chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Malaise, Pain
Clinical narrative: vaccine hurt/ pain; feel terrible for a day; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: vaccine hurt/ pain) and feeling abnormal (Verbatim: feel terrible for a day). The outcome of the pain was not reported and the outcome of the feeling abnormal was resolved (duration 1 day).   It was unknown if the reporter considered the pain and feeling abnormal to be related to Shingles vaccine.     It was unknown if the company considered the pain and feeling abnormal to be related to Shingles vaccine.   Additional Information: GSK received date: 14-Mar-2024 This case was reported by a patient via interactive digital media. The vaccine hurt and made the patient feel terrible for a day but patient was told it's worth it. Patient did not want the pain of shingles. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: sore arm). The outcome of the pain in arm was resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK received date: 14-Mar-2024 This case was reported by a patient via interactive digital media. The shots did not really bother the patient. Patient expected some discomfort but other than a sore arm for a few days, patient stated it was well worth. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: The vaccine hurts like crap; made my arm swell like crazy, but still better than the shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: The vaccine hurts like crap) and swelling arm (Verbatim: made my arm swell like crazy, but still better than the shingles). The outcome of the pain and swelling arm were not reported.   It was unknown if the reporter considered the pain and swelling arm to be related to Shingles vaccine.   It was unknown if the company considered the pain and swelling arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-MAR-2024 This case was reported by a patient via interactive digital media. The patient reported that the vaccine hurts like crap, made his/her arm swell like crazy, but still better than the shingles. Follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: tenderness in my arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (about 15 years ago).   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: tenderness in my arm). The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     It was unknown if the company considered the pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 17-MAR-2024 This case was reported by a patient via interactive digital media. The patient reported that she had same things. The patient reported she had first Zostavax (about 15 years ago), then two dose Shingrix vaccine (a couple of years ago) and only side effect was other than a little tenderness in her arm, she was fine. The patient reported neither of them had developed shingles since their vaccinations. The patient suggested to talk with the physician about vaccinations. This case had been linked to the cases US2024AMR035802 and US2024AMR035805 reported by the same reporter. Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2024AMR035802:same reporter, husband 1st dose case US-GSK-US2024AMR035805:same reporter, husband 2nd dose case
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: achy; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles and blistery rash (that lasts for weeks).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain (Verbatim: achy). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingrix.     It was unknown if the company considered the pain to be related to Shingrix.   Linked case(s) involving the same patient:  US2024AMR035805   Additional Information: GSK Receipt Date: 17-MAR-2024 This case was reported by a patient's wife via interactive digital media. The reporter reported that looked at all the fictional horror stories about getting a vaccine. The reporter's husband has had shingles. It was a burning blistering rash that lasts for weeks. When the Shingrix vaccine became available, he was one of the first to got it. The first dose made him felt a little achy that night. For tolerance of 2nd dose refer case US2024AMR035805. Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2024AMR035805:same reporter, 2nd dose case US-GSK-US2024AMR035796:same reporter, wife case
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: The second dose was just a little sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (1st dose received on an unknown date, for tolerance refer linked case US2024AMR035802).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: The second dose was just a little sore arm). The outcome of the pain in arm was resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     It was unknown if the company considered the pain in arm to be related to Shingrix.   Linked case(s) involving the same patient:  US2024AMR035802   Additional Information: GSK Receipt Date: 17-MAR-2024 This case was reported by a patient's wife via interactive digital media. The reporter reported that the second dose was just a little sore arm. The side effects were nothing compared to the agony of shingles. The reporter reported neither of them had developed shingles since their vaccinations. The reporter suggested to talk with the physician about vaccinations. Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2024AMR035802:same reporter, 1st dose case US-GSK-US2024AMR035796:same reporter, wife case
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue, Wrong product administered
