chrisvoncsefalvay/vaers-outcomes huggingface dataset:
blood sugar rises and went higher; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) (patient's wife) for a sponsored program (002191).  A male patient received bnt162b2 (BNT162B2), administration date 01Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD GLUCOSE INCREASED (non-serious) with onset Apr2021, outcome "unknown", described as "blood sugar rises and went higher". Relevant laboratory tests and procedures are Blood glucose with result of rises available in the appropriate section.  Additional information: Reporter wanted to know what's with the Covid19 vaccine that can cause them to have these reactions.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient given bivalent vaccine for first dose in series instead of monovalent in error.  No adverse symptoms, etc.
Besides a sore arm after the injection, later in the evening I began to have some fibromyalgia symptoms. The fibromyalgia had been in remission since 2006 when I started taking a small dose of amitriptyline before bedtime. The fibromyalgia has increased in intensity in the days since January 19 and appears to be becoming chronic again. So far, I have taken extra strength TYLENOL and (homeopathic) rhus toxicodendron plus rubbing "DOTERRA DEEP BLUE RUB (a cooling agent) onto the most painful areas besides the arnica gel that I normally use. The fibromyalgia is starting to interfere with my daily activities so I will be contacting my primary care physician for ways to ease the symptoms and to learn the advisability of having the second dose of SHINGRIX vs the risk of getting shingles.
Patient has subjective L facial numbness occurring 25-30 times per day, starting on the day of immunization and continuing now 2 weeks after vaccination.
Low grade Fever, Myalgia, Chills on day 2 to day 3.  Then Store throat started on Day 3.  (In clinic visit, she was also tested positive for COVID)
Arm was sore; Had body aches; Low energy and fatigue; Low energy and fatigue; A spontaneous report was received from a consumer(Healthcare Professional) concerning a 61-year-old, female patient, who received Moderna's COVID-19 Vaccine and experienced arm was sore, had body aches, low energy and fatigue.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, Wednesday, the patient received their first of two planned doses of mRNA-1273 (Batch Number: Unknown) in the left arm for prophylaxis of COVID-19 infection.  On 30 Dec 2020, the patient experienced arm was sore (gone by 01 Jan 2021), body aches, low energy and fatigue.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events arm was sore, had body aches, low energy and fatigue was not reported.  The outcome of the event arm was sore was reported resolved. The outcome of the events body aches, low energy and fatigue was not reported.; Reporter's Comments: Based on the current available information and a strong temporal association between the use of the product, the known safety profile of the vaccine and the start date of the reported events, a causal relationship with the events cannot be excluded. Fatigue is consistent with the known safety profile of mRNA-1273.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Patient asked to call 911 -cannot speak English (Mom translated)..seemed the longer he waited he got more anxious after the shot
08/31/22 presents to ED for "chest pain" "lightheadedness". PMHx of "heavy alcohol use, DVT, subdural hematoma, delirium tremens, Warnicke encephalopathy"
No reaction to shot#1. Started to feel ill 6 hours after shot #2, developed  a fever up to 101.6, had bad chills, headache for hours and then finally took tylenol.  Fever/chills lasted about 48 hours.  Fever came down and then my menstrual cycle started, it came 1 week early.  My cycle is always regular, have never been early in 25+years.  Have now had period for the last 12 days, cramps, headache.
I experienced chest pains and started to feel really tired, I got to the point to where I could barely walk small distances without getting very tired and fatigued. I went to the emergency room and they discovered blood clots and I was in the hospital for 9 days, they gave me a specific medication that I don't know the name of, but they was trying to get my IMT within a certain level before they could release me so every 4 hours they would take blood work to see where my IMT level was before they release me from the hospital  to start taking blood thinners and I am taking blood thinners for the rest of my life.
Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 87 and receiving home based primary care for endstage COPD from asbestos exposure. Other comorbidities include PVD, DM, AFib, HTN, HLD
Development of 2-3 cm Bullae on the dorsal surface of the right foot x 2 with several smaller vesicles.
