chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: RV5
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: On multiple unspecified dates, multiple unspecified patientes received improperly stored vaccine; No adverse effect; This spontaneous report has been received from a medical assistant, concerning an 9-week-old female patient.   The patient's concurrent conditions, historical conditions, previous drug reactions, or allergies and concomitant medication were not reported.  On 05-APR-2019, the patient was vaccinated with improper stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (dose, frequency, route of administration unknown) Lot#R016790 and expiration date 20-APR-2020 for prophylaxis. No adverse effects reported.  Additionally, temperature for vaccines were total time and highest temperature above 9°C (9.9 C); time frame: 4 hours; with no previous temperature excursion. The error was identified via a data logger.; Sender's Comments:  US-009507513-1903USA013366:
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: On multiple unspecified dates, multiple unspecified patientes received improperly stored vaccine; No adverse effect; This spontaneous report has been received from a medical assistant, concerning a 10-week-old female patient.   The patient's concurrent conditions, historical conditions, previous drug reactions, or allergies and concomitant medication were not reported.  On 05-APR-2019, the patient was vaccinated with improper stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (dose, frequency, route of administration unknown) Lot#R016790 and expiration date 20-APR-2020 for prophylaxis. No adverse effects reported.  Additionally, temperature for vaccines were total time and highest temperature above 9°C (9.9 C); time frame: 4 hours; with no previous temperature excursion. The error was identified via a data logger.; Sender's Comments:  US-009507513-1903USA013366:
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: On multiple unspecified dates, multiple unspecified patientes received improperly stored vaccine; No adverse effect; This spontaneous report has been received from a medical assistant, concerning a 27-week-old female patient.   The patient's concurrent conditions, historical conditions, previous drug reactions, or allergies and concomitant medication were not reported.  On 03-APR-2019, the patient was vaccinated with improper stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (dose, frequency, route of administration unknown) Lot#R016790 and expiration date 20-APR-2020 for prophylaxis. No adverse effects reported.  Additionally, temperature for vaccines were total time and highest temperature above 9°C (9.9 C); time frame: 4 hours; with no previous temperature excursion. The error was identified via a data logger.; Sender's Comments:  US-009507513-1903USA013366:
Sex: M
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: On multiple unspecified dates, multiple unspecified patientes received improperly stored vaccine; No adverse effect; This spontaneous report has been received from a medical assistant, concerning a 81-week-old male patient.   The patient's concurrent conditions, historical conditions, previous drug reactions, or allergies and concomitant medication were not reported.  On 24-APR-2019, the patients were vaccinated with improper stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # R000555 and expiration date 08-JAN-2020) (anatomical location not reported) for prophylaxis. The measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) vaccine was reconstituted with properly stored sterile diluent. No adverse effects reported.  Additionally, temperature for vaccines were total time and highest temperature above 9°C (9.9 C); time frame: 4 hours; with no previous temperature excursion. The error was identified via a data logger.; Sender's Comments:  US-009507513-1903USA013366:
Age: 1.25
Sex: F
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: On multiple unspecified dates, multiple unspecified patientes received improperly stored vaccine; No adverse effect; This spontaneous report has been received from a medical assistant, concerning a 61-week-old female patient.   The patient's concurrent conditions, historical conditions, previous drug reactions, or allergies and concomitant medication were not reported.  On 25-APR-2019, the patients were vaccinated with improper stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # R000555 and expiration date 08-JAN-2020) (anatomical location not reported) for prophylaxis. The measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) vaccine was reconstituted with properly stored sterile diluent. No adverse effects reported.  Additionally, temperature for vaccines were total time and highest temperature above 9°C (9.9 C); time frame: 4 hours; with no previous temperature excursion. The error was identified via a data logger.; Sender's Comments:  US-009507513-1903USA013366:
Sex: F
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: On multiple unspecified dates, multiple unspecified patientes received improperly stored vaccine; No adverse effect; This spontaneous report has been received from a medical assistant, concerning a 54-week-old female patient.   The patient's concurrent conditions, historical conditions, previous drug reactions, or allergies and concomitant medication were not reported.  On 23-APR-2019, the patients were vaccinated with improper stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # R000555 and expiration date 08-JAN-2020) (anatomical location not reported) for prophylaxis. The measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) vaccine was reconstituted with properly stored sterile diluent. No adverse effects reported.  Additionally, temperature for vaccines were total time and highest temperature above 9°C (9.9 C); time frame: 4 hours; with no previous temperature excursion. The error was identified via a data logger.
