chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 12 year old female with a history of asthma and an allergy to rhinitis, who on 10-SEP-2007 was vaccinated intramuscularly in the left deltoid with the first dose of GARDASIL (Lot # 658100/0525U). Concomitant therapy included vaccination on the same day in the left arm with MENACTRA and tetanus toxoid. It was reported that on 10-SEP-2007 the patient near fainted after vaccination with GARDASIL. The patient sought unspecified medical attention. Subsequently, on 10-SEP-2007, the patient recovered from near fainted. Additional information has been requested.  01/07/2008 This is in follow-up to report(s) previously submitted on 10/12/2007. Follow up information indicated that the patient felt dizzy and light headed about 10 minutes after receiving the vaccine. She did not sit in the office for the recommended 15 minutes after receiving the vaccine. She came back into the office with symptoms and laid down for 10 minutes. Subsequently, on 10-Sep-2007, the patient recovered.
This case was reported by a other health professional via call center representative and described the occurrence of blister in a 67-year-old female patient who received SHINGRIX (batch number 2Y9R4, expiry date 28th February 2021) for prophylaxis. The patient's past medical history included blister (On an unknown date, the patient previously experienced Blisters). On 15th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). In March 2019, several days after receiving SHINGRIX, the patient experienced blister. The patient was treated with ACYCLOVIR. On an unknown date, the outcome of the blister was unknown. It was unknown if the reporter considered the blister to be related to SHINGRIX. Additional details were provided as follows: The patient received 1st dose of SHINGRIX in left deltoid. The patient experienced blister like lesion around her mouth. On 20th March 2019, the physician prescribed Acyclovir as a treatment medication to the patient. The reporter did not consent to follow up. The reporter was unable to provide any additional details.
A Fib event lasting 8 hours from aprox midnight 5/8/2021 to 8:00 M
Severe headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Severe headache) in a female patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (Severe headache). At the time of the report, HEADACHE (Severe headache) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact
Received Hep A #1 0.5ml IM/RD, then received Td 0.5ml IM/ LD- 10 minutes later, passed out. Recovered within 30 seconds. Vaso Vagal response? Abrasion to ? upper back when falling.
Chills; extraordinary, unslakable thirst; exhaustion; detachment from reality; crankiness--duration about 8 hours
DRUG EXPOSURE VIA BREAST MILK; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient's parent received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced drug exposure via breast milk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from drug exposure via breast milk. This report was non-serious.
mom called to report pt had 3" welt/erythema @ inj site for 1 wk p/vax;the arm was also very painful & had limited ROM for the entire week;no fever, no further complications;
Arm itches and is swelling around injection site. Delayed reaction (started 8 days after)
Around 5:30 pm on Friday night, I started feeling really cold; couldn't get warm for 2 hours. Then I started getting a fast heart rate; checked this around 7 pm; BP was 181/80 and heart rate was 135.  I was starting to feel warm along with being cold.  I had a gradually increasing temperature; checked it around 8:30 pm; was 102.1; took 2 tylenol and temperature slowly started going down.  My heart would not slow down; I sat in my recliner and kept deep breathing and had calming herbal tea; was afraid to go to the ER due to Covid.  After more than 4 hours with a racing heart, I felt exhausted and laid down around 12:30 a.m. and fell asleep.  I woke around 3 am with nausea and soaking wet pajamas from sweating.  I fell asleep again and woke around 7 am; I felt very tired, woozy and my heart hurt.  I felt a bit more normal after a few days.  I still feel a bit dizzy and light headed.  I was concerned when I later heard some J&J vaccines were contaminated; on 4/2/21, I called the pharmacy because the number they wrote on my card, 1805D18 wasn't clear; they told me this # was incorrect and should be 037A21B and couldn't explain why this was so. They were going to check into  this and call me; I called them again on 4/5/21 and was told the correct # was 043A21A and that the vaccine was from the Netherlands.  They couldn't offer any more information or explain why the initial # was incorrect. I find this concerning and have been unable to find an answer.
Patient under age 18 was vaccinated with Moderna, which is a vaccine error, on 4/2/21. This was not reported at the time of first vaccination. Troubleshooting: Original scribe and vaccinator did not validate age;  screeners at the beginning of the process did not ask or turn her away on a Moderna-only day. An ID requirement has been put in place to prevent this situation from occurring in the future.  This was caught in the line.physician stated the patient may have the second vaccine per protocol as opposed to waiting until she is 18.
