chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19-2, COVID19-2, COVID19
Symptoms: Alopecia
Clinical narrative: thinning hair/all of the patients hair fell out/body hair is thinning out; patient lost Facial Hair as well/No eyebrows no hair or facial hair. Eye lashes are falling out; This spontaneous case was reported by a patient and describes the occurrence of ALOPECIA (thinning hair/all of the patients hair fell out/body hair is thinning out) and HYPOTRICHOSIS (patient lost Facial Hair as well/No eyebrows no hair or facial hair. Eye lashes are falling out) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 053D22A) for COVID-19 prophylaxis.     The patient reported no chronic disease.  Concomitant products included ATORVASTATIN, TADALAFIL, TADALAFIL (CIALIS), FISH OIL, VITAMINS NOS (MVI [VITAMINS NOS]) and BIOTIN for an unknown indication.  On 14-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 ALOPECIA (thinning hair/all of the patients hair fell out/body hair is thinning out) and HYPOTRICHOSIS (patient lost Facial Hair as well/No eyebrows no hair or facial hair. Eye lashes are falling out). At the time of the report, ALOPECIA (thinning hair/all of the patients hair fell out/body hair is thinning out) and HYPOTRICHOSIS (patient lost Facial Hair as well/No eyebrows no hair or facial hair. Eye lashes are falling out) had not 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.   The patient received his first Moderna Covid 19 vaccine primary series on 23-Jan-2021, Lot number 032L20A expiration date was not known in left arm. The patient reported adverse reactions of a sore left injection site arm. The patient received his second Moderna Covid 19 vaccine on 02-Mar-2021, lot number 013A21A expiration date was Aug-2021 in left arm and patient woke up on 03-Mar-2021 felt light headed and passed out. Patient felt better quickly after resting. The patient received his first Moderna Covid 19 vaccine booster dose on 17-Nov-2021, lot number 067F21A expiration date was not known in left arm and reported some thinning of his hair after the first booster dose a month or so after his first booster dose. Hair grew back fully 6 months after the booster dose. The patient lost facial hair as well. The facial hair did not come back. Patient also suspected a possibility of a Covid-19 infection after his first booster dose at the end of November 2021. Patient tested for Covid-19 and it came back negative however patient thought that he might had tested too early and he did not test again as he thought that it was a bad cold.  No treatment medications were reported.   This case was linked to MOD-2023-713959 (Patient Link).
Sex: M
Vaccine: COVID19-2, COVID19-2, COVID19
Symptoms: Alopecia, Hypotrichosis, Madarosis
Clinical narrative: thinning hair/all of the patients hair fell out/body hair is thinning out; patient lost Facial Hair as well/No eyebrows no hair or facial hair. Eye lashes are falling out; This spontaneous case was reported by a patient and describes the occurrence of ALOPECIA (thinning hair/all of the patients hair fell out/body hair is thinning out) and HYPOTRICHOSIS (patient lost Facial Hair as well/No eyebrows no hair or facial hair. Eye lashes are falling out) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 053D22A) for COVID-19 prophylaxis.     The patient reported no chronic disease.  Concomitant products included ATORVASTATIN, TADALAFIL, TADALAFIL (CIALIS), FISH OIL, VITAMINS NOS (MVI [VITAMINS NOS]) and BIOTIN for an unknown indication.  On 14-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 ALOPECIA (thinning hair/all of the patients hair fell out/body hair is thinning out) and HYPOTRICHOSIS (patient lost Facial Hair as well/No eyebrows no hair or facial hair. Eye lashes are falling out). At the time of the report, ALOPECIA (thinning hair/all of the patients hair fell out/body hair is thinning out) and HYPOTRICHOSIS (patient lost Facial Hair as well/No eyebrows no hair or facial hair. Eye lashes are falling out) had not 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.   The patient received his first Moderna Covid 19 vaccine primary series on 23-Jan-2021, Lot number 032L20A expiration date was not known in left arm. The patient reported adverse reactions of a sore left injection site arm. The patient received his second Moderna Covid 19 vaccine on 02-Mar-2021, lot number 013A21A expiration date was Aug-2021 in left arm and patient woke up on 03-Mar-2021 felt light headed and passed out. Patient felt better quickly after resting. The patient received his first Moderna Covid 19 vaccine booster dose on 17-Nov-2021, lot number 067F21A expiration date was not known in left arm and reported some thinning of his hair after the first booster dose a month or so after his first booster dose. Hair grew back fully 6 months after the booster dose. The patient lost facial hair as well. The facial hair did not come back. Patient also suspected a possibility of a Covid-19 infection after his first booster dose at the end of November 2021. Patient tested for Covid-19 and it came back negative however patient thought that he might had tested too early and he did not test again as he thought that it was a bad cold.  No treatment medications were reported.   This case was linked to MOD-2023-713959 (Patient Link).
