chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from the authors in a literature article concerning an unknown gender 32 year old healthcare worker with MMR vaccine (manufacturer unknown) (route, lot# and dose were unknown). In this retrospective study, the authors report an outbreak of measles, resulting in multiple labor-intensive exposure investigations with no further cases identified. Methods: Measles testing was arranged for suspect cases presenting with rash with some combination of fever (temperature, > 101 Fahrenheit (F)), cough, coryza, or conjunctivitis. Oropharyngeal polymerase chain reaction (PCR) testing was performed for patients presenting within 3 days of rash onset, with urine PCR and measles serum immunoglobulin M (IgM) testing whenever possible. Patients presenting days 4-10 after rash onset had oropharyngeal and urine PCR testing, frequently with measles IgM testing as well. Patients with rash beginning more than 10 days post-exposure had measles IgM testing, with oropharyngeal and/or urine PCR testing on a case-by-case basis. Exposures were defined, per Department of Public Health (DPH) guidance, as persons sharing the same airspace with a measles patient within 4 days before or after rash onset or who were in these areas within 1 hour of an infectious measles case. Clinical information for suspected and confirmed cases was obtained from medical chart reviews and phone/in-person interviews. Acceptable evidence of immunity for those working in high-risk occupations (healthcare/daycare settings) was defined as written documentation of 2 measles, mumps, and rubella (MMR) vaccines doses or positive measles serum IgG. Serology was performed for measles-specific IgM/IgG at HCA or at the facilities where patients presented. All positive samples from community laboratories were confirmed by health care agency (HCA), which used the measles virus IgM/IgG antibody test system. All measles viral RNA reverse transcription polymerase chain reaction (RT-PCR) virologic testing was performed at HCA using RT-PCR assay with the following 3 gene targets: nucleoprotein (N3), hemagglutinin (Hl), and fusion (Fl). The DPH Viral and Rickettsial Disease laboratory performed measles genotype sequencing. Results: Among 22 confirmed measles cases, 5 secondary cases occurred in HCWs. Of these, 4 had direct contact with measles patients; none wore N95 respirators. Four HCWs had prior evidence of immunity and continued working after developing symptoms, resulting in 1014 exposures, but no transmissions. Overall, 13 of 15 secondary cases had face-to-face contact with measles patients, 8 with prior evidence of immunity. The patient developed measles despite evidence of prior immunity and documented the vaccine administration (vaccination failure). The outcome of the event was unknown. The reporter considered the event to be related MMR vaccine (manufacturer unknown). This is one of several reports received from the same reporter. Additional information has been requested.
R leg is Red, warm, and swollen the size of a 50 cents piece coin. Child complains and exhibits signs of trouble walking, cries that it hurts to be touched. Temperature is 98.3 F. We instructed mother to use a warm moist compresses and to call the physician for an appt. if condition worsenes.
I started feeling effects about 20 minutes after vaccination. It started out with a headache that gradually grew worse. I woke up the next morning and had headaches and really bad body aches. I was nauseated. There was pain and swelling at the injection site. All of that last into that day and night. By the next morning everything but nausea was still there. I still had bad headache and body aches. I also had really bad fatigue. This morning, 10/15/2021 there is some pain in my arm but not much. My headache and body aches are minimal and I do not feel extremely tired. The day after the vaccine I did wake up with a urinary tract infection. I did have to go seek care for that but believe it was unrelated to the vaccine.
The patient had previously received Dose 1 - Moderna Lot-004C21A on 6/24/21 through a Mobile clinic. We were not aware of it at time of vaccination.
Loss of vision/crystal vision--needed to wear special glasses for 2 weeks until vision was restored to normal
Patient claims 12 hours after he noticed a large rash on his buttocks near the anus area. He said it itches and is painful. He believes he contracted shingles from the vaccine. However, Dr. does not believe he could have contracted shingles since SHINGRIX is not live.
Extreme leg pain cramps bubbles on bottom of leg on eliquis for a deep vein thrombosis started within a week of the booster
sore arm; felt very tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and FATIGUE (felt very tired) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     The patient had never tested positive for COVID-19. Patient had no history relating to mentioned adverse event and both acute and chronic illnesses at the time of vaccination. Patient had no other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Drug allergy (Sulfa drugs), Allergy to antibiotic (Augmentin drug) and Blood pressure abnormal. Concomitant products included MIRABEGRON (MYRBETRIQ), PREDNISONE and GLYCOPYRRONIUM BROMIDE (ROBINUL) for an unknown indication.    On 29-Apr-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) and FATIGUE (felt very tired). At the time of the report, PAIN IN EXTREMITY (sore arm) had not resolved and FATIGUE (felt very tired) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Other concomitant medication were Medicines for endoscopy.  No treatment information was provided   This case was linked to MOD-2022-535531, MOD-2022-535530, MOD-2022-535529 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2022: Follow up received added reporter details and updated batch number.
