chrisvoncsefalvay/vaers-outcomes huggingface dataset:
yesterday I had my follow-up 2nd shot; minor soreness at the injection site; I´ve been feeling tired all day / tiredness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in December 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information was provided as follows: The age at vaccination was not applicable. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient had been unable to receive second dose Shingrix. The reporter consented to follow up. Consumer declined to provide mailing address and consumer declined to provide further information for safety report.   Follow up information received from consumer on 9th December 2020: On 8th December 2020, the patient received the 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule. In December 2020, the patient experienced minor injection site soreness and feeling of tiredness all day which was unusual for the patient.  The reporter wanted to know was tiredness a possible side effect and how long should it lasts. It was unknown if the reporter considered the injection site pain and tiredness to be related to Shingrix.
Swelling and rash around injection site. Also had mild throat itching. Took Benadryl which helped the throat itching. Continued doses and eventually the rash subsided. I was a nursing student at time. I did not see a doctor.
fainted; nauseated; vomited 4 times; dizzy; bad headache; extremely tired; This is a spontaneous report from a contactable consumer. An 87-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Right arm (at age of 87-year-old) on 21Jan2021 at 12:00 PM as a single dose for COVID-19 immunisation, lot number: EL3247. Medical history was none. Patient had no allergies to medications, food, or other products. Concomitant medications within 2 weeks of vaccination included ibuprofen (ADVIL) and melatonin (minimal usage). Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. It was reported that on 21Jan2021 at 02:45 PM (also reported as 2 1/2 hours after vaccine) patient became nauseated, he vomited four times, was dizzy, fainted, had bad headache and was extremely tired. Events resulted in Doctor or other healthcare professional office/clinic visit. Patient was treated for the events with nausea medications and ibuprofen (ADVIL). Since the vaccination patient had not been tested for COVID-19. Patient recovered with lasting effects from the events.
expired dose of Engerix-B was administered to a patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 26-year-old female patient who received HBV (Engerix B) (batch number 4345R, expiry date 11-AUG-2023) for prophylaxis.   On 27-SEP-2023, the patient received Engerix B. On 27-SEP-2023, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: expired dose of Engerix-B was administered to a patient).  The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date 28 Sep 2023 The pharmacist called to report an expired dose of Engerix-B was administered to a patient, which led to expired vaccine used.  The consented to follow up via email.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On 14-APR-2011, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On 18-NOV-2016, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, 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 (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Throbbing sinus headache that kept me awake.  It has backed off a little at 7:30 am but is still hurting a fair amount.  It could be unrelated to the vaccine because there is a tropical depression (Eta) blowing through and a cold front coming through.  The combination sometimes gives me a sinus headache but rarely this painful.
This spontaneous case reported by a consumer, describes the occurrence of myalgia (her second injection was in March and she experienced some pain in right arm) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 012M20A) for COVID-19 immunization. No medical history reported. On Feb 4, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. In March 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced myalgia (her second injection was in March and she experienced some pain in right arm). At the time of the report, myalgia (her second injection was in March and she experienced some pain in right arm) resolved. No concomitant medication or treatment information provided. This case linked to MOD-2021-015032 (patient link).
pt recv vax;devel fever of 104;to er;mom stated fever would not go down w/ Motrin;
Within an hour  of 1st dose he threw up. From that point on his gag reflex has been extremely sensitive and he often throws up or feels too nauseous to eat much. He has received the complete 2 shot series. 1st dose on 7/20/2021 ,  2nd dose on 08/10/21 These symptoms have been consistent for over a month since the first dose. He has never had these symptoms historically until after the first dose.
Arm soreness, redness at injection site (size of a baseball), warmth, swelling, tenderness to palpation, left axilla now also sore.
After receiving both doses of the vaccine he had a sore arm for 3 days on the side he received the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (After receiving both doses of the vaccine he had a sore arm for 3 days on the side he received the vaccine) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In June 2021, the patient experienced VACCINATION SITE PAIN (After receiving both doses of the vaccine he had a sore arm for 3 days on the side he received the vaccine). In June 2021, VACCINATION SITE PAIN (After receiving both doses of the vaccine he had a sore arm for 3 days on the side he received the vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Patient had a sore arm for 3 days on the side he received the vaccine.  No treatment medications were reported.   This case was linked to MOD-2021-390814 (Patient Link).
