chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tired; Light-headed; throwing up; Diarrhea; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non-HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Lot number: EW0179) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Tired"; DIZZINESS (non-serious), outcome "unknown", described as "Light-headed"; VOMITING (non-serious), outcome "unknown", described as "throwing up"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea".  No follow-up attempts are possible. No further information is expected.
Allergic reaction; 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 HYPERSENSITIVITY (Allergic reaction) 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 HYPERSENSITIVITY (Allergic reaction). At the time of the report, HYPERSENSITIVITY (Allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment medications were not provided by the reporter.    Reporter did not allow further contact
Pfizer-BioNTech COVID-19 Vaccine EUA. Severe and unusual skin itchiness, scratching resulted in immediate bruising, patchy red skin, itchy throat and ears, fatigue, soreness, achiness  Took benadryl and napped. Later took tylenol and ibuprofen
Within 5 minutes of vaccination- severe itching-some redness and mild raised areas where pt was scratching. pt crying. Doctor was called. Child given 1.5 tsp Benadryl at 4:25--mild wheeze to left lobe posteriorly. Otherwise lungs clear- child screaming at time of assessment. Doctor ordered to send pt immediately to main office for evaluation. Pt was evaluated by doctor at main office and was administered 0.2 mg Epinephrine and 1tsp Orapred and instructed to use Orapred 1tsp BID and Benadrl (Doctor's assessment- good breath sounds, no wheezing, scratches to skin)- Prior to vaccination-CDC was contacted to make sure okay to receive MMR and egg allergy. Protopic use- received ok (patient had no allergy to gelatin or any meds per mother).
Rebound Covid. Positive home test on 5/26/22. Return of symptoms on 5/24/22; Rebound Covid. Positive home test on 5/26/22. Return of symptoms on 5/24/22; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Feb2021 at 12:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 20Nov2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 44 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 04Jan2021 at 08:00 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (ongoing); "idiopathic urticaria" (unspecified if ongoing); "depression" (unspecified if ongoing), notes: other medical history :Asthma, idiopathic urticaria,, depression; "known allergies: Clams" (unspecified if ongoing); "adhesive" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE], start date: 01May2022; NYQUIL, start date: 11May2022, stop date: 14May2022; LEXAPRO, start date: 01May2022. Past drug history included: Amoxicillin, reaction(s): "allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 24May2022 at 22:00, outcome "not recovered" and all described as "Rebound Covid. Positive home test on 5/26/22. Return of symptoms on 5/24/22". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: It was reported that other medication was given in 2 weeks. Paxlovid was given as treatment for Covid-19.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This case was reported by a consumer via sales rep and described the occurrence of injection site pain in a female patient who received Shingrix for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced local injection site pain lasting 2 days. The reporter agreed to be contacted for follow up. This case has been linked with US2018GSK153816, reported for the same patient.
Flu like symptoms. Patient then reported vesicular rash on her eyelid on 2/6/19, area of previous shingles outbreak. Patient was sent to ophthalmology for evaluation.
Standard side effects occurred within 24 hours, shivering, chills, body aches, fever of 100.3. Fever would not break until later that evening even when taking one Tylenol every four hours. Day two I couldn't tell if I was actually looking at myself in the mirror. I was dizzy and felt high. I could not remember simple tasks I just did like washing my face in the shower. I felt like I was hallucinating. I went to urgent care and they had no recommendations. I was to take the LSAT today, Saturday, April 9. I had to cancel it because I'm still not fully coherent. I still feel dazed and out of it. I tried to go to work yesterday and old lasted an hour. I had a COVID test performed yesterday on my own accord, not per the request of urgent care, just in case I caught it prior to the vaccine without knowing, and it was negative. I can remember things now at least but I'm still not mentally coherent. It's a scary feeling. I am about three and a half days post vaccine and slowly becoming myself again. I still feel dazed but I am able to have a conversation and remember it.
Pt vaccines done 8/9/06. On 8/12/06, pt developed generalized pruritis and area of erythema, tenderness, and swelling of left arm.
This spontaneous report as received from a nurse practitioner, refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On 22-APR-2016, the patient was vaccinated with improperly stored GARDASIL 9 (which had a lot # reported as M003659 and an expiration date of 20-SEP-2017; however, dose, dosage number, route of administration and anatomical location were not reported). No concomitant medications were reported. Along with GARDASIL 9, PEDVAXHIB, M-M-R II and ROTATEQ also appeared in the list products whose temperature stability was called into question. However, no doses of these vaccines were administered to any patients. The vaccines experienced a temperature excursion of 30.2 F for a time frame of 7.18 hours. There were, reportedly, no previous temperature excursions and the call for the aforementioned one was because of a data logger. Moreover, despite this temperature excursion, no adverse effects were reported and no product quality complaint was involved. This is one of the two reports received from the same reporter. Additional information has been requested.