This spontaneous report as received from an office manager refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On an unknown date in 2017, the patients were vaccinated with incorrectly stored doses of VAQTA injection (lot# M018767, expiry date 01-FEB-2018; exact dose and route of administration were not reported). There were no concomitant therapies reported. The administered doses of the vaccine were exposed to the following temperatures on the following dates: on 01-FEB-2017: 33.746 degrees Fahrenheit (F) for 23 minutes; on 03-FEB-2017: 47.336 F for 6 minutes; on 06-FEB-2017: 34.988 F for 18 minutes; on 07-FEB-2017: 34.772 F for 17 minutes; on 08-FEB-2017: 6.692 F for 1 minute and 34.592 F for 90 minutes; on 09-FEB-2017: 33.89 F for 290 minutes; on 10-FEB-2017: 32.918 F for 298 minutes; on 11-FEB-2017:33.71 F for 317 minutes; on 12-FEB-2017:34.538 F for 302 minutes; on 13-FEB-2017:34.214 F for 255 minutes; on 14-FEB-2017: 34.322 F for 333 minutes; on 15-FEB-2017: 31.108 F for 464 minutes; on 16-FEB-2017: 31.874 F for 284 minutes; on 17-FEB-2017: 31.28 F for 585 minutes; on 18-FEB-2017: 31.316 F for 512 minutes; on 19-FEB-2017: 31.55 F for 517 minutes; on 20-FEB-2017: 30.866 F for 3 minutes and 31.136 F for 566 minutes; on 21-FEB-2017: 31.406 F for 245 minutes and 48.02 F for 47 minutes; on 22-FEB-2017: -4.108 F for 1 minute; on 24-FEB-2017: 34.322 F for 180 minutes; on 25-FEB-2017: 34.106 F for 240 minutes; on 26-FEB-2017: 34.214 F for 263 minutes; on 27-FEB-2017: 34.322 F for 230 minutes; and on 28-FEB-2017: 34.394 F for 289 minutes. A digital data logger was involved. The reporter stated that there were also previous excursions on unspecified dates (details not provided). No adverse experience were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA008835:
c/o itching, swollen, erythematous eyes, hands & feet;rash spread to chest, abd , groin & legs;described rash as raised red bumps;contacted MD;instructed to take OTC antihistamines;
severe cough, fever, muscle aches, SOB, congestion, fatigue, headache, sore throat.
Patient reports standing up and feeling extremely dizzy, sick to stomach, flushed. That evening she fell asleep really early and decided the next morning not to get the second shot. She still felt unwell the next morning but felt better by mid day and decided not to call physician.
In office for immunizations only. Received flu vaccine and GARDASIL. Within 30 minutes hives broke out on the arm and wrist in which flu vaccine was given. No rash on other arm. No hx of egg allergy or any previous problem with flu vaccine. Discussed with PCP. Recommended BENADRYL. To call back if worsens.
Fever that peaked at 101.4 for 14 hours, sore body, congestion, nausea, dizziness, lack of appetite
Pt recv vax on 11/18/98; 2 hr post vax pt exp rash on stomach, chest & upper thighs; tx= Ibuprofen &Benadryl
This spontaneous report as received from a pharmacist via company representative refers to a male patient of unknown age. No current condition was reported. No medical history was reported. On 16-AUG-2014, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported). No concomitant medication was reported. On 19-AUG-2014, patient reported to pharmacist that on an unspecified date in August 2014, he experienced that an area at the site of ZOSTAVAX administration was red. The outcome of an area at the site of ZOSTAVAX administration was red was reported as not resolved. No PQC was involved. The causality between adverse event an area at the site of ZOSTAVAX administration was red and ZOSTAVAX was unknown. This is one of the several reports. Additional information has been requested.
Approx 24 hrs after immunization noticed approximately 2-3" elongated raised area near inj. site. Topical Benadryl applied with relief 24 hrs later approx 3" lower red circular area noted with itching noted, not raised. Topical Benadryl applied with relied. 24 hours later red area size of "large orange" noted with itching, topical Benadryl applied with relief.
It started on 12/25/2021, I begin to breakout in hives. I felt it in the back of my head and then it started down my legs, arms and beast. It would start burning and itchy. I then made a tele doc appt. They doctor told me to take Claritin and Benadryl. I also got Acid Reflux really bad. The itchy got worse so I saw my PCP and she to take all of the meds that was prescribe to me. An when I went in she ran a hold lot of different test on me. I could feel when the hives where about to come. I would get red marks on me and then the hives would appear. The hive isn't that often but they still coming. I was put on Peptic 20 mgs and she said to continue the Claritin.
