chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ADMINISTRATION OF A VACCINE DOSE FROM A PUNCTURED VIAL THAT WAS KEPT AT ROOM  TEMPERATURE FOR LONGER THAN TWO HOURS; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist 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 (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced administration of a vaccine dose from a punctured vial that was kept at room temperature for longer than two hours, and incorrect product storage. The action taken with covid-19 vaccine was not applicable. The outcome of the administration of a vaccine dose from a punctured vial that was kept at room temperature for longer than two hours and incorrect product storage was not reported. This report was non-serious.
physician/gave her a shot/had already completed two rounds; This case was reported by a consumer via media and described the occurrence of extra dose administered in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date) and Shingrix (2nd dose received on an unknown date).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The reporter was the patient's husband. The age at vaccination was not reported. The reporter stated that, his wife's physician gave her a shot not realizing that, she had already completed two rounds. The patient received 3rd dose of Shingrix, which led to extra dose administered. The reporter asked could 3rd shot be harmful.
Post vax, the pt had positive erythema and positive swelling. Increased warmth. Rxed with Keflex.
Fever(up to 102.8), headache, body aces, sore throat,  lethargic, vomiting, diarrhea, dehydration.
This spontaneous report as received from a consumer refers to a 62 year old female patient. No medical history was reported. Drug reactions/allergies was denied. On 13-AUG-2013, the patient was vaccinated with ZOSTAVAX lot # J001692 exp date: 08-MAY-2014, 0.65 ml, once. Patient was unsure whether ZOSTAVAX was administered subcutaneously or intramuscularly. Concomitant therapies included ARMOUR THYROID tablets (unspecified dose/frequency and manufacturer). On 13-AUG-2013, after being administered ZOSTAVAX the patient experienced local red and itchy reaction, aching and swelling in extremities, six inch long area on her arm, swollen hands, legs and feet and aching in the legs, arms and hands. Was treated with a diuretic (unspecified name, dosage/frequency and manufacturer) for five days.  On an unknown date, lab tests "Blood test" was performed, no results information was reported. At the time of the report, the outcome of the events was reported as not recovered. Additional information is not expected.
gets 102 degree fever; Could not speak much next two days; Within one hour or so after:  found on floor, fell on right side; unable to speak like a TIA; disoriented; This is a spontaneous report from a contactable consumer.  An 82-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Feb2021 at 13:00 at single dose for COVID-19 immunisation at the age of 82-year-old. Medical history included dementia, high blood pressure, allergy to drugs with sulfer. Concomitant medications included 2.5 Amlodipine, 81 mg aspirin, 0.5 clonazepam, 20 mg Escitalopram, 10 mg melatonin, 5 mg memantine, 15 mg mirtazapine. The patient was not pregnant. The patient received first dose of received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Jan2021 at single dose for COVID-19 immunisation at the age of 82-year-old. Within one hour or so after the vaccine administration: the patient was found on floor, fell on right side, disoriented, unable to speak like a transient ischemic attack (TIA), out of it. The patient could not speak much next two days. Don 14Feb21 at 15:00, the patient got 102-degree fever. The patient was treated for the events. The patient was recovering from the events. Information on the lot/ batch number has been requested.
No additional AE/PQC; HCP called to report inadvertent administration of expired VARIVAX to a patient; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. Concomitant therapies were not reported.  On 31-AUG-2023, the patient was vaccinated inadvertent with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, at a dose of 0.5 milliliters, once (lot #U026207, with an expiration date on 24-AUG-2023), administered for prophylaxis (strength, and route of administration were not provided).  No additional adverse events were reported.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 77-year-old male patient who received SHINGRIX (batch number C7B9P, expiry date 16th August 2019) for prophylaxis. On 17th August 2018 09:58, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In August 2018, less than a week after receiving SHINGRIX, the patient experienced shingles and chest pain. On an unknown date, the outcome of the shingles and chest pain were not recovered/not resolved. It was unknown if the reporter considered the shingles and chest pain to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX in left deltoid. The pharmacist reported that the consumer who was also a physician called him on the reporting date. The patient reported that he believed he had a shingles after vaccination with SHINGRIX vaccine. The pharmacist did not sure about when the events had started. The patient had a moderate pain in his left chest and it looked like shingles on chest.  The pharmacist stated the patient gave no other description or information. She was calling on his behalf if this could be possible. The call was transferred to medical information system (MIS). The reported batch number was not found in sales data sheet, which changed from C789P to C7B9P.
