chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 46 year old white male patient with no known allergies and vitiligo, and a history of herpes genitalis and hypercholesterolaemia, who on 10/9/03 and 12/5/03 was vaccinated SC in the arm with a first and second dose of varicella virus vaccine live (lot # 643597/0895M). It was noted that the patient was not ill at the time of vaccination. On 8/23/04 the patient developed herpes zoster, and medical attention was sought. The physician reported she performed a clinical diagnosis of herpes zoster but no specimen was taken. The physician reported that the patient's rash was on the left side of frontal scalp that included the left eye, and headache. THe patient was treated with famcyclovir 500mg twice daily and acetaminophen (+) hydrocodone bitartrate and he was referred to an ophthamologist. The patient is recovering, but still experiencing opthalmic symptoms and headache. It was noted the physician requested information on the varicella zoster identification program. Follow up information has been received from the physician who reported that the patient was diagnosed with Ramsay-Hunt syndrome and his symptoms included left facial pain and blistering on the tip of his nose and anterior forehead. It was noted that the patient was seen by the ophthalmologist and he was found to be positive for left eye corneal ulceration. The patient recovered on an unspecified date. Ramsay-Hunt syndrome and left eye corneal ulceration were considered to be other important medical events (OMIC). No additional information is expected.
This spontaneous report as received from a nurse refers to a 19 months 28 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) liquid PEDVAXHIB (injection, lot # K016965, exp date: 20-JUL-201)(dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Pt recvd 2 doses of Engerix-B 10MAY91 & 13JUN91 & 11NOV91 immed p/inject pt exp burning while inject was being given which cont for a few hrs; Reporter indicated that 3 doses of Engerix-B was given 12NOV91 (11NOV91);
Approximately 6 hours after receiving vaccine patient felt chills & shaking from the chills about midnight. This lasted about one hour. Then patient felt she had a fever so she took 2 TYLENOL and went to sleep. She told me she felt ok in the morning except for having a headache.
have a really bad headache; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received the first dose BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, Batch/lot number: EL1284), via an unspecified route of administration on 21Dec2020 at single dose for covid-19 immunization. Medical history included GERD (Gastrooesophageal reflux disease), obsessive-compulsive disorder. Concomitant medication included omeprazole at 40 mg for GERD, fluoxetine at 40 mg for obsessive-compulsive disorder. The patient had a really bad headache in Dec2020. The reporter stated she was a 22 years old pharmacy intern working in a hospital. She received the covid vaccine yesterday (21Dec2020) and she had a really bad headache. The patient further described this as a 'very, very bad headache.' The patient didn't receive treatment for headache. She was wondering if she could take Tylenol for headache. The outcome was unknown.
INCREASED REDNESS, WARMTH, TENDERNESS DESPITE COOL COMPRESSES. BENADRYL AND KEFLEX TIMES 2 DOSES.
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 12-OCT-2012 12:54, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Mother reported that left arm swollen from shoulder to elbow, red and hot to touch.  Taken to see his PCP 3-28-12.
My arm is really red and itchy, little pain and it was really painful but it has went down a lot.
Pt received vaccine on 4/5/15. Returned to pharmacy 4/19/15 stating her had rash on hands and skin; which began 4/16/15. Unclear as to if this was caused by vacccine since it was given 2 weeks earlier. Instructed pt to take BENADRYL and follow up w/MD.
Headache, Myalgia, NauseaVomiting, chills, tiredness, soreness at injection site Narrative:  Other Relevant History:
I developed a fever of 100.5 about 18 hours after receiving the Moderna vaccine. The fever lasted about 5 or 6 hours and body aches continued most of the day.
I had them/ got shingles on left side; awful painful; tingling; felt like committing Harry Carry; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles, pain, tingling and feeling abnormal. The patient was treated with lidocaine (Lidocaine Patch). On an unknown date, the outcome of the shingles, pain and feeling abnormal were recovering/resolving and the outcome of the tingling was not recovered/not resolved.   It was unknown if the reporter considered the shingles, pain, tingling and feeling abnormal to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 16-AUG-2022 Reporter's Comment: This case was reported by the patient via interactive digital media. The patient received a dose of Shingles vaccine and had worst, it was awhile, and the patient did not had the second one when the patient got shingles on left side it was awful painful felt like committing harry carry went to emergency room several times. In last emergency room visit patient's doctor put a lidocaine patch on patient's side and some went. The patient finally got better but still had some tingling for a while. The patient finally got the shots and stated so he/she did not get again they cost because most insurances did not pay so he/she paid for both around 200 dollar each but it was worth it if he/she never get again. Additional Supportive Information: The follow-up would not possible as no contact details were available.
