chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SHARP/STABBING PAIN AT INJECTION SITE ON LEFT ARM; This spontaneous report received from a patient concerned a 56 year old male. The patient's weight was 170 pounds, and height was 66 inches. The patient's past medical history included surgery, and concurrent conditions included diabetes mellitus, hypertension, cholesterol, asthma, allergies, non-smoker, and alcohol use, and other pre-existing medical conditions included the patient had no known drug allergies and no drug abuse/illicit use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, and expiry: 23-JUL-2021) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.   On 01-JUN-2021, the subject experienced sharp/stabbing pain at injection site on left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sharp/stabbing pain at injection site on left arm was not reported. This report was non-serious.
This spontaneous report was received from a physician via company representatives, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 23-MAR-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Lot No. J007946; expiration date 24-MAR-2016), "TF 5mcg/0.5mL Te" (route of administration and anatomical location were not reported). On an unspecified dates, the RECOMBIVAX HB had four temperature excursions: 48 hours (Lowest recorded temperature was 0 F (0 Celsius); 24 hours (Lowest recorded temperature was -1 F (-1 Celsius); 48 hours (Lowest recorded temperature was 1 F (1 Celsius) and 72 hours (Highest recorded temperature was 9 F (9 Celsius). No adverse effects reported. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type of excursion were reported as "Refrigerator(R)". No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
9 days after influenza vaccine reported painful right arm that began few hours after influenza injection and is constant pain with weakness of right arm unrelieved by alternating tylenol and motrin 800mg. Mid right deltoid warm to touch, red and swollen referred to ER for further evaluation and treatment. Prescribed Toradol and Darvon for pain which relieved symptoms after few days of treatment. 8 weeks after influenza vaccine she called to report that her symptoms had reappeared and that she could not work and take the Darvon and Tordal due to drowsiness and she was referred to Human Resources dept. to pick panel physician and have further evaluation.
A 50 year old female patient 4 minutes after receiving her bivalent booster from Pfizer (Lot GH9694) reports feeling itchy in the deltoid area of the left arm, where she received the vaccine.
no description of a rxn submitted; form only states, "recvd Dip/Tet 14jul93;
Pt received MENACTRA & typhoid in (R) deltoid and Tdap in (L) deltoid 2/1/12. On Sunday 2/5 started with redness & "small little bumps" & tenderness. Then on 2/6 bumping was gone & area was just tender, reddened with 3" diameter. Pt concerned very sore.
Red Knot appear at the injection site; Red Knot appear at the injection site / Redness and Heat have decreased; had a big Hot, Red Knot appear at the injection site / Redness and Heat have decreased; muscle achiness in his legs and shoulders; Fatigue; Arm was sore to touch; Swelling; This case was reported by a consumer and described the occurrence of injection site nodule in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th January 2021, the patient received the 1st dose of Shingrix (intramuscular). On 11th January 2021, 2 days after receiving Shingrix, the patient experienced injection site nodule, injection site erythema, injection site warmth, myalgia, fatigue, pain in arm and swelling. The patient was treated with paracetamol (Tylenol) and non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the injection site nodule, myalgia, fatigue, pain in arm and swelling were not recovered/not resolved and the outcome of the injection site erythema and injection site warmth were recovering/resolving.   It was unknown if the reporter considered the injection site nodule, injection site erythema, injection site warmth, myalgia, fatigue, pain in arm and swelling to be related to Shingrix.  Additional details were reported as follows: The patient had a big hot, red Knot appear at the injection site.  He stated his arm was sore to the touch. He also reported fatigue and muscle achiness in his legs and shoulders.  On 14th January 2021, he still had a mark on his arm.  The redness and heat had decreased, but the size of the Knot had increased.  His physician was aware and had recommended ice and tylenol.  The reporter consented to follow up.
