chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Positive PCR test 7 months after 2nd dose; Positive PCR test 7 months after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive PCR test 7 months after 2nd dose) and DRUG INEFFECTIVE (Positive PCR test 7 months after 2nd dose) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 006221A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jan-2022, the patient experienced COVID-19 (Positive PCR test 7 months after 2nd dose) and DRUG INEFFECTIVE (Positive PCR test 7 months after 2nd dose). At the time of the report, COVID-19 (Positive PCR test 7 months after 2nd dose) had not resolved and DRUG INEFFECTIVE (Positive PCR test 7 months after 2nd dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jan-2022, SARS-CoV-2 test: positive (Positive) positive.         Concomitant and treatment medication were not reported. The patient had a positive PCR test today (06-Jan-2022).  This is a case of Lack of efficacy that concerns a 40-year-old male patient with no medical history, who experienced the unexpected non-serious adverse events of special interest, COVID-19. The event occurred approximately 7 months after receiving the second dose of mRNA-1273. SARS-COV-2 Test yielded positive results, no other clinical or treatment details were given. It was reported that the outcome of the event had not resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Sender's Comments: This is a case of Lack of efficacy that concerns a 40-year-old male patient with no medical history, who experienced the unexpected non-serious adverse events of special interest, COVID-19. The event occurred approximately 7 months after receiving the second dose of mRNA-1273. SARS-COV-2 Test yielded positive results, no other clinical or treatment details were given. It was reported that the outcome of the event had not resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Reaction after Dose 2: Extreme dryness did not star until about 5 day after the 2nd shot. My tongues swelled to level of extreme discomfort. Over the next week the dryness, burins continues to get worse and worse. Reaction After Dose 1: Extreme dry mouth, eye, crusty eyes, burning sensation in my mouth, swollen and inflamed tongue. An extreme Sojren's flare that was confirmed by positive antibodies result for m"Early Sojren's antibodies. I had never had those symptoms before the vaccine. The dry mouth happened with an hour of receiving the first shot. One week later it exploded.
Pt c/o experiencing extreme pain, discomfort in shoulder with decreased mobility and decreased strength. Pt c/o burning sensation in shoulder, extending toward elbow.
I got my flue shot first in the left arm and then got the Covid shot in the Right arm.  As soon as the shot was administered I felt my right neck start to throb. I didn't say anything and proceeded to leave the store.  As I was walking to the parking lot the throbbing in my neck became more sever and started moving down  to my upper back.  By the time I reached the parking lot the throbbing had moved to my lower back and was quite sever.  As it move I had a little discomfort in my chest but that didn't last long.  I had trouble sitting because of the intense throbbing but in a few minutes the pain reduced.  Within approximately five minutes all symptoms were gone.  That evening I experienced chills and felt feverish but by the next day I felt fine except for a sore arm at the injection site.
Patient is describing a muscle spasm like sensation in the arm that she was given dose 2 of the shingles shot in.  It is not swollen or inflamed, but she describers intermittent spams or skin crawling sensations at the injection site.  Her second shingles shot was given 2 weeks ago, as of the day of this report.
SORENESS IN LEGS, THEN BY 11-8 UNABLE TO WALK OR USE HANDS/ARMS/LEGS/FEET. DX WITH GUILLAIN BARRE SYNDROME.  STILL AT REHAB FACILITY 12-1-16.
GROWTH START ON HIS RECTUM  AFTER HIS VAX; WORRIED; AFRAID TO ASK; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced growth start on his rectum after his vax, worried, and afraid to ask. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the growth start on his rectum after his vax, worried and afraid to ask was not reported. This report was non-serious.
Approximately two hours after administration, uncontrolled twitching in left eyelid lasting for approximately 30 minutes.