? Sore Throat ? Cough ? Abdominal Pain Diarrhea Sinus congestion
The roof of my mouth began it itch the next couple of day my mouth broke out into small red bumps on the roof of my mouth and them on the tip of my tongue, on the inside of my top and bottom lip as well. The itching in my mouth started almost immediately but i disregarded it. When the bumps began I began to get concerned hoping it would clear up in a day or so. It has not. I used some meds i had at home for trash but it is not helping much. Everything I eat if it contains salt it burns as well as sodas. My lips are tingling and jumping
She started to have a scratchy throat, felt a lump in the throat, hives on the face, SOB, slight cough. Muffled voice, and difficulty talking following. Parents took her to nearby hospital, she was treated for an allergic reaction. Per mom she has never had a reaction to vaccines in the past.
By the following Tuesday after the vaccine the patient noticed swollen lymph nodes in her arm she received the vaccine in.  She reports swelling and tenderness in her armpit, elbow and forearm that has slowly improved but is still present.
About 48 hours after ZOSTAVAX administration patient developed a raised, red, tender rash about 5 inches in diameter near administrative site.
H1N1 vaccination at school. At 11:45 a.m. child experienced elevated temperature of 102.4 degrees, extreme malaise, muscle aching.  Gradually progressed to SOB, fever of 104 degrees with vomiting at 4 p.m. on 11/30/09.  Parents instructed by school nurse to transport child via EMS to Hospital.  Parents of child said that doctor at hospital said child had reaction to vaccine. Attempted to obtain more information from hospital but unsuccessful.
Seizure; pt brought in when she woke up shaking on 3/12/92 at 16:30.
Ten Minutes after nasal spray administered, patient developed a cough which has lasted for 2 weeks. She is under TX constantly with antibiotics for upper respiratory infection as well as ear infection. She was also awaiting results of X Ray to R/O Pneumonia diagnosis. CXR - neg Pleurisy.
Pt experienced hoarseness for a duration of six weeks. Pt also experienced a swollen throat and had difficulty breathing for a duration of four days. Pt developed a fever of 101.5 that lasted for 24 hours. Pt had coughing spells then would choke and had trouble catching breath.
Patient has not reported any symptoms, but she was given a Pfizer COVID booster 6 months after her first dose in the series.  She was also 15 years old at the time of booster dose.
PATIENT COMPLAINED STIFF NECK, PAIN IN LEFT SHOULDER BLADE, LEFT SIDE OF BACK
On January 11th, 2021 patient called to report that he will probably not get the second dose of Moderna due to side effects he had after he received the first dose of Moderna.  He reports that for a week after he had brain fog, ie. couldnt remember common things, he reported that he got a 1/2 dollar size black and blue mark to skin where the injection was given, and reports it is still there two weeks after receiving the injection.  He also stated that his arm was very painful after the injection.
A nurse reported the occurrence of an injection site reaction in a 24 month old female who was vaccinated with Infanrix for prophylaxis. The subject had no relevant medical history reported and was described as a "well child" with no know drug allergies. The subject received no concurrent medications. The subject received her fourth injection of Infanrix on 9/25/02 (557A2). On 9/27/02, the subject developed an injection site reaction characterized by a four-inch red, swollen area around the thigh. As of 12/17/02, the injection site reaction had resolved. This report has been linked to reports A0389651A, A0389653A, and A0389649A due to same reporter.
Within 24 hours of the second dose, symptoms of previously healed herniated disc / sciatica re-emerged and worsened. Lower back pain, numbness/pins and needles in the right calf and foot. Pain and numbness is still severe and has not improved in the course of two weeks.   There was no straining, lifting, movement, or injury that otherwise caused this flare up. The only variable was the vaccine.   On Wednesday, April 21, I received an epidural Epidural Corticosteroid Injection, which did not improve symptoms.   I have been unable to work since receiving the vaccine/ having this complication.
none --Prevnar 13 provide after the publication--Patient requeted Prevnar 13--was aware of protocol changed and is aware that he will requires 2  pneumonia vaccination in a year.
