chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 2 years ago, 2nd not received; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 2 years ago into unknown arm).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 29-NOV-2022  Reporter's comment: The reporter reported that his nephew received only one single dose of Shingrix and they were never informed that Shingrix was given as two doses series, hence they never received a second dose of Shingrix.  No additional information provided. The reporter declined consent for safety follow up with his healthcare professional. The reporter declined providing his relatives information and age. The reporter could not provide Shingrix lot, expiration date information, dosage or route of administration. The reporter reported that they all received the shot in the arm. The reporter did not consent to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. This was one of five cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR179084:Same reporter US-GSK-US2022178660:Same reporter US-GSK-US2022AMR179085:Same reporter US-GSK-US2022AMR179087:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: the second one I had hives; This case was reported by a consumer via interactive digital media and described the occurrence of hives in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (dealt with shingles 3 times before the first shot came out) and chickenpox (at 7 year old). Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received on an unknown date) and Shingles vaccine (had the 1st shingle shot when it came out).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced hives. On an unknown date, the outcome of the hives was unknown.   The reporter considered the hives to be possibly related to Shingrix.     Additional Information: GSK receipt date: 29-NOV-2022 Reporters comment: This case was reported by consumer via interactive digital media The patient he/she sated that had the 1st shingle shot when it came out,he/she had chickenpox when 7 year old,for 1shot of shinrix he/she was ok,before first shot had shingles three times,but the second one experinced hives.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Unusual painful rash; This case was reported by a consumer via call center representative and described the occurrence of painful rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced painful rash. On an unknown date, the outcome of the painful rash was not recovered/not resolved.   It was unknown if the reporter considered the painful rash to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 30-NOV-2022 Reporter's Comments: The case was self reported by the patient. The patient received a dose of Shingles vaccine and now had developed an unusual painful rash.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus
Clinical narrative: Intense itching under injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included pruritus. Concomitant products included COVID-19 VACCINE (COVID 19 BOOSTER).   In November 2022, the patient received Shingrix. In November 2022, less than a week after receiving Shingrix, the patient experienced injection site itching. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the injection site itching was not recovered/not resolved.   It was unknown if the reporter considered the injection site itching to be related to Shingrix.     Additional Information: GSK Receipt Date: 28-Nov-2022 Reporter's Comments:  The reporter stated that the patient said she had the shingrix vaccine a week ago and now has a intense itching under the injection site on her arm.  The reporter said the patient had itching profusely.  She said the benadryl she put on her arm did not really help. The reporter mentioned patient experienced some itching for a few days after she got her covid booster last month. No other information was reported to the agent by the patient. The reporter did not consent to follow-up. Note: As per source document the patient received Covid booster a month ago hence captured as concomitant medication.
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: recurrent spot, Herpes Zoster or Herpes Simplex Virus; This case was reported by a consumer via call center representative and described the occurrence of vesicular rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes zoster.   On 16th November 2022, the patient received the 1st dose of Shingrix. In November 2022, less than 2 weeks after receiving Shingrix, the patient experienced vesicular rash. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the vesicular rash was not recovered/not resolved.   It was unknown if the reporter considered the vesicular rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 28-Nov-2022. Reporter's Comment:  The reporter was the patient, who stated that she received her Shingrix. The patient stated that she had a recurrent spot on her back which her doctor does not know if it was due to Herpes Zoster or Herpes Simplex Virus.  The patient said that the spot had appeared on and off for the past 33 years.  The patient was recently prescribed Valtrex to treat the spot. The reporter did not consent to follow-up.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Immediate post-injection reaction, Injection site discolouration