Headaches everyday since 2/11/2021. I woke up every morning for three after the injection with a headache. I?ve had a headache at some point everyday since.
powder reconstituted with non approved diluent/ received diluent only; powder reconstituted with non approved diluent/ received diluent only; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 20-OCT-2022 Reporter's Comment: The reporter reported that, they had 3 extra Shingrix  gE powder vials.  The medical information asked reporter if they knew what happened with the missing diluents and if they believed patients received diluent only.  The reporter seemed upset about this question and said did not  even go there, did not know what happened but there was no error. The reporter said that, they did not know what happened with the vials and asked medical information if the powder could be reconstituted with a non approved diluent. The reporter did not consent to follow-up. This is 1 of 3 linked cases reported by same reporter, different patients. Additional Supportive Information: The patient received only diluent of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The case was kept valid based upon verbatim that they believed patients received diluent only.; Sender's Comments:  US-GSK-US2022151415:Same reporter US-GSK-US2022AMR152100:Same reporter
First develop axillary pain starting on 1/5 then noticed that the injection site was becoming swollen. On 1/6 I was nauseous on and off throughout the day had to take Zofran. 1/7 the swelling on my arm worsened with redness and warm, axillary pain continued, and had some nausea with diarrhea as well.  Today, 1/8 injection site is less red but still swollen with axillary pain, and I can palpate and enlarged axillary lymph node.
Hives, dizziness, BP 112/70-gave BENADRYL 50mg IM x 1
The patient's caregiver said the patient started to have vision problems around a week after vaccination.  She is seeing some red spots and hexagonal shapes.
Rcvd vaccine on 12/2/99 in r/arm and 12/3/99, elbow and forearm to wrist was severely swollen, bright red and hot to touch.  MD dx cellulitis.
pt reports just didn't feel well the evening of the shot, but then the next morning stated legs were just not wanting to work and almost gave out when trying to walk
muscle is twitching and shaking/muscle is jumping and moving; worse after second dose; muscle is contracting very hard at the site of the injections; side effect; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MUSCLE TWITCHING (muscle is twitching and shaking/muscle is jumping and moving), VACCINATION COMPLICATION (worse after second dose), VACCINATION SITE INDURATION (muscle is contracting very hard at the site of the injections) and ADVERSE REACTION (side effect) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced MUSCLE TWITCHING (muscle is twitching and shaking/muscle is jumping and moving), VACCINATION COMPLICATION (worse after second dose), VACCINATION SITE INDURATION (muscle is contracting very hard at the site of the injections) and ADVERSE REACTION (side effect). At the time of the report, MUSCLE TWITCHING (muscle is twitching and shaking/muscle is jumping and moving), VACCINATION COMPLICATION (worse after second dose), VACCINATION SITE INDURATION (muscle is contracting very hard at the site of the injections) and ADVERSE REACTION (side effect) had not resolved.            No concomitant medications were provided by the Reporter. Patient has stated that he went to physical Therapist and confirmed it was just a muscle damage and not nerve damage and she massaged and suggested patient  to massage everyday to recover.   This case was linked to MOD-2021-233968 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Updated Reporter's E-mail and second name and Updated patient Identifiers and Updated onset of events and outcome as ongoing.
Headaches, nauseous - kind of like my sugar is low, or like I am missing vitamins. I have had MRI, BLOOD WORK. Nothing is irregular, not until I had to have the surgery. They had tried me on anxiety medications. I had to have a VP Shunt due to extra fluid and pressure build up. They said it's due to trauma and an accident I didn't have.  May 2023 I was hospitalized for a week. That's when they found out about the pressure. I had my surgery on October 9th, 2023 at facility.
I start feeling like i was getting a cold; I was feeling so tired and on tuesday I was whit a full cold runny nose sore throat cough; I was feeling so tired and on tuesday I was whit a full cold runny nose sore throat cough; I was feeling so tired and on tuesday I was whit a full cold runny nose sore throat cough; I was feeling so tired and on tuesday I was whit a full cold runny nose sore throat cough; a litttle bit off pain on my chest; more tired I can even get up my body hurts and anything that I drink is working and today wednesday I have headache; This is a spontaneous report from a contactable consumer. A 32-years-old nonpregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection and Batch/Lot Number: 6w0179), via an unspecified route of administration on 16Aug2021 11:00 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not have any known allergies. The patient did not have COVID prior vaccination. The patient did not receive any other vaccine in 4 weeks. The patient got her last vaccine on Monday and later that (16Aug2021) day she starts feeling like she was getting a cold and she was feeling so tired and on Tuesday. The patient was whit a full cold runny nose sore throat cough and a little bit off pain on her chest and more tired she can even get up my body hurts and anything that the patient drink was working and today Wednesday she had headache and like she had really bad cold. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 06Apr2021. The patient received advild and motrin treatment for events.  Follow-up attempts are completed. No further information is expected.
Moderate headache for the last 2 days that wakes me up, minimal relief with Tylenol
redness @ site of inj w/c/o cold sweat;tx w/duricef;rx for Keflex;
This case was reported by a consumer via call center representative and described the occurrence of shingles in a 74-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included famotidine, omeprazole, Thyroxine and ZETIA. On 7th May 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 8th May 2018, 1 days after receiving SHINGRIX, the patient experienced shingles, swelling arm, tiredness, rash and muscle soreness. On 4th June 2018, the outcome of the shingles and rash were recovered/resolved. On an unknown date, the outcome of the swelling arm, tiredness and muscle soreness were recovered/resolved. The reporter considered the shingles, swelling arm, tiredness, rash and muscle soreness to be related to SHINGRIX. Additional details were provided as follows: The reporter was reporting this case for herself. Concomitant medications also included vitamins. The patient received SHINGRIX on the right arm. The patient reported that her arm became swollen to about the size of a baseball and she developed a rash. The patient reported that the day after the injection, she hurt all over (muscle soreness) and felt like a truck hit her (tiredness). On Saturday, 12th May 2018, after the dose she had symptoms on her head and around her temple area and she went to urgent care (emergency room) and was diagnosed with shingles outbreak. The patient reported, about a week later she developed shingles outbreak around her kneecap area. The patient had denied permission to contact their physician.
