chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 12-OCT-2012, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 07-APR-2016, the patient was treated at a hospital for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster or shingles. The patient was prescribed tramadol and acyclovir for management of her painful symptoms. 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 has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Began feeling fatigued 5-6 hrs p/inject; @ 3AM 24SEP91 (16 hrs p/inject) awoke from sleep w/dizziness, muscle aches, tingling in arm recvd inject, disorientation, visual disturbances (saw lights in front of self "spinning"); afebrile t97;
I woke up with my arm feeling very sore in the muscle where the shot was given. I took Ibuprofen later in the morning, which helped a little, but I could tell when it was wearing off that afternoon because I started to feel achy all over by about 4pm, so I took another dose of Ibuprofen. That helped me feel better, but I got tired sooner than usual. I settled into bed by 10pm and felt cold and shivery. I took more Ibuprofen and was able to sleep. The next morning I felt much better, like I do after I get over a fever. I did normal activities, but by the afternoon I felt exhausted like I'd done too much, so I took a nap. I felt okay by the next day.
Reports significant left upper arm pain after 2nd COVID vaccine for 6 months Slowly improving. 7/10 at times. given 2/26/2021
Urticaria red, itchy welts that result from a skin reaction.  The welts vary in size and appear and fade repeatedly as the reaction to contact. I have now been dealing with this for over three weeks. I am using hydrocortisone cream to stem the itching and welts.
11/26  c/o SOB since nov 11th intermittent, pt states covid + nov 16th. Pt aflutter per EMS and new onset afib heart rate 80-130, denies chest pain. The patient had a chest x-ray taken, which showed subtle interstitial opacity at the lung bases versus prominent parenchymal markings.  The patient was admitted.  She was started on Solu-Medrol and she is still currently in emergency room. When seen, patient complained of cough and shortness of breath. 12/2The patient is currently maintained on cefepime, Flagyl, and vancomycin and this is day #5 of all antibiotics.  The patient is also on remdesivir and prednisone. ........... 12/6 The patient is currently maintained on Zosyn and vancomycin.  This is day #2 of both antibiotics.  The patient is also maintained on micafungin, which was started today.  The patient as far as COVID concerned, is very stable and she is on 2 L and saturating 96%  12/9 The patient is currently maintained on Zosyn and vancomycin, day #5.  The patient is also on micafungin.  The patient will be having a midline placed today.  The patient can be discharged on Rocephin 1 g daily for a period of 10 days along with vancomycin 750 mg IV every 12 hours for a period of 10 days with weekly CBC and a comprehensive metabolic panel.   12/1 Discharge
Within a few hours of vaccination, the pt became very irritable, inconsolable most of the time since the injections and decreased sleep. Tylenol ineffective and note no redness or tenderness of injection sites.
She found out that she was pregnant after the shot; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (She found out that she was pregnant after the shot) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. In 2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (She found out that she was pregnant after the shot) (seriousness criterion hospitalization). In 2021, MATERNAL EXPOSURE DURING PREGNANCY (She found out that she was pregnant after the shot) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       No concomitant medications were provided. No treatment information was provided. Reporter stated that his 18-year-old granddaughter had the Moderna COVID-19 vaccine and she found out that she was pregnant after the shot.  Patient stated that she will not be getting the shot.  This case concerns an 18-year-old, female patient with no relevant medical history, who experienced the unexpected events of vaccine exposure during pregnancy. The patient received the first dose of vaccine at unknown weeks of gestation. The event was considered not applicable to the product; however, the reporter's assessment was not provided. The benefit-risk relationship of Spikevax in not affected by this report.; Sender's Comments: This case concerns an 18-year-old, female patient with no relevant medical history, who experienced the unexpected events of vaccine exposure during pregnancy. The patient received the first dose of vaccine at unknown weeks of gestation. The event was considered not applicable to the product; however, the reporter's assessment was not provided. The benefit-risk relationship of Spikevax in not affected by this report.
This spontaneous report as received from a registered nurse refers to a multiple unspecified patients of unknown age and gender. Since 20-JUL- 2017, the patients were vaccinated with improperly stored dose of LIQUID PEDVAXHIB, lot #s N003701, expiration date 01-NOV-2019 and N007750 expiration date 29-NOV-2019 (dose and routed were not reported). The vaccine was exposed from 47 degree Fahrenheit  (°F) to 77 degree Fahrenheit  (°F) (52.7°F) for 2 hours and 15 minutes. There was no previous temperature excursion. The call was made because there was a "data logger". No side effects were reported. This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1708USA004838: US-009507513-1708USA001164:
Headache, muscle aches and nausea. Treatment OTC pain relievers and rest.
