chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure/had the shingles shot / it worked only for three years; it worked only for three years; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a 50-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included immune system disorder (had has lower immune system for arthritis) and arthritis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, 3 years 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 details were provided as follows: The patient self-reported this case. The patient was in a biologic which lower immune system for arthritis. The patient had the shingles shot and it worked for only 3 years. The patient asked if the two shots of Shingrix work better the second time. The patient stated that the website said that 91 percent so might be the patient was in 9 percent, they were talking about. This case was considered as suspected vaccination failure as details regarding the laboratory test confirmation were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Injection site pain, Pain
Clinical narrative: Two doses were greater than 6 months apart; Body aches; Pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (received 1st dose on 18th November 2019 and experienced body aches and injection site pain, refer case US2022006705).   On 24th September 2021, the patient received the 2nd dose of Shingrix .5 ml. In September 2021, 12 hrs after receiving Shingrix, the patient experienced general body pain and injection site pain. On 24th September 2021, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the general body pain and injection site pain were recovered/resolved and the outcome of the drug dose administration interval too long was unknown.   The reporter considered the general body pain and injection site pain to be related to Shingrix.     Linked case(s) involving the same patient:  US2022006705  Additional details were provided as follows: The case was reported by the husband for his wife. The patient's husband stated that after her second dose of Shingrix she had body aches and pain at the injection site for about 2 days. The reporter stated that the patients side effects started about 12 hours after each vaccine and had resolved. The reporter also stated that his wife's two doses were greater than 6 months apart, which led to which led to lengthening of vaccination schedule. The reporter wanted to know if she needed to restart the series. Spoke per content and patient was referred to health care professional. The reporter did not consent to follow-up. This case has been linked to US2022006699, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022006699:Same reporter. US-GLAXOSMITHKLINE-US2022006705:Same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: vaccinated years back, revaccinated; This case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine  (received Shingles vaccine some years ago from reporting date).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The patient was reporter's father. The age at vaccination was not reported. The reporter reported that his/her father in law was in a nursing home and they accidentally revaccinated him with Shingles vaccine, which led to extra dose administered. The reporter asked that would this hurt the patient. The follow-up could not be possible as no contact details were available. Note: The case was conservatively kept as valid one as there is no clarification regarding total number of doses and follow-up could not to follow as no contact details were there.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: Had both shots. Two years later got internal shingles/ Suspected vaccination failure; internal shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had internal shingles (no rash) twice).   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, more than 2 years after receiving Shingles vaccine and 2 years after receiving 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 recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had Shingles shots after first time of having shingles. Two years later got internal shingles again but not hardly as bad or last as long. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming shingles was unknown at the time of reporting.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Havrix expired 2021 was given patient; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number unknown, expiry date July 2021) for prophylaxis.   On 12th January 2022, the patient received Havrix. On 12th January 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 details were provided as follows: The case was reported by the Pharmacist's technician. The age at vaccination was not reported. The patient was indivertibly given an expired dose of Havrix, which led to expired vaccine used. No information was available about the patient involved and lot number of the vaccine at the time of reporting. The reporter consented to follow up via email.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose of Shingrix on 12/7/21 / the second dose on 1/11/22.; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 3AA9T, expiry date 20th April 2023) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 11th January 2022, the patient received the 2nd dose of Shingrix. On 11th January 2022, unknown after receiving Shingrix, 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.  Additional details were provided as follows: The patient received 1st dose on 7th December 2021, batch number 3BD9E  and expiry date 6th April 2023. The patient received 2nd dose on 11th January 2022, early than the recommended time interval, which led to shortening of vaccination schedule. The reporter did not consent to follow up.
