chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She had COVID and she is still testing positive; She had COVID and she is still testing positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "She had COVID and she is still testing positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: She is still testing positive.  Clinical Course: Caller's concern was a caller said that she has an appointment scheduled for tomorrow. She had COVID and she is still testing positive and she is well over most of the symptoms and her doctor feels that she shouldn't get a booster right now. Her doctor said she should wait a few weeks. She shouldn't get a booster just so close to having COVID. She wants to know what our opinion is. Advised the caller I will transfer her to #. However when reading the # the caller interrupted and she said she wanted to know how she will cancel her appointment schedule. Provided the information from the Knowledge Article the caller then hung up. Creating AE Form since the caller had COVID and she is still testing positive and she is well over most of the symptoms and her doctor feels that she shouldn't get a booster right now.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
T98.5;light rash approx beginning 2 days ago 9/27/99;had immun 9/22/99;checked by NP;rash apparently not r/t vax;mom advised to d/c certain items used in baby bath & also detergent;
Sore from day 1. In a few days the patient developed muscle weakness in the Left arm and decreased ROM. This weakness has lasted 6 months. Pt hobby is archery and he can not pull back his elbow, which he could prior to shot.
pt recv vax & became pregnant LMP 5/30/97;the estimated date of delivery is 3/5/98;routine sonograms were performed 5/97;pt exp preterm lab;
Since receiving the COVID 19 second shot I have developed reoccurring migraine headache.  Currently averaging 8-10 migraine headaches/month. I have a history of migraine headaches dating from 1973-1997.   All migraine activity stopped following a complete hysterectomy.   From 1997-March 2021 I had been migraine free.
Patient had several ED visits within 6 weeks of receiving COVID vaccination. DOS include 2/5/21, 2/7/21, 2/22/21, 3/1/21, 3/4/21, 3/5/21 and 4/10/21. She presented to the ED and was subsequently hospitalized on 3/10/21, 3/22/21, 4/18/21, 5/8/21. All of these visits were related to mental health except on 3/1/21 when she had gastroenteritis.
does not feel good; aches and pains; low grade fever; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in a adult male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 20-SEP-2023, the patient received Arexvy. In SEP-2023, an unknown time after receiving Arexvy, the patient experienced pain (Verbatim: aches and pains) and low grade fever (Verbatim: low grade fever). On 21-SEP-2023, the patient experienced feeling unwell (Verbatim: does not feel good).  The outcome of the pain, low grade fever and feeling unwell were not resolved.   It was unknown if the reporter considered the pain, low grade fever and feeling unwell to be related to Arexvy.     It was unknown if the company considered the pain, low grade fever and feeling unwell to be related to Arexvy.   Additional Information: GSK Receipt Date: 21-SEP-2023 The patient reported he got the Arexvy vaccine and next day of vaccination he was not feeling good. He also had aches and pains. He had low grade fever. The patient did not want to provide any information. The reporter did not consented to follow up.
Significant pain, redness, swelling in arm at injection site. Expanded over Day 2-4 ultimately covering most of posterior upper arm. Patient treated with antibiotics and pain med and resolved over next 10 days.
dizziness, h/a, nausea, diarrhea, tired to exhaustion-lasted 3 days; began approx 6 hrs p/vax; pt was given Compazine & Vicodin; took approx 1 wk to gain full energy level back;
slept a lot; bad headache; nausea; lethargy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Feb2021 15:30 (Lot number: GL9265) at the age of 54 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "allergy" (unspecified if ongoing), notes: Deet mosquito repellent. Concomitant medication(s) included: VITAMIN C [ASCORBIC ACID]; VITAMIN D NOS. Vaccination history included: Covid 19 (Dose: 1, Lot number=EK9231, administration time=06:30 PM, left arm.), administration date: 22Jan2021, for COVID-19 immunization. The following information was reported: HYPERSOMNIA (non-serious) with onset 13Feb2021, outcome "recovered" (2021), described as "slept a lot"; HEADACHE (non-serious) with onset 13Feb2021, outcome "recovered" (2021), described as "bad headache"; NAUSEA (non-serious) with onset 13Feb2021, outcome "recovered" (2021), described as "nausea"; LETHARGY (non-serious) with onset 13Feb2021, outcome "recovered" (2021), described as "lethargy". Therapeutic measures were not taken as a result of hypersomnia, headache, nausea, lethargy.  Additional information: The patient did not receive any other vaccine in four weeks. The patient did not have COVID-19 prior vaccination. The patient had not tested COVID-19 post vaccination. The patient had no other medical history. It was reported that the day after vaccine, the patient had bad headache and nausea, lethargy, slept a lot. For 1 full week she continued to get a bad headache and nausea every night for a week. She was starting to get worried, but then it finally dissipated. Shot was on a Friday afternoon and her last about of nausea and headache was the following Thursday evening.  No follow-up attempts are possible. No further information is expected.
