chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant refers to a 14 year old female patient with an unspecified food allergy. The patient's medical history included tonsils removed on an unspecified date. On 03-NOV-2015, prior to successful vaccination, a dose of VARIVAX (Merck) lot # K015992 and expiration date 23-SEP-2016, was tried to be administered, but the vaccine was frozen. The reporter stated that the vaccine was reconstituted and placed syringe in the freeze. The patient skin was pierced not vaccine flowed through since it was frozen. Subsequently, the patient was vaccinated with a correctly reconstituted and stored second dose of VARIVAX (Merck) lot # K015992 and expiration date 23-SEP-2016, 0.5 ml, subcutaneous in the right arm. Concomitant therapies included "MONOVA", GARDASIL, administered in the left arm and HAVRIX also administered in the right deltoid, but different site. On 04-NOV-2015, reported as "within 24 hours", the patient experienced injection site located where the VARIVAX (Merck) was injected. The injection site was red, puffy and itchy. On 04-NOV-2015, the patient went to the medical assistant office for medical attention and lidocaine cream was given as treatment. There was product quality issue involved. The reporter stated that if the reaction got worse and did not improve, they may call back for lot check. The outcome of injection site erythema, injection site pruritus and injection site swelling was reported as not recovered/not resolved. The reporter considered injection site erythema, injection site pruritus and injection site swelling to be related to VARIVAX (Merck). Additional information is not expected since the reporter did not want to be contacted.
Right thigh 1" red swollen lump. Treated with ice pack and Tylenol.
This spontaneous report was received from a nurse referring herself as 63 year old female patient. The patient's historical condition included Pneumonia 3 times in her past (unspecified dates). The patient's concurrent conditions, concomitant medications, drug reactions and allergies were not reported. On 20-JAN-2018, patient was vaccinated with PNEUMOVAX 23 (dose, units, frequency and route not reported) (lot number and expiration date not reported) at an unspecified clinic. Reporter stated that, the vaccination was done incorrectly in that it was administered into the bursae in her shoulder. It was also reported that, immediately, on 20-JAN-2018, patient was feeling pain and it was severe by evening. Reporter stated that patient was not being able to sleep for 4 days due to pain, shaking, throwing up, swelling of the arm (reported as unspecified) and finger, and inability to move her arm. The patient did not seek medical attention and no received the treatment for the events. On 24-JAN-2018, patient was seen by orthopedic surgeon (reported as unspecified Surgeon), prescribed hydrocodone (unspecified brand/manufacturer) for the pain. On an unknown date in January 2018, by day 5 post vaccination the pain subsided and day 7 post vaccination she regained range of motion in the affected arm/shoulder (unspecified). The outcome of the events pain and dyskinesia was reported as recovered/resolved. The outcome of the events sleep disorder, tremor, vomiting and peripheral swelling was unknown. The causal assessment for the events was not provided. No product complaint required. The reporter assessed the events sleep disorder and dyskinesia were determined as serious due to significant disability and incapacity.
Rash; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the left arm on 28Apr2021 at 15:30 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included LAMICTAL from an unknown date for an unknown indication and unknown if ongoing. The patient previously received CODEINE for an unknown indication on an unknown date and experienced drug allergy. On 30Apr2021 at 13:00, the patient experienced rash. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event rash was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On unknown date, the patient was inadvertently administered a pediatric dose 0.5 ml of VAQTA (route and lot # unknown) instead of an adult dose of l ml of VAQTA for prophylaxis. Additional information has been requested.
