chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Seizure; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Seizure) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Epilepsy.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  Three hours after the first dose, the patient experienced SEIZURE (Seizure) (seriousness criterion medically significant).   At the time of the report, SEIZURE (Seizure) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Description: The consumer got the first dose and developed seizure (medically significant) for three hours.  No treatment information was provided.; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of the product and onset of the reported events, and excluding other etiologies, a causal relationship cannot be excluded
Patient had gastroenteritis and has ingested one dose of ROTATEQ vaccine; Patient had gastroenteritis and has ingested one dose of ROTATEQ vaccine whcih was prescribed.; Product use in unapproved indication gastroenteritis; No adverse event; This spontaneous report was received from a 52-year-old male patient (reporting on himself). The patient's concurrent condition included gastroenteritis. No information regarding patient's pertinent medical history, previous drug reactions, or allergies were reported.   On 15-DEC-2021 the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (exact dose, lot#, expiration date, frequency and vaccination site were not provided) for prophylaxis. The vaccine was used for gastroenteritis (Product use in unapproved indication).   On 15-DEC-2021, patient had gastroenteritis and had ingested one dose of the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vaccine (Product administered to patient of inappropriate age). Patient stated that this vaccine was prescribed to him (product prescribing error) and could not recall the name of the prescriber. He stated he felt great and was working good and stated that he had ingested 2 additional medications. No product quality complaint (PQC) and no additional adverse event (AE) was reported.
I did not have an adverse reaction to the vaccine. I tested positive for COVID-19 on 02/08/2023. I felt like I had a mild cold. I contacted my doctor via telehealth, and I got a prescription for Paxlovid. I tolerated the medication without any complications. As of today, I am feeling better with no lingering symptoms.
Patient reports feeling pressure to chest, had difficulty breathing, sweating/clammy, and flushing. Patient reports feeling better after 20 minutes. Reported he only eats once a day for weight loss. Refused transport to ER
Generally lightheaded feeling Saturday and Sunday, but episode of vertigo Saturday night with no prior history.
Pain in my arm that lasted for over 6 months fever for about a week, fatigue, congestion, back pain.
Right arm with redness and swelling began the day patient received vaccines Warm to touch very painful and difficulty raising arm and sent home from school because of pain Doctor reports this at visit: Right upper arm with swelling of deltoid muscle up to shoulder and midway down upper arm with splotchy erythema, tender to palpation and tender as patient moves arm at shoulder.  Treatment plan by physician: Ice area once hourly until bedtime, ibuprofen or TYLENOL for pain, notify clinic for worsening condition.
Arm sore, throbbing, warm to touch, limited range of motion, swollen.  Started 2 hours after injection.  At 3 am, developed nausea, vomiting, diarrhea.  Also experiencing body aches, chills, fatigue.
This spontaneous report was received from a 68 years old female patient. The patient was vaccinated with ZOSTAVAX one dose injection on 28-AUG-2012. Lot# and route were unspecified. Concomitant medication included lisinopril (manufacturer unknown). On 02-SEP-2012 the patient experienced shingles. On 04-SEP-2012, the patient developed a rash all over the left side of her face. On 05-SEP-2012, the reactions became much worse. The patient said it felt like "there are millions of needles in her eye" and her left eye was almost completely swollen. In addition, her "left ear feels like there is stinging in it". On 06-SEP-2012, the patient went to her physician and was prescribed medications. They were: acyclovir, gabapentin, and hydrocodone acetaminophen 7.5-325m. The patient still had shingles and was not recovered yet. No lab diagnostic study was performed. Additional information has been requested.
Seriousness criteria: Important medical Event. Initial unsolicited case received from a consumer (patient herself) on 19 Sep 2017. This case involves 67-year-old female patient who was vaccinated with 0.5 ml one dose of FLUZONE HIGH-DOSE (Batch number: UI845AA, expiry date and dose in series not reported) via intramuscular route in left deltoid on 15 Sep 2017 for immunization. The patient medical history was not reported. It was reported as the patient was previously diagnosed with cellulitis based on a similar reaction to another manufacturer's vaccine in past based on overt symptoms and not a confirmed culture. The patient was not ill at the time of vaccination. Concomitant medications were not reported. On 16 Sep 2017, one day after the vaccination, the patient developed progressing site reaction of warmth, hardness at the injection site with redness that was 6 inches long and 4 inches wide across her arm. On an unknown date, the patient was self-diagnosed with cellulitis. It was reported as the patient was not evaluated or treated by her physician because she stated it was not as big as her other reaction in the past. Relevant lab tests were not reported. The patient was recommended to take BENADRYL by the pharmacist. It was reported that as of 18 Sep 2017, the patient was recovering from her symptoms. Upon internal review the company decided to consider the case as serious, due to important medical event cellulitis. List of documents held by sender: none. Sender's Comments: Patient experienced cellulitis after vaccination. Time to onset is compatible with the role of vaccine. Further information on confirmed diagnosis, medical history, immune status at the time of vaccination, laboratory investigations excluding alternative etiologies would be needed to fully assess this case. Based on available information the role of vaccine cannot be assessed due to insufficient information.