At time of injection:Burning and pain at injection site 11 hours later:Fever of 101, nausea, stomach pain, chills and other flu-like symptoms Appx. 8-10 days later: terrible deep /aching cramp-like pain in upper left arm. Limited range of motion due to pain. Sporadic head aches-unusual for me as i do not hget headaches unless it's sinus which this isn't.
HIGH glucose levels (338-550), Nerve damage (burning in feet and legs, numbing in hand(L). Insulin increased by 20%. Nerve test performed. Still having nerve problems to this day (requiring nerve pain medication).
Patient came to me and showed me their arm. It was red, swollen, and tender to touch. Swollen from injection site to past elbow. Past was self treating with Benadryl and I sent them to urgent care for further examination. Patient was treated with steroid cream, and I am awaiting further details.
Shortness of breath; Cough; Feel moody; This is a spontaneous report from a contactable Other-HCP (patient). A 37-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EL9267), via an unspecified route of administration, administered in left arm on 14Feb2021 05:00 (age at the time of vaccination 37-years-old) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had no known allergies. On 15Feb2021, the patient experienced shortness of breath, cough, and feel moody. No covid prior vaccination. Covid tested post vaccination was unknown. The outcome for all the events was unknown.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Breakthrough case of COVID 05/08/2022. Fever stayed with me, sweats, headache, no cough, a little hoarseness and scratchy throat and exhaustion, went through the course of PAXLOVID then started with a stuffy nose, nothing fierce, could be allergies form the pollen. It lasted about 4 days, before the 5th day I was feeling better. I am really glad I got that booster.
Patient developed a widespread rash within a week of vaccine administration. Rash spread all over back, trunk, and arms, and is described by patient as "very itchy and painful"; is compared by patient to contracting chicken pox. Patient has visited the doctor and received topical steroids, with minimal benefit to the symptoms and rash. Symptoms are still present, almost two months after the vaccine was administered.
Pt was put on schedule for COVID #3, not double checking age pt was given a 6m-4y dose as #3 before booster was even do, they received lower dose vaccine before booster was even need.  Spoke to CDC- recommendations: do not repeat dose. However, providers may administer 1 bivalent booster dose as a repeat dose based on clinical judgement and patient preference. In this case, space the repeat dose after the dose given in error by at least 2 months.
patient was breastfeeding; developed a runny nose; Felt cold; Body aches; had chills; Tired; Headache / headache was pretty bad; This spontaneous case was reported by a nurse and describes the occurrence of RHINORRHOEA (developed a runny nose), NASOPHARYNGITIS (Felt cold), EXPOSURE VIA BREAST MILK (patient was breastfeeding), MYALGIA (Body aches) and CHILLS (had chills) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01320A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced NASOPHARYNGITIS (Felt cold), MYALGIA (Body aches), CHILLS (had chills), FATIGUE (Tired) and HEADACHE (Headache / headache was pretty bad). On 02-Feb-2021, the patient experienced RHINORRHOEA (developed a runny nose). On an unknown date, the patient experienced EXPOSURE VIA BREAST MILK (patient was breastfeeding). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. On 03-Feb-2021, RHINORRHOEA (developed a runny nose), NASOPHARYNGITIS (Felt cold), MYALGIA (Body aches), CHILLS (had chills) and FATIGUE (Tired) had resolved. On 04-Feb-2021, HEADACHE (Headache / headache was pretty bad) had resolved. At the time of the report, EXPOSURE VIA BREAST MILK (patient was breastfeeding) had resolved.        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.   No concomitant medications were reported.
Erythema and swelling from shoulder to elbow on left arm. Induration at injection site (LD). No pain, mild tenderness. Pt taken to ER on 4/20/03, diagnosed with cellulitis and given antibiotic therapy.
At 5:30 AM on 10/15/2009, I I noticed that I had pain, redness,and swelling on and around injection site, which continued through the weekend. Currently the injection site is not as swollen or sore, but is still red and hot to the touch. At 2:00 PM that same day, I began to get aches and pain throughout my body, which continued until 10/17/2009. At about 6:00 PM that same day, I developed a fever of 102 and a headache; the fever and headaches lasted until 10/17/2009. I've had several vaccines throughout my life, but this is the first time I've experienced any adverse reactions.
I had a FLUZONE PF syringe NDC49281-0013-88 break apart in my hand while preparing for an immunization. The syringe was glass, and the broken glass cut my thumb with a deep laceration.