chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm at the site, a little dead arm; Sore arm at the site, a little dead arm; This is a spontaneous report received from a contactable consumer. This consumer (patient's wife) reported for a male patient (reporter's husband). A male patient of an unspecified age received first dose BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 20May2021 as, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced sore arm at the site and a little dead arm. Caller had called with questions and stated she and her husband got the vaccine, the first dose, 20May2021. States the side effects they each had was a sore arm at the site, a little dead arm Friday and Saturday felt good. Caller declined to make a report. States she didn't know that it was necessary and she didn't know where to call as her primary care physician was at a loss and can only answer questions using what she had heard from other patients. The outcome of the events was recovered on MAY-2021.  Information about Lot/Batch number has been requested.
shoulder joint pain, injection was given in joint.... I am now on prednisone, physical therapy, if this doesnt help  will need a MRI .
Mom called office to report patient has some swelling at injection site (L) leg and fever. Mom requesting report be filed.
4/2/2021 - 10:00a.m., felt weakness in legs, 10:30a.m. had problem climbing steep stairs, 12:00p.m. - legs felt heavy - landing heavily and flat footed going down steep stairs. 2.30p.m., walked to gang mail box in next block - shuffled and dragged legs in both directions , 3:00p.m. - felt extremely tired and lay down on sofa. Slept for about and hour. Awoke and felt I had to go to the bathroom - I could not feel or move my legs. Finally used my arms to swing legs over edge of sofa but could not feel or use them. I used the my arms to lift myself to standing position and lost control of bladder - not and accident - felt it totally empty at once. Feeling started to return to legs and I was able to walk to clean myself up. Slowly began to regain use of legs and to stop shuffling and dragging my feet. I was doing better by 6:00p.m. and the leg problem was almost gone the next day. No repeat of the bladder issue.
Fever, fatigue, upset stomach, sore itchy injection site, seemed to have triggered a Crohn's flare as I began to have blood in stool and extra couple days of fatigue.
This spontaneous report was received from a pharmacist directly and via agency (case # US15042779) and refers to a 13 month old male patient. The patient was normally a healthy child. No information about his pertinent medical history, past drug history, concurrent conditions, concomitant medications, drug reactions or allergies was provided. On 11-SEP-2015, the patient was inadvertently vaccinated with both: the first dose of (Oka-Merck) PROQUAD (dose, route of administration, lot#, expiration date were unknown) and a dose of (Oka/Merck) VARIVAX (also reported as "unknown vaccine containing varicella") (dose, route of administration, lot#, expiration date were unknown) during his 12-month well child visit. The patient did not have any reactions. No adverse effect was reported. It was unknown if any relevant lab work was performed and if the patient will continue on the (Oka-Merck) PROQUAD or the (Oka/Merck) VARIVAX. Additional information has been requested.
Extreme erythema covering entire abdomen. Painful, burning, and itchy. Hot to the touch. Lasting 6 days.  Treated with steroid injection and Benadryl. Treatment started January 4, 2021.
Case number PHEH2012US022254 is an initial spontaneous report received from a physician on 07 NOV 2012 with a follow up information received on 15 JAN 2014. This case refers to female pregnant patient of unspecified age. She was vaccinated with FLUVIRIN 2012/2013 (batch number: not reported) intramuscularly on 06 NOV 2012. Upon follow up information received on 15 JAN 2014, it was reported that multiple attempts were made to obtain further information and outcome of pregnancy, but without success. The case was hence considered as a lost to follow up. No further information was reported.   Follow up information received on 15 JAN 2014. Lost to follow-up information updated.
Pt.'s Mother states that after receiving the 2nd dose of Phizer 10/13/2021, started experiencing symptoms 10/14/2021 of fever, cold-sweats, loss of consciousness, and loss of vision. Came to with headache and fever, 10/14/2021 Primary visit with recommendations of Ibuprofen for fever and no Follow-Up of "Booster". Symptoms have subsided.
SORE ARM FOR THE NIGHT AFTER A COUPLE HOURS; LOW TEMPERATURE FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced sore arm for the night after a couple hours, and low temperature fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) Low temperature fever. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm for the night after a couple hours and low temperature fever was not reported. This report was non-serious.
