chrisvoncsefalvay/vaers-outcomes huggingface dataset:
body began to swell; Swelling in her feet; had a lot of swelling in her joints; could not walk or pick up her arms and feet.; screamed in pain; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the first dose via intramuscular in left arm on 19Jan2021 at 18:00 for COVID-19 immunization. The relevant medical history included high blood pressure & diabetes from unspecified date, allergy to penicillin from unspecified date. Concomitant medications included unspecified medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received medications within 2 weeks of vaccination. The patient took the vaccine on 19Jan2021 and she started feeling very still on Friday, by Monday she could not walk or pick up her arms and feet. She screamed in pain and her body began to swell so she went to urgent care and had to be placed on steroids. She could not wear shoes for 3 months due to swelling in her feel and they continue to swell, so she was forced to wear compression stockings. She continued to see a rheumatologist and had to take therapy for 3 months. She was healthy before the shot, but after her body was not the same and she had a lot of swelling in her joints after the first vaccine. The events onset date was reported as 22Jan2021 at 08:00 AM. The events resulted in Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab test included nasal swab showed negative in Jan2021. Therapeutic measures were taken as a result of the events. The outcome of the events was recovering.  Information on lot number/batch number was requested.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events swelling, peripheral swelling, joint swelling, gait disturbance and pain cannot be completely excluded.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.
Severe chest pain in the left side of chest,  stretching to the left shoulder (December 19th) Throat felt full, pain stretching from chest to  throat (December 19th) Loss of hearing in right ear for approximately 2 hours (December 18th) Heightened anxiety (December 18th) Nausea and headache (December 18th) Canker sores, mouth ulcers, on the roof of the mouth, side of tongue, and under the tongue (December 19th-present) Suspected yeast infection/ vaginitis (December 19th-present)
Lot of pain in arm the shot was given - right arm; Pain is a little bit above the elbow; Cannot lift the arm up - right arm; Joint pain but only in elbows - both; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Lot of pain in arm the shot was given - right arm), LIGAMENT SPRAIN (Pain is a little bit above the elbow), VACCINATION SITE DISCOMFORT (Cannot lift the arm up - right arm) and ARTHRALGIA (Joint pain but only in elbows - both) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).  On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.   On an unknown date, the patient experienced VACCINATION SITE PAIN (Lot of pain in arm the shot was given - right arm), LIGAMENT SPRAIN (Pain is a little bit above the elbow), VACCINATION SITE DISCOMFORT (Cannot lift the arm up - right arm) and ARTHRALGIA (Joint pain but only in elbows - both).   At the time of the report, VACCINATION SITE PAIN (Lot of pain in arm the shot was given - right arm), LIGAMENT SPRAIN (Pain is a little bit above the elbow), VACCINATION SITE DISCOMFORT (Cannot lift the arm up - right arm) and ARTHRALGIA (Joint pain but only in elbows - both) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Concomitant drug was not reported.
Moderna COVID-19 Vaccine EUA Fever of 101.9; chills; severe body aches; extreme exhaustion, all lasting appx 24 hours
Tinnitus in right ear; Sore arm at injection site; This is a spontaneous report from a contactable Other Health Professional (patient).   A 62-year-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0191, Expiration date: unknown) via an unspecified route of administration on 08Apr2021 at 02:15 pm (at 62-year-old) in left arm as dose 1, single for COVID-19 immunization. The patient's medical history was reported as none. The patient's concomitant medications were not reported. patient did not have covid prior to the vaccination and was not tested for covid post vaccination. patient did not received any other vaccines in four weeks and other medications in two weeks. On 11Apr2021 at 06:00 AM, within 4 days of first dose the patient developed to tinnitus in right ear. There were no other symptoms other than a sore arm at injection site. The patient also developed a large red and swollen area on the injected arm but not at the injection site. This condition lasted 3 days, and then she lost at least 80 percent of her hearing in the right ear. As of 23Jun2021 she still had tinnitus in the right ear and still had a significant hearing loss. There had not been much improvement to either symptom since 29Apr2021. No treatment was received. The event tinnitus in right ear resulted in disability or permanent damage. The outcome of events was not recovered.  Information on Lot/Batch number was available. Additional information had been requested.; Sender's Comments: Based on description given in the narrative, there is reasonable possibility of causal association between the event Tinnitus and the suspect BNT162B2.    The impact of this report on the benefit/risk profile of the Pfizer drug 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.
