chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Oral Shingles Outbreak; This is a spontaneous report from a contactable consumer (patient).    A 43-years-old female patient (not pregnant) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 01Apr2021 12:00; at the age of 43-year-old, (Batch/Lot Number: EP 6955) as SINGLE DOSE for covid-19 immunisation. Historical vaccination included first dose of BNT162B2 (Lot number: EN 5318) on 02Mar2021 02:00 PM.  Medical history included, lyme disease from an unknown date and unknown if ongoing.      The patient's concomitant medications were not reported.  The patient previously took hydroquinone and experienced drug hypersensitivity.  The patient experienced oral shingles outbreak (herpes zoster) (disability) on 10Apr2021 09:00 with outcome of not recovered.  The patient was seen at Physician Office.  The patient underwent lab tests and procedures on 16Apr2021 which included blood immunoglobulin G: pending results, blood immunoglobulin M: pending result, Sars-cov-2 test: pending the same day (16Apr2021). Therapeutic measures were taken as a result of oral shingles outbreak includes Valacyclovir HCL 1 gram.
Angioedema, Rash, UrticariaPruritus, see next section Narrative: Dose #2, Day #1 swollen eyes, slight headache, drank water; suspects dose #2 Day #23 rash, raised bumps, face (dry flakey skin face and ears) itching, chest, back, arms, legs, which comes and goes. (itching worse after prednisone, beginning Apr, see below) Went to ED/Urgent Care, see below, Apr 6 employee felt like throat wanted to close, constricted, relieved with oral antihistamine, //Dose #1 Day #1LEFT arm soreness, flu-like symptoms for 24-48 hours, took ES tylenol. Dose #2 went to Urgent Care at end of March approx dose #2,Day #28, was prescribed meds as below; had anaphylactic reaction as a child when riding pony, but not as an adult
12:14 PM:  Patient experiencing sudden onset of mild numbness in both hands.  patient denies any SOB, chest pain or any other s/s.  Numbness subsided at 12:18.  VS stable.  BP-147/56 P-67.  Patient released at 12:50 with no numbness.
Nearly 9 months after 2nd jab, I contracted an unknown virus that quickly sapped my strength. Was in hospital for 3 weeks, then a rehab facility for 2 weeks. Now home continuing to recover.
Information has been received from a physician concerning a female who was vaccinated with a 0.65 ml doe of ZOSTAVAX. Subsequently the patient experienced redness at injection site. Unspecified medical attention was sought. At the time of report the patient had recovered. No diagnostic laboratory tests were undertaken. A product quality complaint was not involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/21/2007. Information has been received from a physician concerning a female who was vaccinated with a 0.65 ml dose of ZOSTAVAX. Subsequently the patient experienced redness at injection site. Unspecified medical attention was sought. At the time of report the patient had recovered. No diagnostic laboratory tests were undertaken. A product quality complaint was not involved. No further information is available.
Pt recvd 2 doses of Hep B vax & did not respond;
Muscle spasms and twitches throughout body; Muscle spasms and twitches throughout body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 21-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Apr2022 at 14:00 as dose 2, single (Lot number: FJ1620) at the age of 20 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: FJ1620, Location of injection: Arm Right, Vaccine Administration Time: 03:00 PM), administration date: 13Mar2022, when the patient was 20-year-old, for COVID-19 immunization. The following information was reported: MUSCLE SPASMS (non-serious), MUSCLE TWITCHING (non-serious) all with onset 04May2022, outcome "not recovered" and all described as "Muscle spasms and twitches throughout body". The events "muscle spasms and twitches throughout body" required physician office visit. Therapeutic measures were not taken as a result of muscle spasms, muscle twitching.  Additional Information: The patient had not taken other vaccine in four weeks. The adverse event was described by the patient as Muscle spasms and twitches throughout her body. Patient did not have Covid prior to vaccination; also not tested for Covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Patient became lightheaded after Gardasil and Flu vaccinations, BP lying down was 137/90, pulse 70, after 15 minutes, BP 132/88, patient c/o headache. Patient stated she felt better, after sitting up initially, BP 133/89, pulse 64, final BP 128/86. Pediatric vaccine information sheets given
