chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nausea; Diarrhea; vaccination site redness/swelling; Muscle aches; Pain; Jaw tightness; Eye pain; Sinus pain; Congestion; Chest tightness; runny eyes; tight shoulder/neck; Fever; injection site redness/swelling,; jaw tightness and pain; Headache; Dizziness; Tremors; This is a spontaneous report received from a contactable healthcare professional, the patient. A 41-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via an unspecified route of administration in the left arm on 14March2021 at 14:15 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. Medical history included hypertension, overweight and penicillin allergy eliminated in 2019. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included losartan (MANUFACTURER UNKNOWN), vitamin D3 (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER UNKNOWN), desloratadine (MANUFACTURER UNKNOWN), all for unknown indication from unknown dates and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 21Feb2021 at 17:30 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 15Mar2021 at 02:30, 12 hours post through 36 hours post, the patient experienced severe headache, dizziness, tremors, surges felt head to toe or vibrations and fever for 2 hours up to 102-102.8. On 15Mar2021 at 18:15, 28 hours post dose, the patient experienced nausea, diarrhea, injection site redness/swelling, pain and muscle aches, jaw tightness and pain, eye pain, sinus pain, congestion, dizziness, chest tightness, runny eyes and tight shoulder or neck. The patient received treatment for the adverse events and was treated with acetaminophen (MANUFACTURER UNKNOWN). The clinical outcome of the event fever was recovered on 15Mar2021 and headache, dizziness, tremor, nausea, diarrhea, vaccination site swelling, vaccination site erythema, pain, muscle aches, jaw tightness, jaw pain, eye pain, sinus pain, sinus congestion, chest tightness, watery eyes, neck tightness was recovering.   No follow-up attempts are needed. No further information is expected.
16 days later B/L U/E and L/E weakness, B/L arm pain. Chest pressure.
Patient presented to emergency department on 1/1/2022 following an intentional drug overdose. She was found to be COVID-19 positive during screening for admission. Patient was asymptomatic for COVID-19 during admission and required no treatment or supportive care for infection. Patient was discharged home on 1/8/2022.
Arthralgia, Rash, UrticariaPruritus, STATES SHE WAS GIVEN VACCINE ON 12/31 BUT DEVELOPED SYMPTOMS ON 1/6/21 Narrative:
Vasovagal syncope, prolonged recovery with nausea, vomiting, headache X4 hours
On day one, I felt the typical soreness to site.  Starting day 2, a headache presented.  Starting day 3, in addition to the headache, fatigue, body aches and a knot and soreness at the site.  It is day 9 now post... and body aches & fatigue continue.  In addition, the injection site is inflamed (swollen, red and hot).   I am an RN and one of the docs I work with suggested I may have possible cellulitis at the site and I need to watch it for worsening.
My COVID-19 infection symptoms stared on 02/28/2023 in the evening around 06:00pm. I had cough, headache, lethargic, runny nose, swollen glands. I had no fever. I took Tylenol. On 03/01/2023 the symptoms became worst so I decided to take a home COVID-19 test which was positive. I called my doctor on late Wednesday and did a telehealth  on 03/03/2023. We discussed all the symptoms  for my age and asked about the cough I had. He prescribe me Paxlovid  for 5 day. The medication taste  was so bitter. I had no breathing issues. I still have the lingering cough. I did another telehealth with my doctor on 03/30/2023 about cough. I asked  him  to prescribe me medication for the cough so he prescribe me Benzonatate.  As for now I still have cough. I don't feel  the pressure of coughing as much now.
2 days after vaccination developed L arm swelling to hand with moderate to severe pain.  (Given L deltoid) some redness at inj site.  Started on a course of oral steroids without improvment.  Complains of sharp pains / tenderness still 8 days after vaccination.  Referred to Pediatric ID clinic for ?brachial neuritis.