Sex: F
Vaccine: HEPA
Symptoms: Extra dose administered
Clinical narrative: Patient received 3rd dose; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 31-month-old female patient who received HAV (Havrix) (batch number 2k57n, expiry date 11th December 2022) for prophylaxis.   Previously administered products included Havrix (received first dose of Havrix on 27th April 2021, batch number CE74N and expiry date 19th June 2022). Concomitant products included HAV (Havrix).   On 7th December 2021, the patient received the 3rd dose of Havrix. On 7th December 2021, unknown after receiving Havrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were reported as follows: Age at vaccination was unknown, however could be 30 months or 31 months at the time of vaccination. The patient received third dose of Havrix, which led to extra dose administration. Consent to follow up was granted.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site papule, Injection site pruritus, Injection site swelling
Clinical narrative: Sore arm; itchy; Red at the site of injection; swelling bump at the site of injection, crust on top, dot center; at the site of injection, painful to touch; she experienced a red raised swelling bump (Boil-like) at the site of injection/ red bump (boil-like; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th December 2021, the patient received the 1st dose of Shingrix. In December 2021, less than 2 weeks after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, injection site pain, injection site papule and pruritus. On 20th December 2021, the patient experienced pain in arm. On an unknown date, the outcome of the injection site erythema, injection site pain and pain in arm were unknown and the outcome of the injection site swelling, injection site papule and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site pain, injection site papule, pain in arm and pruritus to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient received first dose of Shingrix on 20th December 2021. The patient had a sore arm immediately after the vaccination.  Then about 7 to 10 days later, she experienced a red raised swelling bump (Boil-like) at the site of injection on left upper arm.  She stated that the bump was red and painful to touch from the sides, but not painful if touched from the top.  She also stated that the bump had a crust on top and a dot on a center.  She stated that it was itchy when she touched or if clothes touch the area, but not itchy all the time.  She stated that the red bump (boil-like) and itchiness were still present and not resolved.  She did not have the information about lot/exp date, route of administration and dose of Shingrix. The reporter consented to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm; itchy; Red at the site of injection; swelling bump at the site of injection, crust on top, dot center; at the site of injection, painful to touch; she experienced a red raised swelling bump (Boil-like) at the site of injection/ red bump (boil-like; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th December 2021, the patient received the 1st dose of Shingrix. In December 2021, less than 2 weeks after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, injection site pain, injection site papule and pruritus. On 20th December 2021, the patient experienced pain in arm. On an unknown date, the outcome of the injection site erythema, injection site pain and pain in arm were unknown and the outcome of the injection site swelling, injection site papule and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site pain, injection site papule, pain in arm and pruritus to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient received first dose of Shingrix on 20th December 2021. The patient had a sore arm immediately after the vaccination.  Then about 7 to 10 days later, she experienced a red raised swelling bump (Boil-like) at the site of injection on left upper arm.  She stated that the bump was red and painful to touch from the sides, but not painful if touched from the top.  She also stated that the bump had a crust on top and a dot on a center.  She stated that it was itchy when she touched or if clothes touch the area, but not itchy all the time.  She stated that the red bump (boil-like) and itchiness were still present and not resolved.  She did not have the information about lot/exp date, route of administration and dose of Shingrix. The reporter consented to follow up.
Sex: M
Vaccine: MENB
Symptoms: Expired product administered, Product administered to patient of inappropriate age
Clinical narrative: expired Bexsero was administered; administered to patient; This case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a adult male patient who received Men B NVS (Bexsero) (batch number ABXA69CB, expiry date 20th October 2021) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used and inappropriate age at vaccine administration. On an unknown date, the outcome of the expired vaccine used and inappropriate age at vaccine administration 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 details were provided as follows: The age at the vaccination was reported. The reporter reported that an expired Bexsero was administered to patient, which led to expired vaccine used and inappropriate age at vaccine administration. The vaccine was administered in late October-early November 2021. The reported had not reported any reactions. The reporter consented to follow up as email was preferred.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain
Clinical narrative: pains, aches; chills; This case was reported by a consumer via call center representative and described the occurrence of pain in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th January 2022, the patient received the 1st dose of Shingrix. On 14th January 2022, 1 days after receiving Shingrix, the patient experienced pain and chills. On an unknown date, the outcome of the pain and chills were not recovered/not resolved.   It was unknown if the reporter considered the pain and chills to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient. The reporter reported that she had Shingrix yesterday (from the date of reporting) and was at the time of reporting experiencing chills, aches and pains. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose in 2019, did not receive 2nd yet; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 3rd May 2019).   On an unknown date, the patient received 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 details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient received did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The lot number and expiry date for 1st dose was not available when asked. The VAERS details were reported for 1st dose. The reporter consented to follow up.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Extra dose administered