No adverse effects reported; gave pediatric patient an adult dosage of VAQTA; This spontaneous report was received from a medical assistant, concerning a pediatric patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.   On 12-AUG-2019, the patient was administered an adult dosage of Hepatitis A Vaccine, Inactivated (VAQTA), lot # S003756 and expiration date on 06-MAR-2020, for prophylaxis (route of administration and anatomical location were not reported). No adverse effects were reported.
Extremely sore throat, burning tonsils and sensations of tonsils "popping", fever feeling, chills, weakness, fog, hurbing nasal passage and post nasal drip
Fever 101 and not eating. States child has knot in leg from IZ. No infection or other problems. Took child to DR, who stated to mom that child had some mild reaction as MD had told her. Advised to give Tylenol for fever and put cool compresses to swollen area and notify MD if any changes in condition.
PATIENT REPORTS STARTING 7/22/2020   1 RED BLISTERY PAINFUL SPOT ON NECK AND 2 SEPARATE RED PAINFUL LUMPS/ SPOTS ON SPINE  THAT ARE NOT BLISTERY       PHARMACY AND PATIENT TRYING TO REACH PRIMARY MD
The pt develped croup-like barking cough within two days of Hep B vaccination. Treated by PMD with Prednisone, Adveer, Singulair and inhaler. Condition persisted for > 4 weeks. The pt never had a problem prior to this event.
Fully vaccinated and tested positive for COVID-19; Fully vaccinated and tested positive for COVID-19; This is a spontaneous report from a non-contactable consumer or other non hcp. An adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single, and received dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single both for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not test COVID-19 positive prior to vaccination. The patient had tested positive for COVID-19 since the vaccination. On 04Aug2021, the patient after both doses of vaccine and fully vaccinated and tested positive for COVID-19. The patient did not received treatment for the events. the events were medically significant. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 04Aug2021. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE and EXTRA DOSE ADMINISTERED in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939902, 043L20A, and 037K20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes mellitus since 1999. Concomitant products included METFORMIN for Diabetes mellitus, CRESTOR, LOSARTAN, and METOPROLOL for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Aug-2021, the patient experienced OFF LABEL USE and EXTRA DOSE ADMINISTERED. On 11-Aug-2021, OFF LABEL USE and EXTRA DOSE ADMINISTERED had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) on 29-Sep-2021, Antibody test 216 (Low).          Treatment medication was not reported.   Most recent FOLLOW-UP information incorporated above includes on 03-Nov-2021 Medical history and concomitant medications updated.
Information has been received from a registered pharmacist concerning a 75 year old female with penicillin and KEFLEX allergy and no pertinent medical history who was vaccinated with a dose of PNEUMOVAX during the last pneumococcal season. Concomitant therapy included XANAX. The patient developed swelling at injection site. The patient recovered from swelling at injection site on an unspecified date. It was reported that the physician would not give the patient any other doses of PNEUMOVAX vaccine because of the adverse event. The patient consulted with pharmacist. Additional information has been requested.
Initial unsolicited report received from a physician on 12-Oct-2017. This case is linked with: 2017SA199365, 2017SA199373, 2017SA199379, 2017SA199386, 2017SA199397 (same reporter). This case involves a male patient (age not reported), who was vaccinated FLUZONE HIGH-DOSE (batch number: UI845AB, expiry date, dose, route and dose in series and site of administration not reported) on an unknown date. Patient's medical history included advanced Parkinson's (ongoing). Concomitant medications were not reported. On an unknown date, following the vaccination, the patient had weakness, dehydration, fecal impaction. On an unknown date, patient got hospital admission. Lab test and corrective treatment was not reported. Outcome of the events were not reported. Documents held by sender: none. Sender's Comments: Patient with underlying advanced Parkinson's received FLUZONE HIGH-DOSE and experienced fecal impaction, dehydration and weakness. Time to onset is unknown. More details regarding patient's medical history, previous vaccination history, concomitant medication and investigation reports are needed for complete assessment. Based on the available information no conclusion can be drawn.