Clinical narrative: 3 dark, quarter-sized, discolored spots at injection site; This case was reported by a other health professional via call center representative and described the occurrence of injection site discoloration in a 18-year-old female patient who received Men B NVS (Bexsero) 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 31st March 2022, the patient received the 1st dose of Bexsero (intramuscular) and Bexsero Pre-Filled Syringe Device. On 31st March 2022, immediately after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced injection site discoloration. On an unknown date, the outcome of the injection site discoloration was not recovered/not resolved.   It was unknown if the reporter considered the injection site discoloration to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2022AMR178699   Additional Information: GSK Receipt Date: 28-NOV-2022 Reporter's Comments: The reporter was the patient's mother and also an unspecified healthcare provider.  The patient received her first Bexsero dose into left deltoid and immediately after, she developed three dark, quarter-sized, discolored spots at the injection site.  Nothing else was reported.  The reporter did not consent to follow up.  Additional Supportive Information: For tolerance of 2nd dose, refer case US2022AMR178699.; Sender's Comments:  US-GSK-US2022AMR178699:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Inappropriate schedule of product administration, Pain, Pain of skin
Clinical narrative: developed body aches; Chills; Headache; 1st dose a year ago; Painful skin; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (1st dose received a year ago, For tolerance of 1st  dose refer case US2022AMR179099).   On 23rd November 2022, the patient received the 2nd dose of Shingrix (intramuscular). In November 2022, 1 day after receiving Shingrix, the patient experienced skin pain. On 23rd November 2022, the patient experienced general body pain, chills, headache and drug dose administration interval too long. Rechallenge with Shingrix was positive. On 24th November 2022, the outcome of the general body pain, chills and headache were recovered/resolved. On an unknown date, the outcome of the skin pain was recovered/resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the general body pain, chills, headache and skin pain to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR179099   Additional Information: GSK Receipt Date: 29-NOV-2022 Reporter's Comments: The reporter was the patient, she reported that she received the 2nd dose in the left arm. On the evening, she developed body aches, chills and a headache.  She reported painful skin.  By the evening of 24th November 2022, her symptoms had resolved.. The reporter consent to follow up. Consent to contact HCP given. Additional Supportive Information: The patient received first dose was a year ago and 2nd dose later than the recommended interval, which led lengthening of vaccination schedule.; Sender's Comments:  US-GSK-US2022AMR179099:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 2 years ago, 2nd not received; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received the fist dose 2 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 29-NOV-2022 Reporter's Comments:  This case was self-reported by the patient.  The patient stated that 2 years ago his wife, brother, nephew, niece and himself, received only one single dose of Shingrix. The patient stated they all received the shot in the arm. The patient was never informed that Shingrix was given in two doses series; hence, they never received a second Shingrix dose.  The patient declined consent for safety follow up with healthcare professional.  The patient declined to provide date of birth and age instead.  The patient declined to provide relatives information and age.  The patient could not provide Shingrix lot, expiration date information, dosage or route of administration. No additional information provided.  The reporter did not consent to follow up.  Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. This is 1 of the 5 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR179084:Same reporter US-GSK-US2022AMR179085:Same reporter US-GSK-US2022AMR179086:Same reporter US-GSK-US2022AMR179087:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Shingrix series in September of 2020 and then received dose two in August of 2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on September 2020).   In August 2022, the patient received the 2nd dose of Shingrix. In August 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.      Additional Information: GSK receipt date: 30-NOV--2022 Reporters comment:  The pharmacist was in a rush to end the call and did not provide further details, but he did grant permission for safety to follow up if needed. The reporter consented to follow-up. Additional Supportive information: The patient received 2nd dose later than the recommended interval, which led to lengthening of vaccination schedule.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: JOHNSON AND JOHNSON VACCINE KILLED BEST FRIEND; This spontaneous report received from a consumer via a company representative via media concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: UNKNOWN) dose was not reported, 1 total, start therapy date 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 patient died. The patient died from unknown cause of death. It was reported as "Johnson and Johnson vaccine killed my best friend". It was unknown whether autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: 20221209949- Johnson and Johnson vaccine killed my best friend. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Body temperature, COVID-19, COVID-19 immunisation, Chills
