chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It kinda rolled through my body, Nausea, pain, fatigue, massive dizziness, vertigo, mental fog unable to function or sleep, swollen arm, shoulder, armpit lympnode. left side of my neck, the swelling was so bad in those structures my arm hung about 3 inches away from my hip. March 9th I woke up with a massive headache and nausea. So I put ice on it and called the doctor until I can get in to see him. Been unable to work normally. Working only 2 days a week. Took predisone between both ER visit. Stopped taking any sugar and it helps. Started using Pepcid.
Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who was administered dose of GARDASIL (dose and route unknown) on 05-SEP-2013, lot # H011350 expiration date: 21-FEB-2015. No adverse event was reported. This is one of the report from the same source. Additional information is not expected.
second dose later than six months after the first; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 17-MAY-2022 Reporter's comment: The case was received from the consumer via interactive digital media. The reporter enquired, what should a patient do if their second dose of Shingrix was later than six months after receiving the first dose. Additional Supportive Information:The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. Follow-up could not be possible as no contact details were available.
6 1/2 x 6 1/2 cm, R deltoid-hot to touch. Noticed 7/12/05/.
they are worried because of the subcutaneous injection done into her; they are worried because of the subcutaneous injection done into her; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable consumer reported that a female patient (reporter's wife) received the 1st shot of our vaccine bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose 1 on last sunday as single dose via her right arm for COVID-19 immunisation. The patient medical history was and concomitant medications were not reported. They are worried because of the subcutaneous injection done into her.  Information on the lot/batch number has been requested. Information on the lot/batch number has been requested.  Follow-up (03Feb2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation regarding the query related to patient initials. The response included:  Response: Delay Forwarding to Safety Site from Vcloud (CEP 2191). Report re-sent to correct previously reported information (Patient Initials).
Presents for hypoxia & productive cough; COVID + 1 day PTA. Admit for hypoxia & COVID pneumonia. Tx: O2 via NRB, decadron, zinc, vit c, remdesivir. DC to SNU for IV abx & PT.
Within first seconds of receiving 1st HPV shot, the patient started feeling nausea, dizzy, became pale white and then had a convulsive syncopal episode with eye rolling, extremity twitching and LOC for 5-6 seconds.
This spontaneous report was received from a pharmacist and a pharmacist student and refers to an unspecified patient of unknown age or gender. Pertinent medical history or drug allergies/drug reactions were not reported. On 15-JUL-2015, the patient was vaccinated with an improperly stored PNEUMOVAX23 (lot number reported as L010598, expiration date 06-AUG-2016) (dose, strength, frequency and route of admministration were not reported) (incorrect product storage). There was no concmitant medication was reported. No adverse effects were reported. Additional information has been requested.
She denied further AE; VAQTA was administered to a patient after experiencing a temperature excursion; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.    On 13-OCT-2021, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 0.5 milliliter, lot # T013204, expiration date 13-DEC-2021 for prophylaxis (anatomical location and route of administration were not reported).   The vaccine was stored at the temperature that was reported as 50.5 degrees of Fahrenheit for 0 hours and 30 minutes. There was no previous temperature excursion reported.  The reporter denied further adverse events.   This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2110USA007269: US-009507513-2110USA007275: US-009507513-2110USA007379: US-009507513-2110USA007316: US-009507513-2110USA007310: US-009507513-2110USA007288: US-009507513-2110USA006972: US-009507513-2110USA007007: US-009507513-2110USA007272:
Temporary Loss of blood to right index finger, causing numbness and cold fingers and toes intermittently after both doses and a few times 3+ weeks mater
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 23-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date of refrigeration of vaccine was 07 may 2021.  No concomitant product reported by reporter. No treatment medication reported by reporter.
