chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recvd Typhoid vax & exp an anaphylactoid reaction, accompanied by seizures; pt was admitted to ICU & is recovering;
Body aches-lasting two days Fatigued-lasting one day  Nausea-lasting two days Headache-lasting 8 days
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Information about patient's medical history was not provided. On an unknown date, the patient was vaccinated with a dose of PROQUAD (Merck) (0.5 ml, subcutaneously, dose number, frequency and indication were not specified) (lot # K008185, expiration date: 05-DEC-2015) that was improperly stored. Concomitant medication was not reported. No adverse experience was reported. No product quality complaint (PQC) was reported. Additional information has been requested.
Both ears popping, stuffed up. Particularly the right ear, during next several days achy muscles, tired, coughing.  Early last week had extreme pain and redness on right side of tongue that lasted through 11/2. Returned to pharmacy on 10/31, diagnosed with ear infection.  Prescribed 850 mg amoxicillin 2x daily which I am still taking.  While stuffiness is better, I am unable to hear properly out of right ear.
I began having seizure episodes, I experienced extreme body pains, then would collapse. Seizures caused anxiety, began different seizure medications, side affects made me too sick. Seizure episodes would leave my body in severe pain for weeks ahead.
Pins & needles, cold & hot, feeling in arm of injection. Started in hand and worked its way up the arm. Fingers became numb, joints were painful, arm swollen - 60 mg prednisone given at ER advised BENADRYL as needed.
extreme body aches, unable to walk or move without assistance for 48 hours, nausea, fever and headaches
Ongoing Fatigue, Brain Fog  on and Off, Ongoing  Neck and Head Pain (Back of Head and Neck on the Right Side)
Hives and Tingling in left arm immediately after vaccine 2 hours later tingling spread to right side of body up chest into cheeks and into my eyes. Since august 24 I have had a tingling sensation in both eyes that has not gone away. The tingling switches from one eye to the other and now is primarily in right eye. I went to optamologist and they have not found anything wrong. Have pcp appointment on the 18 and will most likely see a neurologist  ENT or allergist per optamologosts recommendations
onset of chicken pox 12-25-05, continued through 1/9/06. Follow up - Vaccines were given at another Peds office.  We don't have this information.
Patient kneeled downed to the floor with no injuries, no fall. Patient then noted to become unconscious for 2 minutes (6:40pm-6:42pm) with palpable pulse and labored breathing. Patient was assisted to the floor, placed on her left side with aspiration precautions maintained. Initial vital signs at 6:44pm: BP 100/60, HR 90, O2 Sat 74%. Patient regained consciousness at 6:42pm and was verbally responsive. At 6:50pm vital signs as follows: AO x3, BP 100/70 , HR 104, O2 85%.  Patient's main complaint was syncope. Continued with  vital signs and monitored vital signs until EMS arrival.
Patient got a wet spot right below on the injection site; dizziness; Nausea; Patient fainted for a moment; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Patient fainted for a moment) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Jan-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced SYNCOPE (Patient fainted for a moment) (seriousness criterion medically significant), DIZZINESS (dizziness) and NAUSEA (Nausea). On 21-Jan-2022, the patient experienced VACCINATION SITE DISCHARGE (Patient got a wet spot right below on the injection site). At the time of the report, SYNCOPE (Patient fainted for a moment), VACCINATION SITE DISCHARGE (Patient got a wet spot right below on the injection site), DIZZINESS (dizziness) and NAUSEA (Nausea) outcome was unknown.            Concomitant medication included Soloist, Description anti depressant. No treatment information was provided.  This is a spontaneous case concerning a 29-year-old, female patient with history  medical history treatment with soloist, who experienced the unexpected serious (hospitalization) event of fainting and no-serious events of Patient got a wet spot right below on the injection site, dizziness, nausea. The events started on unknown date on the same month of administration of a dose of mRNA-1273 vaccine. Past medical history of Soloist could be a confounder. The rechallenge was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.; Sender's Comments: This is a spontaneous case concerning a 29-year-old, female patient with history  medical history treatment with soloist, who experienced the unexpected serious (hospitalization) event of fainting and no-serious events of Patient got a wet spot right below on the injection site, dizziness, nausea. The events started on unknown date on the same month of administration of a dose of mRNA-1273 vaccine. Past medical history of Soloist could be a confounder. The rechallenge was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.
