chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache in right side of eye; Didn't fall completely but I tripped over; Body aches; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (Didn't fall completely but I tripped over), MYALGIA (Body aches), VACCINATION SITE PAIN (Sore arm) and HEADACHE (Headache in right side of eye) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Glaucoma. Concomitant products included TRAVOPROST (TRAVATAN Z), APIXABAN (ELIQUIS), METOPROLOL SUCCINATE (TOPROL XL), AMLODIPINE BESILATE (NORVASC) and ALBUTEROL [SALBUTAMOL] for an unknown indication.   On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced BALANCE DISORDER (Didn't fall completely but I tripped over), MYALGIA (Body aches) and VACCINATION SITE PAIN (Sore arm). On an unknown date, the patient experienced HEADACHE (Headache in right side of eye). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, BALANCE DISORDER (Didn't fall completely but I tripped over), MYALGIA (Body aches), VACCINATION SITE PAIN (Sore arm) and HEADACHE (Headache in right side of eye) outcome was unknown.            Other treatment information included cold pack and heat pack.  Action taken with mRNA-1273 in response to the events was not applicable.  Company comment: 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.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 08-APR-2013, the patient was inoculated by a pharmacist with the ZOSTAVAX (lot number, dosage and route of administration not provided) to obtain permanent prevention and protection against shingles and zoster related injuries. On or about 11-OCT-2012 (onset date of events is prior to date of inoculation), the patient was treated by a physician for herpes zoster meningitis. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Upon internal review, herpes zoster meningitis was determined significant medical event. Additional information has been requested.
Fell; This is a spontaneous report based on the information received by Pfizer (Mfr Report# UNT-2021-002835). A non-contactable female consumer reported an 82 years old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunisation on unknown date.  Co-suspect medication included treprostinil sodium (REMODULIN, Lot# 937303, Exp. Date: 31May2022) 10 mg/ml Subcutaneous  at 0.070 ug/kg for secondary pulmonary arterial hypertension since 09Sep2010. Relevant medical history included secondary pulmonary arterial hypertension (ongoing). Concomitant medications included apixaban (ELIQUIS) and tadalafil (ADCIRCA). On 18Jan2021, 10 years 4 months 10 days after initiating SQ Remodulin, the patient fell after receiving the COVID vaccine and was hospitalized.  Action taken with SQ Remodulin was not reported for the event of fall. At the time of reporting, the event of fall was considered as resolved on 18Jan2021. The patient was discharged from the hospital on 22Jan2021. The reporter did not provide causality for the event of fall.  Case Comment/Senders Comment: The company has assessed the event of fall as not related to SQ treprostinil considering that the patient has been on drug for more than 10 years. Fall was likely an accidental event in this elderly patient or could be caused by a syncopal episode associated with the underlying PAH or could also be associated with the administration of COVID vaccine. Additional information has been requested.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient was given COVID 19 Pfizer BioTech 0.2ml  without being mixed with the diluent. Patient has had no reactions.
Joint pain in both knees, ankles and wrists. Began midday and worsened as day progressed.
As soon as I got the vaccine I was able to taste the vaccine,. Within 5 minutes I felt dizzy and within 15 minutes I couldn't feel my arm.  I got a rash throughout my whole arm, and was warm to touch as well as a tingly sensation in my whole arm.  It passed on to my right arm and started losing sensation and the tingly feeling started as well. Within 45 minutes I started breaking out throughout  my whole body, within 1hr 15min. my legs felt weak and I couldn't walk.  I felt dizzy, the whole room was spinning.  They were going to send me to the hospital but I didn't want to go and I went home and injected myself with an EPI pen. and also took 2 Benadryl's. I started feeling my throat close but not all the way, I could feel I was having an allergic reaction.  I just had a really bad headache and went to sleep from the Benadryl . I woke up with my eyes little swollen, and a rash on my left arm and chest area, my whole body was very itchy.  This lasted for two days. The doctor at my work said if it got worse to go to ER and or urgent care.  They didn't recommend me getting second dose.
This case was reported by a healthcare professional and described the occurrence of nausea in an adult subject of unspecified gender who was vaccinated with HAVRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of HAVRIX at 1.0 ml in an unknown arm. Immediately after vaccination with HAVRIX, the subject experienced nausea. At the time of reporting the outcome of the event was unspecified. In the reporter's opinion nausea was probably related to treatment with HAVRIX. It was noted that the occurrence of nausea following administration of HAVRIX happened with three different subjects. The reporter requested replacement of three packs of vaccine (ndc 5816-826-48). All three vaccinations in question had the same lot number and expiration date. Linked cases include A0931343A and A0931346A. According to information received on 09 August 2011 via GSK Quality Assurance, this report involved an adverse event only (no product complaint).
