chrisvoncsefalvay/vaers-outcomes huggingface dataset:
435PM pt laid on bed post inject fainted- did not respond few seconds; CPR started; pale, clammy, c/o stomach ache, hands finger tingling;
Part 2 knocked me on my butt; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling abnormal in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced feeling abnormal (Verbatim: Part 2 knocked me on my butt). The outcome of the feeling abnormal was not reported.   It was unknown if the reporter considered the feeling abnormal to be related to Shingles vaccine.   It was unknown if the company considered the feeling abnormal to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 04-Mar-2023 This case was reported by a patient via interactive digital media. The patient received part 1 and part 2 of the shingles vaccine.  The patient reported that part 2 knocked him/her on butt. The follow up would not possible as no contact details were available.
"Pfizer-BioNTech COVID-19 Vaccine" 12/29 patient developed SOB, fever tmax 103 degrees F, diaphoretic, dry heaves all started approximately 16 hours after vaccination given. patient then transferred to Hospital for further treatment and observation. 12/30  seen at injection site- erythema, swelling, warmth and tenderness Discharged back to home on 1/1 with RX for cephalexin to treat cellulitis of injection site
Patient stated that she had to go to the hospital due to shoulder injury related to the 2 vaccines she had received.
skin rash; Swollen lymph nodes behind neck, ear and jaw; facial rash; facial redness; A spontaneous report was received from a Healthcare Professional concerning a 73-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events skin rash, swollen lymph nodes behind neck, swollen lymph nodes behind ear, swollen lymph nodes behind jaw, facial redness, facial rash.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 27 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 029k20A) intramuscularly for prophylaxis of COVID-19 infection.  The patient experienced skin rash. On 29 Jan 2021, the patient experienced the events swollen lymph nodes behind neck.,swollen lymph nodes behind ear, swollen lymph nodes behind jaw. On 22 Jan 2021, the patient experienced the events facial redness. facial rash.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The Outcome of the event was unknown.
beginning 1 day after the vaccination my patient developed an itchy  papular rash o f back, scalp, chest and arms minimal relief with lyderm
diarrhea; pain in eye that wraps around the head; pain in her neck; she is very uncomfortable; feeling dizzy; left breast swollen; left arm swollen; horrible headache; nauseated; site of injection is swollen; so exhausted that she sleeps; This spontaneous case was reported by an other and describes the occurrence of DIZZINESS (feeling dizzy), BREAST SWELLING (left breast swollen), PERIPHERAL SWELLING (left arm swollen), EYE PAIN (pain in eye that wraps around the head) and NECK PAIN (pain in her neck) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no reported medical history).    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced DIZZINESS (feeling dizzy), BREAST SWELLING (left breast swollen), PERIPHERAL SWELLING (left arm swollen), VACCINATION COMPLICATION (she is very uncomfortable), HEADACHE (horrible headache), NAUSEA (nauseated), VACCINATION SITE SWELLING (site of injection is swollen) and FATIGUE (so exhausted that she sleeps). On 14-Jan-2021, the patient experienced EYE PAIN (pain in eye that wraps around the head) and NECK PAIN (pain in her neck). On an unknown date, the patient experienced DIARRHOEA (diarrhea). At the time of the report, DIZZINESS (feeling dizzy), BREAST SWELLING (left breast swollen), PERIPHERAL SWELLING (left arm swollen), EYE PAIN (pain in eye that wraps around the head), NECK PAIN (pain in her neck), VACCINATION COMPLICATION (she is very uncomfortable), DIARRHOEA (diarrhea), HEADACHE (horrible headache), NAUSEA (nauseated), VACCINATION SITE SWELLING (site of injection is swollen) and FATIGUE (so exhausted that she sleeps) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication were not reported by the reporter. Treatment details not reported by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Red blotches around site of injection appeared about 4 days after injection - also spot on left jaw same side of injection (jaw red spot itched) left shoulder sore for > week. (injection in upper left arm).
Daughter called the pharmacy to report symptoms her mother told her about. Patient reported to daughter that starting 11/27/21 (day of injection) she felt very tired/lethargic, was anxious, and had a headache. As of 11/29/21 she was starting to feel better. She also reported to her daughter on 11/29/21 that her arm under her armpit hurt. Daughter did state patient was starting to feel better, and that she believed the symptoms to be normal response to a vaccine and not of significant concern though she did want to let us know.
lip swelling, entire top lip up to bottom of her nostrils was both swollen and numb; left side of cheek numb, entire top lip up to bottom of nostrils was numb; This spontaneous case was reported by a consumer and describes the occurrence of   in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.  Treatment included putting ice on her lip all day.