Clinical narrative: administrated a third dose of Bexsero; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 17-year-old male patient who received Men B NVS (Bexsero) (batch number abxb39ac, expiry date 3rd July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Bexsero (received 2nd dose on 12th October 2021) and Bexsero (received 1st dose on 3rd August 2021).   On 14th January 2022, the patient received the 3rd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 14th January 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered 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 details were provided as follows: The reporter stated that, the patient was inadvertedly administrated a third dose of Bexsero, which led to extra dose administered. No further events were reported. The reporter consented to follow up.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: given an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA57AA, expiry date 30th September 2021) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th January 2022, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 14th January 2022, unknown after receiving Bexsero and Bexsero 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 details were provided as follows: The reporter stated that, the patient received an expired dose of Bexsero, which led to expired vaccine used. At the time of reporting, the patient had not been re-dosed. The reporter consented to follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: light/social drinker, and non-smoker, and patient had no known allergies. The patient received covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of admin, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on unspecified date for prophylactic vaccination (dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on 30-DEC-2021 for prophylactic vaccination on right deltoid (dose number in series 2). The batch number was not reported and has been requested. No concomitant medications were reported.  On 25-DEC-2021, Laboratory data included: COVID-19 virus test (first at home test) (NR: not provided) negative.  Symptoms (reported as "basically all the symptoms") started on 30-DEC-2021.The patient started getting sick after the booster, at onset patient had chills, diarrhea, and mild fever. On 03-JAN-2022, patient underwent COVID-19 PCR (polymerase chain reaction) test which was positive (confirmed covid-19 infection and confirmed clinical vaccination failure) (dose number in series 1). On 04-JAN-2022 (at the time of report), patient had cough, congestion, and light headache. Patient did not know if fatigue was due to the COVID (COVID-19 Infection) or vaccine. On 04-JAN-2022, patient underwent another rapid test Laboratory data included: COVID-19 antigen test which was positive. Patient works but was on condolence leave.   The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000210755. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.; Sender's Comments: V0 - 20220105653- covid-19 vaccine ad26.cov2.s -Confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: FELT LIKE KICKED IN THE HEAD BY A MULE (MASSIVE HEADACHE); This spontaneous report received from a patient concerned a 60 year old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. The patient was previously vaccinated with Covid-19 vaccine ad26.cov2.s. (manufacturer not specified) (suspension for injection, route of admin, batch number and expiry date not reported), (dose number in series 1) 01 in total, administered dose was not reported for prophylactic vaccination. No adverse events were reported following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient additionally received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D2114, and expiry: Unknown) dose was not reported, (dose number in series 2) 01 total administered in left arm on 27-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, after receiving the booster, the patient felt like she had covid-19, all over again and had a massive headache, felt like she was kicked in the head by a mule (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of felt like kicked in the head by a mule (massive headache) was not reported. This report was non-serious.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fall, Lip discolouration, Loss of consciousness, Migraine
Clinical narrative: SHE PASSED OUT; FACE TURNED WHITE; LIPS TURNED PURPLE; MASSIVE MIGRAINES; BED WITH ACHES AND PAIN; FELL IN CHAIR; CHILLS; FEVER; This spontaneous report received from a consumer concerned a 44 year female.  The patient's height, and weight were not reported. The patient's concurrent conditions included: lot of allergies to things. The patient was previously vaccinated with Pfizer (BNT 162) (form of admin, route of admin, batch number and expiry was not reported) dose was not reported (dose number in series was 1), administered for prophylactic vaccination. On an unspecified date, following vaccination with Pfizer (BNT 162), the patient was sick for one day (dose number in series 1).  The patient received additionally covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number:211D21A and expiry:11-APR-2022) dose was not reported (dose number in series 2), 01 total administered on 04-JAN-2022 at left deltoid for prophylactic vaccination. No concomitant medications were reported.  On 04-JAN-2021, following administration of covid-19 vaccine ad26.cov2.s, her face turned white, lips turned purple and just passed out. She sat down and fell in chair. Pharmacist gave her lollipop to suck but did not gave anything to drink, 30 minutes later when they went home, she had massive migraines, chills and fever, she had bed with aches and pains (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from face turned white, lips turned purple, massive migraines, chills, fever, and bed with aches and pains, and the outcome of she passed out and fell in chair was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220112619 and 20220112632.; Sender's Comments: V0- 20220112654-covid-19 vaccine ad26.cov2.s-She passed out. This event(s) is considered unassessable. The event(s) 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(s).
