chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information was received on 20-APR-2017 from an attorney in the from of an initial legal complaint regarding a female patient (age not reported).  Medical history, concurrent condition and concomitant therapy were not reported. On 13-JUL-2009 the patient was vaccinated with ZOSTAVAX (dose not reported) as recommended for routine adult health maintenance for the prevent of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 16-MAY-2016 the patient was treated for a painful rash which was diagnosed as shingles with post-herpetic neuralgia. Post-herpetic neuralgia is a chronic condition resulting from nerve damage as a residual effect of severe shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result the patient suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
I started having heart palpitations and dizziness when they would order. I went through the heart clinic and got a heart scan, they sent me in to get an ultrasound of my heart. They sent me to rhythmologist to discuss the abnormalities they found, she referred me to a sleep clinic to see if it would help. I do have sleep apnea. I am currently being treated for the sleep apnea. Diagnosed with arrhythmia.
SUSPECTED IMMUNOLOGICAL VACCINATION FAILURE; ASYMPTOMATIC COVID-19 INFECTION; This spontaneous report was received from literature. This report concerned a patient of unspecified age, sex, race and ethnic origin. The objective of this study was to describe predominance of infection of antibody-resistant SARS-CoV-2 variants in vaccine breakthrough cases. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 infection. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose and start therapy date were not reported, frequency time 1 total was administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient had asymptomatic covid-19 infection which was confirmed with COVID-19 RT- PCR (Reverse transcription polymerase chain reaction) test by NP (Nasopharyngeal swab) which was positive for delta variant .Two days later, the patient underwent neutralizing antibodies test which was found to be  2851 (low response for delta variant), 11404 (WT (wild type) D614G), 5702 (alpha), 898 (beta), 11404 (gamma), 2263 (epsilon). SARS-CoV-2 IgG (Immunoglobin G) antibody spike protein test was found to be positive (3889.68), and IgG Nucleoprotein was found to be negative (0.88), and SARS-CoV-2 IgM (Immunoglobulin M) antibody test  was also (0.73) negative. Overall the interpretation of the antibody tests were failure to mount adequate antibody response to the vaccine (suspected immunological vaccination failure). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected immunological vaccination failure and asymptomatic covid-19 infection was not reported. The authors concluded that vaccine breakthrough cases were preferentially caused by circulating antibody-resistant SARS-CoV-2 variants and that symptomatic breakthrough infections may potentially transmit COVID-19 as efficiently as unvaccinated infections, regardless of the infecting lineage. Also, targeted booster vaccinations with monitoring of vaccine efficacy will likely be needed in the near future to control the viral spread in the community. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint. This case, from the same reporter is linked to 20210855269 and 20210855307.; Sender's Comments: V0: 20210861203-COVID-19 VACCINE AD26.COV2.S - Suspected immunological vaccine failure . This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
On 1/16/21 I received my first dose of Moderna covid 19 vaccine. Then on Friday the 22nd of Jan prior to going to bed I noticed a baseball size lump under my left arm pit.  I called my Dr. the next morning and was able to get in and see MD.  She examined me stating that I did have a 2inch diameter swelling of the left axilla. and then recommended that I go for a diagnostic mammogram and ultrasound.  Also told me she was giving me a referral to see a cancer specialist.
Mother reported on 2.19.22 when she brought patient in for the second dose of pfizer.  Mother states about 4-5 days after receiving vaccine that he had vomiting, runny nose, 103 degree fever, headache and could not lift his head. Mother called 911 but decided to drive her son to ER herself and she states  that he was temporarily unconscious.
EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned multiple patients.  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: Unk) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. The batch numbers were not reported and have been requested. No concomitant medications were reported. On an unspecified date, 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.
Information has been received from a registered nurse concerning her daughter (age unknown), who, on unspecified dates, was vaccinated with three different doses of GARDASIL. Subsequently the patient developed an abnormal pap. At the time of the report, the outcome of the patient was unknown. No product quality complaint was involved. Additional information has been requested.
