chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient states she started to develop a rash from her right wrist on 6/18/23 around lunchtime. She believed it was a reaction from her Clindamycin and stopped the medication. She took a Claritin to help with itching. She called the Clinic. She reported the rash on her back was dried up, but had a rash on both arms and her chest that were new. Healthcare provider instructed to take Benadryl now and continue every 6-8 hours. If patient was experiencing difficulty breathing or swelling/tingling in her face, instructed to call EMS or seek immediate medical attention. Patient stated she was a retired nurse and was stable. Follow-up appointment was scheduled for 06/20/23 to determine if the rash was related to Clindamycin vs. vaccine reaction.
I started to develop COVID arm on day 7 (March 10) around 7:15pm. My arm became very hot, painful, and stiff. Upon touching I realized it had fever, hives, and lumps. I took 1 benadryl, 1 famotidine, 2 Tylenol. The hives are gone, the lumps formed into one big lump, and it has turned red and is itchy and painful.
Patient' husband stated patient started having severe itching, slight rash on arms and legs, shortness of breath approximately 45-60 minutes after receiving the vaccine. Patient told husband it was like she could taste the shot. Patient took Benadryl and used her  Albuterol MDI at home but according to husband refused to go to a doctor. No symptoms presented during 15 minute waiting period after the patient received the vaccine.
UTI; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (UTI) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included CALCIUM and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 18-Feb-2021, the patient experienced URINARY TRACT INFECTION (UTI). The patient was treated with ANTIBIOTICS for UTI, at an unspecified dose and frequency.   At the time of the report, URINARY TRACT INFECTION (UTI) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
3 days after receiving  a booster dose of vaccine I experienced significant voice changes (hoarseness, weak/fluctuating voice)
pt recvd vax;onset eve 16nov94;devel fever 102; chilly sensations;less fever on 17nov & 18nov (not recorded)
Approximately 14 hours after (11pm)  booster vaccination patient started feeling severely nauseous and then vomited every 15 minutes until approximately 4 in the morning
I got the vaccine on Saturday at 12:38 and on Sunday evening I had sharp pain in my chest and neck and a feeling of pressure and tightness in my chest. Monday morning I still had the pressure and tightness and my chest felt fluttery so I checked my heart rate throughout the day and while it?s normally 70 at rest, it was around 92 at rest and constantly spiked above 100, even hitting 176 and 149 while I was sitting at a desk. The pain came intermittently throughout the day and these same symptoms continued into Tuesday and so I went to the ER where they diagnosed me with Costochondritis.
Felt weird; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt weird) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Felt weird). At the time of the report, FEELING ABNORMAL (Felt weird) had resolved.            No information was provided on concomitant medication. Treatment information was not provided by the reporter   This case was linked to MOD-2021-375342, MOD-2021-375333, MOD-2021-375327 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: Follow-up received on 09-Nov-2021 contains NNI.
Information has been received from a pharmacist concerning a 76 year old male with a history of cancer and head and neck surgery who on 20-JUN-2008 was inadvertently vaccinated with a double dose of ZOSTAVAX (Merck) (lot # not provided). It was reported that at the time of the report, the patient was in the hospital. The diagnosis was not known. The patient's wife contacted the pharmacist and stated that the patient had also developed shingles in addition to the reason for his hospitalization. As of 09-JUL-2010 the patient had not recovered. Additional information has been requested.
On 5/9/2014 - received 12 month vaccines. On 5/20/2014 - presented with 7 days fussiness, loose stool and 3 days diffuse maculopapular truncal eruption w/ some to face and extremities. Not fussy 5/20/14. Rash self resolved.