Client presented to Public Health Center on 12/10/2021 requesting a Covid 19 booster. Client received dose one of Pfizer on 04/16/2021 and reported no adverse reactions. Client notes 4 days after receiving her second dose Pfizer on 05/07/2021 in left arm, she developed a rash on her left chest. Client also admits she had "puffiness on her upper lip" the day after developing the rash. Client reports she took one dose of Zyrtec and symptoms cleared soon after. Client is requesting a Moderna booster today. Vaccinator consulted with Lead RN. Medical consult placed. Client approved by medical team for Moderna booster. Client educated on signs and symptoms of anaphylaxis and when to seek medical attention. Client verbalized understanding . Client monitored for 15 minutes following vaccination. No adverse reactions noted. Client walked out with a steady gait.
LEFT ARM HURTS WHEN LIFTING AT CERTAIN ANGLE.  HURTS AT INJECTION SITE ALONG AND UPWARDS TOWARDS THE SHOULDER JOINT.
severe nausea, severe headache, disturbed sleep, general malaise ongoing 4+ days
Evening of immunizations administration baby developed a seizure lasting 14 mins. Seen in ER, transferred to medical center. 7/14/06 Received medical records from 2nd hospital which reveal patient was transferred in on 6/20/06 to PICU for seizure activity lasting approx 15-20 min. Afebrile in PICU but had temp in transferring ER.  Septic w/u done.  Blood c/s in ER reported as +.  Final dx: seizure s/p immunizations/ss  7/24/06 Received medical records from 1st hospital which reveal patient seen initially in ER on 6/19 w/fever & seizure.  Continued seizing in ER w/right side only involvement.  Returned to ER on 6/26/06 due to continued seizure.  COnsulted with 2nd hospital & additional meds were given.  Pt to f/u with neuro/ss
had the shingle shot / just moved them to a different location on my body/suspected vaccination failure; had the shingle shot / just moved them to a different location on my body; This case was reported by a consumer via interactive digital media and described the occurrence of  suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient. The age at vaccination was not reported. The age group was not reported but captured as adult as per vaccine indication. The reported stated that he or she had the shingle shot and it just moved shingles to a different location on body. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. No further information would be available.
This 32 year old  black female received the Covid shot on  4/8/21    and went to the ED on  4/18/21 with the following diagnoses listed below. Hemorrhage in early pregnancy, unspecified VAGINAL BLEEDING - PREGNANT
This morning she went to the toilet (went 2) and saw blood in the toilet bowl. She states it was bright red. She is bleeding rectally.; This spontaneous case was reported by a patient and describes the occurrence of RECTAL HAEMORRHAGE (This morning she went to the toilet (went 2) and saw blood in the toilet bowl. She states it was bright red. She is bleeding rectally.) in a 92-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE for an unknown indication.    Patient had no allergies, COVID-19 diagnosis provided as none.  Concurrent medical conditions included Difficulty in walking (She has a problem walking), Walking aid user (She uses a cane) and Blood pressure high. Concomitant products included VALSARTAN for Blood pressure high.   On 12-Nov-2023, the patient received second dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On 13-Nov-2023, the patient experienced RECTAL HAEMORRHAGE (This morning she went to the toilet (went 2) and saw blood in the toilet bowl. She states it was bright red. She is bleeding rectally.) (seriousness criterion medically significant). At the time of the report, RECTAL HAEMORRHAGE (This morning she went to the toilet (went 2) and saw blood in the toilet bowl. She states it was bright red. She is bleeding rectally.) outcome was unknown.            Reported that this was her second Moderna COVID-19 vaccination. She did not have a reaction to the first one. On 12-Nov-2023 she received SPIKEVAX. In the morning of 13-Nov-2023 she went to the toilet (went 2) and saw blood in the toilet bowl. She states it was bright red. She was bleeding rectally. This happened a half an hour ago of the reporting so she has not gone to the toilet again since to see if it was still happening. She did not go to the doctor right away because she doesn't have a car or anyone around her to take her. They give her an influenza vaccine at the same time in her other arm. She has no history of rectal bleeding.  No treatment medications were reported.  Company Comment: This is a Spontaneous case reported by a patient, concerning a 92-year-old female patient, with no relevant medical history, who experienced the unexpected and serious (due to medically significant) event of Rectal haemorrhage, which occurred 1 day after SPIKEVAX 2023-2024, administered as second dose within COVID-19 vaccination schedule. Co-suspect product included Influenza vaccine. As reported, the patient went to the toilet and saw blood in the toilet bowl. She stated it was bright red. She was bleeding rectally. She did not go to the doctor right away because she didn´t have a car or anyone around her to take her. The benefit-risk relationship of SPIKEVAX 2023-2024 vaccine is not affected by this report.   This case was linked to MOD-2021-067305, MOD-2022-551335.