Patient given 3rd dose of Pfizer vaccine and did not meet age guidelines. No adverse reaction known.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 59-year-old female patient who received SHINGRIX (batch number YF64H, expiry date unknown) for prophylaxis. Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis. On 17th October 2018, the patient received the 1st dose of SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season. On 17th October 2018, several hours after receiving SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced pain in arm (serious criteria hospitalization), back pain, headache and mobility decreased. On 28th November 2018, the patient experienced grand mal seizure (serious criteria hospitalization and GSK medically significant) and speech disorder. In December 2018, the patient experienced joint clicking (serious criteria hospitalization). The patient was treated with levetiracetam (Keppra), levetiracetam (Keppra), paracetamol (Tylenol) and non-drug therapy (Heating Therapy). On 5th December 2018, the outcome of the speech disorder was recovered/resolved. On an unknown date, the outcome of the pain in arm, back pain, headache and mobility decreased were recovered/resolved and the outcome of the grand mal seizure was recovering/resolving and the outcome of the joint clicking was unknown. It was unknown if the reporter considered the pain in arm, grand mal seizure, joint clicking, back pain, headache, mobility decreased and speech disorder to be related to SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season. Additional information received as follows: In the morning, the patient received dose of SHINGRIX. In afternoon of same day of vaccination at approximately 4:30 pm she started to feel severe pain in her right arm, back and back of her head. The pain was so severe that she had to sit up in chair that night. She could not put any pressure on the areas. The pain was severe for 48 hour and she could not lift her arm for almost 7 days. The patient took Tylenol and used a heating pad. The patient had a grand mal seizure and was transported to the hospital. She was there for 48 hours and treated with Keppra IV therapy. In December 2018, she took 500 mg Keppra BID and was restricted from driving for 6 months. T the reporting time, the pain had resolved and shoulder clicks. On the day before the reporting day, first time she could make a complete sentence after the seizure. The flu brand name was unknown. Emergency room visit required. The reporter gave consent to follow up. The vaccination date of SHINGRIX was given in Argus core was 6th December 2018 same as GSK-receipt date, so it  was captured as 17th October 2018 from the narrative.
Swelling, redness, hot to touch tightness at injection site was noticed on january 30th the day after injections in her left thigh. The swelling got worse and spread covering her thigh. After weeks of it like this, it faded to a bruise that lasted until april.
Patient received vaccine after its expiration date; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after its expiration date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 014H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after its expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after its expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after its expiration date).    No concomitant medication was reported.  Dosage text reported as unknown. No treatment information was reported.  This case contains information for patient 5 out of 7.   This case was linked to US-MODERNATX, INC.-MOD-2023-727965 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727965:Master Case of Patient 1
1) extreme pain at injection site and in upper arm; redness at injection site traveling under the site and across arm to right before arm pit?red blotches that were very hot to the touch and very red?these lasted for 4 days; 2) severe headache for 4 days;  3) chills for 3 days; 4) fatigue and nausea going on 5 days since vaccine.
Intussusception x 2 (1) 5/23/14 (2) 5/24/14 both reduced by barium enemas.
Bad taste in mouth. 10 minutes after shot. 24 hours later still have same taste.
pt exp 5.5cm redness, swollen w/associated induration of the same size; Follow up report received 3-2-2002. From follow up correspondence received by Aventis Pasteur Inc. on 25-April 2000, it was reported, "Dr. has not seen this patient in over two years." This case is closed.
Patient fainted after the third vaccine for about 30 seconds then regained consciousness. 911 was contacted and the patient was assessed and cleared
pt recv vax 11MAR96 & pt devel a maculopapular, non-pruritic, Y-shaped rash @ inj site;
mom stated pt had high pitched cry for 24 hrs also pt didn't snap back to nl for 3 days;
Approx. 1 hour and 45 minutes, post vax, mom called to pick child up from school. Child stated that it was "hard to breathe" and he felt "puffed up inside". Felt as if he had just come back in from running. Felt like someone was "sitting on his chest". Mom states, she took child home and called pediatricians office. They advised to give child Benadryl. Repeated Benadryl dose 4 hours after his 1st dose and he recovered by evening.
Left thigh cellulitis for one day. Treated with Nafcillin and Clindamycin.  03/23/2007 MR received for an ER admit for c/o Left thigh redness after receiving vaccines in the Left thigh. PE WNL except redness and swelling noted on the left thigh. No fever, no chills, no discharge.  Impression: Left thigh Cellulitis/Reaction (local) to vaccines. Principal DX:  Cellulitis. Secondary DX:  Adverse reaction to vaccination.
