chrisvoncsefalvay/vaers-outcomes huggingface dataset:
all got the first dose, and they all came down with COVID in a week; all got the first dose, and they all came down with COVID in a week; This is Spontaneous report from a contactable Physician. This physician reported similar events for four patients. This is the fourth of four reports.  A patient of an unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, on an unknown date as a single dose for COVID-19 immunisation. Relevant medical history and concomitant medication were not provided. On an unknown date, the patient came down with COVID in a week of vaccination. The outcome of the event came down with COVID in a week was unknown. The reporting physician stated that he doesn't think that them getting the vaccine and having COVID is related, he thinks it is a coincidence.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.,Linked Report(s) : US-PFIZER INC-2021064977 same reporter/drug/event, different patient.
on 06/24/2021  Acute bout of probable Neuritis/Vertigo causing  a fall; treated at Hospital ER  (broken nose, cuts to lips)    Never had these issues prior to this date. I am still, two months later, having bouts of dizziness/
Information has been received from a physician concerning a 22 year old female who on an unknown date was vaccinated with a first dose of Gardasil vaccine (yeast). Subsequently, the patient broke out with acne all over her face. Unspecified medical attention was sought. No diagnostic studies were performed. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 1/16/2007.  Information has been received from a physician concerning a 22 year old female student with a recent upper respirtatory infection and no allergies, who on 24-NOV-2006 was vaccinated IM into the left arm with a first dose of GARDASIL (lot # 653938/0954F).  On 25-NOV-2006, the patient broke out with acne all over her face.  It was noted that the patient and her mother stated that the patient does not usually suffer from acne.  Unspecified medical attention was sought.  No diagnostic studies were performed.  Subsequently, the patient recovered.  No product quality complaint was involved.  Additional information is not expected.
Initial report received from a Pharmacist on 15 Jan 2010: This patient, with an unknown medical history, was vaccinated with one dose of FLUVIRIN (batch no. 104045P1), 0.5 ml, intramuscularly, on an unspecified date. The FLUVIRIN vaccine had been stored at temperatures as low as 34 degrees Fahrenheit and 35 degrees Fahrenheit. No adverse event was reported. No further information was provided.
Cellulitis to injection site. Sulfa Rx x10 days for Tx.
Vials of Pfizer COVID vaccine were stored in the refrigerator with a use-date expiration on 10/19 at 1:30pm. On 10/25, the patient was given their first dose of COVID vaccine from this vial. No harm detected.
received 2 doses of shinrix and had/ shingles 2 years after the second dose/Suspected vaccination failure; had a breakthrough case of shingles; have a spreading rash; This case was reported by a physician via sales rep and described the occurrence of Suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, 2 years after receiving Shingrix and more than 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and rash. On an unknown date, the outcome of the vaccination failure, shingles and rash were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of patient was not reported however was captured as an adult as per vaccine indication. The patient received 2 doses of Shinrix and had a breakthrough case of shingles 2 years after the 2nd dose. The physician stated that it was mild case with no pain but did had a spreading rash. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming herpes zoster were not provided. This case has been linked with case US2021AMR066664, as reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR066664:Same reporter, different patient
Dad brought pt in to office on 6/28/10 c/o cough x 1 week-wheezing at night stated had a "low grade fever" over weekend. Dx: mycoplasma vs viral pneumonia Tx: VENTOLIN MDI 2 puffs every 4 hours, ORAPRED 2 tsp daily x 3d, ZITHROMAX 200 mg x 1 day, 100 mg x 4 days.
Initial report was received from a healthcare professional on 21 June 2012. A 17 year-old-male patient received an injection of MENACTRA, sanofi pasteur Inc., lot number U4002AA (route, site, and number of previous doses not reported) on 21 June 2012. Approximately 10 minutes after vaccine on 21 June 2012, the reporter stated the patient became "very sleepy, passed out, one min. later woke up and was OK." The reporter stated during the time the patient was "passed out"; he had a "small convulsion". The reporter stated upon "waking", the patient was hungry and was provided a snack. The patient was "OK" when discharged from facility, per reporter. The patient's past medical history was not reported. Illness at time of vaccination was reported as none. The patient's mother called his primary care physician (PCP), and the patient was seen at own PCP office (date not specified), where the patient's mother stated the patient had follow-up testing scheduled. The patient was reported as recovered on 21 June 2012. Documents held by sender: None.
