chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tdap Patient came to the ER one day after receiving Tdap. She complained of left arm pain an tingling since getting her Tdap vaccination. Pt states her left hand is swollen, but myself and the staff do not see any swelling, redness, and it is not hot to touch.
Sore arm, and red rash 6x4 inch patch, can see white dot where injection was given.  Rash is flat and light to medium pink.  Denies heat in rash.
Fever over 104, severe chills, severe lower back pain, vomiting (emesis contained frank blood), lethargy, prolonged crying, complete loss of appetite.
Initial and follow-up information has been received from a nurse, for the Pregnancy Registry for GARDASIL, concerning a 25 year old female with allergy to TORADOL who on 10-JUN-2008 was vaccinated intramuscularly with the first and only 0.5 ml dose of GARDASIL (lot no. 659962/1740U).  There was no concomitant medication.  The physician reported that on 27-MAY-2008 the patient had an ultrasound due to complaints of "pain" and the result was negative.  The patient had a history of "negative menses".  On 12-JUL-2008 the patient had a spontaneous abortion when she was eight weeks pregnant.  On the same day, the patient had an evaluation due to a (+) serum beta-human chorionic gonadotropin (missed abortion).  The patient saw the physician to seek unspecified medical attention.  Upon internal review spontaneous abortion was considered to be an other important medical event.  Additional information is not expected.
Headache, Myalgia, Fever, NauseaVomiting,  chills Narrative:
Rash on back of neck that appears and goes away, bumpy, not red, itchy; happens daily multiple times a day since 4/3/21
A few hours after the vaccine, I had a serious, chronic headache and soreness in my arms. I saw the doctor the following day and received Butol for the headache. It helped with the headache. The doctor thinks it was probably due to flu and COVID-19 vaccine on same day.
Approximately 5 mins after vaccine administration patient reported feeling dizzy and like he was going to faint. He was pale in color and diaphoretic. Vital signs were taken, patients blood pressure was 100/70 and heart rate was in the 40s. Patient reported feeling very faint so his feet were elevated and he was given water. A few minutes later his heart increased to 70-80s and he reported feeling much better. He did admit to having syncopal and near syncopal episodes in the past from vaccines and blood draws. Patient was asked to stay an additional 30 minutes to be monitored by staff.
Patient fainted within 10min of receiving Moderna vaccine. She did state that she had a history of fainting with immunizations. She laid her head on the ground after feeling dizzy, after 1min she fainted while on the ground and regained consciousness after 1min. She was coherent, breathing normally but still stayed on the ground as she recovered from fainting. Paramedics were called as soon as she fainted and arrived while she was recovering. When they arrived they assessed the patient and decided to take her to the hospital, which she accepted.
Prickly feeling on skin - (no rash) - all over - (trunk & limbs). (Had shingles on forehead - 2001). No treatment by Dr. Site of injection swelled - large welt - itched.
Headache; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Fatigue) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was provided).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications and medical history were not reported. Treatment taken in response to the events was not reported.   Reporter did not allow further contact
Blood clot causing swelling, pain, redness in left leg from groin to ankle--sent for ultrasound from Vascular surgeon's office at.
She has had dizziness, nausea and vomiting on and off since HPV was given 3/16/09, associated with body malaise.  There was no reported fever.  she had visited the ER 2x and had received IV hydration in 1 occasion.  7/3/09 ER records received DOS 5/15/09. Assessment: Gastritis - acute, no bleeding. Patient presents with vomiting, abdominal pain, dizziness, tired, lethargic, dizziness, facial pain. Dehydration. Posterior pharynx injected. Returned 5/28/08 with c/o sore throat, cough and fever.  DX:  Tonsillitis. T=102'F. Throat injected with exudate with swelling of R tonsil. D/C on amoxicillin.    7/8/09 PCP recs received. Pt in for OV 3/16/08 with cough, congestion, fever and sore throat. Dx with viral throat infection.  HPV#1 given. On 4/6/08 parent reported that pt had experienced dizziness, nausea and vomiting since receiving the HPV vax.  Been 2 ER twice. In for OV with c/o congestion, scratchy throat. itchy nose x 2 days.  nasal turbinates and mucosa boggy with mucoid nasal drip. DX:  Allergic rhinitis.  Acute URI.