Hives developed on arms, torso and thighs approx 8 hours after vaccination
Tired; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired) and PAIN IN EXTREMITY (Sore arm) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX) for Anticoagulant therapy.    On 14-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Tired) and PAIN IN EXTREMITY (Sore arm). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, FATIGUE (Tired) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Clopidogrel (Plavix) used as blood thinners.   This case was linked to MOD-2021-333836 (Patient Link).
felt fatigued, didn't want to do anything; some signals that she thought were sign of infection (redness); This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (felt fatigued, didn't want to do anything) and ERYTHEMA (some signals that she thought were sign of infection (redness)) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced FATIGUE (felt fatigued, didn't want to do anything) and ERYTHEMA (some signals that she thought were sign of infection (redness)). On 19-Jan-2021, ERYTHEMA (some signals that she thought were sign of infection (redness)) had resolved. At the time of the report, FATIGUE (felt fatigued, didn't want to do anything) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment information was not reported.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 09-SEP-2014, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) administered by a physician, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 03-SEP-2016, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster or shingles. On or about 07-SEP-2016, the patient sought subsequent treatment from a physician, a specialist in ophthalmology and medical retina diseases specialist for painful lesions on her eyelids, which were diagnosed as acute shingles facial ophthalmic, a painful condition of zoster infections interfering with the eyes and face. On or about 16-SEP-2016, the patient was treated again by the physician for ongoing symptoms associated with her facial and eye shingles infections. The patient was prescribed VALTREX (in continued and increasing doses) and unspecified artificial tears for management of her painful condition. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Upon internal review, acute shingles facial ophthalmic was determined to be medically significant. Additional information has been requested.
1 of 9 pts immunized from same lot 366949; not the same vial; who exp induration & poss erythematous nodule approx 2 inches in diameter @ the inj site; nodule persisted 6-8wks;
Information has been received from a registered nurse (R.N) concerning a 52 year old male patient who on 20-OCT-2010 was vaccinated into his right thigh with a 0.5mL dose of PNEUMOVAX 23 (lot number 664653/1337Y; expiration date 03-MAR-2011). The nurse stated that the patient on 21-OCT-2010 was seen at the office with fever of 100.4F, pain and swelling at the injection site. The patient was treated with warm compress. At the time of report, the patient's outcome was unknown. This is one of several reports from the same source. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question (Lot # 664653/1337Y) were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Red itchy rash, started as a few dots, spread to about a three inch circle, warm to touch, lasted about 4-5 days, started 9th or 10th day after injection, rash slowly disappeared still some itchy moments ...
I was 6 weeks pregnant when I got my first dose of the vaccine.  I spoke with my OBGYN prior to the vaccine and she said it was safe t get. The day after the vaccine (2/4) I started having some vaginal bleeding, confirmed with ultrasound.  This progressed to having a miscarriage, confirmed via ultrasound 2/9.  My OBGYN said she does not think they are related, but there is no way to tell. Until 2/4, I had no issues with my pregnancy.
I do know 3 other women who developed breast cysts after a Pfizer vaccine. This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BREAST CYST (non-serious), outcome "unknown", described as "I do know 3 other women who developed breast cysts after a Pfizer vaccine."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (14Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101193629 same reporter/product/event, different patient.;US-PFIZER INC-202101193628 same reporter/product/event, different patient.
sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included IBUPROFEN for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment medications included ibuprofen.   This case was linked to MOD21-078128, US-MODERNATX, INC.-MOD-2021-080143 (E2B Linked Report).; Sender's Comments:  MOD21-078128:Husband report US-MODERNATX, INC.-MOD-2021-080143:2nd Dose Case
Wheal over injection site noticed the next day, approximately 3.5 x 4.5 cm.
By 7 pm was feeling achy all over, temp over 99.  About 4 am was having hard chills, temp  over 101.  This continued through the next day (Saturday).   By mid Sunday temp down to 99 and was feeling better.  Red area at injection site about 2 in itchy and very painful.  This continued for several more days.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL (confirmed not GARDASIL 9) (administration route, lot number and expiration date were not provided). No concomitant therapies were reported. No adverse effects were reported. This is one of two reports from the same reporter. Additional information is not expected, since there is no consent to contact the physician to follow up.