Age: 1.33
Sex: M
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: On multiple unspecified dates, multiple unspecified patientes received improperly stored vaccine; No adverse effect; This spontaneous report has been received from a medical assistant, concerning a 64-week-old female patient.   The patient's concurrent conditions, historical conditions, previous drug reactions, or allergies and concomitant medication were not reported.  On 23-APR-2019, the patients were vaccinated with improper stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # R000555 and expiration date 08-JAN-2020) (anatomical location not reported) for prophylaxis. The measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) vaccine was reconstituted with properly stored sterile diluent. No adverse effects reported.  Additionally, temperature for vaccines were total time and highest temperature above 9°C (9.9 C); time frame: 4 hours; with no previous temperature excursion. The error was identified via a data logger.; Sender's Comments:  US-009507513-1903USA013366:
Age: 1.08
Sex: M
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: On multiple unspecified dates, multiple unspecified patientes received improperly stored vaccine; No adverse effect; This spontaneous report has been received from a medical assistant, concerning a 54-week-old male patient.   The patient's concurrent conditions, historical conditions, previous drug reactions, or allergies and concomitant medication were not reported.  On 18-APR-2019, the patients were vaccinated with improper stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # R000555 and expiration date 08-JAN-2020) (anatomical location not reported) for prophylaxis. The measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) vaccine was reconstituted with properly stored sterile diluent. No adverse effects reported.  Additionally, temperature for vaccines were total time and highest temperature above 9°C (9.9 C); time frame: 4 hours; with no previous temperature excursion. The error was identified via a data logger.; Sender's Comments:  US-009507513-1903USA013366:
Age: 1.08
Sex: M
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: On multiple unspecified dates, multiple unspecified patientes received improperly stored vaccine; No adverse effect; This spontaneous report has been received from a medical assistant, concerning a 52-week-old male patient.   The patient's concurrent conditions, historical conditions, previous drug reactions, or allergies and concomitant medication were not reported.  On 12-APR-2019, the patients were vaccinated with improper stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # R000555 and expiration date 08-JAN-2020) (anatomical location not reported) for prophylaxis. The measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) vaccine was reconstituted with properly stored sterile diluent. No adverse effects reported.  Additionally, temperature for vaccines were total time and highest temperature above 9 degree C (9.9 C); time frame: 4 hours; with no previous temperature excursion. The error was identified via a data logger.; Sender's Comments:  US-009507513-1903USA013366:
Age: 15.0
Sex: U
Vaccine: HPV4, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: On Jun 2011, patient received Gardasil, the first dose and Gardasil 9 on 18-APR-2019; No adverse effects reported; On Jun 2011, patient received Gardasil, the first dose and Gardasil 9 on 18-APR-2019; On Jun 2011, patient received Gardasil, the first dose and Gardasil 9 on 18-APR-2019; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concomitant medications, concurrent conditions and drug allergies were not provided.  On an unspecified date in Jun 2011, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) for prophylaxis (strength, route of administration, anatomical site of injection, lot # and expiry date were not reported).  On 18-JUN-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (Lot No. R004689 has been verified to be a valid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast), expiration date not reported, but upon internal validation established as 29-NOV-2020) (inappropriate schedule of product administration) as the second dose of HPV (human papillomavirus infection) vaccination series for prophylaxis (interchange of vaccine products/wrong product administered) (strength, route of administration, anatomical site of injection were not reported). No adverse effects reporter nor product quality complain involved.