Patient had no known side effects.; lmproperly stored vaccine administered to a patient.; This spontaneous report was received from a vaccine coordinator and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 30-DEC-2021, the patient was vaccinated with dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) for prophylaxis (exact dose, lot#, expiration#, route of administration were not reported).  Administered dose of vaccine has been stored in the temperature of 34.3 F for 4 hours and 23 minutes.There were no previous temperature excursions reported. Patient had no known side effects.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2201USA006297:
Passed out while crossing the street. Hit the concrete on the road when I lost consciousness. Had to be transported to the ER. Disoriented upon awakening. Continue to experience dizzy spells and back neck muscles ache.
sharp chest pain on the left side under their pec; Pain in that arm; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CHEST PAIN (sharp chest pain on the left side under their pec) and VACCINATION SITE PAIN (Pain in that arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In July 2021, the patient experienced VACCINATION SITE PAIN (Pain in that arm). On 27-Jul-2021, the patient experienced CHEST PAIN (sharp chest pain on the left side under their pec). On 27-Jul-2021, VACCINATION SITE PAIN (Pain in that arm) had resolved. At the time of the report, CHEST PAIN (sharp chest pain on the left side under their pec) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment information was not provided by reporter.
a dose of Fluzone Quadrivalent was administered to a patient before finding out the product was not viable, No AE; Initial information was received on 01-Sep-2020 regarding an unsolicited valid non-serious case from the other health care professional via phone.  This case is linked to cases 2020SA238410 and 2020SA245000 (same reporter).   This case involves a 24 months old female patient who was vaccinated with a 0.25 mL dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (batch number and expiration date were not reported) via an intramuscular route at an unknown administration site on 01-Sep-2020 for prophylactic vaccination. However, this vaccine administered before finding out that it was not viable to use.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. The patient did not receive any other vaccine concomitantly.    It was an actual medication error case due to poor quality vaccine administered (latency was same day).  At the time of reporting, the patient had no adverse event symptoms.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case
Information has been received from a physician regarding to unspecified patients of unknown age and gender. Information about medical history and concurrent conditions were unspecified. On an unknown date the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L011846, expiration date 16-JUN-2017; lot # L016429, expiration date 09-AUG-2017; dose and route were unknown). The temperature excursion for the vaccine was 47 F, time frame was 36 hours. There was no previous temperature excursion. It was not because of a "data logger". No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Both of my arms are very painful and can't lift them. Is in the area where they gave the vaccine. I can't even carry groceries. It hurts to put my sports bra on. The pain I've had it since the 11/15/2022.
severe headaches; dizziness; fatigue; fever; chills; muscle aches; severe joint pain; tachycardia; This is a spontaneous report from a contactable pharmacist. A adult female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 09Jan2021 as 2ND DOSE, SINGLE for COVID-19 immunization. The patient previously received the first dose of BNT162B2(lot unknown) on an unknown date for COVID-19 immunization.The patient's medical history and concomitant medications were not reported. Clinical course was reported as: On 09Jan2021, symptoms started about 30 minutes after receiving the Pfizer Covid vaccine. The patient experienced severe headaches, nausea, fever, chills, muscle aches, severe joint pain, congestion, dizziness and tachycardia. Her fever did not resolve for 2 days (100.8 - 101.5) and her headache was also consistent for 2 days. Tachycardia started about 3 hours after vaccination. Heart rate was between 130-150 bpm. She had to contact her doctor to receive medication to help with heart rate. It took about 3 days to control the tachycardia. The patient underwent lab tests and procedures which included body temperature and heart rate measurement. Patient received treatment for the adverse events. She is still getting headaches, nausea, fatigue and joint pain and taking medication for tachycardia. The outcome of the events was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Itchy throat, excessive coughing, sweating, trembling of the whole body, little difficulty in breathing, a feeling of swelling in the neck and headache. I already feel better and only my left arm hurts and I feel very tired with a little strong palpitations, a sore throat when swallowing food or drinks and hoarseness when speaking.
