chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recv vax 16NOV95&6 days later devel intestinal cramps,followed by paresthesia,ataxia,& absent reflexes;pt was hosp in DEC95&was dx w/GBS;EMG,CT scan&LP were neg;
Systemic: Patient fainted 2 times due to feeling dizzy and on one occasion for 5-8 seconds was shaking like a mini seizure. EMS came and cleared her, she refused the trip to hospital-Medium, Systemic: Seizure-Mild, Additional Details: As described above
Patient felt a little dizzy after receiving the vaccine. Around 6:30 pm he started stuttering.  He said the stuttering goes away when he things happy thoughts, looks at his dog, or pinches himself. He reports that he has never stuttered in his life. The stuttering only start after receiving the COVID moderna vaccine.
Severe headache vision lost in both eyes, then slowly became blurry to fuzzy now left eye is clear but right eye fuzzy, legs became weak, had some fatigue, and tiredness, dizziness, light headedness.
Information has been received from a licensed practical nurse concerning a 14 week old patient who was vaccinated with the first dose or ROTATEQ (date unspecified). There was no product quality complaint involved. Additional information has been requested.
Body aches, chills, sweating within 12 hours of shot, lasting for about 36 hours. 72 hours post injection a full body rash appeared, with hands especially affected (red & itchy), and swollen sore lymph nodes in armpits
Female presented to the hospital on 7/20/2021 with complaints of headache, cough, and loose stool diarrhea that began 10 days prior on 7/11/2021.  She also reported a fever of 101 the day of admission.  She states that she received the Pfizer vaccine in February and March 2021.  She was treated with oxygen, dexamethasone, and remdesivir.
Received flu shot Tuesday-on Wednesday AM developed hives, type rash on legs, waist arm and red and itchy.
Patient stated that she was anxious about getting the vaccine due to her fear of needles. I counseled her on side effects of the vaccine prior to giving the vaccine. After giving her the vaccine, I told her to sit around for 15 minutes to observe. She comes to the counter less than 5 minutes and stated that her arm and throat was feeling numb and was feeling very anxious. She stated it might be an allergic reaction. She was  conscious and breathing normally. I asked how she was feeling and she said she felt uncomfortable. At this point, I asked her if we should call 911 and she said yes. The emergency personnel arrived about 15 minutes after the call and the patient was still conscious, breathing, and able to walk out of the pharmacy to the ambulance.
Arm soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included ibuprofen for an unknown indication.   On 19th August 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient started ibuprofen at an unknown dose and frequency. On 19th August 2019, less than a day after receiving Shingrix, the patient experienced pain in arm. The action taken with ibuprofen was unknown. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional case details were provided as follows: The patient received the dose of shingrix and experienced the sore arm in the injected arm. The reporter did not consent to follow up. This case has been linked to US2019196456 reported by same reporter for the same patient for the 2nd dose.
A 47 year old male vaccinated on 11/5/01 (signed in to clinic at 08:40, 17th pt of the day). Recheck on 11/13/01 revealed 1.5cm scabbing pustule with 14cm surrounding erythema and tenderness of left axilla. The nurse noted 'obvious reaction to tape'. Recheck on 11/14/01 revealed same area of erythema, no fever. (No central clearing in area of gauze, as would be typical for simple tape reaction). Pt empirically started on cephalexin 500mg BID. Next day, erythema noted to be much improved and the pt stated that he was feeling better. On 11/20/01, sent e-mail stating "Rash is almost gone. No further problems". Clinical dx: possible cellulitis, r/o vigorous primary response to vaccine.
pain at the injection site, pain in the left arm - since after the injection - lasted for 2 days tiredness, fatigue, low grade temp - 99.6 F orally - started on day 2, resolved on it's own by following morning.
Received vaccination on 12/30/20. Around 330a on 12/31/20 began to have chills and fever of 101. Arm soreness where injection occurred. Had nausea.
