chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Hurts a lot; 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 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.   The reporter considered the pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 16-DEC-2022 Reporters comment: This case was reported by a consumer via interactive digital media. The patient received the first dose of shingles vaccine and its hurts a lot. The patent also stated that it's worth it.
Sex: U
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Couldn't lift it above shoulder; Arm was really sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In October 2022, the patient received Shingles vaccine. On an unknown date, less than 2 months after receiving Shingles vaccine, the patient experienced pain in arm and mobility decreased. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the mobility decreased was unknown.   It was unknown if the reporter considered the pain in arm and mobility decreased to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 18-DEC-2022 Reporter's comments: The patient self-reported this case via interactive digital media. The patient received the vaccine about two months ago.  The patient said his/her arm was really sore for four days, could not lift it above his/her shoulder. The patient did not regret it, just letting know if planning on getting it. Additional supportive information:  Follow up would not possible, as no contact details were available
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness at injection site; Swelling at injection site, an allergic reaction?; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema 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 injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were unknown.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-DEC-2022 Reporter's Comment: The case was self reported by the patient. The patient received dose of Shingrix and reported that one of the common side effects presented was redness and swelling at injection site. The reporter asked did this side effects count as an allergic reaction.
Sex: U
Vaccine: VARZOS
Symptoms: COVID-19, Herpes zoster
Clinical narrative: Now have COVID; Full blown case of Shingles that evening; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included discomfort (patient had discomfort in right side).   In November 2022, the patient received Shingrix. In November 2022, less than a day after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced covid-19. On an unknown date, the outcome of the shingles was unknown and the outcome of the covid-19 was not recovered/not resolved.   It was unknown if the reporter considered the shingles and covid-19 to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-DEC-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported that he/she received Shingrix vaccine a month ago from reporting. The patient stated that when he/she went to receive Shingrix vaccine he/she had some discomfort in his/her right side. The patient reported that after received Shingrix vaccine he/she experienced full blown case of Shingles on that evening. The patient reported that he/she now had Covid. Additional supportive information: Follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Exposure via skin contact, Occupational exposure to product, Product complaint
Clinical narrative: Adjuvant leaked in HCP's arm during preparation; Adjuvant leaked in HCP's arm during preparation; Adjuvant leaked in HCP's arm during preparation; This case was reported by a pharmacist via call center representative and described the occurrence of occupational exposure while preparing product for administration in a female patient who received Herpes zoster (Shingrix) (batch number GS57B, expiry date 29th September 2023) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced occupational exposure while preparing product for administration, exposure via skin contact and pharmaceutical product complaint. The action taken with Shingrix was unknown. On an unknown date, the outcome of the occupational exposure while preparing product for administration, exposure via skin contact and pharmaceutical product complaint were unknown.   Additional Information: GSK receipt date: 12-Dec-2022 Reporter's comment: The pharmacist reported an experienced vaccinator. Neither she nor anyone else had previously reported this complaint to the company.  During Shingrix preparation for administration, some of the adjuvant leaked from the stopper and onto the pharmacist's arm.  The vial was held upside-down when the adjuvant was being withdrawn.  The following questions were also asked that the customer inject air from the syringe into the vial during preparation. Prior to tipping vial upside-down and withdrawing adjuvant was the air injected. About 0.5 ml air was injected. From needle puncture in the stopper was leaked. No vial rubber stopper/metallic skirt detach or become loose during handling or without any manipulation. Yes, only the plastic flip-off cap was removed before handling. There was no evidence of leakage in package or carton. The suspect product was not administered to the patient.  