chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fatigue (chronic); This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue (chronic)) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 092L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced FATIGUE (Fatigue (chronic)). At the time of the report, FATIGUE (Fatigue (chronic)) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  Treatment information was not provided.  Reportedly, caller agreed to schedule an appointment with HCP.
extreme ringing on the left side of my ears into my head. It's a constant ringing that doesn't stop; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202200131555 (Pfizer).  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 28Sep2021 08:30 (Lot number: 301308A) at the age of 60 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "pre diabetes" (unspecified if ongoing); "rheumatoid psoriatic arthritis" (unspecified if ongoing), notes: other medical history: rheumatoid psoriatic arthritis; "hyperthyroidism" (unspecified if ongoing); "asthma" (unspecified if ongoing); "walnuts" (unspecified if ongoing), notes: known allergies: walnuts; "smokes" (unspecified if ongoing), notes: known allergies: smokes; "popcorns" (unspecified if ongoing), notes: known allergies: popcorns. Concomitant medication(s) included: LOSARTAN; HYDROCHLOROTHIAZIDE; MULTIVITAMINS [VITAMINS NOS]. Past drug history included: Percocet, reaction(s): "Known allergies: percocet", notes: Known allergies: percocet. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FC3592, Location of injection: Arm Left, Vaccine Administration Time: 08:30, Route of Administration: Intramuscular), administration date: 07Sep2021, when the patient was 60 years old, for COVID-19 Immunization. The following information was reported: TINNITUS (medically significant) with onset 01Dec2021 21:00, outcome "not recovered", described as "extreme ringing on the left side of my ears into my head. It's a constant ringing that doesn't stop". The event "extreme ringing on the left side of my ears into my head. it's a constant ringing that doesn't stop" was evaluated at the physician office visit. Therapeutic measures were taken as a result of tinnitus.  Clinical course: After two months of taking the vaccine the patient developed extreme ringing on the left side of her ears into the head. It's a constant ringing that doesn't stop. She had gone to her primary doctor and he started her on steroids low dose and nasal spray. The doctor advise her to follow up with ENT. After ENT visit, the patient is now taking a higher dose of steroids along with anti histamine. She has to follow up in two weeks, in February. The patient has a history of Rheumatoid arthritis and she already have an inflammatory response going on. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19.; Sender's Comments: Based on possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported events .Case will be reviewed further on receipt of FU information
I am still seeing the Dr. I started seeing him in February and it is a ongoing treatment.  I was having pain that started in my left arm and I didn't give it a second thought and went to my back and this was a course over three weeks and I thought it was gas.  It moved to my back, stomach and now it has settled back to my arm and my neck where it left me I can hardly move my neck to the left.  The chiropractor is manipulating my bones and deep tissue massage.  He has a license to do that.
