chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test abnormal, COVID-19, Cough, Heart rate abnormal, Hyperthyroidism
Clinical narrative: Shortly after receiving the Covid 19 booster shot I was on work assignment. Within a few days I tested positive for Covid 19 as well as several other people. We recovered but I noticed I still had a chronic cough. With this going on our ship started to head into the tropics. I love the tropical weather. As I am coughing I noticed I didn?t want to be outside. It was overbearing. Then my resting heart rate felt like it was 1000 miles per hour. I saw the ship?s medical and asked about it. I was informed my heart rate was 125BPM at rest. They thought my body was just under stress due to being at sea. I?ve been employed for 12 years and I need it wasn?t from that. 2 months pass by with the heart rate going at 125+BPM and I started to lose weight. I was 210 pounds starting work assignment and at this time I was down to 175 pounds. I was not dieting. In fact I was making it a point to eat more food because I noticed I was dropping weight. I was flown off the ship to inland where they did blood work and discovered I had a hyperthyroidism.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Weight decreased
Clinical narrative: Shortly after receiving the Covid 19 booster shot I was on work assignment. Within a few days I tested positive for Covid 19 as well as several other people. We recovered but I noticed I still had a chronic cough. With this going on our ship started to head into the tropics. I love the tropical weather. As I am coughing I noticed I didn?t want to be outside. It was overbearing. Then my resting heart rate felt like it was 1000 miles per hour. I saw the ship?s medical and asked about it. I was informed my heart rate was 125BPM at rest. They thought my body was just under stress due to being at sea. I?ve been employed for 12 years and I need it wasn?t from that. 2 months pass by with the heart rate going at 125+BPM and I started to lose weight. I was 210 pounds starting work assignment and at this time I was down to 175 pounds. I was not dieting. In fact I was making it a point to eat more food because I noticed I was dropping weight. I was flown off the ship to inland where they did blood work and discovered I had a hyperthyroidism.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Aphasia, Laryngospasm, Stridor
Clinical narrative: About an hour after receiving the Moderna bivalent vaccine (right deltoid) and a Flublok flu vaccine (lotUJ893AA) (left deltoid), she began having laryngospasm (stridor and could not talk).   She called our office to report it and we referred her to the local  ED where she received racemic epinephrine and Solu-Medrol.  She was observed for approximately 6-7 hours.
Age: 82.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rash
Clinical narrative: rash on both arms developed day after receiving pfizer bivalent vaccine, resolved by the following day.  did not use anything topically or orally for ADR, did not contact her doctor.  previous vaccinations were with moderna mrna vaccine and no rxn reported
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Administered monovalent vaccine, patient requested bivalent.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heavy menstrual bleeding, Malaise, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Mom called 10-12-22 said her daughter the patient was sick for few days after ,10-4-22 janseen vaccine ; malaise , fever but then felt better , then 5 days later got sick again , headache wont go away , fever and heavy period bleeding with clots . Covid test negative . Advised her to take her to PCP or urgent care to be seen
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Mom called 10-12-22 said her daughter the patient was sick for few days after ,10-4-22 janseen vaccine ; malaise , fever but then felt better , then 5 days later got sick again , headache wont go away , fever and heavy period bleeding with clots . Covid test negative . Advised her to take her to PCP or urgent care to be seen
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Hospitalized. Husband positive at home
Age: 16.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Dizziness, Dyspnoea, Feeling hot, Hyperhidrosis, Paraesthesia oral
Clinical narrative: 13:10--Patient complained of feeling warm, lips feeling tingly. Ice pack and water given. Breathing appeared to increase. Patient then appeared diaphoretic and complained of feeling light-headed. She lied down on the floor. She then complained of difficulty breathing, and tightness in throat. Emergency services were called at 13:25. Epinephrine administered at 13:26. Patient still complained of feeling warm, tingly lips, and difficulty breathing. Rash began to develop around neck. Epinephrine administered again at 13:31. First responders and paramedics arrived two minutes later. She was transported to hospital via ambulance.