This case was reported by a other health professional via call center representative and described the occurrence of fever in a 62-year-old male patient who received SHINGRIX (batch number 9XC39, expiry date 30th January 2020). On 6th March 2018 09:12, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 6th March 2018, less than a day after receiving SHINGRIX, the patient experienced fever, malaise and chills. The patient was treated with TYLENOL. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the fever, malaise and chills were recovered/resolved. It was unknown if the reporter considered the fever, malaise and chills to be related to SHINGRIX. Additional details were provided as follows: The reporter was a Medical Technologist. She called to report an adverse event as advised by a physician. The physician that asked reporter to call was also the patient himself. The patient received SHINGRIX vaccine and within 4 hours experienced fever, chills (teeth chattering chills) and malaise. The patient said that after TYLENOL it was better and lasted for a total of 5 hours. This case was linked to the case US2018GSK096014 (2nd dose), reported by the same reporter for the same patient.
Info has been received from a nurse concerning a 93 year old female who on approx 12/02/2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent in the left arm. Subsequently the pt developed a "marble like bump" on the left arm post vaccination. Additional info has been requested.
This spontaneous report was received from a physician refers to unknown number of patients of unknown demographics. On an unknown date the patients were vaccinated with MMR II (dose, dosage schedule and route of adminitration were not provided). On an unknown date MMR II vaccine was improperly stored and administered to unknown number of patients. The vaccine was exposed to 9 C for total of 60 hours. No adverse effects reported. This is one of 5 reports received from the same reporter (case # 1405USA009347, 1405USA009350, 1405USA009349, 1405USA009348). Additional information has been requested.
Swelling at site, swollen node on (lt) clavicle pain when moving are at node site.
Patient reports redness, swelling, pain and heat of upper arm and shoulder starting the day of immunization and lessening over the next two days. Also reports body aches starting two days post injection and some throat itching. Some swelling, tenderness, and throat itching persist now, 3 days post injection.
1 of 3 nurses who received Engerix-B experienced headache ("Pressure on top of head like head was going to explode"). Experienced "immediately" p/1st of a series of 3 injections. Treated w/Tylenol & headache went away.
Patient received the Moderna Bivalent Booster vaccine for 6mon-5yrs as the first dose of his primary COVID vaccine series.  The dose of this vaccine is lower than the recommended Moderna Bivalent Vaccine for 6mon and older for Primary series.  So patient received a lower dose than recommended.
1st - Fatigue & Headache within hour of shot, 2nd - soreness at site of shot, 3rd- rash on the 10 of September. Circular in size, approximately 2x3 inches. Felt faintness on the same day.
The night of the vaccine, she developed severe headache & facial flushing that lasted through the next day.  On Friday 1/8/21 all symptoms were gone.
itching got worse after second vaccine; my face is swollen; eyes are blurry /  I could hardly read anything; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching got worse after second vaccine), SWELLING FACE (my face is swollen) and VISION BLURRED (eyes are blurry /  I could hardly read anything) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, the patient experienced SWELLING FACE (my face is swollen) and VISION BLURRED (eyes are blurry /  I could hardly read anything). On an unknown date, the patient experienced PRURITUS (itching got worse after second vaccine). At the time of the report, PRURITUS (itching got worse after second vaccine), SWELLING FACE (my face is swollen) and VISION BLURRED (eyes are blurry /  I could hardly read anything) outcome was unknown.            No concomitant medications were provided. No treatment drugs were reported.    This case was linked to MOD-2021-103048 (Patient Link).
Serious menstrual cramps; Heavy menstrual bleeding; This spontaneous case was reported by a consumer and describes the occurrence of DYSMENORRHOEA (Serious menstrual cramps) and HEAVY MENSTRUAL BLEEDING (Heavy menstrual bleeding) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052c21a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jun-2021, the patient experienced DYSMENORRHOEA (Serious menstrual cramps) and HEAVY MENSTRUAL BLEEDING (Heavy menstrual bleeding). At the time of the report, DYSMENORRHOEA (Serious menstrual cramps) and HEAVY MENSTRUAL BLEEDING (Heavy menstrual bleeding) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment drug details were reported.