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Skin discolouration
Clinical narrative: SHE PASSED OUT; FACE TURNED WHITE; LIPS TURNED PURPLE; MASSIVE MIGRAINES; BED WITH ACHES AND PAIN; FELL IN CHAIR; CHILLS; FEVER; This spontaneous report received from a consumer concerned a 44 year female.  The patient's height, and weight were not reported. The patient's concurrent conditions included: lot of allergies to things. The patient was previously vaccinated with Pfizer (BNT 162) (form of admin, route of admin, batch number and expiry was not reported) dose was not reported (dose number in series was 1), administered for prophylactic vaccination. On an unspecified date, following vaccination with Pfizer (BNT 162), the patient was sick for one day (dose number in series 1).  The patient received additionally covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number:211D21A and expiry:11-APR-2022) dose was not reported (dose number in series 2), 01 total administered on 04-JAN-2022 at left deltoid for prophylactic vaccination. No concomitant medications were reported.  On 04-JAN-2021, following administration of covid-19 vaccine ad26.cov2.s, her face turned white, lips turned purple and just passed out. She sat down and fell in chair. Pharmacist gave her lollipop to suck but did not gave anything to drink, 30 minutes later when they went home, she had massive migraines, chills and fever, she had bed with aches and pains (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from face turned white, lips turned purple, massive migraines, chills, fever, and bed with aches and pains, and the outcome of she passed out and fell in chair was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220112619 and 20220112632.; Sender's Comments: V0- 20220112654-covid-19 vaccine ad26.cov2.s-She passed out. This event(s) is considered unassessable. The event(s) 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(s).
Sex: F
Vaccine: COVID19
Symptoms: Chills, Formication
Clinical narrative: This spontaneous report received from a patient concerned a female of unspecified race and ethnicity.The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient previously received covid-19 vaccine ad26. cov2. s (dose number in series 1) (suspension for injection, route of admin, and batch number: Unknown) dose was not reported, 1 total, administered on 07-APR-2021 for prophylactic vaccination. It was unknown if the patient had any adverse events (dose number in series 1).The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number: Unknown, expiry unknown) dose was not reported, 1 total, administered on 07-JAN-2022 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.On 07-JAN-2022, the patient experienced chills. On 08-JAN-2022, in the morning the patient experienced crawling feeling on ankles and feet (dose number in series 2). The patient had not reached out to her doctor.The action taken with covid-19 vaccine ad26.cov2.s was not applicable.The outcome of the chills and crawling feeling on ankles and feet was not reported.This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, SARS-CoV-2 test
Clinical narrative: HEADACHES; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: Unknown) dose was not reported, (dose number in series 1), 01 in total, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  No adverse events were reported following administration of covid-19 vaccine ad26.cov2.s (dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient received additional non-company suspect vaccine bnt 162 (form of admin, route of admin were not reported, batch number: FH8020, expiry: Unknown) dose was not reported, (dose number in series 2), administered on 11-NOV-2021 for prophylactic vaccination On 07-JAN-2022, the patient experienced headaches (dose number in series 2). On 08-JAN-2022, Laboratory data included: COVID-19 PCR (polymerase chain reaction) test (NR: not provided) Negative.  On 10-JAN-2022, Laboratory data included: COVID-19 rapid POC (Point of care) test (NR: not provided) Negative. The outcome of headaches was not reported (dose number in series 2). This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Dermatitis allergic, Pruritus, Rash erythematous
Clinical narrative: ALLERGIC SKIN CONDITION; ITCHING ALL OVER BODY; RED SPOTS; This spontaneous report received from a patient concerned a patient of unspecified age, sex, ethnic origin and race. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose was not reported, dose number in series was 1, 01 in total, administered on an unspecified date for prophylactic vaccination. No adverse events were reported following administration of covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient additionally received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose was not reported, dose number in series was 2, 01 in total, administered on 07-JAN-2022 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in JAN-2022, after vaccination with booster dose, the patient experienced allergic skin condition with red spots and itching all over the body (dose number in series was 2). The patient had been medicated in the hospital twice. The patient was continuing with medication at home, but the symptoms did not stop. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from allergic skin condition, red spots and itching all over body (dose number in series was 2). This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal abscess, Hospice care, Injury, Personality change, Surgery
Clinical narrative: ABDOMINAL ABSCESSES; SURGERY MULTIPLE ISSUES; PERSONALITY CHANGES; INJURED; HOSPICE FOR PAIN; This spontaneous report received from a patient via Social media via a company representative concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on JUN-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date in DEC-2021 (reported as a 7 weeks ago), the patient experienced four abdominal abscesses and surgery multiple issues and was hospitalized. Number of days of hospitalization was not reported. On an unspecified date, the patient experienced personality changes, injured and hospice for pain. As per reporter "I have noticed personality changes. My dad is injured. Took the J &J 7 months ago. 7 weeks ago hospitalized with 4 abdominal abscesses. Surgery multiple issues now going to hospice for pain." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the personality changes, injured, abdominal abscesses, pain and surgery multiple issues was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20220118348-covid-19 vaccine ad26.cov2.s-s-abdominal abscesses, surgery multiple issues . This event(s) is considered unassessable. The event(s) 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(s).
