chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a licensed vocational nurse refers to multiple unspecified patients. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients received improperly stored PROQUAD (Merck) (lot # L041629, expiry date 22-APR-2017 and lot # reported as L050908, expiry date 14-JUN-2017) (dose, route and site of administration were not reported). No adverse effects were reported. Temperature excursion was noted as 11 Fahrenheit for 40 minutes. Also, previous temperature excursion was reported as multiple defrost cycles. This is one of two reports received from the same reporter. Additional information has been requested.
5x3 cm vertical area, warm raised mildly tender induration over (L) deltoid. treatment: Ibuprofen prn
Dizziness, lightheadedness, nausea, headaches, & chills.
wheezing and "throat fullness" has many allergies took her albuterol(2 puffs) and 50 mg Benadryl declines epi-pen and ER transport tongue and lips are WNL, lungs clear upper airway wheezing improved
Patient c/o headaches, dizziness,nausea,back and joint pain.  After 30 minutes patient began feeling a little better.  Likely related to anxiety cleared to go home but advise to monitor for further symtoms.  BG: 162 Pulse: 75  BP: 130/85
itching problems; This case was reported by a consumer via other manufacturer and described the occurrence of pruritus in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included depression, anxiety, migraine and hyperacidity. Concomitant products included famotidine, vortioxetine hydrobromide (Trintellix), topiramate and alprazolam (Alprazolam Er).   In August 2018, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix and an unknown time after starting famotidine, the patient experienced pruritus. On an unknown date, the outcome of the pruritus was unknown.   It was unknown if the reporter considered the pruritus to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. On an unknown date, after receiving Shingrix shot, the patient had a landslide of health problems and the itching started then. The patient had an extreme reaction to Shingrix and had these itching problems. The reporter consented to follow up.
Moderna Booster Shot: 11/19/21, next morning arm felt warm, bruising, hole in arm bleeding, spoke to pharmacist and was told to go to PCP if bruising, bruising starting going away after a day. Patient is still healing from AE
Indurated red area approximately 7.5 cm in diameter, "sore" hurts with arm movement. Instr. Benadryl plus cool compress
This spontaneous report has been received from a pharmacist referring to an unspecified patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not reported. On an unknown date, the patient was vaccinated with GARDASIL (dose, route, lot number and expiration date were not reported) for prophylaxis. On an unspecific date in 2016 (reported as within the last year), the patient developed encephalopathy. The outcome of encephalopathy was unknown. The pharmacist reported that a vaccine adverse event reporting system (VAERS) report was already filed regarding this event but no further information was provided. Upon internal review, encephalopathy was determined to be medically significant
moderate to severed pain upon moving arm, redness radiating approximately 6-10 inches from injection site, patient recovered fully within 48 hours
beginning the day p/vax pt had swelling & redness @ the inj site;no itching;later recalled having a rxn to td 10 years earlier;T98.5;lt deltoid 38.7cm, rt deltoid 34cm, 19cm diameter redness;
Moderna Covid 19 vaccine EUA. Developed a rash on the date mentioned. Now, two days later, the rash has increased in size and is hot to the touch. Nothing significant about the rash, it's just red.
Severe headache, fever for 24 hours.  Severe muscle weakness for 3 days. Severe fatigue extreme tiredness sleeping more than 16 hours a day for 5 days Confusion for 5 days.
mom discovered hives on pt 5AM-some up to size of fifty cent piece; generalized; took pt to ER; t101; given APAP;
Malaise, sore muscles, swollen lymph nodes (supraclavicular- one became rather large that night.  Swelling down but 2 remain swollen 3 days later.), chills.  Lasted over 24 hours following vaccination.  Had to leave work early the next day.  48 hours later much improved except lymph nodes.
pt had gotten moderna as a the first dose in april 14 2021, pt did not tell us and asked for a Janssen vaccine on 5/22/2021 and was given this as well
Had the first seizure I've ever had. No history of seizures and no family history of seizures.