DEVELOPED COVID ARM WITH BOTH SHOTS DEVELOPED MORBILLIFORM DRUG ERUPTION WITH BOTH SHOTS (2ND SHOT WAS WORSE AND STILL SUFFERING AS OF THIS WRITING HAD A SLIGHT FEVER/CHILLS, NAUSEAU, HEADACHE FATIGUE  LASTED 3-4 DAYS
Sharp pain in her arm where the vein is near her wrist, it goes into her hand; Woke up and the next day she couldn't move; Sleeping a lot more; Sharp pain in her arm where the vein is near her wrist, it goes into her hand; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "Sharp pain in her arm where the vein is near her wrist, it goes into her hand"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "Woke up and the next day she couldn't move"; HYPERSOMNIA (non-serious), outcome "unknown", described as "Sleeping a lot more".  Additional information: It was reported that, Had a really bad experience with it, which she hears a lot of people do. No further details provided. Has that real sharp pain in her arm like where the vein was. Didn't have it the day of the COVID shot but has had it since. She doesn't know when it started because she has had so many side effects. She woke up the next day and couldn't even move. On that arm, she doesn't know whether anybody else has had it. Wants to know should she called her doctor. Clarified the sharp pain on her arm near the vein was down towards her wrist and goes into her hand. She drops things once in a while, but not all of the time. She woke up in the middle of the night crying because the pain was so sharp. It eased up and went back to sleep. It happened three times. It happens all day. She was sleeping a lot more. A lot of people say they are sleeping more for the first week and then it goes away. No further details provided. Stated this was not going away. She was having a hard time hearing this agent because she was outside and it was windy. She walked in from outside and got blinded. Caller declined to complete report. Full details not obtained. Loud background noise was present and caller was difficult to hear at times. Attempted to clarify details with caller. Advised caller to follow up with her primary care physician for medical advice and treatment recommendations.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
headache, slight dizziness, injection site pain.  symptoms started about 8 hours after vaccination.
Site: Pain at Injection Site-Severe, Systemic: Bell's Palsy-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Patient returned approximately 1 hour after receiving Pfizer booster complaining of pain radiating from inject site up into left side of face.  Advised to seek immediate medical attention.  Returned with MD orders for Medrol dose pack.
This spontaneous report as received from registered nurse (R.N.) refers to a 55 year old female patient. On 13-AUG-2013 the patient was suppose to receive VARIVAX (Merck), but was inadvertently given the ZOSTAVAX (Lot #, 0.66ml, subcutaneous route). Concomitant therapy was not reported. No adverse effect reported. Additional information has been requested.
This spontaneous report was received from a healthcare worker and refers to a 11 months old patient of unknown gender. The patient's concurrent conditions, past medical history were not reported. On 10-DEC-2015, the patient was vaccinated with an improperly stored ROTATEQ (lot # K014826, expiry date 28-MAY-2016, dose, strength, vaccination site, dose number unspecified). Concomitant medications were not provided. No adverse effects were reported. Product quality complaint (PQC) was not reported. On 26-JAN-2016, a phone call was placed to the physician. The physician was unavailable at the time of call. The phone call was transferred to the Certified Medical Assistant (CMA). The C.M.A. was unable to place specific lot numbers for each of the reported vaccines that experienced a temperature excursion; M-M-R II, ROTATEQ and VAQTA, with the information already supplied for patient identifiers, date of birth and date of vaccination, at this time. The C.M.A. will need to review the records. This is one of the several reports received from the same reporter. Additional information has been requested.
Information has been received from a health professional concerning a 14 year old male who on 01-AUG-2007 was accidentally administered a single dose of ZOSTAVAX (Oka/Merck) (lot# 654504/1406F) instead of VARIVAX. It was reported that no adverse side effects resulted from the vaccination. Further information was not available. additional information has been requested.