Sex: M
Vaccine: COVID19-2, COVID19-2, COVID19
Symptoms: Alopecia, Dizziness, Hypotrichosis, Inappropriate schedule of product administration, Injection site pain
Clinical narrative: thinning hair/all of the patients hair fell out/body hair is thinning out; patient lost Facial Hair as well/No eyebrows no hair or facial hair. Eye lashes are falling out; This spontaneous case was reported by a patient and describes the occurrence of ALOPECIA (thinning hair/all of the patients hair fell out/body hair is thinning out) and HYPOTRICHOSIS (patient lost Facial Hair as well/No eyebrows no hair or facial hair. Eye lashes are falling out) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 053D22A) for COVID-19 prophylaxis.     The patient reported no chronic disease.  Concomitant products included ATORVASTATIN, TADALAFIL, TADALAFIL (CIALIS), FISH OIL, VITAMINS NOS (MVI [VITAMINS NOS]) and BIOTIN for an unknown indication.  On 14-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 ALOPECIA (thinning hair/all of the patients hair fell out/body hair is thinning out) and HYPOTRICHOSIS (patient lost Facial Hair as well/No eyebrows no hair or facial hair. Eye lashes are falling out). At the time of the report, ALOPECIA (thinning hair/all of the patients hair fell out/body hair is thinning out) and HYPOTRICHOSIS (patient lost Facial Hair as well/No eyebrows no hair or facial hair. Eye lashes are falling out) had not 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.   The patient received his first Moderna Covid 19 vaccine primary series on 23-Jan-2021, Lot number 032L20A expiration date was not known in left arm. The patient reported adverse reactions of a sore left injection site arm. The patient received his second Moderna Covid 19 vaccine on 02-Mar-2021, lot number 013A21A expiration date was Aug-2021 in left arm and patient woke up on 03-Mar-2021 felt light headed and passed out. Patient felt better quickly after resting. The patient received his first Moderna Covid 19 vaccine booster dose on 17-Nov-2021, lot number 067F21A expiration date was not known in left arm and reported some thinning of his hair after the first booster dose a month or so after his first booster dose. Hair grew back fully 6 months after the booster dose. The patient lost facial hair as well. The facial hair did not come back. Patient also suspected a possibility of a Covid-19 infection after his first booster dose at the end of November 2021. Patient tested for Covid-19 and it came back negative however patient thought that he might had tested too early and he did not test again as he thought that it was a bad cold.  No treatment medications were reported.   This case was linked to MOD-2023-713959 (Patient Link).