The reporter prepared another vaccine for administration to the patient so the patient would receive the completed dose. The suspect adjuvant vial had already been discarded and was not available for return to GlaxoSmithKline. The reporter was advised to discard the extra antigen vial.  Pictures were not taken.  GlaxoSmithKline will replace with a single-dose pack.  Related adverse event and product quality complaint reports filed under the same case. The reporter did not denied for the follow-up. Additional supportive information: During Shingrix preparation for administration, some of the adjuvant leaked from the stopper and onto the pharmacist's arm, which led to occupational exposure while preparing product for administration and exposure via skin contact.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Headache, Heart rate increased, Herpes zoster
Clinical narrative: Nurse told to only get one Shingrix; Pain; Itchy; Shingles in groin area; Increased heart rate; Dizziness; Weakness; Headache; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received Zostavax vaccine in 2013).   On 17th October 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 17th October 2022, 49 days after receiving Shingrix, the patient experienced shingles, heart rate increased, dizziness, weakness and headache. On 5th December 2022, the patient experienced pain and pruritus. On an unknown date, the patient experienced off label use. On an unknown date, the outcome of the shingles, dizziness, weakness, headache, pain and pruritus were not recovered/not resolved and the outcome of the heart rate increased was recovered/resolved and the outcome of the off label use was unknown.   It was unknown if the reporter considered the shingles, heart rate increased, dizziness, weakness, headache, pain and pruritus to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR186542   Additional Information: GSK Receipt Date: 12 DEC 2022 Reporter's comment: The reporter was the patient. The patient stated that received Shingrix vaccine on in the right arm. The heart rate was resolved but the dizziness, weakness, and headache had not. One week after receiving the Shingrix vaccine the patient had a case of shingles in her groin area, that has now resolved.  The patient reported that had no medication. The nurse told her she would only have to get one Shingrix vaccine now since she had a Zostavax vaccine back in 2013. Reporter consented to follow up. The reporter gave permission for GlaxoSmithKline to contact her HCP. Additional supportive information: On 12-May-2022, she had a second case of shingles on her buttocks that was itchy and painful. It has not resolved, however no separate case needs to created as both the events were merged in one case. The case US2022185879 was identified as duplicate of case US2022AMR186542. The case US2022AMR186542 was deleted and all future correspondence will be added in the present case US2022185879 which stands as case of record.; Sender's Comments:  US-GSK-US2022AMR186542:Same reporter
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Off label use, Pain, Pruritus
Clinical narrative: Nurse told to only get one Shingrix; Pain; Itchy; Shingles in groin area; Increased heart rate; Dizziness; Weakness; Headache; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received Zostavax vaccine in 2013).   On 17th October 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 17th October 2022, 49 days after receiving Shingrix, the patient experienced shingles, heart rate increased, dizziness, weakness and headache. On 5th December 2022, the patient experienced pain and pruritus. On an unknown date, the patient experienced off label use. On an unknown date, the outcome of the shingles, dizziness, weakness, headache, pain and pruritus were not recovered/not resolved and the outcome of the heart rate increased was recovered/resolved and the outcome of the off label use was unknown.   It was unknown if the reporter considered the shingles, heart rate increased, dizziness, weakness, headache, pain and pruritus to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR186542   Additional Information: GSK Receipt Date: 12 DEC 2022 Reporter's comment: The reporter was the patient. The patient stated that received Shingrix vaccine on in the right arm. The heart rate was resolved but the dizziness, weakness, and headache had not. One week after receiving the Shingrix vaccine the patient had a case of shingles in her groin area, that has now resolved.  The patient reported that had no medication. The nurse told her she would only have to get one Shingrix vaccine now since she had a Zostavax vaccine back in 2013. Reporter consented to follow up. The reporter gave permission for GlaxoSmithKline to contact her HCP. Additional supportive information: On 12-May-2022, she had a second case of shingles on her buttocks that was itchy and painful. It has not resolved, however no separate case needs to created as both the events were merged in one case. The case US2022185879 was identified as duplicate of case US2022AMR186542. The case US2022AMR186542 was deleted and all future correspondence will be added in the present case US2022185879 which stands as case of record.; Sender's Comments:  US-GSK-US2022AMR186542:Same reporter
