AE/no PQC. Names of vaccines involved (including lot/exp):; Caller is an office manager who reports administration of vaccine following temperature excursion; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender.  The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On an unspecified date, a temperature excursion issue occurred and on 22-APR-2022, the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 ml/once, orally, lot #1821247, expiration date: 23-JUL-2022 (strength not provided) as prophylaxis. call was made by an office manager who reported the administration of vaccine following temperature excursion. The vaccine underwent a temperature excursion of 11.4 degree Celsius (C) for a period of 4 hours and 45 minutes. The vaccine underwent a previous temperature excursion at 10.7 C for 1 hour and 15 minutes. The patient did not experience any adverse effects after administration. No further information provided.
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Caller is an office manager who reports administration of vaccine following temperature excursion. No adverse effects of administration. No further information provided. No other AE/no PQC.         ?    Names of vaccines involved (including lot/exp; Caller is an office manager who reports administration of vaccine following temperature excursion. No adverse effects of administration. No further information provided. No other AE/no PQC.         ?    Names of vaccines involved (including lot/exp; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender.  The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 18-APR-2022, the patient was vaccinated with an improper storage dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5ml/once, with valid lot #U016064, expiration date: 20-MAY-2023 (strength, route of administration, and indication were not provided); and with sterile diluent (DILUENT MRK) (strength, formulation, dose description, lot #, expiry date, route of administration, and indication were not provided).  Temperature was 14.5 degree Celsius (C) time frame of 10 hours, there was not previous temperature excursion. No adverse effects after administration. No further information was provided.
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products, No adverse event
Clinical narrative: No other AE/no PQC/had no adverse effects or symptoms; caller mentioned that patient received a dose of GARDASIL 9 as a third dose; caller mentioned that patient received a dose of GARDASIL 9 as a third dose; a patient received her second dose of GARDASIL too early; This spontaneous report was received from a medical assistant and referred to a female patient of unknown age. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 04-OCT-2008, the patient received the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) for prophylaxis (strength, dose, and route of administration were not provided; lot #0570X, expiration date was not reported, upon internal validation established as 02-NOV-2010; once).  On 12-NOV-2008, the patient received her second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) for prophylaxis (strength, dose, and route of administration were not provided; lot #0548X, expiration date was not reported, upon internal validation established as 29-NOV-2010; once) too early (inappropriate schedule of product administration). The patient had no adverse effects or symptoms due to early dose.  On 28-APR-2022, the patient received a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) as a third dose in her series for prophylaxis (strength, lot #, expiry date, and route of administration were not provided; once) (inappropriate schedule of product administration and interchange of vaccine products).  No other adverse event was reported.
Sex: M
Vaccine: HPV4, HPV9
Symptoms: Vaccination failure
Clinical narrative: he received GARDASIL and it did not work for him; he is seemingly unhappy; This spontaneous report was received from a pharmacist via company representative, who is also a male patient of unknown age.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with the company unidentified human papillomavirus (HPV) vaccine (strength, exact dose, dose #, lot #, expiry date, anatomical location and route of administration were not provided) (not verify whether the reporter was talking about GARDASIL or GARDASIL 9) for prophylaxis. He stated that it did not work for him (vaccination failure). The patient was seemingly unhappy with this experience.  At the time of reporting, the outcome of the events was unknown.   The causal relationship between the events and the suspect therapy was unknown.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2205USA002125:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; Nurse reporting an AE for MMRII that was administered after the expiration. No additional AE reported. No PQC.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 05-MAY-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin (rHA)) (M-M-R II), 0.5ml, lot #T012808 was confirmed to be valid, expiration date: 14-APR-2022, administered for prophylaxis (strength, dosing schedule site and route of administration were not provided). (Expired product administered) No additional adverse event was reported.
Sex: M
Vaccine: MMR
Symptoms: Autism spectrum disorder
Clinical narrative: autism; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to an male patient (pt) (age not provided). The pt's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 29-FEB-2000, the pt received a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (dosage information, lot # and expiration date were not provided) for its intended purpose: prophylaxis. On unspecified date, after the receipt of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), the patient was diagnosed with autism. As a result of the vaccination with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) the patient was caused and/or in the future will be caused to suffer severe personal injuries, pain, disability, and suffering. At the time of the report, the patient had not recovered from the event. The reporter considered the event to be related to the suspect therapy.   Upon internal review, the event of autism was considered medically significant. The reporter considered the event to be disabling.   This is one of two reports received from the same source.; Sender's Comments:  US-009507513-2205USA002241:
Sex: F
Vaccine: MMR
Symptoms: Autism spectrum disorder
Clinical narrative: autism; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to an  female patient (pt) (age not provided). The pt's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 14-NOV-2006, the pt received a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (dosage information, lot # and expiration date were not provided) for its intended purpose: prophylaxis. On unspecified date, after the receipt of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), the pt was diagnosed with autism. As a result of the vaccination with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) the patient was caused and/or in the future will be caused to suffer severe personal injuries, pain, disability, and suffering. At the time of the report, the patient had not recovered from the event. The reporter considered the event to be related to the suspect therapy.   Upon internal review, the event of autism was considered medically significant. The reporter considered the event to be disabling.   This is one of two reports received from the same source.; Sender's Comments:  US-009507513-2205USA002222:
Age: 54.0
Sex: U
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: No additional AE details; pediatric dose of VAQTA was given to an adult patient; This spontaneous report was received from a medical assistant and refers to a patient of unknown gender who was 56-year-old at the time of reporting. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On an unknown date in October 2020, the patient was vaccinated with a pediatric dose of hepatitis a vaccine, inactivated (VAQTA) pre-filled syringe, first dose, lot #T014590, expiration date: 15-APR-2021 (strength, exact dose, site and route of administration were not provided) for prophylaxis (Product use issue). This was discovered later in electronic medical records. On an unknown date in November 2021, the patient received second dose of vaccine, which was an adult dose. No adverse events were reported (No adverse event).
