chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reports onset shaking, chills "I couldn't hold a glass of water and teeth chattering approx 9 pm. 4 AM (beginning the evening after both influenza and Pneumovax injections.) With assoc subjective fever and myalgias. Now resolved all but myalgias. No tx, pt afebrile. VSS on 10/16/07.
This spontaneous report as received from a pharmacist refers to a 66 year old patient of unknown gender. On 16-APR-2015, the patient was vaccinated with an expired dose of PNEUMOVAX 23 dose and route were not reported (lot # J014401, expiration date: 26-NOV-2014). No adverse effects reported. Additional information has been requested.
Initial misuse report received from a healthcare professional on 06 August 2013. A 6-year-old patient received extra dose of DAPTACEL and IPOL vaccines on 8 August (year not specified). The child had received previous dose of DAPTACEL and IPOL on 12 November (year not specified). No adverse event was reported. List of documents held by sender: none.
with in 24hr of recieving immunization. pt developed 105 fever x 1 day, tenderness, vesicles locally around injection site. Pt was admitted to  Hosp on 7/27/07 and put on Vancomycin to prevent infection and also local Acyclovir for vesicles. Full recovery was made.  09/25/2007 MR received for hospital DOS 7/28-8/01/2007 for DX: Upper arm cellulitis. Erysipelas. Gastritis.  Fever. Asthma. Abdominal pain. Child presented with fever, erythema, and a vesicular rash on the arm where vax were given.  PE significant for decreased breath sounds bilat.  4x5 in area of cellulitis posterior RU arm.  Vesicular rash at the center 1x2 in with an area of necrosis at the center. During hospitalization c/o abd pain and loose stools thought to be gastroenteritis.
pt recv vax 14JAN94 & 16JAN94 exp h/a, nausea, vomiting, severe neck pain, dizziness & difficulty hearing; seen in ER; CT scan & LP were both neg; @ time of report, neck pain persisted; No further details were provided;
Shaking/tremor; Headaches; Body aches; Temperature a 100; Chills; Nausea; This spontaneous case was reported by a nurse and describes the occurrence of TREMOR (Shaking/tremor), HEADACHE (Headaches), MYALGIA (Body aches), PYREXIA (Temperature a 100) and CHILLS (Chills) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in April 2020. Concurrent medical conditions included Thyroid disorder NOS.    On 13-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced TREMOR (Shaking/tremor), HEADACHE (Headaches), MYALGIA (Body aches), PYREXIA (Temperature a 100), CHILLS (Chills) and NAUSEA (Nausea). On 14-Jan-2021, TREMOR (Shaking/tremor), PYREXIA (Temperature a 100), CHILLS (Chills) and NAUSEA (Nausea) had resolved. At the time of the report, HEADACHE (Headaches) and MYALGIA (Body aches) had not resolved. Not Provided      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.   The events shaking, chills, with nausea, tremors and temperature a 100 were  resolved on 14 Jan 2021  Treatment for the event included paracetamol.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
On Wednesday, 12/29/21, Patient came to Covid-19 Vaccination Site for her Pfizer Covid-19 booster vaccine. Client received her Pfizer Covid-19 booster dose (LOT #: FL3157) at 3:17 PM in her left deltoid. During assessment questions, client stated her medical history included no known drug allergies and no pertinent medical history. Client was to be a 15 minute observation. At 3:35 PM, while waiting in Observation Area, client stated to EMT she felt "tingling" on the back of her next extending to her left arm. EMT noted no stroke symptoms or pain and this sensation did not occur after first vaccine. At 3:35 PM vitals started, BP: 124/80, HR: 78, O2 sat: 97%, RR: 16, skin: warm and dry. At 3:45 PM, BP: 120/78, HR: 69, O2 sat: 99%, RR: 16, skin: warm and dry. Client stated she felt "less tingliness." EMT brought client to anti gravity chair and offered her a water bottle which she drank. Client stated she had two glasses of wine last night, no water this morning and only had coffee and a muffin. EMT offered client Benadryl for her tingly sensation and client denied. Client also bdenied SOB, throat constriction, dizziness, lightheaded. At 3:50 PM, BP: 118/78, HR: 72, O2 sat: 98%, RR: 16, skin: warm and dry. Client states tingliness is "much better" and feels comfortable to go home to rest. No further interventions needed. Client was educated by EMT on signs and symptoms of adverse reactions and when to go to the ED/call MD. Client was also encouraged to sign-up on v-safe. At 3:56 PM, client left vaccination site with a steady gait. Her friend drove her home.