This spontaneous report refers to a 62 year old female patient with high blood pressure, depression and drug reactions/allergies with Sulfur (hives). On 05-OCT-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose, frequency and route not reported). Concomitant medication included unspecified antidepressant and unspecified blood pressure medication. The patient reported that she had had shoulder pain and a small rash around the injection site since she received ZOSTAVAX on 06-OCT-2013. The patient sought medical attention by speaking with the pharmacist. No lab diagnostics studies performed. The outcome of the event was not recovered. Additional information has been requested.
pt recv vax; shrill, abn cry lasting 6-8 hrs;nothing would console infant; to call MD if T inc;
Had 1st Hep B vaccine on Wednesday (5/16) at 1:00pm. Noticed hives on forehead, cheeks, behind ears and back of neck at 11:0am (5/17). Took Benadryl and Chlorpheneramine but did not notice improvement. Hives left Monday night roughly (5/21). Had little on Tuesday (5/22).
fever, chills, syncope, unconscious. starting 5-10mins after vaccine received. s/s experienced for about 30min following vaccination emergency services contacted
Seizures; Memory issues; Epilepsy; This is a spontaneous report from a contactable nurse (patient).  A 32-year-old non-pregnant (including at the time of the vaccination) female patient received the 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on arm left on 19Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization at the physician's office.  Medical history included depression and anxiety. Concomitant medication included venlafaxine hydrochloride (EFFEXOR) taken for an unspecified indication and therapy dates. She had no COVID-19 prior to vaccination. The patient received the first dose of PFIZER-BIONTECH COVID-19 VACCINE on 29Dec2020 01:30 PM (Batch/Lot number was not reported) on the right arm as COVID-19 immunization. Then, received the 2nd dose on 19Jan2021. The patient was then diagnosed with epilepsy in Feb2021 a month after getting 2nd dose. On 08Mar2021 10:30, the patient had seizure and memory issues. The patient was brought to the emergency room/department or urgent care due to the events. Then was admitted in the hospital on 08Mar2021. The patient had nasopharyngeal swab on 05Mar2021 and showed negative. The patient received an unspecified treatment for the events but not yet recovered.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Epilepsy.,seizures, memory impairment. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Pt received 12 month vaccination on 5/24. She was already running fevers. The ff day was taken to ER for fever and (R) thigh swelling. Notes from ER said they drained swelling but PE didn't say/describe the swelling. DX: Abscess and BACTRIM was started. I saw pt today in the office. No more swelling, pain, redness accdg to mom. There was just a small palpable wheal on (R) mid thigh.
severe cramps in his stomach; sweating to beat the band; almost feels like throwing up; painful and feels like severe gas; This is a spontaneous report from a contactable Consumer (patient). A male an unspecified age patient received dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 08-FEB-2021 09:00 as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date in 2021 the patient experienced severe cramps in his stomach, sweating to beat the band, almost feels like throwing up. He said it was painful and feels like severe gas. The events outcome was unknown.  Information on the lot/batch number had been requested.
describes soreness in lt arm for 2 days p/shot; then 5 days later was unable to move lt hand or use it to pick up object; strength has slowly been returning but not yet nl; soreness in lt arm persists; referred to MD;
Achiness and tingliness in legs, feet, arms, neck and shoulder area; achiness and tingliness in legs, feet, arms, neck and shoulder area; Soreness in upper legs and buttocks area; Facial tingliness; A lot of jaw aches; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Facial tingliness), PAIN IN JAW (A lot of jaw aches), PAIN (Achiness and tingliness in legs, feet, arms, neck and shoulder area), PARAESTHESIA (achiness and tingliness in legs, feet, arms, neck and shoulder area) and PAIN (Soreness in upper legs and buttocks area) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included Autoimmune disorder in 2016.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced PARAESTHESIA (Facial tingliness) and PAIN IN JAW (A lot of jaw aches). On 03-Mar-2021, the patient experienced PAIN (Achiness and tingliness in legs, feet, arms, neck and shoulder area), PARAESTHESIA (achiness and tingliness in legs, feet, arms, neck and shoulder area) and PAIN (Soreness in upper legs and buttocks area). At the time of the report, PARAESTHESIA (Facial tingliness), PAIN IN JAW (A lot of jaw aches), PAIN (Achiness and tingliness in legs, feet, arms, neck and shoulder area), PARAESTHESIA (achiness and tingliness in legs, feet, arms, neck and shoulder area) and PAIN (Soreness in upper legs and buttocks area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
None noted after injections though was admitted to hospital with COVID + dx on 9/8/21