Headache, Myalgia & CoughWheeze Narrative:  Other Relevant History:
Large red rash at site of administration. Believed to have been administered subq instead of IM. TYLENOL was taken on 10/31/12 when rash was noticed.
Pt c/o intermittent paresthesias beginning 24 hrs after vaccine. 11/19/08-records received for DOS 11/4/08-Allergies to sulfa. Diarrhea. DX: dysmenorrhea. No additional visits in record.
Mild nausea, chills began 12 hours after injection, fever 99.9 F, unable to sleep aching joints and fatigue. Next day about 24hrs stuffy nose dry mouth dry eyes and headache continued aching joints and fatigue. Unable to go to work
Patient presented with redness around the injection site diameter of 3 inches to 4 inches. Patient noticed it around 7 am this morning. As per patient there was no pain just the redness. Advised patient to apply cold compress and to take an antihistamine (Benadryl) as patient has taken it prior. Advised patient if worsens or spreads to immediately call her Physician and seek medical attention.  Called Patient at 4:30pm. Patient has been applying cold compress and as per patient it has gotten better.
7-8-Watery Diarrhea Stools daily x 8 days
Information has been received from a veterinarian concerning her mother, a female in her eighties, who in December 2008 was vaccinated with ZOSTAVAX (Merck).  The consumer reported that almost immediately after the injection the patient experienced symptoms that were finally diagnosed as shingles (no classic lesions though).  The reported stated:  "we are dealing wit a lack of efficacy or a failure to protect or an adverse reaction to the shot itself".  The consumer reported that this all started before Christmas and the way the MDs chose to deal with the problem was with pain killers (for peripheral) nerve pain) that made patient loopy and ataxic resulting in loss of balance, slurred speech and a couple of falls.  They just continued with pain medicaments and pain patches.  The consumer reported that her mother is really depressed and was not sure how much she could take.  It was also stated that the patient's quality of life had decreased.  The outcome is unknown.  Additional information has been requested.
tested Ag positive 09Jun2022; tested Ag positive 09Jun2022; sx mild ST and congestion allergies 08Jun; sx mild ST and congestion allergies 08Jun; sx mild ST and congestion allergies 08Jun; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 24-year-old male patient received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EL3247), on 18Feb2021 as dose 2, single (Lot number: EL3247) and on 11Jan2022 as dose 3 (booster), single (Lot number: FF2589) at the age of 24 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OROPHARYNGEAL PAIN (non-serious), NASAL CONGESTION (non-serious), HYPERSENSITIVITY (non-serious) all with onset 08Jun2022, outcome "unknown" and all described as "sx mild ST and congestion allergies 08Jun"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09Jun2022, outcome "unknown" and all described as "tested Ag positive 09Jun2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Jun2022) Positive, notes: COVID test post vaccination COVID test type post vaccination=Nasal Swab. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, oropharyngeal pain, nasal congestion, hypersensitivity. No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event, vaccination failure and Covid 19 and the role of suspect drug cannot be ruled out. The case will be reassessed once new information is available.
11/7/00 had Lyme tick pulled off by MD and first shot given. 12/2000 second shot MD. 11/14/01 third shot MD. 2/2/02 neck stiff/pain had x-ray. 6/2/02 legs/idiopathy and limp bad limp. 9/02 physical MD x-ray hip arthritis both hips. 10/20/02 knees sore f/u if it with cont. get worse.