Injection site hot to the touch; Injection site area is itchy; Injection site area is red; Injection site pain; A spontaneous report was received from a nurse who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced injection site pain/vaccination site pain, injection site area is red/vaccination site erythema, injection site area is itchy/vaccination site pruritus, and injection site area is hot to the touch/vaccination site warmth.   The patient's medical history was not provided. Concomitant medications reported included Synthroid (levothyroxine sodium) and hydrochlorothiazide.  On 23 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly (batch unknown) in the left deltoid for prophylaxis of COVID-19 infection.   On 23 Dec 2020, the patient received the vaccine and felt some injection site pain, which she didn't find abnormal.   On 05 Jan 2021, she woke up and the injection site was red, itchy and hot to the touch.No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, injection site area is red, injection site area is itchy, and injection site area is hot to the touch was not resolved.  The outcome for the event, injection site pain was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
REDNESS OF NECK AND HIVES FOR 3 DAYS NOW. AM TAKING TO THE DR BECAUSE WONT GO AWAY.
Patient refers feeling dizzy and need of air. Patient oriented in time place and person. Vitals are taken BP 120/80, R 18, P 96, Sat 98, Dextro 95. Patient was laid down and given juice to elevate sugar. Doctor was consulted and recommended keeping patient in observation and to retake vitals and if patient was feeling better to discharge. After 30 minutes vitals were retaken BP 120/80, R 18, P 96, Sat 98, Dextro 104. Patient reports feeling better.
Patient reported they couldnt stand the sight of blood and had fainted during draws before.  Father was present in the vaccine office as well.  Immediately fooling the administration of the vaccine patients eyes glazed over and he fainted.  A few seconds later he began to have a spastic seizure that was short in nature, followed by a voiding of his bladder before he regained consciousness.  Patient was given water, glucose tablets, and instructed to lay on the floor of the room with his feet elevated while a member of the staff stayed with him to treat and watch him.   Followed up with patient and doctor soon after to learn this was the only time it has happened, patient fully recovered.
Large amount of redness, swelling, pain at the injection site about the size of 9x8 area and is increasing in size as the day's pass.
This spontaneous report as received from registered nurse refers to an unspecified patients of an unknown age and unknown gender. On an unknown dates in 2015 (reported as past week), the unspecified patients were vaccinated with improperly stored, oral, ROTATEQ (Lot# K012432 and expiry date: 20-MAY-2016) (dose and frequency were not reported). No adverse effects were reported. No product quality complaint (PQC) was reported for ROTATEQ. This is one of the several reports from the same reporter. Additional information is not expected as the reporter did not wish to contact.
Rash on left upper thigh and right side of neck. body ache, headache, and stuffy nose.
The vaccine help but his will have it/suspected vaccination failure; has it on the optic nerve of his eye; doesn't feel well; stress; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included ophthalmic herpes zoster (had it for over 30 years).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant), feeling unwell and stress. On an unknown date, the outcome of the vaccination failure, feeling unwell and stress were unknown and the outcome of the ophthalmic herpes zoster was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, feeling unwell and stress to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient's wife. The age at vaccination was not reported. The patient got the shingles on the optic nerve of his eye and had it for over 30 years.  It comes on when patient doesn't feel well or was under a lot of stress.  The vaccine had helped the severity, but would always have it. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Within 24 hours Fever 101+ Body aches Severe headache Skin fever Shakey Chills Joint pain Basically full on acute Covid symptoms that hit hard and slowly dissipated over 4 days leaving me physically and mentally exhausted
Little soreness in arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Little soreness in arm at injection site) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE PAIN (Little soreness in arm at injection site). On 17-Mar-2021, VACCINATION SITE PAIN (Little soreness in arm at injection site) had resolved. Not Provided          The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown) was not applicable. Concomitant medication was not reported.  No treatment information was reported.   This case was linked to MOD-2021-018613 (Patient Link).
Patient got FLULAVAL immunization on 10-28-16. Lot # A3AD2, expiration date 5/31/17. Patient said she was dizzy and nauseous as a result of flu vaccine.
Admitted to hospital 9/25/03 for severe thrombocytopenia <1 (thousand). Responded to WonRo and discharged home 9/27.
felt sick; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (felt sick) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B212A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, the patient experienced VACCINATION COMPLICATION (felt sick). At the time of the report, VACCINATION COMPLICATION (felt sick) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter   This case was linked to MOD-2021-233047 (Patient Link).
