chrisvoncsefalvay/vaers-outcomes huggingface dataset:
nausea; vomiting; cheeks were blushed; didn't feel good; fever; pain in arm; body aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), VACCINATION SITE PAIN (pain in arm), MYALGIA (body aches), NAUSEA (nausea) and VOMITING (vomiting) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 10-Feb-2021, the patient experienced PYREXIA (fever), VACCINATION SITE PAIN (pain in arm), MYALGIA (body aches) and MALAISE (didn't feel good).   On 11-Feb-2021, the patient experienced NAUSEA (nausea), VOMITING (vomiting) and FLUSHING (cheeks were blushed).   On 11-Feb-2021, PYREXIA (fever) had resolved. At the time of the report, VACCINATION SITE PAIN (pain in arm), MYALGIA (body aches), NAUSEA (nausea), VOMITING (vomiting), FLUSHING (cheeks were blushed) and MALAISE (didn't feel good) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Just felt sick like I was had the regular flu.  Lasted about 4 to 5 hours
Approx 6 hours after vaccines at well visit: was taking a nap when 12 yo brother heard him grunting, found him with spit up on face, struggling to breathe, blue. Brought him to his mother who saw him limp, blue but still breathing, called 911. By the time paramedics came he was normal. Hx of pyloric stenosis s/p repair, GERD, overfeeding.
Both daughter 23 and my son 19 began have symptoms the next day starting to resemble a severe head cold and overall feeling bad, my son symptoms remain consistent with head cold. My daughter however, progressive got worse, with headache, severe head congestion, throat feels thick, heavy chest , asthma reaction, said feels like throat is closing up, diarrhea , vomiting. The vomiting and diarrhea started last night and worse today. We called several time to doctor his morning and then at 1130 I was finally able to reach someone and they called in Zovoran for her, but as of yet they have not and still waiting to for Doctor office to call this medicine , so we can pick it up. Due to making her asthmas worse she has taking two puffs of albuterol inhaler and 1 puff on Advair disk 30 mins ago. She also took Alkezelzer cold and flu medicine  30 min ago in hopes to help loosen up congestion and headache. . If Breathing gets worse and albuterol doesn't help we will take her to clinic or ER.
BITTER TASTE (HORRIBLE AND BAD) IN MOUTH UPON EATING; DISTORTION IN TASTE/VILE TASTE; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no health conditions. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On SEP-2021, the patient experienced bitter taste (horrible and bad) in mouth upon eating. On SEP-2021, the patient experienced distortion in taste/vile taste. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bitter taste (horrible and bad) in mouth upon eating and distortion in taste/vile taste was not reported. This report was non-serious.
A nurse reported that a 76 year old male received an injection of Pnu-Imune 23 on 10/18/99. On 10/19/99, he developed an injection site reaction. He recovered. This is 1 of 2 reports from this facility of injection site reactions following receipt of Pnu-Imune 23.
10:30 pm. Throat closing - drove to ER. Difficulty swallowing eyes scratchy as if sand inside eyes. Arrived at 11 pm at medical center.
covid test result: Positive; covid test result: Positive; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Mar2021 at 11:00 as dose 1, single (Lot number: EN6198), in left arm and on 20Apr2021 at 11:30 as dose 2, single (Lot number: EW0153) at the age of 43 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Psoriasis" (unspecified if ongoing); "known allergies: Peanuts" (unspecified if ongoing); "known allergies: latex" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01Sep2021, outcome "unknown" and all described as "covid test result: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Sep2021) Positive; (20Dec2021) Positive.  Clinical course: No other vaccine in four weeks. Other medication in two weeks was Tylenol. No COVID prior vaccination. COVID tested post vaccination.; Sender's Comments: Based on the available information and close temporal association, a possible causal relationship cannot be excluded between the suspect vaccine BNT162b2 and the reported events "vaccination failure", "COVID-19".
10-22 shot L deltoid 11:45 AM.  45 minutes later , sore site, began to cough, then wheezing, mild, then eyes bloodshot & oozing thick exudate.  Went home 3:30.  Chills + muscle aches off + on x 5 hours 1:00 pm.  Perfect health following day 10-23-08.
