chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: patient received a dose of Boostrix that had already expired; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 2ZF9N, expiry date 24-SEP-2023) for prophylaxis.   On 27-SEP-2023, the patient received Boostrix. On 27-SEP-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: patient received a dose of Boostrix that had already expired).  The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt date: 27-SEP-2023 A nurse reported that earlier that day, a patient received a dose of Boostrix that had already expired on 24 September 2023 which led to expired vaccine used.  The reporter did not consent to follow-up.  This case was linked with case US2023133461 with same reporter.; Sender's Comments:  US-GSK-US2023133461:Same reporter 2nd patient
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash; This non-serious case was reported by a consumer via call center representative and described the occurrence of rash in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19-SEP-2023, the patient received the 1st dose of Shingrix. On 25-SEP-2023, 6 days after receiving Shingrix, the patient experienced rash (Verbatim: Rash). The outcome of the rash was not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.     It was unknown if the company considered the rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 27-SEP-2023 The reporter was a patient. The patient received the first dose of shingrix vaccine on Tuesday and on Monday she noticed a rash on the flank area of the body.   The rash was beginning to go down to the hip area and underneath the area of both breasts.  The rash was predominately on right and left flank but does not quite go all the way around the back. The reporter consented to follow up.
Age: 77.0
Sex: M
Vaccine: RSV
Symptoms: Arthritis, Condition aggravated, Fatigue
Clinical narrative: tiredness; arthritis flare up; This non-serious case was reported by a consumer via call center representative and described the occurrence of tiredness in a 77-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included arthritis.   On 10-SEP-2023, the patient received Arexvy (left arm). In SEP-2023, an unknown time after receiving Arexvy, the patient experienced tiredness (Verbatim: tiredness) and flare up of arthritis (Verbatim: arthritis flare up).  In SEP-2023, the outcome of the tiredness and flare up of arthritis were resolved (duration 5 days).   It was unknown if the reporter considered the tiredness and flare up of arthritis to be related to Arexvy.     It was unknown if the company considered the tiredness and flare up of arthritis to be related to Arexvy.   Additional Information: GSK Receipt Date: 27-SEP-2023 The reporter was the patient who received Arexvy stated that after he got his dose, he was very tired for the entire week. He also stated that his arthritis flared up on his hands and wrists. The patient had history of arthritis in hands and wrists, but it got worse after receiving Arexvy. The symptoms of tiredness and arthritis flare up lasted about 5 days. The reporter did not consent to follow up.
Age: 12.0
Sex: F
Vaccine: MEN, MNQ
Symptoms: Interchange of vaccine products
Clinical narrative: Interchange of vaccine products; This non-serious case was reported by a nurse via call center representative and described the occurrence of interchange of vaccine products in a 13-year-old female patient who received Men ACWY-CRM NVS (Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine) for prophylaxis.   Co-suspect products included MENACTRA for prophylaxis.   On 21-SEP-2018, the patient received the 1st dose of Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine. On 04-MAR-2019, the patient received the 2nd dose of MENACTRA. On 04-MAR-2019, 164 days after receiving Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine, the patient experienced interchange of vaccine products (Verbatim: Interchange of vaccine products).  The outcome of the interchange of vaccine products was unknown.   Additional Information: GSK Receipt Date: 27-SEP-2023 The nurse reported clinic had a patient that received a dose of meningococcal conjugate, and a dose of Menactra on.  Now stated that school system was saying this patient needed another dose since she did not have a dose after age 16 yrs. The patient received Menactra after protentional GSK  meningococcal conjugate vaccine, which led to interchange of vaccine product. At the time of reporting, another dose has not been administered. The reporter consented to follow up.