Age: 16.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Rash, Respiratory rate increased, Throat tightness
Clinical narrative: 13:10--Patient complained of feeling warm, lips feeling tingly. Ice pack and water given. Breathing appeared to increase. Patient then appeared diaphoretic and complained of feeling light-headed. She lied down on the floor. She then complained of difficulty breathing, and tightness in throat. Emergency services were called at 13:25. Epinephrine administered at 13:26. Patient still complained of feeling warm, tingly lips, and difficulty breathing. Rash began to develop around neck. Epinephrine administered again at 13:31. First responders and paramedics arrived two minutes later. She was transported to hospital via ambulance.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Headache
Clinical narrative: About four to five hours following the vaccine, I developed a headache and a severe bloody nose with passing clots, I packed my nose with gauze, pinched my nose and put ice on the back of my neck, and it took about 45 min for the bloody nose to stop.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Asymptomatic
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, Wrong product administered
Clinical narrative: Moderna monovalent vaccine administered, patient requested bivalent.
Age: 17.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient is an employee at a facility and asked for the Bivalent booster (10-05-22) after appropriate time of completing Pfizer Primary Series. Employee was turned away until proper dosing could be researched. Upon looking up dosing, "Bivalent" or ages 12 and up was noted with a .3 ml dose. I did not see that this was under Pfizer and not Moderna. Employee returned on 10-06-22 for her Bivalent which was given: Moderna Bivalent at .3ml.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Moderna monovalent vaccine administered, patient requested bivalent.
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: The caller confirmed no side effects were experienced; The caller confirmed the dose given to her mother and father was 0.5 ml dose of RECOMBIVAX; This spontaneous report was received from the patient's daughter and refers to her mother of unknown age. The patient's concurrent conditions pertinent medical history, drugs reactions or allergies, and concomitant therapies were not reported.  In approximately August 2022 (reported as "a month ago"), her mother was vaccinated with first dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) 0.5 ml dose, lot  number T032918 with expiration date 12-NOV-2022 (route of administration and anatomical location were not provided) for prophylaxis (Incorrect dose administered). The caller confirmed no side effects were experienced.; Sender's Comments:  US-009507513-2210USA003238:MSD
Age: 17.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: no adverse events have been reported by the patient; a dose of PROQUAD was accidently administered to a 17 year old male on 9/20/22 instead of MMR-II; PROQUAD was accidently administered to a 17 year old male; This spontaneous report was received from a Nurse Manager and referred to a 17-year-old male patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 20-SEP-2022, the patient was accidently administered a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, 0.5 ml, quantity: 1, lot #W007744, expiration date: 04-SEP-2023, administered subcutaneously (SQ) for prophylaxis (strength was not provided) instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection (wrong product administered and product administered to patient of inappropriate age). No adverse event had been reported by the patient.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; Caller is a medical assistant calling to report that an expired dose of ROTATEQ was administered to the patient on 23SEP2022.; This spontaneous report has been received from a medical assistant concerning to a patient of an unknow age and gender. The patient's medical history, concurrent conditions, previous drug reactions or allergies, and concomitant therapies were not reported.  On 23-SEP-2022, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, by defaulted oral route of administration, at a dose of 2 milliliter (ml) (strength and vaccination scheme frequency were not provided; lot number 1742462 that was verified to be a valid lot number with an expiration date reported as and established as 19-SEP-2022) (expired product administered) for prophylaxis.  By the reporting time, the caller confirmed that the dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was not involved in a temperature excursion prior to the date of administration.  No additional adverse event (AE) was reported (no adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: patient received VARIVAX that had undergone temperature excursion; No additional AE reported; This spontaneous report has been received from a healthcare worker regarding to a currently 30-year-old patient of an unknow gender. The patient's medical history, concurrent conditions, previous drug reactions or allergies, and concomitant therapies were not reported.  On an unknown date (reported as before calling), the patient was vaccinated with one improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (strength, dose, vaccination scheme frequency, route of administration and anatomical location were not provided; lot number W003818 that was verified to be a valid lot number with an expiration date reported as 12-NOV-2022, but upon internal review established as 02-FEB-2024) for prophylaxis (product storage error).  The administered vaccine underwent a temperature excursion of 76.1 degrees Fahrenheit (F) with a time frame reported as 322 hours and 15 minutes. There was a previous temperature excursion reported; however, no details were provided.   No additional adverse event (AE) was reported (no adverse event).  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-2209USA009412: US-009507513-2209USA009527:
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional adverse event; expired dose was given to a patient; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. There was no information regarding the patient's medical history, concurrent conditions and concomitant medications provided.  On 28-SEP-2022, the patient was vaccinated with one expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) injection, at a dose of 0.5 ml, lot # T032761 confirmed to be valid with expiration date 30-MAY-2022 (conflicting information, expiration date also reported as 30-JUN-2022) (dose number, route of administration, and anatomical location were not reported) for prophylaxis (expired product administered). The vaccine did not undergo any temperature excursion. There was no additional adverse event and no PQC reported.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional adverse event; Nurse reported a patient was administered a dose of PEDVAXHIB subcutaneously not intramuscularly; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 29-SEP-2022, the patient was vaccinated with a dose of dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) (lot # W006721 , expiration date 10-DEC-2021) 0.5ml, subcutaneously instead of intramuscularly (Incorrect route of product administration). At the time of reporting the outcome of the incorrect route of product administration was not reported, moreover, no additional adverse events were reported.
