chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My right arm became sore at the site of the injection a few hours after receiving the vaccine.  It felt like someone had been punching me in the shoulder, like a deep bruise. Over the last four months, the pain has gotten worse. My arm feels tight, and constantly swollen, and I'm straining to raise my arm above my head, buckle my bra or take off a dress. And I type for a living: After an hour or so my right arm becomes so fatigued I can barely hold up my hand. I can't sleep on my right side. And the arm often spasms uncontrollably twitching for minutes at a time. I read about SIRVA: Shoulder Injury Related to Vaccine Administration ... I think that's what I have. Maybe the shot was placed in the bursa sac instead of where it should have been?
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. On an unknown date in July 2013 the patient was vaccinated with first GARDASIL, (lot number and expiry date was unknown) 0.5 ml, (dosing regimen and frequency unknown) intramuscularly. No concomitant medications were reported. On 11-JAN-2014 the patient was administered with second dose of GARDASIL. No adverse events were reported. Additional information has been requested.
Patient was given vaccine and after about (5) minutes of administering he passed out & fell from seat, hit his head on floor & started to convulse. Paramedics came & by then he was lucid, but had a major gash on forehead.
Itchy; Psoriasis flare-up; Tiredness; This spontaneous case was reported by a physician and describes the occurrence of PRURITUS (Itchy), PSORIASIS (Psoriasis flare-up) and FATIGUE (Tiredness) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ADALIMUMAB (HUMIRA).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itchy), PSORIASIS (Psoriasis flare-up) and FATIGUE (Tiredness). At the time of the report, PRURITUS (Itchy), PSORIASIS (Psoriasis flare-up) and FATIGUE (Tiredness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This spontaneous case was reported by a physician and describes the occurrence of PRURITUS (Itchy), PSORIASIS (Psoriasis flare-up) and FATIGUE (Tiredness) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ADALIMUMAB (HUMIRA).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itchy), PSORIASIS (Psoriasis flare-up) and FATIGUE (Tiredness). At the time of the report, PRURITUS (Itchy), PSORIASIS (Psoriasis flare-up) and FATIGUE (Tiredness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On an unknown date, post vaccination, the patient reported that he experienced symptoms of tiredness, itching and psoriasis.   No treatment information was provided
experiencing headache; a bit of a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (experiencing headache) and INJECTION SITE PAIN (a bit of a sore arm) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-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 HEADACHE (experiencing headache) and INJECTION SITE PAIN (a bit of a sore arm). At the time of the report, HEADACHE (experiencing headache) and INJECTION SITE PAIN (a bit of a sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Vertigo (off and on for about 6 hours) Pins and needles/electric shock feeling felt from both shoulders down to fingers and both upper legs down to toes (extremely bad and painful for about an hour then off and on at a milder level every few days since vaccination) Nausea (off and on for about 12 hours) Fever (100-101 F for about 24 hours...took Extra strength Tylenol and alternated with baby aspirin for 3 doses each) Tinnitus (extremely bad for about 12 hours, then a bit less but ongoing symptom continues even today) "Weak in the knees" with some pain while walking (off and on for about 1 week) Headache and back ache (daily for about 2 weeks...took Tylenol or baby aspirin as needed when pain was really bad) Extreme Fatigue/lightheaded (extreme for 4 days, symptom continues off and on up to today) Insomnia (extreme for 1 week, symptom continues off and on for about 2  days each week up to today) Heart palpitations (off and on almost daily) Pain and warmness at injection site (for about 4 days)
Itching and the sensation of throat swelling. Did not get severe. I took 2 Benadryl with no change. NO RACING PULSE . NO SWELLING OF LIPS OR FACE. Symptoms disappeared after roughly 8 hours.