Clinical narrative: Vaccine exposure during pregnancy; given AREXVY vaccine instead of ABRYSVO vaccine; This non-serious prospective pregnancy case was reported by a lawyer and described the occurrence of vaccine exposure during pregnancy in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: Vaccine exposure during pregnancy) and wrong vaccine administered (Verbatim: given AREXVY vaccine instead of ABRYSVO vaccine). The outcome of the vaccine exposure during pregnancy and wrong vaccine administered were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 20 Mar 2024 Plaintiff was administered with the Arexvy vaccine, which was untested and likely harmful to Plaintiff and her unborn child. Plaintiff and her child, have suffered damage as the result of Defendant administering an incorrect and dangerous vaccine. The patient who was pregnant received Arexvy vaccine, which led to vaccine exposure during pregnancy. The patient who was pregnant given the Arexvy vaccine instead of Abrysvo vaccine which led to Wrong vaccine administered.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Myalgia, Nausea
Clinical narrative: nausea; myalgia; headache; This non-serious case was reported by a consumer via call center representative and described the occurrence of nausea in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12-MAR-2024, the patient received the 2nd dose of Shingrix (right deltoid). In MAR-2024, 15 hrs after receiving Shingrix, the patient experienced nausea (Verbatim: nausea), myalgia (Verbatim: myalgia) and headache (Verbatim: headache). The outcome of the nausea, myalgia and headache were not resolved.   It was unknown if the reporter considered the nausea, myalgia and headache to be related to Shingrix.     It was unknown if the company considered the nausea, myalgia and headache to be related to Shingrix.   Additional Information: GSK Receipt Date: 13-MAR-2024 The patient self-reported this case. The patient did not have lot number and verified product with NDC (national drug code) 58160082311.  The patient stated that 15 hours after receiving the Shingrix vaccine injection she experienced symptoms of nausea, myalgia, and headache. It was reported that all symptoms were mild and have not resolved.  The reporter did not consent to follow-up.
Age: 72.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: 4 months later received dose number 2; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 72-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 10GJ3GR, expiry date 17-JUL-2025) for prophylaxis.   Previously administered products included Arexvy (received 1st dose of Arexvy on 7th November 2023).   On 08-MAR-2024, the patient received the 2nd dose of Arexvy. On 08-MAR-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: 4 months later received dose number 2). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 13-MAR-2024 The other health professional (Emergency Medical Technician) inquired, with the Arexvy vaccine, was it just a single dose patient's over 60 receive or was there now a second dose recommended. The reporter had a patient who received dose number 1, and 4 months later received dose number 2 at patient's pharmacy which led to extra dose administered. The reporter reported just to clarify, they did not administered these vaccines, patient's pharmacy did. The reporter did not consent to follow up,
Age: 31.0
Sex: F
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age, Product use issue
Clinical narrative: Arexvy-use during pregnancy; 31 year old patient received Arexvy vaccine; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of vaccine exposure during pregnancy in a 31-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number TP299, expiry date 04-JUL-2025) for prophylaxis.   On 12-MAR-2024, the patient received Arexvy. On 12-MAR-2024, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: 31 year old patient received Arexvy vaccine). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Arexvy-use during pregnancy). The outcome of the vaccine exposure during pregnancy and inappropriate age at vaccine administration were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 13-MAR-2024 The pharmacist called to ask for safety information regarding the use of Arexvy in pregnant woman.  The HCP (health care professional) mentioned that patient was in the 3rd trimester of pregnancy. The 31-year-old pregnant patient received Arexvy during pregnancy, which led to an inappropriate age at vaccine administration and vaccine exposure during pregnancy. The reporter consented to follow up.
Sex: M
Vaccine: DTAPIPV
Symptoms: Extra dose administered
Clinical narrative: adversely given another dose of Kinrix to a patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a male patient who received DTPa-IPV (Kinrix) (batch number 5H95B, expiry date 16-FEB-2026) for prophylaxis.   Previously administered products included Kinrix (already received the 4 year vaccine dose).   On 13-MAR-2024, the patient received Kinrix. On 13-MAR-2024, an unknown time after receiving Kinrix, the patient experienced extra dose administered (Verbatim: adversely given another dose of Kinrix to a patient). 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 Information: GSK Receipt Date: 13-MAR-2024 The medical assistant called and informed that earlier that day, they had adversely given another dose of Kinrix to a patient, which led to extra dose administrated. According to reporter the patient had already received the 4 year vaccine dose. The vaccine administration facility was the same as primary reporter.