pt recv vax & some time p/vax pt exp tingling & numbness in the inj arm, a local rxn rash (5x4cm) & site induration;
I am a retired Family Physician.  I was called by V-Safe x 2 in Jan/Feb 2022 to inquire whether new health issues I reported during V-safe check were due to vaccine.  In retrospect, recalled (1) intermittent labile BP readings in early 2021 (40's-160's/80-90's); (2) Spring 2021 had spikes of BP to 180's/90-100's with watching adventure/suspense movies; (3) Noticed increased DOE with hill climbing during biking/hiking (attributed to resolving Valley Fever at the time); (4) BP 220/120 on 10/21/21 at clinic (asymptomatic); took metoprolol 25 mg and returned next day to receive Covid #3; (4) Referred by PMD to cardiology for labile HTN ; tests for secondary causes of HTN all neg except for mild OSA; (5) Exercise stress test 12/30/21 with Hypertensive response to exercise and diffuse ST depressions (Duke score -12.50-high risk of ischemia).  Last Fall 2019-NEG for ischemia; (6) 1/10/22 Cath results: 1. Angiographically non-obstructive coronary artery disease in right dominant coronary circulation. 2. Ischemia with no obstructive CAD likely secondary to microvascular coronary artery disease; (7) 1/11/22 Near syncopy at home; given fluids in ER and BP labile, developed symptomatic hypertensive urgency with new-onset chest pain and HA with f/u increasing troponins; (8) Late Jan/early Feb 2022 I received 2 calls from V-Safe after f/u checking from Covid #3 vaccine.  (9) Made appointments for concern of possible adverse reaction to Covid vaccines #2/3 but unable to be seen by Allergy/Immunology and Cardiology 2nd opinion until late June 2022.   Cardiology advised me to complete  VAERS form as she was aware of a possible adverse reaction of of endothelial ischemia from COVID vaccine after hearing a lecture by a cardiologist.  (10) I desire to receive COVID vaccine #4 but now I am unsure if this is a safe decision for me.
This spontaneous case initially received on 19-Dec-2016, was reported by a non health professional and concerns a female patient. Weight: not provided; Height: not provided. Past medical history included high blood pressure. Drug history includes penicillin, sulfonamide, mycin (reaction: drug reactions/allergies). Concomitant medication: refer to appropriate report section. Administration of company suspect drug(s): On an unknown date, the patient received Influenza Virus Vaccine (INN) . Dose regimen: Not reported, Route of administration: Not Reported. Batch number: Not reported. Non-company suspect drugs: ZOSTAVAX. Dose regimen: Not reported, Route of administration: Subcutaneous. Batch number: Not reported. Adverse reactions/events and outcome: On an unknown date, the patient experienced blisters breaking out around the injection site (outcome: not recovered / not resolved), they (blisters breaking out around injection site) are really itchy (outcome: not recovered / not resolved).
Swelling of right foot, pain in whole right foot. Limping when walking and hard time moving foot. Pain now gravitates up right leg
week legs; arm also had red area; awake; sweeting; his feet were very cold; low grade fever/ he was too hot; light headache over eye; shivering/feeling chill; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (week legs), ERYTHEMA (arm also had red area), INSOMNIA (awake), HYPERHIDROSIS (sweeting) and PERIPHERAL COLDNESS (his feet were very cold) in a 74-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 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 PAIN IN EXTREMITY (week legs), ERYTHEMA (arm also had red area), INSOMNIA (awake), HYPERHIDROSIS (sweeting), PERIPHERAL COLDNESS (his feet were very cold), PYREXIA (low grade fever/ he was too hot), HEADACHE (light headache over eye) and CHILLS (shivering/feeling chill). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (week legs), ERYTHEMA (arm also had red area), INSOMNIA (awake), HYPERHIDROSIS (sweeting), PERIPHERAL COLDNESS (his feet were very cold), PYREXIA (low grade fever/ he was too hot), HEADACHE (light headache over eye) and CHILLS (shivering/feeling chill) had resolved.            No Concomitant medications were provided   This case was linked to MOD-2021-049579, MOD-2021-266692, MOD-2021-049559 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow up contains Email address reported. On 18-Oct-2021: Followup received on 18-OCT-2021 considering NNI On 19-Oct-2021: Follow-up information received on 19-OCT-2021 ncluded no new information
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 58-year-old male patient who received BOOSTRIX. On 3rd June 2015, the patient received BOOSTRIX .5 ml. On 3rd June 2015, less than a day after receiving BOOSTRIX, the patient experienced injection site pain. On an unknown date, the patient experienced parkinsonism. On an unknown date, the outcome of the injection site pain was not recovered/no resolved and the outcome of the parkinsonism was unknown. The reporter considered the injection site pain and parkinsonism to be almost certainly related to BOOSTRIX. Additional details were provided as follows: The patient reported that, he experienced left arm pain after receiving BOOSTRIX vaccine. On an unknown date, the patient was diagnosed with Parkinson's disease.
