chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt got Moderna Covid 19 vaccine Lot # 010A21A and developed flushing/tingling from injection site to face in first 15 minutes of observation.  Pt was asked to stay for observation for an additional 15 minutes.She continued to report same symptoms. Pt was then given 50mg Diphenhydramine IM x1 and asked to stay for additional observation.  After 5 minutes symptoms began to resolve and pt was allowed to leave.
Pt reports that 5 days after receiving vaccines, he began experiencing, generalized itching. Two days after itching began he developed generalized hives. No respiratory distress.
None, R/B/SE Discussed with Mom.  Dose was going to be wasted.
sudden death; atuopsy report-cause of death remains undetermined; The poss of a sudden arrhythmia based on a morphologic abnormality of the conducting system of the heart will be investigated further;
12 days after receiving the Moderna booster shot, I starting having dermatographic hives all over my body.  The hives come and go on all parts of my body.  They are warm to the touch and very itchy.  They will fade in one place and then pop up in another place.  I have been dealing with these hives since 11/6/21.
Pt recv vax on 7/10/98; on same day pt exp weight loss &fatigue, autoimmune rx, juvenile rheumatoid arthritis sx, stomach pain; pt has seen several M.D.s
Pt called AM on 5/25/16 and then came to clinic at 16:28 on 5/25/16 with c/o red arm, swollen. Localized reaction to PNA vaccine, patient rapidly assessed with mild erythema and warmth nontender from AC fossa upward anterior bicep. Advised cool compresses, elevation, ALEVE, diphenhydramine 12.5 mg q 6 hrs PRN. And mild erythema.
felt like I had the 24 hour flu; This non-serious case was reported by a consumer via call center representative and described the occurrence of influenza in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On 13-SEP-2023, an unknown time after receiving Shingrix, the patient experienced influenza (Verbatim: felt like I had the 24 hour flu).  On 14-SEP-2023, the outcome of the influenza was resolved (duration 1 day).   It was unknown if the reporter considered the influenza to be related to Shingrix.     It was unknown if the company considered the influenza to be related to Shingrix.   Additional Information: GSK Receipt Date: 19-SEP-2023 On Wednesday, The patient felt like having the 24 hour flu and rested all day.  The patient was much better on Thursday.  No response was necessary. The reporter was requested for follow up.
The pain gradually increases I couldn't lay down in bed from 11/14/2018 so I slept on couch. I had extremely sharp pain in my arm couldn't move from couch for hour 4th day of morning from vaccine date. So I went ER 11/17/2018 took Xray and had toradol shot. I went back to my PCP on 11/20/2018 8:30am took Xray again but Dr told me I must hit my arm somewhere because he see that trace of internal bleeding like bruise in my left arm but I don't have any discoloration surface of my arm. he said I should recover in 3month but I still have pain in my arm and can't lay on left side of body.
About a week after I got the shot my whole upper arm was red and itchy. I had fever and chills, that didn't last long- 2-3 hours maybe. A week after I got a not in my throat. I went to my Dr he did an ultrasound and sent me to an ENT. The ENT did an ultrasound as well and said he would follow up with me in 3 months, but everything looked fine. The lump went away.
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. On 06-FEB-2015 the patient was vaccinated with a dose of GARDASIL 0.5 ml, intramuscular (lot # not reported) that had undergone temperature excursions. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
patient was given covid vaccine and 3 minutes after shot was given patient passed out in waiting room. patient came to and was diaphortic cool rag applied and fan applied and flushed. VS 02 sat 97% HR 82 BP 125/84 R 22 After 15minutes additional patient stated felt fine and was able to drive home denied dizzyness and was not going to pass out. patient has had passing out episodes after flu shot as well and forgot to tell us. patient was going to eat lunch now due to has not eaten yet.
dizziness; This is a spontaneous report from a non-contactable consumer from a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on an unspecified date at dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient (reporter's mother) experienced dizziness 1 week after the first dose on an unspecified date. The outcome of the event was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Began 1/7/03 with red bumps on chest and abd-fluidd center. T 99.8 ax.
Around 3 P.M. started having chills. Hands felt like ice. Went to bed to warm up. Got up around 6 P.M. Went to have some hot tea and a slice of toast. Started shaking.  Right after I finished the tea and toast I threw it up. I was still extremely cold. My eyes looked bloodshot. Also had a faint headache and my arm hurt where the shot was given. In the morning I felt better and my eyes were clearing up. Still had a faint headache. My doctor said it was just my body getting used to the vaccine.  I had not have a flu shot for several years because I don't get sick very often.
Within minutes of vaccination patient felt lightheaded/dizzy. Felt cool/clammy hypotensive bradycardia. NP from Clinic assisted patient prior to 911 call.