Clinical narrative: COVID-19; FELT LIKE HEAD WAS GOING TO BLOW UP; CHILLS; MYALGIA; FEVER/TEMPERATURE WAS 101.4 DEGREES FAHRENHEIT; HEADACHE; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; LOT OF PAIN; SHAKES; NECK PAIN; BACK PAIN; TROUBLE SLEEPING; This spontaneous report received from a health care professional via another pharmaceutical company (Moderna) concerned a 68 year old elderly female of unspecified race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient previously received first dose of 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, administered on an unspecified date for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1).  The patient received first 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, administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Age at time of vaccination 7 decade old. Concomitant medications included atorvastatin and metoprolol.  On SEP-2022, the patient experienced covid-19 (dose number in series 2). The outcome of covid-19 was not reported. The patient additionally received second booster dose of non-company suspect vaccine Moderna covid-19 vaccine (elasomeran) (dose number in series 3) (form of admin, route of admin, and batch number were not reported, expiry date: unknown) dose was not reported, administered on 29-NOV-2022 10:00 for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (dose number in series 3).  On 29-NOV-2022 between 18:00 to 20:00, the patient experienced lot of pain and myalgia (dose number in series 3). On 29-NOV-2022, the patient then got chills, shakes, neck pain, back pain, headache, fever, had trouble sleeping because of the fever and chills (dose number in series 3).  On 30-NOV-2022, the patient felt like head was going to blow up and had temperature of 101.4 degrees fahrenheit and her fever had not came down. Laboratory data included: Body temperature (NR: not provided) 101.4 F (dose number in series 3). The patient felt like she had Covid-19 (dose number in series 3). She was treated with paracetamol (Tylenol) for fever. The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The patient had not recovered from fever/temperature was 101.4 degrees fahrenheit, and the outcome of myalgia, lot of pain, chills, shakes, headache, neck pain, back pain, trouble sleeping, revaccination with different covid-19 vaccine and felt like head was going to blow up was not reported. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Head discomfort, Headache, Insomnia, Myalgia, Neck pain
Clinical narrative: COVID-19; FELT LIKE HEAD WAS GOING TO BLOW UP; CHILLS; MYALGIA; FEVER/TEMPERATURE WAS 101.4 DEGREES FAHRENHEIT; HEADACHE; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; LOT OF PAIN; SHAKES; NECK PAIN; BACK PAIN; TROUBLE SLEEPING; This spontaneous report received from a health care professional via another pharmaceutical company (Moderna) concerned a 68 year old elderly female of unspecified race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient previously received first dose of 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, administered on an unspecified date for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1).  The patient received first 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, administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Age at time of vaccination 7 decade old. Concomitant medications included atorvastatin and metoprolol.  On SEP-2022, the patient experienced covid-19 (dose number in series 2). The outcome of covid-19 was not reported. The patient additionally received second booster dose of non-company suspect vaccine Moderna covid-19 vaccine (elasomeran) (dose number in series 3) (form of admin, route of admin, and batch number were not reported, expiry date: unknown) dose was not reported, administered on 29-NOV-2022 10:00 for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (dose number in series 3).  On 29-NOV-2022 between 18:00 to 20:00, the patient experienced lot of pain and myalgia (dose number in series 3). On 29-NOV-2022, the patient then got chills, shakes, neck pain, back pain, headache, fever, had trouble sleeping because of the fever and chills (dose number in series 3).  On 30-NOV-2022, the patient felt like head was going to blow up and had temperature of 101.4 degrees fahrenheit and her fever had not came down. Laboratory data included: Body temperature (NR: not provided) 101.4 F (dose number in series 3). The patient felt like she had Covid-19 (dose number in series 3). She was treated with paracetamol (Tylenol) for fever. The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The patient had not recovered from fever/temperature was 101.4 degrees fahrenheit, and the outcome of myalgia, lot of pain, chills, shakes, headache, neck pain, back pain, trouble sleeping, revaccination with different covid-19 vaccine and felt like head was going to blow up was not reported. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pyrexia, Tremor