After receiving the booster vaccine, I have had a constant feeling of chest tightness and shortness of breath. It has not affected my ability to complete my daily activities, but I do have a constant feeling as though my chest is heavy.
Severe arthralgias in most joints, small and large, persisting until present time. Member had no arthralgias at time of vaccine.
Severe soreness at injection site. Fever of 101.2 and severe chills. Extreme body aches and head ache. Nausea Ringing in ears.
9 days after receiving vaccine, pt developed rapid onset of ascending paralysis.  No use of legs, minimal use of right arm. Limited use of left arm.  Repiratory difficulty/failure.
Information has been received from a physician concerning a patient female (demographics not provided) who on 03-OCT-2007 was vaccinated IM with the first dose of Gardasil vaccine (Lot # not provided). On an unspecified date post vaccination in October 2007, the patient developed a itchy rash on both of her arms and upper chest. The physician reported that the patient attempted to treat herself with Claritin, which was reported to have helped for awhile, but then the itching came back. The patient sought unspecified medical attention. Additional information has been requested.
Rt upper arm swollen. 5 in x 5 in area of warmth, erythema. No induration.
Narrative: Noted in patients chart that he experienced vertigo in the past after receiving flu vaccination. No other hx or other information present in patient chart.
For 10 days I experienced reynauds syndrome in my hands and feet. Terrible painful touch sensations as well. 8/10 pain. Then it resolved. I received my second dose yesterday.  So far I just feel like every bone in my body hurts and I feel like I have rabdo.
This spontaneous report as received from a registered pharmacist refers to a 59 years old female patient with no drug reactions or allergies. The patient had never had a medical history of chickenpox before. The patient was vaccinated subcutaneously with, a 0.65 ml dose of ZOSTAVAX on 15-FEB-2012 (lot # not reported). No other co-suspects were reported and there was no concomitant medications. On an unknown date the patient developed pock marks that itched, on different parts of her body after receiving the vaccine. The pock marks come and the go away, so they did improve and she recover, but then she got then again. The patient contacted her physician, no treatment was given for the event and no lab diagnostics tests were performed. The outcome of pock marks that itch, on different parts of her body was unknown. The relatedness for pock marks that itch, on different parts of her body was not reported for ZOSTAVAX. Additional information has been requested.
I had a very runny nose, congestion, headache, and a low-grade fever. The doctor prescribed Paxlovid and started that evening and then took 2 a day after. I started feeling better around the 4th day. The fever cleared within 3 days, the runny nose and congestion continued to the 4th day. I tested negative about a week later. I tested positive 2 days later again. I called the doctor again with the same symptoms and he called it a rebound case. I was not told to take Paxlovid again and the symptoms went away again after about a week and a half. It was all like a really bad cold. I would call a mild case.
This spontaneous report as received from a health professional refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with M-M-R II for prophylaxis. On an unknown date the patient experienced measles antibody negative, mumps antibody test negative and rubella antibody negative. The outcome of measles antibody negative, mumps antibody test negative and rubella antibody negative is unknown. Sender's Comments: US-009507513-1708USA010124: US-009507513-1708USA009503: US-009507513-1708USA009693.
Pt. states that after receiving the 1st dose of Jansen 05/04/2021, started experiencing symptoms 05/23/2021 of severe chest pain. Blood clots found in the Superior Mesenteric Vein Thrombosis and Potal Vein Thrombosis. Ambulance transported. Air Transported for treatment. Recommendation Follow-Up with 6 months of Elaquix Blood Thinner.
he got a lump on his arm; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE MASS (he got a lump on his arm) in a male patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (he got a lump on his arm). At the time of the report, VACCINATION SITE MASS (he got a lump on his arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
patients received improperly stored vaccines; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 09-FEB-2021, the patient (also reported as an unknown number of patients) was vaccinated with an improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 1 dose, lot # T032761, expiration date 30-MAY-2022 (exact dose and route of administration were not reported) for prophylaxis. The administered vaccine experienced temperature excursion of 46.9 degrees Fahrenheit for 15 min. Previous temperature excursion included 48.7 degrees Fahrenheit for 3 h 15 min. The digital data logger was involved. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: devicelotnumber: T032761; expirationdate: 30-MAY-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
This case was reported by a healthcare professional and described the occurrence of headache in a 36-year-old male subject who was vaccinated with Havrix (GlaxoSmithKline). Concurrent medications included Tetanus vaccine. On 14 March 2007 the subject received a dose of Havrix at 1440 elisa units, intramuscularly, in the left deltoid. A short time after vaccination with Havrix, the subject experienced headache. At the time of reporting the event was unresolved.
