chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a certified medical assistant (C.M.A.) refers to an unknown number of patients. It was reported that the patients were administered (Oka/MERCK) VARIVAX of unknown strength and dose (Lot # and Expiry date not reported), since June 2014 that had been improperly stored. No adverse events reported. Also no product quality complain was reported. This is one of the several reports from the same source. Additional information has been requested.
Experiencing incredible joint and muscle pain and it is not going away; Experiencing incredible joint and muscle pain and it is not going away; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Sep2023 as dose 1, 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: ARTHRALGIA (non-serious), MYALGIA (non-serious), outcome "not recovered" and all described as "Experiencing incredible joint and muscle pain and it is not going away".  Additional information: After patient would said a week later, patient had been experiencing incredible joint and muscle pain and it is not going away. Patient added this was not lifestyle. It was affecting reporter's quality of life."  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Nausea at 6:00 PM. Vomiting at 7:30 PM until 11:45 PM. Diarrhea at 11:00 PM. Fatigue from 6:00 PM on 11/23/2013 until 6:00 PM on 11/24/2013.
12 days after 1st shot- Blisters on heels , then blisters , swelling,  severe pain of both feet 12 days after 2nd shot- ash on both hands and arms. biopies showed IGA varicosis. 5 weeks of steroids and I can fnally but shoes on. the sores were so bad that the doctor says I will have scars. I have pictures that I would love to send you
Local hives (1 on right hand, 1 on left wrist, 1 on right side torso, 1 on left calf). Small round or oval shaped welts. Itchy.  No treatment. 4 days later 90% improvement. Vanishing.
Patient called to let us know she was experience adverse effects from the vaccine. Stated she had fever, chills, and muscle pain at injection site. Admitted no adverse effects after the 1st dose.
Information has been received from a physician concerning a 12 year old female patient with a history of seasonal allergies and post concussion headaches from an unspecified accident in 2007 (MRI, CAT scan normal) who on 21-JUN-2008 was vaccinated intramuscular with the first and only dose of GARDASIL on left arm (lot # 660553/0070X). Concomitant therapy included CLARITIN, NASONEX and PATANOL. Starting the day after vaccination with GARDASIL on 22-JUL-2008 the patient developed severe muscular ache in the shoulder and neck and lasting no more than a week. Four days after vaccination, the ache became progressively more painful. There were no reports of weakness, numbness of tingling. Nine months after vaccination, on approximately 22-APR-2009 the patient developed headaches. She was recently diagnosed with chronic daily headaches. It was also mentioned that the patient may be seeing a chiropractor and neurologist. Additional information has been requested.
BODY ACHES; CHILLS; FEVER; MUSCLE PAIN; This spontaneous report received from a vaccine facility concerned a patient of unspecified age and sex. 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, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested. On an unspecified date, the subject experienced body aches, chills, fever, and muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, muscle pain and body aches was not reported. This report was non-serious.
This spontaneous report as received from a other health professional refers to a 12 year old patient with prophylaxis. On 23-AUG-2017 the patient was vaccinated with PEDVAXHIB for prophylaxis. Other suspect therapies included GARDASIL 9. On 23-AUG-2017, 1 day after onset of therapy the patient experienced wrong drug administered. On an unknown date the patient experienced no adverse event and product label confusion. Additional information has been requested. Sender's Comments: US-009507513-1708USA010483.
This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 29-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 mL (Vls 10 SDV) (Lot # K007822, expiration date 15-AUG-2015) single dose, route and anatomical location were not provided. There was no concomitant medication provided. No adverse effects were reported. On an unknown date, the PNEUMOVAX had a temperature excursion for 696 hours, the lowest recorded temperature was 20F (-6.667 Celsius). The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". There was no product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
Sudden onset sharp Pressure chest pain for 3 hours starting at 21:00 lasting until midnight on 6/Sept/2021.  She fell asleep at midnight after a regular dose of Advil and Tylenol given at 21:15. Her paediatrician  was notified and EKG performed same week on 9/Sept/2021 which confirmed arrhythmia. Paediatrician has sent out referral to cardiologist. Cardiologist  appointment still pending at this time. Chest pain has subsided but arrhythmia still present.