Information has been received from a medical assistant referring to 10 unspecified patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. In November 2016 (reported as "either 22-NOV-2016 or 28-NOV-2016"), the patients were vaccinated with improperly stored VAQTA (lot # M027879, expiration date 24-JAN-2018, dose and route not reported) for prophylaxis. The doses of vaccine were improperly stored at 49 degree Fahrenheit for 1.75 hours on 22-NOV-2016 and 49 degree Fahrenheit for 1.75 hours on 28-NOV-2016. There was no previous temperature excursion. Data logger was involved. NO adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA001319:
My mouth and tongue started itching; Skin broke out in a rash and became super itchy; Skin broke out in a rash and became super itchy; Have hives; This is a spontaneous report from a   consumer reporting for herself.  A 29-years-old female patient  received the first dose of bnt162b2 (BNT162B2; Lot # em9809) vaccine , via an unspecified route of administration in the left arm on 24Feb2021 14:30 at single dose  for covid-19 immunisation .  Medical history included asthma , attention deficit hyperactivity disorder , polycystic ovaries , sleep apnoea syndrome,  arthralgia , the patient was allergic to Albuterol, Penicillin, Cephalosporin, Iodine, Bees, all types of fish, all types of shellfish, peanuts, all types of tree nuts.  Concomitant medication included cefixime (FLEXERIL), acetylcarnitine hydrochloride (NEUROTIN ), naproxen (MOTRIN).  The patient experienced my mouth and tongue started itching  on 24Feb2021 14:30 with outcome of not recovered , skin broke out in a rash and became super itchy  on 24Feb2021 14:30 with outcome of not recovered , have hives on 24Feb2021 14:30 with outcome of not recovered.  The reported events were considered Life Threatening. The patient received Benadryl, and got epi on hand as treatment.  Follow up information has been requested.
Expired vaccine used. A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse in the military concerning a 38-year-old male. Neither medical history nor concomitant medications were reported. On 26-Jan-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there were no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Follow-up information provided outcome. Information regarding PREVNAR was received from a healthcare professional regarding a nurse who sustained a cut on her thumb when the PREVNAR prefilled syringe broke. Relevant medical history was not provided. Product was administered on an unspecified date. Dose regimen was 1 dose. Concomitant medications were not reported. The nurse sustained a cut on her thumb when the PREVNAR prefilled syringe broke (pharmaceutical product complaint). No injury to patient was noted. The nurse recovered. No additional information was available at the time of this report.
severe low back pain, difficulty standing when getting out of bed, difficulty lifting left leg; stayed home from work and took Fenortho (pain medication from injury in 2018); also used OTC tens device; I was losing weight and exercising daily prior to this event; I was unable to continue exercising for about 1 year; I am just now able to exercise about 3 days a week; I told my doctor but he did not include my concern in my records; I have since started seeing another doctor
headache; body aches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and MYALGIA (body aches) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included IBUPROFEN, PARACETAMOL (ACETAMINOPHEN) and IBUPROFEN (EXCEDRIN IB) for an unknown indication.   On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Jun-2021, the patient experienced HEADACHE (headache) and MYALGIA (body aches). On 27-Jun-2021, HEADACHE (headache) and MYALGIA (body aches) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information were provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.
Patient received the two vaccinations. Upon completion and exit of facility, experienced nausea, vertigo, and light-headedness. Patient stumbled to a wall and blacked out. Paramedics were called and evaluated. Patient returned 10-24-20 stating symptoms no longer present.
Red blotch near the injection site. Painful to the touch. Feels like a bruise.
Confirmed that there were no symptomatic adverse event reported; Inbound call from nurse who reported one dose of VARIVAX was administered following a temperature excursion.  After evaluation, VARIVAX was found to be supported.  Confirmed that there were no symptomatic adverse event reported.  No additional inform; This spontaneous report has been received from a nurse, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 01-JUN-2023, the patient was vaccinated with an improperly storage dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection, at a dose of 0.5 milliliters (ml) once as prophylaxis (lot number: U039723, which was determined to be valid, with an expiration date on 15-DEC-2023) (scheme, route and anatomical location of administration were not reported) (Product storage error).  The administered dose underwent a temperature excursion of between -10 and 8 Celsius (C), for 2 hours 50 minutes. No previous temperature excursion was reported.  No additional symptomatic adverse event reported.