Age: 0.17
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effects reported.; patient born 04/02/2019 received GARDASIL 9 on 06/06/2019.; This spontaneous report was received from a licensed practical nurse and refers to a 9 week old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.  On 06-JUN-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # 1586751 with expiration date of 16-FEB-2021, for prophylaxis (dose were route were not reported). No adverse effects reported. No additional information provided.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse event; the patient was administered one dose of MMR II inadvertently by the intramuscular route; the patient was administered one dose of MMR II inadvertently by the intramuscular route; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Patient's concurrent conditions, concomitant therapies, previous drug, reactions, allergies, historical drugs or medical history were not reported.      On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) subcutaneous injection, via intramuscular route, instead of the subcutaneous route (incorrect route of product administration); lot No. R031636 has been verified to be a valid lot number, expiration date reported as November 2020, but upon internal validation established as 01-NOV-2020 (strength, dose, frequency, anatomical location, and indication were not reported). No adverse event was reported.  The causality assessment between measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) administration and incorrect route of product administration occurrence was not provided by the reporter.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site swelling, Pain in extremity, Pyrexia
Clinical narrative: fever; swelling at the injection site; arm pain; bright red arm; This spontaneous report was received from a 69 year old female patient. The patient did not have any known pertinent medical history, allergies, drug reactions nor concomitant medications. On 06-MAR-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) dose reported as "single injection" for prevent infection(lot # and expiration date were not reported). On the same date, the patient experienced a "fever, swelling at the injection site and a bright red arm." The patient stated that she was also experiencing "arm pain that had not gone away for three months" since receiving the vaccination.   The patient visited the physician, however no treatment was administered for the adverse events. At the reporting time, the patient did not recovered from the aforementioned events. Causality assessment was not provided.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: MMR II was indavertently administered via the intramuscular route.; no adverse effects reported; This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's relevant medical history, previous drug reactions or allergies, concomitant medications, and concurrent conditions were not disclosed.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II), lot # R036582 and expiration date 17-DEC-2020, inadvertently administered via intramuscular route (incorrect route of product administration) for prophylaxis (strength, dose, frequency and anatomical site of injection, were not reported).         By the time of this report, there were no adverse effects reported.
Age: 7.0
Sex: M
Vaccine: MMR
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse effects reported; Second M-M-R II was given too early; Patient is late receiving his vaccines/ received his first dose of M-M-R II on 20-MAR-2019; This spontaneous report was received from a medical assistant, referring to a 7 years-old male patient. The patient's relevant medical history, previous drug reactions or allergies, concomitant medications, and concurrent conditions were not reported.  The reporter stated that the patient was receiving his vaccines late; because, on 20-MAR-2019, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (product administered to patient of inappropriate age) for prophylaxis (strength, dose, frequency, route of administration, anatomical site of injection, lot # and expiration date were not reported).  It was reported that after receiving the first dose, an appointment was scheduled for a month later, to administer the second dose of the vaccine; but this appointment was "moved up" and the second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was administered too early (inappropriate schedule of product administration).  On 02-APR-2019, the patient received the second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (strength, dose, frequency, route of administration, anatomical site of injection, lot # and expiration date were not reported).   By the time of this report, no adverse effects were reported.