Shingrix Vaccine was administered in my left arm/shoulder at 10 am on 2/26/2020.  At 6:00pm that day my left ear started ringing. My ear is still ringing and has gotten worse the last 3 weeks. The pain in my left are went away after the vaccine but started hurting more 3 weeks ago. The pain has moved down to my forearm at times. There have been muscle spasms at times also. I did not have any of these issues prior to the vaccine. I regret getting this vaccine. I would rather have Shingles right now than have taken the vaccine. Todays date is 2 months later. 4/26/2020
RECEIVED A HALF DOSE FOR THEIR  BOOSTER DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 57 year old male of unspecified race and ethnicity. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously received covid-19 vaccine ad26. cov2. s unspecified manufacturer (dose number in series 1) suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on unspecified date for prophylactic vaccination. The batch number was not reported and has been requested.  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2 : suspension for injection, route of admin not reported, batch number: provided was  211A21A, expiry: UNKNOWN) dose of 0.25 milliliters, 1 total, administered on 28-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 28-NOV-2021, the patient received half dose (0.25 milliliters) for their booster dose (coded as vaccine underdose and off label use) (dose number in series was 2). As described by reporter, HCP (health care provider) (from public health dept) stated that there were 33 patients who received half doses (0.25ml (milliliter)) for their booster or 3rd dose a few days ago. Most of them were patients from state. HCP stated that something was printed and disseminated that said to administer .25ml. HCP was not sure where that information came from. Stated it was over the holidays so people could have thought that info changed and staff was just not made aware. HCP did not think it had been reported yet through VAERS. HCP thought that the vendor will file the report with VAERS, not public health department. HCP stated that they figured it out after the event because they could not figure out how so many doses were given. They were looking for a discrepancy in the number of vials perhaps, but then realized that half doses were given. HCP consented to being contacted, but stated that she may not be the best person to contact. If she had an alternate contact she would provide it to whomever reached out to her. The reporter went on to report that HCP stated that Spartan is the vendor. At the time of the discussion they were both teaming up together to gather information and they may have called to report these events as well, so HCP warned to be mindful of possible duplicate reports. (dose number in series was 2) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received half dose for their booster dose and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211202250, 20211201046, 20211201082, 20211201228, 20211201168, 20211200752, 20211201351, 20211202193, 20211200717, 20211200723, 20211200769, 20211201179, 20211201304, 20211201362, 20211201392, 20211201443, 20211201963, 20211202161, 20211202199, 20211202207, 20211202246, 20211202379, 20211201351, 20211201286, 20211201450 and 20211202371.
This case was reported by a nurse via call center representative and described the occurrence of myalgia in a 54-year-old male patient who received SHINGRIX (batch number 9779K, expiry date 11th October 2020) for prophylaxis. Concurrent medical conditions included diabetes and hyperlipidemia. Concomitant products included Atorvastatin, Metformin and glimepiride. On 13th June 2018, the patient received SHINGRIX. On 13th June 2018, several hours after receiving SHINGRIX, the patient experienced myalgia, fever, chills and general body pain. The patient was treated with ibuprofen, TYLENOL and BENADRYL. On an unknown date, the outcome of the myalgia, fever, chills and general body pain were recovering/resolving. The reporter considered the myalgia, fever, chills and general body pain to be almost certainly related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that the patient experienced myalgia, body aches, fever, and chills the night after vaccination.
The pt experienced a large local reaction starting immediately after the vax lasting 3 weeks. The next morning (24 hours later) the pt developed generalized hives, swelling, and itching which lasted 48 hours.
EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. 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: Unknown) dose was not reported, administered on 05-NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-NOV-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.
pt mentioned prior reaction history of seizures but hasn't happened in a long time. Felt anxious when getting vaccine and motioned he thinks he might be having an anxiety attack before shaking. I was near patient when seizure started was able to guide him off chair slowly onto ground to try to protect head but head was slightly bumped on the ground; only lasted 2 to 5 seconds but pt felt fine after awakening and asked how long seizure went on for. Denied EMS services and after 30 minutes of rest with cold water and an ice pack patient felt better and left store.
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 70-year-old male patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. On 30th July 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 30th July 2018, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms. The patient was treated with TYLENOL. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the influenza-like symptoms was not recovered/not resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The patient reported that after receiving the second dose of SHINGRIX at 6:00 PM on left deltoid, he was experiencing flu like symptoms that was more intense than his first shot. He claims that his second shot symptoms were kicking his butt. He was treating the symptoms currently with extra strength TYLENOL. The patient indicated that he was in good shape physically. This case has been linked with US2018GSK143654, reported by the same reporter (case reported for 1st dose).