Initial information received on 14-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 19 years old female patient who was administered with doses of IMOVAX RABIES (lot number, expiry date, dose, dose in series, route and site of administration was not reported) on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to drug dose omission since the patient missed to vaccinate with the second dose of IMOVAX RABIES. It was unknown whether patient had adverse event related to vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Patient reported he received a dose of the Pfizer COVID vaccine 1 day before onset of increasing firm nontender swelling of the left costochondral junction at the level of the 2nd rib.  On exam, this area was nontender and palpated similar to a skeletal prominence but patient endorsed that this was entirely new to him.  He felt discomfort deep to the swelling, but this was not worsened by touching the area.
The next morning after the second dose I felt lightheaded. For about 30min I was nauseous and had upset stomach. When I went to the bathroom I fainted. Not sure how long I was unconscious for but after I woke up my head was spinning for a while and I had a massive headache all day.
Client presented to clinic with small pink papules on face, stomach, back, arms. Legs 15-20 total, on 10/15/04. Mom states she started breaking out yesterday. Child scratching bumps. Recommended Calamine lotion, Aveeno bath and Benadryl.
Pt is 35 weeks pregnant and on 4/20/23 came in for her 1st updated Bivalent booster. The vaccine of 0.5ml was given of lot #011H22A that expires on 5/23/23.  The bottle had puncture date of 4/19/23 at 10:40am.  We contacted the pt on error and notified Moderna for further update.
covid vaccine breakthrough case    dose 1 Moderna  2/12/21  015M20A dose 2 Moderna 3/12/21  002B21A
This patient lied to the technician  about this being their first shot of Covid. He did get a Jassen, but it did not come up in immunization records right away. He only shows up on immunization records when search Patients name. (this was found after he was given the shot.) the patient claimed that he needed a first dose pfizer shot. Before giving the shot he was asked again if this was his first shot, he said yes. He lied, after giving the shot he mentioned about Janssen shot. Then he said he was mistaken and  he did not get it. But searching a little harder immunization records after, it looks like he did get the shot. He is informed he cannot get a second pfizer shot.
Information has been received from a registered nurse (RN) concerning a 10 year old female who on 13-OCT-2000 (also reported as 03-MAY-1996) was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). The RN reported that on 06-APR-2006 the patient broke out with a varicella infection characterized by less than 50 lesions. The patient was noted to be afebrile. Unspecified medical was sought and no treatment was given. At he the time of this report the patient was recovering. No additional information is available.
On 12/6/99, pt developed chicken pox. There was a lot of "lesions" located on face, chest, arms & legs. F/u info from a MD, reports that concomitant vaccinations on 12/6/99, included a 2nd dose of MMRII. On 12/7/99, pt had fever of over 101. 60 day follow up dated 10/25/00 provided no additional data.
This spontaneous report as received from a registered nurse refers to a patient was vaccinated with the first 0.5 ml dose of GARDASIL (Lot # not reported) intramuscularly, on 22-JUL-2014, the patient received the second 0.5 ml dose of GARDASIL (Lot # not reported) intramuscularly and on 22-SEP-2014, the patient received the third 0.5 ml dose of GARDASIL (Lot # not reported) intramuscularly. No adverse effects were reported. Additional information has been requested.
SEVERE, SUDDEN ONSET HEADACHE IN LEFT TEMPORAL LOBE; LEFT EYE/FACIAL DROOPING, ELEVATED BLOOD PRESSURE (NO HISTORY OF HEADACHES OR MIGRAINES); TREATED IN THE ER WITH IV MORPHINE, 'MIGRAINE COCKTAIL', INCLUDING IV MAGNESIUM SULFATE
Information has been received from a registered nurse concerning a 43 year old female who on 27-FEB-2007 was administered Pneumovax 23, 0.1 ml intradermally.  There was no concomitant medication.  On 27-FEB-2007, within several hours of the injection, the patient experienced pain, local heat at the injection site, and swelling from her elbow to her wrist.  Medical attention was sought.  The patient was treated with over-the-counter (OTC) BENADRYL and ice.  At the time of reporting, the patient was recovering.  No other information was available at the time of reporting.  Additional information has been requested. Additional information was received from the registered nurse. The patient experienced sweling at the site and forearm (minimal) which resolved completely in about 24 hours. The patient recovered in approximately 24 hours. No additional information is expected.