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effects were reported; a 38 year old female patient received a dose of PROQUAD; This report was received from a medical assistant (also an office manager), referring to a 38 years old female patient. The patient's medical history and concomitant medication were nor provided.   On 14-MAY-2019, the patient received a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection (lot # R013575 (recombinant Human albumin (rHA)) with expiration date 10-NOV-2019) subcutaneously for prophylaxis (product administered to patient of inappropriate age).  No adverse effects were reported in the patient.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pyrexia
Clinical narrative: fever; Pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of fever in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th May 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In May 2019, less than a month after receiving Shingrix, the patient experienced fever and injection site pain. On an unknown date, the outcome of the fever and injection site pain were recovered/resolved.   It was unknown if the reporter considered the fever and injection site pain to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix vaccine on right arm and experienced fever that lasted for 24 hours and pain at injection site for 4 days. The reporter did not consent to follow-up. No further details were provided. For tolerance of 2nd dose refer linked case US2019GSK103699.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain in extremity
Clinical narrative: arm pain; muscle pain; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number G72ZD, expiry date 24th November 2020) for prophylaxis.   On 10th April 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm and muscle pain. On an unknown date, the outcome of the pain in arm and muscle pain were recovered/resolved.   It was unknown if the reporter considered the pain in arm and muscle pain to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that a patient had the 2nd injection of Shingrix after they complained of arm pain, muscle pain, long term reaction for 6 weeks or more.  The case has been linked with the case US2019AMR099873 (husband's case), reported by same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site erythema, Injection site vesicles
Clinical narrative: shingles/ looks like shingles; vesicles of red below injection site; vesicles of red below injection site; This case was reported by a physician via sales rep and described the occurrence of shingles in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, 2 days after receiving Shingrix, the patient experienced shingles, injection site vesicles and injection site erythema. On an unknown date, the outcome of the shingles, injection site vesicles and injection site erythema were unknown.   It was unknown if the reporter considered the shingles, injection site vesicles and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient came into physician office 2 days after receiving Shingrix at pharmacy. The reporter stated that adverse reaction seem to be what looks like shingles which was right below the injection site and it appeared like vesicles of red below injection site. The patient told the doctor that it did not itch. The physician seem to think that it was a coincidence and believed it was shingles.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm pain; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 62-year-old male patient who received Herpes zoster (Shingrix) (batch number G72ZD, expiry date 24th November 2020) for prophylaxis.   On 10th April 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, the patient had arm pain that resolved in a few days. The batch number reported for Shingrix(d72zd) did not exist and was updated to G72ZD, as per sales database. This case has been linked with the case US2019099069, reported for patient's wife.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This case was reported by a consumer and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 18th October 2018).   On 18th October 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: After vaccination with 1st dose of Shingrix, the patient experienced sore arm. The patinet had no other side effects. For the tollerence of 2nd dose, refere case US2019GSK061598.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise, Pain in extremity
Clinical narrative: sore arm; sick; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm and sickness. On an unknown date, the outcome of the pain in arm and sickness were unknown.   It was unknown if the reporter considered the pain in arm and sickness 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 was selected as an adult as per the vaccine indication. The reporter states that she works in a pharmacy and had heard a lot of people had sore arms and were sick after 2nd dose of Shingrix. The reporter states she was not sure if any these were reported, declined to provide further details. This case has been linked with the cases US2019GSK103032 and US2019098035, reported by same reporter.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Injection site pain, Pyrexia
Clinical narrative: Drug dose administration interval too short; fever; Pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of fever in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (For tolerance of 1st dose refer linked case US2019099058).   On 30th May 2019, the patient received the 2nd dose of Shingrix (intramuscular). In May 2019, less than a week after receiving Shingrix, the patient experienced fever and injection site pain. On 30th May 2019, the patient experienced drug dose administration interval too short. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the injection site pain was not recovered/not resolved and the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the fever and injection site pain to be related to Shingrix.  Additional details were reported as follows: The patient stated he received 2 doses of Shingrix vaccine 3 weeks 2 days apart, which led to shortening of vaccination schedule. In May 2019, less than a week after receiving Shingrix, the patient experienced fever and it was stronger than 1st dose which had at the time of reporting recovered.  In May 2019, less than a week after receiving Shingrix, the patient also experienced pain at injection site which was less than the 1st dose and it was still present. The reporter did not consent to follow-up. No further details were provided.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Hypersensitivity, Swelling of eyelid
Clinical narrative: allergic reaction; Eyelid swelling/ swelling of my eyelids; This case was reported by a pharmacist via call center representative and described the occurrence of allergic reaction in a adult female patient who received Flu Seasonal TIV Dresden (Flu trivalent vaccine) for prophylaxis.   On an unknown date, the patient received Flu trivalent vaccine at an unknown dose. On an unknown date, unknown after receiving Flu trivalent vaccine, the patient experienced allergic reaction and swelling of eyelid. On an unknown date, the outcome of the allergic reaction and swelling of eyelid were unknown.   It was unknown if the reporter considered the allergic reaction and swelling of eyelid to be related to Flu trivalent vaccine.  Additional details were provided as follows: The age at vaccination was not reported. A pharmacist reported that she had an allergic reaction to the flu vaccine which included swelling of my eyelids. The reaction occurred 10 to 12 years ago and she was unsure of the name of the vaccine, but she mentioned it may have been FluLaval. No additional details were provided at time of reporting.