A report received from a health care professional on 12/02/02, concerning an unknown number of vaccinees aged between 3-4 years of age who were inadvertently administered 0.5ml of Fluvirin. On unknown dates between 10/21/02 and 12/02/02, an unknown number of vaccinees aged between 3-4 years of age were inadvertently administered 0.5ml Fluvirin. The vaccinees were administered Fluvirin once if they had received it before and twice if they had not. No adverse symptoms were reported. There was insufficient information to determine the reporter's causality assessment. Cross reference with PJP200200824.
Numbing in mouth jaw & gum, breathing wheezing problems, shortness  of breath, irritations, skin & tongue burning, messed up my monthly period, swollen eyes, swollen lymph nodes, swollen face & mouth..heart achs & discomfort.
Patient somehow instead of receiving the 1st dose, the patient received the booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient somehow instead of receiving the 1st dose, the patient received the booster dose) in a 75-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient somehow instead of receiving the 1st dose, the patient received the booster dose). At the time of the report, ACCIDENTAL UNDERDOSE (Patient somehow instead of receiving the 1st dose, the patient received the booster dose) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drug was reported.  3 weeks later, the patient came back for the second dose. As result of misadministration no side effects reported.  No treatment drug was reported.
Seizure for first time in life, occurred 1 hour and 20 minutes after receiving Covid 19 Vaccine, on 8/5/2021. Two seizures occurred again on 8/17/21, a few minutes apart. Fourth seizure occurred on 8/18/21. Experiencing dizzyness and nausea, vomitting and weakness of limbs. This is occurring frequently.
Rash on skin of pelvic area and buttocks started about 2 weeks after given vaccines. Very itchy. No fever.
Covid breakthrough case:  When I had covid I started out with a sore throat but then I got more congested with a horrible cough that was really dry at times and then sometimes I would cough up a bunch of stuff. After about a week the cough wasn't going away and that's when i couldn't get a breath.  He was just diagnosed with asthma this week and was put on a steriod inhaler and albuterol.
Shingles rash developed on torso within 2 weeks of 2nd dose with associated severe fatigue.
Preterm premature rupture of membranes at 18 weeks gestation (due date 9/4), resulting in pregnancy loss
Coughing started right away and has gotten progressively worse. I saw a specialist about three weeks ago and I'm not bad enough to have COPD but close. Treatments with inhalers with steroids and I have been on those for two weeks. I started feeling pain in back of my left leg. I thought it was a blood clot and went to ER but it wasn't a blood clot. No treatment for that. I still feel the pain occasionally at this time. I have been taking Tylenol for it.
Tested positive for Covid; Tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 81-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Jan2021 at 16:00 as dose 1, single (Lot number: EN5318), in left arm, on 12Feb2021 at 16:45 as dose 2, single (Lot number: EL9266), in left arm, on 23Sep2021 at 13:00 as dose 3 (booster), single (Lot number: 301301A), in left arm and on 30Mar2022 at 13:00 as dose 4 (booster), single (Lot number: FP4554) at the age of 81 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Ulcerative colitis" (unspecified if ongoing); "Low thyroid" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "Chronic nerve pain" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID, start date: 01Oct1999; CRESTOR, start date: 01May2022, stop date: 25May2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25May2022, outcome "recovering" and all described as "Tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25May2022) Positive, notes: I tested positive for Covid; (31May2022) Negative; (01Jun2022) Negative; (04Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient received Paxlovid (Lot number: GA3581) for 5 days from 25May2022 to 31May2022 for the treatment of COVID-19.
This spontaneous report was received from a nurse referring to multiple unspecified patients of unknown age. On 18-AUG-2017, 20-AUG-2017 and 21-AUG-2017, the patients were vaccinated with improperly stored doses of Other suspect therapies included PROQUAD for prophylaxis, which were reconstituted with properly stored sterile diluent (MRK). No adverse events reported. The vaccines were exposed to a temperature excursion -14°C to -10°C, during a time frame of 4 hours and 30 minutes. There was no previous temperature excursion. Sender's Comments: US-009507513-1708USA010604.
