chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache started 4:30 pm 4/8/21 - 6:00am4/10/21, body ache 3:30am 4/9/21 -10:00pm 4/9/21, very tired 3:30am 4/9/21 - 6:00am 4/10/21, slight pain swelling under both side of jaw and left armpit 3:30am 4/9/21 - 6:00am 4/10/21.
presented to ER with SOB. Home tested positive outside our system on 2/3/23
on 12/07 patient received Fluad vaccine on left deltoid  and 3rd  dose of Covid Pfizer vaccine on right deltoid.  12/29 peitnt came to [pharmacy to report that 3 days after his vaccine, his right deltoid was itching then a pus came out and resulting of a scar that appear like a eating flesh scar.  I clean the area with alcohol wipes and highly recommended an urgent followed up with primary care provider or medical facility.
Temp 99.5-100.5 from 5/1/08 through 5/5/08
Red and swollen area on R upper arm where immunizations were given on 8/14/07. She also developed some red, raised areas on L arm and fingers. She took Benedryl and it helped to lessen the degree of redness and puffiness to the bumps.
Patient presented to the clinic for his 1st Pfizer vaccine. Vaccine was administered per protocol, after 20 minutes patient reported slight arm numbness from the elbow down. Continued to monitor in waiting room for an additional 10 minutes. No change in status. Performed sensation test with eyes closed and patient was able to feel sensation when provider was stroking the arm and hand. full ROM intact. Instructed patient to connect with v-safe and also to call clinic with any concerns. He agreed and understood.
An area of 3 cm diameter of erythema appeared at the injection site of the MMR vaccine 10 minutes after it was administered. No dyspnea. Told mom to watch and to give diphenhydramine syrup ordered at the pharmacy.
L arm (injection site) induration (6 x 7 cm) with large inflammatory reaction (pain/erythema) without evidence of infection.
SHIVERING; FEVER; TIRED; FELT ACHY; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 202A21A expiry: 23-JUN-2021) dose was not reported, administered on 10-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-JUN-2021, the subject experienced felt achy. On 10-JUN-2021, the subject experienced shivering. On 10-JUN-2021, the subject experienced fever. On 10-JUN-2021, the subject experienced tired. Laboratory data included: Body temperature (NR: not provided) 102.7-102.9 Unit not reported. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from fever, felt achy, tired, and shivering. This report was non-serious.
Itchy hives around the injection site that has been resolving over the last 3 days, no respiratory distress experienced.
Information has been received from the authors in a literature article titled as stated below concerning an 38 year old father with MMR (manufacturer unknown) (route, lot# and dose were unknown) therapy. In this retrospective study, the authors report an outbreak of measles, resulting in multiple labor-intensive exposure investigation 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. Exposure were defined, per agency guidance, as persons sharing the same airspace with a measles patient within 4 days before or after rash onset or who were in these area 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 setting) was defined as written documentation of 2 MMR vaccine doses or positive measles serum IgG. Serology was performed for measles-specifc IgM/IgG and agency or at the facilities where patients presented. All positive samples from community laboratories were confirmed by agency, 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 agency using RT-PCR assay with following 3 gene targets: nucleoprotein (N3), hemagglutinin (HI), and fusion (FI). The agency performed measles genotype sequencing. Results: Among 22 confirmed measles cases, 5 second cases occurred in HCWs. Of these, 4 had direct contact with measles patients; none wore N95 respirations. 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 (manufacturer unknown). A copy of the published article is attached as further documentation of the patient's experience. This is one of several reports received from the same reporter. Additional information has been requested.
Hard lump under the skin at site of injection. Remained localized tightly at injection site on 7/26 and the hard lump had diffused outward in an even circular pattern to about 2-3 inches in diameter by 7/27. Patient experienced pain at injection site with the tissue thickening.
hives, itching on neck, chest, shoulders.  Treated with Benadryl, will contact Dr. today.
