chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of difficulty sleeping in a 73-year-old female patient who received SHINGRIX (batch number 5MG5E, expiry date 5th May 2021) for prophylaxis. On 1st December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 1st December 2018, less than a day after receiving SHINGRIX, the patient experienced difficulty sleeping and hyperalertness. On an unknown date, the patient experienced shingles, red confluent rash cheeks and discomfort. On an unknown date, the outcome of the difficulty sleeping, shingles and red confluent rash cheeks were recovered/resolved and the outcome of the hyperalertness and discomfort were unknown. It was unknown if the reporter considered the difficulty sleeping, shingles, red confluent rash cheeks, hyperalertness and discomfort to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received the 2nd dose of SHINGRIX in left deltoid and 5 hours later the patient stated that her body went into high alert and she could not sleep that night. One week after receiving the 2nd dose, the patient developed a red, raised strip along her cheekbone that was uncomfortable. The patient believed it was shingles and the red strip went away after 2 days. The patient was not seen by a doctor.
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 10-AUG-2015, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) lot # L000454, expiry date 06-JAN-2017 (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
At first I had diarrhea sleeping a lot. Then I started to have pain on my arms and on one of my legs . Went to the doctor's and they draw blood to see if I have any blood clots . Waiting on results.
Headache, Sedation, Myalgia, Fever, CHILLS Narrative:
Vaccine was administered at pharmacy on so I don't have any lot info.  Patient developed a headache, malaise, and vertigo
Product Storage Error; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Product Storage Error) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product Storage Error). At the time of the report, PRODUCT STORAGE ERROR (Product Storage Error) 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.
Chills, aches, pains, joint swelling&stiffness, dizziness
COVID Vaccine administered Feb 17, 2021. Patient died March 6, 2021. No other interventions during interim. No change in dose or frequency of medications. No new medicines introduced. Patient compliant with medications. No other procedures during the interim.  Abdominal pain March 3 and again morning of March 6 though had abdominal pain radiating up to his chest on March 6. Took NTG morning of March 6 , fed dogs, went back to bed. Wife found him lifeless around noon of March 6, 2021. Did not seek medical attention on either of the occasions.
16 yo female received the 1st dose of the Moderna vaccine. Vaccine is under emergency use authorization for 18 years old +. Patient received vaccine without side effects.
I woke up in the middle of the night with my heart pounding out of my chest. I got up and checked my pulse oximeter and it said that my heart rate was about 140 beats per minute. I woke my husband up and we sat together deep breathing to try to get my heart rate down. It fluctuated and raced for about two hours before it started to come down a bit to between 95-120 beats per minute. The following day it was around 100 beats at rest per minute. I did not seek medical attention but was unsure if this was a typical reaction to the second dose injection.
Info has been received from a nurse concerning a pt with egg allergy who was vaccinated with varicella virus vaccine live. The nurse reported that the pt experienced an allergic reaction to the varicella virus vaccine live, in the form of a rash. The adverse event improved and the pt has recovered. No additional info regarding the adverse event was available. There was no product quality complaint reported. Follow-up info was received from an RN who reported that the pt is unknown to them. The pt sought unspecified medical attention. No additional info is expected.
Reaction on my arm. / It took two or three weeks to get over the redness; This case was reported by a consumer via interactive digital media and described the occurrence of erythema of extremities in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced erythema of extremities. On an unknown date, the outcome of the erythema of extremities was recovered/resolved.   It was unknown if the reporter considered the erythema of extremities to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient never had the chicken pox but insurance wanted to had the shingle vaccine  The patient received Shingrix and had arm redness. The patient was worried and it took two or three weeks to get over the redness.
Fever, chills, debilitating weakness, atrial fibrillation, renal effects
Mild redness & swelling at site of injection - pain with movement no treatment (just rest).
It was reported that a pt (8 of 10) received a TD Adult that was inadvertently administered intradermal. The pt developed a large local red, hard area at the injection site. Further information is being requested.