Patient received vaccines on  2/14/19. Patient returned to clinic for follow-up vaccines on 3/15/19. Patient presented with a rash that began on 2/15/19 on his hands and spread to his arms, torso, and legs. He reported no other problems, including fever, myalgias, or difficulty breathing. Rash appeared to be a combination of large red raised wheals (1-3 inches in diameter) and small scabbed papules. Patient reported  the rash was pruritic and scabbed areas were likely as a result of scratching. He reported having a family member in the home, age 12, who had a similar rash and had not received vaccines. He had not received any other follow up or treatment for the rash or any other problems. Vaccination was deferred and patient was referred to a primary care provider for follow-up.
The patient who is 10 years old was given the adults dose if Pfizer covid bivalent booster. The patient accompanying with the parent walked out the pharmacy without reporting any side effects at the moment
I woke up at approx 2:00am 02/03/2021 with my clothes soaking wet,even my bed sheets. I was chilling, very nauseated, had a headache, diarrhea, heart burn, and a fever of 101, very weak, muscle aches,  very fatigued, and no appetite. These symptoms lasted all day Wednesday 02/03/2021, Thursday 02/04/2021, and Friday 02/05/2021. I was able to eat very little on Thursday. When I woke up on Friday 02/05/2021 I was much more nauseated. I threw up two times Friday morning and was unable to hold my daily medications down. I still had all symptoms that I listed above. I called my endocrinologist Friday morning and he had me come to the infusion clinic to get a bolus of IV fluids and IV steroids....I was able to sleep for 3 hours whenever I came back from the infusion clinic and was able to hold some food down.  101.8 was the highest that I am aware of that my fever was. Saturday 02/06/2021- Monday 02/08/2021 most symptoms had subsided except mild nausea, heartburn and sinus drainage. I was able to return to work on Tuesday 02/09/2021. I had every symptom of COVID-19 other than loss of taste or smell. I was rapid tested and PCR tested on Friday 02/05/2021 and both results were negative.
flu like symptom's; Ache in neck; Ache in back; pain in arm; have been sick/ she does not feel great; Chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptom's), NECK PAIN (Ache in neck), BACK PAIN (Ache in back), PAIN IN EXTREMITY (pain in arm) and MALAISE (have been sick/ she does not feel great) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 048C21A, 022M2014 and 031LZ0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Consumer reported no pre-existing condition nor allergy.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2022, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptom's), NECK PAIN (Ache in neck), BACK PAIN (Ache in back), PAIN IN EXTREMITY (pain in arm), MALAISE (have been sick/ she does not feel great) and CHILLS (Chills). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptom's), NECK PAIN (Ache in neck), BACK PAIN (Ache in back), PAIN IN EXTREMITY (pain in arm), MALAISE (have been sick/ she does not feel great) and CHILLS (Chills) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2022, Blood test: did not find anything (normal) Did not find anything. In April 2022, SARS-CoV-2 test: negative (Negative) Negative.         Concomitant product use was not provided by the reporter.  Patient started to experience symptoms in the evening of vaccine receipt and have been sick for week and half.  It was reported that symptoms are somehow ongoing.  Treatment information was not provided.
PT C/O RAPID HEART BEAT/DIZZINESS/FEVER, DIZZINESS STARTED ABOUT TWO HOURS AFTER INJECTION AND THEN CONTINUED THE NEXT MORNING WHEN SHE WOKE UP, AND INCREASED HEAR BEAT, FEVER OF 100, SHE STATED THAT SHE HAD THE SAME ISSUE WITH HEART RACING WITH FIRST HPV THAT WAS GIVEN TWO MONTHS AGO, BUT SYMPTOMS RESOLVED. PT DID ALSO RECEIVE DEPO PROVERA INJECTION THE SAME DAY FOR CONTRACEPTIVE MAINTENECE.
Headache, Fatigue, body aches for 24 hours (started 3/19/21) Additionally on 3/23/21 GI distress and headache, fatigue for about 12 hours
1 of 3 pts immunized who devel pneumonia or chest congestion, fever; pt recvd vax OCT92 & began developing frequent colds, ear infect, chest congestion & fevers; recovery status unk;
2nd dose would need to be administered by this Sunday (13Feb2022) but it is unknown if the patient will be able to receive dose before then; No additional AE; 2nd dose would need to be administered by this Sunday (13Feb2022) but it is unknown if the patient will be able to receive dose before then; This spontaneous report was received from physician referring to approximately 4-month-old male patient. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not provided.  On an unknown date, the patient vaccinated with first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at age 9-weeks-old (orally, vaccination scheme, and anatomical location of vaccination, lot number and expiry date were not provided) for prophylaxis. Physician stated that a child will receive second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ). Second dose would need to be administered by this Sunday (13-FEB-2022) but it was unknown if the patient will be able to receive dose before then (Intentional product misuse and circumstance or information capable of leading to medication error).  No product quality complaint (PQC) and no additional adverse event (AEs) (no adverse event) was reported.
