chrisvoncsefalvay/vaers-outcomes huggingface dataset:
my throat started burning; Coughing; Horrible stomach pain; Nauseous; very very tired; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 42-years-old non pregnant female patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 27Feb2021 11:45 (Age at vaccination: 42-years-old) as single dose for covid-19 immunization. Medical history included Crohns disease from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine included first dose of Covid-19 vaccine in Left arm on 06Feb2021 11:30 (Age at vaccination: 42-years-old) for covid-19 immunization. Patient did not receive any other vaccine in four weeks. Other medications in two weeks was reported as yes. Patient was not diagnosed with covid prior to vaccination. Known allergies was reported as yes. It was reported that on 27Feb2021 12:00 At the time of receiving the vaccine her throat started burning and she was coughing uncontrollably. That went away after about 10 minutes. 12 hours later she began to get very nauseous and have horrible stomach pain. she also very very tired. Since the vaccination patient was not tested for covid. Patient did not received any treatment for the events. Outcome for the events nauseous, horrible stomach pain and very very tired was reported as not resolved and for remaining events outcome was reported as resolved on 27Feb2021.  No follow up attempts are needed. Information on Lot/batch cannot be requested. No further information is expected.
Patient started with vomiting on 4/10/08, 5pm, lasting sporadically throughout the night.  No symptoms on Friday, 4/11/08.  Vomiting and diarrhea began again on 4/12/08 at 8am, first seizure at 10am. Went to emergency room at 12pm.  Released and sent home.  Second seizure at 3pm.  More vomiting at 6pm and third seizure shortly thereafter at 6:15.  Admitted to hopsital for observation overnight.  On-call pediatrician suggested it may be side effects of the rotavirus. Coincidentally, our older son started having seizures 5 days after his 6 month old shots in 2006.  I will fill out a report for him as well.  Older son, now 2 1/2, was diagnosed with Benign, Familial, Infantile Seizure disorder and treated with Phenobarbitol for 6 months.  After his initial cluster of seizures, he never had another, due to the medication and possibly outgrowing the disorder, which is thought to last 3-6 months.  4/29/08 Reviewed ER medical records of 4/12/2008. FINAL DX: seizures & viral illness Records reveal patient w/vomiting, diarrhea x 2 days & seizure x 1.  No seizure activity in ER.  Tx w/antinausea meds & sent home.  Returned to ER later on same day & admitted overnight for observation.
hard lump under the skin/ Injection site induration; This case was reported by a other health professional via call center representative and described the occurrence of injection site induration in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number E523B, expiry date 5th November 2021) for prophylaxis.   On 26th July 2019, the patient received Shingrix. On 26th July 2019, less than a day after receiving Shingrix, the patient experienced injection site induration. On an unknown date, the outcome of the injection site induration was not recovered/not resolved.   It was unknown if the reporter considered the injection site induration to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix Vaccination and had a hard lump under the skin. The reporter consented to follow up.
Pt reports she ran a temp >100 10/28/05 - 10/30/05. also reports that right arm where Pneumovax was given turned bright red and was sore to the touch. Reports on 10/31/05 that arm is feeling better and not as red.
has gotten COVID; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of COVID-19 (has gotten COVID) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    MEDICAL HISTORY (Parent): Unknown.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (has gotten COVID). At the time of the report, COVID-19 (has gotten COVID) outcome was unknown.        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.   No Concomitant and  treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: NNI - No New Information
Second time patient came by to report adverse reaction to pharmacy, but nothing was filed during first encounter, so submitting a report now as this is first, I am hearing of it...Patient reported to me on 1/24 that she experienced an adverse reaction to her shingles vaccine she received on 1/4/23. She had a large, red rash around the site of injection that appeared a day or so after administration and persisted for a week or so. She stated the rash was warm to the touch. She still has a lump under her skin around the site of injection that has not gone away yet. She did have her PCP look at it and PCP did not seem too concerned. Advised that this is a common reaction and that it may take some time to fully go away.