HDL - good cholesterol really dipped to 39 when they are usually in the 70 or 80s; covid infection; This spontaneous case was reported by a patient and describes the occurrence of HYPO HDL CHOLESTEROLAEMIA (HDL - good cholesterol really dipped to 39 when they are usually in the 70 or 80s) and COVID-19 (covid infection) in a 74-year-old patient of an unknown gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch nos. ASKU, ASKU, ASKU and ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) dosage was changed to 1 dosage form, dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) dosage was changed to 1 dosage form and dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPO HDL CHOLESTEROLAEMIA (HDL - good cholesterol really dipped to 39 when they are usually in the 70 or 80s) and COVID-19 (covid infection). At the time of the report, HYPO HDL CHOLESTEROLAEMIA (HDL - good cholesterol really dipped to 39 when they are usually in the 70 or 80s) outcome was unknown and COVID-19 (covid infection) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: lipid panel showed HDL - good cholesterol really dipped to 39 (usually usually in the 70 or 80s). Cholesterol reading come out really low in the 120's.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Patient was fully vaccinated with Moderna. fully vaccinated with the Moderna, the initial series and two boosters.  Patient had a covid infection in the summer the first week of August. In about a week they were over it. Bad cold symptoms. Soon after that they did do some bloodwork. About 3 weeks after they had covid, and on their lipid panel they HDL-good cholesterol really dipped to 39 when they are usually in the 70 or 80s. It made their cholesterol reading come out really low in the 120's. Treatment medication was not reported.   Reporter did not allow further contact
cough, congestion, fever, nausea, vomiting, dyspnea x 1 week  History of Present Illness   Patient 80 year old female with a PMHx of a flutter, carotid artery stenosis, COPD, GI bleed, IBS, obesity, abdominal pain, hypothyroidism, pulmonary hypertension, type 2 diabetes who presents for 3 weeks of increased cough and dyspnea. Patient reports feeling ill over the past three weeks with sx of fatigue, fevers, cough, chest and sinus congestion, HA, and abdominal pain. She states over the past two days her cough and shortness of breath have become acutely worse. She has not had any recent sick contacts, received Covid vaccine in Jan/Feb 2021, and follows precautions. She additionally has recently finished a 5 day course of Bactrim for recent UTI. She states she has had increased constipation and n/v since starting it. She denies dysuria, frequency, or urinary discomfort.   In the ED, she required 3L O2. She is having significant cough with clear sputum. She tested positive for COVID and will be admitted for acute hypoxia 2/2 to COVID.
At the moment of injection on Oct. 15, 2021, Patient verbalized he felt liquid dropping down to his elbow and rested there at the elbow and didn't go past there. On the 18, he woke up in the morning and could not lift his hand and bring his arm/hand to his chest or lift his arm up.  Had to support his elbow with his other hand in order to support his left arm upwards.  Reports sharp pain 8/10 states constant even while resting slipping. Any little movement triggers the pain. States pain is relieved by gradually bending arm over across chest and bending elbow. States he also has to guide his arm to an extended position when on his back.  Reports that he is unable to lift an object up from the ground nor is he able to hold an object with his arm extended, such as a bag , etc.  States as he is speaking to me, the pain is a stinging pain, constant.  He has to lean in to the left side to hold the car's steering wheel.
This spontaneous report was received from a female patient (registered nurse) of unknown age via a company representative. The patient's concurrent conditions and medical history were not reported. On an unknown date (reported as "some time ago"), the patient was vaccinated with a dose of ZOSTAVAX (exact dose, lot #, expiration date, route of administration and anatomical location were not reported). There were no concomitant medications provided. On an unknown date, the patient experienced pain and redness at the injection site after receiving ZOSTAVAX . The outcome the events was reported as recovered. The relatedness between the events and ZOSTAVAX was not provided. Additional information is not expected as there was no consent for follow up.