Patient had the sensation of nearly passing out that resolved with lying supine post injection.  Patient monitored and transported to Hopsital via FIre Dept
Narrative:  Pt is a78y.o. MALE who died on 05/07/2021 with a h/o dementia with behavioral disturbance, cerebrovascular disease, hyperlipidemia, hypertension. Pt receive Moderna Covid-19 Vaccination 1/2 on 03/27/2021. Pt died on 05/07/2021 at HOSPICE UNIT. Unlikely Moderna Covid-19 vaccine caused/contributed to pt death.
pt recvd flu vax & pt devel wheal which was characterized as near necrosis w/deep bruising & swelling 3-4 days; pt also exp pain & heat in the arm of inject;
Brain fog, dizziness, heart palpitations, increased blood pressure, Muscle spasms, ear ringing. The symptoms have not left, and continues to bother me everyday.
Recurring red rash on forearms, chest, shoulders, thighs. Hives develop on scalp (back of head), progressing down towards shoulders, back, torso, and then to thighs. Hives are extremely itchy, scratching causes raised lines to develop (dermatographia). Hives usually go away in 1-2 hours after first appearing.   Hives usually appear in early afternoon (1-3PM) unless antihistamines are taken before. Red rash on forearms appears daily, regardless of antihistamines.
This spontaneous report as received from a nurse refers to an unspecified patients of unknown age and gender. On an unknown date an unspecified patients received improperly stored PROQUAD (Merck) (route, dose, frequency and lot # not reported). No adverse effects were reported. No further information was provided. This is one of several reports from the same source. Additional information has been requested.
Developed (R) upper leg cellulitis 24-48 hrs after Dtap and polio vaccine.
w/in hrs pt devel lower leg numbness, tingling, diffuse joint pain, pluritic pain 1 hr later worsening followed by very sensitive skin & swelling w/tongue (mild) along w/inc sense anxiety & SOB;
Approx 15 minutes after injection husband stated he couldn't wake his wife up. Pt not verbally responsive. Skin cold/clammy. Pupils dilated. BP 80/50 Epi .3cc given. Pt vomited approx 1500cc coffee-ground emesis. Pt placed on stretcher cool cloth to head. BP 90/70 pulse 88. Pupils returned to normal. Pt verbally responsive. EMS present 11:30.
received the powder portion of PENTACEL diluted with sterile water with no reported adverse event; Initial information received on 25-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2022SA356995.  This case involves a 3 months old male patient who had received the powder portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] diluted with WATER FOR INJECTION [STERILE WATER]with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE); and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE).  On 24-Aug-2022 the patient developed a non-serious event of received the powder portion of pentacel (strength, formulation was unknown, dose: 0.5ml, once (1X), Batch number: U791AA and expiry date: 10-Oct-2023) diluted with sterile water with no reported adverse event (product preparation error,onset date: 24-Aug-2022, Latency: same day) for prophylactic vaccination.  Action taken : not applicable.  Outcome: Unknown  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.
headache, stiff muscles and joints, chills, high fever, nausea, exhaustion
Arching of the back that lasted for weeks after the 19th. The lining of his eyes was off - strabismus that resolved itself months after the vaccine. Silent seizures, problems with digestion.
Initial report received on 26.Aug.2009 from health professional. This 60-year old male started vaccination course with VIVOTIF (Batch no.: 3001583) on 19.Jun.2009, and took one capsule every second day. Concomitantly on 19.Jun.2009 he was vaccinated with booster vaccine i.m. On 27.Jun.2009 he developed a first episode of nose bleeding in the right nostril, followed by multiple episodes of epistaxis over the following 3 weeks until 16.Jul.2009. On 28.Jun.2009, he took oral MALARONE and started the same day his trip out of the country. He still had some bleeding, that lasted until 16.Jul.2009. Since then, he had no further symptoms. The patient had no history of previous episodes of epistaxis. A complete hematological work-up was negative, CT-scan was normal, normal ENT.
Pt did not respond to series of Recombivax;  Engerix-B booster given 21Sep90.  30Jan91 titer was borderline.  2nd booster dose given 26Feb91.
Narrative:  Patient received Moderna Covid #1 on 3/11/21 and #2 on 4/8/21. There are no scanned records or notes to indicate what happened from the date of second vaccine to date of death on 4/26/21. No autopsy reports. There were 18 days from time of second vaccine to date of death.