Patient is a 69-year-old female with past medical history of coronary artery disease status post double bypass on May 2015, hypertension, hyperlipidemia came to emergency room with chief complaint of chest pain going on since Wednesday.  She says that initially the pain started after she ate her food and she has history of gallbladder polyp and hence she thought it might be her gallbladder and indigestion and took Tums.  Pain was associated with nausea at that time.  Her pain recurred next day after eating and she took nitroglycerin after which she felt better.  But today she tried to hurt just toast and nectarine for breakfast after that she had pain again in the middle of the chest and this is when she got worried and she came to the emergency room.  She denied any shortness of breath or vomiting or diaphoresis associated with the pain.  She says that her previous heart attack, she did not have any symptoms.  In the emergency room, her troponin was elevated and given EKG findings of subtle ST changes, code heart was called and cardiology evaluated the patient and canceled code heart as her EKG was pretty stable.  She received a dose of aspirin and Brilinta in emergency room and was started on heparin drip. NSTEMI. Cardiac Catheterization performed.
This report was received from the investigator in a trial on 06 May 2010. A 29 year-old male subject received the following vaccines on 11 May 2009: ACAM2000 (lot number not reported); and anthrax vaccine (other manufacturer and lot number not reported). The subject previously received TYPHIM VI (lot number not reported on 20 April 2009. Twenty eight days after receiving the smallpox vaccine, the subject was diagnosed with prinzmetal angina. The subject had a history of hypertension. An echocardiogram performed on 08 June 2009 and an electrocardiogram performed on June 2009 were both normal. Additional information will be requested from the investigator. Note: There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study.
NO ADVERSE REACTION HOWEVER PATIENT IS 2 MONTHS PREGNANT AND VACCINE ADMIN DID NOT SCREENED THE RECORDS PROPERLY AND GAVE THE IMMUNIZATION REGARDLESS.  SHE WAS GIVEN AFLURIA. LOT NO 04849211A
Patient has a silver dollar size red irritated area on his arm with several small fluid filled blisters.  Patients states no pain, but occasional itching.
tired; sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: sore arm) and tiredness (Verbatim: tired). The outcome of the pain in arm was recovered/resolved (duration 1 day) and the outcome of the tiredness was not reported.   It was unknown if the reporter considered the pain in arm and tiredness to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm and tiredness to be related to Shingles vaccine.   Additional Information: GSK receipt date: 20-Mar-2023 The case was received form the patient via interactive digital media. The patient stated that shingles, vaccination did not gave him or her anything but sore arm for a day and might be a little tired the next day. The patient stated that thanks for pointing out his or her previous comment was not too clear he or she fixed it. The follow-up could not be possible as no contact details were available.
PATIENT REPORTED ON 7/13/21 THAT SHE HAD TO GO TO AN URGENT CARE AND SHE WAS PRESCRIBED ANTIBIOTICS  DUE TO SKIN INFECTION AT  INJECTION SITE
Severe sore throat, congestion of bronchial tubes and upper rt lung, with cough, runny nose, lots of phlegm. Phlegm clear-no color. No temperature increase. Listerene mouth gargle helps for short period...then returns. Now on 12th day...no help from aspirin, Benadryl, Alka-Seltzer. Same adverse effects to wife who had vaccination on 09/14/2012, beginning two days later. We thought it was an allergic reaction to excess pollen. However, today I talked to a person who described identical symptoms, recognizing it must be an adverse reaction.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reaction or allergies and concomitant therapies was reported. On an unknown date, the patient was vaccinated with expired dose of M-M-R II (lot # M032153, albumin status was not provided) subcutaneously for prophylaxis. Concomitant therapies included sterile diluent (STERILE DILUENT). No adverse effect was reported. Additional information has been requested.