She woke up with a nod in a different spot in the same arm; A welt; Arm sore for 5 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm sore for 5 days), SKIN REACTION (She woke up with a nod in a different spot in the same arm) and URTICARIA (A welt) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No medical history reported.  Concomitant products included Omeprozale, ACETYLSALICYLIC ACID (BABY ASPIRIN), MONTELUKAST SODIUM (SINGULAIR) and ALPRAZOLAM (XANAX) for an unknown indication.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm sore for 5 days). On 22-Feb-2021, the patient experienced SKIN REACTION (She woke up with a nod in a different spot in the same arm) and URTICARIA (A welt). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. On 19-Feb-2021, PAIN IN EXTREMITY (Arm sore for 5 days) had resolved. At the time of the report, SKIN REACTION (She woke up with a nod in a different spot in the same arm) and URTICARIA (A welt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
No adverse event; 113 Bivalent doses administered after the BUD to patients 12 and up; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up) and NO ADVERSE EVENT (No adverse event) in a 30-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 27-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up).    Concomitant medications details were not reported by the reporter.  Patient ID was reported.  It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Reportedly, In this report the patient was not Eligible. Breakdown of doses were reported as 51 doses from batch number AS7140C and 60 doses from Batch number AS7148B.  Treatment details were not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-689946 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689946:Master case
No symptomatic AE reported; then a year later a fourth one was given; first two doses were given too close together, so the state flagged him as being due for another dose. A third dose was given; This spontaneous report was received from a licensed practical nurse and refers to a male patient of unknown age. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 01-NOV-2017, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vial (dose description, and route of administration were not provided), lot #N009801, expiration date: 20-NOV-2019, administered as prophylaxis. On 16-MAR-2018, he was vaccinated with a second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vial (dose description, and route of administration were not provided), lot #N021572, expiration date: 01-MAY-2020, administered as prophylaxis. The reported stated that as the first 2 doses were given too close, he was flagged to being due for another dose; therefore, a third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe was given on 09-MAR-2022, (dose description, and route of administration were not provided), lot #U019413, expiration date: 01-NOV-2023, administered as prophylaxis (Inappropriate schedule of product administration). Then, a year later, on 08-MAR-2023, a fourth dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe was given (dose description, and route of administration were not provided), lot #W013165, expiration date: 14-DEC-2024, administered as prophylaxis (extra dose administered). No symptomatic adverse events (AE) were reported (no adverse event).
I started having a low-grade fever, extreme fatigue, sore throat, congestion, and heavy coughing. I took an at-home COVID-19 test on 01/08/2023 which came back positive. It made sense since I had just gotten back from a trip.  I contacted my doctor due to the sore throat and heavy coughing not settling, so I was prescribed a steroid treatment to aid the pain ( ).
Sounds started sounding muffled and then the next day I was completely deaf.  I went to Hearing Specialist that Monday and they sent me to facility that next week and I received cortisone shot in ear drum and it did not help. I now have a cochlear implant.
The patient turned 12 years old 7 days prior to the clinic.  He received his second dose of COVID-19 and was given a 5-11 dose. He and his mother declined the offer for 2 additional doses.  The mother preferred getting the pediatric dose.  She agreed to discuss this issue with the patients doctor
her arm is still hurting; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via Information (reference number: 00341583) and transmitted to Sanofi on 02-Nov-2020.  This case involved a 59-year-old female patient for whom it was reported the arm is still hurting (Pain in extremity), while she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included NA (sodium).  On 18-Oct-2020, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA2048, exoiration date 30-Jun-2021) via unknown route in the left arm for prophylactic vaccination.  On 18-Oct-2020, it was reported the arm is still hurting (Pain in extremity), on the same day following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  No relevant laboratory test was reported.   The patient was treated with paracetamol (tylenol) for pain in extremity.  The patient outcome was reported as unknown.
pt recvd vax 10JAN94 & 13JAN seen by MD for erythema, swelling & warmth @ DTAP inject site; size of react 4 x 6 cm; pt recovered;
Patient is 11 years, 8 months old at time of vaccination. Given 0.3ml of Pfizer covid 19 vaccine. No adverse effects reported at this time.
This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional details were provided as follows: The healthcare professional stated that SHINGRIX was inadvertently stored in the freezer, which led to incorrect storage of vaccine.