Received Bexsero at 2 months; This case was reported by a consumer via interactive digital media and described the occurrence of inappropriate age at vaccine administration in a 2-month-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 03 DEC 2022 Reporter's comment: This case was reported by the patient's parent via interactive digital media. The reporter stated that patient received 1st dose of Bexsero vaccine at the age of 2 months. Additional supportive information: The patient received Bexsero at the age of 2 months which led to inappropriate age at vaccination.
Shortness of breath, tingly, itchy lips, itchy mouth, tachycardia, headache onset approximately two minutes after injection. 50 mg Benadryl p.o administered within 15 min of onset stopped all but the tingly lips approximately 2 hours after administration.
No other AE and no PQC; Administration to a 14 Year Old Patient; This spontaneous report was received from a pharmacist and referred to a 14-year-old patient of unknown gender. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 17-OCT-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant Human albumin (rHA) (PROQUAD) injection, lot #X012610, expiration date: 29-OCT-2024, administered for prophylaxis (strength, anatomical site of administration and route of administration were not provided) administered by a Health Professional (product administered to patient of inappropriate age). No other adverse event (AE).
weight loss; head hurting; stiffness; sick for two days"; sick for two days"; loss of appetite; Swelling; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick for two days"), INFLUENZA (sick for two days"), DECREASED APPETITE (loss of appetite), SWELLING (Swelling) and MUSCULOSKELETAL STIFFNESS (stiffness) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016C21A and 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Narcolepsy. Concomitant products included ALLOPURINOL and AMITRIPTYLINE for an unknown indication.   On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2021, the patient experienced ILLNESS (sick for two days"), INFLUENZA (sick for two days"), DECREASED APPETITE (loss of appetite) and SWELLING (Swelling). On 28-Apr-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiffness) and HEADACHE (head hurting). On an unknown date, the patient experienced WEIGHT DECREASED (weight loss). On 27-Apr-2021, ILLNESS (sick for two days"), INFLUENZA (sick for two days") and DECREASED APPETITE (loss of appetite) had resolved. At the time of the report, SWELLING (Swelling), MUSCULOSKELETAL STIFFNESS (stiffness), WEIGHT DECREASED (weight loss) and HEADACHE (head hurting) outcome was unknown. Not Provided          Treatment History Includes Anti Inflammatory ,Benadryl IV  and Toradol.
Boostrix allergic reaction; This case was reported by a pharmacist via call center representative and described the occurrence of allergic reaction in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix at an unknown dose. On an unknown date, unknown after receiving Boostrix, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Boostrix.  Additional details were reported as follows: The pharmacist reported that the patient had an allergic reaction to a previous tetanus vaccine from an unknown manufacturer. The pharmacist had no information on the vaccine or the patient at the time of reporting. At the time of this report, it was unknown if the suspect vaccine was Boostrix or not.
Large 6x6 cm erythematous Welt: Where + of left thigh @ site of PROQUAD vaccine - warm + swollen to touch - Continued Mon on 4th day after vaccine.
Deceased unexpectedly. From day of second dose 3/18/21, patient reported feeling tired ( no fever, no shortness of breath) but was able to walk 3 flights of stairs on 4/11/21 and felt slightly better. Went to church that Sunday 4/11. Was not seen after that, then found deceased at home 4/14/21 with blood in mouth, no other signs such as lacerations or incontinence or other vomitus.
2AUG93 mom called clinic stated pt had fever 104, fussy, irritable; MD told mom poss meningitis; vomiting, loose stools, pharyngitis, mottled skin, P160, BP 105/79, WBC 20,000;
received the first dose /on 3/26/2018/ administered the second  / on 3/30/2021; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 299BM, expiry date 22nd October 2022) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 26th March 2018).   On 30th March 2021, the patient received the 2nd dose of Shingrix. On 30th March 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were reported as follows: The pharmacy intern reported that a patient received the 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule. The reporter did not consent to follow-up.