Low grade fever (99.9 - 100.6), flu-like symptoms - severe headache, body aches, muscle pain and weakness. Onset of all symptoms began 24 hour after vaccine administration.
sore arm; nausea; feeling off; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 09Mar2021 12:30 (Lot number: EN6200) at the age of 43 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "sore arm"; NAUSEA (non-serious), outcome "recovered", described as "nausea"; FEELING ABNORMAL (non-serious), outcome "recovered", described as "feeling off".  Additional Information: 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 vaccine within 4 weeks prior to covid-19 vaccination. Facility type vaccine: Public Health Clinic/Veterans Administration facility. After the 1st shot of vaccine patient reported - regular side effects: sore arm, nausea and feeling off. The patient reported after 24 hrs. of 2nd shot of vaccine experienced chills, headaches, tiredness, no fever within 24 hrs. on 07Apr2021 and week after 2nd shot, broke out on a rash on left side. Started on forehead then by Friday, 09Apr, rash was on eyelid. Went to Eye dry sat and urgent care on Sunday for more rashes around eyebrows and corner of mouth and underneath lip. Went to dermatologist on Tuesday, 13Apr2021 and treated as shingles. The events result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. On the mend now but it left some scars and pigmentation issue. On PRD 04Oct2021 it was reported that patient did not have anaphylactic reaction. Patient was not hospitalized. Organ involvement Dermatological/mucosal, generalized erythema, Generalized pruritus with skin rash (Herpes zoster), Generalized prickle sensation (Herpes zoster), Red and itchy eyes (Herpes zoster) on an unspecified date and no emergency department/intensive care unit. Patient received treatment as Valtrex 1gm, prednisone 10 mg, bensal ointment. Reporter considered the Pfizer product had a causal effect to the adverse event. Patient's outcome following the potential anaphylactic reaction was recovered  No follow-up attempts are possible. No further information is expected.
This spontaneous (non-serious) report received from a patient, concerned a patient, of unspecified age and sex. The patient's height, weight, past medical history, concomitant medications and concurrent conditions not reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, batch/lot# unknown), route of admin, dose and start therapy date not reported, for immunization. Per procedure, no follow-up will be requested for this case. On an unspecified date, patient experienced chills and fever. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The patient recovered from chills and fever.
Woke up next morning after the shot feeling tired and no appetite. Slept practically the whole day and ate very little. The following day, better but still not strong, ate a little better.
I received the Moderna vaccine 9-13-21 around 6pm. Within 12 hours of getting the vaccine I had extreme body aches, chills, severe pain at the injection site , headache and debilitating fatigue .  The  fatigue continued to be so severe that I lay in bed only getting up out of necessity.  These symptoms continued daily when the headache was the worst headache of my life on 9/21/21 and I developed itching on the left side of my scalp.  This progresses to a burning and painful sensation on my forehead.  I then developed a rash on my forehead on 9/21/21 this was and continues to burn and itch.  The rash started to progressively get bigger and was raised. Over the next few days. On  9/25/21 I developed a severe aching, burning and stabbing pain in my left ear.   I was confirmed to have shingles at Urgent Care on 9/25/21 and given a prescription for Valtrex.
This spontaneous report as received from a other health professional refers to a 11 months old male patient. The patient's medical history was reported as ventricular septal defect (VSD). The patient was vaccinated with the first dose of VARIVAX (lot# was reported as 0079AE) subcutaneous on right thigh on 07-AUG-2012 2:49pm. The patient had no illness at time of vaccination. On 07-AUG-2012 the patient developed redness and swelling at immunization site. On 20-AUG-2012 the patient was seen with several vesicles at immunization site. Spoke with mom on 24-AUG-2012, rash had resolved for the most part. The outcome of patient was reported as recovered on 24-AUG-2012. Additional information is not expected.
Pain in arm; Headaches; muscle spasms; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain in arm, headache and muscle spasm. On an unknown date, the outcome of the pain in arm, headache and muscle spasm were unknown.   It was unknown if the reporter considered the pain in arm, headache and muscle spasm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the vaccine Shingrix injection and had terrible pain in arm, headaches and muscle spasms on and off. The reporter was calling on the behalf of her friend and reporter very limited details. The reporter refused to provide any additional details.
Hive at the site of injection, high fever, sleepy,nauseated. Started evening of injection and became worse for 3 days. Used ice paks and rest and took tylenol.
Patient came to pharmacy and complains of injection site being warm, itchy and raised. It occurred 4 days after vaccination. Told patient she should make an appointment with her PCP.
Sneezing: swollen eyes. No wheezing, no rash. IM epinephrine 0.2. Benedryl in home. Eyes still swollen 4 hours later. Was ov 6hrs.