Flu-like symptoms for 24 hrs or less - didn't take any medication 2 days later - abdominal cramping, legs cramping, headache comes and goes, night sweats, acne on face - have had these symptoms for 3 days
Fever, chills, body aches, headache, injection site pain, swollen lymph nodes left axilla
Vaccine in AM - states with pain and swelling in (R) upper arm, got very hot - went to Urgent Care Friday AM. Started on PCN and Minocycline by Dr.
12Jul95 pt recv 1 dose vax. 09Feb98 pt devel 18-20 pox, mild case. Pt recovered 13Feb98.
Patient requested to have both shots on the same arm. Menactra was given first then the M.M.R.  About 5 to 10 seconds later, he lost consciousness and starting having seizing-like movements which lasted about 20-30 seconds. His mother, who was outside during the vaccine administration, came into the room and patient had a repeat episode in which he woke up about 20-30 seconds later as well. Another pharmacist on duty called EMS to have help dispatched. When they arrived about 5 minutes later, patient was conscious but still feeling dizzy and lightheaded. He was then taken to the hospital via an ambulance.
WICKED HEADACHE, BRIDGE OF NOSE FELT LIKE IT WAS PUNCHED, SNEEZY, RUNNY NOSE. NO TREATMENT ADMINISTERED.
arm was swollen; red; kind of felt like an infection; heat like fever; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm was swollen), ERYTHEMA (red), INFECTION (kind of felt like an infection) and PYREXIA (heat like fever) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (arm was swollen), ERYTHEMA (red), INFECTION (kind of felt like an infection) and PYREXIA (heat like fever). The patient was treated with ACETYLSALICYLIC ACID (ASPIRINA FABRA [ACETYLSALICYLIC ACID]) at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (arm was swollen), ERYTHEMA (red), INFECTION (kind of felt like an infection) and PYREXIA (heat like fever) outcome was unknown.            No relevant concomitant medication was reported.
One week after getting the Moderna shot (3/15/2021) in my left arm at the Clinic  I got a rash over the top part of the left arm where I got the shot that extended down the arm almost to the elbow. I researched what to do and took Benadryl (still taking twice a day). The rash disappeared after about 20 hours but the redness is still there after three days.
Patient had an arrhythmia 3 days after shot. Had to be shocked back to life. Also had a rash on hands. Patient is ok now
Stroke; MEDICATION ERROR (RECEIVED PFIZER COVID19 VACCINE FOLLOWED BY JANSSEN COVID 19 VACCINE); This spontaneous report received from a consumer concerned a male of unspecified age, race, and ethnic origin. 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 was not reported, frequency 1 total, administered in JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included BNT 162 for prophylactic vaccination On an unspecified date, the patient experienced stroke, after receiving covid-19 vaccine ad26.cov2.s as second dose. The patient was informed that it does not matter if the first dose was of BNT 162 (medication error). The patient was hospitalized for stroke on unspecified date for unknown days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stroke and medication error (received pfizer covid19 vaccine followed by janssen covid 19 vaccine) was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0-20210835451-Covid-19 vaccine ad26.cov2.s- Stroke This event(s) is considered unassessable. The event(s) has an compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Has not received the second dose; This case was reported by a consumer via call center representative and described the occurrence of social problem in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in January 2020) and Shingles vaccine (received the old shingles shot approximately 7-8 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix (unknown). On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The case was reported by the patient's wife. The age at vaccination was not applicable for this report. the patient was attempted to got 2nd dose in March but unable to due to clinic being closed during coronavirus pandemic. Till the time of reporting, the patient had not received the 2nd dose.
Client received covid vaccine @ 12:06 pm, complained of feeling lightheaded @ 12:07pm.  Client placed in zero-gravity chair and vital signs taken.  Client denies shortness of breath, denies allergies to anything.  Client given water to drink.  Symptom resolved by 12:28pm, able to stand and walk to observation area.  Client left with steady gait @ 1:00pm.
