chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A report  has been received from a Pharmacist concerning a male subject who had been receiving FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started during 2013. A patient accidentally received expired FLUMIST QUADRIVALENT from the 2013-2014 season which started on 25 SEP-2014. FLUMIST QUADRIVALENT  was discontinued during 2014. The outcome of the event of expired FLUMIST QUADRIVALENT patient accidentally received expired FLUMIST from the 2013-2014 season is unknown. The report was considered to be non-serious.
Information has been received from a physician concerning a male between 12-15 months who in approximately February 2006, "in the past month", was vaccinated SC with a 0.5 ml dose of varicella virus vaccine live (Lot # 650233/0912R). On approximately 01-FEB-2006, "two weeks ago", the patient experienced breakthrough lesions. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Exposure to chickenpox the week of 12/31/02 (cousin). Had varicella vaccine at age 1 with sneezing. No other upper respiratory signs or symptoms. Had temperature of 100.4F with vesicular lesions on erythematous base (1 on abdomen and 2 on anterior neck). Treatment: Rest, fluids and fever control.
Anaphylactic reaction; Chest Pain; Palpitations; SOB on exertion; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion medically significant), CHEST PAIN (Chest Pain), PALPITATIONS (Palpitations) and DYSPNOEA EXERTIONAL (SOB on exertion). At the time of the report, ANAPHYLACTIC REACTION (Anaphylactic reaction) outcome was unknown and CHEST PAIN (Chest Pain), PALPITATIONS (Palpitations) and DYSPNOEA EXERTIONAL (SOB on exertion) had not resolved.            Company comment: This is a spontaneous case concerning a patient of an unknown age and gender with no reported medical history, who experienced the serious (medically significant) expected event anaphylactic reaction, on an unknown date after receiving the second dose of mRNA-1273. Patient also experienced chest pain, palpitations and dyspnoea exertional since vaccination.  Clinical course, diagnostic tests and treatment details were not provided. Events seriousness captured as per IME list. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Concomitant drugs not reported.  consumer reported that one of the fried developed myocarditis with Pfizer vaccine and there was also reporting of increased acute appendectomy in the ages between 12 to 30 with second dose.  No treatment medication were provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.; Sender's Comments: Company comment: This is a spontaneous case concerning a patient of an unknown age and gender with no reported medical history, who experienced the serious (medically significant) expected event anaphylactic reaction, on an unknown date after receiving the second dose of mRNA-1273. Patient also experienced chest pain, palpitations and dyspnoea exertional since vaccination.  Clinical course, diagnostic tests and treatment details were not provided. Events seriousness captured as per IME list. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Have had intermittent difficulty catching my breath and heart beating fast since administration of the 2nd vaccine. Symptoms started the day after the vaccine and have continued for 4 days.
Individual reported tingling in mouth and swelling in throat within fifteen minutes of receiving the injection.  She was given 0.5 mg of epinephrine IM at 6:57 am after having begun her observation period at 6:47.  By 7:07 she reported feeling better.  Tingling in mouth continued until 7:26 and then she reported it stopped.  She left observation at 7:30.
Received a Hepatitis B shot today first of series. Got shot at 9:30 am, began feeling "funny" around 10 am. After lunch she used Albuterol inhaler, but has progressively became more short of breath. Now cannot converse due to shortness of breath. Brought in by school RN.  SOB and wheezing.
Pt reports vaccine hurt more than normal, flinched at time of injection. Now reports pain radiating from neck, all the way down her arm. Reports pain keeps her from raising her arm or holding it in a lifted position. Pt initial contact with me was on Saturday, 10/7/17. Advised pt to take TYLENOL and return if not resolved in a few days.
SON WAS VERY SICK FOR 2 DAYS; This spontaneous report received from a parent via a company representative concerned a 20 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 02-MAY-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 02-MAY-2021, the subject experienced son was very sick for 2 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from son was very sick for 2 days on 05-MAY-2021. This report was non-serious. This case, from the same reporter is linked to 20210526182.
Quarter size lump appeared proximal to R anticubital area before leaving vacc clinic but was not shown to any staff. Arm from wrist to shoulder became blotchy when leaving and turned to a purplish red blotchiness. Pain reported full extent of arm but decrease by next day. Blotchiness gone by next day. Lump remained but decrease over next 5 days and when finally assessed by medical personnel there was very small if any, lump. Pt was given ibuprofen and ice packs on arm during the 1st evening, following vaccine.