Terrible Headache; Fever; Stomach pain; This is a spontaneous report from a non-contactable consumer (patient himself/herself). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Expiry Date: Unknown), via an unspecified route of administration on 01Apr2021 as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Consumer stated, patient had Pfizer vaccine on 01Apr, The first week was nothing, No Pain, Nothing. Now, the patient get headache, very terrible headache and now patient was getting fever and stomach pain and patient want to know, how long it last, patient took two Aspirin (Treatment) and Its goes away then come back again. On an unspecified date, the patient experienced Terrible Headache, Fever and Stomach pain. I took two Aspirin and Its goes away then come back again. Therapeutic measures were taken as a result of events Terrible Headache, Fever and treatment included with took two aspirin. The outcome was unknown for the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Moderna COVID-19 Vaccine EUA About 3 hours after vaccine, nausea and vomiting. Also diarrhea.
I developed hives that started with my hands, but spread to my arms, lips, and knees. It wasn?t impacted by OTC Benadryl and hydrocortisone cream, so I went to urgent care and was prescribed prednisone and an antihistamine
THE ADVERSE EVENT IS THAT A CHILD WHO IS 13 YEARS OF AGE RECEIVED HER SECEOND PRIMARY SERIES PFIZER VACCINE PRESCRIBED FOR 5-11 INSTEAD OF 12+ PATIENT REPORTS NO ADVERSE REACTION, ONLY REPORT IS LESS ARM PAIN THAN WITH FIRST PFIZER VACCINE ON 11/18/2021 WHICH WAS PFIZER EW0187
sent to the emergency room for body rashes and hives.; sent to the emergency room for body rashes and hives.; This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar events for 4 patients. This is a third of four reports. A patient of an unspecified age and gender received BNT162B2(Solution for injection) via an unspecified route of administration on an unspecified date at single dose for immunization. The medical history included allergies to bee stings. The patient's concomitant medications were not reported. The patient sent to the emergency room for body rashes and hives. The outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020502532 same reporter, drug, event  different patient
vaccine on 2/6. On 2/11 pt felt feverish (no thermometer) and daughter said she was delirious. In bed for 2 days, Pain in legs, + developed leg rash (not open or itchy). Called us on 2/16; feeling better + rash + legs pain improved. Type 2 diabetic
On 04/28/2001 the patient developed a fever of up to 103.5F. The patient was treated with Tylenol or Motrin. The temperature would drop to 99.5-100F and then return back to 103F within 4-6 hours. On 04/29/2001 the mother notes a few spots and on 04/30/2001 had a generalized rash over the trunk and face. On 04/30/2001 the patient presented to a doctor for evaluation. The fever persisted through 04/30/2001. The rash resolved after a couple of days.
This spontaneous report was received from a medical assistant via a company representative and refers to a 67 year old patient (gender was not specified). The patient's pertinent medical history or drug allergies/drug reactions were not reported. On 11-NOV-2015, the patient was vaccinated with PNEUMOVAX 23 (lot number, expiration date, dose, route of administration and anatomical location were not reported). There was no concomitant medication reported. On 11-NOV-2015, the patient experienced injection site reaction, injection site swelling, injection site warmth and injection site erythema that resolved in 2 days (13-NOV-2015). There was no product quality issue involved. At the reporting time, the outcome of injection site reaction, injection site swelling, injection site warmth and injection site erythema was reported as recovered on 13-NOV-2015. Additional information has been requested.
vaccine at 5:56pm, at 6:08 pt reported itchy throat and took 25 mg Benadryl; at 6:13 pt was red and itchy all over and took another benedryl; pt reported having an epi pen but did not want to use any epi (even ours) because she would have to go to ED;  at 6:29 she used her inhaler because she had some tightness; at 6:56 pt was less sloptchy and red; O2 sats remained above 93 the entire event and boyfriend drover her home; contacted her at 7:30 and she was much better.  This lady is a nurse practitioner and was acutely aware of her symptoms as she has experienced anaphylaxis multiple times.
vision loss; other zoster-related conditions; other zoster-related conditions; Information was received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age and gender. Information regarding current condition, historical condition and concomitant medication was not provided. On or about 07-MAR-2016, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, strength, route, batch/lot# and expiration were unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequent to zoster vaccine live (ZOSTAVAX) vaccination, the pt was treated by a physician for vision loss and other zoster-related conditions. As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the events was unknown. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, vision loss was considered as medically significant.