Right after the vaccine I had experienced fatigue and tightness in the back of my neck. A few days after, I had woke up one morning with blurred vision that lasted 4 hours. My mom had also noticed I was confused and not particulate my words. During that time I noticed the left side of my neck was swollen. The doctors concluded it was a lymph node.
Post injection employee c/o pain and tingling. Upon evaluation site was warm and swollen. Site iced for a few minutes. Employee was offered ouside tx and declined. Employee was informed if symptoms persist or worsen to let manager or medical staff know.
Within 5-8 hours from injection started getting shakes, fever, fatigue, arm pain, headache, erratic breathing, difficulty breathing, heart palpitations, VERY elevated blood pressure, extremely high BPM, and sweating/chills for  6-8 hours straight. Was unable to sleep and felt as though I was staying awake to focus on not dying. After 2 days most symptoms were gone beside fatigue and arm pain. For the next month and a half I still had trouble exercising as my breathing and heart rate became erratic and I tired extremely easily despite generally exercising 4/5 times a week on average before the shot.
Patient under age of 18 inadvertently given dose of Moderna which is indicated under the EUA for patients over 18 years old.  RN administering thought consent from parent made it OK to administer.  No adverse effects noted and provider notified of error and patient received second dose in series on April 24th in accordance with CDC recommendations and did not have any adverse effects.
One hour following her first COVID19 vaccination the patient passed out in the car for a period of 1-2 minutes.  Following that, she was weak and very groggy for ~ 1hr before starting to recover.  Since then (past three weeks) she has exhibited muscle cramps and pain on her left side, primarily in her left arm and, to a lesser extent in her left leg.  In addition, she has nerve sensitivity in her left arm and hand.   These symptoms are very similar to those following her last previous vaccination which was for tetanus approximately 20 years ago.
Ache joints, concentration difficulty and loss, memory loss, failure and trouble remembering recent, sleep problem.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from Regulatory Authority.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: EP6955), in left arm, on 12Apr2021 as dose 2, single (Lot number: EP6955), in left arm and on 11Nov2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Nail polish" (unspecified if ongoing); "Known allergies: Codeine" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Paxlovid was given as Anti-viral for treatment of COVID-19 on 06Jul2022. Treatment stop date: 06Jul2022, Lot no-GA8851, Administration route: Oral. Other medication details: other medication in 2weeks product: Aurobindo (Fluoxetine 10mg), from 22Jun2022 to 06Jul2022, lot number: 957241257669 via Oral route of administration. Solaray (Quercetin) from 29Jun2022 to 06Jul2022, lot number: 1060560, via Oral route of administration. (Vitamin D3 5000IU) from 22Jun2022 to 06Jul2022, lot number: 496080-01 AW2 via Oral route of administration. Finest Nutrition (Zinc 50mg) from 29Jun2022 to 06Jul2022, lot number: Illegible, via Oral route of administration. Plant (Black seed oil) from 29Jun2022 to 06Jul2022, lot number: 2162337, via Oral route of administration. Patient took Paxlovid at around noon on 06Jul2022. About an hour later, patient noticed metallic taste in mouth. About 6 hours after the dose, patient noticed rash on both arms (upper and lower arms), and on front of both thighs. Patient did not take another dose. Metallic taste is gone, and rash is improving (only slightly visible now). Adverse events start date: 06Jul2022 at 01:00 pm, patient was recovering, treatment was received.
30-45 min post influenza admin (pt's 3rd dose) pt experienced pruritus, interior flushing, redness of face, hives, wheezing.
Burning in the area, numbness, redness, swelling, soreness. The majority of the symptoms were on the next morning.
Less than 24 hours after receiving the 2nd COVID vaccination, I had neck pain that rivaled neck pain year ago after having neck surgery. Some of the nerve pain has come and gone over the years, but this pain has lasted for 5 days and began less than 24 hours after receiving the COVID shot. The pain affects mostly trapezius and levator scapulae (underlying?) muscles on both left and right sides. It feels worse than the muscles aches of having the flu, but only in the neck area. I used Salonpas patches, took ibuprofen and rested.