Flushing, itching, developing some red rash spots on arm, back and stomach area, feeling little tightness in throat. Initially difficulty in breathing.
Information has been received from a physician concerning a 74 year old female with hypertension and hypercholesterolemia, with a history of thyroid cancer and basal cell carcinoma who on 18-JAN-2008, was vaccinated with a subcutaneous single dose of ZOSTAVAX.  Concomitant therapy included hydrochlorothiazide, aspirin and "cholesterol medicine" (therapy unspecified).  One day after receiving the vaccine (19-JAN-2008), the patient developed a 4 cm by 5 1/2 cm area of redness with a single blister at the injection site.  On 21-JAN-2008, she was examined by the physician in the office.  No diagnostic or laboratory studies were performed.  The physician indicated that the patient's symptoms were resolving without requiring treatment.  A product quality complaint was not reported.  This is one of two cases from the same source.  Additional information has been requested.
This spontaneous report was received from a nurse and refers to multiple patient of unknown age and gender. The patients' concurrent  conditions, medical history and concomitant medications were not reported. On unknown dates, the patients' were vaccinated with improperly stored VARIVAX subcutaneously (dose unknown) from lot # M003439 with an expiry date of 19-JAN-2018. No adverse effects were reported. Therapy with VARIVAX was continued. No product quality complaint was involved. This is one of the two reports received from same reporter. Additional information has been requested.
The patient received 2nd dose of Pfizer Covid vaccine in left upper arm at 1230 today. While she was sitting in the waiting area for monitoring, she soon developed a sore/dry throat, difficulty breathing, and felt "strange". She also felt itchy, but had no local injection site reaction, rash, or hives. The first dose of epinephrine administered at 1251; patient developed a dry cough, anterior throat pain with difficulty swallowing, HA, dizziness, and chest heaviness. A second dose of epinephrine was given at 1301. EMS administered 25 mg of IV benadryl, and she started to have relief of her symptoms. She denies any nausea, vomiting, or palpitations. The patient states her throat still feels sore and itchy, but there is no obvious swelling at this time. She was monitored in the Emergency Department and discharged home.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 29Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 07Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid from 19Jun2022 to 23Jun2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Flu-like symptoms; Severe abdominal pain; Chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), ABDOMINAL PAIN (Severe abdominal pain) and CHILLS (Chills) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history).    On 12-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), ABDOMINAL PAIN (Severe abdominal pain) and CHILLS (Chills). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms), ABDOMINAL PAIN (Severe abdominal pain) and CHILLS (Chills) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05May2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 67 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Gastritis" (unspecified if ongoing); "GERD" (unspecified if ongoing); "possible IBD and other stomach issues" (unspecified if ongoing), notes: possible IBD and other stomach issues; "possible IBD and other stomach issues" (unspecified if ongoing), notes: possible IBD and other stomach issues; "known allergies: Yes" (unspecified if ongoing), notes: known allergies: Yes. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.
limpness & choking w/in 24hrs p/vax; was seen @ hosp
cough, runny eyes, dry throat; mucous in mouth; ache in diaphragm when coughing;
Patient was complaining at 7:00 PM (just 4.5 hours after vaccination) that his mouth and cheeks hurt and couldn't open his mouth well, but didn't have a fever. I went ahead and gave him some Motrin. He went to bed around 8:00 PM. He woke up at 11:00 PM that night crying and saying his mouth was hurting and this time had a fever. So I gave him more Motrin. He then woke up at 3:00 crying saying again that his mouth, ears, and neck hurt. I gave him more Motrin. He was probably awake for almost an hour because he was in so much pain. He finally fell back asleep and woke up at 7:00 AM. He said his mouth still hurt and I gave him more Motrin. I called the doctor and left a message that I needed an appointment. So I saw the doctor today, September 8, 2010 at 2:30 PM, just 24 hours after he received the vaccination and she checked him out. He had a double ear infection. She said it was bad. One side much worse than the other. She said that he looked perfect the day before and that his ears were completely clear the day before when she checked them.