Covid Arm/Rash went all the way around her arm; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and RASH (Covid Arm/Rash went all the way around her arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 006B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 01-Mar-2021, the patient experienced PYREXIA (Fever). On 12-Mar-2021, the patient experienced RASH (Covid Arm/Rash went all the way around her arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever) and RASH (Covid Arm/Rash went all the way around her arm) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    Treatment included Tylenol.   No concomitant medication is provided.    Reporter did not allow further contact
No adverse event. Expired vaccine was given. Pt presented in office today for blood work and to receive 2nd dose of the Twinrix. Pt was given immunization with the exp date of 05/24/22. CDC has been contacted and advised that most expired vaccines usually need to be regiven. They also advised that contacting glaxo smith to see if there is a grace period that the immunization can still be valid. Contacted Glaxo Smith and was advised  GSK has not evaluated the immunogenicity or safety following the administration of an expired vaccine dose. GSK does not make recommendations regarding revaccination or serologic  testing following inadvertent administration of an expired vaccine dose. Based on analysis and potency testing, the vaccine remains within the approved specifications until a maximum of 30 days following the expiration date as written on the vaccine package,if stored under appropriate temperature and storage conditions as described in the Prescribing Information.
Pain from the left elbow to the left side of her neck; Pain from the left elbow to the left side of her neck; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included breast cancer.   In October 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced pain in arm and neck pain. On an unknown date, the outcome of the pain in arm and neck pain were unknown.   It was unknown if the reporter considered the pain in arm and neck pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix in her left arm and had pain from the left elbow to the left side of her neck.  No additional information was available. The reporter did not consent to follow up. This case linked with US2020AMR230419 and US2020228595, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR230419:same reporter US-GLAXOSMITHKLINE-US2020228595:same reporter
No adverse event; only had the Moderna Bivalent vaccine at the time and administered it on 22Nov2022; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (only had the Moderna Bivalent vaccine at the time and administered it on 22Nov2022) and NO ADVERSE EVENT (No adverse event) in a 32-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE.    On 22-Nov-2022, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 22-Nov-2022, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (only had the Moderna Bivalent vaccine at the time and administered it on 22Nov2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (only had the Moderna Bivalent vaccine at the time and administered it on 22Nov2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (only had the Moderna Bivalent vaccine at the time and administered it on 22Nov2022).    Concomitant medications were not reported.                                       No treatment information was provided by the reporter.
Several hours after vaccine, chills through out the night, headache, fatigue , lasted for two consecutive days.  Two weeks from vaccine rash, hives all over body.  Everyday I have hives.  No history of hives or allergies
Nausea for 48 hours with vomiting that required medication, fever, headache, arm pain
Report 20000301501 describes facial rash in a 25 year old female who received Engerix-B for prophylaxis of hepatitis B. The vaccinee has no known allergies, medical history, or concomitant medications. On 01/01/1995 (IM), 03/01/1995 (IM), 01/01/1996 (IM), and 09/25/2000 AM (two pediatric doses, IM-left deltoid), and vaccinee received her first, second third, and fourth doses of Engerix-B, respectively. On 09/25/2000, in the late evening, the vaccinee experienceed "a severe facial rash." The vaccinee reported that the rash was red, raised, and itching. Her face felt hot, but she was afebrile. A doctor visit was required on 09/26/2000, and she was treated with diphenhydramine hycrochloride 25 mg PO HS. As of 09/27/2000, the outcome of the event is ongoing.
Morning after injection left 4th and 5th digits are numb and weak and he is not able to fully extend fingers even months after.
Sore arm at injection site. Arm swollen at site. Aches in joints. Blood pressure elevated. Blurred vision. Tired, no energy.
Patient had swelling of her face five days after the vaccine and fluid accumulated under her eyes.  This lasted for 3 days and she took Benadryl to make the symptoms bearable.
INSOMNIA THAT HAS BEEN LASTING UP UNTIL NOW. IT IS SLOWLY GETTING BETTER, BUT I HAVE NEVER EXPERIENCED THAT BEFORE. I WAS ABLE TO SLEEP 2 HOURS AFTER GOING TO BED AND THEN WAKING UP AND NOT BEING ABLE TO FALL ASLEEP AGAIN. I FELT TIRED BUT NOT SLEEPY.