bottom of my feet to my legs all my body got heat like a type of neuropathy heat; It's like inside the body is wounded and it gets hot (when you press on it/got hot/It's getting hot and a little dots/got hot and last night got hot all over my whole body.; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (bottom of my feet to my legs all my body got heat like a type of neuropathy heat) and MILIARIA (It's like inside the body is wounded and it gets hot (when you press on it/got hot/It's getting hot and a little dots/got hot and last night got hot all over my whole body.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048C21A, 024M20A and 032L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced FEELING HOT (bottom of my feet to my legs all my body got heat like a type of neuropathy heat) and MILIARIA (It's like inside the body is wounded and it gets hot (when you press on it/got hot/It's getting hot and a little dots/got hot and last night got hot all over my whole body.). At the time of the report, FEELING HOT (bottom of my feet to my legs all my body got heat like a type of neuropathy heat) and MILIARIA (It's like inside the body is wounded and it gets hot (when you press on it/got hot/It's getting hot and a little dots/got hot and last night got hot all over my whole body.) had not resolved.     No concomitant medications were provided. Patient had been sitting with ice under feet and under butt. Then I waited another week. It was getting hot and a little dot. On 03-Jan-2022 caller states he went to doctor again and he gave patient injection to calm it down and then doctor prescribed him steroids pills. First day patient took 6, second day patient took 5. Today was the second day patient was taking the pills. Once patient got the got injection on Monday, two- or three-hours patient body cooled down. Monday night for the first-time patient slept well. He got hot and had to put ice. The patient was healthy, was eating good and was physical. After physical (in November before vaccine) doctor said patient's (antibodies) was low so he should get the booster.
Slight redness x 2 days after vaccination, then fully resolved.  Today on 1/22/21 (8 days after vaccination) I have a reddened, raised area around the site of the shot.  Not painful.  I just noticed this today so it has not yet resolved.
Rash, urticaria on the left thigh spread to whole body, improved. Residual rash urticaria on previous knee and left thigh
Dizzy spells, nausea and lose bowels spells, diarrhea.
This spontaneous report as received from a healthcare worker refers to a 15 year old patient of unknown gender. No information on patient's concurrent conditions and medical history was provided. On 17-JAN-2001, the patient was vaccinated with dose of (Oka/Merck) VARIVAX (dose, route, lot # and expiration date were not reported). ON about 13-JUL-2015, the patient broke out in a rash on an  unspecified area of the body. On 15-JUL-2015, blood titer was drawn which revealed an immunoglobulin G (IgG) level of greater than 4000 (units not provided) and an immunoglobulin M (IgM) level of less than 0.91 (units not provided). The outcome of events was reported as not recovered/not resolved. The relatedness between the events and the vaccination with (Oka/Merck) VARIVAX was not provided. Additional information is not expected as there is no consent to contact the physician.
Booster; sinus drainage; had not felt well; feeling tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program.  A 46 year-old female patient received bnt162b2 (COMIRNATY), administration date 30Nov2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Psoriatic arthritis" (ongoing), notes: current medical condition. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN, Dose number UNKNOWN, Lot number UNKNOWN), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 30Nov2021, outcome "unknown", described as "Booster"; SINUS DISORDER (non-serious) with onset 2021, outcome "not recovered", described as "sinus drainage"; MALAISE (non-serious) with onset 2021, outcome "unknown", described as "had not felt well"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "feeling tired". Therapeutic measures were taken as a result of sinus disorder.  Additional information: She stated that she also got the COVID Booster shot on 0Nov2021and had not felt well after that for several days, feeling tired and had sinus drainage. 2 days after her first Enbrel shot, her sinus symptoms worsened, to the point that she went to her PCP and was put on antibiotics.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a healthcare worker refers to 3 unspecified patients of unknown demographics. No medical history was reported. The reporter stated that 3 unspecified patients were administered ROTATEQ and RECOMBIVAX (dose, route and frequency unspecified) that were stored improperly. No concomitant medications were reported. Nurse was then placed on the line answer additional questions regarding event. No adverse effects were reported. No further information was provided. Additional information has been requested.
Information has been received from a 54 year old female consumer with  no past medical history and no allergies, who on 8/19/02 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Concomitant therapy included Zestril, alendronate sodium 70mg once a week and "Diertic." Subsequently, the pt developed a rash on her arm and at the injection site that persisted for a couple of weeks. On 9/30/02 the pt reported that the rash was now a bruise. The pt's blood work indicated an ALT of 199, which is "not supposed to be higher than 50." Additional info has been requested.
Swollen face, tongue, and throat. Took Benadryl.  Injection site became extremely sore- went away the next day.