This case was reported by a pharmacist via call center representative and described the occurrence of shivering in a 59-year-old female patient who received SHINGRIX (batch number GG2GA, expiry date 16th April 2021) for prophylaxis. Concurrent medical conditions included diabetes. On 16th February 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a month after receiving Shingrix, the patient experienced shivering, gastrointestinal upset, injection site erythema, burning sensation, increased skin sensitivity, pain localized, tiredness, appetite lost and lymph node tenderness. On an unknown date, the outcome of the shivering, gastrointestinal upset, injection site erythema, burning sensation, increased skin sensitivity, pain localized, tiredness, appetite lost and lymph node tenderness were recovered/resolved. It was unknown if the reporter considered the shivering, gastrointestinal upset, injection site erythema, burning sensation, increased skin sensitivity, pain localized, tiredness, appetite lost and lymph node tenderness to be related to SHINGRIX. Additional deails were reported as follows: The patient received SHINGRIX vaccine on left arm. In 2019, the patient experienced shivering, upset stomach, injection site redness, burning and sensitive skin at the waist, pain at the waist, tender lymph glands under the arms, loss of appetite and tiredness after receiving SHINGRIX vaccine. The patient reported that she was seen by a physician because of these issues, but they resolved one month after receiving the vaccine.
SHIVERING; BACK ACHE; NECK PAIN; SLIGHT HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 620-126, and batch number: 620-126 expiry: UNKNOWN) .5 ml, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced shivering. On 10-MAR-2021, the subject experienced back ache. On 10-MAR-2021, the subject experienced neck pain. On 10-MAR-2021, the subject experienced slight headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shivering, back ache, slight headache, and neck pain. This report was non-serious.
A severe  headache in the first hour followed by fatigue an hour later. Muscle aches and low grade fever in the evening. The next day I has a lot  more fatigue and general muscle pain. I also developed irritable bowels and a loss of appetite. The left arm became very painful to the touch and while moving it. Low grade fever continued. The second day was much of the same but a new symptom which was concerning. Chest pain near breast and rib in the left side. The pains were shooting and intermittent. More fatigue and continued stomach issues and lack of appetite. Day 3 I felt greater fatigue and muscle pain but the arm pain bd headache were better. I took the day to rest mostly. Day 4 (today) I fully expected to feel better but I felt the same and took the day off work to rest. Low grade fever fatigue and muscle pains. Stomach issues turned to diarrhea today.  Headache returned for  a while but chest pains better.  For the record I?ve never experienced adverse reactions to any vaccine. I?m also very healthy and active running hiking and biking 20 miles a day.
Headache, Myalgia, Fever, Muscle Pain, Fatigue, Felt very "disconnected" and foggy. Narrative:
Swelling of eyes and face, throat swelling, rapid heart rate over 140 beats a minute, Blood Pressure  220/132, dizziness. Stayed in hospital emergency room for several hours.
Redness, warm to touch, low grade fever - 99.9, decrease intake and activity. Office visit on 8-8-13 noted 4" X 3" nodule, redness and warm to touch area. Prednisone was ordered during visit.
detected Ring (Tinnitus) in the evening of the Oct 10th 2nd Dose still exposed to symptoms
Staff member inadvertently administered KINRIX to child instead of PEDIARIX. Staff states they mixed the "rix" vaccine re: age group. Action-staff educated of age group for KINRIX and PEDIARIX. The KINRIX box now has age range written on box.
It was discovered after the vaccine had been administered on 10-26-23  that the vaccine had expired on 10-5-23.
Mother of patient reports 29 days after dose of vaccination (on 6/23/23) the patient developed high fever and headaches. Temperatures ranged from 102.4-103.2 F. Fevers appeared resolved by later on 6/24/23 but patient did develop cough starting 6/26/23 (32 days post vaccination).