Patient returned to pharmacy day after immunization to report redness, warmth and itchiness below injection site on left arm. She stated she had taken diphenhydramine tablet yesterday when itching began (in afternoon a few hours after vaccination). After further questioning of patient, she asked if having an allergy to alpha-gal could contribute to her reaction. When I pulled her immunization sheet, she had not listed an allergy. I said it could be a factor in the reaction and told her that I would be reporting the reaction and advised her to watch the reaction site for any changes and to continue diphenhydramine for now. I also counseled her that if the reaction changed or got worse to see medical treatment immediately.
Parent reports redness and "knot" rt thigh where vaccine given. Parent contacted priv MD and was told was "local reaction" and to call health dept.
Per EMS, patient with no history of vaccine reactions felt "dizzy" and had hives on chest post Moderna vaccine #2. BP 142/87 1422 and did not normalize during course of care. No reported reaction to first vaccine. 25 mg diphenydramine IM, transport at patient's request. Patient counseled to consult provider before receiving any additional booster vaccines.
Hospitalized 6/9/03 with bronchitis. Started with seizures post admission and was flown to medical center. Now on 3 seizure meds. Under care of neurologist. The hospital discharge summary received on 1/8/04 states lymphadenopathy, viral syndrome, leukocytosis, status epilepticus, reactive airway disease, and nasal congestion. Discharge summary states fever. msv
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Arm swelling at the injection site (booster)), FRUSTRATION TOLERANCE DECREASED (she is frustrated) and PRODUCT STORAGE ERROR (possible temperature excursion/no temperature monitoring of vial (booster)) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination. No Medical History information was reported. On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (Arm swelling at the injection site (booster)), FRUSTRATION TOLERANCE DECREASED (she is frustrated) and PRODUCT STORAGE ERROR (possible temperature excursion/no temperature monitoring of vial (booster)). At the time of the report, VACCINATION SITE SWELLING (Arm swelling at the injection site (booster)), FRUSTRATION TOLERANCE DECREASED (she is frustrated) and PRODUCT STORAGE ERROR (possible temperature excursion/no temperature monitoring of vial (booster)) outcome was unknown. Concomitant products were not provided. It was reported that patient was contacted by the pharmacy where she received her Moderna booster dose, and the pharmacist stated the dose she received came from a Moderna vial that was stored in a refrigerator without any type of temperature monitoring. Treatment medications were not reported. This case was linked to MOD-2022-525381 (Patient Link).
My left hand began to feel swollen several hours after receiving the shot, particularly when I made a fist. When I wake in the morning now, and make a fist with both hands, the left hand is very stiff and swollen compared to the right. The stiffness diminishes after a minute of opening and closing my hand, but that hand remains noticeably more swollen throughout the day than my right hand.  This was a booster shot, after a JJ initial shot. I have not sought medical treatment, as I don?t believe there is anything to be done about this.
