chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm was red; arm was swollen; Hard at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th April 2022, the patient received the 1st dose of Shingrix. On 13th April 2022, 1 days after receiving Shingrix, the patient experienced injection site erythema, injection site swelling and injection site induration. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site induration were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site induration to be related to Shingrix.     Linked case(s) involving the same patient:  US2021133158   Additional Information: GSK Receipt Date: 15-APR-2022 Reporter's Comment: The patient self-reported this case. The patient received dose of Shingrix vaccine in left arm and on next day his arm was red, swollen and hard at injection site. Referred to HCP (Health Care Professional). Adverse event filed in past with different product. This case has been linked with case US2021133158, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021133158:Same patient
Redness & discomfort to (rt) deltoid. Ice pack placed. Patient treated with KEFLEX 250 mg/5mL 2 tsp. TIX x10d.
Developed pruritus on lower extremities on Nov 26, 2009 followed by generalized hives except on face, chest and back on Nov. 27, 2009. Chills and tactile fever also on Nov. 27, 09. Took oral BENADRYL and CLARITAN. To ER on Nov. 29, 09 because of worsening skin rash. Rash remained for more than 1 week.
Information has been received from a registered nurse concerning a 16 weeks patient who was vaccinated, oral, with ROTATEQ on 15-JUN-2010, 19-AUG-2010, and 23-AUG-2010. No adverse effect was reported. The lot number of third dose was 663908/0176Y, the other lot numbers were no known. The patient sought unspecified medical attention. Additional information has been requested.
This spontaneous report as received from a physician regarding a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 05-JUN-2015, the patient received improperly stored VARIVAX (lot#J012151, expiry date: 28-SEP-2015, dosing details were not specified) which was stored at 23 Fahrenheit for 27:00 hours. There was not concomitant medication reported. No adverse effects was reported and no product quality complain involved. This is one of several reports received from the same reporter. Additional information has been requested.
I verified patient was receiving his first COVID-19 vaccine, to which the patient responded yes. I administered the vaccine after confirming the patient's identity and gave him his vaccine card. He then pulled out a completed COVID-19 Vaccination Record Card and asked if I could combine the three vaccines on one card. The patient deliberately withheld the truth when saying he had not yet received the vaccine. Patient said he was advised by physician to received a third dose because the patient suffers from diabetes and travels frequently.
9/24/10 - Received TDAP - Influenza and pneumococcal polysaccharide 23. At site of PPS - given subq - lg read area 14 x 9 cm - fever chills - aching 2 days after injections. Also nausea and loss of appetite.
This case was reported by a physician via call center representative and described the occurrence of adverse reaction in an unspecified number of adult patients who received SHINGRIX for prophylaxis.  On an unknown date, the patients received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patients experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The age group was not reported, but was captured as adult as per the vaccine indication. The physician stated that he had never seen so many patients with severe reactions, it was worse than any vaccine he had ever seen. Attempt was made in order to gather further details from the healthcare professional, but he declined to provide any information and stated that all the stuff that was in the package insert and it should be already known.
Woke up with the feeling of my heart fluttering or beating fast and felt slightly out of breath.  Had to focus on relaxing and taking deeper breaths to alleviate it.  Found it difficult to sleep that night.  I had never experience this feeling before.    Several times since then, I have felt the same sensation and it seems to coincide with higher stress at work, but I've never had this sensation before I had the vaccine from stress or otherwise.
8 days post vaccination noticed site became reddened, firm, warm and itchy.  Hydrocortisone applied and took Advil, had temp 99.3.  Area is subsiding very slowly
no adverse event; did not refrigerate it; This spontaneous report was received from a pharmacist referring to a female patient of unknown age. The patient's medical history, concomitant medications and concurrent conditions were not reported. On an unknown date in January 2020 (also reported as early January 2020), the patient picked up a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) one dosage form of lot number 1621934, expiry date 29-JAN-2022 (strength and route of administration was not reported) for prophylaxis at a pharmacy, did not refrigerate it, and brought it to her doctor's office for administration several days later (product storage error). The patient did not experience any symptoms (no adverse event). The lot did not undergo any temperature excursion previously and the call was not because of a data logger. There was no product quality complaint (PQC).
Havrix instead of Twinrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a male patient who received HAV (Havrix) for prophylaxis.   On 25-JUL-2023, the patient received Havrix. On 25-JUL-2023, an unknown time after receiving Havrix, the patient experienced wrong vaccine administered (Verbatim: Havrix instead of Twinrix). The outcome of the wrong vaccine administered was unknown.   Additional Information: GSK Receipt Date: 25-JUL-2023 The reporter was a pharmacy technician. The reporter did not consent to follow-up. The reporter called to inform that earlier that day, a patient who wanted to receive Twinrix received only Havrix (due to insurance only paying for HepA and HepB vaccines separately), which led to wrong vaccine administered.