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Caller reporting an AE for PROQUAD being administered after an excursion that occurred on 4/25/2022.; This spontaneous report aws received from a medical assistant and  refers to a patient of unknown age. The patient's concurrent conditions, drug reactions or allergies, pertinent medical history and concomitant therapy were not reported.   On 25-APR-2022, measles, mumps, rubella and varicella (oka-merck) virus vaccine live, (rHA) (PROQUAD), was exposed to -2 Celsius (C) during 1 hour and 12 minutes. Also, the vaccine had previous temperatures excursions: -10°C up to 8°C (7.3C) for 2 hours 37 minutes 0 seconds and -10°C up to 8°C (0.7C) for 2 hours 56 minutes 0 seconds.  On 03-MAY-2022, the patient was vaccinated with an incorrect storage dose of  measles, mumps, rubella and varicella (oka-merck) virus vaccine live, (rHA) (PROQUAD), lot # U029319, expiration date 13-MAR-2023, 0.5 milliliter (route was not reported) (storage error) for prophylaxis. There was no product quality complain reported.  Thias is one of several reports form the same reporter.; Sender's Comments:  US-009507513-2205USA002635: US-009507513-2205USA002473: US-009507513-2205USA002581: US-009507513-2205USA002746: US-009507513-2205USA002531:
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: Very sick; This case was reported by a consumer via call center representative and described the occurrence of sickness in a 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 sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.     Additional Information: GSK Receipt Date: 02-MAY-2022 Reporter's comment: The patient was very sick from first and second was scheduled for the day of reporting; asked would patient be just as bad.
Sex: U
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: shingles rash on my leg; This case was reported by a consumer via interactive digital media and described the occurrence of rash zosteriform in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had 6 month prior to the reporting date).   On 28th April 2022, the patient received the 1st dose of Shingrix. On 1st May 2022, 3 days after receiving Shingrix, the patient experienced rash zosteriform. On an unknown date, the outcome of the rash zosteriform was unknown.   It was unknown if the reporter considered the rash zosteriform to be related to Shingrix.     Additional Information: GSK Receipt Date: 02-MAY-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient got the Shingrix shot on Thursday and the day prior to reporting patient saw a small shingles rash on leg (where patient had it just 6 months prior to reporting). The patient asked should patient take the medications, or did that hurt the impact of the vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Urticaria
Clinical narrative: welt; fatigue, tiredness; This case was reported by a other health professional via call center representative and described the occurrence of welts in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th January 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced welts and fatigue. On an unknown date, the outcome of the welts and fatigue were unknown.   It was unknown if the reporter considered the welts and fatigue to be related to Shingrix.     Linked case(s) involving the same patient:  US2022073178   Additional Information: GSK Receipt Date: 03-MAY-2022 Reporter's Comments: The reporter stated that the patient received Shingrix and experienced a welt, fatigue and tiredness. The reporter was unable to provide full vaccine details. The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022073178:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Get 2nd dose 10 months apart; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in May 2021).   In March 2022, the patient received the 2nd dose of Shingles vaccine. In March 2022, unknown after receiving Shingles vaccine, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 03-May-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The patient stated that since the doses were 10 months apart, did he/she need to get another shot. Additional Supportive Information: The patient received delayed 2nd Shingrix shot, which led to lengthening of vaccination schedule. The follow-up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Painful spot on arm that received the shot; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a 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 injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 6-May-2022 Reporter's Comment: This case was reported by a consumer via interactive digital media. The patient experienced painful spot on arm that received the Shingrix shot. The patient asked was it normal. Additional supportive information: The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Vertigo
Clinical narrative: Terrible vertigo; This case was reported by a consumer via interactive digital media and described the occurrence of vertigo in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 5th May 2022 12:00, the patient received Shingles vaccine. On 7th May 2022, 2 days after receiving Shingles vaccine, the patient experienced vertigo. On an unknown date, the outcome of the vertigo was unknown.   It was unknown if the reporter considered the vertigo to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 7-May-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingles vaccine on Thursday at noon and he/she woke up this morning (day of reporting) with terrible vertigo. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: 3 days later the 2nd dose started getting big blisters spots; This case was reported by a consumer via interactive digital media and described the occurrence of blister in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2022, the patient received the 2nd dose of Shingrix. In April 2022, an unknown time after receiving Shingrix, the patient experienced blister. On an unknown date, the outcome of the blister was unknown.   It was unknown if the reporter considered the blister to be related to Shingrix.     Additional Information: GSK Receipt Date: 7-May-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingrix vaccine 10 days ago and 3 days later he/she started getting big blisters spots all over his/her right side. The patient asked could he/she get Shingles from the vaccine. Additional supportive information: The follow-up would not possible, as no contact, details were available.