chrisvoncsefalvay/vaers-outcomes huggingface dataset:
loss of balance; body rash; Allergic reaction; This is a spontaneous report from a contactable other hcp. A 52-years-old male patient received second dose of BNT162B2( PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported via an unspecified route of administration, administered in Arm Left on 13Feb2021 at13:45 as single dose for COVID-19 immunization. The patient previously took first dose of  BNT162B2( PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported on 13Feb2021 at 01:45 PM via unspecified route of administration in left arm  The patient did not receive any other vaccine in four weeks. No known allergies reported. Medical history included COVID19 infection from an unknown date and unknown if ongoing. Concomitant medication(s) included sildenafil taken for an unspecified indication, start and stop date were not reported. On 14Feb2021 at 14:45 the patient experienced loss of balance, body rash 24 hours after injection, allergic reaction. The patient was given Benadryl. The outcome of events was not recovered.  Information on the lot batch number has been requested.
injection site irritation; Vaccine Administered at Inappropriate Site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site irritation in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (subcutaneous). On an unknown date, unknown after receiving Shingrix, the patient experienced injection site irritation and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site irritation and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the injection site irritation to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported.  The age group was captured as adult as per vaccine indication. The pharmacist reported that he accidentally injected a Shingrix vaccine subcutaneously, which led to intramuscular formulation administered by other route.  He also stated that the patient reported injection site irritation. The pharmacist stated he was not at the pharmacy on the day of reporting, and had no other information to provide at time of reporting, including information related to patient or product.
Severe chills, fever of 103.3 first night- followed by fever of over 101 for next 2 days.
Hives sprouted throughout legs/buttocks area initially (mostly all the way around the belt line), sporadic on torso (sides, right nipple)
12/16/2020 woke up at 10 am and had severe body aches, chills and HA. Took Tylenol and Ibuprofren. The fatigue and chill came back later that day. Symptoms didn't go away till went to sleep. Felt better on 12/17/2020.
I got covid/I had COVID Vaccine both doses, Booster but I haven't had a second Booster; I thought I had a sinus problem infection and they tested me COVID; I got covid/I had COVID Vaccine both doses, Booster but I haven't had a second Booster; I thought I had a sinus problem infection and they tested me COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown), in Mar2021 as dose 2, single (Batch/Lot number: unknown) and in Sep2021 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I got covid/I had COVID Vaccine both doses, Booster but I haven't had a second Booster; I thought I had a sinus problem infection and they tested me COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I went to the Doctor and they tested and they said you have COVID. Therapeutic measures were taken as a result of covid-19 included Paxlovid .  Clinical course: Consumer stated that he was taking Paxlovid for COVID, he had Pfizer COVID Vaccine both doses and then in September last year he had the Booster (Pfizer, COVID Vaccine). He haven't had a second Booster, he was 72 that's how he got a Booster. He was in compromised group or something (medical history) and so he thought he had a sinus problem this week sinus infection and he went to the Doctor and they tested and they said he had COVID, so that's why he was taking Paxlovid. he had just couple of question if we could answer him for the Paxlovid because first time he was taking it. When paraphrased to confirm the concern, consumer stated that he had been taking it (Paxlovid). They gave it to me because he had COVID, so they gave him Paxlovid. he had been taking it. He started Wednesday night, so he took one of the three pills the pack, with the three pills and then he took one Wednesday night he took on that Thursday morning he had a Pack and then Thursday night he had an another pack and Friday had one in the morning and one at night, so he had taken half of the thirty pills. The question was if he had terrible like it seems like he had diarrhea very badly. Could he take Imodium? was that okay to use with it? In response to further probing, consumer stated that he couldn't because he only had 15 minutes until 9 o'clock and he would got to talk to somebody. When probed for Paxlovid LOT# and expiration date, consumer stated that he was looking for it but he didn't see it. As consumer was not willing to proceed the call. Hence further probing could not be done. Limited information available over the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Headache in back of head, behind ears I & on both sides of temples. Upset stomach, just feeling cloudy. I had a very hard time sleeping because of the headache. I actually wrap my head with a bandanna to stop the throbbing. The injection site (upper right arm) was swollen and red. My arm hurt on underside of injection site. I had to leave work early two days in a row.
Initial report received from a healthcare professional on 23 January 2014: A male patient in late 50s had received an intramuscular dose of FLUZONE, (lot number: UH752AB, expiration date: 30 June 2013, dose number and site of vaccination not reported) on an unspecified date of 2012. The patient has had flu vaccines in previous years. The patient's illness at the time of vaccination, pre-existing medical conditions were unknown and concomitant medications were unknown. On an unspecified date of 2012, the patient presented hives all over. Laboratory investigations and corrective treatments were not reported. At the time of this report, the patient had not recovered. Documents held by sender: none. Follow-up information received from a healthcare professional on 07 April 2014: A 52-year-old patient had received 0.5 ml intramuscular dose of FLUZONE on 06 November 2012 in left deltoid. On an unspecified date, within 24 hours of flu shot, the patient developed rash. He went to emergency room on 06 November 2012 and was given steroid shot and oral prednisone. The patient followed up with his doctor who tapered prednisone dosage. The patient was suggested allergy patch testing at allergist or top get a shot at allergist to verify if it continues to be a problem. No laboratory test were done. Patient's medications include pravastatin 10 mg daily and multivitamin one daily.