This individual received a third dose (booster dose) only 4 months from the second dose date.  Under the false pretense that it was her first dose.  Dose 1 given on 5/3/21 and dose 2 given on 5/24/21 at the Center.
Muscle tremors in both arms legs and mouth off and on from around 5 PM until bedtime (8:30 PM).  Pt is currently asleep and it is unknown at this time if the tremors will continue.   She also has a headache which she complained of at 8:15 PM.
nauseas; dry heaves; fever; This is a spontaneous report from a Pfizer sponsored program COVAX US Support. A contactable consumer reported for a female patient (mom) that. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1 SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Calling for mom Just had 1st dose of covid vaccine. Has normal symptoms of vaccine. Said she has nauseas, dry heaves and fever on an unspecified date. Wants to know if we recommend anything. He is concerned if he should stay with her. Advised to reach out to HCP. The event outcome was Unknown.  Information for lot number/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 10-MAR-2014 the patient was vaccinated with an improperly stored dose of M-M-R II single 0.5ml dose (HSA, lot # H014989, expiration date 10-AUG-2014, dose and route unknown). This specified lot number vaccine was exposed to temperature excursion for three times. The total cumulative excursion time of the first time was 16 hours with the lowest recorded temperature of 6 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine this time was freezer (F). The total cumulative excursion time of the second time was 144 hours with the lowest recorded temperature of 33 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine this time was refrigerator (R). The total cumulative excursion time of the third time was 312 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine this time was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Post vax, pt developed 3 or 4 hives on anterior neck at 10:00. Neck reddened and was itchy. No dyspnea or edema. Pt was given 50mg Benadryl po. Further follow-up required.
On 05/18/2000, the patient developed a "scattered papular rash that consisted of about 20-30 lesions. The red raised papules were scattered sparsely on his trunk, extremities, and face. There was no fever, pruritis, pustules, vesicles, or lesions around the injection sites. The lesions appear consistent with insect bites. There were no infected lesions. The patient sought unspecified medical attention. Follow up information from a physician indicated that no treatment was rendered and the patient recovered on 05/21/2000.
This spontaneous report was received from a Registered Nurse concerning a patient of unknown age. On 15-NOV-2013, the patient was vaccinated with a dose of MMR II (dose and route not reported) (Lot # 669032/0255AA; expiration date 21-FEB-2013). No adverse effect reported. At the time of the report, patient's outcome was unknown. Additional information has been requested.
She states that the covax gave her a  boost energy, she felt great; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 73 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "fatique", start date: 2005 (unspecified if ongoing), notes: came down with something of fatigue, fever, muscle weakness; "fever", start date: 2005 (unspecified if ongoing), notes: came down with something of fatigue, fever, muscle weakness; "muscle weakness", start date: 2005 (unspecified if ongoing), notes: came down with something of fatigue, fever, muscle weakness. The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "She states that the covax gave her a  boost energy, she felt great".  Additional information: Patient got covax series and had positive results. 16 yrs. ago patient visited city name withheld and came down with something of fatique, fever and muscle weakness. None of the HCP can figure out what it is. Patient states that the covax gave her a boost energy, patient felt great 24 hr. The best patient has felt in 16 yrs. Patient wanted to let Pfizer know this. Patient has no diagnosis for the condition as of yet.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No adverse events, patient was given vaccines and did not know she was pregnant. Pregnancy test on day of administration was negative.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. On 23-JUN-2014 unspecified number of patients were vaccinated with RECOMBIVAXHB (dose, lot # and expiry date were not reported), that were exposed to temperature out of range (multiple excursion over a 24  hour period totaling 5 hours below 36F, including three cycles below 28F, have occurred on unspecified date reported as prior to the morning 23-JUN-2014) that were not supported by Merck's stability data. No adverse effects have been reported. This is one of several reports received from the same reporter. Additional information has been requested.