This spontaneous report was received from a licensed practical nurse via a company representative concerning a 35 year old female patient with asthma. On 18-NOV-2013, was vaccinated with a dose of PNEUMOVAX23 (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. On 20-NOV-2013, the patient contacted the healthcare professional (HCP) office stating that she had a fever, full body ache, injection site irritation including swelling and redness. The patient sought medical attention. The patient visited an Urgent Care Center where she was diagnosed with cellulitis and she was prescribed with antibiotics (unspecified). She was not admitted overnight. It was reported that there was a confusion as to when the patient visited the Care Center, before or after calling the HCP. It was unspecified if any lab tests were performed. The outcome of cellulitis was unknown. The relatedness for cellulitis was unknown for PNEUMOVAX23. Additional information has been requested.
HEADACHES FOR THREE WEEKS; This spontaneous report received from a patient concerned a female of unspecified age. 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, route of admin not reported, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced headaches for three weeks. Laboratory data (dates unspecified) included: CT scan (NR: not provided) no findings. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headaches for three weeks. This report was non-serious.
stiffness of upper right arm, chills (difficulty speaking, difficulty typing,) fever up to 103F, elevated pulse (highest noted 118 bpm by pulse oximeter but did not monitor entire time.)   Treated with Aleve, Tylenol, rest, drinking water, turning thermostat to > 70F, wearing multiple layers of clothing. Temperature was below 100F by 10:30 PM. Fitbit tracker calculates I had 279 Zone Minutes during the event. I was lying or sitting on the couch after 1:15 PM and did not exert myself.  Clocked out of work approximately 12:57. I answer phones and type during my shift and was unable to perform essential tasks related to my duties.
Rash started yesterday 1/8/2008 at 4 pm, and spread to arms, legs and trunk. Red blisters which subsided to raised red rash. On 1/9/2008, seen in the clinic and the rash is less swollen and better per mother. No fever, motrin 1.25ml given PO at 1/8/2008, 2100.
Over a month after patient received flu vaccine, nurse, from doctor office called and spoke with pharmacist, nurse, to report adverse reaction that patient had reported to her. Patient had flu vaccine on 11/2/18. Patient told nurse that on 11/3/18, she had bilateral severe, sharp pain in stomach and sharp back pain that didn't resolve until on 11/4 - it just stopped. Patient did not report headache and no injection site pain.
ACUTE RESPIRATORY FAILURE 7/31/2022 ACUTE RESPIRATORY FAILURE  HYPOXIA 7/30/2022 ACUTE RESPIRATORY FAILURE
dizziness and lightheadedness given ice pack and made site for additional 30 minutes then patient felt fine and left
Moderna COVID-19 Vaccine EUA: very sore at injection site, ran a fever of 101
Pt experienced a localized urticarial eruption at injection site of (left and right thigh), starting 1 day post injection. Treated with cool compresses and topical steroid cream.
Pt presented with covid and shortness of breath. Treated with remdesivir, and doxycycline.  IV dexamethasone given. pt discharged to snf.
Red, itchy, hot lump at injection site.  Hives/red blotches down left arm
herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 75-year-old female patient (pt). The pt's concurrent conditions, medical history and concomitant medications were not reported. On or about 12-DEC-2012, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, dose#, lot#, expiration date and route of administration were not provided) by a pharmacist in a pharmacy for the long-term prevention of shingles and zoster-related conditions. The pt was treated by the physician for herpes zoster from an unknown date, which resulted from pt's zoster vaccine live (ZOSTAVAX) use. The outcome of herpes zoster was not reported. The event was considered to be related to zoster vaccine live (ZOSTAVAX).
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. On an unknown date in 2014 (reported as "between 19-SEP-2014 and 17-NOV-2014"), unspecified number of patients were vaccinated with a dose of PNEUMOVAX 23 (lot number, Expiry Date, dose, route were not reported), that was improperly stored. PNEUMOVAX 23 was unsupported with in-house stability data. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
I experienced on Sunday sore throat on left side, home test on Monday and it was negative. By Tuesday, my gland became swollen and I went for a COVID-19 test on 4/26/22 and the 27th and it came back positive. Today I have cold symptoms.
A few minutes after receiving the Pfizer vaccine I became very dizzy, The next day I woke up suffering from dizziness and vertigo to the point of nausea. It?s now three months later and I?m still suffering from an underlining dizziness every day.
A week after my booster, I   broke out in severe hives and itchiness. I   also became very swollen from my right ear and eye until I   went to urgent care. They gave me benadryl but I   was itchy for another week with rashes everywhere. The itchiness comes and goes but I   know break out in hives in all areas of my body everyday.