Covid arm  Hard, swollen knots at injection site and below.  Red rash Itch  Pain  Warm to touch
Gave 59 yoa pt FLUAD which is indicated for 65yoa and older. pt is fine and has no adverse reactions at all.
tested positive for covid; tested positive for covid; X-rays on his chest was bad, almost pneumonia; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age (age: 52; unit: unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 15Mar2021 (Batch/Lot number was not reported) as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received the Pfizer Covid vaccine on 15Mar2021. He went to the emergency room today (unspecified date/Mar2021) and tested positive for Covid. The X-rays on his chest was bad, almost pneumonia. No treatment was given but he was sent home with an oxygen and pulse meter. The patient's 2nd dose was scheduled on 05Apr2021. The reporter wanted to know whether the patient should get a second Covid test before receiving his 2nd dose of the Covid vaccine. The outcome of events was unknown.  Information about the lot/batch number has been requested.
The pt complained of redness, swelling (about 3 inches surrounding injection site) pain to left upper thigh.
Pt presented with abdominal pain and was found to have a hernia that contained a portion of the small bowel loop.  Pre-op COVID test was positive.
Restricted mobility in my leg; My knees weren't bending fully; I feel a visible pain in my ankle and my finger; I feel a visible pain in my ankle and my finger; I have visible swelling in my chin and my ankle and possibly my thighs; I have visible swelling in my chin and my ankle and possibly my thighs; This is a spontaneous report received from a contactable consumer (patient). A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 16Jun2021 as 2nd dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (Lot: unknown) on unknown date via an unspecified route of administration for COVID-19 immunisation. On 16Jun2021, patient got the second vaccine at about 04:30 eastern about 9 or 10 hours ago and after 6 hours after getting the vaccine or 5 hours (as reported) after the vaccine the second shot, felt a little bit restricted mobility in leg and knees weren't bending fully and right now 12 hours after the second dose and felt a visible pain in ankle and finger it did not hurt but had visible swelling in chin and ankle and possibly thighs. The outcome of the events was reported as unknown.   Information about lot/batch number has been requested.
About two weeks after the moderna booster shot (3rd shot) I started breaking out in hives on my thighs, feeling pressure on my esophagus and also having a weird feeling in my bowel movements.  Initially thought I had a food allergy but after 3 days of no relief with OTC meds, I decided to look up possible names for what I was experiencing. I came across a medical board discussion where various people like me had similar issue after their booster shots. I verified I had developed dermatographia due to the nature of my rash and hive pattern. I decided  to visit a neighborhood health center due to having no insurance because I was laid off from my job the 15th of December and thus lost my insurance in the process.  It was my first time visiting this place where they ran very minimal testing. The MD I saw, faith in my prior research and prescribed me with prednisone and cetirizine. Today is my first day on the medication.
Strong beating heart, irregular heartbeat; Palpitations and lightheadedness.; Palpitations and lightheadedness.; Body chills; Throbbing headache; Fatigue; Borderline left atrial enlargement; This is a spontaneous report from a contactable consumer.A 33-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on 10Jun2021 at 12:15 (33 years age at the vaccination) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The other medications patient received within 2 weeks of vaccination included Tylenol after the second shot. Patient had no known allergies. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. It was reported that the patient was overall a healthy athlete. On 16Jun2021 at 08:00 AM, after second shot, after body chills, throbbing headache and fatigue passed (2-3 days), the patient started to have strong beating heart, irregular heartbeat, palpitations and lightheadedness. Patient went to urgent care on his 5th day of having this with a very irregular heartbeat, so they took him in right away. All tests clear but EKG/ECG shown borderline left atrial enlargement. Still watching and keeping record today. Adverse event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. No therapeutic measures were taken for the events. The patient recovered from body chills, throbbing headache and fatigue in Jun2021, and patient had not yet recovered from rest of the events.  Information on the lot/batch number has been requested.
Within 2 hours I was in bed with a fever, chills, aches, and immense pain that can only be described as being crushed all over.
Pt became unresponsive. Upon arrival EMS blood sugar was 29. loss of appetite.