thought I had flu together with shingrix reaction; woke up in the middle of the night with chills; massive HEADACHE; sweats; sensitivity to light; sensitivity to noise; terrible body ache / body's ache from head to toe; Felt as bad as a bad/ felt like hit by truck; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (received 1sy dose on an unknown date, refer case US2020AMR035745).   On 23rd February 2020, the patient received the 2nd dose of Shingrix. In February 2020, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, chills, headache, sweating, photophobia, sound sensitivity increased, general body pain and feeling abnormal. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the influenza-like symptoms, chills, headache, sweating, photophobia, sound sensitivity increased, general body pain and feeling abnormal were not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms, chills, headache, sweating, photophobia, sound sensitivity increased, general body pain and feeling abnormal to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient woke up in the middle of the night of vaccination day with chills, then sweats, massive headache, sensitivity to light and noise and terrible body ache. The patient felt as bad as a bad case of the flu.  The patient was in the bed most of the day sick. The patient thought the patient had flu together with Shingrix reaction. On the day of reporting, the patient did not feel well for a second day with headache and body ache. The patient stated the patient's reactions were Grade 3+++ and the patient do not miss work often for illness and was in bed terribly sick. The patient stated that the vaccine made the patient extremely ill for 2 days. The patient still had chills and headache and body's ache from head to toe. The patient felt like the patient was hit by a truck.
Child broke out in blotchy hive-like rash on legs only. Mom brought child to our office immediately (1 PM) and was seen by the doctor. Benadryl Elixir 1/4 tsp. given PO at 1:30 PM. By report from mom, rash significantly faded by 4 PM. Completely gone by the next morning.
Pt states that her arm began itching after injection, her eyes and lip started itching  several minutes after receiving injection
Patient received vaccination on 03/07/2006 and on 03/08/2006 had a red warm to touch area 1 3/4 x 1 3/4 area to left anterior thigh.
Some swelling, no redness, warmth reported on 1/14/16. Seen on 1/15/16 and no redness or warmth on examination. Was told to do MOTRIN, BENADRYL, cool compress. Given AUGMENTIN on 1/18/16. Still with a knot and mild swelling after completing medication on 2/1/16.
I received my first dose at 9:50am on February 3, 2021. Approximately 15 minutes after the first vaccine dose was given (10:05am) I began to get an itchy throat along with an allergic type cough. The cough went away in about an hour but I still had the itchy throat off and on throughout the afternoon. I called my Primary Care provider and she recommended I take 25mg of Benadryl every 6 hours and to call 911 if my symptoms got worse. I took the recommended doses at 5:10pm and 11:15pm that day and all symptoms resolved. I had no symptoms the following day and did not take any Benadryl the following day. I would like to note that I was sent outside the building immediately after the vaccine to wait for the 15 minutes because they could only have 20 people in the room, so there was essentially no monitoring if my symptoms would have gotten worse. We drove to the ER and just sat in the parking lot to be sure the symptoms were not progressing.  I am still waiting to see if it is recommended that I receive the second dose of the vaccine. At my provider's recommendation, I am seeing an allergist tomorrow to further discuss.
Symptoms started same night as injection : nausea, vomited twice during the night with diarrhea, raging headache; report given next morning symptoms gradually getting better.
Pt. reported after 1.5 weeks from Shingrix 1 st dose, pt. developed rash at left side of abdomen that was erythematous, blistering, itchy, burning,   As of today, 5/24/19, rash are gone but sill feels some tenderness around the area where she had rashes.
I experienced the usual achiness post flu shot which was of no concern. In addition, I experienced significant chest pain, sensations of food being stuck in my throat, gagging with and without food or beverage being consumed, frequent and extreme nausea and dizziness.
Extreme swelling, redness, and pain of the left arm (where the vaccine was given and around the surrounding area) at around 8:30pm on June 25, 2021. Hive-like appearance for 5 hours that was itchy, and there are two big red circular raised marks currently (June 29, 2021) that are itchy and painful to the touch that will not resolve with Benadryl or acetaminophen.