Sex: M
Vaccine: COVID19-2, COVID19-2, COVID19
Symptoms: Loss of consciousness, Nasopharyngitis, SARS-CoV-2 test negative, Suspected COVID-19
Clinical narrative: thinning hair/all of the patients hair fell out/body hair is thinning out; patient lost Facial Hair as well/No eyebrows no hair or facial hair. Eye lashes are falling out; This spontaneous case was reported by a patient and describes the occurrence of ALOPECIA (thinning hair/all of the patients hair fell out/body hair is thinning out) and HYPOTRICHOSIS (patient lost Facial Hair as well/No eyebrows no hair or facial hair. Eye lashes are falling out) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 053D22A) for COVID-19 prophylaxis.     The patient reported no chronic disease.  Concomitant products included ATORVASTATIN, TADALAFIL, TADALAFIL (CIALIS), FISH OIL, VITAMINS NOS (MVI [VITAMINS NOS]) and BIOTIN for an unknown indication.  On 14-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 ALOPECIA (thinning hair/all of the patients hair fell out/body hair is thinning out) and HYPOTRICHOSIS (patient lost Facial Hair as well/No eyebrows no hair or facial hair. Eye lashes are falling out). At the time of the report, ALOPECIA (thinning hair/all of the patients hair fell out/body hair is thinning out) and HYPOTRICHOSIS (patient lost Facial Hair as well/No eyebrows no hair or facial hair. Eye lashes are falling out) had not 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.   The patient received his first Moderna Covid 19 vaccine primary series on 23-Jan-2021, Lot number 032L20A expiration date was not known in left arm. The patient reported adverse reactions of a sore left injection site arm. The patient received his second Moderna Covid 19 vaccine on 02-Mar-2021, lot number 013A21A expiration date was Aug-2021 in left arm and patient woke up on 03-Mar-2021 felt light headed and passed out. Patient felt better quickly after resting. The patient received his first Moderna Covid 19 vaccine booster dose on 17-Nov-2021, lot number 067F21A expiration date was not known in left arm and reported some thinning of his hair after the first booster dose a month or so after his first booster dose. Hair grew back fully 6 months after the booster dose. The patient lost facial hair as well. The facial hair did not come back. Patient also suspected a possibility of a Covid-19 infection after his first booster dose at the end of November 2021. Patient tested for Covid-19 and it came back negative however patient thought that he might had tested too early and he did not test again as he thought that it was a bad cold.  No treatment medications were reported.   This case was linked to MOD-2023-713959 (Patient Link).
Sex: U
Vaccine: BCG
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; BCG vaccine that experienced excursion was administered to a patient.; This spontaneous report was received from a pharmacist and referred to a patient of unknown age or gender. The patient's medical history, concurrent conditions, concomitant therapies and drug reaction/allergies were not reported.   On 08-FEB-2023, the patient was vaccinated with bcg live (BCG VACCINE), strength 50 milligram (mg), powder for injection, administered for prophylaxis (lot number W026958 is an invalid lot number for bcg live (BCG VACCINE); expiration date was reported as 31-MAY-2023; dose and route of administration were not provided). The bcg live (BCG VACCINE) experienced excursion and reached a high temperature of 9.7 degrees Celsius for 5 minutes on 08-FEB-2023 (product storage error). No additional adverse event (AE) details were available.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Patient was administered Improperly Stored, Separate VAQTA; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 16-FEB-2023, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, pre-filled syringe, lot #W036135, expiration date: 13-MAY-2024 (dose, dose number, and route of administration were not provided), administered for prophylaxis (product storage error). The vaccine was stored in a temperature of 48.3 degrees Fahrenheit for 1 hour and 30 minutes. The most recent temperature excursion occurred on 15-FEB-2023. There was no previous temperature excursion. No additional adverse event (AE) was reported.