Age: 40.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Caller states patient reports no additional AE; An adult patient who was scheduled to receive a second dose of MRII and VARIVAX in a 2-dose series was inadvertently administered PROQUAD instead.; This spontaneous report has been received from a nurse referring a 40-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions and allergies were not reported. Concomitant medication included sterile diluent.  On 04-OCT-2022, the patient was scheduled to receive a second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous Injection (strength, specific dosage, vaccination scheme, route of administration, anatomical site of application, lot number and expiration date were not provided) and varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (strength, specific dosage, vaccination scheme, route of administration, anatomical site of application, lot number and expiration date were not provided) in a 2-dose series, but was inadvertently administered with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, at a dose of 0,5 milliliter with lot number W020550 that had been verified to be a valid number with expiration date 26-DEC-2023 (strength, vaccination scheme, route of administration and anatomical site of application were not provided), all of them administered for prophylaxis. (wrong product administered) No additional adverse event reported.
Sex: U
Vaccine: VARCEL
Symptoms: Seizure
Clinical narrative: patient experience a seizure; This spontaneous report was received from registered nurse and refers to a pediatric patient of an unknown gender and age.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, administered for prophylaxis (dose, strength, lot #, expiry date, and route of administration were not provided).  On an unknown date, the patient experience a seizure. At the time of reporting, the outcome of the event was not known.   The causal relationship between the seizure and varicella virus vaccine live (oka/merck) (VARIVAX) was unknown.  Upon internal review, the event of seizure was determined to be medically significant.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; The physician reported that a patient received improperly stored vaccine.  No additional AEs were reported, no further information provided.  Names of vaccines involved (including lot/exp) PROQUAD (w012743  10/16/2023) Temperature: 10.1F  Time frame:; This spontaneous report was received from physician and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 06-OCT-2022, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant human albumin (rHA), subcutaneous injection, lot #w012743, expiration date: 16-OCT-2023, administered for prophylaxis (dose, strength, and route of administration were not provided) (product storage error).  Administered dose of vaccine experienced the temperature excursion of 10.1 degrees Fahrenheit (F) for 51 hours. There was no previous temperature excursion.   There was no adverse event reported.
Sex: M
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: The caller confirmed no side effects were experienced; The caller confirmed the dose given to her mother and father was 0.5 ml dose of RECOMBIVAX; This spontaneous report was received from the patient's daughter and refers to her father of unknown age. The patient's concurrent conditions pertinent medical history, drugs reactions or allergies, and concomitant therapies were not reported.  In approximately August 2022 (reported as "a month ago"), her father was vaccinated with first dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) 0.5 ml dose, lot number T032918 with expiration date 12-NOV-2022 (route of administration and anatomical location were not provided) for prophylaxis (Incorrect dose administered). The caller confirmed no side effects were experienced.; Sender's Comments:  US-009507513-2209USA008565.
