chrisvoncsefalvay/vaers-outcomes huggingface dataset:
That night approximately 2300, started with minor chills and tiredness, 0430 with increased chills and body aches, headache, and took ibuprofen and Tylenol.  Every 4-5 hours the body aches and chills came back, still taking the ibuprofen and Tylenol, napped later in the afternoon and woke up approximately 1630 feeling good.  Laid  in a recliner approximately 2000 and dozed off for about 30 minutes, woke up feeling worse with uncontrollably shaking chills, body aches, joint pain, fever of 101. Woke up the next day with minor body aches and joint pain.  Sunday approximately 0730 had headache, joint pain flushed feeling/hot flashes/sweating, the body aches again.
starting 12 hours after injection: unable to sleep, low grade fever, headache, body aches.   Lasted about 20 hours.
May have been given her second dose of Trumenba in the wrong location; Area of redness is well below the deltoid muscle, in the bicep area; This is a spontaneous report from a contactable physician reporting for her daughter via a Pfizer sales representative. A female patient of an unspecified age received the 2nd dose of meningococcal group b rlp2086 (TRUMENBA), intramuscular possibly in the bicep area, in Apr2020, at single dose, for immunisation. The patient medical history and concomitant medications were not reported. Previously the patient receive the 1st dose of Trumenba for immunization in Jun2019. In Apr2020, the patient may have been given her second dose of Trumenba in the wrong location. The area of redness was well below the deltoid muscle, in the bicep area.    No follow-up attempts are needed. No further information is expected.
The initial event started with chills, fever and fatigue. That lasted for two days after the shot. On 04/24/2022, I noticed soreness and redness around my left eye. It continued to spread and I went to the urgent care on 04/28/2022 and the doctor suggested it was a mild case of shingles. I was prescribed Valacyclovir.
Medication Beyond Use Date 10/30/21.  Medication Expire Date 12/21.  Medication administered on 11/1/21.  No adverse reactions noted.   Pt newly confirmed pregnant at this visit.
3/3/2021 Chief Complaint Patient presents with ? Covid-19 Screening      diarrhea, weakness, fatigue. wife is positive.  Clinical Support 3/5/2021 COVID-19 virus infection Dx Medication Infusion  Reason for Visit Encounter Date: 3/5/2021 ? ? Signed    Arrived to the ambulatory infusion site alone via car. Reports intermittent diarrhea, dry nonproductive cough, fatigue.
Spreading rash that started in left groin. it spread rapidly down leg, up the side of the abdomen and into the armpit. Rash was very itch and very red/irritated. It also started to looking like it was bruising as it healed. Rash was unaffected by Benadryl or antibiotics. Was prescribed steroids and it cleared up after about 2.5 weeks.
Lost sense of taste; A spontaneous report was received from a consumer, concerning herself, a 25-year-old, female patient, who received Moderna's COVID-19 Vaccine and experienced lost sense of taste.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 04 Jan 2021, the patient received her first of two planned doses of mRNA-1273 (Lot number 011L20A) via unknown route in her left arm for prophylaxis of COVID-19 infection.    On 04 Jan 2021 at 19:00, after vaccination, the patient had lost her sense of taste. The patient has not taken any treatment for the event.   Action taken with mRNA-1273 in response to the event was unknown.   The event, lost sense of taste was considered not resolved as it was ongoing at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
I got very light headed and felt like I was going to pass out. I got to the couch and my wife said I looked pale gray and had bluish lips. My fingernail beds were also blue. I experienced some chest tightness and cold, tingly fingers. My wife took my blood pressure and it was 80/46. She called 911 and they sent paramedics. While waiting for the paramedics, I was told to take 4 baby aspirins so I chewed those. When the paramedics got there, my lips weren?t as blue, my color got a little better, and I was feeling a little better. The chest tightness had gone away. They took my vitals and blood glucose and everything was normal except my BP was still a little low- 92/50.  I decided not to go to the hospital because I was feeling better, and I felt better throughout the day. I will be seeing my family medicine doctor on Monday to follow up.
Unspecified lot, unspecified route  Patient had MD visit 6/3/21  Complaining of an itchy rash on his back and abdomen, started a few days after getting the second dose of Covid vaccine; Assessment/Plan Skin rash, most probably an allergic reaction to Covid vaccine, start Zyrtec, avoid heat and start prednisone 40 mg for 4 days then 20 mg, follow-up if no improvement
This spontaneous report was received from a Pharmacist and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories. On unknown dates, the patients were vaccinated with 8 improperly stored vials of GARDASIL 9, (dose and route of administration were not provided; lot # reported as 36301 expiration date of December-2017). It was also reported that the administered doses experienced a temperature excursion during 7 hours at a temperature of 32.1 degrees Fahrenheit on unspecified date. No previous temperature excursion was reported. Lot number 36301 is an invalid lot number for GARDASIL 9. Additional information has been requested.
No pain after and during injection. Soreness started 2-3 days post injection. After that 3 days, no pain improvement/worsening. Since then, lingering pain occurs whenever he tries to lift his arm up, but pain stops 30 seconds after he puts his arm down. The pain located on the back of his left upper arm. Per pt, he was given shot (unsure of what that is) to relieve the muscle tension which was diagnosed by his doctor at the time. He's given X-ray as well and still waiting for the result.
Severe nausea with vomiting; lasted approximately 2 hours.  Ate the same food as rest of household for dinner that night.
Allergic reaction on arm; Missed scheduled 2nd dose, interval between doses more than 42 days; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Allergic reaction on arm) and PRODUCT DOSE OMISSION ISSUE (Missed scheduled 2nd dose, interval between doses more than 42 days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Allergic reaction on arm) and PRODUCT DOSE OMISSION ISSUE (Missed scheduled 2nd dose, interval between doses more than 42 days). At the time of the report, HYPERSENSITIVITY (Allergic reaction on arm) outcome was unknown. Not Provided   No concomitant and treatment details were provided.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Information has been received from a certificated medical assistant (also reported as registered nurse) referring to an unspecified number of patients of unknown age and gender. Information about concurrent condition, drug reactions/allergies and medical history was unknown. Concomitant therapies included sterile diluent. On an unknown date, the patients each was vaccinated with M-M-R II (dose, lot # and route unknown) for prophylaxis. No adverse effect was reported. The vaccines were under the temperature of -11.8 degree Celsius (-14 degree Celsius to -10 degree Celsius) for 3 hours and 35 mins. There was no previous excursion. A data logger was used. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA013799: US-009507513-1709USA004610.
DEHYDRATED/ DIZZY SPELLS IN MORNING; VERTIGO; This spontaneous report received from a patient concerned a 65 year old male. The patient's weight was 238 pounds, and height was 155.7 centimeters. The patient's concurrent conditions included abstains from alcohol, non-smoker, and cholesterol, and other pre-existing medical conditions included no known allergy and no history of drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 09-MAR-2021 13:00 at left arm for prophylactic vaccination. The batch number was not reported in follow-up information. Concomitant medications included atorvastatin to control cholesterol.  On 10-MAR-2021, the patient experienced vertigo. On 12-MAR-2021, the patient was dehydrated (dizzy spells) in morning. And patient took IV treatment for dehydration. Laboratory data (dates unspecified) included: Blood test (NR: not provided) all good. It was reported that the patient was not ill at the time of vaccination. The patient did not have pre-existing acute illness 30 days prior to vaccination. The patient did not have history of hospitalization in last 30 days prior to vaccination. The patient did not have any family history of any disease (relevant to vaccination) or allergy. It was also stated that the product was properly stored from receipt to administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vertigo, and the outcome of dehydrated/ dizzy spells in morning was not reported. This report was serious (Other Medically Important Condition).  Additional information was received as follow-up 30/MAR/2021. The following information was updated and incorporated into the case narrative: Patient demographic (height, weight, age), medical history, lab test, reporter (contact), concomitant medication, event of dehydration/dizzy spell in morning and administered IV treatment for dehydration.; Sender's Comments: V1 20210327793-covid-19 vaccine ad26.cov2.s.-Dehydration. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Hives and itching at injection site and down to the wrist on the left arm. Patient instructed to take 1-2 tablets of diphenhydramine 25mg and to call back if symptoms are not resolved or become worse.
Closed fracture of neck of right femur - right hip direct anterior approach total hip arthroplasty. Recovered in hospital. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
1.  My fingertips were numb, all day on the day after I received the vaccine, and for a while on day two 2.  Inside my mouth and lips was very irritated and red
Increased heartrate with some chest pain.  The morning after receiving the vaccine, I noticed my heart rate was increased.  For the first couple of days after the vaccine, I had mild chest pain at times as well  The chest pain has since pretty much gone away, unless I lay on my left side or my wife puts her arm around my chest (pressure sensitive).  I stil have an increased heart rate.  I wake up in the middle of the night sometimes and it bothers me, as I want to rest.  I notice it most when I am sitting or laying down--when my heart rate should be slower.
Hives all over body 13 days after receiving the vaccine. Started on the palms of my hands and back of neck, quickly moved all over my body including the back, chest, hands, feet, groin, legs: thighs and ankles.
Information has been received from a nurse practitioner concerning her 11 year old white daughter, with no medical history and no allergies, who on 26-FEB-1996 was vaccinated with a first dose of Varivax (Lot# 608578/0389B). On 01-APR-2006 the patient experienced full blown breakthrough varicella with 100 lesions and a fever of 100 to 101 degrees Fahrenheit. Unspecified medical attention was sought and she was treated with acyclovir. Subsequently, the patient recovered on an unspecified date. A product quality complaint was not involved. Additional information has been requested. The nurse reported that her three other children had similar events after therapy with Varivax (WAES number 0605USA00089, 0605USA00082, and 0605USA00017).
Information has been received from a physician via a company representative referring to a 65 years old female patient. The patient's medical history, concurrent condition and concomitant therapy were unknown. It was also reported that the patient received PREVNAR 13 in approximately September 2015 (reported as one year ago). On an unknown date, the patient was administered PNEUMOVAX 23 (lot#, expiration date and dose were unknown) intramuscularly. On an unknown date, the patient experienced local injection site reactions including injection site pain, swelling and fever. There patient had sought for medical attention and unspecified treatment was given for the events. The symptoms resolved after approximately one week of receiving PNEUMOVAX 23. Additional information has been requested.
Child presented to clinic, accompanied by parent and interpreter, on 8/4/2016 at 0830, two days after vaccine administration with a 90mmx70mm oval shape, raised, warm to touch and reddened area to left deltoid. Bandaids are still in place. Child denies urticaria, pain or fevers. Parent states site of vaccine became increasingly red as the day progressed on day of vaccine. Initially tender to touch. Child has an appointment with pediatrician following this visit today. Parent has not applied any type of medicine or compress to area. Child previously received MMR without VZV combination.
Had heart flips four days after the first shot; This is a spontaneous report from a contactable consumer, reporting for herself. A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history was reported as none. Concomitant medications included sertraline taken for an unspecified indication, start and stop date were not reported. The patient was not pregnant at the time of vaccination. On an unspecified date, the patient had heart flips four days after the first shot, continued through the whole vaccinated month. No treatment was received. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. There were no allergies to medications, food, or other products. The outcome of the event was recovered on an unspecified date.  Information on the batch/lot number has been requested.
administered with only the AS01B adjuvant of Shingrix.; administered with only the AS01B adjuvant of Shingrix.; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 7C483, expiry date 14th November 2022) for prophylaxis.   On 21st September 2021, the patient received Shingrix. On 21st September 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The patient was administered with only the AS01B adjuvant of Shingrix which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. This case had been linked to the case US2021206994, US2021206991 and US2021206990, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021206991:same reporter US-GLAXOSMITHKLINE-US2021206994:same reporter US-GLAXOSMITHKLINE-US2021206990:same reporter
From initial information received on 10/07/2004 from a healthcare professional regarding an adverse event occurring in the USA, it was reported that a cluster of 5 patients received a dose of TD ADS Adult, lot number U1184AA, administered intramuscularly on an unspecified date.  Sites of administration were not reported, an unspecified amount of time later, four out of five patients developed local reactions.  The reporter did not know the details of the reactions.  It is unknown whether any of the patients recovered from these events.
Strong pain in left arm after 1st dose has persisted and gotten a bit worse. Pain increases if I try to raise or rotate my arm.
muscle cramps at night on both legs; This case was reported by a consumer via call center representative and described the occurrence of nocturnal leg muscle cramps in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2020, the patient received the 1st dose of Shingrix (injection). In February 2020, 1 day after receiving Shingrix, the patient experienced nocturnal leg muscle cramps. On an unknown date, the outcome of the nocturnal leg muscle cramps was not recovered/not resolved.   It was unknown if the reporter considered the nocturnal leg muscle cramps to be related to Shingrix.  Additional case details were reported as follows: The patient reported the case for herself. The patient received the Shingrix vaccine a week ago and after the second night, she experienced muscle cramps at night on both legs.  The muscle cramps were more severe last night and were unresolved at the time of reporting. The permission to follow up was denied.
Hives developed roughly 3 days after injection. Treated with BENADRYL.
Sat down post vaccination, was emotional. Sipping water.  patient fainted in the chair .  came around within 5 minutes.  Attended by EMS and Doctor.
2 hours after office & receiving PNEUMOVAX, pt. noted fever on & off.  Took TGC.  Cold then woke up during night wet with sweats.  24 hours after injection L arm became re & swollen then went on to become itchy.  Pt felt better at 48 hours.
I woke up the next day around noon after my second dose 10/02/2021 and had joint pain and swelling around the whole knee and pockets of swelling on my left knee. Just one knee. I called and got appt with the doctor. Doctor saw me the same day and drained the knee of 2 vials fluid and gave me a steroid shot. I have regular follow-ups every 3 months. I am completely recovered, but every once and while I feel some pain but other than that it's ok no problems walking or anything.
had a spike in blood pressure; lead to the caller's thinking that she was having a TIA; fatigue; injection site pain; nausea; fever; This is a spontaneous report from a contactable consumer, the mother's daughter. A female patient on an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot unknown, first dose) solution for injection intramuscular in Jan2021 (at an unknown age) as a single dose for COVID-19 vaccination. Medical history included hemorrhagic (disorder) and ischemic stroke. Concomitant medications were not reported. The patient had adverse events after the first dose which are namely fatigue, injection site pain, onset of violent nausea, fever that lasted for 4 hours in Jan2021. The consumer mentioned that her mother also had a spike in blood pressure (180/90) which lead to the caller's (consumer) thinking that she was having a TIA (transient ischemic attack) in Jan 2021. The outcome of the events fatigue, injection site pain, nausea, fever was recovered in Jan2021. The outcome of the events spike in blood pressure and TIA was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.  Follow-up (31Mar2021): This follow-up is being submitted to notify that the batch/lot number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
I've had tendonitis in my right arm; In the hip, it feels like crippling arthritis developed over night.; trouble walking; I have to start limping; torn ACL; I had shooting pain in my right arm nce or twice. Mostly on the right side and occasionally on; I had no problems for the first 24 hours, I was just tired.; The aching got worse, more pronounced, and wide spread.; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TENDONITIS (I've had tendonitis in my right arm), ARTHRITIS (In the hip, it feels like crippling arthritis developed over night.), GAIT INABILITY (trouble walking), GAIT DISTURBANCE (I have to start limping) and LIGAMENT RUPTURE (torn ACL) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic, Drug allergy (Propofol and aspirin- bleeding (threw up blood when  took aspirin).Super sensitive to anything that's a medicine) and Anesthesia. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for Pain in hip, VITAMINS NOS for an unknown indication.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TENDONITIS (I've had tendonitis in my right arm), ARTHRITIS (In the hip, it feels like crippling arthritis developed over night.), GAIT INABILITY (trouble walking), GAIT DISTURBANCE (I have to start limping), LIGAMENT RUPTURE (torn ACL), PAIN (I had shooting pain in my right arm nce or twice. Mostly on the right side and occasionally on), FATIGUE (I had no problems for the first 24 hours, I was just tired.) and MYALGIA (The aching got worse, more pronounced, and wide spread.). At the time of the report, TENDONITIS (I've had tendonitis in my right arm), ARTHRITIS (In the hip, it feels like crippling arthritis developed over night.), GAIT INABILITY (trouble walking), GAIT DISTURBANCE (I have to start limping), LIGAMENT RUPTURE (torn ACL), PAIN (I had shooting pain in my right arm nce or twice. Mostly on the right side and occasionally on), FATIGUE (I had no problems for the first 24 hours, I was just tired.) and MYALGIA (The aching got worse, more pronounced, and wide spread.) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No laboratory data was provided.  No treatment information was provided.
Patient received "booster" pfizer vaccine after already receiving dose of J&J (denied previous vaccination upon time of administration)