chrisvoncsefalvay/vaers-outcomes huggingface dataset:
initially, soreness at the injection site.   Today, four days later, my left elbow is extremely sore, I cannot straighten my left arm and my hand is very weak and cannot hold any weight.
I had about 5 minutes left to wait there and at that time I started noticing that my throat was feeling weird, kind of scratchy but also it was harder for me to swallow. The doctor and nurse had come out to keep an eye on me and they gave me some water and it helped the scratchy part, but it was still hard for me to swallow for about 4-5 hours after getting the vaccine and today my throat still doesn't feel normal.
Father noticed swelling, pain and redness of his left arm and rash on his chest about 6PM the day after he received the vaccine. Was treated in the ER and admitted to the hospital for three days. Received steroids, antibiotics and Benadryl.
10 minutes after the injection, my heart rate went up to 90bpm (when checked by nurse), I felt faint, chest was tight, felt throat tight and it was hard to take a deep breath or swallow saliva. This is similar to what I experience with milk or small amounts of cheese. This lasted about 20 minutes and subsided over the next 15 min. Stayed at the facility a total of an hour to be sure.
NEUROPATHY 4/10/2023 ADULT OBSTRUCTIVE SLEEP APNEA, MILD
Approximately five minutes after injection, pt complained of itching at inj site, back, and arms. Inj site swelled to approx. one inch in diameter; she also developed flushing and sweats. Counteracted w/oral antihistamine and injected BENADRYL; blood pressure in normal range before she left.
pt recvd vax & 6wks following vax titer was 0.9;no further details were provided;
Information has been received from a nurse practitioner concerning a "22 year old" female who on 19-MAY-2011 was vaccinated with the first dose of GARDASIL, 0.5 ml IM in the arm. The patient passed out in the office after receiving first dose of GARDASIL on 19-MAY-2011. Patient regained consciousness soon after and was examined and was sent home with no other episode. Patient also experienced redness and pain around injection site. No additional information provided. The patient sought medical attention at the time of administration. No treatment was given for these adverse events. Additional information is not expected.
Pt received seasonal Flu injection 10-27-2009. On 10-28-09 Pt. noticed a rash, raised, on both arms, chest, neck and right leg. Also stated having a low grade fever. Was seen by Dr. was prescribed METHYLPAED - NISOLENE. Patient called Health Dept. 11-5-09. Arms, chest, better, Rt leg continues to spread rash.
SUSPECTED CLINICAL VACCINATION FAILURE; SEVERE BREAKTHROUGH CASE OF VACCINE / SUSPECTED COVID-19 INFECTION; This spontaneous potential legal report received from a consumer concerned a patient of unspecified age, sex, race and ethnicity. Initial information was processed along with the additional information received on 20-OCT-2021. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, Expiry: Unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the consumer reported that patient experienced a severe breakthrough case of the vaccine/suspected covid-19 infection. On an unspecified date, the patient experienced suspected clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe breakthrough case of vaccine/suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint:90000198020.; Sender's Comments: V0: Medical Assessment comment not required as per standard operating procedure for legal case.
HIVES; FEVER; ACHES; This spontaneous report received from a patient concerned a 49 year old female. The patient's weight, height, and medical history were not reported. The patient experienced drug allergy when treated with amoxicillin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 expiry: not reported) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, treatment medications included: diphenhydramine hydrochloride. On 03-APR-2021, the subject experienced aches. On 03-APR-2021, the subject experienced fever. On 09-APR-2021, the subject experienced hives. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aches, and fever on 04-APR-2021, and was recovering from hives. This report was non-serious.
experiencing a TE, where the temperature reached 10.1 C for 59 minutes; This non-serious case was reported by a physician via other manufacturer and described the occurrence of incorrect storage of drug in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Concomitant products included diphtheria vaccine toxoid + pertussis toxoid + tetanus vaccine toxoid (Adacel).   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced incorrect storage of drug (Verbatim: experiencing a TE, where the temperature reached 10.1 C for 59 minutes).  The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 25-Aug-2023 The health care professional called to report that Adacel and Menveo administration after experiencing a temperature  excursion, where the temperature reached 10.1 Celsius for 59 minutes. No additional adverse event or product quality complaint was reported. The patient received Menveo after temperature excursion, which led to incorrect storage of drug.