Sex: F
Vaccine: RSV
Symptoms: Anal pruritus, Injection site erythema, Injection site pain, Injection site warmth, Sleep disorder
Clinical narrative: vaginal itching; intense rectal itching; redness at the injection site; tenderness at the injection site; warmth at the injection site; woke her up in the middle of the night; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 75BS5) for prophylaxis.   Concurrent medical conditions included hemorrhoids (Pre-existing hemorrhoid issues). Concomitant products included INFLUENZA VACCINE, COVID-19 VACCINE (COVID VACCINE) and estradiol (Estrace).   On 22-SEP-2023, the patient received Arexvy. In SEP-2023, an unknown time after receiving Arexvy, the patient experienced sleep disturbance (Verbatim: woke her up in the middle of the night). On 22-SEP-2023, the patient experienced injection site erythema (Verbatim: redness at the injection site), injection site tenderness (Verbatim: tenderness at the injection site) and injection site warmth (Verbatim: warmth at the injection site). On 23-SEP-2023, the patient experienced vaginal itching (Verbatim: vaginal itching) and anal pruritus (Verbatim: intense rectal itching).  The patient was treated with antihemorrhoidals nos (Hemorrhoid Cream). On 22-SEP-2023, the outcome of the injection site erythema, injection site tenderness and injection site warmth were resolved. The outcome of the vaginal itching and anal pruritus were resolving and the outcome of the sleep disturbance was not reported.   It was unknown if the reporter considered the injection site erythema, injection site tenderness, injection site warmth, vaginal itching, anal pruritus and sleep disturbance to be related to Arexvy.     It was unknown if the company considered the injection site erythema, injection site tenderness, injection site warmth, vaginal itching, anal pruritus and sleep disturbance to be related to Arexvy.   Additional Information: GSK Receipt Date: 28-SEP-2023 The patient's current condition was reported as eating a lot of berries lately. It was reported that the patient experienced redness, tenderness, and warmth at the injection site. These issues resolved. The next day on after receiving vaccine she experienced intense rectal itching and vaginal itching. The itching was so intense that it woke her up in the middle of the night. She used a hemorrhoid cream (sounded like Rexicure). She reported that she still had left with this itching all these days later. The itching was not as bad as it was initially, but it had not resolved. The reporter did not consent to follow up. The reporter provided limited information. She refused to provider her street address. The reporter did not get a chance to ask for her date of birth or ask other questions as she ended the call abruptly. This case is linked with US2023133803, same reporter.; Sender's Comments:  US-GSK-US2023133803:Same reporter, different patient
Sex: F
Vaccine: RSV
Symptoms: Vulvovaginal pruritus
Clinical narrative: vaginal itching; intense rectal itching; redness at the injection site; tenderness at the injection site; warmth at the injection site; woke her up in the middle of the night; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 75BS5) for prophylaxis.   Concurrent medical conditions included hemorrhoids (Pre-existing hemorrhoid issues). Concomitant products included INFLUENZA VACCINE, COVID-19 VACCINE (COVID VACCINE) and estradiol (Estrace).   On 22-SEP-2023, the patient received Arexvy. In SEP-2023, an unknown time after receiving Arexvy, the patient experienced sleep disturbance (Verbatim: woke her up in the middle of the night). On 22-SEP-2023, the patient experienced injection site erythema (Verbatim: redness at the injection site), injection site tenderness (Verbatim: tenderness at the injection site) and injection site warmth (Verbatim: warmth at the injection site). On 23-SEP-2023, the patient experienced vaginal itching (Verbatim: vaginal itching) and anal pruritus (Verbatim: intense rectal itching).  The patient was treated with antihemorrhoidals nos (Hemorrhoid Cream). On 22-SEP-2023, the outcome of the injection site erythema, injection site tenderness and injection site warmth were resolved. The outcome of the vaginal itching and anal pruritus were resolving and the outcome of the sleep disturbance was not reported.   It was unknown if the reporter considered the injection site erythema, injection site tenderness, injection site warmth, vaginal itching, anal pruritus and sleep disturbance to be related to Arexvy.     It was unknown if the company considered the injection site erythema, injection site tenderness, injection site warmth, vaginal itching, anal pruritus and sleep disturbance to be related to Arexvy.   Additional Information: GSK Receipt Date: 28-SEP-2023 The patient's current condition was reported as eating a lot of berries lately. It was reported that the patient experienced redness, tenderness, and warmth at the injection site. These issues resolved. The next day on after receiving vaccine she experienced intense rectal itching and vaginal itching. The itching was so intense that it woke her up in the middle of the night. She used a hemorrhoid cream (sounded like Rexicure). She reported that she still had left with this itching all these days later. The itching was not as bad as it was initially, but it had not resolved. The reporter did not consent to follow up. The reporter provided limited information. She refused to provider her street address. The reporter did not get a chance to ask for her date of birth or ask other questions as she ended the call abruptly. This case is linked with US2023133803, same reporter.; Sender's Comments:  US-GSK-US2023133803:Same reporter, different patient
Sex: F
Vaccine: RSV
Symptoms: Peripheral swelling, Pruritus, Rash macular, Swelling
