chrisvoncsefalvay/vaers-outcomes huggingface dataset:
whole right arm is in pain; have a swollen lymph node (i think?) around right clavicle area; Pain with minor touch to clavicle and upper arm (at site of injection); body/muscle aches; body/muscle aches; nausea; At 0230 on 07Jan21 I woke up shivering with a high fever; heart rate of greater than 100BPM all day on 07Jan21; This is a spontaneous report from a contactable Nurse reporting for self. A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot#: El3248), via an unspecified route of administration in right arm on 06Jan2021 15:30 at single dose for covid-19 immunisation. Medical history was not reported. There were no concomitant medications. At 0230 on 07Jan2021 patient woke up shivering with a high fever. Didn't realize it was a fever until 5am when  woke up more, temperature taken at that time was 100.6. Fever stayed all day until 2000, no less than 99.0 even with Tylenol and ibuprofen until that time. Also developed body/muscle aches around 1200 on 07Jan2021, and some nausea. Got sent home from work that day. On 08Jan21 patient synced my (brand withheld) and checked my heart rate for day before. Didn't know it till then, but had heart rate of greater than 100BPM all day on 07Jan2021. Highest it got was 130, my resting heart rate is usually in the 60s. Also on 08Jan2021 no more fever, but whole right arm is in pain and have a swollen lymph node around right clavicle area. Pain with minor touch to clavicle and upper arm (at site of injection). Will be going to visit a doctor to make sure it is just a swollen lymph node since it is now 09Jan08Jan2021 and it's still swollen and there's still a lot of pain to R arm. Outcome of event fever was recovered, of others was not recovered.
This spontaneous report was received from a medical assistant and refers to a unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (concentration, route, dose, frequency and anatomical place of vaccination were not reported) which had a lot # of M015290, an expiration date of 20-SEP-2017, for prophylaxis. The doses were exposed to a temperature of 35F, for a time frame of 2 hours and it was reported because a data logger. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1612USA009486: US-009507513-1612USA003458: US-009507513-1612USA009485:
Chills for about 2 hours at 4am the next day. Bodyaches all day the next day. Sore arm for 2 days.
A week later, my left hip and my left shoulder, it felt like my hip was going to break. It was more intense than with the first shot.; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (A week later, my left hip and my left shoulder, it felt like my hip was going to break. It was more intense than with the first shot.) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced ARTHRALGIA (A week later, my left hip and my left shoulder, it felt like my hip was going to break. It was more intense than with the first shot.). On 17-Apr-2021, ARTHRALGIA (A week later, my left hip and my left shoulder, it felt like my hip was going to break. It was more intense than with the first shot.) had resolved. Not Provided          No concomitant medications reported. No treatment information provided.  The action taken with  mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   This case was linked to MOD-2021-085396 (Patient Link).
No additional AEs were reported; The medical assistant is reporting that a patient received improperly stored vaccine; This spontaneous report was received from a Medical Assistant, referring to a 58-week-old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.  On 07-DEC-2021, the patient was vaccinated with one improper stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (lot number reported as U024221 and expiration date reported as 04-OCT-2023; route of administration, vaccination scheme frequency, anatomical location, lot number and expiration date were not reported) (product storage error).  The administered dose of the vaccine experienced a temperature excursion of 39.55 degrees Fahrenheit (F) for 10 hours. There was no previous temperature excursion reported. No adverse events were reported.  Lot number U024221 has been verified to be a valid lot number for varicella virus vaccine live (oka/merck) (VARIVAX), expiration date reported as 04-OCT-2023 but upon internal validation established as 04-AUG-2023.
This spontaneous report was received from a consumer referring to herself a 70 year old female patient. The patient's medical history included uterine cancer, ovarian cancer, breast cancer, arthritis and psoriasis. The patient also had allergy to morphine, DEMEROL, codeine, ibuprofen, sulfa, clindamycin and penicillin. Concomitant therapies included several unspecified medications. On 14-Nov-2011, the patient was vaccinated with ZOSTAVAX (dosage scheduled, lot# and expiration date were not provided). In June 2016, the patient had an unspecified blood test but the results were not provided. On approximately 31-OCT-2016 (reported as a week ago), the patient developed shingles. It was reported that the patient sought unspecified medical attention and received an unknown treatment. At the reporting time the outcome of shingles was unknown. The causality between the event and ZOSTAVAX was unknown by the reporter. Additional information has been requested.
around the injection site she has "like a spider bite"; Around the injection site, it itches; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE OEDEMA (around the injection site she has "like a spider bite"), VACCINATION SITE PRURITUS (Around the injection site, it itches) and HEADACHE (headache) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced HEADACHE (headache). On an unknown date, the patient experienced VACCINATION SITE OEDEMA (around the injection site she has "like a spider bite") and VACCINATION SITE PRURITUS (Around the injection site, it itches). On 07-Mar-2021, HEADACHE (headache) had resolved. At the time of the report, VACCINATION SITE OEDEMA (around the injection site she has "like a spider bite") and VACCINATION SITE PRURITUS (Around the injection site, it itches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment reported
About 50 hrs after vaccination, pt got fever 102 deg with aches and chills. Also a severe headache. On 2/20 fever was 101 deg and taking Tylenol. On 2/21 at 11 am, pt called us to report and states he has no fever today, but still taking Tylenol and still has aches.