SHOOTING PAIN FROM KNEE TO INSIDE OF THIGH; SLIGHT FEVER ON 1ST 2 DAYS, HIGH FEVER SPIKES ON 9TH AND 10TH DAY; This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: osteoarthritis in left knee. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 206A21A expiry: 21-SEP-2021) dose was not reported, administered on 17-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 17-SEP-2021, the patient experienced shooting pain from knee to inside of thigh. On 17-SEP-2021, the patient experienced slight fever on 1st 2 days, high fever spikes on 9th and 10th day. On 25-SEP-2021, Laboratory data included: Body temperature (NR: not provided) 105 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from slight fever on 1st 2 days, high fever spikes on 9th and 10th day, and the outcome of shooting pain from knee to inside of thigh was not reported. This report was non-serious.
Lips swelled after eating a meal with hot pepper s. I am not allergic to hot peppers normally.  Lips are painfully swollen and red/ itchy/ burning.  Reaction began an hour after eating and continued swelling until morning. Swelling is pronounced and getting worse about 20 hours after beginning. I do not have any cosmetic procedures on my lips. No fillers.
late second dose of Shingrix and the efficacy data for one dose only; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 103-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on March 10, 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: late second dose of Shingrix and the efficacy data for one dose only). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 16-AUG-2023 The pharmacist intern was looking for information about late 2nd dose of Shingrix and the efficacy data for one dose only.  The patient received the 1st dose was 2 years ago. Till the date of reporting the patient did not receive 2nd dose, which led to incomplete course of vaccination. The reporter did not consent to follow-up. This case is linked with US2023111503, US2023AMR111828, by same reporter.; Sender's Comments:  US-GSK-US2023AMR111828:secand case created for second patient US-GSK-US2023111503:same reporter, 2nd case
Fever; Headache; This is a spontaneous report from a Contactable consumer. This contactable consumer reported for a female patient (wife) who received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) at single dose for COVID-19 immunization on unknown date. Relevant history and concomitant drugs were unknown. Reporter stated, his wife get the Pfizer-BioNTech COVID-19 Vaccine and she got a fever and kind of like a headache. So, he was just asking if she could have a pain reliever (Unspecified Medication). Outcome of evens was unknown.   Information on the Batch/Lot number has been requested.
On multiple unspecified dates, multiple unspecified patientes received improperly stored vaccine; No adverse effect; This spontaneous report has been received from a medical assistant, concerning a 54-week-old male patient.   The patient's concurrent conditions, historical conditions, previous drug reactions, or allergies and concomitant medication were not reported.  On 18-APR-2019, the patients were vaccinated with improper stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # R000555 and expiration date 08-JAN-2020) (anatomical location not reported) for prophylaxis. The measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) vaccine was reconstituted with properly stored sterile diluent. No adverse effects reported.  Additionally, temperature for vaccines were total time and highest temperature above 9°C (9.9 C); time frame: 4 hours; with no previous temperature excursion. The error was identified via a data logger.; Sender's Comments:  US-009507513-1903USA013366:
mildly painful in my arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (mildly painful in my arm) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B1321A and 011D21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMIN B COMPLEX (B-COMPLEX [VITAMIN B COMPLEX]), VITAMIN D [VITAMIN D NOS], VITAMIN A [RETINOL], PROBIOTICS NOS and OMEGA-3 NOS for an unknown indication.   On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 16-May-2021, the patient experienced MYALGIA (mildly painful in my arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, MYALGIA (mildly painful in my arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-239035 (Patient Link).
This spontaneous report as received from Licensed Practical Nurse regarding 5 unspecified patients of unknown age and gender. The pertinent medical history of patients and their concurrent conditions were not reported. On an unknown date in April 2016 (also reported as last past two weeks from report time) 5 unspecified patients were vaccinated with improperly stored M-M-R II (lot # L020188, expiry date 03-JUN-2017) dosing details unknown. Concomitant medications were not reported. It was reported that the vaccines were subjected to temperature excursion of 47.1 Fahrenheit for a time frame of 6 minutes and these vaccines were administered to the patients. It was reported that there were no previous temperature excursions. Product quality complaint (PQC) was not filed. Additional information is not expected as reporter did not wish to contact further.