fainted after 1 minute, fainted again after 3 minutes appeared to have seizure and vomited
positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date were unknown), via an unspecified route of administration, administered in left arm on 22Jan2021 as single dose for COVID-19 immunisation (vaccination). Medical history included overweight, diabetes and high blood pressure. Concomitant medications included atorvastatin taken for an unspecified indication from an unspecified start date and ongoing; ibuprofen (ADVIL) taken for her knees (unspecified) from an unspecified start date and ongoing; insulin detemir (LEVEMIR) taken for diabetes mellitus from an unspecified start date and ongoing; hydrochlorothiazide, losartan potassium (LOSARTAN/HCT) taken for high blood pressure from an unspecified start date and ongoing; metformin hcl taken for diabetes mellitus from an unspecified start date and ongoing; semaglutide (OZEMPIC) taken for diabetes mellitus from an unspecified start date and ongoing. Last vaccines gotten were in the Fall season of 2020: Flu. This consumer was administered her first dose of Pfizer COVID-19 Vaccine on 22Jan2021. She had onset of COVID symptoms 30Jan2021. She had positive diagnosis of COVID 31Jan2021. She is scheduled to have her second dose of Pfizer COVID-19 Vaccine today (12Feb2021) at 17:00. She called to ask if she should still get the second dose of Pfizer COVID-19 Vaccine. Onset of symptoms 30Jan2021: tired, cough, chest hurt, lack of taste, post nasally drip stuff; headaches; fever. Went to an urgent care clinic where she reported her symptoms. She had positive diagnosis of COVID via SARS-CoV+SARS-CoV-2 Ag, QI IA Respiratory Specimen test on 31Jan2021. She normally takes her body temperature every day and her normal body temperature sits at like 97.2 degrees Fahrenheit. With fever she got all the way up to 101 degrees Fahrenheit but for the most part she does not really run a fever. Then one day she actually measured a fever probably would have been 01Feb2021 when it was 101 degrees Fahrenheit; every other day she was under 100 degrees Fahrenheit or under 98 degrees Fahrenheit for that matter for the most part. She had a pretty mild case of COVID. Outcome: She is much, much better; would say at this point she is post symptomatic; does not feel like she has symptoms any longer other than being a little bit tired still from time to time. She does not really have the cough anymore; chest does not hurt anymore; she can taste again. They gave her some stuff for the COVID: Albuterol: 2 puffs every 4 hours; Loratadine: 1 pill once daily-she has not taken that in a while though-it was for like post nasally drip stuff; and Benzonatate: 200mg for the cough that was 3 times daily taken for about 3 days. The patient visited physician office for urgent care. It was not provided if patient visited the emergency room. The patient did not receive any other vaccinations four weeks prior to the first COVID-19 vaccination. The patient was recovering from the event.   Information on the lot/batch number has been requested.
2 screaming episodes about 3 hours apart lasting 45-60 minutes T-102.7 x1, T 100.5 rest  am
Injection site redness & swelling pt went to ER for tx. 10/12/10. F/u here 10/14/10.
Patient administered TD vaccine as part of routine health exam.  Td vaccine given SQ in left forearm.  Patient reports feeling irritation and burning immediately under the skin.  That night, he reports swelling, redness and pain of the left forearm.  Patient seen on 06/20/2004 for follow up.  Injection site notably improved.  Prescribed hydrocortizone cream.  On 06/29/2004 injection site with residual redness.  At that visit on 06/18/2004, patient received TD test in right forearm.
More than 36 days after the first dose without receiving the second dose; Left arm swelled up; Red from injection site almost all the way down to the elbow; Itch was terrible; no bumps but white spots in the redness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itch was terrible), SKIN DISCOLOURATION (no bumps but white spots in the redness), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days after the first dose without receiving the second dose), VACCINATION SITE SWELLING (Left arm swelled up) and VACCINATION SITE ERYTHEMA (Red from injection site almost all the way down to the elbow) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 002C21A) for COVID-19 vaccination.     Concomitant products included LOSARTAN and METOPROLOL for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced PRURITUS (Itch was terrible), SKIN DISCOLOURATION (no bumps but white spots in the redness), VACCINATION SITE SWELLING (Left arm swelled up) and VACCINATION SITE ERYTHEMA (Red from injection site almost all the way down to the elbow). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days after the first dose without receiving the second dose). At the time of the report, PRURITUS (Itch was terrible), SKIN DISCOLOURATION (no bumps but white spots in the redness), VACCINATION SITE SWELLING (Left arm swelled up) and VACCINATION SITE ERYTHEMA (Red from injection site almost all the way down to the elbow) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days after the first dose without receiving the second dose) had resolved.            Concomitant product use was provided by the reporter as Unspecified Inhalers. Treatment information was provided as cetirizine and unspecified topical products.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: NNI
Started with soreness at injection site.  Then fatigue set in.  Fatigue became severe and muscle and joint aches began at around 4:00 PM.  Fever and chills set in by 8:00 PM.  All these symptoms remained for 24-36 hours after this.  Symptoms resolved by 6:00 PM or so on 05/16/2016.
Site was hard and warm to the touch, no fever. Skin was tight, muscle was tight, hard to raise arm. No treatment, just observation.
Herpes Zoster (Shingles)- tingling, rash, sharp shooting pains all on left side of face. Acyclovir 1 GM tablet TID
Periodic feelings of having a fast-beating, fluttering, or pounding in center of chest. It happens several times a day. Symptoms started about a week ago.  No problem with breathing or chest pain. Also having some joint pain in fingers
A report has been received from a Health Professional concerning a 10 year old, male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on 04-Dec-2013. The nurse reported that they accidentally administered expired FLUMIST which started on 04-Dec-2013. The outcome of the event of accidentally administered expired FLUMIST is unknown. The report was considered to be non-serious.