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: MURDERED FOR 3 DAYS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced murdered for 3 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from murdered for 3 days. This report was non-serious. This case, involving the same patient is linked to 20220107322.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: TESTED POSITIVE FOR COVID; This spontaneous report received from a patient via a company representative concerned a 70 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 16-DEC-2021, the patient experienced tested positive for covid. Laboratory data included: SARS-CoV-2 test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tested positive for covid was not reported. This report was non-serious. This report was associated with product quality complaint: 90000211543.; Sender's Comments: V0-Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: COUGH; RUNNY NOSE; This spontaneous report received from a patient concerned a female . The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously received with covid-19 vaccine ad26. cov2. S(dose number in series 1) (suspension for injection, route of admin, batch number:unknown and expiry: unknown) dose was not reported, 1 total, administered on MAY-2021 for prophylactic vaccination on right arm.It was unknown if the patient had any adverse event with the following covid-19 vaccine ad26.cov2.S. (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, batch number:unknown and expiry:unknown) dose was not reported, 1 total, administered on 07-JAN-2022 for prophylactic vaccination on right arm.The batch number was not reported and has been requested. No concomitant medications were reported.  On 08-JAN-2022, the patient experienced cough, and runny nose (dose number in series 2). On 11-JAN-2022, Laboratory data included: COVID-19 antigen rapid POC (point of care) test (BinaxNOW) (NR: not provided) negative. On 13-JAN-2022, Laboratory data included: COVID-19 antigen rapid POC (point of care) test (BinaxNOW) (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from runny nose on 11-JAN-2022, and was recovering from cough. This report was non-serious
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Feeling abnormal, Formication, Hypoaesthesia, Joint swelling
Clinical narrative: NEUROPATHY; CONDITION WORSENED; CRAWLING FEELING UNDER THE SKIN/FELT LIKE BUGS ARE CRAWLING UNDER SKIN; SORES (ON ARMS, CHEST, BACK & LEGS); WEIRDNESS IN TOES AND TOE NAILS; ITCHING; SWELLING OF LEGS; SWELLING OF JOINTS OF HANDS; RASH ALL OVER BODY; TINGLING; NUMBNESS/TOES FELT NUMB; This spontaneous report received from a patient concerned a 62 year old female of unspecified ethnic origin. The patient's weight was 160 pounds, and height was 65 inches. The patient's past medical history included: covid-19, and concurrent conditions included: drug allergy, alcohol consumer, and non-smoker. The patient received covid-19 vaccine ad26.cov2.s (dose number in series: 1) (suspension for injection, route of admin not reported, batch number: C42A21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced neuropathy, crawling feeling under the skin/felt like bugs are crawling under skin, sores (on arms, chest, back & legs), weirdness in toes and toe nails, itching, swelling of legs, swelling of joints of hands, rash all over body, tingling, and numbness/toes felt numb (dose number in series: 1). Symptoms started before the vaccine was received, and however, these symptoms got worse after the vaccine was received (condition worsened). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from neuropathy, rash all over body, crawling feeling under the skin/felt like bugs are crawling under skin, sores (on arms, chest, back & legs), numbness/toes felt numb, weirdness in toes and toe nails, tingling, itching, swelling of legs, swelling of joints of hands, and condition worsened. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220124641-COVID-19 VACCCINE AD26.COV2.S-Neuropathy,Condition worsened. This event(s) is considered unassessable. The event(s) 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(s).