I've lost so much sleep,I can barely sleep; a lot of coughing every now and then; a lot of phlegm; soreness in my arm; chills; fever; tiredness; headaches daily; Muscle pain; Joint pain; nausea; This spontaneous case was reported by a patient and describes the occurrence of INSOMNIA (I've lost so much sleep,I can barely sleep), COUGH (a lot of coughing every now and then), PRODUCTIVE COUGH (a lot of phlegm), PAIN IN EXTREMITY (soreness in my arm) and CHILLS (chills) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes and Blood pressure high. Concomitant products included INSULIN HUMAN (NOVOLIN R), INSULIN GLARGINE (LANTUS), ACETYLSALICYLIC ACID (BABY ASPIRIN), FINASTERIDE, ATORVASTATIN, TAMSULOSIN, METFORMIN HCL and MONTELUKAST for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INSOMNIA (I've lost so much sleep,I can barely sleep), COUGH (a lot of coughing every now and then), PRODUCTIVE COUGH (a lot of phlegm), PAIN IN EXTREMITY (soreness in my arm), CHILLS (chills), PYREXIA (fever), FATIGUE (tiredness), HEADACHE (headaches daily), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and NAUSEA (nausea). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, INSOMNIA (I've lost so much sleep,I can barely sleep), COUGH (a lot of coughing every now and then), PRODUCTIVE COUGH (a lot of phlegm), PAIN IN EXTREMITY (soreness in my arm), CHILLS (chills), PYREXIA (fever), FATIGUE (tiredness), HEADACHE (headaches daily), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and NAUSEA (nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
The sensation started Wednesday10th night but by the 11th when I got up I scratched myself.  It continued and by the 12th I realized it wasn?t a scratch but a blister on my left butt cheek.   On Saturday the 13th 10AM I took lysine.
Patient was irritable after vaccines on 11-1-12 and had persistent crying and then had pale/apneic episode w/some twitching. Given oxygen, hospice came out to assist. Some gasping of air but symptoms recovered and now he is resting comfortably on room air.
Vaccine was administered to minor who is 15 years of age. Vaccine not licensed for this age group.  Patient  was monitored for 15 minutes post vaccination. No S/S of complications Client denied any adverse reaction while in clinic. Reviewed with clients parents expected vaccine reactions and encouraged registration of client in the V-Safe Program.
Patient was intended to receive 2nd dose of Moderna but inadvertently received Pfizer.  Sat in observation for 15 minutes with no issues.  Error was discovered after patient left, pharmacist called to discuss and patient sounded fine on the phone.
After receiving Gardasil, patient fainted while walking out of the doctors office.  Completely blacked out, head hit the floor, fainted.  Now (I am an RN) after reading about girls fainting as a side effect, I'm very concerned about the doctors and nurses being warned to keep the person sitting in a chair for a period of time, before they leave the doctors office.  What if she had fainted in the car while she was driving?
Information has been received from a Registered (R.N.) concerning a female with a history of 2 cases of childhood chickenpox who was vaccinated with a dose of ZOSTER vaccine live (Merck).  Recently the patient developed chickenpox.  VARICELLA-ZOSTER virus analysis was offered to pharmacist.  At the time of reporting the patient was not recovered.  Additional information has been requested.
Generalized rash (maculopapular dermatitis), increased temp 102.4.
Lymph nodes enlarged, swollen and painful in genital area. No other nodes enlarged. No temperature increase; no other symptoms. No soreness or redness at site. No joint pain.
This was the second dose in the vaccine series. The patient reported doing well for the first dose. A few minutes after receiving her second dose, the patient started to complain of lightheadedness, lethargy, arm weakness. She reported she did have an anaphylactic reaction to the H1N1 vaccine . Patient reported about 10 minutes after she received the vaccine she was starting to feel better- less lightheaded and was gaining arm strength. She was moved to a chair and she could not support her weight.  EMS was called to the scene and she was transported to the ER.
no adverse effect; Was administered expired dose; This spontaneous report was received from a nurse regarding a patient of unknown age and gender. The patient's relevant medical history, concurrent conditions and concomitant medications were not reported. On 27-AUG-2019, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # N034400/expiration date: 10-MAY-2019) for prophylaxis. On 27-AUG-2019, the reporter informed that the patient inadvertently received an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (expired product administered). The reporter informed that no other adverse effects was reported. This case does not involve any product quality complaint. The outcome of event was unknown.