My son experienced under his left arm he had swelling of lymph nodes, on the middle of his armpit. The next day it was bigger and it was tender to touch, very painful. He also had some swollen lymph nodes on his neck, left side, near the collar bone and side of his ear. His lymph nodes got bigger on Saturday, the one on his left arm was getting smaller and the one on his neck today is going down in size as well.  My son was by a nurse practitioner, and she said that my son did not have any fever, he said it was consistent with the vaccine he received.   To this day his lymph nodes are still present but getting smaller in size.
migraine; This is a spontaneous report from a non-contactable consumer reporting for his wife. A female patient of an unspecified age received BNT162B2 (Lot number was not reported), via an unspecified route of administration on 11Mar2021 as 2nd dose, single for COVID-19 immunization; eletriptan hbr (RELPAX, strength: 40 mg, Lot number was not reported), via an unspecified route of administration from an unspecified date and ongoing, at 40 mg for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient started experiencing migraine in the morning of 12Mar2021 after taking the final dose of the Covid-19 vaccine on 11Mar2021. The patient felt the event was related to use of RELPAX (eletriptan HBr) 40 mg. As of 12Mar2021, the event subsided, and use of eletriptan HBr 40 mg continues. The action taken in response to the event for eletriptan hbr was dose not changed. The patient recovered from the event on 12Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
This case was reported by a consumer via call center representative and described the occurrence of erythema in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced erythema. On an unknown date, the outcome of the erythema was unknown. It was unknown if the reporter considered the erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported redness following SHINGRIX.
allergy issues; runny nose; sneezing; shortness of breath at times during the night; blockage of one nostril; difficulty sleeping; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergy issues), RHINORRHOEA (runny nose), SNEEZING (sneezing), DYSPNOEA (shortness of breath at times during the night) and NASAL CONGESTION (blockage of one nostril) in a 66-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.     Concurrent medical conditions included Diabetes mellitus. Concomitant products included SITAGLIPTIN PHOSPHATE (JANUVIA) for Diabetes mellitus, LORATADINE (CLARITIN [LORATADINE]) for an unknown indication.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced MYALGIA (sore arm). In May 2021, the patient experienced HYPERSENSITIVITY (allergy issues), RHINORRHOEA (runny nose), SNEEZING (sneezing), DYSPNOEA (shortness of breath at times during the night), NASAL CONGESTION (blockage of one nostril) and INSOMNIA (difficulty sleeping). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) at an unspecified dose and frequency. At the time of the report, HYPERSENSITIVITY (allergy issues), RHINORRHOEA (runny nose), SNEEZING (sneezing), DYSPNOEA (shortness of breath at times during the night), NASAL CONGESTION (blockage of one nostril), INSOMNIA (difficulty sleeping) and MYALGIA (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient reported injection site erythema to pharmacy 10/27/14 PM. Advised to apply warm compress to site and report in the AM. AM 10/28/14 warm compress helped but erythema remained. Nurse at patient's work suggested seeking medical attention. Patient reported to MD who prescribed doxycycline for cellulitis staph.
First got Hives, was prescribed Steroides after subsided started again with small red lumps like bug bites, and still happening. Constant itching, went to Dermatologist twice, no cure, prescribed itch cream.  I have never had Hives or any kind of itching like this all my life until I received the vaccine.
11cm x 6cm rash on Left upper arm. MEDROL DOSE PACK, BACTRIM #30 1 PO Q 12h.
4-3-17 - after shot pt. walking to car felt nauseous, faint, has had severe headache since shot, severe tenderness, very hot around injection, very red and injection area swelled up to a tear drop size measured around 42ml in length. 4-11-17 spoke with pt. sym. resolved after 4 days. "She's fine now."
Patient stated he received the Pfizer two dose series - 4/13/21 & 5/4/21.  No boosters.  Patient presented to ED w/ labored breathing, cough, SOA, fever.  Oxygen saturation 91% at rest, worse with exertion.
Flu like Symptoms; itchy; rash; injection site was very red,; headache; very hot to touch; very hot to touch; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like Symptoms), PRURITUS (itchy), RASH (rash), INJECTION SITE ERYTHEMA (injection site was very red,) and HEADACHE (headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included METOPROLOL TARTRATE, AMLODIPINE, OMEPRAZOLE, PIOGLITAZONE, HYDROCHLOROTHIAZIDE, GLIPIZIDE and TRAZODONE for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like Symptoms), PRURITUS (itchy), RASH (rash), INJECTION SITE ERYTHEMA (injection site was very red,), HEADACHE (headache), INJECTION SITE WARMTH (very hot to touch) and INJECTION SITE ERYTHEMA (very hot to touch). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like Symptoms), PRURITUS (itchy), RASH (rash), INJECTION SITE ERYTHEMA (injection site was very red,), HEADACHE (headache), INJECTION SITE WARMTH (very hot to touch) and INJECTION SITE ERYTHEMA (very hot to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications provided by the reporter.
Sever vomiting, tachycardia (149), severe watery diarrhea, muscle pain everywhere, fever 101.1.