Age: 42.0
Sex: M
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: administered a pediatric dose of Engerix-B to an adult patient; administered a pediatric dose of Engerix-B to an adult patient.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 42-year-old male patient who received HBV (Engerix B pediatric) (batch number ZP72S, expiry date 15-DEC-2024) for prophylaxis.   On 13-MAR-2024, the patient received Engerix B pediatric. On 13-MAR-2024, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: administered a pediatric dose of Engerix-B to an adult patient) and adult use of a child product (Verbatim: administered a pediatric dose of Engerix-B to an adult patient.). The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 14-MAR-2024 The clinic manager reported that a medical assistant administered a pediatric dose of Engerix-B to an adult patient, which led to underdose and adult use of a child product.  The reporter consented to follow up via email.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received his first dose of Shingrix 2 years ago and not had the 2nd dose; This non-serious 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).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: received his first dose of Shingrix 2 years ago and not had the 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 15-MAR-2024 Till the time of reporting, the patient did not receive the 2nd dose of Shingrix , which led to incomplete course of vaccination.
Age: 68.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Havrix late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 68-year-old female patient who received HAV (Havrix) (batch number 772YT, expiry date 23-SEP-2025) for prophylaxis.   Previously administered products included Havrix (received 1st dose on 31st January 2016).   On 13-MAR-2024, the patient received the 2nd dose of Havrix. On 13-MAR-2024, an unknown time after receiving Havrix, the patient experienced drug dose administration interval too long (Verbatim: Havrix late second dose). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 18-MAR-2024 The pharmacist reported that the patient received Havrix 2nd dose 8 year and 2 months apart of the 1st dose approximately, which led to lengthening of vaccination schedule. The reporter consent to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Depression
Clinical narrative: Depression; This spontaneous report received from a patient via Johnson & Johnson Corporate account (social media) concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s  (dose series1) (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for  covid-19 prophylaxis.. 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 depression (dose series1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of depression was not reported. This report was non-serious.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Dry skin, Pruritus, Skin disorder
Clinical narrative: Dry Skin; Skin issue; itching; apprent lack of effect; This spontaneous case was reported by a patient and describes the occurrence of DRY SKIN (Dry Skin), SKIN DISORDER (Skin issue), PRURITUS (itching) and DRUG INEFFECTIVE (apprent lack of effect) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and DUPILUMAB (DUPIXENT) (Subcutaneous use) 300 milligram every two weeks. On an unknown date, the patient experienced DRY SKIN (Dry Skin), SKIN DISORDER (Skin issue), PRURITUS (itching) and DRUG INEFFECTIVE (apprent lack of effect). At the time of the report, DRY SKIN (Dry Skin) had not resolved and SKIN DISORDER (Skin issue), PRURITUS (itching) and DRUG INEFFECTIVE (apprent lack of effect) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Treatment information was not reported.  It was reported as Dupilumab was delivered via prefilled pen.  It was reported as state MD (Doctor of Medicine) has suggested the skin issue has been caused by Moderna booster. The patient no longer taking Dupixent due to lack of effect. The event inching daily and still has dry skin. Patient took medication for 2 months and physician stopped due to apparent lack of effect.  Company Comment: This is a spontaneous case concerning an 85-year-old female patient with no reported medical history, who experienced the non-serious unexpected, events of DRY SKIN, SKIN DISORDER, PRURITUS and DRUG INEFFECTIVE, which occurred on an unknown date after a dose of mRNA-1273 vaccine. The event DRUG INEFFECTIVE was considered unrelated to the vaccine, due to alternative explanation (lack off effect is refering to Dupixent). The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever up to 101 F; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever up to 101 F) in a patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch nos. 031B21A, 004C21A and 005C21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Depression and Allergy. Concomitant products included BUPROPION, ETHINYLESTRADIOL, NORGESTREL (CRYSELLE) and HYDROXYZINE for an unknown indication.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021, received third dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever up to 101 F). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever up to 101 F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 F.         OTC treatment was received for the adverse event.   This case was linked to US-MODERNATX, INC.-MOD-2024-763881 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-763881:Same patient different variant of vaccine