Age: 13.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose on 16Aug2022, 2nd on 12Dec2022; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 13-year-old male patient who received HAV (Havrix) (batch number 339TT, expiry date 30th November 2023) for prophylaxis.   Previously administered products included Havrix (received 1st dose on 16th August 2022).   On 12th December 2022, the patient received the 2nd dose of Havrix. On 12th December 2022, unknown after receiving Havrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Linked case(s) involving the same patient:  US2022186701   Additional Information: GSK receipt date: 14-Dec-2022 Reporter's comment: The reporter consented to follow-up. The case was linked with case US2022186701, reported by same reporter for different vaccine. Additional supportive information: The patient received 2nd dose earlier than the recommended interval, which led to shortening of vaccine schedule.; Sender's Comments:  US-GSK-US2022186701:Same reporter
Age: 13.0
Sex: M
Vaccine: HEP
Symptoms: Extra dose administered
Clinical narrative: 4th 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 13-year-old male patient who received HBV (Engerix B) (batch number 333M4, expiry date 7th April 2024) for prophylaxis.   Previously administered products included Engerix-B (received 3rd dose of Engerix-B on 16th August 2022).   On 12th December 2022, the patient received the 4th dose of Engerix B. On 12th December 2022, unknown after receiving Engerix B, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Linked case(s) involving the same patient:  US2022186700   Additional Information: GSK receipt date: 13-Dec-2022 Reporter's comment: The reporter consented to follow-up. The case was linked with case US2022186700, reported by same reporter for different vaccine. Additional supportive information: The patient received 4th dose of Engerix-B, which led to extra dose administered.; Sender's Comments:  US-GSK-US2022186700:Same reporter
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Neck pain, Peripheral swelling, Rash pruritic
Clinical narrative: headaches; neck achy; shoulders achy; swollen hands and feet; itchy rash on back and arms; This case was reported by a consumer via call center representative and described the occurrence of headache in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included immunodeficiency and lung disorder.   On 28th November 2022, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, several hours after receiving Shingrix, the patient experienced headache, neck pain, shoulder pain, peripheral swelling and itchy rash. The patient was treated with paracetamol (Tylenol) and benadryl (nos) (Benadryl). On an unknown date, the outcome of the headache was recovered/resolved and the outcome of the neck pain, shoulder pain, peripheral swelling and itchy rash were not recovered/not resolved.   It was unknown if the reporter considered the headache, neck pain, shoulder pain, peripheral swelling and itchy rash to be related to Shingrix.     Additional Information: GSK receipt date: 14 DEC 2022 Reporters comment:  The patient reported that received dose of Shingrix in the left arm.  Hours later patient experienced headaches, achy neck and shoulders and swollen hands and feet.  Patient stated the swelling has come down some, but still swollen. Patient's back and arms were itchy and noticed there was a rash on back and arms.  Patient notified her health care professional her suggested  to take Tylenol and Benadryl.  The patient also mentioned had a history of lung problems and immunodeficiency. Reporter did not consent to follow up.
Sex: U
Vaccine: HEP, HEPA, MNQ, TDAP, UNK, VARZOS
Symptoms: Product storage error
Clinical narrative: Vx exposed Freezing  temperature 28.6F; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) for prophylaxis, flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis, Herpes zoster (Shingrix) for prophylaxis and Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 15th October 2022, the patient received Havrix, Engerix B, Boostrix, Fluarix Quadrivalent 2022-2023 season, Fluarix Tetra Pre-Filled Syringe Device, Shingrix and Menveo. On an unknown date, unknown after receiving Havrix, Engerix B, Boostrix, Fluarix Quadrivalent 2022-2023 season, Fluarix Tetra Pre-Filled Syringe Device, Shingrix and Menveo, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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: 14-DEC-2022. Reporter's Comment:  The pharmacist reported that below recommended temperature of 28.6F for Havrix, Fluarix, Shingrix, Menveo, Engerix-B, and Boostrix. vaccines were administered to patients after freezing temperature occurred.  The reporter stated that temperature occurred on 15th Oct 2022. Additional Supportive information: The patient received reported that below recommended temperature of 28.6F for Havrix, Fluarix, Shingrix, Menveo, Engerix-B, and Boostrix which led to incorrect storage of drug.