Patient states that her face started tingling, then became numb, and then her lip became swollen.  She took Benadryl 12 hour dose, and then again in the morning.  She contacted our office to report.
PATIENT REMAINED SEATE AFTER VACCINATION, AND ALERTED US AFTER THAT HE HAD JUST PASSED OUT. HE WAS SWEATY AND SEEMED PALE AND LIKE HE WAS LIGHT HEADED.
Patient presented with hypotension, moderate LV dysfunction, Troponin elevation, acute renal failure
This case was reported by a healthcare professional and described the occurrence of gassiness in a 2-month-old male subject who was vaccinated with (ROTARIX, GlaxoSmithKline). Concurrent vaccination included (HIB; manufacturer unspecified; unknown; unknown) given on 5 October 2009; (PEDIARIX; GlaxoSmithKline; unknown; unknown) given on 5 October 2009; and (non-gsk) (PREVNAR; Wyeth Labs; unknown; unknown) given on 5 October 2009. On 5 October 2009 at an unspecified time, the subject received 1st dose of ROTARIX (intramuscular, right thigh) and experienced inappropriate route of vaccination. On an unspecified date, an unspecified time after vaccination with ROTARIX, the subject experienced gassiness, stomach pain, and fussiness. The nurse reported that ROTARIX was administered intramuscularly instead of orally. The subject was seen nine days after maladministration and the subject continued to have fussiness and stomach pain. No further information was provided at the time of reporting. At the time of reporting the outcome of the events was unspecified.
Patient spouse reported arm swollen and red. No pain or change in sensation. No other issues to report.
Suspected vaccination failure; Neuralgia from right breast to the back; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 96-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (patient had Shingles around 15 years ago.).   In MAY-2023, the patient received the 2nd dose of Shingrix. In JAN-2023, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria medically significant) and post herpetic neuralgia (Verbatim: Neuralgia from right breast to the back). The outcome of the vaccination failure was unknown and the outcome of the post herpetic neuralgia was not resolved.   It was unknown if the reporter considered the vaccination failure and post herpetic neuralgia to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and post herpetic neuralgia to be related to Shingrix and Shingrix.   Additional Information: Receipt date: 15-AUG-2023 The reporter was the daughter of the patient who reported that patient received first dose of Shingrix in January 2023 and second dose in May 2023.  The patient had Shingles around 15 years ago.  Now the patient had neuralgia from right breast to the back.  This case was considered as suspected vaccination failure since details regarding time to onset and laboratory confirmation of shingles was unknown.  The reporter did not consent to follow-up.
Prickly feeling; Painful; 2nd dose a year and a half after first dose; This case was reported by a consumer via call center representative and described the occurrence of paresthesia in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received one and half year ago).   In October 2021, the patient received the 2nd dose of Shingrix (intramuscular). In October 2021, 1 day after receiving Shingrix, the patient experienced paresthesia, pain and drug dose administration interval too long. On an unknown date, the outcome of the paresthesia was not recovered/not resolved and the outcome of the pain was unknown and the outcome of the drug dose administration interval too long was recovered/resolved.   It was unknown if the reporter considered the paresthesia and pain to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient for herself. The patient had the second dose of Shingrix about a month ago, and approximately a year and a half after her first dose, which led to drug dose administration interval too long. The patient had no reaction to the first dose.  The patient state that the next day after the second dose that any time she starts any activity that leads to her perspiring she begins to feel a painful prickly feeling all over her body from her legs to the top of her head. The reporter consented to follow-up.
states rec'd 1st dose of maderna covid vaccine on 1/12,  reports developed hives on body that seemed to be rotating on body, took Benadryl to help with symptoms, on 1/17 reports had some facial swelling, on 1/18, reports symptoms had subsided, advised to f/u with PCP regarding symptoms.
Information has been received from a physician concerning a 16 year old female patient who was vaccinated with a first dose of Gardasil. Subsequently, the patient developed a local rash around the injection site. The rash was about 3 inches in diameter. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
PERIOD STARTED EARLY ON 6/11 AND WAS HEAVIER THAN NORMAL. THEN STOPPED FOR A DAY, SPOTTED FOR A FEW DAYS, THEN BEGAN HEAVY AGAIN. PERIOD HAS SINCE LASTED 5 DAYS, ALL HEAVIER THAN NORMAL.