Clinical narrative: COVID-19; FELT LIKE HEAD WAS GOING TO BLOW UP; CHILLS; MYALGIA; FEVER/TEMPERATURE WAS 101.4 DEGREES FAHRENHEIT; HEADACHE; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; LOT OF PAIN; SHAKES; NECK PAIN; BACK PAIN; TROUBLE SLEEPING; This spontaneous report received from a health care professional via another pharmaceutical company (Moderna) concerned a 68 year old elderly female of unspecified race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient previously received first dose of 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, administered on an unspecified date for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1).  The patient received first 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, administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Age at time of vaccination 7 decade old. Concomitant medications included atorvastatin and metoprolol.  On SEP-2022, the patient experienced covid-19 (dose number in series 2). The outcome of covid-19 was not reported. The patient additionally received second booster dose of non-company suspect vaccine Moderna covid-19 vaccine (elasomeran) (dose number in series 3) (form of admin, route of admin, and batch number were not reported, expiry date: unknown) dose was not reported, administered on 29-NOV-2022 10:00 for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (dose number in series 3).  On 29-NOV-2022 between 18:00 to 20:00, the patient experienced lot of pain and myalgia (dose number in series 3). On 29-NOV-2022, the patient then got chills, shakes, neck pain, back pain, headache, fever, had trouble sleeping because of the fever and chills (dose number in series 3).  On 30-NOV-2022, the patient felt like head was going to blow up and had temperature of 101.4 degrees fahrenheit and her fever had not came down. Laboratory data included: Body temperature (NR: not provided) 101.4 F (dose number in series 3). The patient felt like she had Covid-19 (dose number in series 3). She was treated with paracetamol (Tylenol) for fever. The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The patient had not recovered from fever/temperature was 101.4 degrees fahrenheit, and the outcome of myalgia, lot of pain, chills, shakes, headache, neck pain, back pain, trouble sleeping, revaccination with different covid-19 vaccine and felt like head was going to blow up was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: SEVERE ALLERGIC REACTION; This spontaneous report received from a health care professional via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were 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 patient experienced severe allergic reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe allergic reaction was not reported. This report was non-serious.; Sender's Comments: V0-Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: CLOTS; This spontaneous report received from a patient via a company representative via media concerned a patient of unspecified age, sex, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin  not reported, batch number: unknown, expiry: unknown) dose was not reported, 01 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.  Reporter stated that, "Yep I got clots. Vaers did not even acknowledge they heard from me". On an unspecified date, the patient had clots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221211513- clots. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Giant cell arteritis, Magnetic resonance imaging, Rheumatoid arthritis
Clinical narrative: SERONEGATIVE RHEUMATOID ARTHRITIS; TEMPORAL ARTERITIS; This spontaneous report received from a patient via a company representative concerned a 70 year old female of an unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 expiry: UNKNOWN) dose was not reported, 1 total administered on 11-MAR-2021 for covid-19 prophylaxis. Age at time of vaccination 70 years old. No concomitant medications were reported.  On an unspecified date in MAR-2021, 10-14 days after receiving the vaccine, the patient experienced severe left temporal headache for a few days, followed by intense low back pain. She was evaluated by a doctor 01-APR-2021 or 02-APR-2021 and diagnosed with temporal arteritis and given high dose prednisone. Symptoms had persisted for 21 months. On an unspecified date, patient had also been diagnosed with seronegative rheumatoid arthritis. Laboratory data (dates unspecified) included: MRI (Magnetic resonance imaging) diagnosed with rheumatoid arthritis, sero-negative, with joint erosion in hands and fingers. Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from temporal arteritis, and the outcome of seronegative rheumatoid arthritis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221212413- Seronegative rheumatoid arthritis.  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.]