Sex: U
Vaccine: COVID19-2
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever occurred with all Moderna doses as well; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever occurred with all Moderna doses as well) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 051D22A) for COVID-19 prophylaxis.     Concurrent medical conditions included Depression and Drug allergy. Concomitant products included BUPROPION, ETHINYLESTRADIOL, NORGESTREL (CRYSELLE) and HYDROXYZINE for an unknown indication.    On 25-Oct-2022, the patient received fourth 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 PYREXIA (Fever occurred with all Moderna doses as well). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever occurred with all Moderna doses as well) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: up to 101 F..         OTC treatment was received for the adverse event.  On 09-Apr-2021, the patient received first dose of Moderna vaccine (Batch number: 031B21A). On 07-May-2021, received second dose of Moderna vaccine (Batch number: 004C21A, Location of injection: Arm Left). On 07-Dec-2021, received third dose of Moderna vaccine (Batch number: 005C21A, Location of injection: Arm Left)  On 25-Mar-2024, received fifth dose of Pfizer-BioNTech (Batch number: HG5967, Location of injection: Arm Left). On 26-Mar-2024 at 17:00, the patient experienced fever upto 101 F and outcome was unknown (at the time of report). The patient took OTC; Tylenol Prior to vaccination.   This case was linked to US-MODERNATX, INC.-MOD-2024-763879.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-763879:Same patient different variant of vaccine
Sex: U
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: The booster shots and vaccine gave me issues with neuropathy-Moderna 2021; This spontaneous case was reported by a patient and describes the occurrence of NEUROPATHY PERIPHERAL (The booster shots and vaccine gave me issues with neuropathy-Moderna 2021) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Lung cancer in 2020. Concurrent medical conditions included Bipolar disorder, Drug allergy, Anxiety, Migraine, Depression and Restless leg syndrome. Concomitant products included SUMATRIPTAN for Migraine, BUPROPION HYDROCHLORIDE (BUPRION), NAPROXEN SODIUM (ALEVE), LAMOTRIGINE, CLONAZEPAM and METHOCARBAMOL for an unknown indication.   On 21-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (The booster shots and vaccine gave me issues with neuropathy-Moderna 2021) (seriousness criterion medically significant). At the time of the report, NEUROPATHY PERIPHERAL (The booster shots and vaccine gave me issues with neuropathy-Moderna 2021) outcome was unknown.            No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-759480 (E2B Linked Report).  Company comment: This spontaneous case concerns a patient of unknown age and gender, with medical history of lung cancer, Bipolar disorder and Restless leg syndrome. who experienced the unexpected serious (medically significant) event of neuropathy peripheral. The event occurred on unknown date after a dose of mRNA-1273 (described as booster). Temporal relationship is unclear. As reported, the booster shots and vaccine gave patient issues with neuropathy-Moderna 2021. No further information about the events was provided. Above mentioned medical history is a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-759480:Paxlovid case
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: HCP tested positive for covid-19 in January 2024 after receiving a Moderna vaccine on 24OCT2023; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (HCP tested positive for covid-19 in January 2024 after receiving a Moderna vaccine on 24OCT2023) in an 80-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 209F23/2A) for COVID-19 prophylaxis.     The patient's past medical history included Retinal vein thrombosis (retinal vein thrombosis to right eye) and Stent placement (5 stents put in in 2013) in 2013. Concurrent medical conditions included Glaucoma, Hypertension ((being treated for)) and Benign prostatic hypertrophy ((being treated for)).    On 24-Oct-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. In January 2024, the patient experienced COVID-19 (HCP tested positive for covid-19 in January 2024 after receiving a Moderna vaccine on 24OCT2023). At the time of the report, COVID-19 (HCP tested positive for covid-19 in January 2024 after receiving a Moderna vaccine on 24OCT2023) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2024, SARS-CoV-2 test: Positive.     For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   The patient had no allergies. The patient had not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medication was reported. No treatment medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Fatigue, Feeling cold