1 week after vaccine,  I still feel very sick and exhausted with sore throat, swollen glands making me feel crummy, diarrhea, nausea, anxiety, high blood pressure, achey, chills
Sore arm 8pm  Woke with 101.8 fever 12 hours after vaccine (4:30am) Splitting headache and loss of appetite ran concurrent with fever (24 hours) Maintained fever for 24+ hours Fatigue until 48 hours post vaccine
SHOULDER BARELY MOVE; SHOULDER PAIN; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not 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 and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced shoulder barely move, and shoulder pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shoulder pain, and shoulder barely move. This report was non-serious.
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 20-year-old male. Neither medical history nor concomitant medications were reported. On 18-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 12-May-2009 and incorporated into the narrative: Product complaint investigation results.
Initial report received from a health care provider on 13 May 2010. A 52-year-old female patient, with a history of hernia repair, hysterectomy and wound management due to a laceration, had received a subcutaneous injection to the left arm of ADACEL (Tdap), lot number C3158AA, on 10 May 2010 and developed on 12 May 2010 swelling, redness, and tenderness which extended down to left hand. The patient was treated with elevation with ice compresses. The patients concomitant medication was triamcinolone acetonide cream. As of 13 May 2010, the events were reported as not recovered. Follow-up information received on 18 May 2010 from a healthcare professional. The patient's swelling and redness in the left arm has decreased. On an unspecified date she also experienced a fever, which resolved. The patient was seen every day since 13 May 2010. She reported fatigue over the weekend and stated she slept all weekend. As of this report all events have not resolved. Documents held by sender: None.
About 34 hours after inoculation I noticed a rapid & irregular heart rate.  The condition worsened overnight.  I went to ED where I was treated (cardio version) and released.  As I had an ablation and use amiodone, so this episode is baffling.
No further AE details; Improper storage of product in use; This spontaneous report was received from a pharmacist and refers to a 12-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 02-MAR-2023, varicella virus vaccine live (oka/merck) (VARIVAX) was underwent temperature excursion at 70 Fahrenheit degrees (F) for 9 minutes. On 08-JUN-2023, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5ml/once, lot #W025273, expiration date not reported, but upon internal validation established as: 10-AUG-2024, administered for prophylaxis (anatomical location, and route of administration were not provided) (product storage error). It was also reported another lot # W0252273 with expiration date: 02-JUN-2023, but it is an invalid lot # for varicella virus vaccine live (oka/merck) (VARIVAX) and does not match any Company product, and also the registered nurse stated that this lot # was incorrect. There were no adverse events reported (no adverse event).  This is one of several reports received from the same reporter.
Patient reports that the day after her vaccine her arm swelled up and was bright red, hot and painful.  She didn't report until today 10/19/21.  At time of my observations the swollen area was still quite large (about 4-5 inches in diameter ), warm to touch, red (although patient reports the redness as reduced mildly since day 1), and painful.
PATIENT IS EXPERIENCING MUSCLE PAIN, UPPER TONGUE NUMBNESS, AND UNDERNEATH TONGUE PAIN. PATIENT IS WEAK AND UNABLE TO PERFORM BASIC TASKS
Patient reported burning sensation in upper leg (thigh area) that started after receiving SHINGRIX and lasted 7 days, then appeared sporadically. Patient reported symptoms to Dr. who told him it did not appear to be from the shot as there are not relevant nerves in that area. Patient reported the symptoms did not interfere with activities of everyday life. The patient reported the area of sensation to be 4-5 inches in diameter.
I tested positive for COVID-19 three weeks after I was vaccinated. I received a text on my phone that said I was in the area of someone that tested positive for COVID-19 and I decided to get tested with an at home test. It came back positive and I called my PCP and her called in a medication from Pfizer, that was 30 pills in 5 days. I took the medication and I feel much better now. I just had some sneezing, cough, fatigue, and runny nose.
