chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever 101 F Body chills Headache Pain at injection site For now it has been 24 hr
2/12:  developed leg swelling, pain, numbness and tingling.  2/19 developed rash on face and both arms with itching.  2/26 ED visit diagnosed with worsening  of peripheral neuropathy.  3/3 - office visit complaining of worsening peripheral edema
pt recvd measles 29APR90 given MMR/HIB 2JAN93 next day couldn't walk, hi fever went to hosp ER;
It was written and checked that a Hep A Vaccine was administered but the lot number documented indicates it was a Hep B vaccine. There we no s/s that indicated any adverse reaction.
Shortness of breath; This spontaneous case was reported by a pharmacist and describes the occurrence of DYSPNOEA (Shortness of breath) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced DYSPNOEA (Shortness of breath). At the time of the report, DYSPNOEA (Shortness of breath) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.    Reporter did not allow further contact
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications were provided. No treatment medications were provided.
Case number PHEH2014US021025, is an initial spontaneous report from a consumer (patient's spouse) received on 19 Oct 2014. This report refers to a 45-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with 0.5 ml of FLUCELVAX, (batch number: 161211) into deltoid on 13 October 2014 at 12:15 hours. On the same day, post vaccination, she experienced vertigo at 12:45 hours and injection site whole arm numbness at 14:00 hours. It was reported that she could not go to work or drive from 13 Oct 2014 at 23:45 hours till 15 Oct 2014 at 07:15 hours. On 14 Oct 2014, she experienced malaise at 6:00 hours. Event of numbness was resolved on 13 Oct 2014 at 17:30 hours, malaise on 15 Oct 2014 at 5:45 hours and vertigo on 19 Oct 2014 at 12:00 hours. The reporter assessed the events as serious (significant disability). Causality assessment of the events was not reported.
On 6/4/21 at 10:40, res became unresponsive with agonal/snoring respirations, no palpable pulse, but audible apical pulse with irregular rhythm, general pallor nd cyanosis, cool and clammy skin. BP92/58 manual, R 4 initially sats low 90's. Accucheck 181. required heavy tactile sternal rub; Res vomited large amt of yellow/white vomitus and had large diarrhea episode. She became responsive after sternal rub but shortly thereafter became unresposnive again. MD notified with new orders for labs and head CT.
Initial report received on 11 December 2013 from consumer. A 56 year old female patient whose medical history and concomitant medications included as antibiotics, received a dose of FLUZONE ID (route was intradermal, lot # UT4721AA, expiration date unknown and site was left deltoid) on 16 September 2013. Reporter stated that on 16 September 2013 patient developed bump at injection site immediately after vaccine, and site redness. Also stated that bump at site has persisted since vaccination, now bump is red for the last 10 days, patient started abx for infection and on 16 September 2013 bump has turned red. Event was not recovered at the time of report. List of documents held by sender: none. Additional information received on 20 December 2013 from consumer: Concomitant medication added as antibiotics.
This patient was inadvertently given a 3rd Shingrix injection, 6 days after she had received her 2nd Shingrix shot. Patient was followed up within one hour of receiving shot, 24 hours later, 4 days later and one week later. Patient responded that she had not experienced any adverse sign or symptoms.
06/26/2021 I was unable to sleep through out the night and about a month later it progressed throughout the day. my heart rate was elevated. anytime I got up my heart rate would go up. I ended up being diagnosed with POTS
She had high fever before lunch time. She was pale, limp and lethargic before leaving fr office. By the next day fever had spiked very high and remained high for 3 days. Fever came and went for more than a week and her body broke out in a rash all over. Then on 02/13/15 she began having seizures at 10:00 in the evening. We called an ambulance and took her to the hospital. No treatment or tests were done. The following day at 3:30 PM, she had a grand Mal seizure lasting 10 minutes and the post-seizure state lasted all evening. We saw loss of appetite, stomach damage and zero weight gain for 6 months. She was taken to the ER for consistent diarrhea. X-rays and stool samples were done but no treatment was administered. Seizures have continued intermittently but no treatment has been recommended.
had the first dose of his COVID19 vaccination on November 24, 2021. He was mistakenly given the second dose at a school drive only nine days later - yesterday, December 3, 2021. The school's clinic for the first dose was on November 10 and they were instructed at that time that   would not be receiving his shot at school and should be pulled out of the drive.