Initial report received from a consumer (patient's wife) on 25 Oct 2010: This patient received FLUVIRIN (batch number: not reported), intramuscularly in Sep 2010 (date unspecified). On an unspecified date in Sep 2010, the patient felt light headed within 24 hours which was persisted at the time of report also. The patient stated that his emergency room doctor has reported these symptoms were related to a depressive episode. Final outcome of the patient was reported as condition unchanged.
On 03/28/01, telephone call from mother states left leg red and swollen. CHN visited, left leg swollen down to and including the knee. The child playing and walking. Pedal pulse was present, good pulse to leg and the foot. Instructed mom to use ice and Tylenol. Call PMD if worse.
Client felt nauseated  and light headed.  pulse 94  respiration 18  PSO2 98%.  Rested on cot then ate peanuts and water, Felt better.  Informed to seek medical attention for further problems.
Information has been received from a healthcare worker concerning a 73 year old male patient with a history of lymphoma five years ago and with no known drug reactions/allergies who on 20-JAN-2011, was vaccinated with a standard dose of ZOSTAVAX (Merck) (Lot # 669192/1457Z, Exp. Date: 29-JAN-2012) (dose not reported), subcutaneously. There was no concomitant medication. The healthcare worker reported that on 20-JUN-2011, the office first saw the patient with shingles. The patient also could not chew well because of the postherpetic neuralgia he developed after receiving ZOSTAVAX (Merck). The patient was given steroids and antiviral medications for the treatment of the events. No laboratory tests were performed. The healthcare worker also reported that the patient did not have the lesions anymore but still had tingling, burning and numbness sensations. At the time of the report, the patient had not recovered. The patient's postherpetic neuralgia was considered to be disabling by the reporter. Additional information has been requested.
Fever 105 and crying beginning several hours after administration of DTaP, IPV, Hib, PCV vaccinations on 10/27/03.
Systemic reaction. 3 days after injection. Severe, worsening macular-papular rash. Started on Abdomen and groin area. Now diffuse and encompasses chest, neck, and both legs. Very pruritic/itchy. Been taking daily Claritin and Benadryl. Not improving after >4 days.
Patient came in to store on 3/26/21. stated pain started on  3/25/2021 on  right side of neck at base going maybe an inch or two down towards shoulder. Stated pain like "a little bit after she had been exercising", No swelling or warm to touch. She will monitor pain
swollen lymph nodes under her arms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 30Sep2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number: UNKNOWN), for COVID-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "swollen lymph nodes under her arms".  Additional information: Patient had her booster shot on Thursday last week, 30Sep2021, she heard about the symptoms of swollen lymph nodes, she asked if this was something to be alert about as she has swollen lymph nodes under her arms.   Follow-up attempts completed. No further information is expected.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 79-year-old female patient who received BOOSTRIX (batch number C295R, expiry date 8th December 2018). On 2nd September 2016, the patient received BOOSTRIX (intramuscular) .5 ml. On 8th September 2016, 6 days after receiving BOOSTRIX, the patient experienced injection site swelling, injection site itching and injection site redness. On an unknown date, the outcome of the injection site swelling, injection site itching and injection site redness were unknown. The reporter considered the injection site swelling, injection site itching and injection site redness to be probably related to BOOSTRIX. Additional details were provided as follows: The patient received BOOSTRIX in her left arm.
At about the same time the joint pain began, her lungs seemed to feel better. She says her lungs are more flexible after the vaccine; Pain keeps her up at night after 2nd dose; Unrelenting pain after 2nd dose / Very severe pain after 2nd dose / Pain 8/10 after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (At about the same time the joint pain began, her lungs seemed to feel better. She says her lungs are more flexible after the vaccine), MIDDLE INSOMNIA (Pain keeps her up at night after 2nd dose) and MYALGIA (Unrelenting pain after 2nd dose / Very severe pain after 2nd dose / Pain 8/10 after the vaccine) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028a21a) for COVID-19 vaccination.     Concurrent medical conditions included COPD and Chronic bronchitis.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (At about the same time the joint pain began, her lungs seemed to feel better. She says her lungs are more flexible after the vaccine), MIDDLE INSOMNIA (Pain keeps her up at night after 2nd dose) and MYALGIA (Unrelenting pain after 2nd dose / Very severe pain after 2nd dose / Pain 8/10 after the vaccine). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (At about the same time the joint pain began, her lungs seemed to feel better. She says her lungs are more flexible after the vaccine), MIDDLE INSOMNIA (Pain keeps her up at night after 2nd dose) and MYALGIA (Unrelenting pain after 2nd dose / Very severe pain after 2nd dose / Pain 8/10 after the vaccine) outcome was unknown.            No relevant concomitant medications were reported.   This case was linked to MOD-2021-143837 (Patient Link).