Reactive lymphadenopathy axillary region of left arm  swelling goes down into left breast no pain,  no erythema
pt recv vax & 28APR98 began w/15 vesicles on back;afeb;playful
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 at 10:00 as dose number unknown (booster), single (Lot number: GH9694) at the age of 70 years, in left arm for COVID-19 immunisation; BNT162b2 (BNT162B2), on 08Apr2022 at 14:00 as dose 4 (booster), single (Lot number: FK9895), in left arm 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, COVID-19: PAXLOVID from 22Dec2022 to 27Dec2022.  No follow-up attempts are possible. No further information is expected.
throat irritation - previously had injection site reaction Narrative:  Pt initially reported injection site reaction and this was filed as report # 2203 1/7/21 - on 1/11/21 she also reported throat irritation and received COVID test 1/13/21 which was negative
Two months after shot knees swelled up and was unable to walk without severe pain. Went to orthopedic doctor and physical therapy. Received a shot of cortisone. Pain still persists. Doctor mentioned that not enough arthritis to warrant my  symptoms.
Rash at site of injection, red and itchy  following am date of injection . Also generated out break of eczema  on right shoulder. Still evident 24 hours after shot.  Applying  RXfor exzema
Upper left lip swelled and blistered - shot - 11:00 AM swelling 4:00 PM. Dr instructed me to get BENADRYL to reduce swelling. Pharmacist said to get CORTIZONE 1%. Swelling came and went w/BENADRYL. Blisters dried up after 2 weeks. They burned and itched.
Severe adverse side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Severe adverse side effects) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Severe adverse side effects). At the time of the report, VACCINATION COMPLICATION (Severe adverse side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported by reporter. No treatment medication reported by reporter.
Persistent vomiting and diarrhea lasting roughly 4 days. Eczema spots starting for first time.
Decreased ROM, pain at rest and with movement, decreased abduction and raising of right arm for now 2+ weeks.  Current treatment: prednisone 40mg daily for 5 days and Tramadol 50-100mg at bedtime as needed prescription for 6 days
Vesicles erupted after vaccine administration approx. 5 hours later. Redness also present; worsening throughout day - spreading - body aches and pains, fever after 30 hours. Antibiotics.
4 days after FLUMIST nasal, his legs started jerking & this happened for 1 month. He saw neuro & had a normal EEG.
leg pain started in right calf. spread to behind the knee and back of right leg. went to primary doctor who said to treat as muscle strain. over the course of a few days pain got worse so i went to the ER concerned about a blood clot. ultrasound was negative for blood clot. pain is still persisting despite care and i have an MRI scheduled for next Friday.
Case number PHEH2014US003870 is an initial spontaneous report received from a pharmacist on 24 FEB 2014. This report refers to a 15-years old male patient. His medical history and concomitant medications were not reported. It was reported that his patients under 18 years of age was vaccinated with an intramuscular dose of FLUCELVAX 2013/2014 (batch number 010021A) on 19 NOV 2013. No adverse events were reported following the maladministration.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 24 FEB 2014: The BPI labeling of the event "inappropriate age of vaccine administration" changed from listed to unlisted and added second indication as "drug use in unapproved population".
Fatique (5 days) Headache (5days) with Tylenol every 4 hours... Nauseated (8 hours) 101 Fever/Temp (Temp for almost 10 hours) Severe Body Aches (8 hours) Bitter/Metal Taste in Mouth & trying to drink Powerade.(8 hours) Light Headed & Dizzy (5 days)
17 years old; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old). On 25-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
"Patient recieved 1st dose of COVID Pfizer vaccine 1/8/21.   LOT EL1283 exp 4/1/21 L Deltoid at 1330  1340 Patient c/o mild itching that began on R arm and spead to back, face and back of bilateral legs. Vaccination RN's monitored for 30 mins.  Benadryl was offered but declined.  Encouraged if symptoms continued to contact prmary provider and if symptoms worsed to see emergency treatment.  Patient retruned to work unit. --Hospital
coughed up what looked like blood in his spit; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received his first dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine) at a single dose on 14Jan2021 for COVID-19 immunization, and apixaban (ELIQUIS)  via an unspecified route of administration at an unspecified dose from an unspecified date as blood thinner. The patient's medical history and concomitant medications were not reported. The patient received his first shot of vaccine in the morning 14Jan2021 while on apixaban. After going to sleep at night, he woke up a couple hours later and coughed up some spit that looked like it had blood. It was 6 or 7 times. He stated he was "ok now" and it was just last night that one time. The action taken for apixaban was unknown. The outcome of the event was resolved on a unspecified date in Jan2021. He will have his second shot in 4 weeks and he is asking if he should get the second shot and if he should stop taking apixaban before his second shot.  Information on the lot/batch number has been requested.