Age: 43.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: The nurse told field employee that 2 adult patients with who have the same age of 43 years old received PROQUAD instead of VARIVAX and MMR II; No additional AEs were reported; The spontaneous case was received from a nurse via company representative referring to a 43-year-old patient of unknown gender.  The patient's concurrent conditions, historical conditions, concomitant therapies, past drug reactions or allergies, and risk factors were not reported.   On an unknown date, the patient received measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) instead of varicella virus vaccine live (Oka/Merck) (VARIVAX) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (wrong product administered). Date rep learned of the AE was confirmed to be on 16-MAR-2023 also 16-FEB-2023, (conflicting information). No further information was provided. No additional adverse events (AEs) were reported (no adverse event).  This is one of two reports received from the same reporter; Sender's Comments:  US-009507513-2302USA006707:
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; HCP stated expired STERILE DILUENT was used to reconstitute either MMR II or VARIVAX and was administered to a patient. Caller stated the patient received MMR II and VARIVAX on the same day so she is unable to confirm which vaccine was reconstituted; HCP stated expired STERILE DILUENT was used to reconstitute either MMR II or VARIVAX and was administered to a patient. Caller stated the patient received MMR II and VARIVAX on the same day so she is unable to confirm which vaccine was reconstituted; This spontaneous report was received from a Medical Assistant and refers to a patient of unknown age and gender. The patient medical history. patient's concurrent conditions, concomitant therapies, drug allergies or reactions were not reported.  On 17-FEB-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 ml, (Lot # W008711, expiration date: 14-MAR-2024), administered for prophylaxis; and with Virus vaccine, live Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live  (M-M-R II) subcutaneous injection 0.5 ml, (Lot #W023071, expiration date: 05-APR-2024) (strength, and route of administration were not provided). Both vaccines were reconstituted with sterile diluent (STERILE DILUENT) solution for injection/infusion, (Lot #T013413, expiration date: 13-DEC-2022), administered for prophylaxis (strength, and route of administration were not provided) (Expired medical agent used. It was started and clarified that both suspect vaccines were not expired. No additional information as reported. No additional AE reported.  The causal relationship between the event and the suspect therapies were not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Bell's palsy, Herpes zoster, Restless legs syndrome, Scar
Clinical narrative: Bell's Palsy; herpes zoster; scarring from herpes zoster; restless leg syndrome; Information has been received from a lawyer regarding a case in litigation and refers to a currently approximate 63-year-old patient of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 11-APR-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, and route not specified) at a clinic for the long-term prevention of shingles and zoster-related conditions. Subsequently (date unknown), the patient was treated by providers for the following injuries resulting from zoster vaccine live (ZOSTAVAX): Bell's Palsy, herpes zoster, scarring from herpes zoster and restless leg syndrome. The outcome of the events was unknown.  Upon internal review, Bell's Palsy was determined to be medically significant.
