chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm weakness; sore arm; fatigue; felt crazy; felt the pain of my shingles; felt the pain of my shingles; nerve pain I've been experiencing in my left neck/shoulder area; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 31-year-old (non-pregnant) 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, administered in arm right on 20Apr2021 11:00 (at the age of 31-year-old) at dose 2, single for covid-19 immunisation. Medical history included vitamin d deficient, herpes zoster from 2015 to 2018 (I previously had shingles between 2015-18 but there was no rash, no redness, nothing there at all). Concomitant medication included levocetirizine dihydrochloride (XYZAL); multivitamins [vitamins nos] (MULTIVITAMINS [VITAMINS NOS]) both taken for an unspecified indication, start and stop date were not reported. Patient did not have COVID prior vaccination. Patient has not tested for covid post vaccination. Patient did not have other vaccine in four weeks. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in arm left on an unspecified date in Mar2021 11:00 at dose 1, single for covid-19 immunisation and experienced sore arm. On 21Apr2021 08:00 the patient experienced sore arm, fatigue, felt crazy, felt the pain of my shingles, nerve pain i've been experiencing in my left neck/shoulder area, On 23Apr2021 arm weakness. Adverse event: I had no reaction to first dose other than sore arm day of and second day. Second dose sore arm and fatigue first day but the second day I felt crazy because I felt the pain of my shingles in all five places that I previously had shingles between 2015-18 but there was no rash, no redness, nothing there at all. And the nerve pain I've been experiencing in my left neck/shoulder area was the worst it's ever felt. Day three after second vaccine is just arm weakness and fatigue. Patient did not receive treatment for the adverse events. Outcome of the events was resolved on an unspecified date in 2021.  No Follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
weakness in the muscle; Joint pain; lumps under the skin / Little lumps on left hand side; Fatigue; painful if you touch it them / in contact with water hurts like needles; Muscle pain; Tngling; This case was reported by a consumer via call center representative and described the occurrence of muscle weakness in a 63-year-old male patient who received Herpes zoster (Shingrix) (batch number DA9R2, expiry date 30th September 2022) for prophylaxis.   On 19th October 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced muscle weakness, joint pain, mass, fatigue, pain, muscle pain and tingling. On an unknown date, the outcome of the muscle weakness, joint pain, mass, fatigue, pain, muscle pain and tingling were not recovered/not resolved.  It was unknown if the reporter considered the muscle weakness, joint pain, mass, fatigue, pain, muscle pain and tingling to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient for himself. The patient got the dose of Shingrix vaccine in the right arm and developed little lumps on left hand side every 2 ,3 inches, they go to the back, painful if you touch it them, in contact with water hurts like needles, muscle pain, fatigue, tingling, joint pain all mostly on the left hand side  The reporter consented to follow up. For tolerance to the 2nd dose refer case US2021178461; Sender's Comments:  US-GLAXOSMITHKLINE-US2021178461:Same reporter
Pt reported lump and redness at injection site starting on day of vaccination (11/12/21). Then reported dizziness that occurred on Tuesday 11/16/21.
EXPERIENCED TINGLING 4-5 MINUTES AFTER RECEIVING VACCINE.  TINGLING IN CHEST AND THROAT.  BENADRYL 25MG PO GIVEN.
Pt felt throat thickening and tightness. Pt was taken to ER. Pt tx'd with 2 BENADRYL tabs.
A non-serious spontaneous report of administered expired FLUMIST was received from a nurse concerning a ten-year-old female. The patient received FLUMIST on 02-Dec-2008 The patient was given FLUMIST that expired in December 2007. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1)customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication error that occurred shortly after the product expired. Additional information received on 09-Apr-2009: product complaint investigation results.
After receiving first dose patient states " i feel really lightheaded and tingling sensation. ".  Vital sighs initiated, Ice packs applied
Patient did not report any AEs to pharmacy.  Post-vaccine Lot# audit found this may have been administered after expiration date of 8/31/22. Pharmacist has reached out to the patient to determine if any AEs occurred.