Sex: F
Vaccine: UNK, UNK
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: received a 3nd dose, 2 months apart; 1st dose recieved in 2020 and 2nd dose in 10-Oct-2022; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 15-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number 7TP53, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis, Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) for prophylaxis and flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Fluarix (received fluarix 1st dose in 2020).   On 12th December 2022, the patient received the 3rd dose of Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device. On 10th October 2022, the patient received the 2nd dose of Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device. On 10th October 2022, not applicable after receiving Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device and unknown after receiving Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On 12th December 2022, the patient experienced extra dose administered. On an unknown date, the outcome of the drug dose administration interval too long and extra dose administered were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 14-DEC-2022. Reporter's Comment: The reporter stated that patient had received a dose of Fluarix on 10th October 2022 and a second dose on 12th December 2022. The reporter stated that patient did mention that the previous dose had been given in 2020 and did not specify further information. Reporter relayed information for adverse event report and agreed to be contacted further on via email, which was provided. Additional Supportive Information: The patient had received 1st dose of Fluarix in 2020 and 2nd dose of Fluarix in 10th October 2022 which led to lengthening of vaccination schedule. The patient received 3rd dose of Fluarix which led to extra dose administered.
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ, MNQ
Symptoms: Extra dose administered, Interchange of vaccine products
Clinical narrative: Extra dose on 14Dec2022; received a dose of Menactra in 2018 and it was completed with a dose of Menveo on 18Oct2022; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA749A, expiry date 30th November 2023) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) (batch number AMVA749A, expiry date 30th November 2023) for prophylaxis and MENACTRA for prophylaxis.   On 14th December 2022, the patient received the 2nd dose of Menveo. On 18th October 2022, the patient received the 1st dose of Menveo. On an unknown date, the patient received MENACTRA. On 18th October 2022, not applicable after receiving Menveo and unknown after receiving Menveo, the patient experienced interchange of vaccine products. On 14th December 2022, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered and interchange of vaccine products were unknown.   Additional Information: GSK receipt date: 14-DEC-2022 Reporter's comment: The nurse reported that the patient received a dose of Menactra in 2018 and it was completed with a dose of Menveo. The patient received an extra dose of Menveo. The reporter consented to follow up. Additional supportive information: The patient received extra dose of Menveo, which led to extra dose administered. The patient received a dose of Menactra and Menveo, which led to interchange of vaccine products.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Disorientation, Hyperhidrosis, Presyncope
Clinical narrative: Ready to pass out (ER visit); Profuse sweating (ER visit); Severe disorientation (ER visit); This case was reported by a pharmacist via call center representative and described the occurrence of presyncope in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Moderna covid vaccine with an associated reaction of presyncope (had a similar reaction when patient took the Moderna Covid shot for the first time and experienced presyncope).   On 13th December 2022, the patient received the 1st dose of Shingrix. In December 2022, 20 hrs after receiving Shingrix, the patient experienced presyncope, sweating and disorientation. In December 2022, the outcome of the presyncope, sweating and disorientation were recovered/resolved.   It was unknown if the reporter considered the presyncope, sweating and disorientation to be related to Shingrix.     Additional Information: GSK Receipt Date: 14-DEC-2022 Reporter's Comment: The reporter was the registered pharmacist who was the mother of the patient. The patient received first dose of Shingrix yesterday and 20 hours later had a severe reaction including ready to pass out, profuse sweating and severe disorientation. The patient had similar reaction when she took the Moderna Covid shot for the first time. The patient was okay now and she had no such reaction. The reporter just trying to find out if there was a common ingredient or product that exists in both products that could be responsible for the commonality of reactions. The reporter believed that her daughter filed a report with organization today to let them know of the reaction.  The EMS people indicated that it was apparently a response to the Shingrix. Emergency room visit required. The patient was concerned about taking the second shot due to reactions and she was feeling much better.  The healthcare professional did not have the lot or expiration date. The reporter reported that her daughter might have reported this so this might be a duplicate report. The reporter consented to follow up by email.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Atrial fibrillation, Chills, Condition aggravated, Fatigue