got sick for a week "with like, COVID symptoms"; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2023NVX-US-000001361 (Novavax).  A 64-year-old female patient received bnt162b2 (BNT162B2), in Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history included: "COVID symptoms" (unspecified if ongoing), notes: The patient reported she had COVID-19 prior to receiving any COVID-19 vaccines. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: Mar2021, when the patient was 64 years old, for COVID-19 immunization, reaction(s): "Fatigue", "Sickness". The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "unknown"; ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "got sick for a week "with like, COVID symptoms"".  Additional information: On 23Oct2023, it was reported that a patient started treatment with Pfizer BioNTech COVID-19 vaccine dose 1 in Mar2021 and dose 2 in Apr2021 (primary series), and dose 3 (booster) in in Nov2022 "before holiday" but was unsure of exact dates, for COVID-19 vaccination. It was reported that each time the patient got a vaccine or booster, she got sick for a week "with like, COVID symptoms" and fatigue. The patient reported she had COVID-19 prior to receiving any COVID-19 vaccines and stated that her doctor said it could be because she had COVID-19, and the long-term antibodies could be making her ill.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300182857 same patient/ event, different vaccine dose number;US-PFIZER INC-202300358321 same patient/ event, different vaccine dose number;
I had soreness in the left arm initially.  The morning after the vaccine, I woke up feeling sick.  My body was achey and I felt lethargic and flu-like.  I did not have fever.  This largely cleared up by the evening.
Patient was given second full dose; Partial dosage due to syringe leakage; Partial dosage due to syringe leakage; A spontaneous report was received from a nurse concerning a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and the patient was given partial dosage due to syringe leakage and patient was given second full dose.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 14 Jan 2021, around 12:15 PM, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013L20A) intramuscularly for prophylaxis of COVID-19 infection. Due to a syringe leak, the patient was given a partial dose. About five minutes later, the patient received a second full dose of mRNA-1273. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The events, patient was given partial dosage due to syringe leakage and patient was given second full dose, were considered resolved on 14 Jan 2021.; Reporter's Comments: This report refers to a case of Product administration error for mRNA-1273 (Lot number: 013L20A). There was incomplete dose administered due to syringe leakage and after 5 minutes another full dose of vaccine was administered. There were no reported AEs with this case of incomplete dose administered, syringe leak and an extra dose administered error.
Six patients received expired Moderna vaccine booster shots after 30-day Use By Date / after manufacturer date of expiry.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Six patients received expired Moderna vaccine booster shots after 30-day Use By Date / after manufacturer date of expiry.) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Six patients received expired Moderna vaccine booster shots after 30-day Use By Date / after manufacturer date of expiry.). On 27-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Six patients received expired Moderna vaccine booster shots after 30-day Use By Date / after manufacturer date of expiry.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The  concomitant medications on use were not provided. No treatment information was provided.  The vial did not undergone any temperature excursions.   This case was linked to MOD-2021-429240, MOD-2021-429269, MOD-2021-429289, MOD-2021-429321, MOD-2021-429337 (Patient Link).
Redness, swelling and lump to Left thigh. mom gave ibuophen and warm compresses. seen in office on 7-29-16 continued with redness and small lump.
I administered a .25 FLUZONE to a 3yr old on 09/24/2018. Pt mom is aware of this.
Rashes and those rash become swollen; face become swollen; itching; very painful; Lips become swollen; She is bleeding so much of bleeding from there; This is a spontaneous report from a contactable consumer (patient's daughter). A 66-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), dose 2 via an unspecified route of administration on 12May2021 (Batch/Lot Number: EW0172) as 2nd dose, single for covid-19 immunisation. Medical history included diabetes, high blood pressure and high cholesterol. Concomitant medications included amlodipine; insulin lispro (HUMALOG), empagliflozin, linaglipin, metformin hcl (TRIJARDY XR) and lovastatin all taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of bnt162b2 on unspecified date for Covid-19 immunization. On 15May2021, 2 days after vaccine administration, it was reported that the patient's body reacted to the vaccine. The side effect which the patient got was in the form of rashes and those rash become swollen and her face become swollen and is very itching and very painful, her lips become swollen. The daughter went to almost all doctors in urgent care and they are giving basically allergy medication but the allergy medications that they are giving is making worse. And the doctor says this is new for them so they don't know why her body is reacting to the vaccine like this. The patient was administered with treatment medications which includes Prednisone, Pepcid, Benadryl, Claritin, she also got Solu-Medrol, which the daughter reported was making the events worse and now the doctors ae not doing anything. Because the patient was given steroids her sugar and WBC came up. The daughter also reported she is bleeding so much of bleeding from there. The patient underwent blood test on 15May2021, 16May2021 and 17May2021 which were normal. The outcome of the events was unknown.