Information has been received from a company representative concerning a 6 month old female who on an unspecified date was vaccinated with PEDVAXHIB.  The patient developed a "fever" following a vaccination with PEDVAXHIB.  No further information provided.  Additional information has been requested.
Patient reported high fever, chills, and achiness after the second shot. Then it progressed to both legs having spasms which last for some time and the bottoms of her feet were very panful making it hard to to get in and out of bed . The patient developed pitting edema in the feet  and swelling in her hands that lasted for 1 to 2 weeks. Patient states to this day still has some edema in the legs and hands.  The patient reported to me that she has developed really painful joints that are still with her a year later although reports not that it is not as bad as right after the shot.
Throat tightening and racing pulse almost within one minute.  Oral meds: Benadryl, famotidine 40, Zyrtec, and prednisone Developed hives day 5 after injection. Full body itching remains unresolved. Treated with eucerin and hydrocortisone topical cream.  2 visits to ER for iv steroids and normal saline fluids.  Epi administered on second visit today 3/20/21 with good relief (best I?ve felt since getting it on Monday) 10/10 migraine today not relieved by oral triptans. Relieved by triple cocktail IV.
fever, muscle aches, congestion, sinus problems, body aches, sore throat, loss of taste and smell, cough
My daughter has always been healthy, except for the days following a vaccination. She had her first Prevnar shot at 2 months and screamed in agony for about 24 hours, had a fever, and didn't nurse for three days. I somehow let her get it again this week. She had a fever of 102 degrees and has been screaming and throwing tantrums that are far worse than usual, won't sleep, won't eat, and is occasionally lethargic.  I realize that Prevnar is a big-cash vax for Wyeth, but it's injuring children. Sure--the studies that Wyeth PAYS FOR don't confirm this, but parents aren't all morons.
Her husband is currently in the intensive care unit on a ventilator with Covid 19; Her husband is currently in the intensive care unit on a ventilator with Covid 19; This is a spontaneous report from a contactable consumer or other non hcp (patient wife). A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration in Jan2021 as dose 1 and dose 2 via an unspecified route of administration in Feb2021 (Batch/Lot number was not reported) as single for COVID-19 immunization. Patient medical history and concomitant medications were not reported.   On an unspecified date reporter husband was in the intensive care unit on a ventilator with covid 19 (covid-19). Patient received first dose of Pfizer Covid 19 vaccine in Jan2021 and second dose in Feb2021 and he was currently in the intensive care unit on a ventilator with Covid 19. Patient's wife was very concerned and thought they were both protected. She knew there was a chance you could get it but everyone said it would be a mild case and not something you would have to go on a ventilator for. Reporter stated further that if she would have known this, we would have kept our masks on. The patient underwent lab tests and procedures which included sars-cov-2 test: with covid 19 on an unspecified date, currently in the intensive care unit on a ventilator with Covid 19. The outcome of the event covid-19 was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
A physician reported that an 18 month old female received vaccinations on 2/8/01. The following day, the child was not ambulating well and was unable to stand. She also had a fever of 101-103F with pain and crying. She was given an injection of an unspecified pain medication with some relief, however, her symptoms returned. On 2/11/01, the child had a rectal temperature of 103F with no nuchal rigidity, nor erythema or induration at the injection site. The reporting physician is currently testing for meningitis. Follow-up information received on 3/20/01, from the child's physician revealed increased red blood cell (13/uL) and segmented neutrophils (4%) found upon exam of cerebrospinal fluid. Total white blood cell count in CSF fluid yielded a normal level of 2/uL. No signs of meningitis were detected. The child was transfused and admitted to another hospital for further evaluation. Note: This report has been upgraded to a 15-day expedited report upon receipt of follow-up information on 3/20/01, which indicated the pt was hospitalized.
Presented to ER 8 days post booster vaccination with 1 day h/o left facial weakness. Diagnosis: left Bells palsy.  Treated with prednisone 60 mg qd x 7 d, 40 mg qd x 5 d, 20 mg qd x 5 d  and valacyclovir 1 gm tid x 7 d Facial weakness gradually resolved over 10 days. Seen by me 1/28/22 and has normal exam.
rash is itching and stings; chills; sore muscles; tired; Severe rash all over my body; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Apr-2021 and was forwarded to Moderna on 24-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), MYALGIA (sore muscles), FATIGUE (tired), RASH (Severe rash all over my body) and RASH PRURITIC (rash is itching and stings) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced CHILLS (chills), MYALGIA (sore muscles), FATIGUE (tired) and RASH (Severe rash all over my body). On 24-Apr-2021, the patient experienced RASH PRURITIC (rash is itching and stings). At the time of the report, CHILLS (chills), MYALGIA (sore muscles), FATIGUE (tired), RASH (Severe rash all over my body) and RASH PRURITIC (rash is itching and stings) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment details were provided
Patient developed fever over 100 degrees, nausea, chest pressure and dizziness. He went to his doctor and he told him to tell the pharmacy.
