chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headache behind his left eye; back itching; nausea; This spontaneous case was reported by a physician and describes the occurrence of MIGRAINE (headache behind his left eye), PRURITUS (back itching) and NAUSEA (nausea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ENCORAFENIB (BRAFTOVI) and BINIMETINIB (MEKTOVI) for an unknown indication.    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 MIGRAINE (headache behind his left eye), PRURITUS (back itching) and NAUSEA (nausea). At the time of the report, MIGRAINE (headache behind his left eye), PRURITUS (back itching) and NAUSEA (nausea) outcome was unknown.        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.
Sore arm and armpit lymph node, severe aches, chills, 102 fever, brain zaps
pt recv vax 7MAY96 & exp elevated liver enzymes, loss of weight & hepatitis B sx;
Breakthrough case admission after 3 vaccines  Moderna 2/15/21 lot# 031L20A;  Moderna 3/15/21 lot# 030A21A;  Moderna 3/7/22 lot# 016J212A
RIGHT THIGH BEGAN WITH WIDESPREAD REDNESS THE SIZE OF AN ADULT HAND WHICH LATER ENCASED THE WHOLE THIGH.  THIGH WAS WARM TO TOUCH.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 16-DEC-2014 the patient was vaccinated with an improperly stored dose of VARIVAX (Merck), dose 0.5 ml, subcutaneous which was exposed to a maximum of 27.2F for a total time of 9.5 hours. No adverse effects were reported. Additional information has been requested.
Sore arm started with in 1 hour of dose. The next morning there was a Low grade fever, wave of nausea, sore lower back, weak, and almost fainted.
4 welts somewhat resembling a shingles rash developed about a week after shot. Showed it to me on 10/19 and was on his way to see a doctor about that. This also coincided with a re-outbreak of a staph topical infection approximately 2 inch circle on chest which had been successfully treated with marpiroxicam ointment.
This spontaneous report was received from a registered nurse concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. The nurse reported that the patient, received the 1st dose of GARDASIL (quadrivalent) (dose, frequency, route, lot # and expiration date were not provided) on an unspecified date. The nurse also reported that the patient was now (18-MAY-2015) in her office about to receive the 2nd dose GARDASIL 9 (dose, frequency, route and lot # were not provided). No concomitant therapies were reported. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Had a fever of 103.9 the next day with headache, muscle aches and congestion. I'm Postmenopausal and got my period. I went to my Dr. and had blood work drawn along with an Internal Ultrasound. Saw OBGYN and had a saline infusion sonogram. Results were inconclusive. Went to Endocrinologist and had a scan of my Thyroid, no nodules were found. Have been menstruating regularly ever since this dose. In 06/2022 I got a weird rash on my right wrist and started feeling bad again with a headache, fever and congestion. Had more blood work drawn, and tests were inconclusive. In 08/2022 had a severe heavy period. On 09/26/2022 am going to have my Uterus scraped and taken biopsies if needed.
15dec89 pt vax hepta B. following day devel. an urticarial rash. pt had uneventful recovery
Pain in Injection arm; Swelling in the injection arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain in Injection arm) and VACCINATION SITE SWELLING (Swelling in the injection arm) 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 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain in Injection arm) and VACCINATION SITE SWELLING (Swelling in the injection arm). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Pain in Injection arm) and VACCINATION SITE SWELLING (Swelling in the injection arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.; 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.
Lymphadenitis Narrative:  2.5 days after injection, noted tenderness and swelling of lymph nodes in axilla of the arm where she received the shot. possible mild fatigue. denies fever, chills, other s/s of illness or other AEs other than localized tenderness in area of injection.
He had anxiety before the event, and after he had a panic attack and his heart rate was elevated. No fainting, seizures or other signs noted. Advised patient to wait 30 minutes before leaving so as to watch for status epilepticus.
Pt recv vax in 1998; post vax pt exp cellulitis w/ hot to touch; tx=antibiotics
After 3 days, red blotch appeared at injection site then cleared up. After 8 days red blotch reappeared and spread over upper and under arm of injection site and was unbearably itchy.  Took over the counter Claritin and used hydrocortisone cream to help stop the itching.