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Paraesthesia, Peripheral swelling, Pruritus, Rash
Clinical narrative: NEUROPATHY; CONDITION WORSENED; CRAWLING FEELING UNDER THE SKIN/FELT LIKE BUGS ARE CRAWLING UNDER SKIN; SORES (ON ARMS, CHEST, BACK & LEGS); WEIRDNESS IN TOES AND TOE NAILS; ITCHING; SWELLING OF LEGS; SWELLING OF JOINTS OF HANDS; RASH ALL OVER BODY; TINGLING; NUMBNESS/TOES FELT NUMB; This spontaneous report received from a patient concerned a 62 year old female of unspecified ethnic origin. The patient's weight was 160 pounds, and height was 65 inches. The patient's past medical history included: covid-19, and concurrent conditions included: drug allergy, alcohol consumer, and non-smoker. The patient received covid-19 vaccine ad26.cov2.s (dose number in series: 1) (suspension for injection, route of admin not reported, batch number: C42A21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced neuropathy, crawling feeling under the skin/felt like bugs are crawling under skin, sores (on arms, chest, back & legs), weirdness in toes and toe nails, itching, swelling of legs, swelling of joints of hands, rash all over body, tingling, and numbness/toes felt numb (dose number in series: 1). Symptoms started before the vaccine was received, and however, these symptoms got worse after the vaccine was received (condition worsened). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from neuropathy, rash all over body, crawling feeling under the skin/felt like bugs are crawling under skin, sores (on arms, chest, back & legs), numbness/toes felt numb, weirdness in toes and toe nails, tingling, itching, swelling of legs, swelling of joints of hands, and condition worsened. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220124641-COVID-19 VACCCINE AD26.COV2.S-Neuropathy,Condition worsened. This event(s) is considered unassessable. The event(s) 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(s).
Sex: F
Vaccine: COVID19
Symptoms: Skin lesion
Clinical narrative: NEUROPATHY; CONDITION WORSENED; CRAWLING FEELING UNDER THE SKIN/FELT LIKE BUGS ARE CRAWLING UNDER SKIN; SORES (ON ARMS, CHEST, BACK & LEGS); WEIRDNESS IN TOES AND TOE NAILS; ITCHING; SWELLING OF LEGS; SWELLING OF JOINTS OF HANDS; RASH ALL OVER BODY; TINGLING; NUMBNESS/TOES FELT NUMB; This spontaneous report received from a patient concerned a 62 year old female of unspecified ethnic origin. The patient's weight was 160 pounds, and height was 65 inches. The patient's past medical history included: covid-19, and concurrent conditions included: drug allergy, alcohol consumer, and non-smoker. The patient received covid-19 vaccine ad26.cov2.s (dose number in series: 1) (suspension for injection, route of admin not reported, batch number: C42A21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced neuropathy, crawling feeling under the skin/felt like bugs are crawling under skin, sores (on arms, chest, back & legs), weirdness in toes and toe nails, itching, swelling of legs, swelling of joints of hands, rash all over body, tingling, and numbness/toes felt numb (dose number in series: 1). Symptoms started before the vaccine was received, and however, these symptoms got worse after the vaccine was received (condition worsened). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from neuropathy, rash all over body, crawling feeling under the skin/felt like bugs are crawling under skin, sores (on arms, chest, back & legs), numbness/toes felt numb, weirdness in toes and toe nails, tingling, itching, swelling of legs, swelling of joints of hands, and condition worsened. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220124641-COVID-19 VACCCINE AD26.COV2.S-Neuropathy,Condition worsened. This event(s) is considered unassessable. The event(s) 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(s).
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Oropharyngeal pain, Pain, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: This spontaneous report received from a patient concerned a 41 year old male.The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808780 expiry: UNKNOWN) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-JAN-2022, the patient experienced sore throat, cough, runny nose, and body aches. Laboratory data included: COVID-19 rapid POC test (NR: not provided) Negative.The action taken with covid-19 vaccine ad26.cov2.s was not applicable.The patient had not recovered from sore throat, cough, runny nose, and body aches.This report was non-serious.