MD rpt pt recv 1dose varivax 4/27/98 & 5/11/98 devel inject site induration & redness
Large bruise on arm extending from injection site to elbow.  Greatest area of bruising near elbow.
FEVER OVER 104 F. HEADACHE, BODYACHE, BELL'S PALSY, DRY MOUTH, LOSS OF CONFIDENCES. LASTED FOR 6 DAYS OR MORE.
Right arm had injection site reaction. Injection site was red, had inflammation that looked like a ring around injection site, was hot to the touch only above injection site.
Anaphylactic Reaction,  facial swelling, facial Redness, Face felt like it was burning, face flushing, throat swelling, heart palpitations, trouble swallowing , feet swelling, light headed,  anxiety.  Hospitalized  from the 12/23/20 to 12/26/2020 .  Medications now on Epinephrine, diphenhydramine, cetirizine, famotidine, prednisone, lorazepam, cephalexin.  on 1/1/2021  was taken to E.R. by ambulance  around 11:00 am  left hand was tingle  started to go numb  traveled up my arm into left side of my face ,ear, tongue, and then down to the left side of my leg and into left foot, could not move left side of body for a good 7 to 8 mins then went away transferred to ambulance enroute to ER blood pressure was high  and  and started having right ear pain and right side frontal severe  headache, arrived to ER and was given diphenhydramine ,ketorolac, metoclopramide HCI,  lorazepam.  MRI was ordered and Neurologist found two small lesions on right side of frontal brain, following up  now with neurologist.   added more meds naproxen
Started ice and ibuprofen in afternoon by night time couldn't use left arm had extreme pain in lower back, neck and migraine. 800mg of ibuprofen every 6 hrs didn't relieve any pain for 5 days. Arm was extremely sore for 10 days. Unable to sleep due to pain.
My face began to itch around 9 pm last night. I woke this morning with a slightly swollen face and extremely itchy face even my ears. I took a antihistamine which has helped but it still itchy. It?s currently 1 pm the following day after the first dose
Two weeks after receiving Rotateq - 05/03/07 dx with intussusception - requiring surgical intervention.  5/22/07 Received vax records & operative note from PCP which reveals patient experienced intussusception which was initially reduced by contrast.  However, symptoms persisted & contrast study was repeated which revealed recurence of IS right at ileocecal valve & patient taken to OR.  Findings at surgery were ileoileal IS successfully reduced w/o difficulty, Peyer patch & incidental appendectomy was done.  Vax record corrects lot numbers, VAERS database updated.  7/17/07 Received hospital medical records which reveal patient experienced vomiting, bloody stool, lethargy, dehydration & decreased appetite.  FINAL DX: Intussusception.
Patient received booster dose of Moderna vaccine on 5/23/2022 at 1145 using expired dose with beyond use date of 5/21/2022. No harm to patient or monitoring provided. Per CDC guidelines, Moderna manufacturer has been contacted for information on the stability of the vaccine and whether the dose needs to be repeated. The patient will be contacted for follow-up once this information is available.
Information has been received from a registered nurse referring to a 15 year old patient of unknown gender. On 16-JUL-2015 the patient was vaccinated with GARDASIL (lot # K008931, intramuscular, expiration date and dose were unknown) which excursed the storage temperature (incorrect product storage). No reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Unknown Pt died in her sleep morning of 10/19, she did have low grade, subjective fever 10/17 and 10/18. No additional information in discharge summary rec'd 11/9/05/sr Additional information added from Autopsy report rec'd 01/11/2006: Preexisting condition -- chronic bronchitis. Patient's sibling was hospitalized for flu & fever & had full recovery & sibling's admission medical record included.  Post mortem viral c/s were neg./sr
Red welt - due to Tdap Lt arm. Ice, MOTRIN. Get worse to go Urgent Care.
Information has been received from a health professional concerning a pt who was vaccinated with ehp b vaccine recombinant. It was reported that 21 days post vaccination the pt experienced tingling in bilateral extremities. Unspecified medical attention was sought. No other information was available. Additional info has been requested.
4/15/2021  8am-Lower back pain, 3:30pm Severe stomach cramping (menstrual type cramps), 6:30pm chills, fatigue and severe stomach pains which lasted until I fell asleep around 11:30pm.  Woke up the next morning and all symptoms were gone.