Age: 66.0
Sex: F
Vaccine: HEPAB, HEPAB, VARZOS
Symptoms: Alanine aminotransferase increased, Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine; elevated ALT; Drug dose administration interval too long; This case was reported by a consumer via call center representative and described the occurrence of alanine aminotransferase increased in a 66-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis and Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on unknown date.).   On 22nd April 2019, the patient received the 1st dose of Twinrix (intramuscular) 1 ml. On 30th May 2019, the patient received the 2nd dose of Twinrix (intramuscular) 1 ml. In December 2018, the patient received the 2nd dose of Shingrix. In December 2018, not applicable after receiving Twinrix and Twinrix and unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On 23rd May 2019, the patient experienced alanine aminotransferase increased. On 30th May 2019, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the alanine aminotransferase increased, drug dose administration interval too long and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the alanine aminotransferase increased to be related to Twinrix.  Additional details were provided as follows: On 22nd April 2019, the patient received the 1st dose of Twinrix. Around 23rd to 24th May 2019, she had bloodwork done and it showed her Alanine aminotransferase increased elevated to 44. The preferred range on the test was 6 to 29. Her Alanine aminotransferase increased tends to run a little high, but at 30 to 31, not as high as 44.  On 30th May 2019, she received her 2nd dose of Twinrix, which was past 1 month for the 2nd dose, which led to lengthening of the vaccination schedule. The reporter, previously received Shingrix and got her 2nd dose in December 2018, and it was 2 to 3 weeks past 6 months, which led to lengthening of the vaccination.  The reporter consented to follow up.      Lab Comments: On unknown date, the test ALT tends to run a little high, but at 30 to 31
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site pain, Injection site swelling, Underdose
Clinical narrative: injection site redness; injection site tenderness; injection site swelling; Underdose; Vaccine Administered at Inappropriate Site; This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number 99D9F, expiry date 14th April 2019) for prophylaxis.   On 14th April 2019, the patient received the 1st dose of Shingrix (subcutaneous). On 14th April 2019, unknown after receiving Shingrix, the patient experienced accidental underdose and intramuscular formulation administered by other route. On an unknown date, the patient experienced injection site erythema, injection site tenderness and injection site swelling. On an unknown date, the outcome of the injection site erythema, injection site tenderness, injection site swelling, accidental underdose and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the injection site erythema, injection site tenderness and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The nurse reported that some vaccine was loss during administration to the patient, less than 0.5 mL, health care professional was unaware of how much was actually lost as she did not administer the vaccine, which led to accidental underdose. After administration, less than a year after receiving Shingrix, the patient reported localized redness, swelling and tenderness at the injection site. The health care professional reported that the dose was administered more towards the back of the arm, and might have been injected subcutaneously on an unknown arm, which led to intramuscular formulation administered by other route. No additional details provided. This case was linked to case US2018203376 reported by same reporter.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling hot, Hot flush, Immediate post-injection reaction
Clinical narrative: Vaccine immediately felt hot going into my arm.  For 3 days experienced chills & hot flashes, nausea, muscle aches, fatigue, pain in arm.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Pain in extremity
Clinical narrative: Vaccine immediately felt hot going into my arm.  For 3 days experienced chills & hot flashes, nausea, muscle aches, fatigue, pain in arm.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Myalgia, Pain
Clinical narrative: Soreness in arm muscle; dizziness; extreme fatigue; shivering; fever.  Soreness, shivering and fever lasted 2-3 days.  Dizziness and fatigue are still present 7 days later.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Soreness in arm muscle; dizziness; extreme fatigue; shivering; fever.  Soreness, shivering and fever lasted 2-3 days.  Dizziness and fatigue are still present 7 days later.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received the 2nd dose of Shingrix 11 days prior to the 2 to 6 month window.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13
Symptoms: Pyrexia, Vaccination complication
Clinical narrative: Had fever of 105, went to Medical Center emergency department - adverse reaction to MMR vaccine
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Headache, Injection site pain, Oropharyngeal pain, Pyrexia
Clinical narrative: Patient reported headache, rhinorrhea, sore throat, cough, low fever of 100F, painful at the injection site.  All symptoms persisted for 2 to 3 days.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rhinorrhoea
Clinical narrative: Patient reported headache, rhinorrhea, sore throat, cough, low fever of 100F, painful at the injection site.  All symptoms persisted for 2 to 3 days.