Severe rash with welts on back, chest, stomach and left arm. Severe dizziness, headache, ringing in left ear, severe fatigue, sneezing.
Temp excursion in the vaccine refrigerator over the weekend and HPV 9 vaccine given to patient.  Patient declined a booster dose.
She felt dizzy immediately upon standing. She has a hx of SVT with cardiac ablation in Feb 2020. No medications noted.  Experienced rapid heart beat within 10 minutes with dizziness and shortness of breath. Complained of chest pain, Rapid response team called. Per team - NSR, vital signs stable. Taken to ER for further evaluation.
Blood Clot in lungs.  Chest pain,  shortness of breath.  Hospitalization on Heparin Drip.
Varivax was administered within 28 days of MMR administration. MMR was administered on 8/23/2023.
First day, 11 Jan, a large raised red bump on arm, approximately 2X2 inches.  Very itchy and hot to the touch.  Eventually the large bump went down and redness went to pink.  The bump and redness went away by 15 Jan.  Yesterday, 21 Jan,  the bump returned, red, very itchy and hot to the touch, approximately 2X2 inches.  Today, 22 Jan, the bump is much larger, a deeper red, heat penetrating though shirt sleeve and itchy.  My arm is not sore and I feel well.  I do not have a fever.  No discharge from the injection site.
COVID-19 symptom onset 5/3, hospital admission 5/11, and death on 5/18/2021. Primary cause of death acute hypoxic respiratory failure, underlying cause COVID-19 viral pneumonia
Felt a little weak and tired - lasted 1 1/2 days. Also, slight dizziness.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old 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 pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's husband. Six months before the date of reporting, the patient received 1st dose of SHINGRIX and experienced pain in arm. For tolerance to the 2nd dose of SHINGRIX refer case US2018216884, reported by the same reporter for the same patient.
Patient experienced numbness/pain in L mid-arm and hand with 15 minutes following injection.  Patient reports having same reaction after the 1st vaccine given 4/29/2021.  At that time, patient followed up with PCP who prescribed Naproxen 500mg q day, Claritin, Omeprazole,  and Ibuprofen prn.  Patient was given 25mg Benadryl following 2nd reaction and instructed to stay in observation area an additional 15 minutes.  She reported improvement in L hand numbness; no change in forearm status.  Patient instructed to f/u with PCP.
patient  diagnosed with  Bells Palsy on 3/3/21 at ER.  patient reported having symptoms on 3/2/21 patient went to brush her teeth and water was dripping patient looked at the mirror and saw her mouth "had shifted" . patient also reported headaches
got a sore arm; feeling queasy; her back hurt; fever; This is a solicited report from a non-Pfizer sponsored program (marketing program name not available) from a contactable consumer, based on information received by Pfizer. This case was split from master case 2021163836 for BNT162B2 experienced sore arm, fever, feeling queasy and her back hurt. This is a spontaneous report from a contactable consumer or other non hcp.   A female patient of an unspecified age received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 04Feb2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included etanercept (ENBREL), denosumab (PROLIA), methotrexate (MTX [METHOTREXATE]) and hydroxychloroquine (HYDROXYCHLOROQUINE). The patient began Enbrel, Single Dose Prefilled Autoinjector, Prolia, Single Dose Prefilled Syringe on an unknown date. The patient began Enbrel on an unknown date. On an unknown date, the patient experienced cough or sniffles, she had gone without her Enbrel. When she was not taking her Enbrel she was in pain with her feet throbbing and her wrists hurting. The patient resumed Enbrel therapy. The patient's rheumatologist said she could not take Enbrel and MTX for two weeks after each COVID-19 injection. She usually takes her Enbrel on Sundays but had put it off. She never had good luck not taking her Enbrel and MTX over the nine years. She said afterwards, (after having covid-19 injection) on an unspecified date in 2021, she did have reactions including she got a sore arm, fever, feeling queasy and her back hurt. On an unspecified date she got a slight headache, slightly nauseous and her temperature went up two degrees or so and was achy. Symptoms lasted five to six hours. The patient feels fine on. Also, the patient reported after a couple of days without both medications usually Tuesday or Wednesday she would be so sore she would had to leave work to go home just to take her Enbrel injection. When patient went to clinic to get COVID-19 vaccine, it was advised she take her medication now, but after second vaccine dose she should hold off for two weeks. The patient was due for Prolia injection at the beginning of March and wanted to know if it was okay to take COVID-19 vaccine along with Prolia and Enbrel. No treatment information was received. The outcome of the events fever, pain, nausea and headache were reported as unknown.   No follow up attempts are possible. No further information is expected.