Information has been received from a nurse referring to multiple unspecified patients. Information about concurrent condition, concomitant medication and medical history was not provided. On multiple unspecified dates, the patients were vaccinated with improperly stored RECOMBIVAX HB (dose unknown, lot # L025738, expiration date 14-AUG-2017, lot # L038018, expiration date 13-SEP-2017, lot # L048849, expiration date 04-FEB-2018) by unspecified route. The vaccines had been exposed under temperature 1.05 degree Centigrade for 49 hours, but did not undergo previous excursion. Data logger was used. This is one of several reports received from the same reporter. Additional information has been requested.
Swelling, heat, redness at site; Swelling, heat, redness at site; Swelling, heat, redness at site; left Achilles tendon pain; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 16Apr2021 at 07:00 (at the age of 52-years-old), as a single dose for COVID-19 immunisation. Medical history included allergy to shellfish and derivatives. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included melatonin (MANUFACTURER UNKNOWN), alprazolam (XANAX) and cannabis sativa (MEDICAL MARIJUANA) (as reported); all for unspecified indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 26Mar2021 at 07:00 (at the age of 52-years-old), as a single dose for COVID-19 immunisation. On 16Apr2021 at 09:00, the patient experienced swelling, heat, redness at site and left achille's tendon pain. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of events. The clinical outcome of the events swelling, heat, redness at site and left achille's tendon pain was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Per patient she received the shot on Wednesday 9/21/22 in her right arm. Didn't take a look at it until the next morning and noticed and injection site reaction. Arm was red and swollen about 2 1/2". Reported to pharmacist on duty on Thursday. Let the vaccine administrator know Friday night. Tried to follow up and left voicemail. Patient called back Saturday afternoon. Reported that redness/warmth has spread to about 7". Pt took aleve the night of and then an antihistamine Thursday. Tried cold compress as well. Recommended to follow up with a doctor to be safe, continue with anti-inflammatory and cold compresses.
body aches; Swollen lymph node in armpit of injection site; This is a spontaneous report from a non-contactable consumer (patient). A 31-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via unspecified route of administration on 08Feb2021 (age at the time of vaccination was 31, pregnant at the time of vaccination) as DOSE NUMBER UNKNOWN, SINGLE for COVID 19 Immunisation at Clinic. The patient's medical history included hypothyroidism. The patient received other medications in two weeks. Patients had no known allergies. No other vaccines within 4 weeks PRIOR to the COVID-19 vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, had not been tested for COVID-19. The patient experienced Swollen lymph node in armpit of injection site and body aches on 09Feb2021. The patient had not received treatment for events. The outcome of events was not recovered.  No follow-up attempts were possible; information about lot/batch number could not be obtained.
2 hours after shot administered pt C/O fever, chills and headache. She was jut mildly sore after first vaccine. Next morning fever/headache gone. Still C/O body aches.
Information has been received from a health professional concerning a 35 year old female who on 11Jan05 was vaccinated with a first IM dose of hep B virus vaccine rHBsAg (yeast) (lot 647987/0865P) and complained of pain and soreness in her left arm and could barely lift her arm. On 02May05 the pt was vaccinated with a second IM dose of hep B virus vaccine rHBsAg (yeast) (Lot648212/0479P) and c/o numbness of her entire left side, tingling and temporary paralysis in both lower extremities. She was seen by the family doctor on 18May05 and an MRI was ordered. The pt was seen by a neurologist and he ordered an MRI/MRA in Jul 2005 to rule out a brain aneurysm. The tests were negative. It was reported that the pt recovered. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Pain in left arm, barely lift her arm, numbness of entire left side, tingling and temporary paralysis in both lower extremities were considered to be immediately life threatening, disabling, and other important medical events (OMIC) by the reporter. Additional information has been requested.
mom states pt was grey, cold & hard to wake up for 2 hrs on the evening p/vax 12JUL95; went to ER waited 1 1/2hrs in waiting room & pt fine when seen by MD
Swollen glands of the neck; Sore throat; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swollen glands of the neck) and OROPHARYNGEAL PAIN (Sore throat) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced SWELLING (Swollen glands of the neck) and OROPHARYNGEAL PAIN (Sore throat). At the time of the report, SWELLING (Swollen glands of the neck) and OROPHARYNGEAL PAIN (Sore throat) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
lymphadenophaty right axilla; flu like symptoms; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 42 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid right, administration date 22Dec2020 15:00 (Lot number: EK9231) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Mild asthma" (ongoing), notes: Childhood. There were no concomitant medications.  The following information was reported: LYMPHADENOPATHY (non-serious) with onset 23Dec2020, outcome "recovered" (29Dec2020), described as "lymphadenophaty right axilla"; INFLUENZA LIKE ILLNESS (non-serious) with onset 23Dec2020, outcome "recovered" (29Dec2020), described as "flu like symptoms". Therapeutic measures were not taken as a result of lymphadenopathy, influenza like illness.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.