Red, raised rash noted to right arm, hands bilaterally, and neck area. Swelling noted to bilateral hands 6 days post injection. Patient given Decadron for symptom relief per PCP.
The Patient got pale, sweating and confused + dilated pupils. Pulse felt weak. Epinephrine (1:1000) 0.3cc given SO and 911 called. Afterward, he was transferred to ER.
Tested positive for COVID using self-test kit on 2/18/2023. Symptoms were flu-like. Achy with very sore throat. Temperature slightly elevated but no fever. Contacted PCP (details above) and was prescribed Paxlovid Starting on day 2 of symptoms.  Self-isolated alone at home for 10 days. Symptoms lessened day by day. Tested negative 2/28/2023.
build up of sinus pressure, ear pain, headache in both ears starting around 23-Sep-2021. switched taking sudafed and Dayquil and zyrtec to manage symptoms. Symptoms were not resolving . Went to urgent care doctor on 11-Oct-2021 to be treated with antibiotics and steroids for sinus infection and fluid buildup behind ear. After completion of antibiotics and steroids, infection resolved, however headache and ear pain was not resolved. Went to ENT on 19-Oct-2021  to have a sinus scope which showed clear of sinus infection. However, sinus pressure, ear pain and headache still persist.
Patient fainted/passed out in the waiting area after receiving the Pfizer COVID vaccine. The patient was ok after he woke up and the paramedics were called to assess the patient. The patient was fine and was allowed to go home after being assessed.
Cellulitis of upper limb, rash - lt arm deltoid - 4.5 cm x 7.5 cm in diameter, irregular borders. Tx: Cefdinir 250 mg/5ml oral susp. Take 8 ml qd PO with meals x 10 days.
Patient received Pfizer, bivalent yesterday. Bivalent boosters are only approved for people 12+.
Patient experienced facial numness/tingling, chest tightness,  possible throat swelling, and shortness of breath about 10 minutes after administering Moderna Covid vaccine dose 1.  Instructed patient to stay in consultation room for observation.  I stayed with the patient and called 911.  EMS arrived on scene about 5-10 minutes later.   Took vitals, oxygen saturation within normal limits, elevated bp, normal heart rate.  EMS monitored patient for about 15 minutes after which patient was still conscious and alert.  EMS advised patient to go to hospital for further evaluation and patient accepted.  EMS took patient to hospital.   Patient generally seemed fine when he left the pharmacy which was about 30 minutes after receiving the vaccine.
8 days after the shot, my left arm, at the site of the shot, started to itch and swell and turned red in about a 3? circle.  It was hot and swollen.  It is now 36 hrs later and it has started to subside.
NO ADVERSE SIDE EFFECTS. DOCUMENTING THAT 0.3ML OF UNDILUTED PEDATRIC PFIZER COVID 19 VACCINE (5-<12 YEARS OF AGE) ADMINISTERED TO PATIENT IN ERROR.
Information has been received from a nurse practitioner (NP) concerning a 2 month old patient with no medical history or allergies who on 05-SEP-2008 was vaccinated PO with the first dose of ROTATEQ. Concomitant therapy included vitamin D (unspecified). The NP reported that on 26-SEP-2008 (24 hours after vaccination), the patient developed greenish foul smelling stools. The patient also exhibited a decreased appetite and sleepiness. The patient's mother called the office for medical attention. There were no lab diagnostic studies performed and the course of treatment was not reported. The outcome was reported not recovered / not resolved. A product quality complaint was not involved. Additional information has been requested.
Dose received in parts 0.05ml and then 0.45 ml; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of OFF LABEL USE (Dose received in parts 0.05ml and then 0.45 ml) in a 61-year-old patient of an unknown gender who received mRNA-1273 (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (unknown route) .45 ml. On 29-Apr-2021, the patient experienced OFF LABEL USE (Dose received in parts 0.05ml and then 0.45 ml). At the time of the report, OFF LABEL USE (Dose received in parts 0.05ml and then 0.45 ml) outcome was unknown.        The action taken with mRNA-1273 (Unknown) was unknown.   For mRNA-1273 (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment information was provided.