Clinical narrative: chills/ shivering; loss of appetite; having to lay down all day, weakness; feeling cold; tired; This is a spontaneous report received from a Nurse from medical information team.  A female patient (unknown if pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Jan2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset 2024, outcome "unknown", described as "chills/ shivering"; FEELING COLD (non-serious) with onset 2024, outcome "unknown"; ASTHENIA (non-serious) with onset 2024, outcome "unknown", described as "having to lay down all day, weakness"; DECREASED APPETITE (non-serious) with onset 2024, outcome "unknown", described as "loss of appetite"; FATIGUE (non-serious) with onset 2024, outcome "unknown", described as "tired".  Additional information: Caller is a caregiver calling on behalf of her husband, Caller states her husband got the Comirnaty Covid 19 vaccine on 14MAR2024, as well with the shingles vaccine. Caller states after this, her husband started with multiple Covid 19 alike symptoms like: chills, loss of appetite, having to lay down all day, weakness, shivering, feeling cold and tired, not subsided much since then, she states "sometimes he gets up but has to go back to bed". After this they went with their Doctor and tested for COVID 19, test came back negative. Caller states she had the same problems back on January with the vaccine.   Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Infertility, Ovarian failure
Clinical narrative: Premature Ovarian Insufficiency; infertility; This is a spontaneous report and received from Consumer or other non HCPs.  A 17-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose number unknown, single) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OVARIAN FAILURE (disability) with onset 01Nov2022, outcome "not recovered", described as "Premature Ovarian Insufficiency"; INFERTILITY (disability) with onset 01Nov2022, outcome "not recovered". Therapeutic measures were taken as a result of ovarian failure, infertility. Additional information: Premature Overian Insufficiency. As medical studies are reporting neither Pfizer nor Moderna did sufficient testing on teenage girls who are now experiencing never before seen rates of POI directly related to Pfizer/Moderna vaccines. Reporter's daughter now faces a lifetime of infertility, hormone replacement therapy and other symptoms due to negligence.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400072969 Same reporter/drug/AE, different patient;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid; Covid; This is a spontaneous report received from a Consumer or other non HCP.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "unknown" and all described as "Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested positive for 22 days even though she felt better. Clinical course: patient was fully vaccinated and had booster in fall. The patient had not gotten recent one and she got Covid anyway and had Covid earlier at end of Feb.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Malaise, Pain, Tinnitus
Clinical narrative: had tinnitus before I got the shot, this made it much worse (Covid Shot) really interfering with my life works; every bone in my body hurts; I was very achy and in bed; I felt very ill, a lot of pain; This is a spontaneous report received from a Consumer or other non HCP.  A 75-year-old female patient received BNT162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 11Mar2024 at 10:30 as dose 1 (toppac), single (Lot number: HJ7224, Expiration Date: 11Apr2024) at the age of 75 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "tinnitus" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: COVID-19 vaccine moderna (2nd dose, lot 011421A), administration date: 04Mar2021, for covid-19 vaccination; BNT162b2 (3rd dose, lot EW0185), administration date: 27Oct2021, for COVID-19 immunization; BNT162b2 (4th dose, lot SK9729), administration date: 11Apr2022, for COVID-19 immunization; Covid-19 vaccine moderna (1st dose, lot 12M20A), for covid-19 vaccination. The following information was reported: MALAISE (non-serious) with onset 12Mar2024, outcome "unknown", described as "I felt very ill, a lot of pain"; PAIN (non-serious) with onset 12Mar2024, outcome "recovered" (13Mar2024), described as "I was very achy and in bed"; BONE PAIN (non-serious) with onset 12Mar2024, outcome "unknown", described as "every bone in my body hurts"; TINNITUS (non-serious) with onset 12Mar2024, outcome "not recovered", described as "had tinnitus before I got the shot, this made it much worse (Covid Shot) really interfering with my life works". Therapeutic measures were taken as a result of bone pain, pain, malaise.  additional information: The patient had tinnitus before she got the shot, this made it much worse (Covid Shot) really interfering with her life works. The patient took Aspirin.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from an Other HCP.  A 55-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing), notes: Other medical history: Diabetes, HBP; "HBP" (unspecified if ongoing), notes: Other medical history: Diabetes, HBP; "Known allergies: Walnuts, peanuts" (unspecified if ongoing), notes: Known allergies: Walnuts, peanuts; "Known allergies: pineapple" (unspecified if ongoing), notes: Known allergies: pineapple. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid treatment).  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: A causal relationship to the suspect drug BNT162B2 OMI XBB.1.5 cannot be excluded for event drug ineffective. This case will be reassessed upon receipt of additional information.
