chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approximately 7 days after immunizations a hive-like rash appeared on our sons neck, stomach, and portions of his legs. It cleared up after approximately 4 days. Approximately 14 days after the immunizations, our son had a bump on the back of his head/neck, and developed a stiff neck. He cried frequently and rubbed his face/head as if he had a headache/pain. We took him to the doctor and were told it was likely  a swollen lymph node and a neck muscle strain. Our son's head was tilted to the side for roughly 4 days, after which it slowly regained motion.
Fatigue, headache within 2 hrs of injection.  Achy joints at about 15 hrs after injection that lasted about 18 hrs.  Painful arm at site of injection for 72 hrs. All other symptoms faded by 48 hrs after injection.
Breakthrough COVID infection. Symptoms of shortness of breath, abdominal pain with symptoms onset around 12/12/2022. Positive COVID test collected 12/14/2022
pt recvd vax;devel frontal ha followed by n;exp violent muscle spasms of arms & legs;palpitations to er;2 hrs later felt better;
Female patient 45 was sitting down in a chair after her vaccine and had mild anxiety attack. Patient was AOx4, Patient has a history of anxiety attacks for the past 10 years. Prescribed lexapro and ativan. Patient refused to be transported to hospital. Patient left in her own care.
This spontaneous report as received from a healthcare worker refers to unspecified patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown dates since 06-NOV-2015, the patients were vaccinated with GARDASIL 9 lot # L016429, expiration date 09-AUG-2017 (dose, site and route of administration were not reported), which were exposed to temperatures outside of the recommended range. There was no adverse effects reported. No product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Acute pulmonary edema. Patient tested positive for COVID-19 in early February, has not recovered fully from it and presented to ER on 03/12/2022 with increasing shortness of breath backache headache dysuria. thickening but at no tenderness in the right upper quadrant.  Treated as heart failure initially with IV Lasix infusion, responded to this, IV Lasix twice daily and changed to oral Lasix at discharge. She received ceftriaxone for UTI, urine grew Klebsiella pneumoniae. Changed to oral cipro at discharge. She required oxygen a few days but not at the time of discharge.  ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Severe local reaction 4-5 inches induration, redness warmth from deltoid into Biceps and had systemic reaction of chills, fever, drenching night sweats. Systemic reaction. Used TYLENOL.
My right arm is soar and has been since the second injection/shot. The area around the injection is painful and hurts badly. My right arms muscles are extremely tender and feels like arm-fall-off at any time, especially when trying to stretch it over my head and shoulders.
Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Chills-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Weakness-Mild
This spontaneous report as received from an office manager refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients had been VAQTA (dose, frequency, route, lot # and expired date were not reported) that fell to refrigerator outside the prescribing information, despite being supported. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a consumer concerning her 14 year old daughter who was vaccinated with a first and second dose of varicella on 01/06/1988 and 02/19/1993. On 06/17/2000, the pt developed chickenpox that consisted of approximately 40 lesions on her face. The lower part of her body had very few skin lesions.
Mother reports swollen arm, lump in right thigh, along with one episode of purulent drainage from injection site.
Severe swelling and inflamation at Injection site and shoulder. Possibly due to one of the components of the Vaccine or FMF auto-immune disease reaction according to physician per Patient. October 6th and 7th was the reaction to shot given on 10/4. Patient is to follow up with a Neurologist
Soreness; Flu-like Symptoms; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness) and INFLUENZA LIKE ILLNESS (Flu-like Symptoms) in a patient of an unknown age and gender 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 an unknown date, the patient experienced PAIN (Soreness) and INFLUENZA LIKE ILLNESS (Flu-like Symptoms). At the time of the report, PAIN (Soreness) and INFLUENZA LIKE ILLNESS (Flu-like Symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-056194, MOD-2021-056207, MOD-2021-056528, MOD-2021-056467, MOD-2021-056534 (Patient Link).