SUSPECTED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 76 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: hypertension, penicillin allergy, and erythromycin allergy. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 1 total administered at left arm on 13-MAR-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 74 years old. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient received second dose of non-company suspect vaccine Moderna (elasomeran)  (Dose number in series 2) (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, administered at left arm on 27-OCT-2021 for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with second dose of vaccine Moderna (elasomeran) (Dose number in series 2). The patient received additional third dose of non-company suspect vaccine Moderna (elasomeran) (Dose number in series 3)(form of admin, route of admin, batch number and expiry were not reported) dose was not reported, administered at left arm on 15-APR-2022 for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with third dose of vaccine Moderna (elasomeran) (Dose number in series 3).  The patient received additional fourth dose of non-company suspect vaccine Moderna (elasomeran) (Dose number in series 4) (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, administered at left arm on 16-SEP-2022 for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (Dose number in series 4). Concomitant medications included finasteride, krill oil, and metoprolol succinate. On an unspecified date in 2023, the patient experienced suspected covid-19 infection (Dose number in series 4) and was treated with drug nirmatrelvir/ritonavir (form of admin, route of admin, and batch number were not reported) dose and frequency were not reported from 28-APR-2023 to 02-MAY-2023 for covid-19 treatment.  On 7-MAY-2023, patient experienced paxlovid rebound with cough, runny nose, low grade fever, congestion (Dose number in series 4). The action taken with covid-19 vaccine ad26.cov2.s, elasomeran, elasomeran, and elasomeran was not applicable. The patient was recovering from suspected covid-19 infection, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Started with a headache and that has still lasted through until present day. I started feeling fatigue and that has also lasted - I'm still having issues with that. Indigestion - that has since lessened. I still have it but not as often. That really started dropping off about two weeks ago - early September, around the 7th or so (the indigestion). Breast sensitivity - but any temperature change at all would affect both of my breasts. That lasted for a month or three weeks or so. Food aversion - stomach was growling but no food sounded appetizing at all - that lasted for about a month. Then around August 25, I started having midline pelvic pain and I questioned whether or not I was pregnant and so I stopped taking my birth control and then consulted my doctor. The doctor called it sinusitis - he said that I had inflammation of nasal cavities. I completed the antibiotic - I completed that on September 7 (the day I went and got my second COVID shot) and still had all of those symptoms. He is counting that as a failed treatment.
Patient was given 2nd dose Shingrix and Pfizer booster dose on 12/03/22. On 12/8/22 she was given Fluzone HD. The next morning the patient  was experiencing blurr vision  in both eyes (worser on the right eye) which is still not resolved. Patient used cool and warm compress on the eyes  and was given Restasis to help alleviate the problem by her optometrist which also not helping.
Experiencing tinnitus, constant hissing loud sound.  Reported to both naturopath and to Dr.  Will see an audiologist.
Patient was given the monovalent vaccine and was supposed to be given the bivalent vaccine. No reaction occurred patient aware of error.
Rash developed over site. Started as a doughnut-shaped collection of "bumps" (as described by caregiver) and grew, by week 4, to a curiously uniform, raised, smooth hypopigmented (faintly erythematous), painless, annular marking.
Developed rash (small red bumps) over entire body starting about 24 hours after vaccine. Rash got worse overnight, itchy with some hives. Is especially red at injection site. Called pediatrician and they requested pictures be sent electronically. Pedi advised to give benadryl and stop amoxicillin. At 48 hours after vaccine, rash is same as this morning (bumps all over, itching is managed by benadryl).