Moderna rash; got a red,raised,itchy rash; itchy rash; got a red, raised, itchy rash; Felt awful; This spontaneous case was reported by a nurse and describes the occurrence of FEELING ABNORMAL (Felt awful), RASH (Moderna rash), VACCINATION SITE SWELLING (got a red,raised,itchy rash), RASH PRURITIC (itchy rash) and VACCINATION SITE ERYTHEMA (got a red, raised, itchy rash) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LINUM USITATISSIMUM SEED OIL (FLAX SEED OIL) and MAGNESIUM for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced FEELING ABNORMAL (Felt awful). On 14-Mar-2021, the patient experienced RASH (Moderna rash), VACCINATION SITE SWELLING (got a red,raised,itchy rash), RASH PRURITIC (itchy rash) and VACCINATION SITE ERYTHEMA (got a red, raised, itchy rash). The patient was treated with HYDROCORTISONE for Rash, at an unspecified dose and frequency. On 14-Mar-2021, FEELING ABNORMAL (Felt awful) had resolved. In March 2021, RASH (Moderna rash), VACCINATION SITE SWELLING (got a red,raised,itchy rash), RASH PRURITIC (itchy rash) and VACCINATION SITE ERYTHEMA (got a red, raised, itchy rash) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient  called  the event as a Moderna rash.   Lot number of the second Moderna COVID-19 vaccination was provided  only 003.
bleeding at injection site right after administration; nerve pain in her skin along her back and side; This case was reported by a pharmacist via call center representative and described the occurrence of nerve pain in a 93-year-old female patient who received Herpes zoster (Shingrix) (batch number JC55P, expiry date 15th November 2021) for prophylaxis.   The patient's past medical history included shingles (4 years prior to the date of reporting).   On 19th November 2019, the patient received Shingrix (intramuscular). In November 2019, less than a week after receiving Shingrix, the patient experienced nerve pain. On 19th November 2019, the patient experienced injection site hemorrhage. On an unknown date, the outcome of the nerve pain and injection site hemorrhage were unknown.   It was unknown if the reporter considered the nerve pain and injection site hemorrhage to be related to Shingrix.  Additional case details were reported as follows: The patient experienced bleeding at injection site immediately after vaccination. The patient also had nerve pain in her skin along her back and side, at the same places where she prior had a shingles outbreak.
This spontaneous report was received from a female patient of unknown age reporting on herself. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX for prophylaxis (dose, frequency, route of administration, lot number and expiry date were not reported). On an unknown date, after receiving ZOSTAVAX, the patient experienced shingles (herpes zoster). The outcome of the event and the relatedness between the event and ZOSTAVAX were not reported.     No product quality complaint was involved. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age. Since 30-NOV-2015, the unspecified number of patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot# L003227; expiry date: 13-OCT-2016, lot# K007826; expiry date: 03-FEB-2016). No adverse effects were reported. Additional information has been requested.
Fever of 105 on 11/24/2001 and 11/25/2001. Evaluated in private MD's office on 11/24/2001 who ruled out infection ear, throat etc. Stated oft vaccination MMR.
Redness, swelling at the site of injection. Backache, body ache, headache, pain in knee; started about 2 hours after vaccination.
She gets really shaky, shaky parts happen often. She gets dizzy, she has panic attacks now. seems to be low sugar or BP thing we are not sure.
Very high fever (103) that didn't go away for a couple of days, chills, bad headache, severe fatigue/muscle aches
patient complained of pain with the 1st injection of Shingrix; This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacy student reported that a male patient complained of pain with the 1st injection of Shingrix. The reporter consented to follow up. The pharmacy student stated that she did not have any information related to the adverse event (AE) at the time of the call. For tolerance to 2nd dose, refer case US2019AMR133564.
This spontaneous report as received from a physician refers to a 2 months old patient. The patient was vaccinated with dose 3 RECOMBIVAX HB on an unknown date (dose, route, site of administration and lot # not reported). No other co-suspects were reported. No concomitant medications were reported. It was reported that on an unknown date, a 3rd dose of RECOMBIVAX HB was administered during 2nd month. There was no adverse reaction. Additional information has been requested.
Pain and swelling at the injection site on upper left arm. Red blistery rash on upper left arm at and below the injection site.