exhausted; rash on upper chest, thighs and the edges of the face; face felt tight in a pre-swelling phase; This is a spontaneous report from a contactable consumer (patient). A 27-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: GN6204), via an unspecified route of administration, administered in arm left on 26Mar2021 at 17:45 (at the age of 27-year-old), as dose 2, single for COVID-19 immunization. The patient medical history included mood disorder, asthma, migraine, arthritis and ADD, allergic to mosquitos, fire ants, sun. The patient concomitant medications included lithium; verapamil; amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL XR), topiramate and fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA), all drugs taken for an unknown indication from unknown date to unknown date and unknown if ongoing. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: gn6206), via an unspecified route of administration, administered in arm left on 04Mar2021 at 17:30 as dose 1 single for COVID-19 immunization and experienced bruising at the injection site for a week and a half with minor soreness. The patient past drug event included lamictal, imitrex, neosporin and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Mar2021 at 21:45, about 4 hours after the second dose, the patient experienced rash on upper chest, thighs and the edges of the face. The right side of face felt tight in a pre-swelling phase. The patient had prior allergic reactions to meds and insects, and this had the same early precursors because of the time elapsed, what read in the patient guide and no breathing issues. The next day, the patient's left arm felt like a bat hit it and the patient was more exhausted than normal for about 24 hours on 27Mar2021. The patient received treatment for the events rash, swelling face which included benadryl and tylenol regiment for reactions which worked within one to two hours. Outcome of all the events was recovered on an unspecified date in 2021.   No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a nurse refers to a 67 year old male patient. The patient did not have concurrent conditions, medical history or concomitant medication. The patient had allergies or drug reactions to amoxicillin and CLARITIN D with headaches. On 28-MAR-2017, the patient was vaccinated with a dose of PNEUMOVAX23 injection administered subcutaneously in the right arm, for prophylaxis (dose not reported). The patient stated that two hours after administration, he experienced shortness of breath, diaphoresis, right arm edema and pain. Therefore, at that time, the patient went to the hospital and was admitted for observation. During the admission, he was prescribed Levofloxacin. On the same day, he underwent an ultrasound and a chest and head computerized tomography scan (results were not provided). On 29-MAR-2017, a right upper extremity venous Doppler was performed (result was not provided) and was discharged from the hospital. On 30-MAR-2017, the patient went back to other hospital still presenting right arm redness, edema, swelling and pain. The patient's antibiotic therapy was switched from levofloxacin to doxycycline. The outcome of the events of shortness of breath and diaphoresis was unknown. The causal relationship between the events and the therapy with PNEUMOVAX23 was not reported. It was confirmed that the lot #M037669 and expiration date: 09-MAY-2018 is not valid for PNEUMOVAX23. Additional information has been requested.
Patient receive Fluarix on 22 Nov 06.  Macular erythema developed within 3 days with no induration at site of vaccination on left deltoid.  Patient complained of itching but not pain.  Better today (per mother) than yesterday.  Provided reassurance and hydrocortisone cream for symptomatic treatment.
Very sore arm/ pain and soreness at the injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had many times in the past 5 years).   On an unknown date, the patient received the 1st dose of Shingrix (left arm). On an unknown date, immediately after receiving Shingrix, the patient experienced injection site pain (Verbatim: Very sore arm/ pain and soreness at the injection site). The outcome of the injection site pain was resolved (duration 6 days).   The reporter considered the injection site pain to be possibly related to Shingrix.     The company considered the injection site pain to be possibly related to Shingrix.   Additional Information: GSK Receipt Date: 02-OCT-2023 and 04-OCT-2023  The patient was self-reported this case. The patient reported that she received first dose of Shingrix vaccine and it only gave her a very sore arm for 6 days. The patient experienced pain and soreness at the injection site immediately after received Shingrix vaccine.
Patient returned two days after vaccine given for TB test read. Reported fever (101) for last two days - redness to left deltoid - soreness, swelling 4x5 inch area.
Patient experienced fever blisters around the mouth and area up to the nose a couple of days after receiving shot. She also noticed a blister appear on an area on the hip where she previously had shingles. She experienced the fever blisters after the first and second dose of SHINGRIX.
no big problems that I noticed until saturday. then suddenly Very serious rash all over the body. Big plaques. Small balls. Big balls. Lines. Very red. Very itchy.Started to itch and became not supportable within two hours on Saturday late afternoon, I was at a movie and at the end I tried to go eat but instead I went directly to urgent care. I do not know if I wrote the correct type of vaccine, it was Recombinant Zoster (Shingles) Vaccine, RZV, the new shingles, first dose. The doctor told me NOT to get the second dose.  A few years ago I took the old shingles vaccine and had no problem, so i was surprised this was had such terrible effect.