Sex: F
Vaccine: HPV9
Symptoms: Rash
Clinical narrative: FBE reports that he learned of the AE on 3/3/2023. FBE reports that a patient developed a rash after receiving their second dose of GARDASIL 9.; This spontaneous report was received from field-based employee (FBE) on behalf of a physician assistant and refers to an adult female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date, the patient was vaccinated with the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient developed a rash. She fully recovered and there was no need for any medical intervention. The patient did not elect to receive a third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9).  Causality assessment was not provided.
Sex: F
Vaccine: HPV9
Symptoms: Autoimmune disorder, Female reproductive tract disorder
Clinical narrative: Diagnosed with an unspecified autoimmune disorder; fertility issues; This spontaneous report has been received from a nurse practitioner referring a female patient of unknown age. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On an unknown date (reported as years ago), the patient was vaccinated with hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, specific dosage, vaccination scheme, route of administration, anatomical site of application, lot number and expiration date were not provided)  On an unknown date, the patient was diagnosed with an unspecified autoimmune disorder and fertility issues (female reproductive tract disorder).   The outcome of the events were not provided. The causal relationship between the events and hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not reported. The patient believed these issues were caused by hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) .    Upon internal review, the event autoimmune disorder was determined to be medically significant.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other adverse events reported; Caller reports that a patient was administered an expired MMR II today.; This spontaneous report has been received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history, drugs reactions or allergies and concomitant medications were not provided.  On 03-MAR-2023, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin (rha) (M-M-R II) subcutaneous injection (valid lot number U006489 with an expiration date on 26-FEB-2023) (dose, route of administration, strength, frequency, and anatomical injection site were not provided) for prophylaxis (expired product administered), and sterile diluent (STERILE DILUENT)  (valid lot number W010864 with an expiration date on 23-OCT-2024 or valid lot number W010871 with an expiration date on 17-NOV-2024 [conflicting information both lot number were reported, the reporter was unsure which was used]).  No other adverse events reported.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Herpes zoster, Pain, Vaccination failure
Clinical narrative: I had two of those shots. I still got shingles/suspected vaccination failure; felt like bad sunburn; internal stabbing pains; shingles/still got shingles/affected area spread until it was my left breast, up b to my shoulder, and over to my armpit; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine (had the old shot).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, burning sensation and pain. On an unknown date, the outcome of the vaccination failure, burning sensation and pain were unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, burning sensation and pain to be related to Shingrix and Shingrix.     Additional Information: GSK receipt date: 28-Feb-2023 Reporter's comment: The case was received from the patient via interactive digital media. The patient received two shots of Shingrix when it came out and still got shingles but not nearly as bad as they could had been according to his/her physician. The patient reported that it felt like bad sunburn, then internal stabbing pains and also, the affected area spread until it was his/her left breast, up to his/her shoulder, and over to his/her armpit.  The patient's skin looked normal, no rash or redness.  It took 3 months to totally clear up. The patient had recommend the vaccines, had no side effects from them. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. As it was reported that it took 3 months to totally clear up therefore for shingles outcome was captured as recovered.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site mass, Injection site swelling, Pain
Clinical narrative: Lump under injection site was bigger, still aches; injection site turned red; injection site warm to touch; injection site swollen; injection site hurts; Swelling arm; fever; chills; Body aches; This case was reported by a consumer and described the occurrence of injection site lump in a 52-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included chronic pain (have had chronic pain and for which taking Oxycodone). Concomitant products included oxycodone.   On 20th February 2023, the patient received Shingles vaccine. On 21st February 2023, 1 days after receiving Shingles vaccine, the patient experienced fever, chills and general body pain. On 22nd February 2023, the patient experienced injection site lump, injection site erythema, injection site warmth, injection site swelling, injection site pain and swelling arm. On an unknown date, the outcome of the injection site lump, injection site erythema, injection site warmth, injection site swelling, injection site pain and swelling arm were not recovered/not resolved and the outcome of the fever, chills and general body pain were unknown.   It was unknown if the reporter considered the injection site lump, injection site erythema, injection site warmth, injection site swelling, injection site pain, swelling arm, fever, chills and general body pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 25-FEB-2023. Reporter's Comments: The patient got the shot and the following day she had fever and chills and body ached, she noticed at that time the injection site had turned red, was hot to the touch.  By the following day she noticed the lump under the injection site, the following day it was bigger and it still ached, hurted, swollen and red at the injection site typical and prescribed medication were not help or giving relief. She was very concerned of a reaction or complication with the vaccine. On 22nd February 2023, 2 days after receiving Shingles vaccine, the patient experienced injection site induration, injection site erythema, swelling arm, injection site warmth, injection site swelling and injection site pain.
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Lump under injection site was bigger, still aches; injection site turned red; injection site warm to touch; injection site swollen; injection site hurts; Swelling arm; fever; chills; Body aches; This case was reported by a consumer and described the occurrence of injection site lump in a 52-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included chronic pain (have had chronic pain and for which taking Oxycodone). Concomitant products included oxycodone.   On 20th February 2023, the patient received Shingles vaccine. On 21st February 2023, 1 days after receiving Shingles vaccine, the patient experienced fever, chills and general body pain. On 22nd February 2023, the patient experienced injection site lump, injection site erythema, injection site warmth, injection site swelling, injection site pain and swelling arm. On an unknown date, the outcome of the injection site lump, injection site erythema, injection site warmth, injection site swelling, injection site pain and swelling arm were not recovered/not resolved and the outcome of the fever, chills and general body pain were unknown.   It was unknown if the reporter considered the injection site lump, injection site erythema, injection site warmth, injection site swelling, injection site pain, swelling arm, fever, chills and general body pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 25-FEB-2023. Reporter's Comments: The patient got the shot and the following day she had fever and chills and body ached, she noticed at that time the injection site had turned red, was hot to the touch.  By the following day she noticed the lump under the injection site, the following day it was bigger and it still ached, hurted, swollen and red at the injection site typical and prescribed medication were not help or giving relief. She was very concerned of a reaction or complication with the vaccine. On 22nd February 2023, 2 days after receiving Shingles vaccine, the patient experienced injection site induration, injection site erythema, swelling arm, injection site warmth, injection site swelling and injection site pain.