Clinical narrative: red blotches on torso and back; lump on her back and both arms; itchy blotches on torso and back; This non-serious case was reported by a other health professional via sales rep and described the occurrence of red blotches in a elderly female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   In SEP-2023, the patient received Arexvy. In SEP-2023, less than 2 weeks after receiving Arexvy, the patient experienced red blotches (Verbatim: red blotches on torso and back), local swelling (Verbatim: lump on her back and both arms) and pruritus (Verbatim: itchy blotches on torso and back).  The outcome of the red blotches, local swelling and pruritus were unknown.   It was unknown if the reporter considered the red blotches, local swelling and pruritus to be related to Arexvy.     It was unknown if the company considered the red blotches, local swelling and pruritus to be related to Arexvy.   Additional Information: GSK Receipt Date:28-SEP-2023 The healthcare professional reported that a female patient in her 70's received AREXVY about 2 weeks ago and had a lump on her back and both arms, and red, itchy blotches on torso and back. No lot number was provided. No other information provided. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: female patient received an expired Shingrix dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a female patient who received Herpes zoster (Shingrix) (batch number KK3JM, expiry date 25-SEP-2023) for prophylaxis.   On 27-SEP-2023, the patient received the 1st dose of Shingrix. On 27-SEP-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: female patient received an expired Shingrix dose).  The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 28-SEP-2023 The Medical Assistant reported that day before reporting a female patient received an expired Shingrix dose which led to expired used. The reporter stated that this would be patient's 1st dose. The reporter declined to provide Date of birth, age and initials when asked. The reporter consented to follow up.
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: expired dose of Engerix-B was administered to a patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 26-year-old female patient who received HBV (Engerix B) (batch number 4345R, expiry date 11-AUG-2023) for prophylaxis.   On 27-SEP-2023, the patient received Engerix B. On 27-SEP-2023, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: expired dose of Engerix-B was administered to a patient).  The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date 28 Sep 2023 The pharmacist called to report an expired dose of Engerix-B was administered to a patient, which led to expired vaccine used.  The consented to follow up via email.
Sex: F
Vaccine: VARZOS
Symptoms: Limb discomfort, Pain in extremity
Clinical narrative: Arm hurt; arm hurt and felt like a weight; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In MAR-2023, the patient received the 1st dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: Arm hurt) and heaviness in arm (Verbatim: arm hurt and felt like a weight).The outcome of the pain in arm was unknown and the outcome of the heaviness in arm was resolved (duration 3 months).   It was unknown if the reporter considered the pain in arm and heaviness in arm to be related to Shingrix.  It was unknown if the company considered the pain in arm and heaviness in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-SEP-2023 The reporter did not want to provide any patient demographics. The reporter stated that she had her Shingrix vaccination in the left arm. After the vaccination the patient stated that her arm hurt and felt like a weight was on it when she moved or lifted it for 3 months.  No further information was known. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Illness, Pain
Clinical narrative: achy; sick; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   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) and sickness (Verbatim: sick).  The outcome of the pain and sickness were unknown.   It was unknown if the reporter considered the pain and sickness to be related to Shingrix.     It was unknown if the company considered the pain and sickness to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-SEP-2023 The reporter reported that the patient received her 1st dose of Shingrix over 2 years ago, and never got the 2nd dose because it made her really sick and achy. The reporter did not have any further information to provide about this event. The reporter did not have any information about the Shingrix such as lot, expiry, route or location of administration, or patient information. The reporter consented to follow up.
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received dose one of Havrix on 22Sep2023 and dose two of Havrix on 28Sep2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 3-year-old male patient who received HAV (Havrix) (batch number 3397T, expiry date 30-NOV-2023) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE (HAVRIX).   On 28-SEP-2023, the patient received Havrix. On 28-SEP-2023, an unknown time after receiving Havrix, the patient experienced drug dose administration interval too short (Verbatim: Received dose one of Havrix on 22Sep2023 and dose two of Havrix on 28Sep2023).  The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 28-SEP-2023. Medical Assistant reported that a patient received dose one of Havrix on 22-SEP-2023 and dose two of Havrix on 28-SEP-2023. The reporter consented to follow up. The patient received booster dose of Havrix vaccine, earlier than the recommended interval, which led to shortening of vaccinations schedule.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose of Shingrix was administered in 2019 to a patient and no second dose has been administered yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received on 18th November 2019).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: First dose of Shingrix was administered in 2019 to a patient and no second dose has been administered yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 28-SEP-2023. Pharmacist called to report that a first dose of Shingrix was administered in 2019 to a patient and no second dose had been administered yet. The reporter consented to follow up. The follow up was agreed via email. Lot number was asked to reporter, but the information was not available. The reporter reported that till the time of reporting the patient had not received the 2nd dose of Shingrix vaccine, which lead to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose on February 5th 2021, second dose on July 13th 2023; 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 adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 5th February 2021).   On 13-JUL-2023, the patient received the 2nd dose of Shingrix. On 13-JUL-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: first dose on February 5th 2021, second dose on July 13th 2023).  The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 28-SEP-2023 The pharmacist stated that an adult female received the first dose of Shingrix on February 5, 2021, and received the second dose on July 13, 2023. The pharmacist believed that the patient's age was between 56 to 58 years old. The pharmacist provided limited information. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule. (Drug dose administration interval too long) plus 7 days. The reporter did not consent to follow up.