Pt recvd vax & 4 days later devel optic neuritis; exp severe pain in the lt eye for apporx 10 days; exp a dec in vision resulting in complete loss of vision in lt eye;
Service member reporting that she developed Type 1 Diabetes in temporal association to receipt of anthrax vaccination #6 on 15 Sept 09. States she began to experience irritability, sluggishness, thirst and 'not feeling myself' over the next months. She was diagnosed in Feb '10 and has been followed by endocrine by out referral. Service member has learned that others have developed DM 1 and have linked it to receipt of the the anthrax vaccine.
inadvertently given daptacel instead of adacel with no reported adverse event; Inappropriate age at vaccine administration; Initial information was received on 29-Aug-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 11 years old female patient who was inadvertently given diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] instead of diphtheria-2/tetanus/5 AC pertussis vaccine [AdaceL] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV vaccine VLP RL1 4V (YEAST) (Gardasil), meningococcal vaccine A/C/Y/W CONJ (TET TOX) (Menquadfi) and COVID-19 vaccine for Prophylactic vaccination.  On 29-Aug-2023, the patient received a 0.5 ml, once dose of suspect diphtheria-15/tetanus/5 AC pertussis vaccine (Suspension for injection)  (lot C6013AA, expiration date: 05-Jul-2024, strength: standard) via intramuscular route in the left deltoid for Immunisation and patient was inadvertently given daptacel instead of adacel with no reported adverse event (wrong product administered) and (product administered to patient of inappropriate age) (Latency: same day). Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
shots given 1115AM started screaming constantly for 45min-1hr; 1230PM vomited x2; seen by MD sent to ped MD; HR 200 beat/min, monitored; t102; pt taken home around MN up q hr crying & vomiting more; CBC was OK; APAP given;
This spontaneous report as received from a nurse refers to an unspecified number of patients of unkown demographics. No concurrent conditions or medical history were provided. The nurse reported that PROQUAD (Merck) underwent a temperature excursion on 31-JUL-2014, stability was supported. An unspecified number of patients received doses of these vaccines on unspecified dates after 31-JUL-2014 (in August 2014) (dose, frequency and lot # unknown) subcutaneously. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
My mom received her first dose feb 11, 2021 and second dose of the pfizer covid vaccine on Mar 4, 2021. She experienced two brain bleeds, one after the first shot and the second brain bleed after the second dose. Both brain bleeds were detected by hospital's CAT  scan. The emergency room neurosurgeon indicated that he saw evidence of the old brain bleed that happened several months back and this new one that brought her into the emergency room on july 17, 2021. My mom died of this brain bleed on july 22, 2021
Patient underage (15) at time of vaccine. Janssen s approved for 18 and up. Pharmacist discovered error post-vaccination. Informed mother of patient of error and patient was monitored thoroughly prior to leaving facility for adverse reactions. No result of adverse reaction. Mother was made aware of potential side effects and what to expect going forward.
(R) thigh swelling, redness, tightness. Slight pain at site of injections. Mother gave 1 tsp BENADRYL and cool compress.
Pain - couldn't lift arm more than 5" - very red at injection site; swollen at site; felt like I had flu; muscle aches, no appetite; super tired; headache for 3 days; shivering so bad the bed shook.
Patient received influenza vaccine 12/1/10 and called 12/2/10 to report arm red and swollen where received vaccine. On 12/3/10 came into office to have checked left upper arm from injection site (deltoid) to antecubital red, swollen, tense, itchy per patient.
Pfizer-BioNTech COVID-19 vaccine EUA Patient passed out after waking up at 3 AM the day after the shot was administered. Symptoms included nausea and dizziness. Fever around 100°F begin the following day April 11, 2021 and persisted throughout the day.
Severe pain at injection site with large red area with bumps (raised from skin) on 12/30/2020 red area still present on skin
This case was reported by a nurse and described the occurrence of upper respiratory infection in a 55 year old female subject who was vaccinated with hep A vaccine inactivated (Havrix) for prophylaxis. The reporter is the pt. Concurrent medical conditions included seasonal allergy and possible viral illness. There were no concurrent medications. On 16May05 the subject received 1st dose of Havrix in the right arm. On 19May05, 3 days after vaccination with Havrix, the subject experienced an upper respiratory infection. On 23May05, approx 7 days after vaccination with Havrix, the subject experienced a rash on her arms and trunk. On, 24May05, the subject was seen by a physician, who felt the rash was viral in nature and not related to vaccination with Havrix. As of 09June05, the outcome of the events was unk.