Pt states on 5SEP91 had reddened rash to occur along w/swollen knee joints w/pain that lasted 3 days; had difficulty bending & straightening knees for 3 more days; then for 4 days had swollen fingers w/tingling & pain @ 1st joints fingers;
Within 5 minutes after administration, felt hot, weak, dizzy, diaphoretic with warm extremities. Placed in decubitus on exam tableBP 100/70, pulse 68/min.  no itching, redness, shortness of breath or throat symptoms. Initially improved but felt dizzy again and blood pressure decreased to 88/60 and subsequently to 74/54. Received Epinephrine 1:1000 (AuviQ) 0.3 mg im right thigh and was placed in Trendelenburg position. Initially felt better but subsequently felt dizzy and weak again. BP 110/74 then 140/80. Sent to ER for observation.
At first it was severe arm pain, more than the Pfizer, Felt run down and tired, My fever 101.2. I felt awful and feeling of unwellness and arm pain. Severe Chills. Virtual doctor. took Tylenol. At most 48 hours and then I was good. COVID- 3rd burning in upper chest, like my chest was on fire. It went away the next day. Then had sore throat ( felt like fire) very painful, no body aches and fever. fatigue. Several days till yesterday, then the cough and congestion started.
can't walk straight; developed dizziness/ so dizzy; nauseous; thrown up; This is a spontaneous report from a contactable consumer (Patient). A 53-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number were not reported), dose 1 via an unspecified route of administration on 17Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, patient can't walk straight, developed dizziness/ so dizzy, nauseous and thrown up on 21Apr2021. When she woke up today, after she was up for a while she developed dizziness. She told that she was so dizzy that she was nauseous. She had even thrown up.  She stated that she could not stop spinning and was sure what was going on, was that normal. She told that every time she moved her head, she started spinning again and she could not walk straight. By the time she walked to her bathroom and back, she was on the verge of throwing up again. She wants to know if this was normal. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained
Immediately after injecting vaccine patient had severe injection site (localised) swelling & bruising. Approximate area = 3 inches x 3 inches (bluish red). No change after a day except for turning more red at injection site.
My vision was going black and I passed out; I had severe ringing in my ears/ Throughout the rest of the day my ears were ringing; Light headed /Dizzy; My heart rate was at 148bpm/ my resting heart beat never dropped below the 120s bpm.; Nausea; Bad headache; This is a spontaneous report from a contactable other health care professional (patient). A 24-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 10Sep2021 17:00 (at the age pf 24-year-old) (Lot Number: Fc3183) as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included latex allergy. Concomitant medication included topiramate (TOPAMAX) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On 11Sep2021 10:30, the patient woke up and got up to brush her teeth and shower and had severe ringing in her ears, was light headed, dizzy, vision was going black and passed out. The patient's heart rate was at 148bpm when she regained consciousness. Throughout the rest of the day her ears were ringing, had a bad headache, nausea, and reported that her resting heart beat never dropped below the 120s bpm. The patient did not receive any treatment for the events. The outcome of the events was recovering.; Sender's Comments: Based on the reported information ,a causal relationship between the event loss of consciousness and suspected drug cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
experiencing higher glucose than usual. Type 2 diabetic. Running 20 to 40 points higher than usual.; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on 10Mar2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 dose 1 on an unspecified date for COVID-19 immunisation. It was reported that after 2nd covid vaccine on March 10, the patient was experiencing higher glucose than usual. Type 2 diabetic. Running 20 to 40 points higher than usual. It started about week after 2nd shot and continues to present. The patient mentioned that there was nothing different in his/her eating or activity or meds. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
pt recvd vax & exp flu-like sx fever, aches; No further details available;
THE PATIENT COMPLAINED OF SLIGHT DIZZINESS. THE PATIENTS FATHER EXPLAINED THAT THE PATIENT GETS DIZZY ANY TIME SHE GETS A SHOT. THE PATIENT WAS PLACES ON A STRETCHER AND LAID DOWN THE PATIENT EXPLAINED THAT SHE WAS FEELING BETTER AND THAT THE DIZZINESS WAS GONE
patient complained of dizziness and leg numbness. PT was monitored for 45 minutes and then released when no longer complained of numbness or dizziness.