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort
Clinical narrative: Stomach upset; This case was reported by a consumer and described the occurrence of upset stomach in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Fluticasone propionate (was taking Fluticasone propionate for mucus, refer case USCH2023AMR009231). Concurrent medical conditions included cholesterol (for cholesterol patient was taking Atorvastatin). Concomitant products included atorvastatin.   On 22nd February 2023, the patient received Shingrix. On 24th February 2023, 2 days after receiving Shingrix, the patient experienced upset stomach. On an unknown date, the outcome of the upset stomach was not recovered/not resolved.   It was unknown if the reporter considered the upset stomach to be related to Shingrix.     Additional Information: GSK Receipt Date: 25-FEB-2023. Reporter's Comments: The patient simply got a Shingrix vaccination from her local chemist and had stomach upset. The symptoms were treated. The reporter gave permission to contact.  Suspect was coded as per narrative information. As patient was taking medication for mucus but it was not clear what actually patient had mucus problem therefore indication Fluticasone propionate was coded as mucus problem which auto coded as ill defined disorder in patient tab.;
Sex: U
Vaccine: VARZOS
Symptoms: Limb discomfort
Clinical narrative: Arm felt like was kicked by a mule; This case was reported by a consumer via interactive digital media and described the occurrence of arm discomfort in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced arm discomfort. On an unknown date, the outcome of the arm discomfort was recovered/resolved.   It was unknown if the reporter considered the arm discomfort to be related to Shingles vaccine.     Additional Information: GSK Receipt Date- 25-FEB-2023 Reporter's Comments-The case was received from the patient via interactive digital media. The patient reported that while the shot itself was not painful, his/her arm felt like he/she was kicked by a mule, for almost a week.  The patient not looking forward to the second shot. Additional supportive information: The follow-up could not be possible as no contact details were available. As no vaccination details were provided therefore case was kept valid for only 1st dose.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: NEUROPATHY AGGRAVATED; This spontaneous report received from a patient concerned an 8 decade old elderly male of an unspecified ethnicity. The patient's weight was 250 pounds, and height was 74 inches. The patient's past medical history included: concussion (in college), broken 22 bones, and several operations, and concurrent conditions included: cats allergy, alcohol user (a little bit), non-smoker, blood pressure, and neuropathy in both hands, and other pre-existing medical conditions included: Patient had no history of drug abuse or illicit drug usage. The patient had not had any internal issues like heart or kidney issues, just structural before vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total administered on an unspecified date in 2021 for covid-19 prophylaxis. Age at time of vaccination 8 decade old. The batch number was not reported and has been requested. Concomitant medications included olmesartan for blood pressure, and apixaban.  On an unspecified date in 2021, few weeks after vaccination, the patient experienced paresthesia on the right side of his face and ear. Patient reported that he was experiencing tingling, crawling, paresthesia on the right side of his face. He stated that it comes and goes but it seems like now it was here to stay and it was aggravating (neuropathy aggravated). He spoke with his physician about it and physician was going to refer patient to a neurologist. Patient reported that he thinks that the paresthesia on his face/ear might be related to his vaccine and if he put his hand on the right side of his head, that was about the normal area, that was being affected by the paresthesia. It was on the side of his head covering his eyebrows going through his ear and cheek. Patient stated it was not a burning sensation and it had never been painful but it was getting to where it was painful. When patient spoke with his physician about the complaint, his physician gave him cortisone injections in his hands and got him some hand braces, neither of which did anything. Patient stated that he did not get a cortisone injection to his face or ear as he had not had a cortisone injection above his shoulders since he had a concussion in college. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from neuropathy aggravated. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230302319-Neuropathy aggravated. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: MEDICAL HISTORY. Therefore, this event is considered inconsistent with vaccine administration.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: MIGHT HAVE GOTTEN AN EXPIRED VACCINE; This spontaneous report received from a pharmacist 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 (suspension for injection, route of admin not reported, batch number: 202F21A expiry: 07-FEB-2023) dose, start therapy date were not reported for covid-19 prophylaxis. The drug was associated with Medication error. No concomitant medications were reported. On an unspecified date, the patient experienced might have gotten an expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of might have gotten an expired vaccine was not reported. This report was non-serious. This case is a duplicate of 20230309055.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was initially stored in refrigerator on 23Jan2023 and administered on 23Feb2023; No Adverse Event; 6 patients administered doses after the BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (6 patients administered doses after the BUD), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 23Jan2023 and administered on 23Feb2023) and NO ADVERSE EVENT (No Adverse Event) 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)) (batch no. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Feb-2023, 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 23-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (6 patients administered doses after the BUD). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 23Jan2023 and administered on 23Feb2023) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (6 patients administered doses after the BUD), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 23Jan2023 and administered on 23Feb2023) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (6 patients administered doses after the BUD) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 23Jan2023 and administered on 23Feb2023).    This case belongs to the 3rd out of 6 patients who had received the vaccine as described by the reporter. No concomitant information was reported. It was reported that the 6 patients had received the vaccine beyond BUD. No symptoms reported. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-713876 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 03-Mar-2023: Live Follow-up received: Updated suspect batch number.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713876:(Master Case pt 1 of 6)