Pt recv vax on 3/1/99; on 3/3/99 pt exp sore arm, fever (103), tender abdomen, wheezing, tight chest & throat, throat tickle
This case was reported by a lawyer and described the occurrence of joint pain in a male subject of unspecified age who was vaccinated with LYMERIX. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). At an unspecified time after vaccination with LYMERIX, the subject experienced joint pain, stiffness, fatigue, flu-like symptoms, headaches, possible memory loss, decreased activities of daily life, rheumatologic, neurologic and/or cognitive impairment of an autoimmune, immune-mediated, or other mechanism, all reportedly caused by vaccination with LYMERIX. At the time of reporting the outcome of the events was unspecified. This information was received via a Statement of Injuries. Follow up information was received on 19 November 2008 via medical records. The subject received his first dose of LYMERIX on 24 May 1999, and his second dose on 16 June 1999. In June 1999, one week after his second vaccination with LYMERIX, he developed pain including his neck, lower back, shoulders, arms, and ankles. He was treated with LORCET, and was seen on 09 July 1999 for follow up of his LYMERIX vaccine. Impression included calf pain of unclear etiology. He was evaluated by a neurologist on 30 August 1999, and described pain from the knee down, tingling of his feet, and some low back pain, and stated that his legs "fail me at the end of the day". Neurological examination was normal. He was seen by a rheumatologist on 20 October 1999 for evaluation of musculoskeletal discomfort, at which time he reported a history of stiffness in his hands of approximately two years duration. At that time antinuclear antibodies were negative, but rheumatoid factor was mildly elevated (51). In January 2000, he was evaluated for musculoskeletal symptoms. On 11 April 2000, notes indicated that health care provider's concern for rheumatoid arthritis. He presented on 06 May 2000 for a second opinion regarding arthritis with a nine-month history of arthralgias and myalgias that were "certainly coincident with the Lyme vaccine". On 04 April 2002, notes indicated that the subject had been diagnosed with rheumatoid arthritis. The event of rheumatoid arthritis was assessed by GSK to be medically significant. During the course of treatment, the subject's medications included VIOXX, CELEBREX, LORCET, RELAFEN, and methotrexate. Follow up information was received on 20 November 2008 via an interview between lawyers and the subject. The subject reported that he received the first and second dose of LYMERIX in the summer of 1998 (contradicted by medical records). He reported that immediately following the second LYMERIX vaccination, he developed flu-like symptoms, neck pain, shoulder pain, back pain, foot pain, fatigue, hand pain, hand numbness, swollen hands, stiffness, lethargy, loss of stamina, and loss of grip strength. Treatment included methotrexate. The events were unresolved at the time of reporting.
Blisters appeared all over body, with huge ones on the arms, especially at site of vaccine administration. The blisters resembled insect bites and after 3 physicians, the dermatologist tested a fluid sample which confirmed Varicella.
Pt. had an adverse reaction to 1st dose of Pfizer vaccine. Pt. had complaints of subjective chills, malaise, runny nose, and lightheadedness.
3 hours after she received Vaccine her hands and knees started trembling; the vaccine hurt and it was gurgling when it was put in her arm and sounded like bubbles; Initial information received on 29-Sep-2023 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 78-year-old female patient (45.35 kg) who stated 3 hours after she received vaccine her hands and knees started trembling and the vaccine hurt and it was gurgling when it was put in her arm and sounded like bubbles after receiving influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On 15-Sep-2023, the patient received an unknown dose of suspect influenza quadrival A-B high dose HV vaccine (strength, expiry date, form, lot number: unknown) via unknown route in unknown administration site for influenza. Information on batch number was requested.  On 15-Sep-2023 the patient had events of 3 hours after she received vaccine her hands and knees started trembling (tremor) (latency: 3 hours) and the vaccine hurt and it was gurgling when it was put in her arm and sounded like bubbles (injection site pain) (latency: same day) following the administration of influenza quadrival A-B high dose HV vaccine.  Reportedly, 3 hours after she received Vaccine her hands and knees started trembling. Trembling lasted about 2 hours. She said it may have been due to her weight maybe. She stated that her husband took the vaccine and had no side effects. Consumer says she received the vaccine at a pharmacy on 15Sep2023 and didn't have any confidence in the woman that gave it to her as she seemed distracted. Says she had it in the left arm and no other vaccines the same day. Says the vaccine hurt and it was "gurgling" when it was put in her arm and sounded like bubbles. Says she only weighs 100 pounds but doesn't know if that has anything to do with it.  It was unknown if any lab data/test results available.  Action taken with quadrivalent influenza vaccine (Fluzone High-Dose Quadrivalent) was not applicable.  It was not reported if the patient received a corrective treatment for the events.  Outcome: Recovered / Resolved on an unknown date for the event.