A day after receiving vaccine,  small area around the vaccine location on left arm  was harden  with redness cause some pain when touch. After about a week , the  affected area  was enlarge to cover most of upper arm , look like a  big rash , red, harden and  feel hot and itchy when touch. Symptom similar to being described as Covid Arm.  Will contact Dr.  to schedule an appointment on Monday2/22  for a check up.
left arm is swollen; itchy; very hard; painful; redness now it is going big; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (left arm is swollen), PRURITUS (itchy), INDURATION (very hard), PAIN IN EXTREMITY (painful) and ERYTHEMA (redness now it is going big) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (left arm is swollen), PRURITUS (itchy), INDURATION (very hard), PAIN IN EXTREMITY (painful) and ERYTHEMA (redness now it is going big). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BANOPHEN) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (left arm is swollen), PRURITUS (itchy), INDURATION (very hard), PAIN IN EXTREMITY (painful) and ERYTHEMA (redness now it is going big) outcome was unknown.        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.   Concomitant product use was not provided by the reporter.
Information has been received from a physician, via a company representative, concerning a female patient (age not reported), who on an unknown date was vaccinated with a dose, 0.5ml, of Gardasil (Lot # not provided).  After the vaccination, the patient experienced "dizziness for only a moment."  At the time of this report, the patient had recovered from the event.  Additional information has been requested.
Pharmacist called to report that her patient recently developed HPV at approximately 26-years-old after receiving the full 3-dose series of GARDASIL 9 at 18-years-old.; This spontaneous report was received from a pharmacist and refers to a 26-year-old female patient. No information on patient medical history, current conditions and concomitant medications was provided. On unknown date patient had pap smear and result was HPV positive.      On an unknown dates (when she was 18 years old) the patient was vaccinated with all three doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly for human papilloma virus immunization (exact dose, lot# and expiration date were not provided).         On an unknown date the patient experienced papilloma viral infection. The outcome of papilloma viral infection was reported as not recovered. The action taken with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) regarding the event was not applicable.   The causality between the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the event papilloma viral infection was not provided.
fever 100;lethargy, anorexia, gen achiness, local inj site soreness sx lasted 3 days-no tx
chills; fever; headache; lots of body aches; This is a spontaneous report from a contactable other healthcare professional, the patient. A 20-year old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), via intramuscular route of administration in the left arm on 03Jan2021 at 08:00 AM (at the age of 20 years-old) as a single dose for COVID-19 vaccination. Medical history was unknown. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 03Jan2021, the patient experienced chills, fever, headache, and lots of body aches. The report was reported as non-serious. It was unknown if the patient was treated for chills, fever, headache, and lots of body aches. The clinical outcome of chills, fever, headache, and lots of body aches was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  Information on Lot/batch number has been requested.
My son had seizure hospitalized 10 days cannot play anymore not talking as before, continues fever, lost appetite and sleeps frequently.  9/25/07 Reviewed hospital medical records which reveals patient experienced episode of unconsciousness then was confused & pale.  Had HA evening prior to LOC which had resolved.  Had 2 witnessed seizures in ER.  Admitted7/24-7/26/2007.  Neurology consult done.  No further seizures s/p med dosing.  D/C home on antiseizure meds. FINAL DX: Partial complex seizures w/secondary generalization. Per 60 day follow up: Patient has long term seizure, brain damage, fatigue, not listening, angry all the time, fussiness. Continue taking seizure medication TRILEPTAL 150 mg tablet 2 tablets in morning 3 at night. 1/12/2010 Continue having seizure, mood changes, behave changes.