Pt recv vax on 4/13/99; on 4/15/99 pt exp red/ swollen lt buttock
Patient presented to ED with SOB for 2 weeks. Patient was treated with IV Lasix. Cardiology suspected heart failure exacerbation and patient was discharged home. Per the EUA, hospitalizations are to be reported irrespective of attribution to the vaccine
Passed out. Low BP 83/42.Felt better after fluids. Also chills and achy flu symptoms lasting 12 hrs.  This was 2nd dose; no reaction to first other than sore arm.
Information has been received from a certified medical assistant concerning a 9 weeks old female patient with no pertinent medical history and no drug allergy or reaction who on 17-OCT-2011 was vaccinated with the first dose of ROTATEQ (Lot number not reported) orally. On 17-OCT-2011 the patient experienced vomited in the office after receiving her first dose of ROTATEQ. At the time of the report, the patient's present status was unknown. Follow-up information has been received from a physician concerning the patient who on 17-OCT-2011 3:00 PM was vaccinated with the first dose of ROTATEQ (lot # 12011Z is an invalid lot number for ROTATEQ) orally. The physician reported that there was no adverse event. The patient spit out dose on 17-OCT-2011 3:00 PM. The physician checked to see if needed to be repeated. It was reported answer was no. Emergency room or doctor visit was not required. No further information is available.
Patient received vaccine and said she had a metallic taste. Patient waited a couple of minutes to ensure she would not have sycope. Patient called after leaving pharmacy saying she has some pain in her neck and swelling. I reviewed common side effects with her and stating she might have muscle pain, she was not feeling well so she went to urgent care.
my throat started to feel constricted; hives/rash developed on the left side of my neck, and across my chest; This is a spontaneous report from a contactable consumer ((the patient, reported for self).  A 28-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot/Batch number: ER8736, Expiration date: UNKNOWN) via an unspecified route of administration, administered in Arm Left on 11May2021 17:15 (at the age of 28-year-old) as single for covid-19 immunisation.   The patient Medical history included food allergy to Peanuts, soy, shellfish, fish, sesame, legumes, coconut, nuts, stone fruit; Drug allergy to penicillin; Anaphylaxis allergic reaction from an unspecified date an unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient concomitant medications were not reported. The patient did not receive any other vaccine within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination.   On 11May2021 17:15 within two minutes of getting the shot patient stated that her throat started to feel constricted, within five minutes of getting the shot "hives/rash developed on the left side of my neck, and across my chest." She stated that throat continued to get constricted. She had a history of Anaphylaxis allergic reactions to various food, so she had felt her throat tighten due to food before, but this was different. Patient had visited Doctor or other healthcare professional office/clinic. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken because of throat continued to feel tight as she took Benadryl on the ride to the (ER) Emergency room/department or urgent care. No epi was taken before arriving at the hospital. Patient received steroids and Antihistamines at the ER. The outcome of the events were unknown.  Device Date : 12May2021  Information on Lot/Batch number was available. Additional information has been requested
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Lot number: ER8734), in left arm, on 23Apr2021 as dose 2, single (Lot number: EW0153), in left arm and on 31Oct2021 as dose 3 (booster), single (Lot number: 30155BA) at the age of 22 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: positive test Saturday. Therapeutic measures were taken as a result of vaccination failure, covid-19.