Muscle aches, constant headache, mild weakness, stomach pain, severe constipation that is still an issue (with occasional diarrhea), and weight gain. My diet never changed.
accidentally left the refrigerator door open too long due to Human error, 3 separate excursions with the same vaccine Total: low of 1.85C for 30 minutes and a high of 8.74C for 60 minutes with no reported adverse event; administered to the patient post excursion with no reported adverse event; Initial information received on 22-Jul-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 10 years old female patient who received the vaccine IPV (VERO) [IPOL] from the refrigerator, of which the door open too long due to human error, 3 separate excursions with the same vaccine total: low of 1.85c for 30 minutes and a high of 8.74c for 60 minutes and administered to the patient post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 08-Jun-2023, accidentally left the refrigerator door open too long due to human error, 3 separate excursions with the same vaccine IPV (VERO) and total: low of 1.85c for 30 minutes and a high of 8.74c for 60 minutes with no reported adverse event (product storage error) and the vaccine IPV (VERO) administered at a dose of 0.5 ml (Frequency = Once) of standard strength suspension for injection with (lot: V1A021M, Expiry date: 27-Feb-2024) via intramuscular route in unknown administration site for Immunization to the patient post excursion with no reported adverse event (poor quality product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for both the events.  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 the Directive 2001/83/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.
Patient was given the Moderna booster vaccine earlier then recommended. Patient received his second dose of Moderna vaccine on 7/21/2021 and was given his booster dose (0.25ml) on 12/15/2021. Patient was observed at clinic, no adverse reaction was noted. Patient and provider is aware of the incident.
Pregnant patient received the 1st dose of the vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant patient received the 1st dose of the vaccine) in a 36-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy and Subfertility. Concurrent medical conditions included Type 1 diabetes mellitus. Concomitant products included LEVOTHYROXINE SODIUM (TIROSINT) and INSULIN for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 25-Aug-2020 and the estimated date of delivery was 27-May-2021. On 16-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant patient received the 1st dose of the vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twentieth week of the pregnancy.  On 16-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnant patient received the 1st dose of the vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment information for the event was provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jan-2021: Internal review on 19-JUL-2021 resulted in updates to pregnancy details.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 36-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Injection site area still very sore with some black and blue areas. It has been 27 days since the injection.
Period started early and was heavier and lasted longer than normal.  Also developed rash on arm near injection site.  Both resolved within 7 days.
81 yo F who gets most of her health care at Local Center. She has a PMH of polymyositis, restrictive lung disease on chronic 2L NC O2, Obesity, Graves Dis treated w/  I-131 now hypothyroid, chronic AFib on coumadin, CHF, CAD, PVD,  HX DVT, and RA. She is on chronic prednisone 5mg daily. She p/w worsening cough and progressively more SHOB over the past week with productive clear sputum. She denies chills, sweats, fevers, chest pain, hemoptysis, syncope, N/V, hematochezia, melena, abdomen pain, dysuria, HA or confusion. She has chronic peripheral edema and what she describes as chronic vascular leg wounds treated with wraps and HHN wound care. She feels weak and fatigued ---has limited mobility at baseline (wheelchair use) and found that she needed assist of 2 persons last eve to get up. She has had up to 3 loose stools daily over the past 5 days. She started cefuroxime (from her PCP for bronchitis) last pm, otherwise has had no recent antibiotics. In the ED, she has T 99.3,  HR 80s NSR on EKG, BPs 140-150s/60-80s, RR 26; hypoxic to 83% on RA; ABGs on home 2L O2: 7.36/54/75/30. She is up to 95% sat on her home 2L NC O2. She has leukopenia (3.43) and thrombocytopenia (98).  K+ 3.2, BUN/creatine 13/0.8, alk. phos 150, PCT 0/18, lactate nl, 5G TNT flat @ 37 x2. PT/INR 56.2/4.8. COVID positive. CXR: "medial RUL airspace dis, left basilar atelectasis vs airspace dis"; CTA chest:  "No PE; patchy consolidation RUL with patchy ground-glass changes seen in left lingula. Infectious process suspected--COVID pneumonia could give this appearance."  She had deep penetration on June 2021 VFSS. Rocephin and azithromycin was  started in the ED, pharmacist reported that patient, family, and her PCP office do not know if indeed an allergy to azithromycin and rocephin as listed and what RXN was --She tolerated first doses and will monitor on continued. Hospital Medicine has been asked to admit the patient. PATIENT IS INPATIENT AT THIS TIME.