no adverse event; VARIVAX had t/e on 16-AUG-2023 and was administered to patient; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 01-SEP-2023, the patient was vaccinated with a 0.5 mL dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # reported as W039699) (route not reported) that had a temperature excursion on 16-AUG-2023. The temperature of excursion was 25.8 °C for a time frame of 9 hours 24 minutes. There were no previous excursions. The reported also stated that the freezer units have ice packs in them that never melted during the excursion.  Lot # W039699 is an invalid lot number for varicella virus vaccine live (oka/merck) (VARIVAX).  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2309USA006884: US-009507513-2309USA009905: US-009507513-2309USA009906: US-009507513-2309USA009907: US-009507513-2309USA009908: US-009507513-2309USA009909: US-009507513-2309USA009910: US-009507513-2309USA009911: US-009507513-2309USA009912: US-009507513-2309USA009913: US-009507513-2309USA009915: US-009507513-2309USA009927: US-009507513-2309USA009928: US-009507513-2309USA009929: US-009507513-2309USA009930:
On 4/7/2021 I was hospitalized with a heart attack due to an embolism in my LAD. Had to be re-stented. In ICU for 5 days- regular hospital 2 and discharged after total of 7 days
Chest pain 15 hours after 3rd dose of Pfizer administered. Improved mildly, then worsened again. EKG w/ widespread ST segment elvation. Pleuritic  chest pain, unable to lie on left side.. High sensitive troponin at admission 4,306, increased to peak of 16,000.  Supportive care given. Cardiology/ID consulted. Discharged on aspirin, ibuprofen and PPI.
Pain in her arm (injection site); Pain in her arm then her neck all the way down to the feet on left site; Pain in her arm then her neck all the way down to the feet on left site; Numbness and tingling and weakness in arm; Numbness and tingling and weakness in arm; Numbness and tingling and weakness in arm; This is a spontaneous report from a contactable consumer.   A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) in the arm, on an unspecified date, in 2015, at single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, in 2015, 6h after the vaccination, she experienced pain in her arm (injection site) then her neck all the way down to the feet on left site. Also had numbness and tingling and weakness in arm. Chiropractic treatment was performed. The patient did not recover from the adverse events.   No follow-up attempts are needed, information about batch number cannot be obtained.
Received vaccine at about 10:00 am, approximately 20 minutes later I began to feel flushing and clammy, at about 12:00 pm I noticed nausea, dizziness and weakness, at about 2:00 pm my hands became visibly red and tingling.  At about 5:00 pm the tingling of the arms worsened and traveled to my legs.  On 11-20-09 visited the ED were I received meclizine and ondansetron.  The nausea and dizziness improved but the tingling and pain in the limbs still persists.
This spontaneous report was received from a Certified Medical Assistant (C.M.A) regarding a 4 year old patient of unspecified gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 17-JUN-2016, the patient was vaccinated with improperly stored PROQUAD (lot # L050910, expiry date 14-JUN-2017) dosing regimen unknown. Call was because of a data logger. It was reported that the vaccine administered was subjected to temperature excursion of 23 degree Celsius for a time frame of 1 hour and 29 minutes. The vaccine was not subjected to any previous temperature excursion. No adverse effect was reported. Product quality complaint (PQC) was not filed. This is one of several reports received from the same reporter. Additional information has been requested.
This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a subject of unspecicifed age an gender who was vaccinated with ENGERIX B (GlaxoSmithKline) for prophylaxis. Concurrent medical conditions included dialysis. Subjects had previously received Recombivax and did not respond to therapy. On a unspecified date the subject received unspecified dose of Engerix B (unknown). At an unspecified time after vaccination with Engerix B, the subject did not respond to therapy as laboratory results did not show anti-hepatitis b antibodies. At the time of reporting the outcome of the event was unspecified.