No Adverse Event; received a Moderna Bivalent Vaccine for his first Primary Series dose of the Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (received a Moderna Bivalent Vaccine for his first Primary Series dose of the Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No Adverse Event) in a 59-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7165B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Jan-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 02-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (received a Moderna Bivalent Vaccine for his first Primary Series dose of the Moderna Covid-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, WRONG PRODUCT ADMINISTERED (received a Moderna Bivalent Vaccine for his first Primary Series dose of the Moderna Covid-19 vaccine) 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 assessment was provided for WRONG PRODUCT ADMINISTERED (received a Moderna Bivalent Vaccine for his first Primary Series dose of the Moderna Covid-19 vaccine).    No concomitant medication were reported.  The patient received a Moderna Bivalent Vaccine for his first Primary Series dose of the Moderna Covid-19 vaccine on January 2, 2023 lot number AS7165B Expiration date May 31, 2023 No other adverse reactions were observed. The error was discovered when the patient came back for the second dose of his Moderna Covid-19 Primary Series.  No treatment medication were reported.
Information has been received from a licensed vocational nurse (LVN) referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of improperly stored GARDASIL (lot # K011562, exp. date: 08-APR-2017; K016966, exp. 10-MAY-2017; L006549, exp. 06-APR-2017; strength, dosage, frequency and route unspecified). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sleeps a lot; Sore it's now on the entire body; Right arm injection site itchy; Injection site pain; Injection site pink; Injection site on R arm swollen; Tired more than usual; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Sleeps a lot), PAIN (Sore it's now on the entire body), VACCINATION SITE PRURITUS (Right arm injection site itchy), VACCINATION SITE PAIN (Injection site pain) and VACCINATION SITE ERYTHEMA (Injection site pink) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included EZETIMIBE, ROSUVASTATIN, MEMANTINE, PANTOPRAZOLE, chlorotine and SALBUTAMOL (ALBUTEROL HFA) for an unknown indication.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSOMNIA (Sleeps a lot), PAIN (Sore it's now on the entire body), VACCINATION SITE PRURITUS (Right arm injection site itchy), VACCINATION SITE PAIN (Injection site pain), VACCINATION SITE ERYTHEMA (Injection site pink), VACCINATION SITE SWELLING (Injection site on R arm swollen) and FATIGUE (Tired more than usual). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, HYPERSOMNIA (Sleeps a lot), PAIN (Sore it's now on the entire body), VACCINATION SITE PRURITUS (Right arm injection site itchy), VACCINATION SITE PAIN (Injection site pain), VACCINATION SITE ERYTHEMA (Injection site pink), VACCINATION SITE SWELLING (Injection site on R arm swollen) and FATIGUE (Tired more than usual) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment provided also included a topical cream.   This case was linked to MOD-2021-064152 (Patient Link).
The evening around dinner time I vomited and then I started having a horrible headache for a full 7 days. I took TYLENOL and or ADVIL to help the pain and it eased the pain somewhat, but it didn't take it completely away. I called my doctor and at the end of May I saw him, and he did blood work which came back normal. I was given ZOLOFT for anxiety dealing with the headaches.
Headache, body aches, diarrhea, large area of erythema/induration
Raised, fluid-filled rash covering arms, hand, legs, feet, neck, ears, and some on face. Severe, dibilitating joint pain especially in ankles making it impossible to walk.
I experienced symptoms of a fever of 101.6 at highest point, loss of appetite, scratchy throat, cough, chills, intermittent headaches, urine became darker even with proper hydration of 100 oz to 120 oz of fluid a day, and one bout of diarrhea. This began on 06/23/2022 which was 24 hours after my 0.5mg Tetanus booster and B12 shot. The symptoms have been coming in waves, and 3 to 4 hours after taking Advil the symptoms worsen. The symptoms have not resolved and have still been coming in waves on a daily basis. I think it is a result of taking my Tetanus shot two weeks after my COVID-19 Dose 4.