Not healing properly; has had complications; This is a spontaneous report from a contactable consumer or other non HCP. A 54-years-old non-pregnant female patient received bnt162b2 (COMIRNATY,solution for injection), via an unspecified route of administration on unspecified date (Batch/Lot Number: UNKNOWN) as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 (COMIRNATY, solution for injection) received on an unspecified date as Dose 1, single (batch/lot: unknown) for COVID-19 Immunisation. On unspecified date, the patient experienced Not healing properly and postoperative complication. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
12/03/21 presents to ED for "cough and loss of taste". PMHx of "bladder cancer, hypertension, hyponatremia"
Patient/employee reported concern that her 2nd covid-19 vaccine was placed very low on her upper arm. Pictures were supplied to employee health. No usual pain or other side effects were reported by the patient.
post herpetic neuralgia; herpes zoster; painful rash; Initial information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown gender who at the time of vaccination with zoster vaccine live (ZOSTAVAX) was at least 59 years old. No information was provided regarding the pt's medical history, concurrent conditions or concomitant medications. On or about 07-APR-2016, the pt was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for the long-term prevention of shingles and zoster-related conditions. Subsequently, on unknown dates, the pt was treated by healthcare providers for the following injuries resulting from the pt's zoster vaccine live (ZOSTAVAX) use: painful rash, herpes zoster, and post herpetic neuralgia. The outcome of the events was not provided. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Received 2nd Twinrix 11/20/06, 11/21/06 in PM developed itchy, red, generalized rash, middle finger right hand swollen, took Benadryl 11/22 still itchy, by PM hands swelling and itchy took Benadryl, 11/23 continued Benadryl rash remained hands and wrist swollen. 11/24 Hospital ER, DX contact dermatitis VS vaccine reaction, RX with steroids and antihistamines. TC to ACHD 11/27 to discuss above, TC 12/08/06 responded to RX okay.
52F with no known PMH developed progressive chest pain on 4/30/2021, admitted to Medical Center 5/2/2021 and found with NSTEMI with 95% proximal LAD occlusion w/ moderate thrombus successfully treated with drug-eluding stent x1. Pt received Pfizer vaccine #1 on 4/29.  Of note, pt has not seen a doctor in several years, but labs notable for leukocytosis (WBC 14.0), polycythemia (Hgb 16.9) and thrombocytosis  (PLT 959) concerning for undiagnosed polycythemia vera. If so, it is not clear whether her NSTEMI was a coincidence or whether the vaccine increased her risk of thrombosis.
Burning shoulder; stiff neck; A rash at the right side of the chest; aching arm; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PAIN IN EXTREMITY (aching arm), MUSCULOSKELETAL DISCOMFORT (Burning shoulder), MUSCULOSKELETAL STIFFNESS (stiff neck) and RASH (A rash at the right side of the chest) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history found).    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (aching arm). On 12-Feb-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (Burning shoulder), MUSCULOSKELETAL STIFFNESS (stiff neck) and RASH (A rash at the right side of the chest). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), PAIN IN EXTREMITY (aching arm), MUSCULOSKELETAL DISCOMFORT (Burning shoulder) and MUSCULOSKELETAL STIFFNESS (stiff neck) was resolving and RASH (A rash at the right side of the chest) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       no concomitant medication provided
Rash on most of her body; This case was reported by a physician  and described the occurrence of generalized rash in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose on an unknown date).   On 21st January 2021, the patient received the 2nd dose of Shingrix. On 22nd January 2021, 1 days after receiving Shingrix, the patient experienced generalized rash. On 22nd January 2021, the outcome of the generalized rash was recovered/resolved.   It was unknown if the reporter considered the generalized rash to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported, but it could be 81 or 82 year. The patient received 2nd dose and experienced a rash on most of her body. The rash was resolved within a day. The reporter consented to follow up.  Note: The event onset date was captured as per the vaccination date, as the TTO should be 1 day (mentioned in the narrative).
COVID-19 pneumonia, remdesivir, steroids, oxygen 4L refused antibiotics until 10/7 when accepted IV Zosyn; developed afib w RVR
This spontaneous report as received from a nurse refers to a 67 year old patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. In 2006, the patient was vaccinated with the dose of hepatitis B vaccine (recombinant) (manufacturer unknown; also reported: "cannot rule out RECOMBIVAX") (dose, route, lot # and expiration date were not reported). On an unknown date (reported as shortly after), the patient experienced an anaphylactic response of throat closing. The outcome of the adverse event was unknown. The relatedness between the adverse event and hepatitis B vaccine (recombinant) (manufacturer unknown) was not provided. Upon internal review, the adverse event of anaphylactic reaction was considered to be medically significant. Additional information has been requested.