I had shot on Monday with minor reaction.  On Friday I had incident of rapid irregular heartbeat, 159, but pulse was normal.  I also experienced chest tightening, coughing and extreme fatigue.  I went to ER but due to overwhelming large numbers of patients I left after triage.  My EKG was done results not given to me.
Heart attack, 100% blockage LAD. had lots of inflammation and body pain which is normal after a Covid booster for me. Symptom of heart attack was slight tightness in my chest, and a cramp feeling in my esophagus.
patient received vaccine at 17 years old; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient received vaccine at 17 years old) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 immunisation.     No Medical History information was reported.    On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient received vaccine at 17 years old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient received vaccine at 17 years old) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non-Significant follow up
Exactly 2 weeks after receiving first dose of the vaccine an itchy rash developed at the site of injection. It lasted 3 days.
The day she received the vaccine she got worst headache and had extreme nausea. She has had extreme fatigue. The next Am 7-19-13 she had 4 bumps on her breast that blistered up and felt very itchy. She continued to be tired and has been taking naps every day since vaccine. Her left arm is also red and hot to touch. She took 2 extra strength Tylenol on 7-19. Pharmacy called prescriber and left message with nurse. She will discuss with MD and call patient.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "recovered" (2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: feeling better and a negative test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid from 31Aug2023 to 04Sep2023 as treatment of COVID-19.   The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300298227 same patient, different drug/event;
This spontaneous report was received from a patient's mother and refers to a her baby of an unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with a doses of ROTATEQ (orally, exact dose and lot # were not reported, expiration date 28-MAY-2016). On an unknown date, the patient experienced an unspecified problem. The outcome of the event was unknown. The relatedness between the event and oral ROTATEQ was not reported. Additional information has been requested.
Injection site hot to touch; There was a knot at injection site; Injection site redness; Injection site bruising; Injection site bruising; Freezing; Soreness from the injection/painfully sore; Unable to sleep; A spontaneous report was received from a 75 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced soreness from the injection site,  bruising,  knot, redness, hot to touch and unable to sleep.   The patient's medical history was not provided. There were no concomitant medications provided.    On 06 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (Lot # 011J20A) intramuscularly, in her left arm, for prophylaxis of COVID-19 infection.   On 06 Jan 2021, the patient experienced the non-serious event of soreness from the injection site, immediately following. On 07 Jan 2021, the injection site was painfully sore and bruised and she was unable to sleep. On 08 Jan 2021 there was a knot at injection site,hot to touch. The patient experienced freezing from the night of vaccination until 08 Jan 2021. There was no treatment information provided.  Action taken with mRNA-1273 in response to the reported events was not reported.  The event of freezing was resolved after on 08 Jan 20201. The outcome for the reported events of soreness from the injection site, injection site bruising, unable to sleep, there was a knot at injection site, injection site redness, and injection site hot to touch, was unknown at the time of this report.; Reporter'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.
My left side of my face went numb. Same side I got vaccine on  has been getting less numb; This is a spontaneous report from a contactable other health care professional (HCP) patient. A 61-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection (Lot Number: EN62D6) via unspecified route of administration at left arm (at the age of 61-year-old) on 05Mar2021 15:45 as a single dose for COVID-19 immunisation. Medical history was known allergies Peaches. Concomitant medications were not reported. The patient previously received amoxicillin; clavulanic acid (AUGMENTINE) and experienced allergies. Patient did not on any vaccination four weeks prior. Patient did not take other medications in two weeks. Patient did not diagnosed with COVID prior to vaccination and post COVID vaccination. On 05-MAR-2021 15:45 patient experienced left side of my face went numb. Same side she got vaccine on has been getting less numb. No treatment was received for the events. Outcome of the event was recovering.   No follow-up attempts are possible. No further information is expected.
large red skin react 6cm x 6cm; sl raised; hot & very sore to touch w/dark bruising; noted several days p/inject; no fever noted;