Slept a lot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 64 years for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), in Oct2022 as dose number unknown, single (Batch/Lot number: unknown), in left arm for immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: astrazeneca coviD-19 vaccine (Dose: 01, Time: 10:00am, Anatomical site of injection: Right Arm, Route of administration: Intramuscular, Lot number: A-03324), administration date: 22Dec2020, when the patient was 62-year-old, for COVID-19 Immunization; astrazeneca coviD-19 vaccine (Dose: 02, Time: 10:00am, Anatomical site of injection: Right Arm, Route of administration: Intramuscular, Lot number: A-03468), administration date: 19Jan2021, when the patient was 62-year-old, for COVID-19 Immunization; BNT162b2 (Dose 3 (Booster), Time: 02:00pm, Anatomical site of injection: Right Arm, Route of administration: Intramuscular, Lot number: FE3590), administration date: 24Oct2021, when the patient was 63-year-old, for COVID-19 Immunization; BNT162b2 (Dose: 04, Time: 01:00pm, Anatomical site of injection: Left Arm, Route of administration: Intramuscular, Lot number: FM9992), administration date: 23May2022, when the patient was 64-year-old, for COVID-19 Immunization.  The following information was reported: HYPERSOMNIA (non-serious) with onset 29Jan2023, outcome "unknown", described as "Slept a lot". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of hypersomnia.
With the first vaccine on 1/29/21 I feel slight soreness at injection site and itching all over about eight hrs after which lasted a day. With the second vaccine on 2/16/21 I felt itching after about six hours for a day and took Benedyl and tylenol.  In the 21th I began to be sore all over, my knees, back, shoulders, ached and it was painful to rise from a seated position. It was all my joints were inflamed. I did not have a temperature, my blood pressure went down to 119/55. I am taking warm baths, tylenol, and waiting for the pain to subside. I also feel fatigued. I will call my primary Doc if I don't continue to improve.
joint pain; fever of 100.3 Fahrenheit; chills; nausea; headache; This case was reported by a consumer via other manufacturer and described the occurrence of joint pain in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   Co-suspect products included thyroid for product used for unknown indication and lenvatinib mesilate (Lenvima) for product used for unknown indication.   Concurrent medical conditions included endometrial carcinoma. Concomitant products included pembrolizumab (Keytruda).   On 7th October 2020, the patient received Influenza vaccine Quadrivalent 2020-2021 season. On an unknown date, the patient started thyroid at an unknown dose and frequency and Lenvima 20 mg at an unknown frequency. On 8th October 2020, 1 days after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced joint pain, fever, chills, nausea and headache. The action taken with thyroid was unknown. The action taken with Lenvima was unknown. On an unknown date, the outcome of the joint pain, fever, chills, nausea and headache were unknown.   The reporter considered the joint pain, fever, chills, nausea and headache to be related to Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The patient has endometrial carcinoma C54.1.  The patient was taking with Keytruda. The age at vaccination was not reported. The patient reported having chills, fever of 100.3 degree Fahrenheit and nausea on the first day of taking Lenvima (8th October 2020). Patient thinks that it was related to her Thyroid dosage decreased on Tuesday 6th October 2020and getting the flu shot on Wednesday 7th October 2020, does not think that it was related to Lenvima. The patient reported headache and joint pain that she has had since she starting Lenvima.
severe difficulty swallowing worsening;  sore throat; severe throat tightening; redness of face, chest and ears; rapid heartbeat;irregular heartbeat, pounding in chest; discomfort in chest above breast from the front into the back and worsened(increased) when swallowing. Polysorborate 80 - Positive Allergic Response skin test.***Interestingly, all adverse reactions presented when exposed to PEG & Polysorborate 80 agents have similar characteristics but to a significantly lesser degree the Pfizer V 1st dose
the medication leaks out and one time the needle just came off, with no AE; nurse went to inject the patient and the vaccine leaked down his arm, with no AE reported; Initial information received on 22-Oct-2021 regarding an unsolicited valid non-serious case from another health professional via Medical Information (Reference number- 00824901).  This case involves a 82-year-old male patient who was vaccinated with suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] experienced needle was loose under the luer lok adaptor and some of the vaccine leaked out (underdose and syringe issue).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On 19-Oct-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ765AC and expiry date: 30-Jun-2022) (Frequency = once) via intramuscular route in the left deltoid for prophylactic vaccination.  It was an actual medication error case due to vaccine underdose and syringe issue. (latency on same day).  It was reported "when she attached the needle to the FLUZONE HIGH DOSE QUADRIVALENT vaccine the needle was loose under the luer lok adaptor and no matter how hard she tries to tighten it, it will not tighten and just continues to turn without locking. When a nurse preps the dose and or attempts to inject the dose, the medication leaks out and one time the needle just came off."  At time of reporting, no adverse event was reported.