pt recv vax #2 on 2/4/94 & suffered extremely severe demyelinating disease characterized by almost complete paralysis, blindness & confusion;slow recovery;relapse in Jan95 w/optic neuritis & temp blindness after Vax #3;partial recovery
Acute transverse myelitis; Quadriplegia; This case was reported by a lawyer and described the occurrence of myelitis transverse in a 62-year-old male patient who received Herpes zoster (Shingrix) (batch number unk, expiry date unknown) for prophylaxis.   The initial information was received on 11 June 2021 via medical record. ( Case is medically confirmed). Recent shingles vaccination which occurred on 21 October 2019. On 10 December 2020, patient complaint had Transverse Myelitis. The patient had Acute transverse myelitis in demyelinating disease of cnsl at the cervical cord , now stable in the last few days, C spine MRI with abnormal signal at C3 level and Quadriplegia, unspecified.
Narrative:  Edema was improving prior to apixaban being stopped, however apixaban was eventually stopped in late February 2022. Patient has not yet received second Shingrix dose, unsure he will.
didn't check for fever until 12pm and fever was 101. Got up to 103.3; body aches; headache; gassy stomach; nausea; lethargy; I had chills; This is a spontaneous report received from a contactable other hcp. A 32-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONECHC COVID-19 VACCINE, Batch/Lot Number: EH9899), Solution for injection, via an unspecified route of administration, administered in Arm Left on 20Jan2021 16:00 (at the age of  32-year-old) as single dose for covid-19 immunisation. Medical history included asthma and juvenile rheumatoid arthritis. There were no concomitant medications. The patient previously took cardec and experienced cardec allergy. Patient historic vaccine included first dose of bnt162b2 (PFIZER-BIONECHC COVID-19 VACCINE, Batch/Lot Number: EH9899) Solution for injection, via an unspecified route of administration, administered in Arm Left on 30Dec2020 01:45 PM as single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and she did not receive any other medication in two weeks. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vac-cination. On 21Jan2021 03:00, the patient had chills, didn't check for fever until 12pm and fever was 101. got up to 103.3, body aches, headache, gassy stomach, nausea and lethargy. The patient underwent lab tests and procedures which included body temperature: 101 on 21Jan2021 got up to 103.3. Adverse event resulted in doctor or other healthcare professional office/clinic visit. No treatment was received due to adverse events. The events was recovered on an unspecified date in 2021.  Follow-up attempts completed. No further information expected.
Fever 100.8, chills, body aches, exhaustion, pain in left arm gradually spreading over entire left side of the body, numbness/tingling of left lower lip
Information has been received from a licensed practical nurse concerning an 18 month old male with a history of immunization who on 02-MAY-2009 was vaccinated with a dose of PNEUMOVAX (lot # 661577/1161X) instead of PREVNAR due to human error (route and site not reported). No adverse event was reported. The patient had received the first and second dose of PREVNAR on 23-SEP-2008 and 03-FEB-2009. Follow-up information was received from the licensed practical nurse. The patient was 22 months old. The nurse indicated that the mistake was due to human error. She reported that both vaccines were stored next to each other on the same shelf and the nurse "inadvertently grabbed the wrong one". She said that the label was clear. Follow-up information was received from the physician who reported that the patient was given PNEUMOVAX instead of PREVNAR by mistake. The physician reported that on an unspecified date, the patient experienced a mild skin reaction. At the time of the report, the patient had recovered. No other untoward effects. It is unspecified if the patient sought medical attention. No further information is available.