Moderna COVID-19 Vaccine EUA - Twenty-four hours after receiving the shot, I had headache, fever (100.4) and chills.   With Tylenol, the fever went down and all symptoms were gone within 12 hours.
Patient came in for his booster Pfizer vaccine #3.  Received a booster shot and was being observed for 15 minutes. Upon the 10 minute timeframe, patient started to experience itchiness to both his eyes, then started to feel itchiness to his neck.  At that time, patient consented to 25 mg. Benadryl IM.  Ten minutes later, patient itchiness started to subside.  VS stable.  Temp. 36.6.  BP    115/92, O2 96%., respiration 18.
Pain, swelling, redness recurrence at original vaccination injection site on left deltoid after routine Enbrel administration on abdomen on 01/14/2021. Treatment has included ice application to vaccination site and NSAIDs (acetaminophen.) Has lasted 2 days so far.
no additional AE reported; Nurse reported that GARDASIL 9 was administered to one patients since the reported excursion on August 4, 2020; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies were not provided.      On 04-AUG-2020, the temperature excursion of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was 33.8 degrees Fahrenheit  for 4 hours and 33 minutes and 35.2 degrees Fahrenheit (below 36 degrees Fahrenheit) for 2 hours and 47 minutes. On 05-AUG-2020, at 14:00, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (0.5 milliliter, lot # S020255, expiration date 09-DEC-2021; strength and frequency were unknown) intramuscularly for prophylaxis (product storage error). There was no previous temperature excursion. Data logger was involved. There was no additional adverse event reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S020255; expirationdate: 09-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Patient got a full body rash 2 days after getting the vaccine. He took Benadryl and applied hydrocortisone cream and was instructed to call MD
Left arm started having pain, redness, and swelling that spread to her neck and glands. No trouble breathing. Advised to see doctor.
Patient complained of throat feeling as though it was trying to close & it was hard to swallow. She also stated that she felt light headed initially when she was at home. Administered the epi pen & pt stated she could easily again. Pt is going to ED to be seen. EMS came to evaluate the pt.
Generalized hives over entire body 2 hrs post inject; called into ER was told to take antihistamines; 1st post-exposure dose; had pre-exposure dose;
Patient was recommended to sit 15 minutes after injection, as she and her husband were together, they decided to go shopping in the grocery store for a few minutes before going home. Ten minutes later, patient was escorted back to pharmacy observation chairs to sit, as she was experiencing "terrible back spasms." 911 was called as a precaution. She sat upright, awaiting paramedic arrival for evaluation, conscious, answering questions to pharmacy staff to relay to 911 dispatcher on the phone. No other symptoms. Paramedics arrived on scene, evaluated patient, ran tests on BP, heart, cognition. Pt was able to stand after around 20-30 minutes for heart eval by paramedics, and back spasms lessened. Patient then talked with emergency personnel and decided to go home. Patient and husband walked out of the store.
Vaccine received 11/21/08. Pt presented 12/3/08 with inability to bear weight on (L) leg - no trauma, no recent illness, no fever, (-) X-ray, on 12/8 had wrist pain post MMR Arthralgia.
swollen eyes; itchy eyes; This case was reported by a consumer via interactive digital media and described the occurrence of eye swelling in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th October 2021, the patient received the 2nd dose of Shingrix. On 26th October 2021, 1 days after receiving Shingrix, the patient experienced eye swelling and eye pruritus. On an unknown date, the outcome of the eye swelling and eye pruritus were unknown.   It was unknown if the reporter considered the eye swelling and eye pruritus to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received second dose of Shingrix vaccine and experienced itchy swollen eyes on right side starting on next day of the vaccination.