mom reports through interpreter that pt had high fever (degree unk) & screaming for 2 days following vax;gave APAP for fever; MD not consulted;
( I am a physician )First 24-36 hours noted minimal site discomfort. On 1/1/21 @ 6 PM with dinner noted some difficulty chewing food and minor sensation on right lower lip. As evening progressed it was noticeable a small right facial droop and distorted smile. By 1/2/21 5 AM, facial droop was more noticeable as well as distorted smile. So I decided to to ED to be checked out.ED MD was contemplating between unusual presentation of Bell's Palsy, small stroke or COVID 19 presentation. Vitals except for slightly elevated BP (145/85) were NLas well as lab ( see below). PEx: tender area posterior to R Jaw. So left with Right madibular trigeminal inflammation ( limited Bell's Palsy) and consideration for steroids. I opted NO steroids since I wanted to COVID vaccine response. Since it was a holiday weekend, I finally got to talk to my PCP on 1/4/21 ( Dr, from Internal Medicine at Hospital) who agree with me n no steroids. Also no vaccine until we see course and newer recommendations over next few weeks from CDC. I am being monitored with CDC text messaging but have not received a call from them yet. since 1/1/2021 there has been improvement in that there tenderness behind the right jaw is gone. There are no new symptoms but he weakness of right lower lip and eating issues persists. When a move water around in my mouth with closed lips , it tends to leak on right side. I am hoping for full recovery but time will tell. Summary of ED physician assessment from 1/2/21 Medical Decision Making  Patient seen by me on:  1/2/2021 Assessment:  72 year old male presenting with right sided facial weakness. No paralysis on exam but mildly notably weaker on R side. Otherwise, neurologically intact on exam. Differential diagnosis:  Bell's Palsy, Incomplete Bell's Palsy, CNS lesion, vaccine adverse effect, lymphadenopathy Considered CVA, not a TPA candidate based on timing and minor deficits. May need to obtain MRI to evaluate. Plan:  EKG, basic labs Discussed with patient, who is a physician, given risk factors and not classic Bell's Palsy, will proceed with MRI brain. ED Course and Disposition:  MRI unremarkable. I feel this adequately rules out stroke and CNS lesion as a cause of facial weakness. CBC, CMP unremarkable. Patient's exam remains stable. We discussed risks/benefits of steroids. Concerns being his diabetes as well as blunting immune response to vaccine. He has mild facial asymmetry but not complete and will hold off on steroids unless worsening symptoms. COVID testing sent as discussed with patient. He will return to ED or see PCP if symptoms worsen.  Dx- Bell's Palsy  01/02/21 1231
Information has been received from manufacturer (report number HQ4742722OCT2002) concerning a pt who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Subsequently the pt developed a pulmonary embolism. The outcome of the event was unknown. Pulmonary embolism was considered to be an other important medical event (OMIC). This was originally reported by a pharmacist. Additional info has been requested. Follow-up from a pharmacist concerning a 65 year old male with  no allergies and a history of COPD, acute renal insufficiency, and diabetes who on 10/2/02 while preparing for discharge from the hospital was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. The pt had been hospitalized on 9/30/02 with a diagnosis of pneumonia. Concomitant medications included levaquin, Zocor, prednisone, insulin and a nebulizer. On 10/2/02, the pt was dressed and ready to be discharged from the hospital when he was administered a dose of the pneumococcal vaccine 23 polyvalent and 10 minute later, the pt had a respiratory arrest, coded and died. It was reported that the preliminary autopsy report stated tha tthe pt did not have an enaphylactic reaction and the report did state that the pt had blood in his lungs. The reporter stated that "they do not known why the pt died and they do not know if it was related to the pneumococcal vaccine 23 polyvalent or not." Additional info has beenr requested.
Symptom onset was 04/19/2022, cough, SOB, runny nose, congestion and fatigue. Case was admitted to hospital 05/02/2022 with pneumonia and tested positive for COVID-19.
severe platelet problem after receiving the vaccine; This is a spontaneous report from a contactable consumer. A patient (doctor) of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced a severe platelet problem after receiving the vaccine. The reporter was looking for information on patients with autoimmune diseases (specifically scleroderma and thrombocytopenia) who received the vaccine. The outcome of the event severe platelet problem was unknown.   Information about Lot/Batch number is requested.
pt recv vax 29AUG95 & on 28JUN97 pt devel chickenpox that consisted of vesicles on face, trunk & palms & a sore throat;pt was found to be strep negative & IgG & IgM antibody levels were 5.27;
Expired vaccine is administered due to minunderstading when  establishing the expiration date in the database report
PATIENT PRESENTD HIS VACCINE CARD FROM HIS HOME COUNTRY WITH 2 DOSES ADMINISTERED ALREADY. LAST DOSE DATE  ON 3/28/2022. THIS DATE WAS OVERLOOKED BY VACCINATING NURSE AND A COVID VACCINE WAS ADMINISTERED ANYWAYS.  MAKING THE DOSE ON 4/05/2022 AN EARLY DOSE.  PATIENT RECEIVED 3 DOSES IN A 4 MONTHS TIME FRAME.
3rd pregnancy, due 10/14 - no previous complications or health problems relating to pregnancy or vaccinations.
Administered Moderna vaccine incidentally to a 16 y/o. 16 y/o did well with vaccination, without any adverse event