Age: 71.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Chest pain, Dyspnoea, Fatigue, Feeling abnormal
Clinical narrative: Chest pain; Shortness of breath; Exhausted; Struggle to function; This case was reported by a pharmacist via other manufacturer and described the occurrence of chest pain in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included TOZINAMERAN (COVID-19 VACCINE PFIZER) (batch number GH9703, expiry date unknown) for prophylaxis.   Concurrent medical conditions included heart disease, unspecified and allergy.   On 27th September 2022, the patient received the 1st dose of Shingrix and the 1st dose of COVID-19 VACCINE PFIZER (intramuscular). On 28th September 2022, 1 days after receiving Shingrix, the patient experienced chest pain (serious criteria hospitalization), shortness of breath (serious criteria hospitalization), exhaustion (serious criteria hospitalization) and feeling bad (serious criteria hospitalization). On an unknown date, the outcome of the chest pain, shortness of breath, exhaustion and feeling bad were recovered/resolved.   It was unknown if the reporter considered the chest pain, shortness of breath, exhaustion and feeling bad to be related to Shingrix.     Additional Information: receipt date: 05-OCT-2022 Reporters comment: The patient receives did not received any vaccines within 4 weeks prior to the COVID vaccine. The patient received Pfizer Covid 19 vaccine on 27th September 2022, 11:30 AM in right arm and received shingrix in right arm on same day. 1 day after Covid-19 vaccine, the patient ended up in the hospital with Chest pain,shortness of breath, exhausted, and struggle to function on 28 September 2022 at 01:45. It was unknown if the reporter considered the chest pain, shortness of breath, exhaustion and feeling bad to be related to Covid-19 vaccine.    The reporter had given permission to contact for follow up.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure, Vaccine breakthrough infection
Clinical narrative: breakthrough shingles after both doses /Suspected vaccination failure; patient had a breakthrough shingles; This case was reported by a pharmacist via sales rep and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included immunocompromised.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 05-OCT-2022 Reporter's comment: The reporter stated that an immunocompromised patient had a breakthrough shingles case and was already vaccinated with both doses of Shingrix. Additional supportive information: This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got both shingles shot, now have shingles/Suspected vaccination failure; Shingles on thigh; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 62-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (patient received shingles shot in his/her 50s).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 05-OCT-2022 Reporter's Comment: Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported that he got the original shingles shot in his/her 50s. The patient stated that then the new shingles 2 dose shot came out and his/her doctor had asked him/her to get both the doses. The patient was 62 years and now he got the shingles on his thigh. Additional supportive information: This case was considered as suspected vaccination failure as details regarding, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Back pain, Computerised tomogram abdomen abnormal, Diverticulitis, Electric shock sensation, Herpes zoster
Clinical narrative: Diverticulitis; Shingles; Pain wraps around to my back; Skin feels burned; Feels like electrical shocks inside; This case was reported by a consumer via interactive digital media and described the occurrence of diverticulitis in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 25th August 2022, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 2 months after receiving Shingles vaccine, the patient experienced diverticulitis (serious criteria GSK medically significant), shingles, back pain, burning sensation skin and electric shock sensation. On an unknown date, the outcome of the diverticulitis, shingles, back pain, burning sensation skin and electric shock sensation were not recovered/not resolved.   It was unknown if the reporter considered the diverticulitis, shingles, back pain, burning sensation skin and electric shock sensation to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 05-OCT-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The patient had it right now at the time of reporting. The patient had one shingles vaccine on 25th August 2022.  The patient having his/her second dose in November 2022.  The patient had a CT scan and had diverticulitis in addition to shingles on his/her side.  The pain wraps around to his/her back.  The patient did not had a rash but his/her skin felt burned and it feels like electrical shocks inside and it was terrible. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Skin burning sensation
Clinical narrative: Diverticulitis; Shingles; Pain wraps around to my back; Skin feels burned; Feels like electrical shocks inside; This case was reported by a consumer via interactive digital media and described the occurrence of diverticulitis in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 25th August 2022, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 2 months after receiving Shingles vaccine, the patient experienced diverticulitis (serious criteria GSK medically significant), shingles, back pain, burning sensation skin and electric shock sensation. On an unknown date, the outcome of the diverticulitis, shingles, back pain, burning sensation skin and electric shock sensation were not recovered/not resolved.   It was unknown if the reporter considered the diverticulitis, shingles, back pain, burning sensation skin and electric shock sensation to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 05-OCT-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The patient had it right now at the time of reporting. The patient had one shingles vaccine on 25th August 2022.  The patient having his/her second dose in November 2022.  The patient had a CT scan and had diverticulitis in addition to shingles on his/her side.  The pain wraps around to his/her back.  The patient did not had a rash but his/her skin felt burned and it feels like electrical shocks inside and it was terrible. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Dyspnoea exertional, Fatigue, Feeling abnormal, Malaise
Clinical narrative: I haven't felt right; Very tyred; Brain fog; Shortness of breath upon exertion; weakness; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th September 2022, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced feeling unwell, tiredness, foggy feeling in head, exertional dyspnea and weakness. On an unknown date, the outcome of the feeling unwell, tiredness, foggy feeling in head, exertional dyspnea and weakness were unknown.   It was unknown if the reporter considered the feeling unwell, tiredness, foggy feeling in head, exertional dyspnea and weakness to be related to Shingrix.     Additional Information: GSK receipt date: 02-OCT-2022 Reporter's comment: This case was reported by a consumer via interactive digital media. The patient reporterd that he/she have not felt right since getting Shingrix second dose 7 days ago. The patient experienced very tired, brain fog, shortness of breath upon exertion, weakness. Additional supportive information: Follow up would not possible, as no contact details were available.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Pain, Pyrexia