2 1/2 days after vaccine the child woke up with a 1-2 period of "painful crying". Not her usual cry. Then became pale and listless with ax temp of 95 degrees. Was wrapped in blankets - between 1-2 hr later she was back to normal.
Shingles; Anti-viral medication, prednisone, and pain meds; currently on day 7.
Positive COVID-19 Test; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive COVID-19 Test) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced COVID-19 (Positive COVID-19 Test). At the time of the report, COVID-19 (Positive COVID-19 Test) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment details were not provided  Patient tested Positive for COVID-19 after vaccine.
It's given two of my friends Gillian Beret syndrome: paralyzation and pain.; It's given two of my friends Gillian Beret syndrome: paralyzation and pain.; It's given two of my friends Gillian Beret syndrome: paralyzation and pain.; Initial information was received on 10-Nov-2020 regarding an unsolicited valid serious social media case from a consumer/non-hcp (healthcare professional).  This case involves a patient with unknown demography who experienced guillian beret syndrome: paralyzation and pain (Guillain-Barre syndrome, paralysis and pain), while he/she received INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number and expiration date were not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious gillian beret syndrome: paralyzation and pain. (Guillain-Barre syndrome, paralysis and pain), unknown latency following the administration of INFLUENZA VACCINE. These events were assessed as medically significant.  Laboratory data was not reported.  It was not reported if the patient received any corrective treatment or not.  The outcome of all the events were unknown.  Batch number has been requested for suspect product for this case.; Sender's Comments: This poorly document case concerns a patient with unknown demography who experienced Guillain-Barre syndrome, paralysis and pain, after vaccination with INFLUENZA VACCINE, produced by unknown manufacturer. The time to onset is unknown. However, patient's medical condition at time of vaccination and lab test ruling out alternate etiologies were not reported. Based upon the reported information the role of vaccine cannot be assessed.
And her son also has covid but has not yet had a booster./  She stated they all have had the Pfizer Covid vaccine for their vaccinations.; And her son also has covid but has not yet had a booster./  She stated they all have had the Pfizer Covid vaccine for their vaccinations.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "And her son also has covid but has not yet had a booster. She stated they all have had the Pfizer Covid vaccine for their vaccinations.".  Clinical course: Question: Does Nurtec (Rimegepant) interact with Paxlovid?Caller states that she takes the Nurtec for migraine and has recently felt the beginning of one coming. She was also put on dexamethasone (unknown manufacturer) for her cough while she is being treated with the Paxlovid for her Covid infection. She also stated that it is cloudy outside and that will also cause her to get migraines. In addition, caller mentioned that she had her 4th Pfizer Covid vaccine booster and recently was diagnosed with Covid. Her brother was also boosted with his 4th booster and recently was diagnosed with Covid. And her son also has Covid but has not yet had a booster. She stated they all have had the Pfizer Covid vaccine for their vaccinations.  No follow-up attempts are possible. No further information is expected.
My arm began to hurt again 7 days after the first shot. I noticed a small bump at the injection. Within hours it had enlarged to 5 inches down by almost 2 inches across in a raised, hot and hard line. My arm was very sore, my lymph nodes started to swell under the arm, and in my throat and lower back. By the night fatigue had set in, chills and soreness all over. It lasted 2 days and the arm is still hot, but not hard just looking like a large bruised area and my ending with cold-like symptoms after the first night of flu-like symptoms.
Patient  was  17 weeks 5 days pregnant at the time of vaccination. Patient experienced chills, body aches, joint pain, insomnia, GI pain, and diarrhea.
Information has been received from a physician concerning an 8 year old female who on 10-JAN-2006 was vaccinated with a first dose of MMR II (route, site, dose and lot number not reported). On 05-JAN-2010, the patient experienced mumps diagnosed on 07-JAN-2010). The patient was afebrile and had parotitis (both sides). On 07-JAN-2010, first blood work was done (IgM <1:10, IgG 7.66, serum amylase 257). The outcome for mumps was not reported. No further information is available.