By 10:00pm left upper arm hurting very bad, couldn't hardly move; couldn't sleep due to pain;  finally took Tylenol at 3:00am and got a couple hours sleep;  through weekend arm hurt very bad, any movement, especially lateral movement caused extreme pain, could not get shirts on or off; range of motion has slowly returned, after 5 days most motion is back albeit with soreness and some pain;  shoulder area is still sore.   Last year had almost not reaction to quadrivalent vaccine !
Information has been received from a pharmacist concerning a 78 year old male with a history of unspecified prostatic operation who on 07-NOV-2008 was vaccinated with ZOSTAVAX (Merck). Concomitant therapy included statin (unspecified) and unspecified prostate medication. On 13-NOV-2008 the patient developed shingles. The patient was put on BANCTROBAN and was feeling much better "today" (19-NOV-2008). At the time of this report, the patient was not recovered. The patient sought medical attention by office visit. Shingles was considered to be immediately life-threatening and disabling. Additional information has been requested.
fever 104 started @ 10PM on 21JUL94; did not respond to APAP q 4 hrs; 6AM 22JUL94 responded to Ibuprofen; extremely irritable all night leg was swollen-local to shot area;
By 6pm, I started feeling feverish, with chills, nausea, chest pains and abdominal pain. I also experienced headaches and my fever got up to 102.5. I went to the ER and they gave me fluids. I was told it was a reaction to the vaccine, but my paperwork said upper respiratory infection. My cough started out dry, I had SOB, weakness, fatigue, diarrhea and joint pain. My PCP put me on a steroid and an antibiotic Keflex (500mg, 3 times a day). I get lightheaded just walking around the house. I'm still experiencing SOB, fatigue and the cough. Today is the first day that I could get up an move around. I'm fine when I first wake up, but I eventually feel depleted.
This case was reported by a consumer via other and described the occurrence of Guillain Barre syndrome in a 71-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis. Previously administered products included SHINGRIX (received 1st dose on an unknown date). On an unknown date, the patient received the 2nd dose of SHINGRIX and Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving SHINGRIX and Influenza vaccine Quadrivalent unspecified season, the patient experienced Guillain Barre syndrome (serious criteria death, hospitalization and GSK medically significant), cardiac arrest (serious criteria death and GSK medically significant) and feeling unwell. On an unknown date, the outcome of the Guillain Barre syndrome and cardiac arrest were fatal and the outcome of the feeling unwell was unknown. The patient died on 24th November 2018. The reported cause of death was cardiac arrest and Guillain Barre syndrome. It was unknown if the reporter considered the Guillain Barre syndrome, cardiac arrest and feeling unwell to be related to SHINGRIX and Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that a good friend of a friend passed away past Saturday before the time of reporting and said that it was such a shock as she had not been ill. The patient had the new 2 dose shingles vaccine and then a flu shot and commented how she did not feel well after all of that. The husband of the patient took her to hospital on Friday and was diagnosed with Guillain Barre Syndrome. The patient went into cardiac arrest and then died. The patient had bridge at her home on Monday evening, went into hospital on Friday and died a week later on Saturday. Reported Cause(s) of Death: cardiac arrest; Guillain Barre Syndrome.
Patient developed a unilateral rash on their arm and legs days after receiving vaccine. Patient?s father reported, and said patient finds relief from topical hydrocortisone cream.
STARTED OFF WITH DISCOLORATION OF SKIN AND REDNEDDNESS AND A RAISED BUMP THE SIZE OF A GOLFBALL 40 MIN AFTER THE SHOT. 5 DAYS LATER A REDDISH RASH (RASH DOES NOT ITCH) ON RIGHT SHOULDER AND BOTH FOREARMS APPEARED. ALSO KNEES HAVE SOME ARTHRITIC PAIN. ALSO HAD SLIGHT FEVER ON DAY 4 AFTER THE SHOT.
30 minutes post vax, the pt's knees felt funny. He slept for three hours. He woke up pale, with a fever of 101, pain all over the body, and general malaise. An ER visit was required. No treatment was given.
left his hand and fingers swollen and red; left his hand and fingers swollen and red; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer reported for a male patient (reporter's husband). A male patient of an unspecified age, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on an unknown date (reported as "Thursday morning") for COVID-19 IMMUNIZATION. Relevant medical history and concomitant medication were not provided. On an unknown date, the patient experienced left his hand and fingers swollen and red. The patient received treatment for the event. The patient decided to take two acetaminophen (TYLENOL) to see if the swelling would go down and stated if the medicine did not work that the patient will call his physician. The outcome of the events left his hand and fingers swollen and red was unknown.   No follow-up attempts are possible. No further information is expected.