05/31/08- SOB and chest pain                     06/01/08- Chest pain, pericardial effusion, Pericarditis 6/3/08-records received for DOS 5/31-6/2/08-DC DX: Pericarditis. Presented with chest pain for about 10 days and 2 days after vaccination for human papilloma virus.
AFTER VACCINE GIVEN, DEVELOPED BLURRED VISION, DIZZINESS, FELT FAINT, APPEARED PALE PER STAFF, BROUGHT TO OBS VIA WHEELCHAIR, GIVEN SNACK/WATER/JUICE, REPORTED FEELING BETTER, COLOR RETURNED. VSS LYING TO STANDING, ESCORTED WITH FATHER TO EXIT WITH NO ISSUES ONCE SYMPTOMS RESOLVED AT 0900. 0840 INITIAL BP 105/70 HR 68 RR 18 SATS 98% ON RA 0850 STANDING BP 108/71 HR 63 RR 18 SATS 98% ON RA
After getting my 2nd Moderna covid booster, I got a headache that has not gone away. Booster received 10/14/22. Headache started on 10/20/2022. Over the counter medication such as Tylenol and Advil have not helped. Doc prescribed medication has not helped either.
101.3 highest fever started the next day, and lasted for 3 days. Tiredness lasted for 3 -4 days after vaccine. Sneezing, runny nose, productive cough lasted for about 10 days. All cold related symptoms started the day after the first shot. He did not lose smell or taste.
3 cm induration and central crusting at injection site, of VARICELLA, no blisters.
This spontaneous report was received form a physician refers to multiple unspecified patients of an unknown age. The patients' pertinent medical history, concomitant medications and drug reactions/allergies are not reported. On an unknown date, the patients were vaccinated with improperly stored VAQTA (lot # M011116 and expiry date 17-JUN-2017). Temperature excursion occurred at 46.8 F for 10 hours. No adverse events were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
I gave the patient SHINGRIX vaccine to day and instructed patient to wait in the store 20 minutes after administration, about 45 minutes after the vaccine, patient came back complaining of swelling in tongue and numbness in her mouth and throat, and unable to swallow, I gave her a BENADRYL and water asked to stay and relax for some time, also asked her if she would like me to call the ambulance, she said no, lets wait and see if the BENADRYL works first. I stood and watched her, told her not to worry, I'm trained to handle such emergency -and that seems to calm her a bit - after few minutes she reported starting to feel better and swelling of the tongue going down, after about 30 minutes she reported feeling normal  and she feels she is ok to go home, her son was with her and stated that he is going to drive her home. Instructed her to be careful of dizziness and falling because of the BENADRYL today unusual.
Local swelling, redness, fever x 3-4d. Treated with azithromycin, ice/ibuprofen.
Nervous system symptoms, entire body felt like "fire" under skin.  Was unable to stand on feet for more that a few minutes.
Myocarditis; abnormal heartbeat; intense chest pain; Shortness of breath; The pain in my chest felt like intense bruising. I still feel a sharp bruising pain when I lift something too heavy or turn quickly.; This is a spontaneous report from a contactable consumer (patient). A 22-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 22Feb2021 16:30 (Batch/Lot Number: EL9266) as single dose for covid-19 immunisation at the age of 22-year-old. Medical history included covid-19 prior to the vaccination. No known allergies. Concomitant medications included levothyroxine sodium (SYNTHROID) and levonorgestrel (KYLEENA) (reported as Kyleena IUD). No other vaccine received in four weeks. It was reported that I woke up with intense chest pain two days after the first dose. Thought I was having a heart attack. Now realizing it was Myocarditis. Intense pain when moving and lifting heavy objects. Apple watch detected an abnormal heartbeat which fixed itself later on in the day. I experienced shortness of breath. The pain in my chest felt like intense bruising. I still feel a sharp bruising pain when I lift something too heavy or turn quickly. The events stated on 24Feb2021 08:00. No treatment received, and outcome of events was recovered with sequelae on unspecified date in 2021. The patient hasn't been tested post vaccination.