Approximately 7 hours after vaccine- I started a fever of 100 degrees,  my body ached,  I had a head ache, and stomach ache/nausea.
Patient had a mental status change at home.  Was having seizure-like activity and was becoming combative.  Head CT upon arrival showed new neoplasm in left frontotemporal region, left to right midline shift and small amount of hemorrhage.
A mother and son came to the pharmacy during the evening of 5/23/2022 requesting a booster dose of the Pfizer vaccine for the son. The pharmacist mistakenly misread the age of the child as 12 years old and administered the adult dose of Pfizer Covid vaccine. No known adverse reaction is yet known, due to current attempts to contact the parents being unsuccessful.
This spontaneous report was received from a Medical assistant refers to a 6 months old patient who on 07-JAN-2013 was vaccinated intramuscularly with a dose of GARDASIL (dose and Lot # not reported). No other co-suspects were reported. No concomitant medications were reported. The Medical assistant reported that the patient was to have received the third dose of PENTACEL (dose of PENTACEL had not been administered at the time of the call). No product confusion discovered, just medication error. No adverse event reported. Patient's outcome was unknown. Action taken was not applicable. Additional information has been requested.
Started having gross hematuria with clots but no other associated symptoms. Never had this symptom before and otherwise no history of UTI, renal disease. No history of chronic disease. This is the first time happened
This case was reported by a consumer via call center representative and described the occurrence of hematocrit decreased in a 62-year-old male patient who received SHINGRIX for prophylaxis.  On 4th August 2018, the patient received the 2nd dose of SHINGRIX. On 7th August 2018, 3 days after receiving SHINGRIX, the patient experienced hematocrit decreased. On an unknown date, the outcome of the hematocrit decreased was unknown. It was unknown if the reporter considered the hematocrit decreased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Three days after receiving SHINGRIX, the patient had a routine annual physical with blood labs and his hematocrit came back low at 38.2. The patient had denied permission to contact their physician.
Approximately 3 days after received 1st dose of SHINGRIX vaccine, patient developed red, swollen, tender right arm. The redness spread from the upper right arm, down towards the hand. She sought medical attention to alleviate symptoms. Patient denies allergic symptoms of rash, hives, or difficulty breathing.
2 yo wm just given DTAP shot presents to UC with dizziness, diaphoresis, warmth, flushing, face tingling.
Loss of hearing in left ear; Felt pains; Vertigo; Numbness in left side of face, including ear canal; Felt general malaise; This is spontaneous case, initially received from other health professional (nurse) via Communications (reference number: SEQ-04129) on 08-Oct-2019, concerning 59-year-old, female patient.  The patient's medical history included thyroid cancer and breast cancer in remission.  The patient concomitant medication included Synthroid (levothyroxine sodium), tamoxifen and cortisone; indication was not provided.  On 29-Sep-2019, the patient was administered Flucelvax Quadrivalent [Influenza vaccine, subunit influenza virus vaccine polyvalent; NDC: 70461-0319-03, dose: 0.5 ml; batch number, expiration date, route of administration and anatomical location: not reported] as influenza prophylaxis.  On 30-Sep-2019, one day after vaccination, the patient felt general malaise.  On 04-Oct-2019, five days after vaccination, the patient felt pains and experienced vertigo, numbness in left side of face, including the left canal and loss of hearing in left ear. On the same day, the patient was hospitalised due to the events. In hospital was ruled out the possibility of a stroke.  On an unknown date in Oct-2019, the patient underwent magnetic resonance imaging, electrocardiogram, computerised tomogram scan, carotid doppler study and ENT (ear, nose and throat examination). The results of these test were not provided.   On 05-Oct-2019, the patient was discharged from the hospital.  At the time of this report, the events of numbness in left side of face, including ear canal and loss of hearing in left ear were not resolved, while the outcome for malaise, pain and vertigo was not reported.  The case was assessed as serious and the reporter did not provide causality assessment.; Sender's Comments: The patient experienced deafness unilateral, pain, vertigo, hypoaesthesia and malaise after vaccination with the suspect product Flucelvax Quadrivalent. Chronology is plausible. Medical history of thyroid cancer and breast cancer may provide alternative aetiology for the events. Causality was also confounded by therapy with concomitant drugs, Synthroid (levothyroxine sodium), tamoxifen and cortisone. Considering all the above mentioned, causal role of the suspect product cannot be totally excluded and is assessed as unlikely related.