CAUSE OF DEATH LISTED ON DEATH CERTIFICATE: COVID PNEUMONIA, LUNG CARCINOMA
This spontaneous report as received from a nurse concerning multiple patients. Medical history and concurrent conditions were not reported. On an unknown date, patients were vaccinated with M-M-R II (dose, strength, route, lot number and expiration date were not reported). Secondary and concomitant therapies were not reported. Nurse reported that one of their health care providers has stored vaccines incorrectly from November 2013 to 03-MAR-2014. Multiple patients, ages pediatrics up to less 18 years of age, were vaccinated with improperly stored vaccines. No adverse event was reported on the original call. This is one of 5 reports received from the same reporter. Additional information has been requested.
Rash all over body.  extreme swelling at injection site 8 days after injection Treatment  Benadryl.  outcome ongoing
Information has been received from a physician concerning his 80 year old mother in law, who was vaccinated with a dose of ZOSTAVAX (Merck). After receiving the vaccine, the patient developed shingles. It was also reported that the patient's left arm was hurting. At the time of this report the patient had not recovered. The patient sought unspecified medical attention. Follow up information received on 08-MAY-2009 from the physician stated that the patient was a retired female with high blood pressure and a history of varicella zoster as a child. Concomitant therapy included MICARDIS. On 22-FEB-2009 the patient experienced pain under her left arm - between breast. On 27-FEB-2009 blisters/lesions appeared. She realized that it was shingles, the shingles spread around back. On 28-FEB-2009 the patient started VALTREX. The patient was taking pain pills at night, and a sleeping pill either TYLENOL or AMBIEN. On 05-MAY-2009 the patient was still experiencing pain under her left arm, but no rash or blisters. Additional information has been requested.
Mother called 8/17/05 to report swelling 3-4 times normal left arm from above shoulder to elbow. Called Pediatrician and told alternate Motrin with Tylenol and ice packs. Swelling increased and took child to ER and told same instruction and see pediatrician if needed. Took to MD and said was definite reaction to immunization to immunization. Very sleepy. Follow up 8/18/05: Phone call to parent. Arm back to normal size. Knot present at deltoid injection site. Normal activity level.
Beginning around 4pm on 2/22/21 I began feeling hot, but did not have a fever (98.8). I was also more tired than usual. Later that evening my injection site was sore, itchy, and raised, like a hive.  On 2/23/21 I woke up at about 7:30AM and the injection site was the same as before, but I also had a sore/stiff neck and headache at the base of my skull.  The reactions have not warranted a trip to the doctor, but I remember hearing somewhere that the CDC was interested to know about any side effects that may be related to the vaccine.
The Lymph Node in my left armpit swelled up. I noticed it Wednesday Morning after getting out of the shower. No treatment at this time. My doctor said to keep an eye on it and if does not get better by the 3rd of November to call her back.
pt recv vax 23NOV98 & 27NOV98 pt exp fever of 105.0 & conjunctivitis & was hosp;the fever persisted as of 4DEC98;
Immediately following site injection-his site injection- his face became red and blotchy. His arm had a huge bump and swollen. A few hours later the swelling went down and his face cleared up. Fast forward to day 5 - He started off with fevers and red watery eyes. He had fevers ranging from 102-104.7 for 5 days. I took patient to the doctor on 4/10/18, they claimed it might have just been a cold or something viral. Upon examining him no ear infection was present, they advised me to keep an eye  on him and call them if his symptoms worsen. 2 days later, on 4/12/18) I call them back to let them know his fever was at 104.7 (This was around 7PM), they advised me if his fever doesn't break after an hour or if he becomes lethargic to take him to the emergency room or  bring him in the following morning. On 4/13/18 (DAY 10) his fever was finally lowering to 101.5 but he was developing pox/red dots on his face and his arm where the injection site is, was red as well.  He was beginning to develop pox all over his body. They did bloodwork and attempted to take a urine sample to rule out sepsis or a UTI. All which resulted in negative labs. Per the doctor, her suspicions were that he had roseola. Upon checking on the CDC.gov website, I realized he had an adverse reaction which was a mild case of the measles. His arm still has a red lump surrounded by a few red lump surrounded buy a few red bumps. It looks like a big bug bite where the site is now.