numbness in fingers and toes, loss of muscle strength  eventual dx of Guillain Barre Syndrome
Rebound infection - I tested negative for COVID on 10May and 11May. Tested Positive again and had symptoms on 13May; Rebound infection - I tested negative for COVID on 10May and 11May. Tested Positive again and had symptoms on 13May; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Rebound infection - I tested negative for COVID on 10May and 11May. Tested Positive again and had symptoms on 13May". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Rebound infection; (10May2022) Negative, notes: tested negative for COVID on 10May; (11May2022) Negative, notes: tested negative for COVID on 10May and 11May; (13May2022) Positive, notes: Tested Positive again and had symptoms on 13May. Therapeutic measures were taken as a result of drug ineffective, covid-19.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Uncontrollable movements/ spasmodic movements bilateral upper extremities, headache, dizziness
Lower leg became mottled within 1-2 minutes of administration, in addition to mottled areas of the skin there were 3 blotchy areas of erythema
This is a spontaneous report from a contactable physician via a Pfizer sales representative. A female patient of an unspecified age (reported as Age: 65; Units: Unknown) and ethnicity started to receive PREVNAR 13 via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced pain at the injection site for a few days. The event took place after use of pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein). Outcome of the event was unknown. Information on batch and lot numbers has been requested.
Please note, I did not report the event(s) to my HCP at this time as I did not require any treatment for the event(s). This is the reason I left HCP data blank but will provide if needed. I am on an oral contraceptive with 100% compliance daily. On 18-APR-2021, I received 2nd dose of COVID vaccine. On Tuesday, 20-APR-2021, my period started ~7 days early (sugar pill was to start on Sunday 25-APR-2021, it usually starts the following Tuesday). On this day, bilateral lower extremity pitting edema was noted in addition to knee pain/swelling. My period lasted for 26 days, stopping finally on 15-MAY-2021. It was light. The lower extremity edema also subsided around this time. The knee pain and swelling stopped 0n 28-APR-2021.
Received his doses on Day 1, Day7, and Day 14 instead of Day 21 or Day 28; Case reference number US-BN-2021-001675 is a spontaneous case report initially received on 6-May-2021 from other health professional and concerned a male patient of unspecified age.  The patient's medical history was not provided.  The patient's concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with first dose of RabaVert (Inactivated Rabies Virus Vaccine; batch number: ARBA801A) at standard dose (as reported), via intramuscular route of administration for 'vet student getting pre-exposure vaccines'.   On an unspecified date, on day 7 after the first vaccination, the patient received second dose of RabaVert (Inactivated Rabies Virus Vaccine; batch number: not reported) at unknown dose or unknown route of administration for 'vet student getting pre-exposure vaccines'.  On an unspecified date, on day 14 after the first vaccination, instead of day 21 (or 28) (explicitly coded as 'Inappropriate schedule of vaccine administered'), the patient received third dose of RabaVert (Inactivated Rabies Virus Vaccine; batch number: not reported) at unknown dose or unknown route of administration for 'vet student getting pre-exposure vaccines'.  At the time of this report, it was confirmed that the patient did not experience any adverse events after vaccination.  No further information was provided.; Reporter's Comments: Inappropriate schedule of product administration is listed by convention. Reportedly, the patient received the third dose of RabAvert on day 14 after the first dose (instead of day 21 or 28) and that is condidered as inappropriate schedule of vaccine administered. The patient did not experience any adverse events after vaccination. Inappropriate schedule of vaccine administered is not related to the suspect product but to a human action.; Sender's Comments: Inappropriate schedule of product administration is listed by convention. Reportedly, the patient received the third dose of RabAvert on day 14 after the first dose (instead of day 21 or 28) and that is considered as inappropriate schedule of vaccine administered. The patient did not experience any adverse events after vaccination. Inappropriate schedule of vaccine administered is not related to the suspect product but to a human action.
Dizziness, Headache, Myalgia & NauseaVomiting Narrative: Severe Chills, Nausea, Headache, Dizziness, increased pain.
BlurredVision, Confusion, Headache, Rash, NauseaVomiting, HYPOtension, Syncope,  fatigue, injection swelling, redness, rash, lymph node swelling not reported but advised to see PCP
Flu-like: headache, fatigue, body aches, muscle soreness, weak body, fever, some chills
Constant headaches since my 1st shot on 23 Apr 03. Fill out back of 2766C every subsequent shot.