Sleepy; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleepy) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Hidradenitis suppurativa, Crohn's disease and Ulcerative colitis.    No Medical History information was reported.   On 03-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Dec-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, pre-filled pen. On an unknown date, the patient experienced SOMNOLENCE (Sleepy). At the time of the report, SOMNOLENCE (Sleepy) outcome was unknown.            No concomitant medications were provided by the reporter. It was unknown if the patient was enrolled in a COVID-19 Vaccine trial. Primary reporter did not have the lot number information, because the packaging was discarded. No treatment information was provided by the reporter.
pt recv vax 21AUG96 lt arm & 22AUG96 mom called states inj site looks like a pen stab w/red streak from inj site to elbow;pt advised to call PMD;
I got sick on 12/15/2022 and I had tested positive for COVID-19 on 01/03/2023 at the clinic. I had sore throat, water eyes, runny nose, body aches, cough, and fatigue. I also had a headache, loss of taste and smell, and sinus congestion. I still have lingering symptoms.
Erythematous rash with raised petechia at site of injection that persisted 3 weeks before clearing.
muscle /joint aches, unusual fatigue, tachycardia (the evening following vaccination). Woke up in the morning with left eye anterior uveitis/iritis, with associated photophobia, redness, irritation. ( I have had this previously, associated with immune stress. Last episode over two years ago).  Also woke up with HSV outbreak ( 7 mm herpetic lesion at base of spine), typically happens with significant stress.
WE OFFERED A FLU CLINIC AT THE ENTRANCE OF OUR WAREHOUSE. PATIENT CAME TO THE TABLE. WE OFFERED HIM THE FLU SHOT FOR 65 YEARS OF AGE AND OLDER AND HE ACCEPTED. HE NOTED ON HIS FORM THAT HE HAD NOT HAD ANY VACCINES WITHIN THE LAST 4 WEEKS ON HIS IMMUNIZATION CONSENT FORM. I GAVE HIM THE FLUAD VACCINE. AFTER THE CLINIC WAS OVER I ATTEMPTED TO PROCESS THE VACCINE THROUGH HIS INSURANCE AND IT WAS REJECTED NOTING THAT HE RECIEVED THE VACCINE ALREADY ON 9/1/23. PATIENT WAS NOTIFIED AND HE CLAIMED HE THOUGHT HE WAS GETTING THE NEW COVID VACCINE. HE ALSO CLAIMS H IS HAVING MEMORY ISSUES.
fatigue; Vomiting; nausea; teeth were chattering, had chills; Fever; Joint pains; Headache; starting to itch; arm hurts; arm is red; A spontaneous report was received from a healthcare professional who was also a female patient of unknown age who received Moderna's Covid-19 vaccine (mRNA-1273) and developed fatigue, nausea, chills, vomiting, fever (pyrexia), joint pains (arthralgia), arm hurts (pain in extremity), arm is red (erythema), itch (pruritus), and headache.  Historical condition included tested positive for Covid on 13 Dec 2021. Concomitant product use was not provided by the reporter.   On 31 Dec 2021, at 11 am, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) for prophylaxis of COVID-19 infection.   The patient felt fine until 11 pm on 31 Dec 2021, when she felt fatigue and nauseas. Later on, her teeth were chattering, had chills, vomiting, fever and joint pains. She stated she stopped vomiting on 01 Jan 2021 (reported as Friday) but still had fever and headache. She stated her arm was red and started to itch.   Treatment for the events were not provided.   Action taken with mRNA-1273 in response to the events was not provided.   The event of vomiting was resolved on 01 Jan 2021. The events of fever and headache were not resolved at the time of this report. The outcome of the events of fatigue, nausea, chills, joint pains, arm hurts, arm is red, and itch was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On unspecified dates, the patients were vaccinated with improperly stored GARDASIL 9 lot # L007560 and expiry date of 15-JUN-2017, after the temperature excursion. No adverse effects were reported. There was no product quality complaint involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Case number PHEH2015US019552, is an initial spontaneous report from a health care professional received on 30 Sep 2015. This report refers to a 57 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUCELVAX, (batch number: 173539) at a dose of 0.5 ml intramuscularly on 23 Sep 2015. It was reported FLUCELVAX was at room temperature for 24 hours before administration. No adverse event was reported.