About 10min after vaccine given, patient c/o dizziness, tingling to lips, no SOB nor difficulty breathing. VS stable.  A rapid response was called but patient monitored. Dizziness resolved.
140PM mom called clinic reported pt had t103 R-had given APAP-lt leg red & swollen some dyspnea; instructed to call pvt MD; MD prescribed ATB Amoxil for red throat-went to ER 1045PM t105 R & listless w/some cry;
Body aches; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches) and HEADACHE (Headache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Body aches) and HEADACHE (Headache). At the time of the report, MYALGIA (Body aches) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.
Patient sent photo of red area over injection site in right thigh that developed on night of flu vaccine. She has egg allergy but had no other swelling or symptoms.  She has no sign of pain at the site. Recommended applying ice, motrin if needed for pain and call/returning if no resolution in two days.
Medical Assistant correctly drew up 2.2 mL of normal saline to dilute the vial of vaccine. She then mistakenly administered 2.2 mL of vaccine (not 0.2 mL) to inoculate the patient.
Child noted to have redness, swelling, induration extending from top of shoulder down to elbow and around half of circumference of arm.  Had not previously complained of pain/decreased range of motion. Upon identification was treated w/ oral Motrin, topical corticosteroid and ice pack.  Symptoms resolved over next 24-48 hrs.
Pain at injection site spread through entire arm and through upper shoulder into neck. Pain was so extreme that the arm was immobilized- any movement no matter how small caused pain to flare. It felt like a broken bone. Injection at 2:30pm, pain peaked around 10pm. Next morning awoke with same extreme pain and added severe body aches in lower back and legs along with a headache. Pain persists as of report
The spot where the injection went is hot; Unable to function; Running a fever; The spot where the injection went is swollen; The spot where the injection went is very painful; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (The spot where the injection went is hot), MOBILITY DECREASED (Unable to function), PYREXIA (Running a fever), VACCINATION SITE SWELLING (The spot where the injection went is swollen) and VACCINATION SITE PAIN (The spot where the injection went is very painful) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 24-May-2021, the patient 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 received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, the patient experienced VACCINATION SITE WARMTH (The spot where the injection went is hot), MOBILITY DECREASED (Unable to function), PYREXIA (Running a fever), VACCINATION SITE SWELLING (The spot where the injection went is swollen) and VACCINATION SITE PAIN (The spot where the injection went is very painful). At the time of the report, VACCINATION SITE WARMTH (The spot where the injection went is hot), MOBILITY DECREASED (Unable to function), PYREXIA (Running a fever), VACCINATION SITE SWELLING (The spot where the injection went is swollen) and VACCINATION SITE PAIN (The spot where the injection went is very painful) outcome was unknown.            Concomitant information was not reported. Treatment information was not reported. The action taken with mRNA-1273 with the event was considered as not applicable.
Patient is a 38 y.o. male with history of obesity, HTN, hypogonadism who presents after his first COVID vaccine with sensation of throat tightness, nausea, and flushing of the arms which started about 25 minutes after the vaccination. Pt denies any history of asthma, allergies, or anaphylaxis. Upon arrival to our ED, patient is awake, alert, and answering questions appropriately. Normal HR, RR, and O2 sat. Hypertensive with SBP max in the 160s (never headache, vision change, chest pain).  Physical exam notable for mild flushing but not hives over his right shoulder.  Rest of exam with normal findings including no respiratory distress or visible oral swelling.  He is tolerating his secretions well, no stridor, talking in full sentences, good breath sounds b/l. Initial ASAP score 4 - for flushing, nausea without vomiting, and sensation of tight throat. In discussion with the patient, given improvement in flushing/diaphoresis and no worsening of symptoms, patient received cetirizine and famotidine with plan to escalate care if symptoms worsened.  Patient was observed in the emergency department for at least 2 hours.  Patient clinically improved - resolution of throat symptoms and ASAP score to 1.  He had residual mild nausea for which he received zofran and then was able to PO without issue and reported feeling much better and feels comfortable with discharge. Patient is safe to discharge home with supportive care instructions including s/s requiring return to the ED.  Prescription for cetririzine and famotidine/ranitidine provided.