Patient received his first Pfizer shot on March 20th.  He began to have pain in the back of his right knee which sent him to the ED.  Upon further investigation, he was found to have a blood clot and was given Eliquis as a blood thinner.  His physician requested that he make a report as he received his first COVId shot 8 days prior to the blood clot.  He denies any diabetes, chemotherapy that may have irritated his vessels.  Gabapentin,
Pt's mother stated he displayed marked increase in tics, post vax. He had tics prior to vaccines. Affect of increased tics more noticeable after environmental stimulation. In clinic only minimal evidence of tics activity on 3/13/01. Note: mother believes older sibling had permanent (neurologic) changes following immunizations.
felt dizzy; felt weak; face felt weird; couldn't walk in a straight line; felt drunk and on drugs; felt shaky; bruise/bruised; couldn't use her arm for a day (couldn't move for a few days); headache; fatigue; arm had agonizing pain; felt a tight band around my thyroid; felt a tight band around my thyroid; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received first dose BNT162B2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included allergies such as penicillin, sulfa (have a lot of allergies), and accidental radiation leak which damage the thyroid and sometimes it created a tight band around her throat. The patient's concomitant medications were not reported. The patient previously received a tetanus shot (arm was sore for 4-6 days). It was reported that patient was due to receive her second dose of the Pfizer vaccine next Wednesday (also reported as COVID-19 vaccine). Patient stated that weird stuff happened to her after she got the vaccine and was not sure if she could get her second dose. It was stated that immediately after getting the vaccine she walked out to the waiting room, after her first dose patient experienced that she instantly felt dizzy and needed help to sit in a chair but it didn't last too long. Patient was weak (just felt weak) and stated she waited 1.5 hours before leaving the hospital (also reported waited 1 hour and half in the waiting room) and felt a tight band around her thyroid but no difficulty breathing. It was further stated that the vaccine must have impacted her thyroid. It lasted for an hour and went way. She never felt it again. She reported that she had an accidental radiation leak which damage the thyroid and sometimes it created a tight band around her throat. Further reported that face felt weird didn't had trouble breathing, fuzzy headed and felt drunk. Patient just felt drunk and on drugs. She couldn't walk in a straight line and just felt shaky. She informed that she received a tetanus shot, her arm was sore for 4-6 days but the Pfizer vaccine was far worse. It didn't swell but she had a big bruise. Stated arm had agonizing pain, agonizing for the first 1-2 days and on third day it was gone. Patient couldn't use her arm for a day (also reported couldn't move for a few days and was bruised). Secondary felt fatigue and headache (after she got home). It was questioned if she should receive second dose. The outcome of the events felt dizzy was recovered on unspecified date (didn't last too long), felt a tight band around my thyroid was recovered on unspecified date (lasted for an hour) and arm had agonizing pain was recovered on unspecified date (third day it was gone), while unknown for the other events.  Information on the lot/ batch number has been requested.
pt reports experiencing heart palpitations in March.  first noted at a wedding which she thought stress/anxiety. but reports they have been happening much more frequently since then and even when not stressed.
This spontaneous report was received from a consumer referring to a 13 year old female patient with no pertinent medical history or drug reaction or allergies. Concomitant therapies included meningococcal vaccine and diphtheria toxoid, pertussis acellular vaccine. On 18-JUL-2018, the patient was vaccinated with the first dose of GARDASIL 9 lot # R003557 (expiration date 20-NOV-2018) intramuscularly in the right arm for prophylaxis. On approximately 25-JUL-2018 (reported as one week after vaccination), the patient developed a swollen knee. Since this reaction developed, the patient underwent two MRI tat confirmed that there was no tissue or ligament damage. Only fluid could be seen on the patient's knee. It was also stated that the patient had a low positive ANA (antinuclear antibody) marker. The patient has gone to 5 weeks of physical therapy and was on naproxen. Other laboratories performed were a full CDC infection diseases test, an autoimmune panel and a test for Lyme disease, however, no results were provided. At the time of the report, the outcome of joint swelling and antinuclear antibody positive was reported as not recovered. No relatedness assessment was provided.
pt reports SIRVA, states the RX intern gave shot too high and she has had pain since shot. She reports she still has pain 1w after ortho visits scheduled.