Her 2nd dose was due; My right arm broke out in hives; I was short of breath; I had a large bruise that started from my elbow & covered my shoulder; I felt tired; Achy; My arm was sore at the injection site; Like I had the flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Like I had the flu), URTICARIA (My right arm broke out in hives), DYSPNOEA (I was short of breath), VACCINATION SITE BRUISING (I had a large bruise that started from my elbow & covered my shoulder) and FATIGUE (I felt tired) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lymphedema (In left arm). Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), AMLODIPINE and METOPROLOL TARTRATE for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Like I had the flu), VACCINATION SITE BRUISING (I had a large bruise that started from my elbow & covered my shoulder), FATIGUE (I felt tired), MYALGIA (Achy) and VACCINATION SITE PAIN (My arm was sore at the injection site). On 12-Feb-2021, the patient experienced URTICARIA (My right arm broke out in hives) and DYSPNOEA (I was short of breath). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Her 2nd dose was due). At the time of the report, INFLUENZA LIKE ILLNESS (Like I had the flu), URTICARIA (My right arm broke out in hives), DYSPNOEA (I was short of breath), VACCINATION SITE BRUISING (I had a large bruise that started from my elbow & covered my shoulder), FATIGUE (I felt tired), MYALGIA (Achy), VACCINATION SITE PAIN (My arm was sore at the injection site) and PRODUCT DOSE OMISSION ISSUE (Her 2nd dose was due) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications provided by the reporter.   On 05-Feb-2021, patient reported of having a large bruise that started from her elbow & covered her shoulder (injection site), her arm was sore at the injection site, patient felt tired, achy, like had the flu.  Patient admit that did see doctor within a few days for the bruise and doctor felt that it might be that the person giving the injection may have hit a vessel.  On 12-Feb-2021, patient's right arm broke out in hives and was short of breath.  Patient requested to give the shot in right arm, because of having lymphedema in left arm.  On 20-Jul-2021, patient's 2nd dose was due.  Company Comment: 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.; 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.
Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows:  The age at vaccination was not reported.  The age group was not reported but it was captured as adult as per vaccine indication. The patient received shingles shots and still got shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown.
Left arm pain from my shoulder the elbow; injection site arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left arm pain from my shoulder the elbow) and VACCINATION SITE PAIN (injection site arm hurt) in a 78-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) (batch nos. AS76428 and AS746B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 28-Apr-2023, the patient received sixth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On 02-Jun-2023, received seventh dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. In 2023, the patient experienced PAIN IN EXTREMITY (Left arm pain from my shoulder the elbow) and VACCINATION SITE PAIN (injection site arm hurt). At the time of the report, PAIN IN EXTREMITY (Left arm pain from my shoulder the elbow) and VACCINATION SITE PAIN (injection site arm hurt) outcome was unknown.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  On 30Sep2022, patient received his fifth Moderna booster dose (lot number AS7146B). The patient received the vaccine in his left arm. On 06Oct2023, patient received his 8th overall Moderna booster dose on (lot number 3032264, expiration date not known). Patient received the vaccine in his left arm. The patient did not feel anything and has no side effects. The patient wonders if he actually goes the vaccine.  Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-744772 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-744772:Monovalent case
This spontaneous report was received from a registered nurse reporting on a female patient of unknown age (the reporter's sister-in-law). No information was provided regarding the patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies. On 17-MAY-2017, the patient's daughter was vaccinated with VARIVAX injection (dose, frequency, lot number or expiration date were not reported), for prevention of chickenpox. The vaccine was reconstituted with the Merck (MRK) sterile diluent (lot # and expiration date were not reported). Over the following weekend, the patient's daughter developed "a bumpy, pox-like" rash across her body that could have actually been mosquito bites (captured in MARRS# 1705USA012785). On an unknown date in May 2017 (reported as "over the following weekend"), the patient developed a fever, rash (not described), cough and congestion, which was reported as either potential upper respiratory infection or secondary transmission of VARIVAX virus from the patient's daughter. The outcome of the events was not reported. The causality assessment between the events and VARIVAX was not provided. This is one of several reports received from the same reporter. Additional information is not expected as there was no consent for follow-up.; Sender's Comments: US-009507513-1705USA012785: US-009507513-1706USA004797:
Pt started bleeding after the shot, he reported that it did not stop bleeding , changed the dressing 4-5times until he went to the ER