At approximately noon the day after my approximate 6:30p shot the day before, I began experiencing symptoms including headache, body aches (including, but not limited to, the site of the injection), dizziness and nausea. Throughout the afternoon I developed a minor fever which, at about 6:00p was 100.2. At that time I was able to take and keep down some Tylenol which brought my fever down. Overall, symptoms mostly subsided 12 hours after onset (approximately 30 hours after vaccine administration).
fever, chills, joint and muscle aches, night sweats, fatigue, lightheadedness, foggy headedness, - 3 days in a row starting April 8 then subsided and started again a few days later
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; UNABLE TO SLEEP LYING DOWN AND HAD TO SIT IN BED TO  SLEEP; This spontaneous report received from a patient concerned a 52 year old male. The patient's height, and weight were not reported. The patient's past medical history included: bilateral pneumonia, and concurrent conditions included: asthma, non smoker, and abstains from alcohol, and other pre-existing medical conditions included: The patient had no known allergies and no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, and expiry: UNKNOWN) dose was not reported, 1 total administered to left arm on 07-APR-2021 for prophylactic vaccination (Dose number in series 1). No concomitant medications were reported. On 20-DEC-2021, the patient experienced confirmed clinical vaccination failure. The patient experienced very bad symptoms that started on (monday) 20-DEC-2021: difficulty breathing, fever of 101.9 F, could not sleep down and had to sit in bed to sleep, headaches and body aches and went to Emergency room on same day. On 20-DEC-2021 Laboratory data included: Body temperature (NR: not provided) 101.9 F, Influenza A virus test (NR: not provided) Not reported., Influenza B virus test (NR: not provided) Not reported., Laboratory test (NR: not provided) Not reported., and Mycoplasma test (NR: not provided) Not reported. The doctors said that it was probably related to history of asthma and was discharged home with treatment medications dextromethorphan hydrobromide/promethazine hydrochloride, and prednisolone.  The patient stated that symptoms were getting worse, and went to emergency room again on 22-DEC-2021, there laboratory data included: Chest X-ray (NR: not provided). Physicians stated that lungs were very inflamed but no liquid present, so they ruled out pneumonia. Treatment medications included: dexamethasone. On 23-DEC-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. The patient stated that difficulty breathing and the fact he needs to sit up to sleep are still present until 25-DEC-2021. Fever, body aches and headache gone since 23-DEC-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection, and unable to sleep lying down and had to sit in bed to sleep, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with regulatory authority: 90000208727.; Sender's Comments: V0. 20211256656-Covid-19 vaccine ad26.cov2.s -confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Patient received a COVID vaccine at an outside pharmacy, he is unsure of which one (asked if it was Pfizer, Moderna, or J&J - he does not know). Next day with some nausea, then became tachypneic, presented in DKA with pH 7.05 requiring hospitalization.
When I was reading my emails for work the next day I realized the letters were wiggly. I couldn't make out what it was saying. I can't tell if it is getting better or worse. It also impacts my driving. I have an appointment in December.
I have a rash all over my body, but it is more intense in my upper body, in my left arm and my chest and neck. It itches a lot. It began in my left arm (in the vaccine site) and spread to my neck and body on Friday, June 18.  Today I still have the rash.
Pt reports onset of fever, chills & all-over body aches on 8/30/09, injection was given 8/28/09.
This spontaneous report was received from a medical assistant and refers to 3 patients of unknown age and gender. The patient's pertinent medical history or drug allergies/drug reactions were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (lot # L019125, expiration date 27-MAy-2017) (dose, route of administration and anatomical location were not reported). There was no concomitant medication reported, and no adverse effects were reported. Additional information has been requested.
pt became lethargic, lips swelling, diff breathing, gen red rash from head to toe;taken to peds office by mom;MD gave epi & DPH;sx appeared w/in 1-2hr p/vax;
Intractible Headache. Onset of headache 2 days ago after flu shot. Took Vicodin and went to sleep by 3am. On Wednesday she felt a little better took Vicodin 1 four times a day with minimal effect and got went to sleep by midnight and felt better that morning. Around 9am patient felt a little better but had to take some Vicodin by noon. About 1 hour later vomit with no blood. The headache got worse.  For breakfast patient ate a salad of shrimp for lunch with dressing -- no one else sick at facility. NO abd pain, diarrhea. Last bowel movement on 9/13.  Pt was seen seen by provider around 3:20pm and Had not had another Vicodin for 3 hours. NO vision or hearing or balance in the last 2-3 days. No Fever, chills, head congestion, myalgias. NO more weakness or numbness on one side or another. Pt took all other usual medications.
got the shot the evening before, when I woke up next morning I was dizzy, nauseous, achy, and unable to do anything but sleep/lay down. If I got up, I would start spinning and had to immediately lay down. This lasted well into the evening  when I was able to at least get up for a few minutes at a time. I could not eat anything.
On 10/14/2022, my face broke out in a bright red burning flush when I drank alcohol. It happened again in December and January. I have been using a lotion twice a day for Rosacea. The doctor says it will never go away.
Information has been received from a health professional concerning a 13 (also reported as 12) month old health female who, in the last month, in approx Jun05, was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). It was reported that 10 days after vaccinated with measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3), in approx June 2005, the pt developed a fever of 105F and an atypical measles rash. It was reported that the pt recovered. Unspecified medical attention was sought. No product quality complaint was involved. Additional information is not expected.
Vaccinee became pregnant following vaccination (LMP = 2/20/03) despite using birth control.  An ultrasound on 4/14/03 indicated a viable pregnancy of 6 weeks, 2 days gestation.  Fetal heart activity was not identified, but would also not be expected at this gestation.   She has been entered into the CDC Smallpox Vaccination Pregnancy Registry.