tested positive for covid infection; This is a spontaneous report from a contactable consumer.  A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 22Jul2021 (Batch/Lot Number: FA7484) as dose 1, single (at the age of 44 years old) for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient got the first dose of the Pfizer BioNTech Covid-19 Vaccine last 22Jul2021 and tested positive for covid infection last 30Jul2021. She is scheduled to have her second dose on 12Aug2021. The patient asked if she should she get the second vaccine dose on 12Aug021 or does she need to wait. She took the covid test on Friday 30Jul2021 in the ER. She was not admitted into the hospital she was sent back home the same day. The positive result was notified to her on Sunday 01Aug2021. It was 2 tests actually done, they did a rapid and a test that was sent off for which the results would come in 2-3 days. Rapid test result was actually negative, but because of the symptoms she was experiencing they decided to do the other nasal swab test and sent it off. She was at work on Friday and felt like she was hit by a bus or run over. Her muscles were aching, she had a head cold but without the symptoms in the head, the inside of her nostril and the back of the throat was raw and everything even while breathing felt raw. It felt horrible. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Sep2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: acidic like tomatoes, oranges" (unspecified if ongoing); "Known allergies: Anything acidic like tomatoes, oranges, birth control" (unspecified if ongoing); "Known allergies: Anything acidic like tomatoes, oranges, birth control" (unspecified if ongoing); "papillary thyroid cancer" (unspecified if ongoing); "post procedural hypothyroidism" (unspecified if ongoing); "osteopenia" (unspecified if ongoing); "Mast cell activation syndrome" (unspecified if ongoing); "ehlers-dahlos" (unspecified if ongoing); "narc keratoconus" (unspecified if ongoing); "IC" (unspecified if ongoing). Concomitant medication(s) included: LEVOXYL, start date: Mar2016; NUVIGIL, start date: Mar2007; ELMIRON, start date: Mar2013; FLUOXETINE, start date: 01Sep2006; ALOE VERA, start date: Mar2013; VITAMIN D NOS, start date: Mar2003. Past drug history included: Cardizem, reaction(s): "Known allergies: cardizem"; Nuvigil, reaction(s): "Known allergies: Nuvigil". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti viral details:  Product: COVID 19 Treatment; Brand: Pfizer; From May2023 to May2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information and the known product safety profile, a causal relationship between the reported events drug ineffective, covid-19 and BNT162B2 is considered possible.
A medical assistant called to determine the valiidity of the dose of PROQUAD given to 24 year old; No additional AE's; This spontaneous report was received from a certified medical assistant and refers to a 24-year-old patient of unknown gender. The patient's medical history, concomitant medications, concurrent conditions and drug allergies were not reported.  On an unknown date, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (exact dose, lot number, expiration date, route of administration and anatomical location were not reported) for prophylaxis. The reporter called to determine the validity of this administered vaccine. No additional adverse events were reported.  This is one of 2 reports received from the same reporter.; Sender's Comments:  US-009507513-2204USA005463:
Friday night arm became bright red and swollen from shoulder to elbow. Took BENADRYL. Saturday arm was the same. Sunday swelling worse, also had swollen lymph nodes in her supraclavicular region as well as axilla. Monday developed red itchy rash of the injection site, scalp, palms, face, chest and legs. Swollen ankles.
10 days later on 12/18 - onset of severe hives. I was  prescribed prednisone. My hives are less severe now but still present 2.5 weeks later and I have flare up multiple times per day.
Arm pain started around 2 days after the vaccine was given and has lasted for a few weeks.  Patient states it is causing decreased mobility. Patient states it is upper part of arm.  He is using a cream to help with the muscle pain and that is helping a little.  On a pain scale 1-10 patient states pain level is a 6 with 10 being the worst.  He says the muscle pain has stayed the same over the last few weeks.
PATIENT HAS A SMALL BLISTER THAT APPEARED ON HER LEFT DELTOID FOLLOWING HER BOOSTER DOSE.