Mold case of shingles diagnosed 08/31/2011 (3 weeks after immunization).  Date and time of onset unknown.  Symptoms of shingles = group of blisters on lower ribcage, both sides, toward front.  Also muscle aches all around lower ribs.    (Symptoms of shingles is not listed as a potential side effect in the CDC VIS-Shingles handouet.)
sniffles; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (sniffles) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 RHINORRHOEA (sniffles). At the time of the report, RHINORRHOEA (sniffles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Child woke up screaming and was unable to be calmed. Noted severe changes in behavior when responding to sensory input: becoming afraid of noises, motion sickness, suddenly adverse to tactile stimuli, seeking deep pressure. Noted decrease in verbal skills; using fewer words and more limited vocabulary. Regression in potty training and sleep behaviors. Child became fearful of movement activities such as swinging, climbing and jumping. Child became very emotionally fragile with periodic unprovoked crying and meltdowns. Decreased eye contact and social interactions. Unexplained vomiting 1-2 times a month for 10 months following vaccine. Treatment consisted of 9 months of intensive occupational therapy to address sensory processing concerns. Concerns have lessened but child continues to have difficulties with sensory processing.
pt recv vax 24SEP96 & 30MAR97 pt devel 20 vesicles over face, trunk & extremities which was described as a mild case;
Discomfort from dull pain/pressure just under, front center left ribcage. Worsened when lying down on back and left side making it difficult to sleep. Lasted 5 days with discomfort peaking on the 3rd evening.   Severe shoulder joint pain.   Lasted 4 days.  Has continued as dull soreness.
Myopericarditis. Chest pain that has now resolved, but continued troponin leak and EKG changes
fatigue, headache, body aches After three days a red, warm, itchy spot developed below the injection site.  Treatment limited to lots of sleep and water/fluids. No over the counter medications
Localized hives at the site of the vaccine administrations.  Denies hives anywhere else or any other symptoms including respiratory distress.
Developed pruritic rash on bilateral lower extremities. Rash evaluated on 2/15, blanchiry, erythematous macules. Increasing area of legs involved on 2/16 so patient returned to office for revaluation, had nonblanchiry macules. Biopsy done on 2/16. Patch report showed leukocytoclastic vasculitis. Rash resolved over following 5 days.
Patient received vaccine in 2021 with no adverse events.  Patient tested positive for COVID 19 and passed away on 1/13/2023.
1st: Sore arm, fatigue, and about a week later swollen glands in neck and under arm   2nd: Sore arm, throbbing at injection site, fatigue, not sure on glands yet
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 14-JUN-2018, the patient was vaccinated with an expired Oka-Merck PROQUAD, lot # M046943, expired date 27-MAY-2018, by subcutaneous route, (dose number and anatomical location were not reported), for prophylaxis. No adverse effects were reported.
Patient reported chills, fever of 100 degrees, lump at site of injection, red, hot, swollen arm 4-5 inches down from site of injection.
experience daily crazy itchness; hives (full body, except face); allergy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05May2021 08:30 (Lot number: EW0175) at the age of 40 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Mild with shrimp" (unspecified if ongoing), notes: Known allergies: Mild with shrimp an seafood.; "Seafood" (unspecified if ongoing), notes: Known allergies: Mild with shrimp an seafood.; "Covid-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8732, Location of injection: Arm Left, Vaccine Administration Time: 08:30 AM), administration date: 14Apr2021, when the patient was 40 years old, for Covid-19 immunization. The following information was reported: PRURITUS (non-serious) with onset 30May2021, outcome "not recovered", described as "experience daily crazy itchness"; URTICARIA (non-serious) with onset 30May2021, outcome "not recovered", described as "hives (full body, except face)"; HYPERSENSITIVITY (non-serious) with onset 30May2021, outcome "not recovered", described as "allergy".  Adverse event: Since the 2nd dose consumer have been experience daily crazy itchness follow by hives (full body, except face). After self-test different antihistamines, the only one that temporarily stop the allergy was the Cetirize. Consumer just would like to know if was safe for her to get the booster because she don't wanna get worse than what she have been experienced. The patient had not been tested for covid post vaccination. Covid prior vaccination. The patient had not been tested for covid post vaccination.  No follow-up attempts are possible. No further information is expected.