SORENESS IN MUSCLE/TENDON REDUCED RANGE OF MOTION, WEAKNESS IN ARM. Suspect the vaccination was given too anteriorly in the deltoid, and affected his should ROM
Rash/hives appeared across upper abdomen/below breasts roughly 8 hours after injection. Growth of redness, swelling, and pain at injection site for up to 48 hours after injection. Ibuprofen and benadryl taken for 48 hours post injection.  Redness/swelling/pain at injection site improved 72 hours post injection. Rash/hives improved 4 days post injection.
Left arm large red burning area covering entire rear arm area with a hard raised area a shot injection site about 1"x.5"
shortness of breath, chest tightness, throat fullness within 5 minutes of administration. With CPAP support (I use this at night for my autoimmune disease), I did not require intervention. Lasted 24 hours.
This is a spontaneous report received from a noncontactable consumer or other non-HCP. A female patient received the 1st and 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient experienced illness (got super, super sick afterwards), with outcome of unknown. Relevant laboratory tests and procedures available in the appropriate section. Additional information: This reporter's mother-in-law completed the Pfizer COVID-19 vaccine series (she thinks in Jun). She got super, super sick afterwards. She received COVID-19 antibody test; results: negative ("zero" for antibodies a week or two). She wanted to know if this is typical. She is wary of getting the vaccine if it does not work. She provided no demographic information, age, batch/lot number or further information regarding her mother. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Rec. shot 9/14 AM - 7 PM pain in shoulder. 9/15 AM could not raise arm. Leaving for 2 week vacation 9/15 AM. 9/16 AM Called Doctor, he said go to ER - ER took x-ray's, pills, ice and sling. He directed me to orthopedic surgeon. 9/19 Dr. took x-rays, shot, sling and ice. Pain for 10 days (Could not raise arm, no driving, exercise vaccination shot .
This case was reported in a literature article and described the occurrence of anaphylaxis in a 27-year-old female subject who received Flu seasonal TIV Dresden. This case refers to patient 28 in the literature article. Co-suspect products included influenza vaccine. On an unknown date, 2 hrs after receiving Flu seasonal TIV Dresden, the subject developed anaphylaxis. Serious criteria included GSK medically significant and life threatening. Additional event(s) included generalized erythema, generalized rash, eye red, eye pruritus, palpitation, throat swelling and chest heaviness. The subject was treated with antihistamine and acetaminophen. The outcome of anaphylaxis was recovered/resolved. The outcome(s) of the additional event(s) included generalized erythema (recovered/resolved), generalized rash (recovered/resolved), eye red (recovered/resolved), eye pruritus (recovered/resolved), palpitation (recovered/resolved), throat swelling (recovered/resolved) and chest heaviness (recovered/resolved). The investigator considered that there was a reasonable possibility that the anaphylaxis, generalized erythema, generalized rash, eye red, eye pruritus, palpitation, throat swelling and chest heaviness may have been caused by Flu seasonal TIV Dresden and monovalent influenza vaccine. Additional information was provided: This case was reported in a literature article and it described the occurrence of a vaccine-triggered anaphylaxis in a 27-year-old female patient who had received an unspecified monovalent influenza vaccine (manufacturer unknown) and an unspecified trivalent influenza vaccine (manufacturer unknown). The patient was a female. No further information on the patient's concurrent medical conditions, medical or family history, or concomitant medication was provided. On an unspecified date, between the 1st of January of 2009 and the 31st of December 2011, the patient received an unspecified dose of an unspecified monovalent influenza vaccine and an unspecified trivalent influenza vaccine (dosages unknown; administration routes and sites unspecified; batch numbers not provided). On an unspecified date, 2 hours after the vaccination, the patient developed generalized erythema and rash, red itchy eyes, increased heart rate, palpitations, throat swelling and "chest heaviness". This was classified as anaphylaxis by the emergency department doctor. According to the authors the case was considered as Brighton level 1 and setting of initial evaluation was emergency department. The patient was treated by oral antihistamine and acetaminophen. At the time of reporting the outcome of the events was recovered. The patient was referred to primary care physician. The event was classified as vaccine related according to the authors. The authors concluded that "Anaphylaxis after vaccination is rare in all age groups. Despite its rarity, anaphylaxis is a potentially life-threatening medical emergency that vaccine providers need to be prepared to treat. This case is 1 of the 28 valid cases reported in the same literature article.