Sex: U
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: OFF LABEL DOSING FREQUENCY; This spontaneous report received from a health care professional concerned a patient of unspecified age, sex, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient previously received first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin and batch number were not reported) 1 in total, dose, start therapy date was not reported for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination of covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient again received second 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) 1 in total, dose, start therapy date was not reported for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination of covid-19 vaccine ad26.cov2.s (dose number in series 2). The patient additionally received third dose of covid-19 vaccine ad26.cov2.s (dose number in series 3) (suspension for injection, route of admin, and batch number were not reported) 1 in total, dose, start therapy date was not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. The product was associated with Off label dosing frequency (dose number in series 3). No concomitant medications were reported.  On an unspecified date, the patient received a total of 3 doses of the covid-19 vaccine (Off label dosing frequency) (dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of off label dosing frequency was not reported. This report was non-serious.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a consumer via a company representative via media and concerned a 75 year old male. The patient's weight, height, and medical history were not reported. The patient previously received two doses (first and second dose) of covid-19 vaccine (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of admin was not reported batch number: Unknown, expiry: Unknown) dose was not reported, administered on an unspecified date for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with two doses of covid-19 vaccine (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 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. Age at time of vaccination 8 decade old. The product was associated with revaccination with different covid-19 vaccine (dose number in series 2). No concomitant medications were reported.  On an unspecified date, the patient experienced a bad cold and had covid (suspected covid-19 infection) (dose number in series 2).  The consumer stated "My husband and I got 2 jabs plus one booster. all against my better judgment. I just do not like taking new meds or vaccines but I was 73 and my husband was 75. my husband still got covid a bad cold I slept in the same bed every night and did not get it I sprayed lysol like crazy. obviously the vax does not prevent you from catching covid or spreading it. so no reason to continue to get these boosters that do not work and last just weeks and if you do the research. we were the lab rats read further and you will find out all the other things they cause including death!" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: SIDE EFFECTS OR ILLS DUE TO VACCINE; 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. The patient's concurrent conditions included: allergic to some ingredients. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were 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 patient experienced side effects or ills due to vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from side effects or ills due to vaccine. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Administration of an expired dose; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of an expired dose) and NO ADVERSE EVENT (no adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of an expired dose) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of an expired dose) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Administration of an expired dose).    Concomitant products were not reported.  It was reported that had an issue with moderna injection about how long it went past expiry date. Product associated with event was unknown.   Treatment medications were not reported.   Reporter did not allow further contact
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Headache, Palpitations, Pyrexia, Vomiting
Clinical narrative: heart razing; terrific headache; vomiting/ uncontrollable vomiting; high fever; This spontaneous case was reported by a patient and describes the occurrence of PALPITATIONS (heart razing), HEADACHE (terrific headache), VOMITING (vomiting/ uncontrollable vomiting) and PYREXIA (high fever) in a 66-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 059e21a) for COVID-19 prophylaxis.     Concurrent medical conditions included Migraine, Hypothyroidism (takes medication.), Hypercholesterolemia (takes medication), Heart disorder and Immunocompromised. Concomitant products included METOPROLOL for Heart disorder.    On an unknown date, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (heart razing), HEADACHE (terrific headache), VOMITING (vomiting/ uncontrollable vomiting) and PYREXIA (high fever). At the time of the report, PALPITATIONS (heart razing), HEADACHE (terrific headache), VOMITING (vomiting/ uncontrollable vomiting) and PYREXIA (high fever) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant products included hypothyroidism medication and high cholesterol medication.  Reportedly, patient was not sick at all. Patient received a third full dose of Moderna vaccine.  Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Reported events resolved 24 hours after the event started.  No treatment information was provided.   This case was linked (Patient Link).