Age: 64.0
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: booster dose was administered today September 28, 2023. This is being reported as a possible late 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 64-year-old male patient who received HAB (Twinrix) (batch number 797F9, expiry date 30-DEC-2025) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 8th September 2022), Twinrix (received 2nd dose on 15th September 2022) and Twinrix (received 3rd dose on 29th September 2022).   On 28-SEP-2023, the patient received the 4th dose of Twinrix. On 28-SEP-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: booster dose was administered today September 28, 2023. This is being reported as a possible late dose).The outcome of the drug dose administration interval too long 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: 28-SEP-2023 The reporter stated that patient received the first dose of the Twinrix accelerated dosing schedule last year.  This was being reported as a possible late dose. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up. The patient received 4th dose of Twnrix later than the recommended schedule, which led to lengthening of vaccination schedule. The case had been linked to US2023133825, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023133825:Same reporter, different patient
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine/2nd dose was given at 6 weeks; This non-serious case was reported by a other health professional via sales rep and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   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 drug dose administration interval too short (Verbatim: Inappropriate schedule of vaccine/2nd dose was given at 6 weeks).  The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 28-SEP-2023 The reporter informed that patient received 2nd dose of Shingrix before 2 months and 2nd dose was given at 6 weeks. The patient received 2nd dose of Shingrix, earlier than the recommended interval, which led to shortening of vaccination schedule. No additional information available. It was unknown if follow up was permissible. This case had been linked with US2023135142 and US2023135132 due to same reporter.; Sender's Comments:  US-GSK-US2023135142:Same reporter US-GSK-US2023135132:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: had first shingrix vaccine on 09 march 2022 and missed his second shot; This non-serious case was reported by a pharmacist 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 first dose on 09 March 2022).   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: had first shingrix vaccine on 09 march 2022 and missed his second shot). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 28-SEP-2023 The healthcare professional (HCP) stated patient who administered the first dose of shingrix on 09 March 2022 and had missed his second shot. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The healthcare professional (HCP) wanted to know if they need to start the series over. No additional information was provided. The reporter consented to followup.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure inadequately controlled, General physical health deterioration, Myocardial infarction, Renal failure, Venous occlusion
Clinical narrative: KIDNEY FAILURE; ONE HEART ATTACK; GENERAL HEALTH PROBLEMS; RIDDLED WITH BLOCKAGES/BLOCKAGE IN A VEIN OF BRAIN; BLOOD PRESSURE (BP) HAD BEEN UNMANAGEABLE; This spontaneous report received from a patient and from a company representative via social media concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: At the time of vaccination, the patient was 135 pound healthy with zero heart disease, nor kidney issues. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 total, dose and start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced one heart attack, kidney failure, general health problems, riddled with blockages/blockage in a vein of brain, and blood pressure (BP) had been unmanageable. Patient experienced one heart attack and learned abut the blockage in vein of brain. Patient was riddled with blockages. Reporter stated that, "I am having all kinds of health problems because of your vaccine" and "Your vaccine is killing me. Heart disease and kidney failure. I had zero concerns with either prior to receiving your poison. What will you do about it. Besides try to bury me and my complaint. Thanks for the death sentence". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the general health problems, one heart attack, kidney failure, riddled with blockages/blockage in a vein of brain and blood pressure (BP) had been unmanageable was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000298807, 90000298815. The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria as records 90000298815 and 90000298807 are duplicate reports of medical adverse events for the patient related to the vaccine. There is no product quality issue described in the reported information) based on the PQC evaluation/investigation performed. This case is a duplicate of 20231001068 and 20231000937.; Sender's Comments: V0: 20230970754-one heart attack, kidney failure. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19 immunisation, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a consumer via other manufacturer (Pfizer) concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: penicillin allergy, and tetanus vaccine allergy. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805025 expiry: UNKNOWN) dose was not reported, 1 total administered at left arm on 10-MAR-2021 13:00 for covid-19 prophylaxis. No concomitant medications were reported.  It was unknown whether patient had any adverse events following vaccination (Dose number in series 1).  The patient received additional non-company suspect vaccine Moderna covid-19 vaccine (elasomeran) (Dose number in series 2) (form of admin, route of admin were not reported, batch number: 034F21A expiry: UNKNOWN) dose was not reported, administered at right arm on 17-NOV-2021 14:30 for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (Dose number in series 2). On unspecified date in 2023, the patient experienced suspected covid-19 infection (Dose number in series 2) and received treatment medication paxlovid (nirmatrelvir/ritonavir) from 13-SEP-2023 to 17-SEP-2023. On 18-SEP-2023 after taking paxlovid, covid symptoms reappeared for approximately 2 weeks. The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The patient was recovering from suspected covid-19 infection, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Sex: M