We had patients who were administered the vaccine that underwent temperature excursion; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (We had patients who were administered the vaccine that underwent temperature excursion) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021 at 3:40 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Nov-2021 at 3:40 PM, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (We had patients who were administered the vaccine that underwent temperature excursion) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (We had patients who were administered the vaccine that underwent temperature excursion) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion (Vials in question stored in a super cold Freezer) and minimum reached temperatures was negative 82 degrees Fahrenheit. The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been. The vial moved from freezer to refrigerator on 19-Nov-2021, it was a day when the Moderna Covid-19 vials went from the super cold freezer to the refrigerator. The vials were returned to the freezer/refrigerator, or maintained at room temperature.  The reporter stated that total 70 vials were still in the ultra cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No Previous temperature excursions was reported. No treatment medications were provided.  Total 280 patients received Moderna Covid 19 stored at minus 82 degrees Fahrenheit.
Administer expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) in a 77-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine). On 24-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No treatment medications were reported.  Reporter stated that they have administered expired Moderna COVID-19 vaccine that were given as booster shot to the patient. It was reported that the vaccine was stored in freezer and they took out one to two vials and placed in fridge each day as needed.
Petechial rash to right medial thigh region--2cm x 6 cm in size.  Skin is intact.
I want to report to Pharmacy and/or CDC what I have experienced with both shots (separate arms).  In both cases, my upper shoulders into my neck hurt and tighten the day after the shot.  The following day it was gone but it returned on or around day 4 and it has not gone away.  I have seen my medical doctor, acupuncturist, chiropractor and a massage therapist. My doctor believes the shot activated some sort of chemical tendonitis.  I took my second shot last Friday, in the other arm hoping it was simply coincidental, but I am having the same experience. I wanted to know who I should call to report this and was curious if anyone else has experienced this challenge.  Thank you.
Information has been received form a pharmacist concerning a 64 year old female with a history of "previous outbreaks of small red dots" who on 13-SEP-2010 was vaccinated with the first dose of ZOSTAVAX (lot number 665518/1311Y, expiration date 03-OCT-2011). Concomitant therapy included an unspecified anti-depressant. On an unspecified date the patient "had experiences of recurrent outbreaks of small red dots at various body sites" while on ZOSTAVAX. The patient was given ZOVIRAX cream for treatment. At time of the report, the patient's out come was unknown. Additional information has been requested.
After I received my second vaccine I started having problems with my gums and jaw aching and hurting and it hurts up into my head and gives me a headache
Area red, slight edema below injection site on Lt arm from where Tdap vaccine was given - tender to touch.
Unfortunately on review of patient's vaccine record it was noted that he had received expired vaccinations. The confounding factor is that our EHR used to autopopulate lot numbers and expiration dates and if the MA didn't change it, it would default to the wrong information. It is more likely this is the case than an expired vaccination was given. I explained the situation to MOP. He did not have any unusual side effects that she remembers. He has had subsequent doses of all of the vaccines that were marked as expired, except the rotavirus vaccine which is obsolete for his age group, so I did not recommend revaccinating.
Pt presented to pharmacy to receive his 2nd Covid19 dose.  During counseling he stated that he received his first dose of Moderna Covid19 on Monday, 04/05/2021. On Friday, 04/09/2021 he experienced pain on his left side ('pain in lungs).  Then, on Saturday, 04/10/2021 he went to the hospital, where an x-ray showed a clot in his lungs, He also experienced a stroke.   He we home on Eliquis 5 mg : TAKE 2 TABLETS BY MOUTH 2(TWO) TIMES DAILY FOR 7 DAYS, THEN 1 TABLET 2(TWO) TIMES DAILY FOR 23 DAYS.  INDICATIONS VENOUS THOMBOEMBOLISM  ('Dr not sure this was related to vaccine'.  His doctor 'approved a second dose of Covid19')
12/30/20 after vaccination very pt was very hyperactive; following days chills and headache . 1/4/20 Large knot appeared in shoulder right collar bone, pt could push down shoulder, uncomfortable feeling when touched and very hot to touch. Knot in right collarbone of shoulder is still present but not as large.  Follow up with PCP; PCP has referred patient to infectious specialist for f/u
ANGINA, UNSPECIFIED 1/20/2023 HX OF NON ST ELEVATION MI