with in 3 weeks my very mild tinnitus like level 1 went to level 9 now its 5/6  The increased volume had me discuss with councler and medical doctors
pt c/o nausea, light headedness, flushed and anxious. Water given, vitals stable. Dc'd from clinic.
We administered a vaccine that had been stored improperly (kept in the refrigerator longer than beyond use date).
Patient started having short of air and sensation of throat swelling 15 minutes past inoculation. Progressed but no loss of conscious and vital signs stable.
pt recv vax 11SEP97 & 6OCT97 pt devel an abscess @ the site of inj & was hosp for 4 days;the abscess required an incision & drainage w/prolonged IV & oral ATB therapy;
swollen uvula, nausea. Uvula swelled up the day after the vacccine adn gradually went down each day. It had gone back to normal around day 5.
severe skin reaction generalized progressively worse over two months. itching red/purplish grey color  crusted raised
Received COVID #2 on 6/12 and developed cold symptoms with ear pain and loss of taste. On 6/22/2021, developed right facial droop and was seen in the ER - diag with Bell's palsy and placed on Abx, Prednisone, and acyclovir.  Lyme came back negative.  Was seen in f/u 6/25 in clinic with improved but still apparent right facial droop.  Abx discontinued at that point.  He is doing much better now (7/6) with some residual facial droop.
Fever and tiredness Can take ibuprofen/motrin/tylenol for fever, use cool compress/wet rag on forehead to help 4/9-Spoke with wife. Patient slept all day yesterday and then woke up this morning feeling fine and went to work. Did not really take anything other than 1 expired ibuprofen.
The patient was administered a dose of ACT-HIB that was reconstituted with sterile water, no AE; Initial information regarding an unsolicited valid non-serious case was received from a physician via inbound (reference number- 00579444) and transmitted to Sanofi on 27-Apr-2021.  This case involves a five month old female patient who was administered a 0.5 ml dose of suspect HIB (PRP/T) VACCINE [ACT-HIB] (lot number and expiry date: not reported) via intramuscular route in unknown administration site for prophylactic vaccination on 20-APR-2021 that was reconstituted with sterile water (product preparation error).  The patient's past vaccination included DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL) in FEB-2021 (dose 2) for prophylactic vaccination.  The patient's medical history, past medical treatment(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE LIVE ORAL 1V (ROTARIX) and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination.  It was a case of an actual medication error due to wrong diluent used (latency same day).  The reporter wanted to know, whether dose needs repeating.  At the time of reporting no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/3/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. (compulsory)  There will be no information available on the batch number for this case.
03/24/2021: Patient presented and was admitted through emergency room for CC of melena. stated that she had a BM and had bright red blood at the end. The patient does have a history of peptic ulcer disease and GI bleed.  She was admitted last year with GI bleed and was found to have multiple ulcers in the duodenum. Pertinent labs on admission - Initial H&H was 8.9 and 29.6.  Repeat H&H 3 hours later?was 7.8 and 24.8.   Per the EUA, hospitalizations are to be reported irrespective to attribution to vaccine
Inappropriate schedule of vaccine administered/First dose of vaccine on 02 Apr 2021 and second dose on 23 Apr 2021; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered/First dose of vaccine on 02 Apr 2021 and second dose on 23 Apr 2021) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. EW0162 and ER8733) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu shot (Manufacturer-ID) Lot No-3477h Route-Intramuscular Body site-Right Deltoid Dose1). Past adverse reactions to the above products included No adverse event with Flu shot. Concurrent medical conditions included HIV infection. Concomitant products included EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (DESCOVY) for HIV infection NOS.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered/First dose of vaccine on 02 Apr 2021 and second dose on 23 Apr 2021). On 23-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered/First dose of vaccine on 02 Apr 2021 and second dose on 23 Apr 2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information were reported.   This case was linked to MOD-2022-437761 (Patient Link).