This case was reported by a consumer via call center representative and described the occurrence of shingles in a 77-year-old male patient who received SHINGRIX (batch number 3Z4KL, expiry date 6th October 2019). Co-suspect products included VALTREX tablet for shingles and post herpetic neuralgia. The patient's past medical history included post herpetic neuralgia (had 8 episodes of shingles and post herpetic neuralgia since June 2016), shingles and gastroesophageal reflux disease. Previously administered products included ZOSTAVAX (received prior to SHINGRIX). Concurrent medical conditions included multiple allergies (general allergies). Concomitant products included ACIPHEX, ALLEGRA, Aspirin (Baby) and glucosamine. On 29th December 2017, the patient received SHINGRIX (intramuscular). In June 2016, the patient started VALTREX (oral) 1 g 3 times daily (3 g daily). In June 2016, less than a month after starting VALTREX, the patient experienced abnormal dreams and upset stomach. On 29th December 2017, the patient experienced pain in arm. On 29th January 2018, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, post herpetic neuralgia and lack of drug effect. VALTREX was continued with no change. On an unknown date, the outcome of the vaccination failure and lack of drug effect. VALTREX was continued with no change. On an unknown date, the outcome of the vaccination failure and lack of drug effect were unknown and the outcome of the shingles, post herpetic neuralgia, abnormal dreams and upset stomach were recovering/resolving and the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the vaccination failure, shingles, post herpetic neuralgia and pain in arm to be related to SHINGRIX. It was unknown if the reporter considered the shingles, post herpetic neuralgia, abnormal dreams, upset stomach and lack of drug effect to be related to VALTREX. Additional details were provided as follows: The patient reported that during his shingles and post herpetic neuralgia in June 2016, the patient received VALTREX, 1 gram three times daily. After receiving VALTREX, the patient experienced stomach upsets and screwy dreams. On 29th December 2017, the patient received SHINGRIX on right arm. Less than a day after receiving vaccination, the patient experienced arm soreness. After receiving SHINGRIX, the patient experienced another episode of shingles and worsening of post herpetic neuralgia with latency of 31 days. On 17th February 2018, the patient experienced another episodes of shingles. The patient reported that his post herpetic neuralgia was worse than before with these last 2 episodes. The reported batch number of SHINGRIX 324KL did not exist and was updated to 3Z4KL, as per sales database. Upon internal review following corrections were performed on 30th March 2018: The event vaccination failure was deleted since the patient had only dose of SHINGRIX and the case was downgraded to nonserious.
Hand, foot, and leg on my right side where I got the injection is numb.; This is a spontaneous report from a contactable consumer, the patient. A 18-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 28Aug2021 at 09:00 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient did not have any known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included cannabidiol (CBD OIL), famotidine (PEPCID) and paracetamol (TYLENOL); all from unknown dates, for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 29Aug2021 at 19:00, the patient experienced hand, foot, and leg on her right side, where she got the injection, was numb. This started 36 hours after her vaccine. It was the next day, on the day of the report, and it was still persisting. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measure were taken as a result of the reported events. The clinical outcome of the event hand numb, foot numb and leg numb was not recovered at the time of report.   The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 06-OCT-2017, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 injection, lot # N013541 with expiration date: 23-JAN-2019 (dose and route of administration were not reported). The temperature excursion ranged to 31.2 degrees Fahrenheit for unknown time frame. There was no previous temperature excursion. Digital data logger was used. No adverse effects were reported. Product quality complaint was not involved. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1710USA009002.
Treatment of COVID-19.; Treatment of COVID-19.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Batch/Lot number: unknown), on 07Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 05Dec2021 as dose 3 (booster), single (Lot number: FJ1611) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "pre-diabetic" (unspecified if ongoing); "esophagectomy from esophageal cancer" (unspecified if ongoing); "esophagectomy from esophageal cancer" (unspecified if ongoing); "Known allergies: Sulfa antibiotics" (unspecified if ongoing). Concomitant medication(s) included: ELIQUIS; METOPROLOL; PANTOPRAZOLE. The following information was reported: VACCINATION FAILURE (medically significant) with onset 2022, outcome "unknown", COVID-19 (medically significant) with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: tested positive for covid. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course of the events: Covid symptoms returned and tested positive for covid 6 days after completing 5 day Paxlovid regiment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
severe chills with shuddering shakes all night 03/06, temperature 2 degrees above my normal for 1 day, severe headache for 3 days,  constipation for 3 days,
Patients receiving second dose after more than 6 weeks of getting first dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patients receiving second dose after more than 6 weeks of getting first dose) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patients receiving second dose after more than 6 weeks of getting first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patients receiving second dose after more than 6 weeks of getting first dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not applicable.