Severe topical reaction; This case was reported by a pharmacist via sales rep and described the occurrence of skin reaction in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) for prophylaxis.   On an unknown date, the patient received the 1st dose of FluLaval Quadrivalent .5 ml. On an unknown date, unknown after receiving FluLaval Quadrivalent, the patient experienced skin reaction. The patient was treated with prednisone. On an unknown date, the outcome of the skin reaction was unknown.   It was unknown if the reporter considered the skin reaction to be related to FluLaval Quadrivalent.  Additional details were provided as follows: This case was reported by the reporter for his/her one of the prisons employee. The age at vaccination was not reported. The reporter stated that the patient had severe topical reactions to FluLaval. This is 1 of the 2 cases reported by the same reporter.
Severe nightly pain in anterolateral (L) shoulder, at site of injection, After 5 wks the pain is still there, no palpable mass to suggest a hematoma or abscess.
Pt developed painful lesions on L trunk and back on 12/15/09. Pt encouraged to seek treatment/care.
Patient passed out, fell back on to the bed, got up, stated he felt really odd. Gave him apple juice and crackers, and cold water. Gave patient cold rag to put onto forehead.
What occurred after the Pfizer vaccination  I got the second shot of Pfizer vaccine on March 24, 2021 without the symptoms as described on the Internet except only the shot arm pain.   But from the early April, I felt coarse and dry in my mouth with my lips often stuck with the teeth.  The lips sticking to the teeth became worse around May. The skin inside the mouth discolored with the inside lower lip appearing blue and some red spots, and the right part in the mouth also appearing some red spots.   And one night when I was sleeping in the bed I just felt my heart was whirling fast, and I was very anxious especially after searching some information about the dryness.   So I contacted the family doctor PCP in May who referred to ENT doctor first and then the rheumatology doctor.  In early June the ENT doctor didn?t find anything with a biopsy of the lower inside lip within her specialty. And in the middle of July when I saw the rheumatology doctor, the symptoms as described above were disappearing but were still with me.  After some special blood tests, the rheumatology doctor said everything looked normal with the blood tests.   And in September the PCP doctor arranged a blood test for me again with most things ok, but the Vitamin B12 is 1958, which is far above the range.   All these times especially from April to July I drank water all the time.   Now it is October. Although it looks the symptoms are further disappearing, it is still dry and coarse in the mouth, and the lips stick to the teeth from time to time, and I just feel the saliva in my mouth is salty.   And the problem is that I don?t know how for the next step or where to find further medical help or what medicine to take?
Reported muscle aches; chills, lump in throat; watering & excess mucous formation in eyes; lethargy; blisters in mouth; face flushing; did not take temp.
This spontaneous report was received from an office manager refers to an unknown number of patients of unknown age and gender. No pertinent medical history and drug reactions/Allergies were reported. On an unknown dates, the unknown number of patients were vaccinated with improperly stored doses of ROTATEQ (lot # M004544 and expiry date 18-OCT-2017) (dosing regimen was unknown by the reporter). No concomitant medications were reported. The vaccine was exposed to temperature excursion of 31.3 Fahrenheit for 15 minutes. No adverse effects were reported. No product quality complaint (PQC) was reported. This is one of several reports received from the same reporter. Additional information has been requested.
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Jun2022 as dose 4 (booster), single (Lot number: FM7553) at the age of 65 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "breast cancer survivor" (unspecified if ongoing), notes: breast cancer survivor; "hypothyroid" (unspecified if ongoing), notes: hypothyroid; "interstitial cystitis" (unspecified if ongoing), notes: interstitial cystitis; "acid reflux" (unspecified if ongoing), notes: acid reflux; "sulphas" (unspecified if ongoing), notes: sulphas, seasonal allergies; "seasonal allergies" (unspecified if ongoing), notes: sulphas, seasonal allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Sep2022) Negative; (24Sep2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: The reported COVID-19 positive after BNT162b2 COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Patient was given Fluzone HD and patient is under 65, no symptoms yet as of today 10/16/21
Patient reports a very large lymph node in her armpit approximately 5 inches in diameter. This lymph node is very painful.
Pt came to ER c/o SOB, fatigue, diarrhea, fever.  Onset 10 days.
Patient got up from seat to get water, begin to see lights, fell forward/ employee caught him,  didn't quite remember falling, we had patient lie on ground, elevate feet, placed cold pack on head, and cloth underneath head. Called EMS, they arrived shortly
Pt vaccinated with Engerix-B developed papular rash, pruritus.