feeling dizzy; vertigo; tired; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2020, the patient received the 1st dose of Shingrix. In October 2020, 1 week after receiving Shingrix, the patient experienced dizziness, vertigo and tiredness. On an unknown date, the outcome of the dizziness, vertigo and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the dizziness, vertigo and tiredness to be related to Shingrix.  Additional details were provided as follows: The reporter was patient's daughter. The age at vaccination was not reported. The patient received dose 1 of Shingrix three weeks before the date of reporting.  It was reported that two weeks before the date of reporting the patient was feeling dizzy, vertigo, and tired.  The reporter did not consent to follow-up. The reporter stated she might call back later to provide more information.
All abdominal pain,  bloating, burning sensation , diarrhea for 5-6 days. Heart beat faster.  Most pain located to right side of the abdomen, around the gallbladder,  liver or kidney, but also radiate to the ovaries. Also a lot of nausea.  Today is the still have dull pain around my gallbladder.  Called dr office 3 different times, the nurse told me it?s normal. Dr. was on vacation, I got appointment after tomorrow.
shoulder & elbow pain since inject; 2DEC93 No response to request for more info;
Redness and swelling of upper part of 2 arms. develop. During 40 - 48 hours a prev vaccine. No fever, No pain. Reaction resolved at 72.
Shortness of breath. Light headedness. Itchy skin no hives. Bradycardia.
middle area of her back started to itch; sensation of little stabbing needles / in the middle of her back; This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received in 2018.).   On 3rd October 2018, the patient received Shingrix. On 24th January 2021, 844 days after receiving Shingrix, the patient experienced pruritus and pins and needles. On an unknown date, the outcome of the pruritus and pins and needles were not recovered/not resolved.   It was unknown if the reporter considered the pruritus and pins and needles to be related to Shingrix.  Additional details were provided as follows:  The patient had both doses in 2018. After searching paperwork, the date 3rd October 2018 was found as vaccination date but the reporter was not sure if that was the first dose or second dose date. After receiving Shingrix, the patient experienced the middle area of her back started to itch and the sensation of little stabbing needles presented, and it was under her bra area in the middle of her back. The reporter did not consent to follow up.
Information has been received from a licensed practical nurse as told to her by the patient's mother concerning a 12 year old female with no known drug allergies and a history of headaches, who on 12-JUN-2008 was vaccinated with the first dose of GARDASIL (lot # 654272/0073X), 0.5 mL, IM into her left deltoid.  On approximately 19-JUN-2008, the patient developed the following behavioral symptoms: increase in the frequency of headaches, auditory hallucinations and fear of sleeping in the dark.  The patient was hospitalized for an unspecified period of time and treated with unspecified medication.  She continued taking medication to relieve the behavioral symptoms.  No other symptoms or treatment reported.  At the time of reporting, the patient was recovering.  Additional information has been requested. 8/28/08-records received for DOS 7/17-7/19/08-DC DX:Anxiety disorder (NOS).  Admitted with C/O having images in her head of people killing her. She was not seeing the them but they were images in her head. Tends to be a worrier. Strong family history of anxiety with panic attacks. Admitted for observation and participation in group therapy.
tested positive for Covid about a year later; tested positive for Covid about a year later; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), 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 and concomitant medications were not reported.  The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "tested positive for Covid about a year later". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I was tested positive for COVID about a year later.  Clinical course: Patient stated, she/he had three shots for COVID. Two vaccinations (Later suspect clarified as Pfizer COVID-19 Vaccine) and a booster and then she/he was tested positive for COVID about a year later and was wondering would the medication Paxlovid, will that be a good drug for patient to take?"  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Moderna COVID-19 vaccine EUA: weakness, bodyaches, headache, 102.4 fever, chills, sob, upper chest pain and extreme Thirsty. Symptoms lasted 3 days
Child broke out with lesions on trunk that spread to face, scalp, and limbs. Lesion count was greater than 100 when patient was seen and diagnosed with varicella on 06/27/2011 by Dr.