Itching began at injection site 7 days post injection.  Mild itching, slight swelling and pale red  rash around injection site on 8th day.  Larger, more pronounced  rash area today, 9th day.  Area is not tender or warm to touch.
SORE ARM AT INJETION SITE. RESOLVED IN 2 DAYS Narrative:
Injection spot bled quickly. Bubble appeared under skin at injection site. Seemed to be immediate allergic reaction or blood had formed a pocket under the skin.
COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 20-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose 2 (booster), single (Batch/Lot number: unknown) at the age of 20 years, in left arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), in Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset Nov2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
The infant cried for 1 hour. Vitals were stable. The infant has tested positive for allergic reactions to HIB.
This spontaneous case reported by a consumer, describes the occurrence of vaccination site pain (injection site tenderness) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. Previously administered products included tetanus vaccine (for an unreported indication). On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced vaccination site pain (injection site tenderness). At the time of the report, vaccination site pain (injection site tenderness) resolved. No concomitant product use or treatment information reported.
Redness, induration, warmth, swelling around injection site. Reaction site is approximately 5 inches in diameter (a circle). Very painful and tender.
body aches,neck ache, headache, shakey, feverish, nausious, felt like flu
This solicited report has been received from a patient's mother, as part of a marketing research program, refers 2 patients (age and gender were not reported). The patients' concurrent conditions, medical history and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with a dose of GARDASIL (lot number, expiration date, dose, route and anatomical location of administration were not reported). On an unknown date, the patients experienced adverse reaction. The reporter stated "I have known two people with adverse reactions. I did not trust GARDASIL vaccine (in response to the question "what specific aspects of the commercial (language, images, ideas etc.) make you feel..."). The reporter also stated "I thought it was a scare tactic. It annoyed me that they played that card-like parents were horrible if they choose not to do the vaccine. Cancer from HPV vaccine (manufacturer unknown) was very rare-meanwhile I knew two teens who had reactions from the vaccine, [gave my children all other vaccines-even flu. Not this one" (In response to the question "what about this commercial make you less likely to favor vaccination?"] Action taken was not reported. The outcome of the event was not reported. The causality between event and therapy with GARDASIL was not reported. Additional information is not expected as the reporter did not consent for further follow up.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 13-APR-2016, the patient was vaccinated with an improperly stored dose M-M-R II injection, 0.5 ml lot # L026553, expiration date 16-JUL-2017 (route and site of administration were not reported). According to the reporter, the vaccine was stored at a temperature of 11.1 degrees Celsius for 1 hour and 36 minutes and also at a temperature of -12.3 degrees Celsius for 1 hour and 33 minutes (excursion dates were not reported). Digital data logger was involved. No adverse symptoms. This is one of several reports received from the same reporter. Additional information has been requested.
Fever, body aches, chills, within 24 hours of second injection. Red/warm spot just below injection site. Getting bigger. This happened about 36 hours after second dose.
Temperature; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Temperature) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced PYREXIA (Temperature). At the time of the report, PYREXIA (Temperature) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
The morning of the 22nd, I awoke to a decreased sense of hearing in the left ear with accompanying tinnitus.
Patient under age 18 was vaccinated with Moderna, which is a vaccine error.  Troubleshooting: 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.  Follow up to be done by Physician or delegee will include specific description of next steps for obtaining dose 2. Initial education provided by MD.
Vaccine was administered in left deltoid, patient immediately had a burning sensation and the feeling of fluid going down her arm, had numbness/tingling down arm, into palm and 3rd and 4th finger. Patient can move shoulder no obvious shoulder pain or discomfort reported. Taking tylenol and ibuprofen, applying  heat, which feels good, cold causes more discomfort. Patient was seen by MD on 9/28/2020 for evaluation.