Slight nausea and severe headache on 2/4/21. Upper arm rash 2/11/21.
Started with feeling of abnormal movement of my heart in chest while lying down. Then developed bradycardia (HR <60) at rest with intermittent with tachycardia (HR>160) with SOB on rising. Sometimes SOB when doing nothing special, just standing around.
Numbness radiating into the hand & up into neck. Numbness to pain to sick.
This spontaneous report as received from a healthcare worker refers to a 4 year old patient of unknown gender. The patient's concurrent conditions and medical history were not reported. On 26-JUN-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (lot number K010211 and expiration date 17-JAN-2016, dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
The pt experienced a 6.5cm x 8.5 cm raised erythematous lesion on left thigh at injection site. The pt was treated with oral antibiotics for possible cellulitis.
Moderna Lot Number 045J21A was inadvertently used one day beyond the expiration date of May 2, 2022. Guidance, Moderna was contacted on May 3, 2022 about the vaccine storage error.  Moderna conducted research on the same lot number and simulated the same conditions noted by Public Health.  Moderna found that the vaccine met the required activity to produce the needed immune response.  This is Moderna Case Number CEA-2351. Although Moderna noted this vaccine was sufficient to produce the needed immune response, patient was encouraged to speak with their provider to determine the next steps appropriate for them. Patient has experienced no know adverse events.
Received vaccine at 1:48pm at PODsite. Initially, no reaction. By following morning, 2/11, woke with sore arm, slightly stiff neck, and heart palpitations that persisted throughout the day. Had trouble sleeping as palpitations continued throughout the night and varied in degree from a flutter to a thump. No chest pain, no chest pressure and no breathing issues. By morning of 2/12, symptoms were still present and numbness in both arms from elbow to finger tips occurred. Called my healthcare nurse's line for advice to determine if I should see my doctor or go to ER. I was advised to visit the ER. Arrived at ER at approximately 12:56pm where I was immediately admitted and assigned to doctor. After my first 30-60 mins of observation, I was informed that my heart rate and blood pressure were high. I informed doctor that I have never had high blood pressure, so that is unusual. Was discharged around 4pm and instructed to submit an adverse reaction report and to see my general practitioner in 2 days. I was informed the following: no evidence of an acute cardiopulmonary process.  Heart size and contours are normal.
This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. On an unknown date the patients were vaccinated with improperly stored doses of GARDASIL (dosing details were not reported (incorrect product storage). There were several previous temperature excursions. Time frame and temperature excursion were not reported, but the reporter stated that the temperatures the vaccine were exposed were above the rand and the range was back. There were prior excursions reported. It was unknown if the call was due to data logger. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information had been requested.
Patient reports that she woke up with extreme nausea during the early morning on October 19th. She had difficulty balancing, but made it to her bathroom where she proceeded to have an episode of vomiting. She felt better by midday.
Localized pain and swelling at injection time. After two days, persists as soreness, redness, moderate swelling, very hot to touch.
I developed pressure in my head in about an hour after receiving the vaccine, and this continued for approximately 8 days.  I also had violent shivering, chills, fatigue, and insomnia.  Now, I still have a little fatigue and insomnia still a problem.
Exquisitely tender testicles. Treatment: Naprosyn 500mg BID. Referred to urologist.
Patient came for first Monderna vaccine. Pharmacist reviewed VAR with patient and discussed. Patient had felt lightheaded in past following vaccinations. Patient attributed it to anxiety with needles. Vaccine was administered in Left deltoid. Pharmacist stayed with patient to monitor. Patient was responsive in small talk, said he felt lightheaded. Pharmacist was about to ask pt to lie down, but patient was sitting upright and suddenly unresponsive for approximately 10 seconds, which is when technician was instructed to call 911. Patient regained consciousness, while asking patient how he felt (alert and responsive for approx. 30 seconds), he returned to unresponsive state for 10-15 seconds. Patient lost bladder control during this time. Medics were in route to pharmacy. Patient unaware of lost responsiveness. Medics checked BP/HR and blood glucose; all within normal limits per EMTs. Patient refused additional medical support.
Brief episode of lightheadedness about 2 minutes after administration, lasting about 1 minute.