Information has been received from a healthcare worker referring to a 52 years old female patient. On 13-JAN-2015, the patient was supposed to receive ZOSTAVAX, but was inadvertently administered VARIVAX (Merck), injection, 0.5 ml, (strength, route, lot number and expiry date were not reported). No adverse effects reported. No dose of ZOSTAVAX administered. Additional information is not expected since follow-up was not permitted by the reporter.
Pt reported via phone c/o extremely weak on both arms, general fatigue, diaphoresis (duration approximately 40 sec). On 9-15-12 felt better but had another episode as symptoms described above on 9-18-12 again.
This spontaneous report as received from a pharmacist refers to 65 year old female with hypertension, hypothyroidism and drug reactions/allergy to CIPRO, penicillin and sulfonamides. On 05-AUG-2013 the patient was vaccinated with a dose of ZOSTAVAX lot # J001005 expiry date 24-APR-2014, subcutaneously, dose unknown. On 05-AUG-2013, immediately after administration of ZOSTAVAX the patient experienced "a bump" at the injection site. No treatment was given. There were no lab tests performed. The patient sought medical attention in pharmacy. The bump has persisted since 05-AUG-2013 and has not resolved. The relatedness between adverse event and ZOSTAVAX was not reported. Additional information has been requested.
About four days after the third dose she presented hives all over her body. She was very itchy with big red patches. this has also happened after her second dose but this time was much worse. We were advised to give her Benadryl and to put hydrocortisone and Benadryl cream all over the rash.
arm sore but it's not unbearable (muscle pain); he's also very tired but not overly tired; he slept all day; This is a spontaneous report from a contactable consumer or other non-HCP (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On unknown date the patient experienced arm sore but it's not unbearable (muscle pain), he's also very tired but not overly tired, he slept all day. He doesn't have chills or joint pain. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Vaccination was administered in the right thigh and covered with a bandaid.  Upon removal of the bandaid the next day a hard lump under the skin and a circular rash area was discovered.  The lump and rash did not get worse or get better after 36 hours since the vaccination.  Patient was seen by the public health nurse who administered the vaccination and the nurse at the local medical clinic was consulted.  Heat pack was advised and then a follow up visit the next day.  Heat pack was applied and there was visible but not complete recovery at the follow up visit.  Heat pack treatment is being continued, size of the lump is diminishing and the rash is subsiding.  There was no pain or discomfort or related fever or irritability for the patient associated with the skin reaction to the vaccination.
Two locations of bruising without any known cause. Bruising on left forearm, circumference of approx. 2 inches.  Bruising on left ankle and on top of left foot with no known cause. Forearm bruise noticed on day after vaccine, Foot bruising noticed on Monday , 3 days after vaccine. No known causes for either of these,  pain associated with forearm  site. Also the night of injection chills and severe left arm pain was experienced.
Patient said 12 hours after receiving 1st dose of pfizer vaccine her heart rate went up to 180 per smartwatch. She stated she went to hospital and had 102 degree fever and her arm was very hot (says they took temperature of her arm with ir thermometer and was 110). She said the providers thought she may be having an allergic reaction to the COVID vaccine and stated she had to stay in hospital for 8 days (did not give specifics of admittance/stay). She said she has since recovered from it.
Pt was seen @ ER in PM 30AUG91  c/o crying inconsolably, intermittantly; swollen lt thigh, heat @ site of inject; tx APAP w/codeine;
Sore body and tired on day 2. Day 3 rash all over and itchy.