Sex: U
Vaccine: VARZOS
Symptoms: Alopecia
Clinical narrative: hair loss; This case was reported by a consumer via call center representative and described the occurrence of accelerated hair loss in a adult 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 accelerated hair loss. On an unknown date, the outcome of the accelerated hair loss was unknown.   It was unknown if the reporter considered the accelerated hair loss to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had significant increased hair loss. The patient was wondering if hair loss was a reported side effect of the Shingrix vaccine.  The reporter did not see hair loss listed in the prescribing information. The reporter was working with primary care provider and have ruled out everything else, including thyroid dysfunction.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Rash vesicular
Clinical narrative: shingles rash on his back; This case was reported by a consumer via call center representative and described the occurrence of vesicular rash in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced vesicular rash. On an unknown date, the outcome of the vesicular rash was unknown.   It was unknown if the reporter considered the vesicular rash to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's wife. The age at vaccination was not reported. Last week before the time of reporting, the patient received a dose of Shingrix. At the time of reporting, the patient had developed a shingles rash on his back. The reporter wanted to know, what should do the patient. The reporter needed to know immediately because the shingles antiviral must be taken within first 72 hours.
Age: 44.0
Sex: M
Vaccine: TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: extra dose administered; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 44-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 97NL3, expiry date 5th June 2021) for prophylaxis.   Concomitant products included DTPa (Reduced antigen) (Boostrix).   On 16th April 2019, the patient received Boostrix (intramuscular). On 16th April 2019, unknown after receiving Boostrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: This case was reported by medical assistant. On 16th April 2019, the patient accidentally received a Boostrix dose when he already had the dose received on 10th April 2019. This case was identified as duplicate of US2019069958. Case US2019069958 was deleted and all the future correspondence will be added in the present case which stands as case of record for this patient.   Follow up information was received from other health professional on 15th May 2019: At the time of reporting, the patient was doing fine with no adverse reaction. The VAERS details were updated.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Influenza like illness, Pain in extremity, Pyrexia
Clinical narrative: Inappropriate schedule of vaccine; fever; chills; Flu-like symptoms; pain in arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 1st August 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, the patient received the 2nd dose of Shingrix. On 1st August 2018, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pain in arm. On 2nd August 2018, the patient experienced fever, chills and influenza-like symptoms. On an unknown date, the patient experienced incomplete course of vaccination. On 15th August 2018, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the fever, chills and influenza-like symptoms were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   The reporter considered the pain in arm, fever, chills and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The patient received the 1st dose of Shingrix in the left deltoid. The patient experienced pain in her arm, fever, chills and flu-like symptoms. The patient wanted to know, if it would be fine to receive the 2nd dose even though it was not within the 6 month time frame, which led to the incomplete course of vaccination. The representative advised the patient according to the Centers for Disease Control and Prevention (CDC), she should receive the 2nd dose, as soon as possible.