13JUN98 pt noticed red area on rt arm where recv inj;area large, painful w/numbness down arm & into axilla (pt feels vax was given below deltoid in SC manner);16JUN98 seen for OV 11x12 area of erythema, hot to touch, sl indurated;
Tested Positive for Alpha-Gal; Initial Report Received on 12-Mar-2021  A 51-year old female patient (race and ethnicity not provided) reported that she received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and tested positive for alpha-gal.  Medical history was reported as type II diabetes, food allergies and pseudocholinesterase deficiency.    No relevant concomitant medications were reported.  On 16-Oct-2020, the patient received the first dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported), route and site of administration unknown, from a community health center. Concomitant vaccines administered included the flu vaccine (Lot # not reported), route and site of administration not reported.   On an unspecified date after having been vaccinated with HEPLISAV-B, the patient recently tested positive for alpha-gal.  Additional information has been requested.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
There was a 2-3 cm ovoid patch of erythematous induration with vessicles and papules within, noticed on 12/17/2004.
Flu-like symptoms beginning 12 hours after the 2nd dose. Joint aches, mild headache, low-grade fever lasting ~24 hours. Symptoms abated after 24 hours and gone by 48 hours after the administration of the 2nd dose or 36 hours after I became symptomatic. NO symptoms other than a slightly sore arm after the 1st dose.
This spontaneous report was received from a physician via a company representative and refers to a male patient of unknown age. Concurrent conditions, medical history and allergies were not reported. On an unknown date in 2014, the patient was vaccinated with a dose of ZOSTAVAX, (strength, dose, frequency, route, anatomical location, lot number and expiration date were not reported). Other suspect and concomitant therapies were not reported. The reporter indicated that on an unknown date in 2014, 3 to 4 days after the vaccination with ZOSTAVAX, the patient experienced a very bad case of shingles and had to be hospitalized on an unknown date in 2014. It was unspecified if treatment was given for the adverse event and if lab diagnostics studies were performed. The outcome of herpes zoster was unknown. The relatedness between herpes zoster and therapy with ZOSTAVAX was not reported. The reporter considered that the bad case of shingles was a medically significant event. Additional information has been requested.
Within a few hours - Dad called and (L) deltoid area where flu shot given - red, swollen, painful and pt. lethargic.
face broke out rash; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 2019SA116434.  A 13 year-old female patient received COVID-19 Vaccine - Manufacturer Unknown, administration date Jul2021 (Batch/Lot number: unknown) at the age of 13  as dose 1, single for covid-19 immunisation; dupilumab (DUPILUMAB), first regimen subcutaneous from Jan2021 (Batch/Lot number: unknown) to Jan2021 at 400 mg (400 mg once,200mg every other week), second regimen subcutaneous from Jan2021 (Batch/Lot number: unknown) to Jan2021 at 400 mg (400 mg 1x subcutaneous) and third regimen subcutaneous since 2021 (ongoing) (Batch/Lot number: unknown) at 200 mg (200 qow subcutaneous) for asthma; crisaborole (EUCRISA), since 2021 (Batch/Lot number: unknown) for rash erythematous. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "not recovered", described as "face broke out rash". Therapeutic measures were taken as a result of rash. Additional info-On an unknown date in Jul2021, patient received first dose of COVID-19 vaccine once (strength, formulation, dosage, route, batch number, expiry: unknown) used as COVID-19 vaccination. On her first COVID vaccine, on an unknown date in Jul2021, after unknown latency, the patient had her face broke out in a rash which did not go away. On an unknown date in Aug2021, patient received second dose of COVID-19 vaccine. On her her second COVID vaccine on an unknown date in Aug2021, after unknown latency, patient had her face rash got worse that was red and raw (rash erythematous and skin erosion). Patient was being told to make sure dupilumab should not be given one week before the vaccine and should be okay to give 48 hours after the vaccine per doctor's recommendation   No follow-up attempts are possible. No further information is expected.
This case was reported by a nurse and described a 13 month old female pt who inadvertently received hep A vaccine inactivated (Havrix). On 09Jun05, the pt received an injection of Havrix (lot AHAVA018BA). On the same day, the pt also received injections of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix), measles, mumps and rubella virus vaccine (MMRII), varicella virus vaccine (Varivax) and 7-valent pneumococcal conjugate vaccine (Prevnar). Havrix is only recommended for children and adolescents 2 to 18 years of age. The nurse stated the pt developed a slight fever after administration of the vaccines. The fever resolved at an unspecified time later.
Pt had a syncopal episode right after the last of 4 immunization injections were given.  Regained composure in about 10 min.
Peeling and itching to the hands 1 day after vaccine followed by 4 days of arm hives that resolved spontaneously
pt passed out in the office while was paying bill; had a sz did not know anything; body was jerking eyes were open; lasted about 3 to 5 mins; pt was shaking a lot;