Patient called on 12/10/2017 to ask if the vaccination could have triggered a seizure because she experienced one after receiving the flu shot on 12/9/2017 when she arrived home. Patient has had a history of seizures for several years and has been treated with Phenytoin 100 mg 4 capsules a day for control. I asked the patient when her most recent seizure was, she said she wasn't sure. I asked if it had been years or months and she said she wasn't sure, maybe years. She did document her history of seizures and is well known to the pharmacy. She also received a flu shot on 12/09/2016 with no adverse events and reported no previous seizure history after vaccinations. When asked to describe the seizure she said she fell a little into the counter and hurt her thigh. That was the most description she provided even when asked again to describe the episode. She said she is fine now but was just wondering if the flu shot could have caused it.
Pt recvd vax APR91 & 2nd dose MAY91 & following 2nd dose pt exp achiness & weakness; just couldn't function;
This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VAQTA 25/0.5 (units not provided), lot # M036459, expiration date: 18-JAN-2018, (dose number, route and anatomical location of administration were unknown). The temperature excursion reported was: 51.3 F for 40 minutes. There was no previous temperature excursion. The temperature excursion was detected by a digital data logger. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Dizziness,Weakness, very low and then High blood pressure.(Uncontrollably)
Narrative: COVID infection following COVID vaccine series 01/29 08/17 COVID swab, result: not detected 02/26 Pfizer, dose #1 NON-FACILITY 02/06 Pfizer, dose #2 NON-FACILITY 08/13 COVID swab, result: not detected 08/17 COVID swab, result: detected 08/18 pt cc: chills, cough, fever, headache exposure: unknown
One day after immunizations, started with pain around RT ear and face getting progressively droopy. Recent URI as well.  No rash.   PERTINENT POSITIVES: droopy RT face.  Periauricular RT pain, mainly just above ear. Mild 2/10.  PERTINENT NEGATIVES: No  Fever, visual changes, excruciating HA.  No Emesis, weakness anywhere else.
Within 2 minutes of shot, patient vomited 5 times.  Then, complained of painful pruritis, lump in throat, mucousy sounding in chest.  Developed full body urticaria, dusky on legs, frantically scratching at eyes, face, nose, torso, scaly.  Benadryl given, monitored for 1 hour.  Did not require epi but did continue to feel ill and was hospitalized.  8/8/08 Hospital medical records for 6/6/08. FINAL DX: allergic reaction to vaccinations Records reveal patient experienced immediate vomiting after injections, then had itchy mouth & vomited again.  Tx w/antihistamine & steroids. Developed hives all over w/wheezing that resolved.  Exam revealed eyelid swelling & erythema, facial redness but hives had also resolved.  Remained stable & d/c to home same day on continued antihistamine x 48 hours.
Large red rash 5 inches in circumference appeared below injection site. Very Red , warm to touch, slightly tender slightly itchy, fading at 72  hours almost gone
I noticed that I was getting short of breath so when I was at church. I started singing & I couldn't hold the note which I was always able to hold a note but I was very short winded & also I am forgetting things. I was told I was allergic to one of my meds that I had been taking for over 6 yrs so they took me off Lisinopril & put me on another med.
I went to Acute Care on 06/21/2021. They tested me for COVID and the test came back negative. I woke up on 06/26/2021, I was putting on lotion and I realized that I couldn't smell anything. My boyfriend and my daughter had just been diagnosed with COVID the week prior. I was in quarantine with my family from work. I put Vick's vapor rub under nose and could not smell it. I became very ill after that. I felt like my nerves were being pinched in my joints. I developed a rash on my hands, had headaches, backaches and chest pain. I felt nauseous at times and could hardly eat anything. The only thing that I could taste was the sweetness or bitterness of candy. I felt very tired at times too. I was re-tested for COVID and this time it came back positive. I felt like someone was ripping my muscles apart. It was a terrible pain that I felt.
Arm soreness; This non-serious case was reported by a nurse via other manufacturer and described the occurrence of pain in arm in a female patient who received HAV (Havrix) for prophylaxis.   On an unknown date, the patient received Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced pain in arm (Verbatim: Arm soreness). The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to Havrix.     It was unknown if the company considered the pain in arm to be related to Havrix.   Additional Information: GSK Receipt Date: 21-APR-2023 Nurse who called on behalf of herself (patient).  The patient said she experienced arm soreness after receiving Havrix dose.  No additional adverse event reported.  No Pharmaceutical product complaint reported.  No further information was provided.