Vaccine: UNK
Symptoms: Pain
Clinical narrative: pain in entire body; This spontaneous case was reported by a non-health professional and describes the occurrence of PAIN (pain in entire body) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) dosage was changed to 1 dosage form and third dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (pain in entire body). At the time of the report, PAIN (pain in entire body) had resolved.            Concomitant medication information was not reported.  The patient had pain in entire body for a few days after first, second and third doses of Moderna COVID vaccine.  Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pharmacist stated that a female adult was given two doses of Spikevax 2023-24 formula of 0.5ml 5 minutes apart on the same day; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Pharmacist stated that a female adult was given two doses of Spikevax 2023-24 formula of 0.5ml 5 minutes apart on the same day) and NO ADVERSE EVENT (no adverse event) in an adult female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch nos. ASKU and ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (Pharmacist stated that a female adult was given two doses of Spikevax 2023-24 formula of 0.5ml 5 minutes apart on the same day) and NO ADVERSE EVENT (no adverse event). At the time of the report, ACCIDENTAL OVERDOSE (Pharmacist stated that a female adult was given two doses of Spikevax 2023-24 formula of 0.5ml 5 minutes apart on the same day) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL OVERDOSE (Pharmacist stated that a female adult was given two doses of Spikevax 2023-24 formula of 0.5ml 5 minutes apart on the same day).    Concomitant medications were not reported.   Treatment medications were not reported.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Myalgia
Clinical narrative: headache; muscle pain; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), MYALGIA (muscle pain) and ARTHRALGIA (joint pain) in an adult female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     Patient did not report any medical history or condition.     On 02-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache), MYALGIA (muscle pain) and ARTHRALGIA (joint pain). At the time of the report, HEADACHE (headache), MYALGIA (muscle pain) and ARTHRALGIA (joint pain) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Patient wanted to know if she could take something to help with the pain. Treatment medications were not reported.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (COVID-19) in a 77-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    In September 2022, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In September 2023, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had resolved. Not Provided      The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  They reported that patient all previous shots were Moderna. They did not have the patient records handy.  Treatment medications were not reported.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Greater than 100 degree fever every time; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PYREXIA (Greater than 100 degree fever every time) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Greater than 100 degree fever every time). At the time of the report, PYREXIA (Greater than 100 degree fever every time) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: greater than 100 degree fever every time.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-742945 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-742945:PFS case
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (headache) in an adult male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.   Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-743693 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-743693:Wife case
Sex: U
Vaccine: UNK
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No adverse event; 2 children received the adult version of the Spikevax 2023-2024 prefilled syringe; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (2 children received the adult version of the Spikevax 2023-2024 prefilled syringe) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030355) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) .5 milliliter. On 03-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced WRONG PRODUCT ADMINISTERED (2 children received the adult version of the Spikevax 2023-2024 prefilled syringe). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (2 children received the adult version of the Spikevax 2023-2024 prefilled syringe) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (2 children received the adult version of the Spikevax 2023-2024 prefilled syringe).    No concomitant medications were reported. No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-743700.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-743700:1st Child case