After receiving the booster shot, I took two Aspirins. After a few hours I was not feeling that well. A couple of hours after I developed a fever, chills, a body ache, joint pain, headaches, dizzy, and nauseous as well. I was still taking fever reducer, however the symptoms persisted for about 2 days. The feeling of something is off continued for about a week and the joint pain is something that I am still suffering from today. It was the most intense symptoms I had in all 3 vaccines.
Patient received COVID19 (Pfizer) dose at 2:18pm from a vial that had been out of storage since 8:15am. The acceptable time to give the vaccine was from 8:15am-2:15pm. The dose given was out of the 6 hour window in which it should have been given, and therefore patient was given an expired dose.
ACHY; CHILLS; TENDERNESS ON TOP OF THE HEAD; SORE ARM; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 18-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-JUN-2021, the subject experienced tenderness on top of the head. On 18-JUN-2021, the subject experienced sore arm. On 19-JUN-2021, the subject experienced achy. On 19-JUN-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tenderness on top of the head on 21-JUN-2021, achy, and chills on JUN-2021, and sore arm on 26-JUN-2021. This report was non-serious.
2 days post vax, pt had seizure, 5-6 sec. 1/30 exp seizure lasting few sec. 1/31 exp  2 seizures lasting few sec. Seizures continued and inc in frequency. Admitted to hosp, seizures were partial w/ spikes coming from left temporal region. The pt was placed on valproic acid and released bu continued to have seizures every hour and then placed on Tegretol. 60 day follow-up dated 7/24/00 provided no additional data. Information has been received from a physician concerning a 12-month-old patient with a history of otitis media and sinusitis who on 27-JAN-2000 was vaccinated with PNEUMOVAX 23. On 29-JAN-2000 the patient had one seizure that lasted a few seconds. On 30-JAN-2000, the patient had another seizure that lasted a few seconds. On 31-JAN-2000, the patient had two seizures that lasted a few seconds. The patient came into the office for a visit. In the office, the patient had another seizure and an EEG and blood work were done. The patient went home and had a few more small seizures on the way home. The patient was admitted to the hospital where an EEG. MRI, and blood work were performed. While taking the EEG, the patient had another seizure. The seizures were determined to be partial seizures with spikes coming from the left temporal region. The blood work and MRI were normal. The patient was placed on valproic acid and sent home. The patient continued to have seizures every hour on the valproic acid. The patient was put on Tegretal and the valproic acid was discontinued. Additional information has been requested.
Chills, sweats, fever of 102. Site got really red and widespread. It swelled and was filled w/fluid. Itch and hurt.
pt recvd vax & devel a 3-4 inc diameter rash @ the site of inject & on front & back of trunk; this lasted 2 days; On 3rd day larger red raised bumps appeared; these were tender to touch & lasted 10 days; severe h/a & genl malaise;
This spontaneous report was received from the Vaccine Coordinator referring to a 2 year old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 09-NOV-2017, the patient was vaccinated with an improperly stored dose of VARIVAX with one of these lot #'s reported M017292, expiration date on 07-APR-2018; lot # N017701, expiration date on 09-JUN-2019 or with lot # N019127, expiration date on 22-JUN-2019 (Strength, route, dose, frequency, and anatomical location were unknown) for prophylaxis. There was no adverse effect reported. The administered dose of vaccine experienced the temperature excursion of 7.52 F degrees Fahrenheit for 24 hour, and had a previous temperature excursion of 5.5 F degrees Fahrenheit for 1 hour. There was a digital data logger involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA008693.
2 lumps under lt arm then next day 1 lump under rt arm; reddness also noted on lumps; lumps came & reduce & then inc in size over approx 2 wks time;
Immediately after returning from the flu clinic, she felt faint, flushed, was diaphoretic and vomited twice.
No additional adverse effects reported.; A medical assistant states that on 09/30/2020 an expired dose of VARIVAX (lot R026715. expiration 09/18/2020) was administered on 09/30/2020.; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.    On 30-SEP-2020, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection (strength, dose, vaccination scheme, route of administration and anatomical site of vaccination were not reported; lot number R026715, which has been verified to be valid, expiration date reported and validated as 18-SEP-2020) as prophylaxis. The vaccine administered did not experienced any temperature excursions. No additional adverse events were reported.
pt recv vax 3AUG95 between 1600 & 1630;1410 4AUG9 pt was sleeping alot, limp, eyes rolled back @ noc;woke up to eat, & rectal temp was 98.6;@ this time mom called MD to report adverse events;5AUG95 pts t104, not eating well was sleep pale
Pain/Generalized Aching, Rhinorrhea/Runny Nose; Pharyngolaryngeal pain/ Sore throat. Information regarding Flumist (2003-2004 formula) nasal solution (frozen)) was received from a mother of a 10 year old female who experienced runny nose, sore throat and aches. At 10 years of age, the patient received a dose on 13-Dec-2003. The patient experienced runny nose (rhinorrhea), sore throat (pharyngolaryngeal pain) and aches (pain) on 16-Dec-2003. No additional information was available at the time of this report.