Headache, Myalgia, fatigue, pain injection site Narrative:  Other Relevant History:
expired Ipol vaccine was given to a patient/no AE; Initial information was received on 10-Jul-2020 regarding an unsolicited valid non-serious case received from a non-health care professional.  This case involves 1 month old male patient who was vaccinated with IPV (VERO) [IPOL] on 07-Jul-2020 which was already expired on 02-MAY-2020 (batch number P1A25, dosing details, route not reported) at left thigh for prophylactic vaccination(Expired product administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 07-Jul-2020, patient received concomitant medications DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP); HEPATITIS B VACCINE (HEPATITIS B VACCINE); HIB VACCINE (HIB); ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete unknown manufacturer), for COVID-19 immunization.  The following information was reported: FATIGUE (non-serious), outcome "unknown".  Clinical information: What reporter only want to know was for the teenagers when they get the booster shot, the fatigue, how long that usually last if they are fatigued. Can it last a month or two or it was just a few days. Product details, Pharmacy details and other details could not be probed as reporter was unwilling to complete the report. Hence further probing could not be done. Limited information available over the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Within 48 hours post vax pt developed axillary discomfort and palpated a lump of the right axillary with some redness at the injection site.
This spontaneous report as received from a healthcare professional, as part of a marketing research program, refers to an unspecified number of immunocompromised patients 65 years or older (gender unknown). On unknown dates, the patients were vaccinated with PNEUMOVAX 23 (lot number, dose and route were not reported) and with PREVNAR 13 (lot number, dose and route were not reported) (overdose). Concomitant therapy was not reported. It was reported that the Advisory Committee on Immunization Practices (ACIP) revised pneumonia vaccine schedule, saying all patients 65 or older who are immunocompromised should received both vaccines. The outcomes of overdose was unknown. Additional information has been requested.
9/16 felt achy (body aches) left arm has redness (below injection site). 9/18 redness has subsided in one area and moved downward and around upper arm. Now on inside portion of arm.
Information has been received from a physician concerning a 6 year old pt who was vaccinated with doses of Haemophilus B conjugate vaccine (manuf unk), and concomitant therapy diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid. Subsequently one day after the vaccines were administered the pt became cyanotic, and floppy. It was noted that at a 60 day follow-up the pt had been diagnosed with diffuse cutaneous mastocytosis. It was indicated that either vaccine may have caused the mastocyte release, and subsequent drop in blood pressure and cyanosis. This was originally reported by a health care professional. VAERS ID number 174721-1. Upon internal review it has been determined that cyanosis and diffuse cutaneous mastocytosis are other important medical events (OMIC). Additional info has been requested.
Patient complained of palpitations & itching to her face & scalp at 1:33pm post pfizer second dose vaccine. BP=168/85, P-93, SPO2-99%, RR-24 at 1:33pm. No complaints of shortness of breath. No hives or swelling noted. Patient self medicated with Benadryl 50mg PO at 1:35pm. Assisted patient to the nurse's station. BP=149/79, PULSE-83, RR-22, SPO2-99% at 1:57pm. Patient observed for an hour and left with no distress noted. She stated "I feel better" at 2:15pm. Doctor informed & cleared patient.
Patient had soreness and redness at injection site, and severe body aches. This occurred a few hours after the injection. There was no improvement the next day.
Reddened, hard lump 6 cm x 6 1/2 cm warm to touch, itchy and burning
Donor called on 7/5/15 at 10:30 AM to report tenderness at site of injection of tetanus, received on 6/24/15. She also reported pain in the deltoid muscle on trying to raise her arm and pain radiating to L neck. The symptoms have been present for 10 days.
PT SAID HE LOST VISON AND GOT DIZZY AND HAD SYNCOPE.  SKIN WAS EXTEMELY PALE AND THEN HE VOMITTED