Information has been received from a registered nurse concerning a 65 year old female with no major medical history, who in March 2008, was vaccinated with a dose of PNEUMOVAX 23 (Lot # 658673/0990U). Concomitant therapies included calcium (unspecified) (+) vitamin D (unspecified) and vitamins (unspecified). Subsequently the patient experienced extreme, severe pain in her left shoulder. It was reported that as of 29-SEP-2008 the patient was still stiff and sore. The physician noted that the patient had a good range of motion. However the patient had to take narcotic pain relievers for pain. At the time of the report, the outcome of the patient was unknown. Additional information is not expected.
Information has been received from a physician concerning a 7 month old patient who on 24-FEB-2009 was inadvertently vaccinated orally with the first dose of ROTATEQ 2 ml (Lot # 1358X).  No adverse effects were reported.  The outcome of adverse event was not reported.  It was not reported whether the patient sought medical attention.  Additional information has been requested.
Abnormal periods hemorrhaging, Adenomyosis, and development of fibroids. 12/28 uterus, ovaries, and cervix removed. Bloating, fatigue and mood swings.
has had sore arm since inject; had nausea & vomiting w/muscle aches; will see MD on 7DEC re: pain in arm;
A report has been received from a Health Professional concerning patients of unknown gender. No information regarding relevant history, concomitant disease and concomitant medications were provided. The patients had been receiving nasal FLUMIST QUADRIVALENT which was started on an unknown date. An office nurse reported that they have had over 12 breakthrough cases of FLUMIST QUADRIVALENT recipients testing positive for flu. Every patient tested positive for Flu A. The outcome of the event of testing positive for flu A was unknown. The reporter considered the event to be non-serious.
Pt started feeling faint and nauseous after immunization. Did not improve with time and laying down. VS stable. Pt given 25 mg IM BENADRYL without improvement. Transport to hospital via ambulance.
4-15-08 p.m. right arm became red, swoolen and warm (approx 4 inch long) around whole upper arm.  Gave Motrin.  4-15-08 p.m. Saw Dr.  4-16-08 a.m. advised cold pack, given allergy and cream.  Advised her to mark area with pen so can evaluate if condition worsens/improves.  Call Dr. if worsens.  When next Td due, advise Dr. of reaction.
swelling in my hands and lips; swelling in my hands and lips; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (swelling in my hands and lips) and PERIPHERAL SWELLING (swelling in my hands and lips) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 024M20A or 026M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ACYCLOVIR [ACICLOVIR] for an unknown indication.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1. On 12-Mar-2021, the patient experienced LIP SWELLING (swelling in my hands and lips) and PERIPHERAL SWELLING (swelling in my hands and lips). The patient was treated with IBUPROFEN for Swollen lips and Hand swelling, at an unspecified dose and frequency. At the time of the report, LIP SWELLING (swelling in my hands and lips) and PERIPHERAL SWELLING (swelling in my hands and lips) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient received Moderna Bivalent Covid-19 vaccine that expired on May 30, 2023; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Bivalent Covid-19 vaccine that expired on May 30, 2023) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 020H22A) for COVID-19 prophylaxis.     It was reported that patient did not have information about previous COVID-19 vaccination doses.     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Bivalent Covid-19 vaccine that expired on May 30, 2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Bivalent Covid-19 vaccine that expired on May 30, 2023) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Bivalent Covid-19 vaccine that expired on May 30, 2023).    No concomitant information was reported. Suspect product dosage text was reported as unknown. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-728286 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728286:Master case
She began to experience tachycardia about 10mins after vaccine admin. She was brought over and assessed. The pt stated that her heart was racing and she felt like she was breathing through a straw. Initial vitals @ 1400: 112/86 (pt reports high for her), HR: 110 and 95% O2 sat. She continued to state, "I just can't get a deep breath". Did not note pallor, no clammy skin, pt alert and oriented x 3. Doc assessed the pt who had clear lung sounds and a tachy but normal heart rhythm. At 1409, the pt's BP: 114/78, HR: 105 and 93% O2 sat. The pt was moved to a chair for comfort at 1415 and states, "well that made me feel fuzzy". During the transition, her heart rate accelerated to 124. Her BP at this time was 117/82, HR: 109 and 92% O2 sat. At 1422: BP: 114/84, HR: 101, 91% O2 sat. No change in her symptoms at this time. Still "tight" in her throat. Doc reassessed at this time and the decision was made to administer epinephrine. She was given 0.3mg of Epinephrine at 1430 (Lot: OGM433, Exp: Sept 2022). The pt started to feel less tightness in her throat about 3 mins after the epi. BP to follow: 118/87, HR: 150, 95% O2 Sat. EMT team called, arrived at 1435 and transferred to hospital
Information has been received from a nurse concerning a female patient who at an unknown dates was vaccinated with first and second dose of Gardasil. Subsequently the patient experienced heart palpitations after both doses. Unknown medical attention was sought. The patient's outcome is unknown. No product quality complaint was involved. Additional information has been requested.