This spontaneous report was received from a pharmacist referring to a patient of an unknown gender and age. The patient's pertinent medical history, concurrent conditions and concomitant therepies were not reported. On 27-NOV-2016, the patient was vaccinated with an expired dose of M-M-R-II human serum albumin, lot# K015374, expiration date 18-SEP-2016 (dose and route of administration were not reported) for prophylaxis. No adverse effects were reported. Additional information has been rerquested.
Husband positive for Covid-19; Head cold; Sinus congestion; Mild fever; eft arm soreness at the site of the injection; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Husband positive for Covid-19), NASOPHARYNGITIS (Head cold), SINUS CONGESTION (Sinus congestion), VACCINATION SITE PAIN (eft arm soreness at the site of the injection) and PYREXIA (Mild fever) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced VACCINATION SITE PAIN (eft arm soreness at the site of the injection). On 18-Mar-2021, the patient experienced NASOPHARYNGITIS (Head cold), SINUS CONGESTION (Sinus congestion) and PYREXIA (Mild fever). On 23-Mar-2021, the patient experienced COVID-19 (Husband positive for Covid-19). At the time of the report, COVID-19 (Husband positive for Covid-19), NASOPHARYNGITIS (Head cold), SINUS CONGESTION (Sinus congestion) and PYREXIA (Mild fever) outcome was unknown and VACCINATION SITE PAIN (eft arm soreness at the site of the injection) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Body temperature: 100 (High) 100 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient is taking medications for BP and Cholesterol. Treatment medicine include Tylenol.   This case was linked to MOD-2021-060892 (E2B Linked Report).; Sender's Comments:  MOD-2021-060892:wife case
CHEST PAIN, SOB, COUGH, ALTERED SENSE OF TASTE, EMESIS,
Initial report received from a health care professional on 17 October 2014. A female patient (age not reported), had received an intradermal dose of FLUZONE ID vaccine (lot number: unknown, dose number and site of administration was not reported) on 16 October 2014. The patient illness at the time of vaccination was unknown. The patient pre-existing physician diagnosed allergies, birth defects and medical conditions was unknown. On 17 October 2014 i.e. one day after vaccination patient had experienced Blistering, hardness and induration at injection site. It was reported that patient was evaluated at the hospital emergency room and intent of call was for treatment recommendations. Corrective treatment and laboratory investigations were not reported. At the time of this report, patient outcome was unknown. Documents held by sender: None. Follow-up information received from a non-health care professional on 11 March 2015. No new information was reported. Documents held by sender: none.
Pt. developed 3 inch red swollen circle at administration site. Extremely itchy.
When I got the shot I Immediately didn't feel good. I slept for days it was like I was tired. I began my lymphodema treatment and I started noticing things on my legs that were hot and looked like pus pockets. I didnt have insurance at first so I was going getting my leg looked at they were giving me antibiotics and cream. They began to grow and it formed on one leg on a tattoo I've had for 8 years they thought it was a form of sarcodosis. After a biopsy it wasn't.
lower back pain; chills; put me in bed; This case was reported by a consumer via interactive digital media and described the occurrence of back pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than a day after receiving Shingles vaccine, the patient experienced back pain, chills and mobility decreased. On an unknown date, the outcome of the back pain, chills and mobility decreased were recovering/resolving.   It was unknown if the reporter considered the back pain, chills and mobility decreased to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the second Shingle vaccine and that put him/her in bed with lower back pain and chills.  The patient was all better next morning. The patient's SIL got shingles and said it was very painful.
A non-serious spontaneous report of administration of expired product has been received from a Registered Nurse concerning a female employee "in her 20's" who received FluMist.  Medical history and concomitant medications were not reported.  On 15-Dec-2008, the patient was administered FLUMIST which expired on 12-Nov-2008.  There was no adverse event associated with this medication error;  therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired.  Additional information received on 29-Dec-2008 and incorporated into the narrative included patient demographics and lot number of FLUMIST.  The reporter confirmed there were no late-occurring adverse events.  Follow-up information was received on 09-Apr-2009:  Product Complaint Investigation results.