Age: 63.0
Sex: F
Vaccine: PNC20, RSV
Symptoms: Erythema, Injection site erythema, Peripheral swelling, Pruritus
Clinical narrative: Patient reported itching, redness and swelling that was spreading around her arm.  It started on Friday and Saturday 3/21-3/22 and was a red ring around the injection site, then it progressively kept spreading. When she reported the issue on 3/26/24, I recommended the patient to take benadryl orally and to use ice packs to help with the swelling.  Followed up on 3/28/24, patient said the symptoms were much improved with the benadryl and the redness and swelling had decreased.
Age: 38.0
Sex: F
Vaccine: FLUA4
Symptoms: Blood test, Computerised tomogram, Conversion disorder, Dyspnoea, Electrocardiogram
Clinical narrative: Shortness of breath, seizures, conversion disorder with seizure or convulsion
Age: 38.0
Sex: F
Vaccine: FLUA4
Symptoms: Electroencephalogram, Seizure, Urine analysis, X-ray
Clinical narrative: Shortness of breath, seizures, conversion disorder with seizure or convulsion
Age: 0.58
Sex: F
Vaccine: MMR
Symptoms: Culture urine, Decreased eye contact, Febrile convulsion, Lethargy, Limb discomfort
Clinical narrative: On 3/22/23 around 7:55pm, pt spiked a fever of 100.8. At 8pm, fever jumped to 102.9. A few minutes later, parents noticed pt moving arm uncontrollably, not focusing or making eye contact, and lethargic. Pt was taken to the ED via ambulance. In ED< pt was dx with simpple febrile seizure and UTI was also pertinent to this visit. Pt was started on Cephalexin 175mg 4x per day for 10 days for UTI.
Age: 0.58
Sex: F
Vaccine: MMR
Symptoms: Microscopy, Pyrexia, Respiratory syncytial virus test, SARS-CoV-2 test, Urinary tract infection
Clinical narrative: On 3/22/23 around 7:55pm, pt spiked a fever of 100.8. At 8pm, fever jumped to 102.9. A few minutes later, parents noticed pt moving arm uncontrollably, not focusing or making eye contact, and lethargic. Pt was taken to the ED via ambulance. In ED< pt was dx with simpple febrile seizure and UTI was also pertinent to this visit. Pt was started on Cephalexin 175mg 4x per day for 10 days for UTI.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Erythema, Pruritus, Skin disorder, Urticaria
Clinical narrative: Hives across neck, red welts, itching;  Took Benadryl for a week.  Hives returned when contracted COVID in December.  Skin did not recover.  This week started a month of Allegra and Triamcinolone .1% Ointment recommended by dermatologist.  Can no longer use face creams (with retinol, Gold Bond crepe)
Age: 42.0
Sex: M
Vaccine: HEP, HEPA, MMR, TDAP
Symptoms: Back pain, Paraesthesia
Clinical narrative: After 15 minutes of administering the above vaccines for the patient,  the patient complaint of feeling tingling on the left lateral back area, then complaint of severe pain of 8/10 on the left lateral lower back area.  Nursing called 911 as NP instructed and patient picked up by paramedics to hospital for further assessment and treatment.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever up to 101 F; This is a spontaneous report received from a Consumer or other non HCP.  A 33-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Mar2024 as dose 1, single (Lot number: HG5967) at the age of 33 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION; CRYSELLE; HYDROXYZINE; ENSURE [NUTRIENTS NOS]. Vaccination history included: moderna (Dose Number: 4, Batch/Lot No: 051D22A, Location of injection: Arm Left), administration date: 25Oct2022, for Covid-19 immunization, reaction(s): "Fever"; moderna (Dose Number: 3, Batch/Lot No: 005C21A, Location of injection: Arm Left), administration date: 07Dec2021, for Covid-19 immunization, reaction(s): "Fever"; moderna (Dose Number: 2, Batch/Lot No: 004C21A, Location of injection: Arm Left), administration date: 07May2021, for Covid-19 immunization, reaction(s): "Fever"; moderna (Dose Number: 1, Batch/Lot No: 031B21A), administration date: 09Apr2021, for Covid-19 immunization, reaction(s): "Fever". The following information was reported: PYREXIA (non-serious) with onset 26Mar2024 at 17:00, outcome "unknown", described as "Fever up to 101 F". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.  Additional information: No drug allergy and known allergies noted. Facility where the most recent COVID-19 vaccine was administered noted as Doctor's office/urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Reported event noted Fever up to 101 Fahrenheit  (note: fever occurred with all Moderna doses as well). Treatment received noted OTC (over the counter); Tylenol.  No follow-up attempts are needed.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive of 20Jan2024; tested positive of 20Jan2024; This is a spontaneous report received from a Consumer or other non HCP from product quality group, Program ID.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and in Jan2022 as dose 3(booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20Jan2024, outcome "unknown" and all described as "tested positive of 20Jan2024". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Jan2024) Positive; (26Jan2024) Negative. The patient had Pfizer Covid- 19 vaccines and the booster.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  An 84-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Sep2022 as dose 5 (booster), single (Lot number: GH9694), in left arm and on 17May2023 as dose 6 (booster), single (Lot number: GM1767), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: EL9263), in left arm, on 14Feb2021 as dose 2, single (Lot number: EL9269), in left arm, on 26Aug2021 as dose 3 (booster), single (Lot number: EW0187), in left arm and on 14Apr2022 as dose 4 (booster), single (Lot number: FJ9989), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hyperlipidemia" (unspecified if ongoing); "GERD" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19, treatment was Paxlovid from 15Mar2024 to 21Mar2024.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  A 74-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 73 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19, treatment was Paxlovid from 17Mar2024 to 21Mar2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Dyskinesia, Insomnia, Muscle twitching
Clinical narrative: long nights of insomnia; muscle jerking and twitching; muscle jerking and twitching; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): NUS2024US051168_NC.  A 21-year-old patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "food intolerances" (unspecified if ongoing); "allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INSOMNIA (non-serious), outcome "unknown", described as "long nights of insomnia"; MUSCLE TWITCHING (non-serious), DYSKINESIA (non-serious), outcome "unknown" and all described as "muscle jerking and twitching".  Additional information: Patient reported had a bad reaction to the Covid vaccine and ever since then life had become so small and miserable. Patient reported doing better than was, but still have long nights of insomnia, muscle jerking and twitching, almost like body was flipping itself around when try to sleep. Patient have so many food intolerances/allergies. Patient could not live a normal life.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Caller said she developed Covid December of 2023, December 23rd, 24th, and she has been negative since the 27th; Caller said she developed Covid December of 2023, December 23rd, 24th, and she has been negative since the 27th; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and in Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "recovered" (27Dec2023) and all described as "Caller said she developed Covid December of 2023, December 23rd, 24th, and she has been negative since the 27th". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Dec2023) Negative, notes: been negative since the 27th. Additional information: patient mentioned that she had her Pfizer Covid 19 vaccines and the booster. She got the booster of Jan2022. Caller said she developed Covid Dec2023, December 23rd, 24th, and she has been negative since the 27Dec2023. Caller said she was around 3 months since she had covid. Caller is asking when should she be getting another booster shot.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.