Information has been received from a certified nurse practitioner concerning an 8 year old female who on 28-AUG-2007 was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck) (LOT# 658196/1018U) in left arm, subcutaneously. On 29-AUG-2007, the patient experienced a small raised area at the site of injection then redness spread. On 30-AUG-2007, the red area was spreading (8X8 cm), swelling with yellow drainage, and fever up to 101. She was diagnosed with cellulitis. The outcome of the patient's events were not reported. Additional information has been requested.
Severe pain / needed to use crutches; joints, feet, elbows and knees swelling; feet / swelling; Severe pain / needed to use crutches; This case was reported by a consumer via other manufacturer and described the occurrence of pain in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 4 hrs after receiving Shingles vaccine, the patient experienced pain, swollen joints, swelling of feet and crutch user. On an unknown date, the outcome of the pain, swollen joints, swelling of feet and crutch user were unknown.   It was unknown if the reporter considered the pain, swollen joints, swelling of feet and crutch user to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself. The age at vaccination was not reported. The patient reported of having a reaction in the past to the 2nd dose of Shingles vaccine. The patient experienced joints, feet, elbows and knee swelling and was in severe pain and needed to use crutches. The reporter's and healthcare professional s consent to follow-up was reported as not applicable.
Patient went home Sunday after getting both vaccines and patient's wife states that patient became incoherent and incontinent. Wife monitored patient until Tuesday and then called 911. Patient was seen in ER on Tuesday and was diagnosed with mini-stroke per patient's wife. Wife said that patient was told he was very dehydrated and she hopes he will be released today 10/26/23.
This spontaneous report was received from a 62 year old female patient regarding herself. No medical history or drug allergies were reported. On 04-FEB-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route not reported). No concomitant medications were reported. On 05-FEB-2013, the patient experienced the following injection site reactions after receiving ZOSTAVAX: redness, swelling and the skin was warm to the touch. The outcome of injection site reactions was reported as not recovered. No treatment was received. No laboratory diagnostics tests were performed. No medical attention was sought. The causality of injection site reactions for ZOSTAVAX was unknown. Additional information is not expected.
m.d. rpt on 30JUL98 that after 1dose of vax pt exp seizure-like sx w/flexing the neck, blank stares, mother noted child ``throws back his neck as he runs'' 4/SEP/98 eeg was performed, norm; f/u requested. vitamin therapy
Started with body aches  6 hrs. After the shot.  Progressed to extreme body aches, muscle weakness, low grade fever, and Chills.
Joint aches, rash on pts trunk. Symptoms came on pt the night after receiving shot that day. Tx: 80 mg deopmedrol IM.
NO ADVERSE REACTIONS. PATIENT GIVEN EXPIRED VACCINATIION (EXP DATE 9-21-21)
~20-30 minutes during monitor period, pt developed mild chest tightness and SOB, both partially but not totally reliveved by rescue inhaler.  Pt requested to be placed on O2 and then transported to the hospital.
I had a subacute left pontine stroke.  I have run 30 marathons and completed numerous other distane events.
On Sunday, February 28 and Monday, March 1 my arm was itchy at injection site.  On Tuesday, March 2 my arm had red spots from injection site and half way down the arm to the elbow.  Slight red color to skin and also with the itchy skin. On Wednesday the red skin increased to the upper portion of the arm, not including the skin underneath.  Itchy feeling stated to decrease. March 3, Per doctor, continue to watch and if the red skin spreads more, I will contact them and they will issue an antibody.
Sudden onset  2 episodes rapid heart rate - 5-10 seconds.  Ongoing mild chest pressure with and without exertion multiple times every day since.   Two days - January 28 and Feb 13 - of severe malaise.  Also,  Feb 13,  episodes of erratic heart rate between 7 - 9 pm - spontaneously resolved.
Arm soreness; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 32-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm soreness".  Additional information: No Covid-19 prior vaccination. Post-vaccination, the patient was not tested with COVID-19.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I had a sudden syncope episode with LOC as I walked to my bedroom.  Didn't wake up until my head hit door jam and I was on the floor.
headache; arm pain; arm was warm at the site; really tired; body was aching; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 48 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 01Apr2021 (Lot number: ER8732) at the age of 48 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 02Apr2021, outcome "recovered" (Apr2021), described as "headache"; PAIN IN EXTREMITY (non-serious) with onset 02Apr2021, outcome "recovered" (Apr2021), described as "arm pain"; VACCINATION SITE WARMTH (non-serious) with onset 02Apr2021, outcome "recovered" (Apr2021), described as "arm was warm at the site"; FATIGUE (non-serious) with onset 02Apr2021, outcome "recovered" (Apr2021), described as "really tired"; PAIN (non-serious) with onset 02Apr2021, outcome "recovered" (Apr2021), described as "body was aching".  Additional information: The next day, 02Apr2021, she started to feel these symptoms. She confirms by the fourth day, she started to feel better. She recovered completely from these symptoms. Emergency Room: No, Physician Office: No. Patient had no prior Vaccinations (within 4 weeks): No AE(s) following prior vaccinations. Patient's Medical History (including any illness at time of vaccination): No Concomitant products: She had not been on any medicines. Relevant Tests: No.  No follow-up attempts are possible. No further information is expected.