Clinical narrative: Injection site pain; Aches; Chills; Fever; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hashimoto's disease (she had hypothyroidism (Hashimoto's disease)).   On 3rd June 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced injection site pain, pain, chills and fever. On an unknown date, the outcome of the injection site pain, pain, chills and fever were recovered/resolved.   It was unknown if the reporter considered the injection site pain, pain, chills and fever to be related to Shingrix.     Linked case(s) involving the same patient:  US2022141408   Additional Information: GSK Receipt Date: 03-OCT-2022 Reporter's comment: Reporter reported that reporter was the patient who received 2 doses of Shingrix. She had received her first dose of Shingrix. She stated that after her first dose, she had experienced aches, chills, fever, and pain at the injection site.  These symptoms were resolved. The reporter did not consent to follow-up. Additional supportive information: For tolerance of second dose, refer case US2022AMR141776 that was reported by same patient. This case has been linked with DK2022EME142376 reported by same reporter.; Sender's Comments:  US-GSK-US2022141408:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Shot hurts; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 03-Oct-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient stated that the Shingles shot hurts almost as bad as the shingles. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: pretty sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR142042   Additional Information: GSK Receipt Date: 02-OCT-2022 Reporter's Comments:  The reporter stated that it was a little bit of a rough shot, but way better than getting Shingles. The patient did not get covid or flu shots of course they would vary from person to person. The patient was pretty sick after 1st shigles shots, but the patient heard, getting shingles was considerable worse and recommend getting the shots. Additional supportive information: For tolerance of 2nd dose refer case US2022AMR142042; Sender's Comments:  US-GSK-US2022AMR142042:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: shot was painful; This case was reported by a consumer via interactive digital media and described the occurrence of pain in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles shot (took last year 1 other shingles shot).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 04-Oct-2022 Reporter's Comment: This case was reported via interactive digital media. The reporter stated that got the first shot which was painful for their old folks but going for number 2 in about a week, sure don't want this shingles heard bad things; now they did take just last year 1 other shingles shot, but was told was not strong enough, take these new ones x2. Additional Supportive Information: This case had been linked with US2022AMR142459, reported by same reporter. The follow up would not possible, as no contact, details were available.; Sender's Comments:  US-GSK-US2022AMR142459:reporter´s case
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: vaccine makes you sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine, 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 Shingles vaccine.     Additional Information: GSK receipt date: 04-OCT-2022 Reporter's comment:  This case was reported by patient via interactive digital media. The patient had vaccine 2 years ago from reporting and stated he/she knew how sick it makes you. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first vaccination over 4 years ago; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 78-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received a dose of Shingles vaccine over 4 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 7-Oct-2022 Reporter's comment: The patient received only one vaccination over 4 years ago and second vaccination was not available after trying for several months. The patient asked that if a second shot gave him/her protection or did he/she need to start over again.  Additional supportive information; Till the time of reporting, the patient did not receive second shot of Shingles vaccine, which led to incomplete course of vaccination. The case was linked with case US2022AMR144043, reported by same reporter for different patients. The case was kept valid with event incomplete course of vaccination in worst approach as it was not clear that was there any product availability related issue, at the time of reporting.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR144043:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first vaccination over 4 years ago; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received a dose of Shingles vaccine over 4 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 7-Oct-2022 Reporter's comment: The patients received only one vaccination over 4 years ago and second vaccination was not available after trying for several months. The reporter asked that if a second shot gave them protection or did they need to start over again.  Additional supportive information; Till the time of reporting, the patients did not receive second shot of Shingles vaccine, which led to incomplete course of vaccination. The case was linked with case US2022AMR144042, reported by same reporter for different patient. The case was kept valid with event incomplete course of vaccination in worst approach as it was not clear that was there any product availability related issue, at the time of reporting.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR144042:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Back pain, Burning sensation, Erythema, Myalgia, Pain in extremity
Clinical narrative: back muscle pain; arm redness; burning; muscle pain; soreness in arm; This case was reported by a consumer via interactive digital media and described the occurrence of erythema of extremities in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 6th October 2022 16:00, the patient received the 1st dose of Shingles vaccine. On 7th October 2022, 1 days after receiving Shingles vaccine, the patient experienced muscular back pain. In October 2022, the patient experienced erythema of extremities, burning sensation, myalgia and pain in arm. On an unknown date, the outcome of the erythema of extremities, burning sensation, myalgia, pain in arm and muscular back pain were not recovered/not resolved.   It was unknown if the reporter considered the erythema of extremities, burning sensation, myalgia, pain in arm and muscular back pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 05-Oct-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received the first dose of Shingles vaccine on Thursday at 4 pm. Less than a week after vaccination, the patient experienced usual arm redness, burning, muscle pain and soreness in my arm.  The patient got up Friday morning with back muscle pain. The patient still had it. The patient was asking could this be from the vaccine. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles/After one week after getting the vaccine, got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 week after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 3-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. After one week after getting the vaccine, the patient got the shingles. The patient stated that did not recommended vaccine. The reporter denied to follow-up.