Clinical narrative: shivering; fatigue/ very tired; upset stomach; A Fib got worse after 2nd dose; Pain at injection site; very hard and rapid heart pounding; This case was reported by a consumer via call center representative and described the occurrence of atrial fibrillation aggravated in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of atrial fibrillation (received 1st dose in 19th September 2022, on the right arm). Concurrent medical conditions included atrial fibrillation.   On 14th December 2022, the patient received the 2nd dose of Shingrix (intramuscular). On 14th December 2022, less than a day after receiving Shingrix, the patient experienced shivering. In December 2022, the patient experienced atrial fibrillation aggravated (serious criteria GSK medically significant), injection site pain, heart pounding, fatigue and upset stomach. On an unknown date, the outcome of the atrial fibrillation aggravated, injection site pain, heart pounding, fatigue and upset stomach were unknown and the outcome of the shivering was recovered/resolved.   It was unknown if the reporter considered the atrial fibrillation aggravated, injection site pain, heart pounding, shivering, fatigue and upset stomach to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR188512   Additional Information: GSK Receipt Date: 15-DEC-2022 Reporter's Comments: The reporter that a patient with occasionally A Fib. The reporter stated that he had the 1st dose of Shingrix vaccine on 19th September 2022. The patient did not have symptoms at all with the 1st dose.  The patient had the 2nd dose 14th December 2022 at a pharmacy facility at 11 am.  The reporter reported that both vaccines were administered on the right arm.  The reporter reports that he had symptoms of A Fib before getting the 2nd dose but they got worse after the vaccine. At the end of the day the patient was very tired heart pounding very hard, upset stomach, fatigue, shivering, rapid heart pounding, pain at injection site. Not all information was available. Lot and expiration dates of both vaccines were unknown.  The reporter was consented to follow up.; Sender's Comments:  US-GSK-US2022AMR188512:same reporter - 1st dose case
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Palpitations
Clinical narrative: shivering; fatigue/ very tired; upset stomach; A Fib got worse after 2nd dose; Pain at injection site; very hard and rapid heart pounding; This case was reported by a consumer via call center representative and described the occurrence of atrial fibrillation aggravated in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of atrial fibrillation (received 1st dose in 19th September 2022, on the right arm). Concurrent medical conditions included atrial fibrillation.   On 14th December 2022, the patient received the 2nd dose of Shingrix (intramuscular). On 14th December 2022, less than a day after receiving Shingrix, the patient experienced shivering. In December 2022, the patient experienced atrial fibrillation aggravated (serious criteria GSK medically significant), injection site pain, heart pounding, fatigue and upset stomach. On an unknown date, the outcome of the atrial fibrillation aggravated, injection site pain, heart pounding, fatigue and upset stomach were unknown and the outcome of the shivering was recovered/resolved.   It was unknown if the reporter considered the atrial fibrillation aggravated, injection site pain, heart pounding, shivering, fatigue and upset stomach to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR188512   Additional Information: GSK Receipt Date: 15-DEC-2022 Reporter's Comments: The reporter that a patient with occasionally A Fib. The reporter stated that he had the 1st dose of Shingrix vaccine on 19th September 2022. The patient did not have symptoms at all with the 1st dose.  The patient had the 2nd dose 14th December 2022 at a pharmacy facility at 11 am.  The reporter reported that both vaccines were administered on the right arm.  The reporter reports that he had symptoms of A Fib before getting the 2nd dose but they got worse after the vaccine. At the end of the day the patient was very tired heart pounding very hard, upset stomach, fatigue, shivering, rapid heart pounding, pain at injection site. Not all information was available. Lot and expiration dates of both vaccines were unknown.  The reporter was consented to follow up.; Sender's Comments:  US-GSK-US2022AMR188512:same reporter - 1st dose case
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Granuloma annulare, Skin test, Urticaria
Clinical narrative: GRANULOMA  ANNULARE ON TORSO BACK OF 1 ARM AND LEGS; BAD HIVES; This spontaneous report received from a patient concerned a 64 year old  female. The patient's height, and weight were not reported. The patient's concurrent conditions included: eczema (mild used topical Flucinonide occasionally when needed), and drug allergy (allergies to Propolis, Iodopropynyl Butylcarbamate), and other pre-existing medical conditions included: The patient had no Chronic or long-standing health conditions. The patient was not pregnant at the time of vaccination. The patient did not have an adverse event following any previous vaccine. The patient previously received dose 1 with covid-19 vaccine ad26.cov2.s (Dose number in series 1), (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total administered start therapy date were not reported for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination (Dose number in series 1). The patient received booster with covid-19 vaccine ad26.cov2.s (Dose number in series 2), (suspension for injection, route of admin not reported, batch number: 1855191 expiry: UNKNOWN) dose was not reported, 1 total administered on 13-DEC-2021 11:00 to right arm for covid-19 prophylaxis. Age at time of vaccination 64 years old. Concomitant medications included fluocinonide for eczema, calcium, colecalciferol, curcuma longa, cyanocobalamin, fish oil, paracetamol, and tocopherol.  