Grave's disease; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient (non-pregnant at time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left arm on 01Mar2021 at 10:30 (Lot number: EN6208) as single dose for COVID-19 immunization. Patient also received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left arm on 22Mar2021 at 12:45 (Lot number: EN6202) as single dose for COVID-19 immunization. Medical history included hoshimoto's; allergies, allergies to shrimp. Concomitant medication included cetirizine hydrochloride (ZYRTEC ALLERGY) over the counter for allergies. The patient previously took erythromycin, cefazolin, methocarbamol that all experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that between patient first and second doses, her autoimmune disease swung from Hoshimoto's to Grave's disease on 15Mar2021 at 12:00. The patient had labs from January as a baseline and then labs from mid-March, both were unknown results. Patient had never been in hyperthyroid scenario previously so thought it worth mentioning just in case. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event including prescribed propranolol & methimazole. The outcome of the event was recovering.  Information on the lot/batch number has been requested.
Liver is very painful; Diarrhea; arm pain; This is a spontaneous report from a contactable nurse (patient). A 37-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection: Lot number: unknown), via an unspecified route of administration on 09Feb2021 at 09:00 am in right arm as a single dose for covid-19 immunization Workplace clinic. The patient's medical history included allergy to tetracycline. Concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. No covid prior vaccination. Since the vaccination, patient had not been tested for covid-19. On 14Feb2021 at 08:00, the patient experienced Diarrhoea, arm pain. The patient stated that her liver was very painful. The patient had a physician office visit due to the events. It was unknown whether the patient was treated for the events. The outcome of the events was not resolved.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
This spontaneous report as received from a registered nurse via pharmaceutical companies refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On an unknown date, the patient was vaccinated with PNEUMOVAX23, lot number, expiration date, dose and route of administration not reported. On an unknown ate, the patient experienced redness, pain and swelling at the injection site. The physician felt this was a more severe reaction than a normal local reaction. The reporter wanted to know whether the patient could receive PREVNAR 13. The outcome of redness, pain, and swelling at the injection site was unknown. The relatedness between the events and vaccination with PNEUMOVAX23 was not reported. Additional information has been requested.
Swelling, mass at site of injection in muscle, unable to lift arm. Placed on steroids, physical therapy.
hypothermia; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HYPOTHERMIA (hypothermia) in a male patient of an unknown age 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 HYPOTHERMIA (hypothermia) (seriousness criterion medically significant). At the time of the report, HYPOTHERMIA (hypothermia) outcome was unknown.            No treatment medication were provided. No concomitant medication were provided. Action taken for Moderna COVID-19 Vaccine was not applicable.  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.   Reporter did not allow further contact; 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.
Faint; Weak; Chills; Feverish; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Faint) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0402B1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in November 2020.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced CHILLS (Chills) and PYREXIA (Feverish). On 27-Apr-2021, the patient experienced SYNCOPE (Faint) (seriousness criterion medically significant) and ASTHENIA (Weak). At the time of the report, SYNCOPE (Faint), ASTHENIA (Weak), CHILLS (Chills) and PYREXIA (Feverish) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, SARS-CoV-2 antibody test: positive (Positive) Positive. In March 2021, SARS-CoV-2 antibody test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications taken by the patient included thyroid medications and cholesterol medications. No treatment information was provided.  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.; 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.
INJECTION SITE SWELLING; DRUG INDUCED LUPUS; This spontaneous report received from a patient concerned a 58 year old female The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: Unknown and expiry: Unknown) dose was not reported, (dose number in series 1) 01 total, administered on 04-AUG-2021 for prophylactic vaccination. The patient developed lumps/tumors (diagnosed as marginal B-cell lymphoma) she had injection site pain which she was not sure whether due to the original or the booster and had injection site lump (dose number in series 1). The patient had not recovered from injection site pain, injection site lump and marginal B-cell lymphoma (dose number in series 1). The patient additionally received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855194 and expiry: Unknown) dose was not reported, (dose number in series 2) 01 total administered in left deltoid on 19-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  The patient reported that she during that first dose that she received the booster and was not sure if it worsened her symptoms. On an unspecified date patient had injection site swelling which was rated as a 1/10 but it was noticeable and was still there. The patient did the blood work on 26-JAN-2022 with the diagnosis of drug induced lupus. She stated she spoke to health care professional (HCP) and she was stunned with the report, she stated she was going for additional testing in several days (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site swelling, and the outcome of drug induced lupus was not reported (dose number in series 2). This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20220145846.; Sender's Comments: 20220146890-COVID-19 VACCINE AD26.COV2.S-Drug induced lupus. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).