Initial report received on 23 August 2012 from the Investigator participating in the post-marketing study under the reference number M5 A16. A case of pertussis in a three-year-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3200AA received on 17 December 2008, lot number C3228AA received on 13 February 2009, lot number C3284AA received on 17 April 2009 and 1 dose of DAPTACEL; lot number C3192AA received on 18 January 2010 (routes and sites of administration not reported). The subject developed a cough and cold-like symptoms on 24 July 2012, approximately 30 months after the last dose. On 26 July 2012, the subject developed paroxysmal cough with a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 20 August 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 21 August 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 21 August 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 28 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Oct2023 at 12:00 as dose 1, single (Lot number: HF9275) at the age of 71 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (non-serious) with onset Oct2023, outcome "unknown", described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19 as Paxlovid from 11Oct2023 to 16Oct2023.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300336156 same patient, different drug and event;
Approx. 4-5 hours after baby received vaccines became increasing fussy, temp. up to 101, injection sites bruised appearing. Checked by physician in office 8/28/13.
Fri 4/23 Heavy flu-like symptoms, could not lift head at times to sip water, threw up Tylenol I tried to take Sat 4/24 Did not feel sick at all but had no energy and was unsteady on my feet. Felt better in the evening Sun 4/25 My injection site became red, splotchy, and inflamed and additional red swollen patches appeared on my arm in the afternoon. In the evening, a rash spread across my upper arms and back and overnight it spread all over my chest, bottom and legs as well. Mon 4/26 Woke up to find my face red, swollen and puffy and my eyes squinted shut. My neck and upper chest were still angry red textured splotches, but the rest of my rash was starting to fade Saw Dr.  who diagnosed immune response and recommended antihistamines for comfort but not to interfere because it would short-circuit my immunity to the virus. Felt much better in the evening Tues 4/27 Woke up to balloon-like swollen red hands that seared with a burning feeling when my skin was touched. I looked like a cartoon character whose hands pop out. Otherwise I felt  pretty normal (took Zoom calls for work but could not write or type) Wed 4/28 Hands were almost normal but had the balloon-swollen, red, burning sensation around my ankles and the top of my foot. Otherwise felt like myself and was able to work from home.
Patient developed malaise, fever, bruise, swelling, redness the size of her hand with a hematoma at the site. It has lasted 1 week. Redness is starting to get better.
Left eye was red / moved to the right eye; Left eye / raised / Moved to the right eye; blotchy area on her face; Red area on her eyelids; Rash itches / crept under the eye / and in the corner of her eyes on her right eye / eye rash got worse; Red / area on her face; chills; flu like symptoms; This case was reported by a consumer and described the occurrence of chills in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number ZJ432, expiry date 27th May 2022) for prophylaxis.   Concurrent medical conditions included penicillin allergy.   On 30th November 2020, the patient received the 1st dose of Shingrix (intramuscular). On 30th November 2020, less than a day after receiving Shingrix, the patient experienced chills and influenza-like symptoms. On an unknown date, the patient experienced eye red, eye swelling, skin blotches, erythema eyelid, itchy rash and red face. The patient was treated with acetic acid (Apple Cider Vinegar) and antifungals for topical use (Antifungal Cream). On 1st December 2020, the outcome of the chills and influenza-like symptoms were recovered/resolved. On an unknown date, the outcome of the eye red, eye swelling, skin blotches, erythema eyelid and red face were unknown and the outcome of the itchy rash was not recovered/not resolved.   It was unknown if the reporter considered the chills, influenza-like symptoms, eye red, eye swelling, skin blotches, erythema eyelid, itchy rash and red face to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient herself. The patient reported that, she received the 1st dose of Shingrix and that night she awoke with the worst chills and flu like symptoms ever that lasted one day. Within two days, her left eye was red and raised and then it moved to the right eye.  The patient went to a doctor and they said that it was not consistent with shingles.  The patient had not changed anything prior to getting the rash and within that week she had purchased new mascara and eyeliner.  The patient also experienced a red, blotchy area on her face but it looked different than the red area on her eyelids.  The rash itches in phases and it has crept under the eye (more so on the left eye) and in the corner of her eyes on her right eye.  The patient tried apple cider vinegar which helped a little and she received an antifungal cream that she just received today on the day of reporting. Her eye rash got worse and then spread to both eyes and has slowly resolved somewhat but it was still there.  The patient had a drug allergy to penicillin. The reporter consented to follow up.
p/vax pt exp large red bullseye rash & hot to the touch; legs were shaky & would go numb all day; severe h/a & stomach ache
6 days from vaccine patient has no feeling in her right leg, visit pcp, vascular scan for bloodclots
Dizziness; feeling anxious. BP 133/64; HR 60; RR 24.  Instructed to relax & increase PO fluids.  Given 2500ml water. Pt stated feels better; released from vaccination site & recommended to f/u with PCP
Received MMR and Varivax on 9/28/00. Atypical rash developed on 10/8/00, from face to lower limbs. No treatment given. Atypical measles per MD.