Severe  chills,  Muscle  aches, and    development of   approx  2  cm  enlarged  painful  lymph  node  in the   LT axilla   which  has  taken a  week  to  diminish  in  size
A non-serious spontaneous report of administration of expired dose was received from a health professional concerning a 12-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. On 12-Dec-2011, the patient inadvertently received expired FLUMIST. The product expired on 04-Dec-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
COVID-19; COVID-19; This is a literature report.  This study involved 179 individuals aged 12 to 18 years hospitalized for laboratory-confirmed COVID-19 and a control group of 285 adolescents hospitalized for other causes between June and September 2021. Six vaccinated patients were hospitalized for COVID-19, and none were admitted to the intensive care unit (ICU) or died. It excluded partially vaccinated individuals. A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 2, single and administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset 2021, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: laboratory-confirmed COVID-19: (2021) positive.; Sender's Comments: Based on the information currently available, a lack of efficacy with bnt162b2 vaccine in this patient cannot be completely excluded,Linked Report(s) : US-PFIZER INC-202101695462 Same article/ drug/event and different patient
Fatigue; Body aches; A low grade fever; This is a spontaneous report received from contactable reporter(s) (Other HCP), Program ID.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 18Mar2021 as dose 2, single (Lot number: EN6207) at the age of 67 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: coviD-19 vaccine (Dose #1: manufacture: unknown , Date: 25Feb2021, Lot: EN6198, NDC: unknown , Expiry: unknown), administration date: 25Feb2021, when the patient was 67-year-old, for Covid-19 immunisation, reaction(s): "Fatigue", "Body aches", "Low grade fever". The following information was reported: FATIGUE (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "Body aches"; PYREXIA (non-serious), outcome "unknown", described as "A low grade fever".  Additional information: Caller dose not sees any prior vaccinations (within 4 weeks) in patient's chart. No family medical history and relevant tests was reported.
During day of 6/7, was able to keep down a little food, but still experiencing nausea; diarrhea; Range of motion in arm was also quite limited; could not engage in normal activities; Nauseated; arm was very sore; bouts of dizziness which continued for next two days; felt very hot; face flushed; This is a spontaneous report from a contactable consumer (patient).  A 38-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 04Jun2021 17:45 (Batch/Lot Number: EW0171) age at vaccination of 38-years-old, as single dose, for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing (Prior to vaccination). The patient was not pregnant and was not pregnant at the time of vaccination. Concomitant medications included ascorbic acid (VIT-C) taken for an unspecified indication, start and stop date were not reported; ergocalciferol (VIT D) taken for an unspecified indication, start and stop date were not reported; calcium citrate (CALCIUM CITRATE) taken for an unspecified indication, start and stop date were not reported and multivitamin for an unspecified indication, start and stop date were not reported. The patient previously took trimox ketone and experienced drug hypersensitivity.  Immediately after shot, on 04Jun2021 18:00, the patient felt very hot and face flushed; then approximately 1 hour after, had bouts of dizziness which continued for next two days. During the evening of 05Jun2021, became nauseated (and arm was very sore), and most of day during 06Jun2021, had diarrhea and additional nausea, could not engage in normal activities and range of motion in arm was also quite limited. During day of 07Jun2021, was able to keep down a little food, but still experiencing nausea. No treatments were given for the events. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was recovering from the events.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 01-SEP-2013, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) by a physician/MD, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 01-MAY-2015, the patient was treated by the physician/MD for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Child had TDAP, meningococcal; and varicella. Child felt lightheaded; dizziness; and pale after injections. Mom reports child had inhaled a breakfast sandwich just prior to vaccines. Child did not pass out.
Headache (5 hours), chills (4 hours), fever (4 hours), arm soreness (24 hours).