Redness and hives and itchiness on face, chest and lips; Redness and hives and itchiness on face, chest and lips; Redness and hives and itchiness on face, chest and lips; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness and hives and itchiness on face, chest and lips), URTICARIA (Redness and hives and itchiness on face, chest and lips), PRURITUS (Redness and hives and itchiness on face, chest and lips) and DIARRHOEA (Diarrhea) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ZILEUTON and HYDROXYZINE for Allergy.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced ERYTHEMA (Redness and hives and itchiness on face, chest and lips), URTICARIA (Redness and hives and itchiness on face, chest and lips), PRURITUS (Redness and hives and itchiness on face, chest and lips) and DIARRHOEA (Diarrhea). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 16-Mar-2021 for Hives, at an unspecified dose and frequency and LOPERAMIDE for Diarrhea, at an unspecified dose and frequency. On 16-Mar-2021, ERYTHEMA (Redness and hives and itchiness on face, chest and lips), URTICARIA (Redness and hives and itchiness on face, chest and lips) and PRURITUS (Redness and hives and itchiness on face, chest and lips) had resolved. On 23-Mar-2021, DIARRHOEA (Diarrhea) had resolved.            No medical history was provided. The patient experienced redness and hives and itchiness on face, chest and lips, right after the dose that she had to take 4 diphenhydramine capsules with 45 minutes of each other on 16-Mar-2021 and loperamide for one week for diarrhea.
GOT VERY SICK FROM THE SHOT ALMOST  DEATH; This spontaneous report received from a patient via a company representative concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced got very sick from the shot almost death. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got very sick from the shot almost death was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Severe hypoglycemia with blurred vision and neuropathy in legs roughly couple hours after receiving vaccine
Client reported that 12 noon on 08/25/2008 she started having abdominal pain, vomiting, feeling feverish, having chills.  Advised to seen medical follow up.
Vaccinated 9-20-11. Reports that on 9-21-11 fever of 104.1. Continued for 3 days. No other symptoms.
Pt given PNEUMOVAX 23 in Drs office around 2pm. Returned home started having difficulty breathing. GI issues. Went to ER given steroid and antihistamine with relief of symptoms.
Post vax, in 2001 the patient experienced severe arm soreness which resolved within 2 days. The medical assistant also reported that 2 other patients experienced adverse events after being vaccinated with the pneumococcal vaccine 23 polyvalen. Additional information has been requested.
Fever of 102.2, chills, loss of appetite lasting for approximately 24 hours.  Ibuprofen 800 given at showing of fever and throughout the symptom process.  Menstrual cycle started a week after vaccine which was considered early in my cycle.
Acute Hematuria. No other signs and symptoms.  No Previous history of urinary symptoms or any previous kidney disease.
Sedation, Myalgia, Arthralgia, Fever, chills and fatigue. pain, redness and swelling at injection site Narrative:
February 2, I developed 30 red, raised, itchy welts all over my body, including arms, legs, back stomach. Welts were dime sized. No breathing difficulty,  Began benadryl 50 mg q 6 hours  around the clock for one week. Benadryl did not cause the welts to subside.  Welts worsened into larger 2x2 areas of redness and itching.   Contacted my physician, who prescribed a medrol dose pak.  Took from 2/1 to 2/5.  Welts improved but did not go away.  2/10/2021 - welts are still developing, Have 6 new welts today 2/10/21... taking benadryl but not improving .  Will call my doc back this date
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around 08-SEP-2017, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose the prevention of shingles (herpes zoster). Shortly after receiving the ZOSTAVAX, the patient suffered a persistent strain of herpes zoster and was diagnosed with shingles. As a direct and proximate result of the ZOSTAVAX vaccine, symptoms have resulted in physical limitations not present prior to using zoster vaccine.The patient has also experienced mental and emotional distress due to resulting physical limitations and the seriousness of his condition. As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered. Persistent strain of herpes zoster/zoster was considered disabling. Additional information has been requested.