RespDepression found to have low potassium Narrative:  Patient reports experiencing shortness of breath 24 hours after the vaccine was administered, went to ER and admitted for one night. Informed her supervisor she had low potassium.
Patient received a dose of the vaccine with it diluted with 0.8ml of Nacl instead of 1.8ml of Nacl that's recommended.
Arm swollen, fever, chills, chest pain, heart palpitations, migraine headaches.
pt recv vax 13MAY97 & that same day pt devel redness & pain @ inj site & a fever of 100.1;
Site is red and swollen. Took Benadryl 25mg. Reported to doctor.
Pt felt nauseated and as though she might faint while stopped at redlight and planned to pull into adjacent parking lot as soon as the light turned green, but had syncopal episode and drove through the light, veering into the opposing traffic lanes, hitting 3 cars. No injuries, no airbag deployment, did not hit head. Pt denies any pain other than some soreness at injection site.
PATIENT GIVEN THE 5-11 PEDIATRIC DOSE, INSTEAD OF THE DOSE FOR 12 AND OVER NO ADVERSE OUTCOME
tested positive for covid19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for covid19) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 19-Jan-2021, the patient experienced COVID-19 (tested positive for covid19). At the time of the report, COVID-19 (tested positive for covid19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Jan-2021, COVID-19: (Positive) positive.         No treatment information and concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: second dose information
fevers within 24 hours up to 100.3, red puffy eyes, fussy, liquid stool, rashes on skin, lethargic/sleepy
I was calling I got my second Covid shot yesterday, last time my left eye is all kind of red and so this morning I woke up kind of crested,  I never had pinkeye before I don't know if its is pinkeye; I was calling I got my second Covid shot yesterday, last time my left eye is all kind of red and so this morning I woke up kind of crested,  I never had pinkeye before I don't know if its is pinkeye; This is a spontaneous report from a contactable consumer. This consumer (patient) of unspecified age and gender received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), dose 1 via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE and as dose 2 via an unspecified route of administration on 25Jun2021 (Batch/Lot Number: FA6780) as DOSE 2, SINGLE, for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient got second Covid shot yesterday, last time patient's left eye was all kind of red and so this morning patient woke up kind of crested, patient never had pinkeye before don't know if it was pinkeye (Jun2021), patient concern was it something might be having a shot would get. Patient stated, yes would like to talk to someone, patient just want to if it was a side effect, it was Saturday, his/her doctors office was not open. The outcome of both events was not recovered.  Call could not be transferred to Medical information department and Patient hung up the call abruptly.  Limited information available over the call.
A report has been received from a Health Professional concerning a 14 year old, male subject, who had been receiving FLUMIST. FLUMIST started on an unknown date. The nurse reported that the son of one of the nurses received full dose of FLUMIST in one nostril which started on 25-Nov-2013. The outcome of the event of the son of one of our nurses received full dose of FLUMIST is unknown. The report was considered to be non-serious.
Her reported symptoms are: In the arm that she got the HPV vaccine (R) she had almost immediate pain and a sensation like it was crawling up her arm and into her shoulder. Had palpable  muscle tension along this area and up into occipt.  Then about an hour later she got a migraine, nausea and vomited several times. Felt a little dizzy. Later that night had some tightness in her R chest which was worse with deep breaths and palpation.  these started to improve over the next 24-48 hours. exam was normal other than tight trapezius muscle
Had a temperature of 101F-102F within 12-18 hours, post vax, with nausea and vomiting. Phoned family doctor who felt it was flu/cold. By 36-40 hours, temperature was 103.5F and was unable to keep anything down. Was dehydrated and not urinating. Was taken to MD. Labs showed increased alk phos. Pt was given Tigan Supp and Tylenol for Rx. Lesser temperature and nausea and vomiting after the 1st dose. Mother thought it was flu. Temperature down on 3/18/01. MD determined it was a vaccination reaction.