On 09-JAN-2022 11:00, the patient experienced rash and was diagnosed with granuloma annulare on torso back of 1 arm and legs (Dose number in series 2). On same day, the patient also experienced bad hives along with symptoms of allergies and swelling of lips and tongue (Dose number in series 2). Laboratory data (dates unspecified) included: Biopsy to determine the Rash was Granduloma Annulare, and Skin test showed allergies to Propolis, Iodopropynyl Butylcarbamate. The patient also visited physician office. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from granuloma annulare on torso back of 1 arm and legs, and bad hives. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Coma
Clinical narrative: COMA; This spontaneous report received from a consumer via a company representative via social media concerned multiple (2) patients of an unspecified age, sex, race and ethnicity.   The patient's weight, height, and medical history were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patients went into coma. It was reported as "I personally know 2 people that went in a coma from the vaccination". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of coma was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20221241346.; Sender's Comments: V0-20221241416- Coma. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; VACCINE WERE NOT EFFECTIVE; This spontaneous report received from a patient via a company representative via social media (J and J Corporate account) concerned a patient of unspecified age, sex, race and ethnicity.   The patient's weight, height, and medical history were not reported. The patient previously received dose 1 with covid-19 vaccine ad26.cov2.s (Dose number in series 1), (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total administered start therapy date were not reported for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination (Dose number in series 1). The patient received dose 2 with covid-19 vaccine ad26.cov2.s (Dose number in series 2), (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced two severe suspected covid-19 infection with severe long term health complications from the covid-19 and reported that vaccine were not effective (Lack of drug effect) (Dose number in series 2). It was reported as "I had two J and J covid vaccines. They were not effective. Got two severe covid cases with severe long term health complications from the covid". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and vaccine were not effective was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000263876.; Sender's Comments: V0- 20221241813- Suspected Covid 19 infection. The event is deemed to be scientifically implausible, i.e., there is scientific evidence against a drug/event relationship; AND there is no known class effect. Therefore, this event is considered inconsistent with vaccine administration.  V0- 20221241813- Vaccine were not effective . The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: SPECIAL SITUATIONS. Therefore, this event is considered inconsistent with vaccine administration.
Sex: U
Vaccine: COVID19
Symptoms: Allergy to chemicals, Autoantibody positive, Autoantibody test, Food intolerance, Inflammation
Clinical narrative: CHEMICAL INTOLERANCE; SUDDEN HIGH LEVELS OF AUTOANTIBODIES; SEVERE PAIN; SEVERE INFLAMMATION; FOOD INTOLERANCE; This spontaneous report received from a consumer via a company representative via social media concerned multiple patients (unspecified numbers) of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical histories were not reported. The patients previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: UNKNOWN) dose was not reported, 1 total, start therapy dates was not reported for covid-19 prophylaxis. It was unknown whether patients had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (Dose number in series 1).  The patients additionally received booster dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, and batch number were not reported, expiry: UNKNOWN) dose was not reported, 1 total, start therapy dates was not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patients experienced chemical intolerance, sudden high levels of autoantibodies, severe pain, severe inflammation, and food intolerance (Dose number in series 2). Laboratory data (dates unspecified) included: Autoantibody test sudden high levels. It was reported as "So you are now going to study the very condition that your covid vaccines have caused me and many others. Seriously. I filed a VAERS report, which has been filed with the CDC and FDA, but these reported adverse events go nowhere. There is currently no help or studies being done for/on those of us who are having sudden high levels of autoantibodies triggering severe pain and inflammation, food intolerance, chemical intolerance, since being vaccinated and boosted with your covid Vaccine. Apparently, you discovered your covid vaccine triggers autoantibodies, then quit the mass manufacturing of it, and now you are going to finds the answer/treatment for the condition you have caused in so many from your vaccine, I sure hope an investigation occurs into J and J covid vaccine adverse events". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chemical intolerance, sudden high levels of autoantibodies, severe pain, severe inflammation and food intolerance was not reported. This report was non-serious. This case, from the same reporter is linked to 20221241836.