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore injection site arm for 2 or 3 days; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (sore injection site arm for 2 or 3 days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A, 047A21A, 058P21A and 038A22A) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Prenatal vitamins. Past adverse reactions to the above products included No adverse reaction with Prenatal vitamins. Concurrent medical conditions included Asthma and Allergy (Patient takes over the counter allergy medication).   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore injection site arm for 2 or 3 days). At the time of the report, VACCINATION SITE PAIN (sore injection site arm for 2 or 3 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  The patient received first Moderna Covid-19. Patient had a sore injection site arm for 2 or 3 days.  The patient received second Moderna Covid-19 vaccine. Patient had a sore left arm.  The patient received next Moderna Covid-19 vaccine. Patient had a sore injection site arm.  The patient received her next Moderna Covid-19 vaccine. Patient had a sore left injection site arm.   This case was linked to US-MODERNATX, INC.-MOD-2023-743819, US-MODERNATX, INC.-MOD-2023-743825 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-743819:Same patient, PFS moderna vaccine Breast feeding case US-MODERNATX, INC.-MOD-2023-743825:Same patient, Bivalent moderna vaccine Pregnancy case
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction, Malaise
Clinical narrative: They got really ill after the first dose; After second dose had minor reactions; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (They got really ill after the first dose) and IMMUNISATION REACTION (After second dose had minor reactions) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (They got really ill after the first dose) and IMMUNISATION REACTION (After second dose had minor reactions). At the time of the report, MALAISE (They got really ill after the first dose) and IMMUNISATION REACTION (After second dose had minor reactions) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   This case related to patient 3 out of 4 patients.  Concomitant medication was not provided.  Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-743464, MOD-2023-743536 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-743464:Master Case MOD-2023-743536:Patient 3
Sex: F
Vaccine: UNK
Symptoms: Erythema, Pruritus, Pyrexia
Clinical narrative: Every bone in her body ached; fever; her arm has a big red round circle and is puffy and the redness is large like 2 inches diameter; itchy joints; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), VACCINATION SITE ERYTHEMA (her arm has a big red round circle and is puffy and the redness is large like 2 inches diameter), PRURITUS (itchy joints) and BONE PAIN (Every bone in her body ached) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Allergic to pennicilin.  Previously administered products included for Product used for unknown indication: Flu shot and RSV. Past adverse reactions to the above products included Injection site erythema with Flu shot; and No adverse event with RSV. Concurrent medical conditions included Penicillin allergy.    On 01-Oct-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 01-Oct-2023, the patient experienced PYREXIA (fever), VACCINATION SITE ERYTHEMA (her arm has a big red round circle and is puffy and the redness is large like 2 inches diameter) and PRURITUS (itchy joints). On an unknown date, the patient experienced BONE PAIN (Every bone in her body ached). At the time of the report, PYREXIA (fever), VACCINATION SITE ERYTHEMA (her arm has a big red round circle and is puffy and the redness is large like 2 inches diameter) and PRURITUS (itchy joints) had not resolved and BONE PAIN (Every bone in her body ached) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication not reported.   Treatment medication not reported.  The patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. She mentioned she had minor side effects with the past Moderna vaccines. She usually gets a red arm that stays red for a long time, even with the flu shot. She received the latest Moderna vaccine this past on 01-Oct-2023. About 5-6 hours later her arm was red. She was used to that but not so soon. After 24 hours she started having fever. It bothered her. She did not have fever in 20 years. Every bone in her body ached. Her arm has a big red round circle and is puffy and the redness is large like 2 inches diameter. She was not having fever anymore, but the arm was still red and she has itchy joints.   This case was linked to US-MODERNATX, INC.-MOD-2023-743542 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-743542:Same patient, Monovalent Dose
Age: 32.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Maternal exposure during breast feeding
Clinical narrative: COVID-19; exposure via breast milk; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) and MATERNAL EXPOSURE DURING BREAST FEEDING (exposure via breast milk) in a 32-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 014H22A) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Pfizer (First dose, Lot-ER2613) on 20-Mar-2021, Pfizer (Second dose, Lot-EW0164) on 07-Apr-2021, Pfizer (Third dose, Lot-FF8028) on 05-Nov-2021 and Flu shot on 03-Oct-2023. Past adverse reactions to the above products included No adverse reaction with Flu shot, Pfizer, Pfizer and Pfizer.    On 10-Nov-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 10-Nov-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (exposure via breast milk). On an unknown date, the patient experienced COVID-19 (COVID-19). On 10-Nov-2022, MATERNAL EXPOSURE DURING BREAST FEEDING (exposure via breast milk) had resolved. At the time of the report, COVID-19 (COVID-19) 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 and treatment medications were not reported.  Patient registered for the Spikevax covid booster and was 9 weeks pregnant and thought to call the pregnancy registry exposure number. Spikevax vaccine was scheduled for 09 October 2023 as fifth dose. Dose has not been administered yet at the time of call.