I had a rash that started on the upper leg the rash was big and blotchy red. The rash then turned into small dots on my torso, buttocks and lower body. Also my upper arms and underarm. The rash is itchy, hot and at times sore. I saw my GP and was prescribed ointment and steroids however the rash did not clear up. I saw a Dermatologist and was prescribed  cimetidine 20 mgs and hydrocortisone 5% (topical cream) I have also been taking OTC Advil, Zyrtec and Benadryl to help me sleep at night.
Pt reported rash on arms and legs, itching, shortness of breath, difficulty breathing. Went to ER, received epinephrine, Benadryl, and steroid injections.
pruritic rash devel on neck (hives) same day;seen by MD;red swollen indurate around rt thigh;also h/o not breathing;
He became suddenly moody, sullen, clingy, was very cranky for no reason, and kind of listless, and very clingy, for about 2 weeks.
Multiple symptoms started 5-7 days after 2nd dose, as intermittent numbing, burning & tingling from left toes upwards along side of my leg to my hip. At the same time I accidentally hit my bare left foot & ankle on the edge of furniture, where small fluid-filled blisters appeared at the sites of contact. I noticed bumps & a red rash on my left instep & the back of my left calf. Hours later I began to itch all over, accompanied by itching hives at forehead hairline & between brows. Also a Meibomium cyst on lower left lash line started to swell up. Ball of my left foot & under the big toe is sensitive to pressure from body weight when I stand on it.
PATIENT CRYING AND GRUNTING. BREATH SOUNDS NORMAL WITHOUT WHEEZING. SPLOTCHY BLANCHING RASH ON FOREHEAD THAT FADED AFTER 20MINS (AFTER TYLENOL GIVEN)
Pt recvd 3 doses of Heptavax & 2 doses of engerix-B & did not respond;
Different and lesser side effects after second dose; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE REACTION (Different and lesser side effects after second dose) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 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 VACCINATION SITE REACTION (Different and lesser side effects after second dose). At the time of the report, VACCINATION SITE REACTION (Different and lesser side effects after second dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Antibody test: 35 (Low) Low.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided. Treatment information was not provided.   This case was linked to MOD-2021-281076 (Patient Link).
Initial misuse report received from a healthcare professional on 18 October 2013. The cases were received on 21 March 2014. An 84-year-old patient received FLUZONE HD on 30 September 2013 and again on 07 October 2013 (No other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Pt. was given Hep B instead of TWINRIX. We gave pt. Hep A (ped) dose per pharmacist at Glaxo Smith Kline.
Patient was light headed after shot. Sat for 30 minutes and walked around with supervision for another 10 minutes. When leaving Patient fainted and was having shortness of breath.  Epi pen administered and Patient was taken to the hospital.
Patient received Vaxelis instead of getting varicella; This non-serious case was received during monitoring on 12-APR-2023 with the following Primary ID 2570580-1. The original narrative from the sender is the following:  Patient received Vaxelis instead of getting varicella. Patients mother was notified, manufacturer , and safety report from office was completed.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "Patient received Vaxelis instead of getting varicella".  No further information is expected.
Pain in left arm; Redness; Swelling; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in left arm), ERYTHEMA (Redness) and SWELLING (Swelling) 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 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in left arm), ERYTHEMA (Redness) and SWELLING (Swelling). At the time of the report, PAIN IN EXTREMITY (Pain in left arm), ERYTHEMA (Redness) and SWELLING (Swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. 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.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow up information was received: Updated contact information. No new information; 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.
Arm swelling and redness at the injection site, arm pain, and  fever >102F
I got a large rash across most of my body.; Extremely itchy; This is a spontaneous report from a contactable consumer (patient). A 20-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 13Apr2021 17:45 (at the age of 20-year-old) (Lot Number: EW0151) as dose 1, single for COVID-19 immunization. Medical history included none. The patient did not have any known allergies. The patient's concomitant medication included Vita fusion MultiVites. The patient did not receive other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient experienced a large rash across most of his body on 16Apr2021 08:00. The patient reported that it started in small spots and then quickly spread across his arms, stomach, back, and legs. It was extremely itchy but not painful. The patient required Doctor or other healthcare professional office/clinic visit. The patient received treatment with prednisone and fexofenadine (ALLEGRA). The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.