Psychosis; Pfizer vaccines affected his autoimmune system; Psychosis";; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the parent.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Schizophrenia" (unspecified if ongoing). Concomitant medication(s) included: CLOZAPINE taken for schizophrenia; LITHIUM taken for schizophrenia. The following information was reported: PSYCHOTIC DISORDER (hospitalization, medically significant), outcome "unknown", described as "Psychosis"; AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "Pfizer vaccines affected his autoimmune system"; CONDITION AGGRAVATED (medically significant), outcome "unknown", described as "Psychosis";". The events "psychosis" and "pfizer vaccines affected his autoimmune system" were evaluated at the physician office visit. Clinical comment: The patient received Clozapine and Lithium for over 7 years and lives a normal life without any psychotic episode for the last 7 years. After administration of the first dose of the Pfizer covid vaccine, he went into psychosis 2 weeks later.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient reported headache, hive on her face, tongue swelling. She reported that she took Benadryl for few days but it did help that much. She went to Urgent care and was referred to ER where she was prescribed Prednisone for 5 days. She reported feeling better after she started taking Prednisone.
12 hours after vaccine admin in left arm (both flu/pneumovax per patient preference) she developed tender, throbbing, red knot that increased to size of an orange. Fever/chills/swollen nodes in groin/axilla L>R. Smaller tender lump at injection site was present on 1/11/18.  Treated with ibuprofen, moist heat, close monitoring for cellulitis.
I had full blown diarrhea.; mild diarrhea; nausea.; I had extreme fatigue; fever of 100.6F; I became violently ill; Within 4 hrs, my arm became swollen/The swelling was about a 4 inch diameter; it was hard; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (I became violently ill), DIARRHOEA (mild diarrhea), DIARRHOEA (I had full blown diarrhea.), VACCINATION SITE SWELLING (Within 4 hrs, my arm became swollen/The swelling was about a 4 inch diameter) and VACCINATION SITE INDURATION (it was hard) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 from 14-Aug-2021 to 19-Aug-2021.    On 07-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Dec-2021, the patient experienced ILLNESS (I became violently ill), VACCINATION SITE SWELLING (Within 4 hrs, my arm became swollen/The swelling was about a 4 inch diameter) and VACCINATION SITE INDURATION (it was hard). On 08-Dec-2021, the patient experienced DIARRHOEA (mild diarrhea), NAUSEA (nausea.), FATIGUE (I had extreme fatigue) and PYREXIA (fever of 100.6F). On 09-Dec-2021, the patient experienced DIARRHOEA (I had full blown diarrhea.). On 10-Dec-2021, ILLNESS (I became violently ill), VACCINATION SITE SWELLING (Within 4 hrs, my arm became swollen/The swelling was about a 4 inch diameter) and VACCINATION SITE INDURATION (it was hard) had resolved. At the time of the report, DIARRHOEA (mild diarrhea), DIARRHOEA (I had full blown diarrhea.), NAUSEA (nausea.), FATIGUE (I had extreme fatigue) and PYREXIA (fever of 100.6F) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. Patient received Regeneron monoclonal treatment. On 8-Dec-2021 patient reported 21days due for second dose.
c/o palpitations/ irregular racing heart; newly diagnosed arrythmias;  HR-78-101;  complicated PMH & laundry list of daily meds for RA, HTN, lupus; newly dx 2 weeks prior for arrythmias.  HR irreg.  Radial pulses thready bilaterally.  TX mask removed / fresh air - seat reclined; H2O; emotional support - monitored additional 15 mins. advised to pull over & dial 911 if SX worsen.  husband drove car off lot.
Child started to have symptoms of eye rolling and involuntary side to side head movement. The onset of these  symptoms started to occur within 12-hours of vaccine administration.
he feel sick; This is a spontaneous report from a contactable consumer (patient's Mother). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19  VACCINE, Solution for injection; lot number  EW0178 and expiration date: not reported), via an unspecified route of administration, on Right arm, on 09Jun2021 18:37 as 2ND DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number EW0175 and expiration date: not reported) via unspecified route of administration, on 19May2021 as 1ST DOSE, SINGLE DOSE for covid-19 immunization. The patient didn't receive any other vaccines within 4 weeks prior to the COVID -19 vaccine. The patient felt sick on Jun2021. The reporter would like to know whether any medication can be given to the patient for sick. No treatment was received for the adverse event. The outcome of event is unknown.