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: flu-like symptoms; This case was reported by a physician via call center representative and described the occurrence of influenza-like symptoms in a adult 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 influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms 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 was selected as an adult per the vaccine indication. The reporter stated that, the patient received the first dose of Shingrix and afterwards experienced flu like symptoms. The Healthcare professional would like to know clinical data after receiving just 1 dose of Shingrix. No information provided on patient.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Inflammation, Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Patient received her vaccination in the late afternoon on 6/5/19.  She started to develop swelling and  redness on her arm that spread from the injection site on her  around to the underside of her arm.  She contacted me on 6/6/19 to report this to me and to ask what she should do.  I had requested the patient to stop by the pharmacy so I could access her arm, but she stated she wasn't nearby and could not come in.  I asked her if she had any shortness of breath or swelling on her face/tongue/lips, she stated no.  I advised her to try to take Zyrtec to see if it helped with the itching (I decided against Benadryl due to her age and psychiatric medications/psychiatric history- it is very sedating) and to follow up with the pharmacy to let us know if it got any worse.  Patient contacted the other pharmacist at my pharmacy, on 6/7/19, to report increased arm pain and fever.  She went over the possible adverse reactions to the vaccine.  Patient did not seem overly concerned or upset, she was just wondering how to proceed.  Patient went to urgent care on 6/8/19 and was told by urgent care that she had Post-Injection Inflammatory Reaction and cellulitis.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus, Pyrexia
Clinical narrative: Patient received her vaccination in the late afternoon on 6/5/19.  She started to develop swelling and  redness on her arm that spread from the injection site on her  around to the underside of her arm.  She contacted me on 6/6/19 to report this to me and to ask what she should do.  I had requested the patient to stop by the pharmacy so I could access her arm, but she stated she wasn't nearby and could not come in.  I asked her if she had any shortness of breath or swelling on her face/tongue/lips, she stated no.  I advised her to try to take Zyrtec to see if it helped with the itching (I decided against Benadryl due to her age and psychiatric medications/psychiatric history- it is very sedating) and to follow up with the pharmacy to let us know if it got any worse.  Patient contacted the other pharmacist at my pharmacy, on 6/7/19, to report increased arm pain and fever.  She went over the possible adverse reactions to the vaccine.  Patient did not seem overly concerned or upset, she was just wondering how to proceed.  Patient went to urgent care on 6/8/19 and was told by urgent care that she had Post-Injection Inflammatory Reaction and cellulitis.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Patient received vaccination on Saturday and returned on Monday. Her entire upper shoulder was red, swollen, and painful to the touch. I contacted her doctor while she was here and they were going to see her the same day.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Pharyngeal erythema, Pharyngeal swelling, Rash generalised, Rash morbilliform, Skin discolouration
Clinical narrative: Measles like rash (Friday 5/17 5pm). Progressively got worse throughout the night and into the morning (5/18/19) Full body rash. (5/19-5/20) Morphed into one huge full body cluster. Swollen, discoloring (purple). Red swollen throat. Fever. Took to ER Sunday evening (5/19/19) when we noticed parts of her body/rash turning purple!
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Swelling
Clinical narrative: Measles like rash (Friday 5/17 5pm). Progressively got worse throughout the night and into the morning (5/18/19) Full body rash. (5/19-5/20) Morphed into one huge full body cluster. Swollen, discoloring (purple). Red swollen throat. Fever. Took to ER Sunday evening (5/19/19) when we noticed parts of her body/rash turning purple!