Half of day after receiving the shot the left arm was sore after vaccine.  Itchy on right on red ,hot and swollen after the allergy shot . Itching  whole body and also the roof of mouth and the back of throat was itching .  Head aches .  No new symptoms.
approx. 4- 6 hrs. after 2 vaccines- RSV & flu Mom developed nausea, vmtg, respiratory distress & urinary incontinence.   911 was notified & she was taken to the ED  where she was diagnosed with severe edema in her lungs and an anterior wall MI.  No symptoms of dyspnea, or chest pain earlier in the day.
EKG: Irregular heartbeat Comments: Arrythmia; severe fever/ high fever; vomiting; cough; nausea; loss of appetite; headaches; The initial safety information received was reporting only non-serious adverse drug reactions. Upon receipt of follow-up information on 20Aug2021, this case now contains serious adverse reactions. Information processed together.  This is a spontaneous report from a contactable consumer (patient). A 20-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0186), intramuscular in left arm on 12Jul2021 at 18:15 (at the age of 20-years-old) at dose 2, single for COVID-19 immunization. Medical history included chronic migraine from Feb2013 and ongoing. She has no COVID-19 prior to vaccination. Concomitant medications were reported as none. Prior vaccines were reported as none. Family history included her brother having an autoimmune disorder and her father with NFZ and PFO (as reported). The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0186), intramuscular in left arm on 21Jun2021 at 18:15 (at the age of 20-years-old) at dose 1, single for COVID-19 immunization. Vaccination facility type was reported as doctor's office/urgent care. On 13Jul2021 at 06:00, the patient experienced severe high fever, vomiting, cough which were reported as causing persistent/significant disability/incapacity. She also experienced nausea, loss of appetite, and headaches on Jul2021. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of all the events. Vomiting was specifically treated with omeprazole-D 40 mg and cough was specifically treated with benzonatate 100 mg, 3x day. The patient underwent lab tests and procedures on 19Jul2021 which included full blood panel: normal range, EKG: irregular heartbeat/ arrhythmia, and COVID test: negative for COVID. The outcome of the event fever and vomiting was recovered on 19Jul2021; recovered on 05Aug2021 for cough; unknown for arrhythmia; and recovered with sequel on Jul2021 for all other events.
I gradually felt shortness of breath about a week after 1st Pfizer shot. I went to the hospital three weeks after the shot because it became worse and worse. Clinic exam shows blood oxygen level dropped to 80s percent. Blood oxygen level takes 5 months to become nearly normal.  My doctor said we cannot prove the 1st shot caused that issue, even if it does, my low blood oxygen level will make me vulnerable if I don?t take the 2nd shot and get infected. So I took the 2nd shot. Then my heartbeat rate doubled within 24 hours. I am not recovered yet after 5 months. A doctor called an ambulance to send me to ER during a clinic visit in early Feb 2022 (about 5 months after 2nd shot), because my heartbeat was too fast. Then I was held in hospital overnight. I could not do any exercise or intensive work after the 2nd shot for months.
Weakness in legs, fever off 100.1. Two days later on 03/16/2017 patient developed red spots all over his body like chicken pox.
dizziness; her arm became floppy; This is a spontaneous report from a contactable consumer or other non hcp (patient) via Pfizer-sponsored program. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration on 17Feb2021 (last Wednesday) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. That evening, she experienced dizziness. The dizziness continued until it is hard for her to do anything. She also mentioned her arm became floppy. On 17Feb2021 at evening, the patient experienced dizziness which continued until it is hard for her to do anything and also her arm became floppy. The outcome of the events was unknown.   Information about Lot/Batch number has been requested.   Follow-up attempts completed. No further information expected.