still had shingles / Suspected vaccination failure; Still had shingles; Still very painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure/ still had shingles) (serious criteria GSK medically significant), shingles (Verbatim: Still had shingles) and pain (Verbatim: Still very painful). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 25-MAR-2023 This case was reported by a patient via interactive digital media. The patient still had shingles a lighter case but still very painful. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
On top of the common chills, body aches,  fever, skin sensitivity and fatigue. I noted right supraclavicular lymphadenopathy on Sat. 01/30/2021. (4 days after receiving vaccine). First time this has ever happened to me. Slight tender. Definitely noticeable and easily palpable. No other illness prior to vaccine. I have had to take OTC Tylenol for discomfort. I have scheduled an appt. with my PCP to discuss this on Thurs 2/4/2021.
Repeated vomiting lasting 4-6 hours. Noticed change in cognitive function subsequently, which is persistent and progressive.
Rash RED RING AROUND INJECTION SITE. COOL TO TOUCH. Narrative:
This spontaneous report as received from a nurse refers to a 6 months old patient of unknown demographics. The patient's current conditions or medical history were not reported. The nurse reported that the patient received the first, second and third the second doses of LIQUID PEDVAHIB at 2 months of age, at 4 months of age and at 6 months of age, respectively. No adverse experiences were reported. At the time of the report the outcome was unknown. Additional information has been requested.
Broke her ankle 7yrs ago and never had any problem until after taking the vaccine and it became inflamed all joints in body hurts
On 28OCT devel hivey rash that persisted on & off; some lip selling, which quickly resolved; DPH given;
pt. vax'd w/1st dose of hepatitis B & subsequently developed swelling, redness & pain at the injection site.
Facial flushing noted several hours after vaccination. Primary MD ordered BENADRYL. Joint pain, and achiness since. No fever.
break-through COVID-19 infection; break-through COVID-19 infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: EP6955), on 09Apr2021 as dose 2, single (Lot number: EP6955) and on 28Nov2021 as dose 3 (booster), single (Lot number: FJ1620) at the age of 54 years, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "allergy: Gluten" (unspecified if ongoing), notes: known allergies: Gluten. Concomitant medication(s) included: FLUOXETINE. Past drug history included: Codeine, reaction(s): "Allergy", notes: known allergies: Codeine. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 28Apr2022, outcome "not recovered" and all described as "break-through COVID-19 infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Apr2022) Positive. Therapeutic measures were not taken as a result of covid-19. Additional information: Facility where the most recent COVID-19 vaccine administered was pharmacy or drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination was fluoxetine. Reported event was break-through COVID-19 infection. Prior to vaccination, the patient did not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.   Follow-up attempts are completed. No further information is expected.
24 hours after 2nd dose my heart rate was elevated at an abnormal rate for more than 24 hours. The highest I recorded was 104 at resting. My normal is 74. I felt tired but wired and started recording it on my smart watch. After 48 hours it returned to more of a normal rate but still continues to be more elevated than before. I will follow up with my PCP this week. I had other symptoms that seemed normal-headache, chills, exhausted, sore arm, etc.
Patient reported redness, swelling, itching from 9/25/16 to 10/1/16. Patient saw physician, who prescribed diphenhydramine and prednisone.
Mom reports fever starting on 9/4/18 to 9/5/18 did not report how high temp was. Also reports rash that started after fever, on 9/7/18.
10/15 lesions widespread on legs, feet, back, torso, arm and scalp.
Patient began with red area at injection site 8/24/20. Area grew, is warm to  touch + patient began with fever. Treated  today for cellulitis
The buzzing and ringing in ears began about 14 days after the Vaccine.  Maybe sooner but this is the time frame I remember it beginning.  It was not constant then not until the booster shot later in November then it has been constant and is loud all day and all night.  24/7
pt recvd vax 8FEB94 & reports rt arm shoulder area is twice the size, red & feels warm; no other sx reported; referred to ER;