The patient record indicated that she has not gotten her first booster yet, and when patient was asked if she wanted to get her booster she agreed.  The family came in and said that the patient had gotten her first booster 7/8/22  of Moderna but was given again Pfizer vaccine 7/25/22.
aching, pain in RUE from inj site up to shoulder & down to wrist;
Patient reported having some lightheadness and dizziness. Patient stated that all she had this morning was some juice because she was told not to eat. Patients vital signs @ 1:07 BP 137/71 HR 65 O2 98% Temp 98.1 BS 89 Patient rested for about 30 mins and vitals were BP 124/79 HR 60 O2 98%
Headache; migraine; pretty uncomfortable; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient just had first dose of the Pfizer Vaccine (Covid-19 Vaccine) yesterday at 1 PM. On an unspecified date, the patient was just dealing with the headache and the migraine at this point was pretty uncomfortable. The patient was trying to not take anything and was holding to able to take an Excedrin and cannot find anything online everything, the piece of paperwork the patient got said that cannot take an Excedrin. Outcome of the events were unknown.  Information about lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
pt recv vax 12AUG97 & morning of 13AUG97 pt was swelling & warmth noted in deltoid area of lt arm;pt started breaking out in whelps around inj area;whelps progressively moved down the arm & up the shoulder;
post injection dizziness, seeing spots few minutes after. brought obs via wheelchair, states anxiety with injections. sitting on side of stretcher, patient states feeling better and back to baseline after given water. vss throughout stay in obs 1412 bp 131/75 hr 61 rr 18 sats 97%, denies dizziness upon standing. escorted to private vehicle without issues at 1435.
Reaction at injection site: patient experienced redness, warm to touch, itching, and pain, and a hard knot. Headache. No treatment reported.
The patient felt faint 5 minutes post-vaccination while in the monitoring area; she was seated. She was brought over to be seated closer to the pharmacy by a friend. While seated, she fainted for about 5 seconds according to her friend. Upon inspection, she looked pale and her lips turned blue. She recovered fully after resting in the chair. She was monitored for another 20 minutes before leaving.
On Saturday, April 3rd I got my first Pfizer Covid shot. I didn?t have any side effects like what they said could happen such as Covid symptoms.  On Tuesday, April 13th, 10 days after I had gotten the shot I noticed these red marks by my eye, it was in the morning and they came out suddenly so I thought I had gotten bit by some thing.   Over those previous 10 days I noticed that my hands were extremely sore but I have arthritis in my fingers and can have tightening and soreness when the weathers bad so I chalked it up to that.  Even though it was worse than what it normally would be.  By Friday the 16th, the reddened areas of my face were swollen, my lymph nodes in my neck and around my ear started to swell.  My cheek bone,in jaw bone, and eye socket were in terrible pain.  I went to medical and they thought it was a spider bite that was getting infected they put me on an anabiotic.  I have pictures.  Saturday the 17th I was so exhausted!  I could not get off the couch. I slept all day Saturday, literally getting up to take a couple of bites of food and either laying back on the couch are going back to bed.  Sunday I woke up I felt better not 100% but I had some energy. The marks on my face were no different and now they are getting more painful burning, itching, still swollen and very painful to the touch.  4/20/21 nothing has gotten better. I went to the urgent care one of the PAs said it looks like it?s shingles.
This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE, ILLNESS, PERIARTHRITIS, and HYPERSENSITIVITY in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE and ILLNESS. On an unknown date, the patient experienced PERIARTHRITIS and HYPERSENSITIVITY. At the time of the report, PRODUCT DOSE OMISSION ISSUE, ILLNESS, PERIARTHRITIS, and HYPERSENSITIVITY outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure systolic: 200 (High).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jun-2021: Follow up received on 26-JUN-2021. No New Information On 27-Jun-2021: Follow up received on 27 Jun 2021, no new information updated.
9 cm swollen area left deltoid, tender and itchy, started 24 hours after shots. 72 hours after shots, vomiting, temp 100 degrees.