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: CHEMICAL INTOLERANCE; SUDDEN HIGH LEVELS OF AUTOANTIBODIES; SEVERE PAIN; SEVERE INFLAMMATION; FOOD INTOLERANCE; This spontaneous report received from a consumer via a company representative via social media concerned multiple patients (unspecified numbers) of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical histories were not reported. The patients previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: UNKNOWN) dose was not reported, 1 total, start therapy dates was not reported for covid-19 prophylaxis. It was unknown whether patients had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (Dose number in series 1).  The patients additionally received booster dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, and batch number were not reported, expiry: UNKNOWN) dose was not reported, 1 total, start therapy dates was not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patients experienced chemical intolerance, sudden high levels of autoantibodies, severe pain, severe inflammation, and food intolerance (Dose number in series 2). Laboratory data (dates unspecified) included: Autoantibody test sudden high levels. It was reported as "So you are now going to study the very condition that your covid vaccines have caused me and many others. Seriously. I filed a VAERS report, which has been filed with the CDC and FDA, but these reported adverse events go nowhere. There is currently no help or studies being done for/on those of us who are having sudden high levels of autoantibodies triggering severe pain and inflammation, food intolerance, chemical intolerance, since being vaccinated and boosted with your covid Vaccine. Apparently, you discovered your covid vaccine triggers autoantibodies, then quit the mass manufacturing of it, and now you are going to finds the answer/treatment for the condition you have caused in so many from your vaccine, I sure hope an investigation occurs into J and J covid vaccine adverse events". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chemical intolerance, sudden high levels of autoantibodies, severe pain, severe inflammation and food intolerance was not reported. This report was non-serious. This case, from the same reporter is linked to 20221241836.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Thrombosis
Clinical narrative: BLOOD CLOTS; HURT ALL OVER MOSTLY LOWER BACK; This spontaneous report received from a patient via a company representative via social media (J and J Corporate) concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: Graves disease (under control). The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis.  It was unknown whether patient had any adverse event following vaccination with first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1).  The patient also received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The drug was associated with off label use (off label dosing frequency, dose number in series 2). The outcome of off label dosing frequency was not reported. The patient additionally received first booster of covid-19 vaccine ad26.cov2.s (dose number in series 3) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clots and was on thinners but hurt all over mostly lower back (Dose number in series 3). Reporter stated that, "I have Graves under control had 2 j j vac and 1 booster now blood clots on thinners but hurt all over mostly my lower back". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clots and hurt all over mostly lower back was not reported. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20221245467 (dose number in series 2).; Sender's Comments: V0: 20221242050-Blood clots. The event has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Sex: M
Vaccine: COVID19
Symptoms: Death, Myocardial infarction
Clinical narrative: DIED; MASSIVE HEART ATTACK; This spontaneous report received from a consumer via a company representative through social media concerned a male of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 1) (suspension for injection, form of admin was not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis.  It was unknown whether the patient experienced any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, form of admin was not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced massive heart attack  (Dose number in series 2). On an unspecified date after 28 days of Janssen booster, the patient died (Dose number in series 2). The date of death and cause of death was unknown. It was unknown whether an autopsy was performed. It was reported as " My husband died 28 days after his J&J booster. massive heart attack gone in minutes. I will never get another one". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of massive heart attack was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0: 20221242060 -died. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.   20221242060 - massive heart attack.  The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DIED; This spontaneous report received from a consumer via a company representative through social media concerned multiple patients of an unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose not reported,1 total, administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patients died from unknown cause of death after they were fully vaccinated. It was unspecified if an autopsy was performed. The reporter stated that, "They were right the only people that I know who have died are fully vaccinated". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0-20221243109-Died. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH