chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DIZZY SPELLS; SHARP PAIN IN LEFT LEG; STOMACH PAIN; HEADACHE; This spontaneous report received from a patient concerned an 87 year old female. The patient's height, and weight were not reported. The patient's past medical history included brain bleed, and surgery, and concurrent conditions included iodine allergy, drug allergy, shellfish allergy, and heart problems. The patient experienced drug allergy when treated with amoxicillin, cefalexin, codeine, cortisone, ciclosporin, ibuprofen, gramicidin/neomycin sulfate/polymyxin b sulfate, and prednisone.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. Concomitant medications included alprazolam, iron, and meclozine hydrochloride.  On 13-APR-2021, the subject experienced headache. Treatment medications included: paracetamol. On 14-APR-2021, the subject experienced stomach pain. Laboratory data included: CAT scan (NR: not provided) unknown. On 15-APR-2021, the subject experienced sharp pain in left leg. Laboratory data included: CAT scan (NR: not provided) unknown. On 19-APR-2021, the subject experienced dizzy spells. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach pain on 15-APR-2021, and headache on 14-APR-2021, had not recovered from dizzy spells, and the outcome of sharp pain in left leg was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
itchy rash; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itchy rash) in a  patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (itchy rash). At the time of the report, RASH PRURITIC (itchy rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.   Reporter did not allow further contact
Within 11 hours of receiving the vaccine my jaw became stiff and tight on both sides. I didn?t think it could possibly be related but my daughter (who was also vaccinated at the save time),  without knowing about my jaw stiffness, told me this morning her jaw was tight. (She will be filing a report for her experience)
I was typing in this section when I was timed out due to "inactivity". Pls change your definition of "inactivity". I do not believe that I will be able to duplicate what I previously wrote before being timed out. I will do the best I can. To the best of my recollection and ability. NOTE: Automatic Wrist BP readings (also takes pulse) closely follows manually-taken Stethoscope Sphygmomanometer readings. 4/22/21 Doing active range of motion pre and post injection. 7:45pm Signs & Symptoms (S/S) Mild - arm discomfort w/swelling, fatigue, lightheadedness, and body ache. Ice- alternating periods of 15 minutes on, then off - done several times. Lessen arm discomfort, no redness noted. Slow increase S/S through night. 4/23/21 mid afternoon- marked increase S/S plus start sporadic flush feeling, noted 1 x 1 inch oval red area over site. 8pm- Increased & more constant flushed. Temp 98.9 F. Noted marked increase body ache, first moving across chest, then descending to both toes/feet. 9pm- Temp 100.4 F. Monitoring temp, hoping peaked. 9:30pm 99.9 F- 9:50pm Felt very dizzy, self-palpated pulse- felt weaker than my normal, noted more distended veins on arms. Asked wife to get pulse oximeter- sat/pulse ranging 93-97, depending on finger, hand, how long on each; noted amplitude lower than my normal; 82-86 range pulse. 9:53pm Obtained BP R wrist supine 105/61 Pulse 82. Felt too dizzy for BP to be done in sitting. BP confirmed by second reading. BP wrist supine sys about 30 -35 & diastolic about 10-20 below baseline. 9:56pm Took 1000mg Acetaminophen. 11pm Temp less than 99, marked decrease head to toe pain, more towards my mild lightheadedness at times due to my mild TB baseline. Able to ambulate. 4/23/21 4-5 am Temp low 98 range (more my normal). 7am BP L wrist supine 135/70 Pulse 69. Sat 98 reading obtained very quickly, pulse amplitude more my normal. Feeling better but not to Pre-vax. Repeated BP & Sat readings twice during the rest of date. Don?t recall time of 1st BP 135/70 Pulse 70 & Sat 96/Pulse 69, noted injection site redness. 9:30pm- started having headaches, pain on L side head (near site of my head wound/mild TBI site), slight increase lightheadedness, injection site red area increased in pain & size to covering almost full deltoid area. BP 125/73 Pulse 65 Sat 97/ Pulse 65. Both Sat numbers obtained very quickly, as per my normal. Ice used. Alleviated pain to tolerable. Monitoring size of red area & intensity/duration of lightheadedness. Recall a strong tingling sensation going down my left arm once. Noted change in sensation afterwards. Slight increase lightheadedness felt due to what usually happens in change in weather, like rain coming. Rain occurred. 4/25/21- Basically the peripheral of deltoid showing redness with some scattered redness centrally. At 8pm redness fully covering deltoid area. Will continue to monitor ("Covid arm"). Other than fatigue thought due to vax, NO S/S of markedly reduce platelets. If need be, will contact Teledoc. Have prior training as a respiratory therapist & occupational therapist.
Little raised red bumps mainly covering upper thighs, noticed few on Tuesday or Wednesday.  These spread to backs of ankles, some along edges soles of feet near my heels, and sparsely on lower legs and abdomen.  Not too itchy and we keep it cool in the house so I wear layers all the time and did not notice the appearance of all the bumps until today (23APR2021) how much it had spread.  The ones on my soles feel like I was getting blisters but they are just the raised bumps.
03/24/09 Sore + tender - Hurt with movement 3-25-09 redness started on hours later but less tender 3-20-09 - still red to arm, warm to touch.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient fainted face down after receiving the covid vaccine. Patient indicated that she blacked out. She regained consciousness after a few seconds and became aware of her surrounding. Patient was rehydrated with water and orange juice.
He started hemorraging and throwing up necrotic Tissue.  It started 8 days after the first vaccine.  It continued happened March 17th, then about two weeks later on March 30, then he had the second vaccine on April 8th and it happened again on April 16th and then the 20th.  He was given 5 units of Blood during that time.
75 yof (103#) got FLUZONE HIGH DOSE 10/4/13 at 11:30 am by 9 pm not feeling well. 10 pm severe, jerking chills and fever body aches all over, fatigue. Stayed in bed all day 10/5/13. Felt better 10/6/13 but had fine red rash all over torso. 10/6/13 developed headache. Rash lasted 3 days. (10/15/13-> pt fine today).
8/29/21 PMHx of HTN, HLD and DMII, dementia who presented for AMS and cough
The Tdap was in the right arm, there was no reaction at all. The Varicella (shingrix) was given in the left arm. The arm got heavy and I got the chills as the first vaccination. But a headache started also. The next morning the chills were gone but my arm was swollen down under the arm into the breast. The left breast and lymph nodes were swollen and very sore. My headache keep increasing in severity. I tried my imitrex and it did little good.  I tried to get into the clinic but they would not let me come in because the symptoms "may" be something else. I ended up in the ER on June 15th six days after receiving the shot because my headache had still not gone away and I could not control the pain. The pain was lessened with the ER visit but I am still battling a major headache. I am not able to work or go about normal activities.  This is not like any headache I have experienced before. It has been eleven days of misery. Unless I get some answers and help I will be telling everyone I know not to get the vaccination. Nothing is worth going through this pain.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was reported. On an 06-MAR-2017, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # M034894 with expiration date 11-NOV-2018 or M037771 with expiration date 21-FEB-2019 (not specified by the reported) for prophylaxis (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion between 0 to 2 degrees of Celsius for 2 hours 32 minutes. Previous temperature excursion was between 0 to 2 degrees of Celsius for 8 hours 59 minutes. Data logger was involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA002800:
Redness, warmth, swelling, tenderness at site of injection (Left deltoid) of about 12cm by 8cm.
Already had  hip pain, side pain and abdomen pain weeks before taking the Janssen shot. Only had a severe headache and fatigue for 2 days after taking the shot , started on 3-25-2021 and ended by the end of the day on 3-26-2021.  Chest tightness started on 3-27-2021 and still on going today.    I didn't think anything of the chest pain or the headache because I suffer with migraine headaches and occasional shortness of breath due to (CHF)
Information has been received from a nurse practitioner concerning a now adult male who was, on unspecified date, vaccinated with 2 doses of MMR II as a child and has a negative titer for mumps. No further information is available.
Weakness 24 hours post administration. Rash turning to hives 2 days post shot. Itching, red, swollen
Information has been received from a registered nurse concerning a female who on approximately 15-DEC-2006 was vaccinated with a 0.5 ml dose of Gardasil. On approximately 15-DEC-2006 the patient developed high fever, dizziness and "several adverse events." Unspecified medical attention was sought. At the time of the report, the patient was recovering and the physician discontinued further series of Gardasil. Additional information has been requested.
Starting 01/18/2022 I started feeling poorly. I got a Rapid COVID test the same day and it was positive. To this day, I still experience brain fog and fatigue, but it's getting better.
Headache; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for Covid-19 immunisation. The following information was reported: HEADACHE (non-serious), outcome "recovered", described as "Headache"; FATIGUE (non-serious), outcome "recovered", described as "Fatigue".  Additional information: Patient was three years younger than reporter (patient's elder sister). Patient had both doses of the Pfizer Covid vaccine and patient had all of the regular symptoms. Reporter clarified that patient had fatigue and a headache. Later, patient was fine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I received my shot around 11AM on January 17th. At about 10PM I started getting chills. They got progressively worse until I was shaking uncontrollably. Also got a severe headache. Took TYLENOL for my fever and headache. When I woke up in the morning I still had a headache. I felt weak and tired the rest of the day.
Information has been received from a physician concerning a 14 female who on 11-APR-2007 was vaccinated with a 0.5 mL dose of Gardasil (Lot # "03874"). Subsequently, the patient fainted 5 minutes after receiving the Gardasil. At the time of this report, the patient had recovered. No product quality complaint was involved. Additional information has been requested.
down for the count; chills; fever; headache; swelling; A spontaneous report was received from a healthcare professional concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events down for the count, fever, chills, headache, swelling.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 12 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 029K20A or 027K20A) intramuscularly for prophylaxis of COVID-19 infection.  On 12 Feb 2021, the patient experienced the events down for the count. fever, chills, headache and swelling.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, down for the count, fever, chills, headache and swelling was unknown.
At 01:30, 16 1/2 hours after immunization, awoke with urticaria, generalized, and slight tongue swelling. Given Benadryl. Urticaria gave in AM. No respiratory symptoms.
Area of erythema measuring 7" x 8" (L) deltoid with induration, warm and tender to touch. Associated with temp 102 that broke spontaneously.
Looks like shingles; Rash/Hives on left side of my trunk/ribs; Rash/Hives on left side of my trunk/ribs; Tiny, little blisters; Rash/Hives on left side of my trunk/ribs/Tiny, little blisters/Moderate sensitivity and itch; Rash/Hives on left side of my trunk/ribs/Tiny, little blisters/Moderate sensitivity and itch; This is a spontaneous report from a contactable consumer (patient). A 50-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6205), via an unspecified route of administration into left arm on 05Mar2021 as a single dose for Covid-19 immunisation. Medical history included hypertension. Concomitant medications included metoprolol succinate (TOPROL XL) 50 mg; rosuvastatin calcium (CRESTOR) as 5 mg 1x/day. The patient previously took morphine and experienced allergy. The patient did not received any vaccine in four weeks. On 08Mar2021 at 07:00 am patient experienced 3-inch Rash/Hives on left side of my trunk/ribs. Tiny, little blisters. Moderate sensitivity and itch. Looks like shingles. It was reported that I never received the Shingles vaccine. (I have photos). No treatment was received for the events. No COVID prior vaccination and COVID not tested post vaccination. The outcome of the events was reported as recovering.  No follow-up attempts are possible. No further information is expected.
I had a sore arm and a lazy day after receiving the vaccine.  I had severe chills and difficulty staying awake for a few days prior to testing positive for COVID-19. I tested positive for COVID-19 and viral pneumonia on 05/04/2023 in the emergency room. I had difficulty breathing. I was admitted to the hospital for five days on the COVID floor. Got home and self-isolated.  My breathing is better, and my muscles are very weak.
Pt complained of back pain 1 min after injection. Pt slumped in chair/non-responsive/but no difficulty breathing 5 min after injection x 2 min. ECG indicative of vasovagal resp; pt taken to hospital for observation.
This literature marketed report as received from a physician on a literature article refers to a 19 month old male patient. He had no personal history of varicella, no exposure to sick contacts with varicella, and no known exposure to the virus. The patient was otherwise completely healthy with no signs or symptoms of immunocompromise. The patient was up-to-date on his vaccinations. On an unknown date, at 13 months of age the patient received his first dose of vaccination with varicella virus vaccine live (oka/merck) (manufacturer unknown) (dose, route, lot/batch# were not reported) for prophylaxis. On an unknown date, 6 months after receiving vaccination he presented to the dermatology clinic with a rash that began 2 days prior on the right groin and spread to the right leg. The patient's mother denied that the child had been febrile and noted that the rash did not appear to bother him in any way. The physical examination revealed grouped vesicles on an erythematous base on the right thigh, right sacrum, and lower abdomen that did not cross the midline. There were no other pertinent physical examination findings. The eruption was most consistent with Herpes zoster (HZ) but concern remained for Herpes simplex virus (HSV) or impetigo. On an unknown date, a bacterial culture and polymerase chain reaction assay for Varicella zoster virus (VZV) and HSV from skin swabs was ordered. The patient was prescribed acyclovir (20 mg/kg every 6 hours) for 5 days. Laboratory testing revealed a positive result for VZV on polymerase chain reaction and a negative result for HSV. The majority of the patient's lesions had crusted after 2 days of treatment with acyclovir, and the rash had nearly resolved 1 week after presentation. Subsequent evaluation with a complete blood cell count with differential and basic metabolic profile was normal. Levels of IgG, IgA, and IgM also were normal however IgE was slightly elevated. The outcome of Herpes zoster was considered as recovering. The authors stated that the possibility for vaccine strain-induced HZ should be considered when HZ presents in a vaccinated immunocompetent child without a history of varicella infection or exposure.
PAIN UPON INJECTION; This spontaneous report received from a consumer/other non health professional concerned multiple patients. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown) dose was not reported, administered on 04-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-MAR-2021, the patient experienced pain when receiving injection.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pain upon injection was not reported. This report was non-serious. This case, from the same reporter is linked to 20210312999.  Additional information was received from consumer/other non health professional on 06-MAR-2021. It was determined that 20210317681 was a duplicate of this case. All relevant information regarding this case will be submitted under 20210317609. Upon review following information was updated in the case: Case characteristic of multiple patient was added.
Arm Soreness; Eyes became very sensitive to light/ Light Sensitivity (eyes); This case was reported by a consumer via call center representative and described the occurrence of photophobia in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th January 2022, the patient received the 1st dose of Shingrix. In January 2022, 24 hrs after receiving Shingrix, the patient experienced photophobia. On 25th January 2022, the patient experienced pain in arm. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the photophobia and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the photophobia and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received Shingrix on Tuesday.   The patient stated that her eyes became very sensitive to light starting the next day on 26th January 2022 (approximately 24 hours after she received the vaccine).   The patient stated she took Benadryl and laid down.   The patient stated she still had light sensitivity, but it was not as bad as it was the day before.    The patient also stated that she still had left arm soreness which began less than a day after vaccination with Shingrix. The reporter gave consent to follow up with health care professional (pharmacy).
Vaccine given on Thursday 2/7 at 11:00am and first reaction noted Friday about 5:30PM. First numbness left arm and then the next day numbness, swelling and tingling of left arm and left hand. Clavicular lymph node swollen on same side. Left side of neck and left upper chest felt tight.  Rash developed and patient call her doctor Monday am. She was then seen Monday at 4:30PM.  Vaccine given at work.
sore arm and swelling severe migraine severe fatigue insomnia heart palpitations/rapid pulse
Patient was given a pediatric Pfizer vaccine that was not mixed with any diluent (saline)
Infection; Confusion; Could not get out of the bed; Very sick; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INFECTION (Infection) and CONFUSIONAL STATE (Confusion) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was provided.     On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFECTION (Infection) (seriousness criterion hospitalization), CONFUSIONAL STATE (Confusion) (seriousness criterion hospitalization), BEDRIDDEN (Could not get out of the bed) and MALAISE (Very sick). At the time of the report, INFECTION (Infection), CONFUSIONAL STATE (Confusion), BEDRIDDEN (Could not get out of the bed) and MALAISE (Very sick) had not resolved.            Concomitant product use was not provided. Treatment information was not provided.  Company Comment: Very limited information regarding the events has been provided at this time. Reporter did not provide permission to follow-up.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding the events has been provided at this time. Reporter did not provide permission to follow-up.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 37 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "POTS" (unspecified if ongoing). Concomitant medication(s) included: BYSTOLIC; EFFEXOR SR; MICROGESTIN FE. Past drug history included: Ceftin, reaction(s): "Known allergies: ceftin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
erythema & induration w/central vesicle on site of vaccine starting1wk p/vax;vesicle becoming hemorrhagic;