Got the shot few days later took the shingle again/ Suspected vaccination failure; Got the shot few days later took the shingle again; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (four times).   On an unknown date, the patient received Shingles vaccine. On an unknown date, several days after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age group was not reported but was selected as adult as per vaccine indication. The age at vaccination was not reported. The patient got the shot and few days later had the shingles again. Physician said that the patient broke the record. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, exact time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Vaccine error- vaccine was administered past its beyond use date. The vaccine had been stored in the refrigerator beyond the time frame recommended by the manufacture.
Patient had 2 immunizations administered in right thigh, MMR and IPV.  Two days post administration Mom noticed redness, tenderness and swelling approximately the size of a quarter.  The next morning the area had significantly enlarged.  At her appointment time 10:40 on 2/08/2008 the size measured 3 inches by 2 1/2 inches.  Reaction as described was felt to be superficial with no muscle affected, no underlying induration.  Patient exhibited a normal gait.
Has had some fatigue and a mild headache but so far nothing further; Has had some fatigue and a mild headache but so far nothing further; This is a spontaneous report from a contactable consumer, the parent. A 21-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 01Apr2021 at 10:30 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. Medical history included kostmann's syndrome, acute myeloblastic leukemia, bone marrow transplant (first of its kind), did not take as quickly as hoped and was immunocompromised. The patient has not been storing antibodies for vaccines. The patient also had multiple drug allergy. The list was quite extensive from antibiotics to Dextran 40. The patient was taking multiple medications (unspecified) for post BMT (bone marrow transplant). 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 vaccines within four weeks prior to the vaccination. The reporter was not sure where to contact. The patient was compromised and a post bone marrow transplant (BMT) patient whose system did not recover quite like it should. They were iffy about giving the vaccine to the patient but his mother, the reporter insisted. He was doing great with it. Has had some fatigue and a mild headache on 01Apr2021 at 15:00, but nothing further 20 hours post shot. They said they don't have data on these patients. The reporter would keep track of any responses the patient has. Did not know if he would store the antibodies. He so far has not with any other vaccine. Therapeutic measures were taken as a result of fatigue and mild headache and included treatment with ibuprofen (MANUFACTURER UNKNOWN). The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fatigue and mild headache was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from a medical assistant concerning a 37 year old male with hypercholesterolaemia and no drug allergies who on 12-OCT-2007 was vaccinated SC with is first 0.5 mL dose of varicella virus vaccine live (Oka/Merck).Concomitant drug therapy included Pravachol. On 19-OCT-2007, the patient developed "a few scattered red bumps." The patient contacted the physician's office by phone and no treatment was recommended. No labs or diagnostic studies were performed. The patient was noted to be recovering. There was no product quality compliant. Additional information has been requested.
This spontaneous case was reported by a patient family member or friend and describes the occurrence of DECREASED APPETITE (appetite is cut in half at least) and FATIGUE (fatigued) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (appetite is cut in half at least) and FATIGUE (fatigued). At the time of the report, DECREASED APPETITE (appetite is cut in half at least) and FATIGUE (fatigued) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported. No treatment medication was reported.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 02-JUN-2016, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 18-AUG-2016, the patient was treated at a medical facility for a painful condition, which was diagnosed as herpetic ulcers.  As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Patient woke on 1/01/2021 with headache; swelling of left-side of neck; swelling of tongue
Yellow fluid coming out form nose, not mucusy it's watery; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Yellow fluid coming out form nose, not mucusy it's watery) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced RHINORRHOEA (Yellow fluid coming out form nose, not mucusy it's watery). At the time of the report, RHINORRHOEA (Yellow fluid coming out form nose, not mucusy it's watery) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported No treatment medication were reported.
Soreness on the right underarm and on the side of the right breast of the arm that that vaccine was administered. Soreness last 5 days and the soreness subsided on 5/7/2021.  Twitching in the right eye for 5 days. The twitching started on Sunday. Two days after the vaccine. The twitching stopped on 5/7/2021.
Palpitations Narrative:  Reclined the patient and recovered after a glass of water.    Other Relevant History:
This spontaneous report as received from a pharmacy technician refers to a 1-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported. On 06-APR-2018 he patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry date: 23-AUG-2019) (dose, frequency and route were not reported) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1802USA001558.
Immediately after vaccination, a soft + bump (approximately 1 inch in diameter) appeared at the site of vaccination.  An ice pack was applied for about 5 minutes and when removed, the bump was barely noticeable.  Patient said he felt fine and his arm didn't hurt.