8 days after receiving shots, pt began a high fever (to 103) and rash on trunk and limbs.
Initial misuse report received from health care professional on 07 May 2014. A patient (date of birth and gender was not reported) had received a doses of ADACEL, MENACTRA, IPOL, PENTACEL, TUBERSOL, FLUZONE, ACTHIB and TENIVAC on an unspecified date. It was reported from 1 August 2014 temperature for all vaccines was 65 F for 16 hours, which led to incorrect product storage. No adverse event was reported. List of documents held by sender: None.
Injection site warm; Injection site itchy; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Injection site warm) and INJECTION SITE PRURITUS (Injection site itchy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced INJECTION SITE WARMTH (Injection site warm) and INJECTION SITE PRURITUS (Injection site itchy). At the time of the report, INJECTION SITE WARMTH (Injection site warm) and INJECTION SITE PRURITUS (Injection site itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment for the event is not provided.   This case was linked to MOD-2021-008434 (Patient Link).; 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.
2 1/2 hours after receiving Adult Hep B + Influenza Vaccine at work developed chest pain, flushing, nausea and increased heart rate. Sent to Freeport Hospital ER. All tests were normal.
Pt reports 30 minutes after injection, severe migraine - like headache. 1/31/01 headache continues, back of neck sore/stiff, sore throat, sensitive to light, left side of body sore. 2/1/01 headache continues, other symptoms resolved. Pt went to school today.
Case number PHEH2012US021639 is an initial spontaneous report received from a pharmacist on 23 Oct 2012. This report refers to a patient whose identifiers were not reported. The patient was vaccinated with 0.5 ml intramuscular dose of MenA lyophilized conjugate component of MENVEO (batch number: not reported) reconstituted with sterile water, instead of MenCWY liquid conjugate component on an unknown date. No adverse reaction was reported.
88 year old male patient presented with c/o fever, generalized weakness, nausea, trouble urinating and cough x 3 days.  Pt with significant cardiac history, carotid stenosis, CAD, Hx of DVT, DM2, BPH presented for evaluation after feeling general weakness, cough and SOB for the past 3 days. Pt tested + for COVID on 10/28/2021. Pneumonia due to COVID-19, acute hypoxic respiratory failure. Elevated troponins 0.06, 0.71, 1.10.  + fever.  D-dimer 925. Required room air.  11/1 worsening respiratory status and required intubation. non ST elevation mycoardial infarction.  acute kidney injury.  Required steriods and antibiotics. Pressors, Levophed, Versed and heparin drip.  Pt expired on 11/14/2021
Apparent vaso vagal syncopal episode 20 hours after receiving his first rabies vaccine (for pre-exposure prophylaxis prior to travel).  He noted aching in both shoulders.  Loss of consciousness for about 5 seconds.  No other known precipitators to the syncopal event. 8/8/07-records received for DOS 5/30/07-Syncopal episode. Felt hot and sweaty, blacked out, uper body arms and shoulders twitching and shaking. Unconscious. Confused. Family history of Brugada Syndrome.   On 6/1/07-Procainamide Challenge and Implanted Reveal device
lymphdemia; enlarged chest/breast with burning and sensitivity; enlarged chest/breast with burning and sensitivity; enlarged chest/breast with burning and sensitivity; Dose Number 3/ 3rd shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Nov2021 10:00 (Batch/Lot number: unknown) at the age of 35 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EP7533, Location of injection: Arm Right, Administration Time: 02:00 PM), administration date: 02Apr2021, when the patient was 34 years old, for COVID-19 immunization, reaction(s): "enlarged chest/breast with burning and sensitivity", "lymphdemia", "enlarged chest/breast with burning and sensitivity", "enlarged chest/breast with burning and sensitivity"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6207, Location of injection: Arm Right, Administration Time: 02:00 PM), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 23Nov2021 10:00, outcome "unknown", described as "Dose Number 3/ 3rd shot"; LYMPHOEDEMA (non-serious) with onset 26Nov2021 20:45, outcome "recovering", described as "lymphdemia"; BREAST PAIN (non-serious), BREAST ENLARGEMENT (non-serious), CHEST PAIN (non-serious) all with onset 26Nov2021 20:45, outcome "recovering" and all described as "enlarged chest/breast with burning and sensitivity". The events "lymphdemia", "enlarged chest/breast with burning and sensitivity", "enlarged chest/breast with burning and sensitivity" and "enlarged chest/breast with burning and sensitivity" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were not taken as a result of lymphoedema, breast pain, breast enlargement, chest pain.  Additional information: Prior to vaccination, the patient was not diagnosed with covid-19 and post vaccination, the patient had not been tested for covid-19. It was reported that 3rd shot resulted in lymphdemia and enlarged chest/breast with burning and sensitivity.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Bruising (L) deltoid. Localized rxn. 4 days after vaccine. No abx needed - to date - will follow.