I got a flu shot and within 30 minutes started to feel sinus pressure and slight dizziness.  The symptoms gradually got worse and 6-7 hours later I had sinus pressure and pain (like a sinus infection), the roof of my mouth and throat felt tight and swollen, I had hoarseness of breath, dizziness, my eyes were slightly red, and I had shortness of breath.  I took Benadryl over the next 8-12 hours which stopped the symptoms from progressing.  Approximately 20-24 hours after receiving the shot the only remaining symptoms were slight sinus pressure and pain (like a mild sinus infection).  All symptoms were completely gone within 48 hours.
Information has been received from a health professional concerning a 7 year old male who on 16Dec98 was vaccinated with a dose of varicella virus vaccine live. It was reported that the pt has developed chickenpox. Later this morning, on 11Aug05 the pt was being seen in the office. On 11Aug05, the physician's office submitted 3 swabs for PCR analysis for the pt who had developed breakthrough. No product quality complaint was involved. Follow up information received on 29Sep05 reported that the pt's VZV results from testing on 11Aug05 showed wild type VZV. Additional follow up information was received from the VZV ID program which confirmed that a specimen was obtained from the pt on 14Aug05 and the source was a lesion. The specimen was sent to the lab on 15Aug05 and it arrived in the lab on 16Aug05. The results showed that VZV was amplified and the VZV strain identified was wild type. No additional information has been requested. The pt's brother experienced severe shingles, iritis and eye droop following vaccination with varicella virus vaccine live (WAES0508USA02122).
Some wheezing; Arm swelling; Sore; This spontaneous case was retrieved on 18-Apr-2023 from physician via Regulatory Communications (reference number: SEQW23-01243), and concerned a child (born in 2019), male patient.  The patient's medical history included wheezing. The patient's concomitant medications included albuterol, used for unreported indication.   On 10-Oct-2022, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration and anatomical location: not reported) for prevention of influenza disease. The batch number was reported as 942377 and the expiry date was 02-Jun-2023.   On the same date, after administration of Flucelvax Quadrivalent, the patient experienced arm swelling, and sore. 60-90 minutes after receiving Flucelvax Quadrivalent, the patient experienced some wheezing. There were no treatment measures associated with the events.   On the same date, the patient recovered from the event of wheezing. Wheezing was resolved quickly.  On unspecified date in Oct-2022, the patient recovered from the events of arm swelling and 'pain'. the arm swelling and sore resolved after a few days.   The reporter did not provide causality assessment.   The case was assessed as non-serious.  Company comment: A child patient (born in 2019) experienced wheezing, peripheral swelling, and pain on the same day, after receiving the suspect product Flucelvax Quadrivalent. Based on suggestive temporal relationship, causality for the reported events is assessed as possibly related.; Sender's Comments: A child patient (born in 2019) experienced wheezing, peripheral swelling, and pain on the same day, after receiving the suspect product Flucelvax Quadrivalent. Based on suggestive temporal relationship, causality for the reported events is assessed as possibly related.
The patient called the pharmacy 5/18/19 reporting a silver dollar sized area over the injection site that was very red, burning and itching.  She tried icing the area and hydrocortisone cream.  On 5-21-19 she came into the pharmacy as the site of irritation had increased in size to about 3x3 inches.  The area was red, had slight raised bumps/rash and warmth.  She was instructed to try benedryl to reduce itching and redness at the site.  There was no nodule/knot/swelling or red streaking at the injection site.  She had no impairment of use of the limb.  She had tried to contact her primary provider regarding the incident, but has been unsuccessful.  She will continue to try to contact him if the antihistamines do not work.  I have planned to follow up with the patient in the next two days to see the results of what we discussed.
lt eye started to swell 2hr p/vax; 24hr brought back to office, hives, urticarial rash, lt eye still swollen & rt eye sl swollen;rx w/steroids & antihistamines;
Patient received first dose on  2/11/2021.  Presented for second dose on 2/23/21 and received vaccination which was too early.  Error discovered while patient at site and she waited 30 minutes post vaccination with no reaction.
Muscle spasms of right forearm (extensor tendons), mid back (between scapulae), and low back; nausea; abdominal pain, and dizziness.
On day following the vaccination, my memory was severely impaired. I couldn't recognize the name of the local road vary near my house that connects to the interstate. Some confusion.