Age: 99.0
Sex: U
Vaccine: COVID19-2
Symptoms: Dyspnoea, Feeling abnormal
Clinical narrative: After getting the booster shot I can not breathe right; I feel terrible now; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (After getting the booster shot I can not breathe right) and FEELING ABNORMAL (I feel terrible now) in a 99-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNEA (After getting the booster shot, I cannot breathe right) and FEELING ABNORMAL (I feel terrible now). At the time of the report, DYSPNEA (After getting the booster shot, I cannot breathe right) and FEELING ABNORMAL (I feel terrible now) outcome was unknown.            No concomitant medication was reported.  No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: they have had Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (they have had Covid) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (they have had Covid). At the time of the report, COVID-19 (they have had Covid) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product reported by reporter.  Patient confirmed that they had the first two and one booster dose and all were moderna.  No treatment medication reported by reporter.    Reporter did not allow further contact
Age: 0.5
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Second dose of the Moderna COVID-19 vaccines was administered after the published expiration date of 04Dec2022; First dose was administered on 10-Aug-2022 and second dose was administered on 05-Dec-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Second dose of the Moderna COVID-19 vaccines was administered after the published expiration date of 04Dec2022), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was administered on 10-Aug-2022 and second dose was administered on 05-Dec-2022) and NO ADVERSE EVENT (No adverse event) in a 10-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Influenza. Past adverse reactions to the above products included No adverse event with Influenza.   On 10-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Dec-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 05-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Second dose of the Moderna COVID-19 vaccines was administered after the published expiration date of 04Dec2022) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was administered on 10-Aug-2022 and second dose was administered on 05-Dec-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Second dose of the Moderna COVID-19 vaccines was administered after the published expiration date of 04Dec2022), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was administered on 10-Aug-2022 and second dose was administered on 05-Dec-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Second dose of the Moderna COVID-19 vaccines was administered after the published expiration date of 04Dec2022) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was administered on 10-Aug-2022 and second dose was administered on 05-Dec-2022).    Concomitant medications details were not reported by the reporter.  Reportedly the patient received other vaccines in the 4 weeks prior to COVID-19 vaccine.  Patient had not reported any symptoms.  Treatment details were not reported by the reporter.
Sex: U
Vaccine: COVID19-2
Symptoms: Fatigue, Gait inability
Clinical narrative: unable to walk; extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (unable to walk) and FATIGUE (extreme fatigue) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced GAIT INABILITY (unable to walk) and FATIGUE (extreme fatigue). At the time of the report, GAIT INABILITY (unable to walk) and FATIGUE (extreme fatigue) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. It was reported that patient had extreme fatigue and unable to walk for 24 hrs after each dose of Moderna Covid-19 vaccine. No treatment medication were provided.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Administered after the published expiration date; No Adverse Event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered after the published expiration date) and NO ADVERSE EVENT (No Adverse Event) in an elderly male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 020H22A) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Hx of Hypertension, COPD, Hyperlipidemia, and Anxiety.  The patient's past medical history included COPD, Hyperlipidemia and Anxiety. Previously administered products included for Drug use for unknown indication: Influenza vaccine on 30-Nov-2022. Past adverse reactions to the above products included No adverse reaction with Influenza vaccine. Concurrent medical conditions included Hypertension.    On 05-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered after the published expiration date) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered after the published expiration date) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Administered after the published expiration date).    No concomitant medications were reported.  Patient received other vaccines in the 4 weeks prior to COVID-19 vaccine. On 05-Dec-2022, patient was administered vaccine after the published expiration date. Drawn up into a syringe on Friday and administered this morning.  No treatment drugs were reported.
Age: 12.0
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, Incorrect dose administered, No adverse event
Clinical narrative: This patient was given a 50 mcg dose from the 6-11 year vial; 12 year old pediatric patient received a lower than authorized dose of the incorrect product; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of INCORRECT DOSE ADMINISTERED (This patient was given a 50 mcg dose from the 6-11 year vial), ACCIDENTAL UNDERDOSE (12 year old pediatric patient received a lower than authorized dose of the incorrect product) and NO ADVERSE EVENT (no adverse event) in a 12-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (This patient was given a 50 mcg dose from the 6-11 year vial), ACCIDENTAL UNDERDOSE (12 year old pediatric patient received a lower than authorized dose of the incorrect product) and NO ADVERSE EVENT (no adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (This patient was given a 50 mcg dose from the 6-11 year vial), ACCIDENTAL UNDERDOSE (12 year old pediatric patient received a lower than authorized dose of the incorrect product) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for INCORRECT DOSE ADMINISTERED (This patient was given a 50 mcg dose from the 6-11 year vial) and ACCIDENTAL UNDERDOSE (12 year old pediatric patient received a lower than authorized dose of the incorrect product).    Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Health care professional did not want to provide any additional details on the patient at this time however consent follow-up was given.