Information has been received from a registered nurse referring to a 6 month old patient of unknown gender. ON 23-JUN-2015 the patient was vaccinated with ROTATEQ (Oral, lot # K017573, expiration date and dose were unknown) which was excursion the storage temperature. No reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
This is a spontaneous report from a contactable consumer. A 19-year-old female patient received TRUMENBA, intramuscular at single dose in the left arm on 12Jul2016. The patient medical history was none. Concomitant medication included oral doxycycline at 1 DF once daily on ongoing for acne. On 13Jul2016, the patient experienced pain at the injection site, fever, aches and pains, flu-like symptoms and weakness, all with outcome of recovering.
I started noticing that the palms of my hands and bottom of my feet itched around 2 weeks after the 2nd vaccination.  Then in the following days I began experiencing spontaneous hives. The hives appeared on my neck, chest, stomach, arms, legs, hands and feet. The hives came on randomly and last about 20 - 30 minutes, with an itching/burning sensation. My face and ears would have areas get red and feel like they were burning.  Even in  areas that I don't have the hives, if I scratch myself red lines will appear where I have scratched and remain for up to 10 minutes.  It is like my skin has become hyper sensitive.  I have not had any prior allergic reactions similar to this, but I contacted my dermatologist to inquire about this being an allergic reaction to the terbinafine prescription I had been on for about 30 days at that point.  She suggested I stop the terbinafine and use OTC antihistamines  I started with Claritin, then added Zyrtec and Benedryl into my daily routine to control the outbreaks.  My doctor did mention that this was not acting like a typical drug reaction (because the hives come, go, and move around). Drug allergies like this usually subside within a matter of weeks.  I am now 7 months into taking Loratadine in the morning and Banophen at night.  This helps to control the outbreaks, when I skip a dose they are worse.  This seems to be more of an immune system response created by the Moderna COVID vaccine.
Pain at injection site followed days later by tingling back of hand and 3rd finger with intermittent tetany.
intense pain and stiffness at the injection site, limited mobility of the arm during the day after. 2 days later some mobility back but continued pain and stiffness of the arm.
Increase in blood pressure compared to baseline and headache beginning within two days of first vaccine dose.  Occipital headache and elevated blood pressure persisted for over two weeks after vaccine and as of reporting date have not resolved.
Lower gastrointestinal bloating and pain. No other associated symptoms. Taking ibruprofen and drinking plenty of fluids. Symptoms have not resolved yet.
c/o of warmth to tongue and throat area. Benadryl 25mg po given. Symptoms stable so d/c home. Pt had reaction after 2nmd moderna vaccine and provider requested 2 hr observation
covid vaccine was placed in refrigerator and was expired past 30 days; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (covid vaccine was placed in refrigerator and was expired past 30 days) in a 50-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (covid vaccine was placed in refrigerator and was expired past 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (covid vaccine was placed in refrigerator and was expired past 30 days) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided. No treatment information were reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow-up received with patient demographics, date of vaccine administration were added.
pt recvd vax 27JAN93 AM-by evening, hands & feet were swollen & covered w/hives; seen by nurse 29JAN93; DPH administered; pt recovered; pt has recently devel allergy to horses; no hx of react following prev immun;
Redness, swelling, severe pain at the injection site in the form a 2x3 inch rash. Patient in a lot of discomfort and tried to use ice pack to help but it provided no relief.
This spontaneous report was received from a registered nurse refers to unspecified patients of unknown age and gender. No pertinent medical history was reported. On an unknown date, the patients were vaccinated with a dose of improperly stored VARIVAX (Merck) (dose, route, lot # were not reported). No adverse effect reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Pt recv vax on 4/27/98; on 4/28/98 pt exp fever (103F); 5/2/98 pt exp herpangina x 2-3 days