The evening of shot #2 on 1/29/21, I got a fever of 100.4. Had serious chills, took hot baths, slept fitfully.  Felt tired.  Fever continued until 5 pm the next day (Saturday).  Didn?t eat much.  Fever broke late afternoon on 1/30  and I felt better.  Slept better.  But was very, very tired the next two days (1/31 and 2/1).  Felt normal the 4th day, 2/2.              My first shot was on 1/12/21 and I had no reaction other than a sore arm. For 24 hours.
deep joint pain in a shoulder; two separate patients that received the Pneumovax 23 from the same lot, and they both had intense arm pain beyond what we expect from vaccines; We sent one for a MRI and have sent her to orthopedics because she was esentially unable to use her arm; This spontaneous report was received from a medical assistant and refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # T016159, expiration date not reported but after lot validation established as: 28-FEB-2022 (dose and route of administration were not reported), administered in deltoid, for prophylaxis.    On an unknown date, the patient experienced intense arm pain beyond what was expected from vaccines and deep joint pain in the shoulder. She was sent for a magnetic resonance imaging (MRI), however, the results were not provided. She was also sent for orthopedics, because, as reporter stated, she was essentially unable to use her arm.  The outcome of the events of deep joint pain in shoulder, intense arm pain beyond what was expected from vaccines and decreased mobility of injected limb was unknown. The causal relationship between the reported events and vaccination with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was related.  This is one of two cases received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T016159; expirationdate: 28-FEB-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2011USA010192:
Moderna vaccine was accidentally administered to patient under 18.  No adverse symptoms noted. Pt scheduled for Moderna second dose per CDC Interim  guidelines. Education provided to staff regarding medication error.
Circular wheal and redness at injection site, larger than silver dollar (MENACTRA). Site is improving.
Pt had vaccine at approx 10:30AM. Mom called and infant had cried x 3 hrs and wouldn't nurse. "Strange cry", re-checked in office, admitted to hosp overnight for close observation. 6/1/06 Received medical records from hospital which reveal patient admitted 4/26/06 afternoon after receiving vax same day in AM w/irritability, constant crying & refusal to feed.  Pregnancy & birth history were neg.  Admitting dx: irritability reaction to immunization w/poor feeding.  D/C home following day when exam was WNL/ss
pt recv vax approx 1996 & on 7/7/98 pt exp shingles. treated w/Zovirax.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 06-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Information has been received from a other health professional (reported as immunization coordinator) referring to ten patients of unknown age and gender. On an unknown date(s), the ten patients were vaccinated with VARIVAX (Merck) (dose, strength, route were not reported, lot # reported as K003411, expiration date: 06-MAR-2016) which were stored improperly. There were no adverse event reported since the administration of the vaccinations. This is one of two cases (MARRS# 1503USA011471 and MARRS#1501USA010212) from the same source. Additional information has been requested.
Got COVID after vaccination; shortness of breath; headaches; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Got COVID after vaccination), DYSPNOEA (shortness of breath) and HEADACHE (headaches) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Got COVID after vaccination), DYSPNOEA (shortness of breath) and HEADACHE (headaches). At the time of the report, COVID-19 (Got COVID after vaccination), DYSPNOEA (shortness of breath) and HEADACHE (headaches) outcome was unknown.            Concomitant product use was not provided by the reporter.   No treatment information was provided.
New onset numbness and tingling in her right arm and leg shortly after getting her COVID shot. Patient advised to seek evaluation in the ED but denied recommendation. Resolved without treatment. Unknown duration of symptoms but can confirm no residual symptoms when patient was contacted for follow up 1/24/23.
No adverse events. Minor patient received 1st dose of Moderna erroneously at an alternate site on 2/22/21 and received her 2nd dose at our location on 5/25/21.