She received her 2nd vaccine and started feeling very chilled and tired around 6:30 that evening, started shaking and feeling like restlessness.  She went to bed and covered up under lots of covers, and just froze.  She put on extra clothes, layers of blankets and her legs felt swollen, painful.  She kept having to urinate a lot, could not sleep, was awake all night, her arm started hurting as well, could not lay on that side, and then started getting cold/hot flashes.  She felt as though her heart was racing, and her brain as well trying to figure out what was happening.  Her husband took her temperature in the morning and it was 101.9, which her normal is 97.9.  At that point she was exhausted from being up all night, and was frightening and couldn't stop trembling all night long into Saturday.  When day broke on Saturday shew as not able to get out of bed for the entire day.  She could not eat, had no appetite and drank water day.  On Sunday she felt a little better, ate breakfast and the rest of the day went okay other than being exhausted.  This morning, 3/22/21, she still feels lofty, is able to function and feels a little removed/foggy feeling.   She is still not feeling completely well, but is on her way.  Not steady on her feet yet.   She took some Bayer aspirin for the symptoms.
Blistering, itching, and redness appeared on upper left chest area. Kept the area clean and applied vitamin E.  Blistering, itching, and redness healed and went away after about a week.
Narrative:  Patient passed away from complications from bladder cancer and hemorrhagic shock. Death not thought to be related to administration of COVID-19 vaccine.
Information has been received from a physician concerning a 17 year old female who on 19-MAR-2007 was vaccinated with her third dose of Gardasil (yeast). Since 28-MAR-2007 the patient has had very heavy period and not her usual flow. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
87y.o. female who presented to the hospital with SOB and cough. She tested + for COVID and found in A Fib with RVR. Please note that the patient lives in a Hotel as had water in her House and is under construction, she is not certain of the PTA medication she is taking. Patient was found in A Fib with RVR and started on IV cardizem, with improving of her rapid rate, she was continued on Xarelto, propafenone and cardizem. She was seen by cardio and Echo was technically difficult, showed EF 50% and no WMA. Patient will contnue with same meds as PTA and F/U with her Cardiologist. She was seen by ID for COVID, completed 5 d of remdesivir. CXR showed hazy opacities but PCT was normal. She required O2 intermittently in the hospital, but she was weaned off and did pass home O2 evaluation test.  She is stable for DC home with family.
Still lying in bed (had worked until 5 AM, work nights a lot) started noticing dizziness when turning on my side. When I got out of bed almost fell down because I blacked out, had extreme dizziness, vertigo, nausea that lasted about 5 days, gradually getting better as time went by. Had a total of about 5 micro blackouts (one while driving, pulled over to let my wife drive it was so frightening).
small gray dot on leg; Vaccine administered at inappropriate site; This case was reported by a nurse via sales rep and described the occurrence of skin discoloration in a 4-month-old patient who received DTPa-HBV-IPV (Pediarix) (batch number N7HL3, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAEMOPHILUS B CONJUGATE VACCINE (TETANUS) (ACTHIB) for prophylaxis and PNEUMOCOCCAL 13 VALENT CONJUGATE VACCINE (PREVNAR) for prophylaxis.   Previously administered products included Pediarix (The patient received Pediarix 1st dose on 27th May 2022. Batch no X9HS4-Refer case US2022AMR148961.).   On 28th July 2022, the patient received the 2nd dose of Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, the patient received ACTHIB and PREVNAR. On an unknown date, less than 3 months after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced skin discoloration and vaccine administered at inappropriate site. Rechallenge with Pediarix was positive. On an unknown date, the outcome of the skin discoloration was not recovered/not resolved and the outcome of the vaccine administered at inappropriate site was unknown.   It was unknown if the reporter considered the skin discoloration to be related to Pediarix and Pediarix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 14-OCT-2022. Reporter's Comments: The reporter stated that Prevnar and Acthib were also given in same leg so were not sure which vaccine caused the reaction. The reporter stated that a dose of pediarix in the thigh, patient had a small gray dot on leg that has lasted and not gone away. Additional Supportive Information: It was unknown if the reporter considered the skin discoloration to be related to Prevnar and Acthib.  For 3rd dose refer case US2022AMR149561.; Sender's Comments:  GSK-US2022AMR148962:same reporter GSK-US2022AMR148919:same reporter GSK-US2022AMR149551:same reporter GSK-US2022AMR148961:same reporter GSK-US2022AMR149561:same reporter GSK-US2022AMR148962:same reporter