Varicella vaccine breakthrough. Diagnosed in our office with Varicella on 12-8-06. Had 100 to 150 pox. No fever.
shortly after receiving covid vaccine, pt complained of light headedness and was blacking out.  she felt weak and said she was going to pass out. pt sat for  a few minutes and had some water and a snack and felt better.
SIDE EFFECTS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced side effects. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effects was not reported. This report was non-serious.
5-10 minutes after vaccination, pt had swelling/rash on feet, ankles. Breathing/pulse NL. Pt left, denied ambulance and I followed her with 4 hours after. Swelling had reduced. No other apparent symptoms.
slightly sore arm; pain in neck; pain in arms; pain in hips; feeling fatigue; right arm all of her joints began aching; getting less sleep; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (getting less sleep), LIMB DISCOMFORT (slightly sore arm), NECK PAIN (pain in neck), PAIN IN EXTREMITY (pain in arms) and PAIN (pain in hips) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP), CYANOCOBALAMIN, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE (VITAMIN B 1-6-12) and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, the patient experienced INSOMNIA (getting less sleep) and ARTHRALGIA (right arm all of her joints began aching). On an unknown date, the patient experienced LIMB DISCOMFORT (slightly sore arm), NECK PAIN (pain in neck), PAIN IN EXTREMITY (pain in arms), PAIN (pain in hips) and FATIGUE (feeling fatigue). The patient was treated with IBUPROFEN (ADVIL RELIVA) for Joint ache, at an unspecified dose and frequency. At the time of the report, INSOMNIA (getting less sleep), LIMB DISCOMFORT (slightly sore arm), NECK PAIN (pain in neck), PAIN IN EXTREMITY (pain in arms), PAIN (pain in hips), FATIGUE (feeling fatigue) and ARTHRALGIA (right arm all of her joints began aching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-104631 (Patient Link).   Reporter did not allow further contact
PATIENT RECEIVED EXPIRED FLUAD 2021-2022; NO ADVERSE EVENT REPORTED.
like a stroke/The whole left side of her body was not working; Blurred vision/couldn't open her left eye; Couldn't walk straight/left side of body went limp; second dose PREVNAR 13; This is a spontaneous report from a contactable consumer.  A 68-year-old female patient received second dose pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13)  on 25Sep2019 at 10:45 at single dose in left arm for pneumonia bacterial immunisation.  Medical history included Hypertension, Blood cholesterol increased, asthma, low thyroid, nasal congestion, post-traumatic stress disorder (PTSD), allergies, acid reflux, Joint disorder.  Concomitant medication included losartan for Blood pressure high, levothyroxine sodium from 2002 for low thyroid, simvastatin from 2004, mometasone furoate (FLONASE) from 2013 to help nasal congestion, lamotrigine from 2007, trazodone from 2007 for PTSD, gabapentin (NEURONTIN) from 2013 for PTSD, diazepam for PTSD, montelukast sodium (SINGULAIR) for allergies, unspecified multivitamin ,calcium citrate (CITRACAL slow release) , Ranitidine  for acid reflux, chondroitin sulfate, glucosamine (MOVE FREE) for joints, bacillus coagulans (DIGESTIVE ADVANTAGE), tiotropium bromide (SPIRIVA) for Asthma, an unspecified drug from Mega Red and an unknown drug from Wixela for Asthma. Patient previously took first dose of pneumococcal 13-val conj vaccine in left arm for immunization. The patient got pneumococcal 13-val conj vaccine on 25Sep2019 and she ended up within 15-20 minutes,  and at 11:30 she had what looked like a stroke. The whole left side of her body was not working; left side of body went limp, blurred vision, she couldn't walk straight and couldn't open her left eye. She was getting it back slowly but still having difficulties. She has had all kinds of vaccines with no reaction. Due to this she was hospitalized in ICU from 25Sep2019 to 28Sep2019. Patient was recovering from what looked like a stroke, outcome of the other events was unknown.Information on lot has been requested.