Sex: U
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Fluarix administered in <6 months old; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a infant patient who received Flu Seasonal QIV Dresden (Fluarix Tetra) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Fluarix Tetra and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Tetra and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 03-OCT-2022 Reporter's comments: Physician reported that a patient who was younger than 6 months old received a Fluarix dose. The reporter had consented to follow-up. Additional supportive information: The patient who had received Fluarix Tetra was younger than 3 years which had led to inappropriate age at vaccine administration.
Age: 8.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: Expired Kinrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 8-year-old male patient who received DTPa-IPV (Kinrix) (batch number YZ97N, expiry date 26th August 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th September 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 30th September 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 03-OCT-2022 Reporter's Comment: The registered nurse reported that a dose of Kinrix given to the patient and it was already expired.  The reporter did not consent to follow up.  The Vaccine Administration Facility was the same as primary reporter. Additional Supportive Information: The use of Kinrix dose, which was already expired on 26th August 2022, which led to expired vaccine used.
Age: 62.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: administration of an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 62-year-old male patient who received HAV (Havrix) (batch number 7YA99, expiry date 30th September 2022) for prophylaxis.   On 3rd October 2022, the patient received Havrix. On 3rd October 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.    Additional Information: GSK Receipt Date: 03-Oct-2022 Reporter's comment: The nurse called and asked for the information about the administration of an expired dose.  The reporter asked for recommendations about patient re-vaccination.  The consent to follow up was granted. Additional Supportive Information: The patient received expired dose of Havrix, which led to expired vaccine used.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on 01-APR-2020, 2nd not received; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose of Shingrix vaccine on his left arm on 1st April 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 03-OCT-2022 Reporter's Comments:  The patient reported that patient did not get the 2nd dose of the vaccine.  Patient would share medical information with health care professional/primary care physician and registered pharmacist for follow up with GlaxoSmithKline. The consent for follow up was not requested.  Additional Supportive Information: The patient did not get the 2nd dose of the vaccine, which led to incomplete course of vaccination.
Age: 74.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Administered diluent only; Administered diluent only; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 74-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA714A, expiry date 30th June 2023) for prophylaxis.   On 3rd October 2022, the patient received Menveo. On 3rd October 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.     Additional Information: GSK Receipt Date: 03-OCT-2022 Reporter's Comment:  Medical Assistant administered by error a Menveo diluent without powder to a patient.  Reporter consented to follow up via email. Additional supportive information: As patient received only Menveo diluent without powder, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Peripheral swelling
Clinical narrative: red at the injection site; hot at the injection site; hard at the injection site; swelling at the injection site; swollen arm; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number 44T97, expiry date 18th September 2023) for prophylaxis.   On 26th September 2022, the patient received the 1st dose of Shingrix. In September 2022, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site warmth, injection site induration, injection site swelling and swelling arm. On an unknown date, the outcome of the injection site erythema, injection site warmth, injection site induration, injection site swelling and swelling arm were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site warmth, injection site induration, injection site swelling and swelling arm to be related to Shingrix.  Additional Information: GSK Receipt Date: 03-OCT-2022 and 04-OCT-2022 Reporter's Comment: The reporter reported that, a patient who received a Shingrix vaccine last week and was now experiencing a red, hot, hard swelling at the injection site. The symptoms were still present.  The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.