chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had the vaccine twice but still got them/ suspected vaccination failure; got them in my eye; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and ophthalmic herpes zoster were unknown.   It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided are as follows: The case was reported by patient himself/ herself. The age at vaccination was not reported. The patient had the Shingles vaccine twice but still got them in his/her eye. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not be possible as no contact details were available.
patient reported feeling dizzy and faint 5 minutes after vaccine while sitting donw. water was offered.  3 minutes later, patient was still feeling dizzy and requested to lie down. upon helping patient to a place to lie down, they fainted in the store. paramedics were called and personnel stayed with patient until paramedics arrived
Day 1-3 had painful and sore arm near injection site. (It felt like the vaccine settled in my arm about an inch below the injection site. It seemed slightly inflamed and was sore to the touch).  Bruise developed at injection site (possibly due to needle bursting blood vessel) which is still present 7 days after vaccination was administered.  One week after vaccination a rash developed on my left arm in the same area that was painful immediately after the injection of the Moderna vaccine. Rash is red, firm, slightly inflamed/raised, warm to the touch, and itches.  I have been treating with topical ointments (benadryl cream, cortisone cream) and ice packs applied to the area.  Other symptoms that manifested the same day the rash began: gas, lose stool, fatigue, body aches, swollen lymph nodes in throat.
On 6/2/99, pt recv'd Engerix-B vax.That same day,pt complained of pain & redness at injection site;which progressed to total body weakness.3-5 days after vax,pt dvlped probable transverse myelitis.Pt was hospitalized. Pt continues to
Pt recv vax on 2/3/99; 1/2 hr post vax pt exp LA warmth, redness & swelling, cellulitis; tx=Duricef
Initial report received on 21 May 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a two-year-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance System (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3306AA received on 14 July 2009, lot number C3430AA received on 14 September 2009 and lot number C3432AB received on 13 November 2009 and 1 dose of TRIPEDIA; lot number U3282BA received on 03 June 2010 (routes and sites of administration not reported). The subject developed cold-like symptoms and cough on 20 April 2012, almost 2 years after the last dose. On 01 May 2012, the subject developed a paroxysmal cough with a whoop. The subject also experienced posttussive vomiting, apnea and sleep disturbance. Laboratory testing included positive PCR on 05 May 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 05 May 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 05 May 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 15 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Did not even remotely start feeling like myself again until yesterday/Did not feel like herself; Headache; I was bruised and achy everywhere; I was bruised and achy everywhere; Getting hot and then cold, hot and then cold; get really hot, my ears get red, my face, my neck I just start getting hot/Feeling hot in her ears, face and neck; My ears get red; chattering my teeth; sweat; Fever; This is a spontaneous report from contactable consumer (patient) reported for herself. A 48-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received her first dose of the Pfizer-Biontech Covid19 vaccine this past Monday. On an unspecified date, it was reported that she did not even remotely start feeling like myself again until yesterday, the headache was the first thing that came up, but that was gone in the morning then the next day I felt like I'd been hit by a truck, I was bruised and achy everywhere and that yesterday I was pretty good. The lingering symptom that she was asking about, that she did not see in her consumer fact sheet, is I keep getting hot and then cold, hot, and then cold temperature swings, how long is that supposed to go on I get really hot, my ears get red, my face, my neck I just start getting hot. Then I will cool down and get back to normal. There for the first few days I was chattering my teeth, but now I just get hot. I wake up at night with my pillow soaked, had to pull a blanket up on me because I am cold and had to kick them back off again because I am hot. She was asking how long she should expect these symptoms to last. Response received as per attached: (systemic side effects) including fever and chills were observed with the first 1 to 2 days after vaccination and resolved shortly thereafter. Also provided that frequency data is reported in the 7 days following either dose (tables 1 & 2) [LAB-1457-11.0; Revised: 12Aug2021] Referred back to HCP for treatment if needed. It was reported that she had a headache on the first day after the vaccine, and it resolved overnight. Was not feeling like herself and felt better yesterday. The clinical outcome of the events headache, chills, fever on an unspecified date 2021 was resolved and rest of the events was unknown.  Information on the lot/batch number has been requested.