24 hours post vaccine patient began to experience blurred vision, tinitis, stabbing headache, and bilateral tremors in hands. Patient reported to ER for evaluation and was referred to his Neurologist.
Red, hot to touch, swollen 60 ml by 75 ml area left upper outer arm.  Nurse follow up on 07/30/04 states: "cellulitis."
Irregular heartbeat that lasted for 10 minutes on both vaccinations 31 Jan 2021 and 05 Mar 2021
Symptoms started exactly 2 months after her 2nd shot. Started with headaches, nausea, vomiting, strep throat and body aches. Continues on with non-epileptic seizures, twitches, unconsciousness, long and short term memory loss, hair loss, fatigue, joint pain and neck and back pain. Continues on after 3 1/2 months.  4/27/09 Received vaccine & PCP medical records of 8/1/08-2/3/2009. FINAL DX: encephalopathy w/memory loss. Records reveal patient experienced good general health on 8/1 when seen for sports physical.  RTC 8/26 w/insect bite w/swelling, warmth & pain LUE, felt sick, nausea, HA.  Tx w/antibiotics.  RTC 12/18 w/vomiting, abd pain, nausea, chest pain x 1 mo, coughing, earache, migraine HA increased in frequency, sore throat, fatigue & malaise x 5 mo, excessive sleeping.  Tonsils enlarged, strep test (+) & dx/tx for strep pharyngitis.  RTC 1/5/09 appearing ill w/sore throat, cervical lymphadenopathy, sick stomach, nausea, vomiting, low grade fever, HA, decreased appetite, dizziness.  Dx w/continued strep pharyngitis.  Tx w/IM antibiotic & continued on oral antibiotics for another course.  Seen in ER on 1/8/09.  RTC 2/3/09 w/sore throat, sister w/strep throat.  Parent reported episodes of seizure like posturing, gaze palsy, opisthotonos since 1/7/09 daily until 1/19.  Had multiple ER visits.  Hospitalized overnight for EEG which was WNL.  No further seizure episodes but significant memory loss.  Neuro-psych eval dx w/30% remaining memory.  Missed a lot of school.  Dx 2/3 w/pharyngitis, probably viral; encephalopathy w/memory loss, uncertain nature & cause.  5/18/09 Received hospital medical records of 1/16-1/17/2009. FINAL DX: nocturnal spasms Records reveal patient experienced muscle tension, arching back, eyes rolling back, unresponsive & dystonia nightly x  7-10 days lasting 15 min to 2 hr.   School performance had been affected since mid-Dec when episodes had started. Admitted for 24-hr video EEG which was WNL.  Neuro exam WNL.  Referred to Psych.  5/20/09 ED records received multiple DOS 1/7/09 to 1/12 FINAL DIAGNOSIS: Syncope, seizure, acute vomiting, cephalgia and neck stiffness Post vaccination: nausea, vomiting, body aches, twitching, unresponsive at home, headache, neck stiff. Dizziness, numbness, tingling in hands and feet, crying. Hyperventilation with carpal pedal spasms. Myoclonic tremors.
Pt c/o dizziness 15 mins after receiving 2nd dose of the vaccine. She reported that she had no problem with the first dose. She noted that her medical hx is depression controlled with meds but she has some anxiety because she lost an uncle to COVID-19 yesterday. She was assessed and monitored by NP, EMT, and paramedic. BP - 121/81, HR - 127, O2 sat -97% on RA, ST on monitor, blood glucose -148. She was given H2O, she declined snacks, instructed on relaxation measures. Expressed condolences to her for the loss of her uncle. She was kept until she relaxed and noted that she felt better. She was given the Vaccination information sheet, reinforced instructions on ADRs/SEs to call 911 and go to ED and follow up with her PCP and specialist and also to register with V-safe. She verbalized understanding and willingness to comply. She left site w/o complaints, in no acute distress, awake, alert, oriented to person, place, time and situation, had no suicidal or homicidal ideations. She noted that her husband will be driving her home.