After receiving the second vaccination dose of the COVID19 Moderna shot, I experience soreness in my left arm around the injection site. Within 6 hours I had chills, achy and sore muscles, and mild sinus congestion which lasted on and off for about 24 hours once the symptoms began. About two days later I noticed that the around where the vaccine was injected was raised, warm to the touch, and painful, as well as a little itchy. After doing some online reading, it seems like I have the "covid arm" that is being talked about.
administered to a patient who got the flu shot 4 days before; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (administered to a patient who got the flu shot 4 days before) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 21-Apr-2021, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (administered to a patient who got the flu shot 4 days before). At the time of the report, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (administered to a patient who got the flu shot 4 days before) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Developed swelling on March 1, 2021 in right breast and right arm.  Seen by Radiation oncologist  and diagnosed with lymphedema of right breast and right arm, referred to physical therapist
This spontaneous report as received from a physician and from a support services director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 11-APR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # L037339,  0.5 ml - 10 Pk SD PFS-, expiry date 09-FEB-2018; route of administration was not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to three separate temperature excursion (dates unspecified): one lasting for 24 hours, with the lowest recorded temperature of 30 degrees Fahrenheit (-1.1 degrees Celsius), the second one lasting for 96 hours, with the lowest recorded temperature of 32 degrees Fahrenheit (0 degrees Celsius) and the third one lasting for 80 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (1.1 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects 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.
leg cramps /severe leg cramps; joint pain all over /joint pain; headache; Covid arm; Discomfort; Itching at injection site; Large swelling at injection site; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE SPASMS (leg cramps /severe leg cramps), IMMUNISATION REACTION (Covid arm), DISCOMFORT (Discomfort), VACCINATION SITE PRURITUS (Itching at injection site) and VACCINATION SITE SWELLING (Large swelling at injection site) in a 70-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Nov-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In November 2022, the patient experienced IMMUNISATION REACTION (Covid arm), DISCOMFORT (Discomfort), VACCINATION SITE PRURITUS (Itching at injection site) and VACCINATION SITE SWELLING (Large swelling at injection site). On 19-Nov-2022, the patient experienced MUSCLE SPASMS (leg cramps /severe leg cramps), ARTHRALGIA (joint pain all over /joint pain) and HEADACHE (headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, MUSCLE SPASMS (leg cramps /severe leg cramps), IMMUNISATION REACTION (Covid arm), DISCOMFORT (Discomfort), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE SWELLING (Large swelling at injection site), ARTHRALGIA (joint pain all over /joint pain) and HEADACHE (headache) outcome was unknown.            No concomitant information provided. Patient took the offered four doses Covid Moderna vaccine, at the appropriate times.  Patient was in relatively good health and patient had O negative blood. Patient had no fever or life threatening issues.  It was reported that patient had previously received different vaccines, that did nothing of the sort. Patient had a general doctor appointment coming up and would report this.   This case was linked to MOD-2022-675368 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Nov-2022: Live Follow-up Significant information which includes Events added
Neuropathy affecting bilateral feet starting 3/29/21 followed by bells palsy 4/9/21
Red itchy bumps on her arm ,back, face, chest, legs, elbows, hands, feet; Red itchy bumps on her arm ,back, face, chest, legs, elbows, hands, feet; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Red itchy bumps on her arm ,back, face, chest, legs, elbows, hands, feet) and ERYTHEMA (Red itchy bumps on her arm ,back, face, chest, legs, elbows, hands, feet) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced PRURITUS (Red itchy bumps on her arm ,back, face, chest, legs, elbows, hands, feet) and ERYTHEMA (Red itchy bumps on her arm ,back, face, chest, legs, elbows, hands, feet). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; FAMOTIDINE (PEPCID [FAMOTIDINE]) at an unspecified dose and frequency and RANITIDINE HYDROCHLORIDE (ZANTAC) at an unspecified dose and frequency. At the time of the report, PRURITUS (Red itchy bumps on her arm ,back, face, chest, legs, elbows, hands, feet) and ERYTHEMA (Red itchy bumps on her arm ,back, face, chest, legs, elbows, hands, feet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment for the events included OTC benadryl, pepcid, steroids and zantac.; 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
Administered dose of Gardasil 06/07/07 to right gluteus. Notified office, via telephone, on 06/11/07 of 3 episodes numbness in RLE and site rash since injection. Went to ER 06/12/07 w/c/o RUE, RLE numbness.