"The day after, I noticed  a little red cluster of red dots at the site, the next day it got bigger, the next day it got bigger and it continued to get bigger each day. Now it looks like a raspberry stain with redness around the edges, longer than it is wide and not uniform, it is irregularly shaped. I have minor discomfort at site of injection that comes and goes. The area is not hot to touch. Today I felt warm, my temperature was 98.6 however my normal temperature is 97.6.  More air conditioning for comfort than usual."  No treatment at this time.      Outcome- will monitor the injection site and contact us of any changes or new concerning signs/symptoms.
keeps getting rash, it comes and goes in body/broke out in rash and mostly on the trunk of body, little bit on neck and little bit on the sides/ breaking out with rash; immune response; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Dec2022 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, Batch/ Lot number unknown), for COVID-19 immunization. The following information was reported: RASH (non-serious), 2 weeks after the suspect product(s) administration, outcome "not recovered", described as "keeps getting rash, it comes and goes in body/broke out in rash and mostly on the trunk of body, little bit on neck and little bit on the sides/ breaking out with rash"; IMMUNISATION REACTION (non-serious), 2 weeks after the suspect product(s) administration, outcome "not recovered", described as "immune response". The events "keeps getting rash, it comes and goes in body/broke out in rash and mostly on the trunk of body, little bit on neck and little bit on the sides/ breaking out with rash" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient got the booster shot at the beginning of December and kept getting rash; it came and went in his body after receiving the booster shot. The patient broke out in rash about two weeks later of booster vaccination, mostly on the trunk of his body, little bit on his neck and little bit on the sides. He kept breaking out with rash and had been to two doctors and had a biopsy done which was inclusive for Viral fungi and so first, he could not figure out; went to another doctor and they could not figure it out. The doctors said they did not know, and the reporter and patient were wondering if other people had broken out with a rash that came and went; they checked out everything. It was not shingles and they have cross checked and very concerned of that it was may be just an immune response and wondered of other people experienced it. The reporter and patient checked up everything from laundry detergent, to what the patient was eating and was just sort of scratching their heads, it is what happens sometimes. They were glad that they got the booster and everything like that, and liked to know about the rash that comes and goes.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
26 hours after the flu shot I had severe nausea and vomiting Every 20 min or so , that didn?t stop for 2 hours. Worse case of nausea and vomiting I have ever had in my life.  No redness or rash anywhere Else. My face became flush red and swelling around my lips and eyes that I woke up with the next morning.  I am still swollen and red.
Migraine one hour following the vaccination.  Within two weeks of the 2nd dose, I experienced mild chest pain and heart palpitations.  At present time, the heart palpitations occur daily and are mild.  This could be related to Anxiety and if so, it would seem people like me with Anxiety could also experience these side effects.
2 out of 3 shots of GARDASIL administered. Alopecia was the diagnosis after seeing doctor August 27, 2008. Blotchy hair loss in the front of her head (pictures taken) 1st shot given in November, 2007 and second given in April, 2008.  Hair loss began approx. June, 2008 and is progressively getting worse. Doctor prescribed Selenium Sulfide Lotion to use twice a week for 2 weeks.  Does not believe there will be a change.  Also went for blood work to check thyroid (August 28, 2008) Results not given as of yet.
After receiving Pfizer Covid vaccine, patient developed symptoms of dizziness, nausea, a little shortness of breath.  Reported she had a history of asthma and said she felt like "her limbs weren't working".  She agreed to be taken to ED for evaluation.  Was treated with fluids, ondansetron, and lorazepam IV push one time.  Never treated for allergy/anaphylaxis.
This spontaneous report was received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with ZOSTAVAX (lot # 671019/0749AA, exp 18-AUG-2012) which was reconstitute with expired diluent (lot# E011001, exp. FEB-2012) on 23-JUL-2012. No adverse effect reported. Additional information has been requested.