Fever, muscle aches, fatigue, Patient described arm and being very heavy had a hard time moving it.
He also had a mild case of COVID-19 in the fall of 2022.; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (He also had a mild case of COVID-19 in the fall of 2022.) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In 2022, the patient experienced COVID-19 (He also had a mild case of COVID-19 in the fall of 2022.). At the time of the report, COVID-19 (He also had a mild case of COVID-19 in the fall of 2022.) outcome was unknown.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Patient had received the Moderna original vaccine plus 2 booster vaccines in 2022. Patient also had a mild case of COVID-19 in the fall of 2022.  Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 13-Oct-2023: Live follow up was received. References were added.
Five days after receiving the varicella vaccine small bumps started to appear  on his hands and legs and he started to itch. I gave him Benadryl to reduce the itching. Then another red bump appeared above his left eye. Tonight,  I noticed one of the bumps turned in a painful fluid filled blister.
The patient received the shot, and after a few minutes the patient passed out on the chair.  After noticing the patient slumped over we made sure the patient was still breathing.  We got the emergency equipment and contacted the emergency protocol, and the patient woke back up promptly and communicated that they felt dizzy.  We allowed the patient to lay down and waited for the emergency services.  She felt better as time passed and by the time her dad made, they refused to go to the hospital and made it home on their own accord
Shortly after getting my second (booster) shot I experienced a flare-up of fibromyalgia in my right arm that I did not experience with the first shot. This is the same arm I got my shots in. The pain has continued for more than 2-1/2 months.
Severe arm pain; This case was reported by a physician via sales rep and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The reporter stated that the patient in her 60's received the 1st dose of vaccine and experienced severe arm pain. The reporter did not agree to the follow up.
During administration, needle came loose from syringe resulting in unknown amount of vaccine leaking and not being administered. No side effects from the vaccine was noted when historically patient has had high fevers and other symptoms, in addition to one infection of COVID 4-5 months prior
Just 2 hours after the shot, I started to break out in hives all over my body.  The hives (mistaken by ER doctors as chicken pox or herpes the same day) concentrated at my joints.  Hives also impacted my tongue and roof of mouth making it difficult to breath and eat.  Treatment was Valtrex but biopsy (result  one week later) proved that the Moderna shot caused the allergic reaction.  I was hospitalized (ER) and remained in hospital for 4 days, not including the ER visit week prior.  Given a multitude of medicines, primarily steroid treatment intravenously to reduce swelling and rash.    No change in my fingers and swelling of joints (chronic), since May 19th, I have no feeling in fingers and chronic pain (hands on fire especially at night or sitting still). Visiting a Neurologist today and a Rheumatologist on July 19th.
A few minutes after receiving the vaccination, the patient complained of headache and flushing.  Patient given Tylenol.  Patient assessed by MD at chairside, after approximately 45 minutes, patient feeling better, headache subsiding.  Discharged to home with spouse.  Vitals stable.
Myalgia, Diarrhea, FATIGUE,JOINT PAIN Narrative:
Left arm pain 7/10, swelling.  Amoxicillin, acetaminophen.
pt recv vax; exp joint pain in hands; 1 month later, exp knee joint pain;
mild headache; Body temp. went up 2 degree: 97-99F; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on [05Jan2021], this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer from a Pfizer sponsored program, Pfizer RXPathways. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number and expiry date unknown, via an unspecified route of administration on the left arm on 14Sep2020 14:00 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced mild headache for 12 hours, no medication needed-very mild and body temperature went up 2 degrees 97-99f on an unspecified date with outcome of unknown. The patient stated these side effects were only present with second dose on 14Sep2020, no side effects with first injection.   Information on the Lot/Batch number has been requested.
Rash type around injection site, spread to small area on the lower arm. Will take BENADRYL/ibuprofen to see Dr if not getting better in a day.