Arm got sore and red patient put ice on it. Next day swollen and stiff put more ice on it. Next day very stiff and swollen doctor friend told him to go to ER. Dr said patient had cellulitis. Gave him rx for KEFLEX.
Persistent nausea; headaches in the morning; She is extremely fatigued, zero energy she said; This is a spontaneous report from a contactable consumer (mom/caregiver). A 44-year-old female patient (daughter) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: not provided), via an unspecified route of administration in Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient (daughter) works at a hospital as a Radiation Therapist. The patient got her first vaccination of the Pfizer vaccine a week ago (Jan2021). She was in bed unable to function for two days and was experiencing persistent nausea, headaches in the morning, and she was extremely fatigued, zero energy she said. The mom stated "This is so not like her. I think she may have gotten too big a dose of the vaccine. Please advise of what I can do to help her. I am a worried mom". The events were assessed as non-serious (reported as "Serious: No"). Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Chills,fever, hotness, headache, very tired,muscle aches,nausea , skin tenderness
Patient presented with rash on forehead, that extended towards the right side of her nose. The patient denied pain, but pruritus was present. The rash was red and small sores were visiable at close proximity. They were advised to see doctor and follo-up with pharmacy.
She has urticaria only on face 5 minutes after immunization, possibly after Rotateq oral administration. Urticaria resolved 30-35 hours later without any further treatment.
Patient has a pruritic rash, discrete papules with a erythematous base on both arms, thighs, upper chest, upper back 4-5 days after vaccine was given (on 5-13-2013).
Ever since getting the second vaccine I've been having on and off sore throat, fevers, nausea, dizziness, headaches, fatigue, and pleurisy. It is not explained by any bloodwork, x-rays, etc, everything is normal and yet I feel like crap almost every day. The only explanation I can see is the vaccine.
Achy; Arm was tender; Second shot hurt more; Little tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy), PAIN IN EXTREMITY (Arm was tender), INJECTION SITE PAIN (Second shot hurt more) and FATIGUE (Little tired) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054C21A and 006C21A) for COVID-19 vaccination.     no medical history has been provided.  Concomitant products included MESALAZINE (DELZICOL), IBUPROFEN, PREDNISONE, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (FLUTICASONE + SALMETEROL), SALBUTAMOL SULFATE (PROAIR [SALBUTAMOL SULFATE]), LORATADINE, PSEUDOEPHEDRINE SULFATE (CLARITIN D 12 HOUR) and COLECALCIFEROL (VITAMIN D3) for an unknown indication.   On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-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 PAIN (Achy), PAIN IN EXTREMITY (Arm was tender), INJECTION SITE PAIN (Second shot hurt more) and FATIGUE (Little tired). At the time of the report, PAIN (Achy), PAIN IN EXTREMITY (Arm was tender), INJECTION SITE PAIN (Second shot hurt more) and FATIGUE (Little tired) outcome was unknown.            Prednisone was taken by the patient after the first dose for Lupus flare up. Ibuprofen was taken by the patient after the second dose to help alleviate the adverse events.   This case was linked to MOD-2021-285055 (Patient Link).
This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 51-year-oold female patient who received FLUARIX. On an unknown date, the patient received FLUARIX (injection) .5 ml. On 1st October 2014, unknown after receiving FLUARIX, the patient experienced pain in arm and mobility decreased. On an unknown date, the outcome of the pain in arm and mobility decreased were recovering/resolving. The reporter considered the pain in arm and mobility decreased to be possibly related to FLUARIX. Additional information received: A nurse reported adverse events for 3 patients. Each patient was a female adult patient between 30 and 40 years of age. The patients all received the Flu vaccine from the same lot number. Each patient experienced extreme arm pain and limited arm mobility. The patients are recovering. The dose given was 0.5 mL for each patient. The field rep had no other information about the event. Additional information received on 07 April 2015: This case was reported for a 51-year-old female patient. On 01 October 2014, the patient experienced extreme arm pain and limited mobility in the arm. DOB was added.