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Pain, redness, and swelling at the injection site Muscle pain Tiredness headache fever-up to 101.7 Chills
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Myalgia, Pyrexia
Clinical narrative: Pain, redness, and swelling at the injection site Muscle pain Tiredness headache fever-up to 101.7 Chills
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Pain, redness, and swelling at the injection site Muscle pain Tiredness headache fever-up to 101.7 Chills
Age: 52.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema
Clinical narrative: redness, began approx. 2 days later, appears mild, no other symptoms reported
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Blindness, Eye haemorrhage
Clinical narrative: Vision Loss & Bleeding in the Right Eye
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site dermatitis, Injection site erythema, Injection site swelling
Clinical narrative: pt went to Health Center on 6/8/19 @ around 10:30 Am. pt was c/o red swollen Left arm. pt deltoid was red and swollen area measure 13cm x 15cm. pt was dx with cellulitis and treated with Keflex 250 /5mL - 8ml bid for 10 days. Doing much better Red & swollen gone  No fever.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Pyrexia
Clinical narrative: Arthralgia, Fever & WEAKNESS
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache
Clinical narrative: Headache & FATIGUE
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Discomfort, Erythema, Fatigue
Clinical narrative: Injection was EXTREMELY PAINFUL when it was given--unlike anything I've ever experienced--severe burning and pain.  Local:  "Grade 3 Pain - defined as significant pain at rest; prevents normal everyday activities."  (Pain in arm SEVERE, unlike anything I have ever experienced in my life.  The area of pain was 4" x 6" to 5" x 7".  Unable to sleep, unable to find comfortable position the first night.) Local:  Grade 3 Redness - 2 1/2 inches diameter  (Days 1 - 7) Local: Heat in area of Redness - (Days 1 - 7) Local:  Grade 3 Swelling  (Days 1 - 5) Local:  Itching (Days 2 - 6, Day 4 the worst) General:  Grade 3 Muscle & joint pain Grade 3 (feels like severe case of flu) (Days 2 & 3) General:  Grade 3 Fatigue (Days 1, 2 & 3) General:  Grade 3 Shivering Grade 3 (Days 2 & 3)
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain, Insomnia, Loss of personal independence in daily activities, Myalgia
Clinical narrative: Injection was EXTREMELY PAINFUL when it was given--unlike anything I've ever experienced--severe burning and pain.  Local:  "Grade 3 Pain - defined as significant pain at rest; prevents normal everyday activities."  (Pain in arm SEVERE, unlike anything I have ever experienced in my life.  The area of pain was 4" x 6" to 5" x 7".  Unable to sleep, unable to find comfortable position the first night.) Local:  Grade 3 Redness - 2 1/2 inches diameter  (Days 1 - 7) Local: Heat in area of Redness - (Days 1 - 7) Local:  Grade 3 Swelling  (Days 1 - 5) Local:  Itching (Days 2 - 6, Day 4 the worst) General:  Grade 3 Muscle & joint pain Grade 3 (feels like severe case of flu) (Days 2 & 3) General:  Grade 3 Fatigue (Days 1, 2 & 3) General:  Grade 3 Shivering Grade 3 (Days 2 & 3)
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Skin warm, Swelling
Clinical narrative: Injection was EXTREMELY PAINFUL when it was given--unlike anything I've ever experienced--severe burning and pain.  Local:  "Grade 3 Pain - defined as significant pain at rest; prevents normal everyday activities."  (Pain in arm SEVERE, unlike anything I have ever experienced in my life.  The area of pain was 4" x 6" to 5" x 7".  Unable to sleep, unable to find comfortable position the first night.) Local:  Grade 3 Redness - 2 1/2 inches diameter  (Days 1 - 7) Local: Heat in area of Redness - (Days 1 - 7) Local:  Grade 3 Swelling  (Days 1 - 5) Local:  Itching (Days 2 - 6, Day 4 the worst) General:  Grade 3 Muscle & joint pain Grade 3 (feels like severe case of flu) (Days 2 & 3) General:  Grade 3 Fatigue (Days 1, 2 & 3) General:  Grade 3 Shivering Grade 3 (Days 2 & 3)
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Patient called 2 days after vaccination reporting an injection site reaction of swelling, redness, and pain at site. Described as a sizeable knot under the skin around the injection site. States she also had mild fever and some nausea but denies other symptoms/reactions.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient called 2 days after vaccination reporting an injection site reaction of swelling, redness, and pain at site. Described as a sizeable knot under the skin around the injection site. States she also had mild fever and some nausea but denies other symptoms/reactions.