Sore arm; Aching; Body ache; Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PAIN (Aching), PAIN (Body ache) and INFLUENZA LIKE ILLNESS (Flu like symptoms) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03M20A and 040A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), PAIN (Aching), PAIN (Body ache) and INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, PAIN IN EXTREMITY (Sore arm), PAIN (Aching), PAIN (Body ache) and INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
Day 1: Patient reports redness, swelling, and pain at injection site and felt achy later in day of injection. Awoke middle of night 3am injection arm pain, redness, and swelling. She describes as 9 inches from top of shoulder to bottom of redness/swollen area and 4-6 inches wide. She took ibuprofen and iced area. Day 2: Next day, patient felt much worse with joint pain, full body aching, and fever 101 and R arm swollen, red, and tender. L arm (non-inj arm) now experiencing "throbbing" pain in area of lymph node which she describes as "like a muscle spasm". Day 3: Patient reports felt better but still with R shoulder (inj site) swollen more at top vs. bottom of upper arm. Day 4: Patient called me today to report. She has not yet notified her Dr. I told her to notify Dr and I would submit report, and send copy to patient and PCP.
flu; Initial information received on 21-Oct-2021 regarding an unsolicited valid social media non-serious case received from a consumer via social media via Digital Media.  This case is linked to case 2021SA356566 (partner case).  This case involves an adult patient who experienced flu (influenza), after receiving INFLUENZA VACCINE.  Patient had mild Coronavirus disease (COVID-19) this year.   No other medical history, concomitant disease or risk factor reported.  The patient past medical treatments, vaccinations, concomitant medications and family history were not provided.  On an unknown date couple years ago, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date were not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious event flu (influenza), (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/ events.  It was reported " Got a few shot couple years, as well as my partner, we both got the flu anyway, was way worse than the mild Coronavirus disease (COVID) we had this year."  There were no laboratory data/ results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome of the event was reported as unknown.  There will be no information available on the batch number for this case.
Started ringing in the left ear. Got much worse after the 2nd shot on April 1, 2021. It is now extremely loud and interfering with my quality of life, work, being able to hear.
Itch, headache, forget thing, lumps, involuntary movement arms and legs, cramps, changes blood pressure, lost power legs and arms.
At home, approx. 45 minutes after shot, lips started tingling, then itching. Around 10 minutes later, throat began feeling irritated/scratchy. Approx. 10 minutes later lower lip became swollen. I took half a Benadryl. Never had any difficulty breathing or swallowing. Presentation never got any worse. Tingling of lips lasted most of day, but milder than initial reaction - other symptoms gone in approximately an hour after taking the Benadryl.
He received a phone call from vaccine facility next day that the vaccine of 2nd dose was expired.; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (He received a phone call from vaccine facility next day that the vaccine of 2nd dose was expired.) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 031B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (He received a phone call from vaccine facility next day that the vaccine of 2nd dose was expired.). On 13-May-2021, EXPIRED PRODUCT ADMINISTERED (He received a phone call from vaccine facility next day that the vaccine of 2nd dose was expired.) had resolved.            oncomitant product use was not provided by the reporter. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-132200 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-132200:
PROJECTILE BLEEDING FROM EYEBALLS; GRIZZLY SKELETONS PEER BACK; HEART MUSTERS A FAINT BEAT; SALIVA TASTES LIKE SOAPY PENNIES; FEELS LIKE SOMEONE WAS USING A DRILL BIT ON 3 SECTIONS OF THE SPINE.; VOMITED UP SPLEEN; SENDING MY MUSCLES INTO A VIOLENT SPAS; MY BONES FEEL LIKE A THOUSAND SMASHED BOTTLE SHARDS GRINDING AGAINST MY TISSUES, TEARING APART MY INARDS BEFORE LOCKING IN PLACE; TALCUM MERCURY COARSING THROUGH MY VEINS EVERY 2-3 SEC; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose,1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported. On an unspecified date, the subject experienced projectile bleeding from eyeballs, grizzly skeletons peer back, saliva tastes like soapy pennies, feels like someone was using a drill bit on 3 sections of the spine., vomited up spleen, heart musters a faint beat, sending my muscles into a violent spas, my bones feel like a thousand smashed bottle shards grinding against my tissues, tearing apart my inards before locking in place, and talcum mercury coarsing through my veins every 2-3 sec. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the projectile bleeding from eyeballs, saliva tastes like soapy pennies, feels like someone was using a drill bit on 3 sections of the spine., vomited up spleen, heart musters a faint beat, sending my muscles into a violent spas, grizzly skeletons peer back, my bones feel like a thousand smashed bottle shards grinding against my tissues, tearing apart my inards before locking in place and talcum mercury coarsing through my veins every 2-3 sec was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210329150-covid-19 vaccine ad26.cov2.s-projectile bleeding from eyeballs, grizzly skeletons peer bac. 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).