experiencing tingling throughout my body/ the tingling "feeling comes very randomly" and that its, "like a prickly sensation in my arms, hands, feet, legs, and face."; experiencing tingling throughout my body/ the tingling "feeling comes very randomly" and that its, "like a prickly sensation in my arms, hands, feet, legs, and face."; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 25-year-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on 11Aug2021 at 16:00 as dose 1, single for COVID-19 immunisation. The medical history and concomitant medications of the patient were not reported. The reporter reported she received the first dose of Covid19 Pfizer vaccine and within about 12 to now 24 hours later (on 12Aug2021) she experienced tingling throughout her bod. She wanted to know if that was a normal side effect or something she should be concerned about. She reported the tingling "feeling comes very randomly" and that its, "like a prickly sensation in my arms, hands, feet, legs, and face". She also stated there were people who said they had experienced this online. She had been feeling like tingling in her body and feet. The outcome of the event was reported as not resolved.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.
Redness; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 9AB33, expiry date 6th December 2021) for prophylaxis.   On 11th September 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 11th September 2019, less than a week after receiving Shingrix, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on left deltoid. The patient experienced redness 4 inches wide at the site of injection site and it had been 7 days at the reporting date the redness had still not improved.  No further details were provided.
rapid heart rate; elevated blood pressure; mast cell activation; Waldenstrums; Was very dizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Batch/Lot number: unknown) at the age of 62 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "chronic back pain" (unspecified if ongoing); "asthma" (unspecified if ongoing); "allergies" (unspecified if ongoing), notes: Other medical history: allergies. The patient's concomitant medications were not reported. The following information was reported: DIZZINESS (hospitalization, disability) with onset 26Mar2021, outcome "not recovered", described as "Was very dizzy"; WALDENSTROM'S MACROGLOBULINAEMIA (hospitalization, disability) with onset 11Apr2021, outcome "not recovered", described as "Waldenstrums"; BLOOD PRESSURE INCREASED (hospitalization, disability) with onset 11Apr2021, outcome "not recovered", described as "elevated blood pressure"; MAST CELL ACTIVATION SYNDROME (hospitalization, disability) with onset 11Apr2021, outcome "not recovered", described as "mast cell activation"; HEART RATE INCREASED (hospitalization, disability) with onset 11Apr2021, outcome "not recovered", described as "rapid heart rate". The patient was hospitalized for dizziness, heart rate increased, blood pressure increased, mast cell activation syndrome, waldenstrom's macroglobulinaemia (hospitalization duration: 3 day(s)). The events "was very dizzy", "rapid heart rate", "elevated blood pressure", "mast cell activation" and "waldenstrums" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (unspecified date) elevated; Cardiac stress test: (unspecified date) normal; Heart rate: (unspecified date) rapid; various blood tests: (unspecified date) Unknown results; SARS-CoV-2 test: (May2021) Negative, notes: Unknown; (02Dec2021) Positive, notes: Unknown. Therapeutic measures were not taken as a result of dizziness, heart rate increased, blood pressure increased, mast cell activation syndrome, waldenstrom's macroglobulinaemia.  Clinical course: Was very dizzy within first hour of getting the vaccine. Started going to the ER about two weeks after the vaccine dose for rapid heart rate and elevated blood pressure (gets worse when laying down at night). Doctors were not sure what to do and would send me home when I was stabilized, but things continued to get worse. Have been having trouble getting various blood tests ordered, but cardiac and stress test results are normal. Still seeking medical help at this time, but concerned it could be mast cell activation, and at least one doctor is thinking it could be Waldenstrums. No covid prior vaccination. Covid was tested post vaccination on 02Dec2021  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.