Clammy, nauseated, headache, low blood pressure, passed out, temperature, sweating, bowel movement
Fever, DATIGUE, CHILLS, MUSCLE PAIN/ACHE, PAIN TO INJ SITE Narrative:
Information has been received from a medical assistant concerning a 7 year old male patient who was vaccinated with varicella virus vaccine live (Oka/Merck) (Lot #658432/1246U). Subsequently, the patient developed an injection site reaction described as injection site swelling and injection site itching. The patient sought unspecified medical attention. There was no product quality complaint. This report is one of several from the same source. Additional information has been requested. This is in follow-up to report(s) previously submitted on 5/16/2008.  Follow up information has been received on 24-MAR-2008 from a medical assistant concerning a 7 year old male patient with no pre-existing allergies, birth defects, or medical condition who, on 11-DEC-2007, was vaccinated with a second dose of VARIVAX (Merck) (Lot #658412/1246U) subcutaneously in the left thigh at 9:30 AM.  It was also reported that the patient did not have any illnesses at the time of vaccination.  Other vaccinations received the same day included VAQTA (lot number 659186/1258U) intramuscularly in right thigh.  On 13-DEC-2007 (also reported as 13-DEC-2008), the patient developed redness, pain, 2 mm red indurated area around VARIVAX (Merck) (lot 658432/1246U) injection site on left thigh.  On an unspecified date, the patient recovered.  No further information is available.
Pfizer 4/22/21, 5/20/21. Positive on 12/9/22.
child inadvertently given a kinrix when a prevnar (pneumococcal 13) and hib had been ordered.  No adverse effects immediately noted.  Family notified.  Will wait one month then give prevnar and hib.
This spontaneous report was received from a medical assistant a 11.5 months old patient. The patient was vaccinated with dose 1 of VARIVAX (lot # and route not reported) at 11.5 months of age. No concomitant medications were reported. No adverse symptoms were reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Started with weakness, then runny nose and cough the next day with a fever of 99.5 which lasted 3 days, then 104 fever and severe coughing for 3 more days.  The Dr prescribed oral steroids for cough, continued Advil and Tylenol, and antibiotics.
Information was received from a 46 year old female consumer referring to herself. The patient's drug reactions/ allergies were unknown. The patient's pertinent medical history included chickenpox (at 14 years old) and car accident. Concomitant therapy included warfarin. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, frequency and route not reported). On an unknown date, the patient experienced fever. The patient did not seek any medical attention. No treatment was given for this event. The outcome of the event was unknown. The relationship between the event and PNEUMOVAX 23 was not reported. Additional information is not expected as there is no consent to contact.
This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a adult female patient who received HAV (HAVRIX pediatric) (batch number 39Y4G, expiry date 29th October 2018) for prophylaxis. On an unknown date, the patient received HAVRIX pediatric. On an unknown date, unknown after receiving Havrix pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown. Additional details were provided as follows: The age at vaccination was not reported. An adult patient was given a pediatric dose of HAVRIX which led to underdose and adult use of a child product. This case has been linked with case US2018100653, reported by the same reporter for the same event.
I have not gotten my period since I was vaccinated, it was scheduled to come two days later and I still have not received it and I am not pregnant, and my period has never been more than a day late, it is now 7 days late.
I had mild symptoms, body chills, aches, low-grade fever, I used a home COVID-19 test that did come back positive. Within the hour of the test coming back positive, I called my doctor's office, spoke to a physician assistant. We discussed my positive test result as well as my symptoms. She prescribed the Paxlovid, I was able to start the Paxlovid on March 4, 2023, I started feeling better with three days.
Treatment of COVID-19; Treatment of COVID-19; Moderna Dose Number: 2; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 28Nov2021 as dose 3 (booster), single (Lot number: Fg3s27) at the age of 46 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 21Mar2021 as dose 1, single (Lot number: 046a21a), in left arm and on 18Apr2021 as dose 2, single (Lot number: 041b21a), in right arm for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 19Dec2022 as dose number unknown, single (Lot number: As7166b), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing); "polyarteritis nodosa (in remission)" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "chronic migraine" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Klonopin, reaction(s): "Known alleries: Klonopin"; Morphine, reaction(s): "Known allergies: Morphine". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 28Nov2021, outcome "unknown", described as "Moderna Dose Number: 2"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 15Sep2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Sep2023) negative; (24Sep2023) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 16Sep2023 to 20Sep2023.