This spontaneous report was received from a physician refers to a 54 year old female patient. In December 2012, the patient was vaccinated with PROQUAD (Merck) (lot # H015642; exp date; 06-JAN-2014) o0.5 ml, intramuscular injection as immunization. On an unknown date, the patient received PROQUAD (Merck), and after had swelling at the injection site "the size of a golf-ball" and a rash across the torso that was red, but did not itch or hurt. She reports both adverse reactions went away after three days. She did not seek medical treatment for adverse effects. Laboratories were not performed. At the time of the report, the outcome of swelling at the injection site and rash was recovering. The events of swelling at the injection site and rash were unknown related to PROQUAD (Merck). Additional information is not expected.
soreness in the arm/ pain in the arm; cant raise arm; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in the arm/ pain in the arm), MOBILITY DECREASED (cant raise arm) and FATIGUE (fatigue) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis rheumatoid.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness in the arm/ pain in the arm), MOBILITY DECREASED (cant raise arm) and FATIGUE (fatigue). At the time of the report, PAIN IN EXTREMITY (soreness in the arm/ pain in the arm), MOBILITY DECREASED (cant raise arm) and FATIGUE (fatigue) outcome was unknown. Not Provided      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. Lab details were not provided.
Information has been received from a pharmacist concerning a 78 year old female with no pertinent medical history or drug allergies who on 01-OCT-2007 was vaccinated SC with a 0.65 ml dose of ZOSTAVAX (Oka/Merck) (lot# 658085/0882U).  There was no concomitant medication.  On 09-NOV-2007 the patient experienced shingles.  Medical attention was sought through the pharmacist.  No labs or diagnostic studies were performed.  The outcome was unknown.  There was no product quality complaint.  Additional information has been requested.
After the vaccine the same day I got chilis , ran a fever, experienced body aches. bad headaches. and I didn't have a appetite. I had very bad joint pains. My joint pains were very painful, and around the fifth day I was able to walk and go back to work. A month experienced my hands and joints started to become swollen.
Pt recvd vax on 28AUG92 & 5SEP92 pt devel a macular pruritic rash which began on buttocks & over the following days spread to involve trunk, arms, legs, face;also had some congestion, elevated temp, 2 episodes of vomiting;
in evening after vaccines administration, patient started vomiting and became febrile ( 102F). Multiple emesis episodes  til 3:00am next day. Taken to local emergency room by parent for evaluation. Treated w/ Zofran and fever reducers. Discharged home. As per parent's report , still febrile after 24 hours.
Within 24-36 hours of injection, there was warm, indurated injection site and several walnut size red nodes in injection arm.  There were chills, muscle and joint pain (which continues), nausea, vomiting and a very severe generalized headache and stiff neck which lasted 24 hours.
At aproximately 3 in the morning on the day after the shot pt reports being awakened with a fever around 102.5. She was aching  and fever continued for about 36 hours. Patient alternated TYLENOL and ibu.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information on medical history was not reported. It was reported that on 23-JUL-2010 the patient might have been inadvertently administered VARIVAX (Merck) injection (lot # reported as 1752X, expiry date not reported) (strength, dose, route, frequency, not reported) instead of PROQUAD (Merck). No adverse effect was reported. The outcome of inadvertently administered VARIVAX (Merck) instead of PROQUAD (Merck) was unknown. Additional information has been requested.
Pt w/a long-standing hx of severe hearing impairment, claimed exp inc hearing loss 16 days p/recvd flu vax; On 24SEP91 pt c/o vertigo & poss Meniere's disease;
Became dizzy. Blacked out and fell, striking the kitchen floor with the back of my head, splitting my head open. I was transported by ambulance to the ER where I received 5 staples on the back of my head. I was diagnosed with a severe concussion. I was referred to my primary care physician. Over the next 3 months I was given several tests on my brain including a CT scan. I was referred to my cardiologist for tests on my heart. A cardiac event was ruled out and it was determined that my fall was a result of the vaccination.
brief episodes of dizziness/vertigo several hours after vaccine and several times 1/10/21 and 1/11/21
This spontaneous report has been received from a pharmacist referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug and allergy history. On 15-OCT-2017, the patient was vaccinated with an expired dose of ZOSTAVAX 19400 PFU (frequency and route of administration were not provided) lot # M024700, expiration date 18-JUL-2017 for prophylaxis. Concomitant therapies included sterile diluent. No adverse events were reported.
pt recvd vax; pt had a febrile illness lasting x 4 days; pt presented w/ generalized hypotonia worse in lower extremities than upper;  Pt had persistent hypotonia & dec mobility of right leg;