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine administered on 23FEB2023 after initially being stored in the refrigerator on 23JAN2023; No Adverse Event; patients administered doses after the BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients administered doses after the BUD), PRODUCT STORAGE ERROR (Vaccine administered on 23FEB2023 after initially being stored in the refrigerator on 23JAN2023) and NO ADVERSE EVENT (No Adverse Event) 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)) (batch no. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Feb-2023, 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 23-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients administered doses after the BUD). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered on 23FEB2023 after initially being stored in the refrigerator on 23JAN2023) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients administered doses after the BUD), PRODUCT STORAGE ERROR (Vaccine administered on 23FEB2023 after initially being stored in the refrigerator on 23JAN2023) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (patients administered doses after the BUD) and PRODUCT STORAGE ERROR (Vaccine administered on 23FEB2023 after initially being stored in the refrigerator on 23JAN2023).    This case contains information for the 5th of 6 adult patients described by the reporter.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-713876 (Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 03-Mar-2023: Live Follow-up received in which batch number was added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713876:(Master Case pt 1 of 6)
Age: 27.0
Sex: F
Vaccine: COVID19-2
Symptoms: Maternal exposure during breast feeding, No adverse event
Clinical narrative: No adverse event; Maternal exposure during breast feeding; This spontaneous case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) and NO ADVERSE EVENT (No adverse event) in a 27-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5051C) for COVID-19 prophylaxis.     No Medical History information was reported.  On 23-Feb-2023, 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 23-Feb-2023, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). On 23-Feb-2023, MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) had resolved. At the time of the report, 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 MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding).    No concomitant and treatment medications were reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: vial was initially stored in refrigerator on 23Jan2023 and administered on 23Feb2023; No Adverse Event; Patients administered doses after the BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients administered doses after the BUD), PRODUCT STORAGE ERROR (vial was initially stored in refrigerator on 23Jan2023 and administered on 23Feb2023) and NO ADVERSE EVENT (No Adverse Event) 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)) (batch no. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Feb-2023, 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 23-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients administered doses after the BUD). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in refrigerator on 23Jan2023 and administered on 23Feb2023) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients administered doses after the BUD), PRODUCT STORAGE ERROR (vial was initially stored in refrigerator on 23Jan2023 and administered on 23Feb2023) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patients administered doses after the BUD) and PRODUCT STORAGE ERROR (vial was initially stored in refrigerator on 23Jan2023 and administered on 23Feb2023).    No concomitant medication was provided.  It was reported that the 6 patients had received the vaccine beyond BUD and no reported symptoms were provided.   Treatment medication was not provided by the reporter.  The case belongs to the sixth patient out of 6 patients who had received the vaccine as described by the reporter   This case was linked to US-MODERNATX, INC.-MOD-2023-713876 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 03-Mar-2023: Live significant follow up was received. Batch/lot number was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713876:(Master Case pt 1 of 6)
Age: 35.0
Sex: M
Vaccine: COVID19-2
Symptoms: Immunisation reaction
Clinical narrative: Vaccination adverse reaction; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) in a 35-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5051C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 15-Jan-2023, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown.        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 were not provided. Treatment medication were not reported.
Age: 36.0
Sex: F
Vaccine: COVID19-2
Symptoms: Maternal exposure during breast feeding, Maternal exposure during pregnancy, No adverse event
Clinical narrative: No adverse event; Maternal exposure during breast feeding; Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding), MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and NO ADVERSE EVENT (No adverse event) in a 36-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5051C) for COVID-19 prophylaxis.     No Medical History information was reported.  On 05-Feb-2023, 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. Last menstrual period and estimated date of delivery were not provided. On 05-Feb-2023, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). On 05-Feb-2023, MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. At the time of the report, 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 assessments were provided for MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy).    No concomitant and treatment medications were reported.  Company comment: This spontaneous prospective pregnancy case concerns a 36-year-old, female patient with no medical history information reported, who experienced the unexpected non serious events of maternal exposure during pregnancy and maternal exposure during breastfeeding with no adverse events reported. The patient received the 4th dose of mRNA-1273 bivalent BA.4/BA.5. No information about last menstrual period and estimated date of delivery as well as gestational age at  time of exposure was provided. It was reported that patient was pregnant and was nursing. No further information about the events was provided. The benefit-risk relationship of mRNA-1273 bivalent BA.4/BA.5 is not affected by this report.   Reporter did not allow further contact