Post vax pt developed an injection site reaction characterized by redness, swelling, warmth, and tenderness. No further info was available at the date of this report. Manufacturer's Comment: The reporter indicated that 5 or 6 pts experienced this event; however, they are not presently identifiable. Addtl reports will be generated when identifying info is provided.
Breakthrough COVID-19. I had symptoms starting on 12/26/2021 and tested positive on 12/27/2021.
"got sick with the flu" around the time of their scheduled 2nd dose which was 19Jun2021; Did not get 2nd dose yet; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA ("got sick with the flu" around the time of their scheduled 2nd dose which was 19Jun2021) and PRODUCT DOSE OMISSION ISSUE (Did not get 2nd dose yet) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA ("got sick with the flu" around the time of their scheduled 2nd dose which was 19Jun2021) and PRODUCT DOSE OMISSION ISSUE (Did not get 2nd dose yet). At the time of the report, INFLUENZA ("got sick with the flu" around the time of their scheduled 2nd dose which was 19Jun2021) and PRODUCT DOSE OMISSION ISSUE (Did not get 2nd dose yet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant product usage were not reported by the reporter. No treatment details were added.
Patient presented to the emergency department complaining of a burning pain in her chest. She was discharged the following day in stable condition.
Lethargy; Sore arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargy) and MYALGIA (Sore 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LETHARGY (Lethargy) and MYALGIA (Sore arm). At the time of the report, LETHARGY (Lethargy) and MYALGIA (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
After 8 days post vaccine, a red raised rash appeared at injection site.  Rash was circular and 5 inches in diameter.  There was pain in elbow area (lymph nodes?) as well.   No other symptoms. There was no rash or redness after the vaccine, only appeared 8 days later.
Four years post-menopaus, but bled vaginally, very minimally.  But nontheless.
Expired vaccine given to client on 09/01/22 and vaccine expired 08/31/22. No adverse symptoms occurred that  day of vaccination or thereafter that I am aware of. Contacted client of expired vaccine given.
Information has been received from a registered nurse concerning a 57 year old female who was vaccinated with the first dose of PNEUMOVAX (LOT# not reported), on 12-DEC-2008, was vaccinated IM with the second dose of PNEUMOVAX (LOT# 661528/0867X).  Concomitant vaccine including diphtheria toxoid + pertussis acellular vaccine (unspecified) + tetanus toxoid (manufacture unknown) at same office visit.  Within 3 days of vaccination of the 2nd dose of PNEUMOVAX, the patient developed an injection site reaction.  The patient developed a small bruise, redness, soreness, warmth and a 6.5X5.5 cm area of erythema.  The patient was also tired.  The patient treated with AUGMENTIN, BENADRYL, IBUPROFEN and warm compresses.  The outcome of adverse event was not reported.  It was reported that the patient sought medical attention:  seen in office.  This is one of several reports received from the same source.  Additional information has been requested.
She got her vaccines, she could not figure out what happened.  She had a sore arm and then had the headache that she took 2 Advil and the pain went away.  It was okay, had a headache, took some Advil and then continued on and off for a few days and then realized that it was from the vaccine.  She continued to the Advil and the third day it went away and she stopped taking the Advil.  She did not have any other symptoms.  She does not normally have headaches.
This spontaneous report as received from a pharmacist refers to a 66 year old female patient. No medical history or concurrent conditions were reported. On 10-JAN-2013 the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous at an unknown site. No lot number or expiration date was reported. No other co-suspects were reported. No concomitant medications were reported. The pharmacist stated that the patient developed jaw pain shortly after administration of ZOSTAVAX. The patient sought medical attention by calling the pharmacy but did not received treatment for the adverse event. The jaw pain resolved but lasted for about one week. No reporter causality was provided. Additional information has been requested.
strange feeling in tongue & diff swallowing occurring approx 20min p/inj;MD was notified & advised to wait 15min longer to see if sx disappeared or if they inc to give adrenalin;sx disappeared & no tx was given;