A 16-year-old female patient had received a first dose, left deltoid, intramuscular injection of Menactra, lot number U1968AA, on 05 June 2007. On the same day, she experienced severe body aches, headache, and light sensitivity. There was no illness on the day of vaccination. Diagnostic testing was none. The patient recovered from the event. The reporter in this case is the same as in case 2007-02212.
the patient was administered improperly stored VARlVAX; This spontaneous report was received from a physician, referring to a 19-months-old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.   On 30-JUL-2020, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX), subcutaneously (strength, dose, vaccination scheme frequency and anatomical location were not reported; lot number S032355, which have been verified to be valid, expiration date reported and validated as 14-OCT-2021) as routine vaccination (product storage error). It was reported that the sterile diluent (MERCK STERILE DILUENT) used to reconstitute the vaccine was properly stored (lot number S032591, which have been verified to be valid, expiration date reported and validated as 16-AUG-2022).  The administered dose of the vaccine experienced a temperature excursion of 6 degrees Fahrenheit (F) to 14 degrees F (13.6 degrees F) for 12 hours (multiple excursions); 15 degrees F to 46 degrees F (16.0 degrees F) for 30 minutes, as recorded by a data logger. There was no previous temperature excursion reported.; Sender's Comments:  US-009507513-2009USA001256: US-009507513-2009USA001233:
Patient was seen to administer the FLU and Pfizer booster vaccines. She was accompanied by mother who consented to receiving both vaccines. Vaccine screening was complete, and no noted contraindications were noted. Vaccine possible side effects were reviewed.  AT 10:14-10:15AM  vaccines were administered following county guidance. She experienced dizziness within seconds of receiving both the FLU and Pfizer vaccines. She requested water post vaccination and was noted with paleness. I stayed with patient while calling for assistance to get cot, water and emergency bag. I immediately assisted her to lie down. She explains had not had breakfast as her and mom were rushing out to their appt. She reports not feeling anxious or nervous prior to the vaccine or having a similar incident in the past. 10:15am -10:20am She drank water, rested on the cot, applied ice pack to back of neck and took vital signs. She reported feeling much better right after lying on the cot. VS were as follows BP 110/78 P 75-82 R: 18 02: 98-100% RA. 10:25am  She was assisted slowly to a sitting/dangled position and reported feeling "good". She then slowly sat up and tolerated. Mother was at her side the whole time.  10:30 Patient reported feeling well and ready to head out. Educated on staying hydrated and other possible side effects post vaccinated. Patient and mother verbalized understanding.
Localized pain, redness, swelling, involving entire upper arm (right). No fever but marked left shift to WBC S22 B2 L67, S81 L15, CRP 1.05-0.35. Decreased redness, swelling S 56 L 33, CRP 0.35 at d/c hospital. 4/27/06 Review of 10-page  d/c summary done. Final diagnosis was cellulitis. Tx with IV Ancef and Solu-Medrol. Recovering well. Sent home on cephalexin, Benadryl, and prednisone.
Reported to hospital ER 1/7/07 at 1439pm with c/o rash on face/neck, moved to trunk and abdomen, and runny nose. Pt was DX with L otitis media. ER doctor said rash was macular and similar to measles.
Patient received his flu shot on 01/26/18, noted some pain days after the vaccine and started to be concerned around 02/09/18 when he called the pharmacy for the first time. He reports difficulty when lifting certain things and with certain ranges of motion. He noted the pain most while shoveling. At that time I instructed him to call his doctor for a follow up because most pain subsides within days. Patient spoke with staff 02/13/2018 and picked up a copy of VIS and monograph at this time. Patient went to his doctor's office on 02/13/2018. I called to follow up today and he has said he had read about this online extensively. He stated the pain moves to different parts of his arm and shoulder at different times. He says it's like a deep bee sting that won't go away and often feels like he slept on his arm wrong.
I developed ear ringing, fullness in ears which turned out to be Tinnitus which is awful.  Also, developed  Vertigo AND Ulcerative Colitis. I am taking meds for UC and have this under control the best I can, But this Tinnitus is NOT under control and is affecting my life in a very negative way.  This J & J vaccine is the cause of Tinnitus, no doubt in my mind. More and more people are getting this so called rare side effect, it is real and awful.