Beginning early March I first noticed irregular and then rapid heartbeats and tracked them on my watch. Contacted cardiology who diagnosed me with inappropriate sinus tachycardia. Then April 1 I developed loss of color vision and acuity diminished in my right eye. Spent 4 days in the hospital diagnosed with optic neuritis. Then followed up with neurologist who ordered a spinal tap which revealed 5 OCB bands. My brain mri confirmed brain lesions, optic neuritis and now my CSF shows Multiple Sclerosis. Which i didn?t have prior to the vaccine.
11/19-noticed right side of forehead was tender to touch, intermittent pain in right side of head, just didn?t feel right. 11/20 same thing as the day before but now pain in right ear, in front of ear, in back of head, in back of neck that would come and go not relieved with continued ibuprofen 600 mg every 6 hours. 11/21-woke up with rash on right side of forehead into scalp , 1 spot on eyelid, & many spots on my head which I knew to be shingles. Made an appt to see NP. Started Valacyclovir that morning.
The third day the jaw pain; Slept all day the second day; Tiredness the day of the shots; This is a spontaneous report from a non-contactable consumer, the patient. A 16-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the left arm on 02Aug2021 at 11:00 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received amoxicillin (MANUFACTURER UNKNOWN), for unknown indication from an unknown date and experienced drug allergy. On 02Aug2021, the patient experienced tiredness the day of the shots, slept all day the second day (on 03Aug2021) and the third day (04Aug2021 at 04:00) the jaw pain started up to the moment 15Aug2021. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tiredness the day of the shots, slept all day was unknown while that of the jaw pain started up was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
He had COVID-19 after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (He had COVID-19 after vaccination) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concomitant products included GUSELKUMAB (TREMFYA), NEBIVOLOL HYDROCHLORIDE (BYSTOLIC) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced COVID-19 (He had COVID-19 after vaccination). On 24-Jan-2021, COVID-19 (He had COVID-19 after vaccination) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jan-2021, SARS-CoV-2 test: covid-19 Positive. On 24-Jan-2021, SARS-CoV-2 test: covid-19 Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Patient was treated for Covid-19 infection with Regeneron Monoclonal antibody, intravenously on 20Jan2021
Patient states she was at parking lot when she started feeling dizzy, out of breath, with palpitations and blurred vision. She was able to drive to work, where she was monitored by nurse practitioner, her B/P was 146/86, symptoms subsided after 40 minutes after drinking water and eating candy.
patient received half a dose of the vaccine at the time of the first dose; This spontaneous case was reported by a health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (patient received half a dose of the vaccine at the time of the first dose) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 001B21A) for COVID-19 vaccination.     no medical history was provided by the reporter.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced ACCIDENTAL UNDERDOSE (patient received half a dose of the vaccine at the time of the first dose). At the time of the report, ACCIDENTAL UNDERDOSE (patient received half a dose of the vaccine at the time of the first dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   NO Concomitant products were provided. no treatment medications were provided. HCP inquires that  the patient should receive a third dose of the vaccine.
woke up at 7pm, at 8 pm head started really bad, then tummy start to hurt, body aches, temperature of 100.7, all day today 99.3, also started with diarrhea last night, both arms are hurting, left arm more. Yesterday felt nauseous, no nausea today. At ER 99.7 temperature was noted, BP, pulse, pulse ox was good.  HA 6-7 /10 intensity, crying in pain, throbbing, light sensitivity, phonobia. No migraine headaches  in the past, but mother and maternal aunt and grandma have a hx of migraine. No hives
nausea, headache, fever & fatigue beginning on 3/27/2021, mostly resolved as of today. Caller woke up today with facial swelling under left eye and cheek. No swelling of tongue or mouth, no swelling in neck or of any lymph nodes. Denies chest pain, shortness of breath or difficulty breathing. Took ibuprofen & claritin this morning before work, unsure if medications are helping. Advised to contact PCP or urgent care if she feels that facial swelling is getting worse.
I ordered Spikevax (new): Comirnaty thinking they were bivalent. 16 comirnaty & 8 spikevax were administered as booster doses after August 31, 2022