joint & muscle aches, chills, dizziness, n, weakness, shakes, difficulty breathing, ears, nose & throat soreness, h/a, diarrhea, blood in urine, backache;dx macrohematuria,back pain, lt leg pain & numbness rxn to vax, fatigue, muscle  pain
1st dose of Shingrix on October 2021 and 2nd dose on 20th September 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 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on October 2021 ).   On 20-SEP-2023, the patient received the 2nd dose of Shingrix. On 20-SEP-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose of Shingrix on October 2021 and 2nd dose on 20th September 2023). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 20-SEP-2023 The vaccine administration facility was the same as primary reporter. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. The reporter did not consent to follow up.
no adverse event; Doses were administered after the excursion happened on 15Nov2022; Product storage error/freezer went to -10.5 C for 24 minutes; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses were administered after the excursion happened on 15Nov2022), PRODUCT STORAGE ERROR (Product storage error/freezer went to -10.5 C for 24 minutes) 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. 015H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Nov-2022, 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 15-Nov-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses were administered after the excursion happened on 15Nov2022) and PRODUCT STORAGE ERROR (Product storage error/freezer went to -10.5 C for 24 minutes). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses were administered after the excursion happened on 15Nov2022), PRODUCT STORAGE ERROR (Product storage error/freezer went to -10.5 C for 24 minutes) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (Doses were administered after the excursion happened on 15Nov2022) and PRODUCT STORAGE ERROR (Product storage error/freezer went to -10.5 C for 24 minutes).    No concomitant medications were reported. It was reported that they need to confirm with Moderna that the monovalent and bivalent vaccines are ok.Max temp: -10.5 C (no breakdown available) It took 24 minutes to get back down to normal range. The medical assistant has data logs if needed.  No treatment medications were reported.
Patient felt faint approximately ten minutes after receiving the vaccine and had to sit and sip water to regain composure. After approximately 15 minutes of sitting down, she felt fine and was able to leave.
Neck and shoulder pain; neck and shoulder pain; Not horrible, just uncomfortable; Swollen lymph node at left collar bone; This is a spontaneous report from a contactable consumer reporting on behalf of a patient.  A 32-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EH9899, expiration date unknown) via an unspecified route of administration on 07Jan2021 (at the age of 32-years old) at an unspecified dose in the left arm for COVID-19 vaccination. The patient's medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient was administered the vaccine in the hospital The patient's historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number and expiration date unknown) via an unspecified route of administration on 17Dec2020 (at the age of 32 years old) at an unspecified dose in the left arm for COVID-19 vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced neck and shoulder pain on 08Jan2021 which was described as, not horrible, just uncomfortable. The patient also experienced a swollen lymph node at the left collar bone on 08Jan2021. The patient did not receive any treatment for the events. The clinical outcomes of neck and shoulder pain, discomfort and swollen lymph nodes was reported as  recovering  It was also reported that since the vaccination the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Rash, vert heavy rash; Itching and very itchy; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash, vert heavy rash) and PRURITUS (Itching and very itchy) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Thyroid disorder NOS and Drug allergy (Patient cannot take Benadryl.). Concomitant products included MONTELUKAST for Asthma, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid therapy, FAMOTIDINE (PEPCID [FAMOTIDINE]) for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced RASH (Rash, vert heavy rash) and PRURITUS (Itching and very itchy). The patient was treated with OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) at an unspecified dose and frequency. On 15-Jan-2021, RASH (Rash, vert heavy rash) and PRURITUS (Itching and very itchy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Information has been received from a registered nurse concerning a 17 year old female with a codeine allergy who on 07/24/2001 was vaccinated with the first dose of hep b vaccine recombinant IM in the left deltoid at 4pm. On the same day at 4:30pm, she experienced numbness in the left arm, swelling from shoulder to fingers and the arm was very tender to touch. Ice was applied and the pt took diphenhydramine hydrochloride (Benadryl). The pt recovered by 07/26/2001 from her experience. Additional info has been requested.
Janssen (J&J) COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Janssen Vaccine on 07/10/2021. Patient started having symptoms on 7/31/2021 and presented to ED on 8/2/2021. Patient received dexamethasone and enoxaparin at outside hospital. Patient rapidly declined eventually requiring mechanical ventilation and was then transfered to ED on 8/5/2021. Patient was diagnosed with bilateral pulmonary embolisms. Patient received dexamethasone, enoxaparin, remdesivir, & ceftriaxone. Hospital course progressed without meaningful recovery of lung function ad patient expired on 8/18/2021.
Received Flu Shot on 10/12/16.  On 10/14/16 when she woke up noticed arm was hurting a little but as the day went on, noticed it was itching alot.  Arm had erythema, warm to the touch, and measured 65 mm wide x 37 mm tall.  Plans to use over-the-counter medications and ICE as needed.