Aching all over body; headache (extreme) Friday - Saturday; Temp to 100; Shortness of Breath w/ extreme cough; extreme fatigue; sore throat w/ trouble swallowing; cough continued Mon - Wed; sleeplessness;  Thursday aches had gone, but continue to experience cough and chest congestion
Narrative:  Patient was hospitalized at hospital 5/8/2021 with severe hypokalemia after he completed labs the same day as his COVID 19 vaccination 5/7/2021. They hypokalemia was also present on previous labs in 12/2020. ADR being submitted related to time association with Vaccine only.
This spontaneous report concerning a patient of an unknown gender and age was received from a nurse practitioner. The patient's concurrent conditions and medical history were not provided. On 14-JUL-2016, the patient was vaccinated with VARIVAX lot #: M006731, expiration date 09-FEB-2018 (strength, dose, route and frequency were not provided). The reporter stated that the VARIVAX was improperly stored at a temperature of 27.7F for 1 hour and 12 minutes. There was no previous temperature excursion. There were no concomitant medications and symptoms reported. No product quality complain was involved. Additional information has been requested.
About 2 weeks post injection, patient noticed large (approximately 4 in x 4 in) area on arm - red, warm to touch, slightly raised. Patient contacting PCP on Monday 1-3-14.
Achalasia; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was previously in perfect health. Patient not had any other vaccines in over 30 years. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced achalasia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of achalasia was not reported. This report was non-serious. This case, from the same reporter is linked to 20230636250 and 20230636293.
She received MENVEO vaccine at 10:00 AM by 5:00pm became very tired, developed chills. On 7/17/15 went to walk in and had full blown sinus infection. Was given OMNICEF for 14 days.
"Covid arm". Red rash and blotch at and near the injection site on the arm that received the injection. Rash is itchy and hot to touch. Started feeling uncomfortable on day 7 after injection, full blown on day 8.  On day 9 and rash is still there.
09/23  The patient presents with facial droop x1 hour ago with associated fever and slurred speech that has resolved. Hx of TIA. Per EMS, the pt's son had called due to the pt's symptoms after checking on her this morning. Her last well known was 11PM last night. Denies fever, chills, sore throat, cough, SOB, CP, abdominal pain, N/V/D, dizziness, and HA.  Risk factors consist of diabetes mellitus, hypertension and TIA. Associated symptoms: fever, slurred speech, denies chest pain, denies headache, denies nausea, denies vomiting, denies dizziness and denies confusion.
felt like arm hit with a baseball bat; soreness on injection site since January; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (felt like arm hit with a baseball bat) and VACCINATION SITE PAIN (soreness on injection site since January) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced VACCINATION SITE PAIN (soreness on injection site since January). On an unknown date, the patient experienced PAIN IN EXTREMITY (felt like arm hit with a baseball bat). At the time of the report, PAIN IN EXTREMITY (felt like arm hit with a baseball bat) and VACCINATION SITE PAIN (soreness on injection site since January) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient does not have any medical conditions, but was recently prescribed with high blood  pressure medication in May after the vaccine.  No treatment medications were reported.   This case was linked to MOD-2021-379693 (Patient Link).
It took me a full two day to recover from the 3rd Moderna shot administered on 1/17. On 1/18 and 1/19 I experienced flu like symptoms sleeping most of the two days.  Sweats, chills, temp (99.8) nausea, shakes, lethargy. At approximately 1AM on 1/20, I experience severe headaches (upper neck/lower head) followed by severe night sweats. Once that episode was over, I began to feel normal again. I experienced the same thing during the evening of 1/21 and 1/22. Severe headache / pressure in upper neck and lower head followed by heavy night sweats. These episodes last approximately 90 minutes. Again, once those episodes are over I feel normal. I have been feeling fine during the day. My lymph node under my left is very swollen and sore which started on 1/20. The swelling and soreness has subsided this morning, but still abnormal. I experience something very similar after my second shot with flu like symptoms lasting for only one day followed by swollen lymph nodes in my neck and under my arm (left). No reaction to lymph node in my neck this time.
Patient c\o generalized itching and received Benadryl po with good effect. Symptoms resolved prior to discharge.