29JAN93 115AM temp 104.2 R; APAP given; 430AM t104.5 R given APAP; R65, P170 resp labored; 930AM seen by MD; 1030 APAP given t104.2 R; 100 t102 R50; 315 t104.5 R, APAP given;
my thumb kept getting stuck (as if in a trigger position); when I woke up the injection arm was feeling tight; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 51 year-old female patient received bnt162b2 (BNT162B2), administration date 12Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for Covid-19 immunization. The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious) with onset 13Feb2021, outcome "unknown", described as "my thumb kept getting stuck (as if in a trigger position)"; MUSCLE TIGHTNESS (non-serious) with onset 13Feb2021, outcome "unknown", described as "when I woke up the injection arm was feeling tight".  Additional information: Call transferred. Caller reported that on the next morning, she experienced events. Caller wanted to know if these are normal side effects of the vaccine and had these been reported"? Offered to transfer Caller accepted. Checked with line and had "20 calls ahead" in queue. Informed caller and mentioned she is willing to wait. Cold transferred Caller and e-transmitting possible AE. It is unknown that reporter is Healthcare Professional (HCP): Unknown. Verbatim and event description: Swap from (removed). Caller is having side effects from the Covid vaccine and she wanted to know who she could speak to and find out if they are normal or not. Provided Number and was going to transfer to for AE, but there are 17 calls holding. Transferred to (Name) with and he took call. Fax to (removed) for AE, since caller is reporting side effects from the Covid vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pregnant; Experienced sore arm both times; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnant) and PAIN IN EXTREMITY (Experienced sore arm both times) in a 32-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 028L20A) for COVID-19 vaccination.     No Medical History was provided by the reporter.  Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 25-Sep-2021. On 30-Dec-2020, the patient experienced EXPOSURE DURING PREGNANCY (pregnant) and PAIN IN EXTREMITY (Experienced sore arm both times). On 30-Dec-2020, EXPOSURE DURING PREGNANCY (pregnant) had resolved. At the time of the report, PAIN IN EXTREMITY (Experienced sore arm both times) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.
The pt experienced tenderness, swelling and marked inflammation with cellulitis around the injection site which measured 8x8 cm.
This spontaneous report was received from a physician via company representative refers to a male patient of unknown age. No concurrent condition or medical history was reported. On an unknown date the patient was vaccinated with GARDASIL (dose 1, intramuscular, dose not provided). The patient experienced bradycardia and he felt light headed and faint immediately following the vaccination. The patient recovered from the events while he was still at the Physician's office. On an unknown date the patient was vaccinated with second dose of GARDASIL (intramuscular, dose not provided) in accordance with the vaccine schedule. The events reappeared after second vaccination. The physician implemented conservative measures when the second dose was administered which included having the patient lie down. The patient again recovered from all the events while he was still at physician's office. The causality assessment was not reported. No product quality issue was reported. Additional information has been requested.
I've been experiencing a high fever up to 102, chills, and diarrhea everyday for the past 10 days after the 2nd dose of the covid vaccine. My UC is also flaring up worse than before. Fever goes away with tylenol.
This spontaneous report was received from a registered nurse and refers to a multiple unspecified number of patients of an unknown age and gender. There was no information about the patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies. The reported stated that improperly stored doses of M-M-R II, lot number L036851, expiration date 23-SEP-2017 (dose, route, and anatomical location were not reported), were administered to the multiple unspecified number of patients on unspecified dates, for prophylaxis. The vaccines were exposed to a range of temperature of more than 8 degrees Celsius but less than 25 degrees Celsius for 1 hour and 30 minutes, due to a data logger issue. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source.  Additional information has been requested.; Sender's Comments:  US-009507513-1702USA007055: US-009507513-1702USA001638:
This spontaneous report as received from a consumer, mother of  the patient, who refers a 16 year old male patient with migraines and with no allergies or drug reactions. In "may or June 2013", the patient was vaccinated with the first dose of GARDASIL (dose, indication, route and lot were not reported). On 15-OCT-2013, the patient was vaccinated with the second dose of GARDASIL, route reported as "injection" (dose, and lot were not reported). Concomitant therapies included amitriptyline hydrochloride (manufacturer unknown). On 15-OCT-2013, the patient experienced shortness of breath, woke up this morning feeling very fatigued, his chest hurt and felt like he was going to pass out. The patient was went to the physician to see medical attention. No treatment was given. Lab diagnostics were not performed. The outcome of shortness of breath, woke up this morning feeling fatigued, felt like he was going to pass out and his chest hurt was reported as not recovered/not resolved. Therapy with GARDASIL was continued. Additional information has been requested.
death D69.6 - Thrombocytopenia, unspecified Respiratory failure Intercranial mass