chrisvoncsefalvay/vaers-outcomes huggingface dataset:
some trouble concentrating; pain in my chest; both  arm are sore; slight congestion; anxiety; tired; slight pain at the injection site; temperature and it was up to 100.7; headache; light chills,; This spontaneous case was reported by a consumer and describes the occurrence of DISTURBANCE IN ATTENTION (some trouble concentrating), CHEST PAIN (pain in my chest), PAIN IN EXTREMITY (both  arm are sore), NASAL CONGESTION (slight congestion) and ANXIETY (anxiety) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 39K20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced DISTURBANCE IN ATTENTION (some trouble concentrating), CHEST PAIN (pain in my chest), PAIN IN EXTREMITY (both  arm are sore), NASAL CONGESTION (slight congestion), ANXIETY (anxiety), FATIGUE (tired), INJECTION SITE PAIN (slight pain at the injection site), PYREXIA (temperature and it was up to 100.7), HEADACHE (headache) and CHILLS (light chills,). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DISTURBANCE IN ATTENTION (some trouble concentrating), CHEST PAIN (pain in my chest), PAIN IN EXTREMITY (both  arm are sore), NASAL CONGESTION (slight congestion), ANXIETY (anxiety), FATIGUE (tired), INJECTION SITE PAIN (slight pain at the injection site), PYREXIA (temperature and it was up to 100.7), HEADACHE (headache) and CHILLS (light chills,) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, Body temperature: 100.7 (High) Fahrenheit and 99.1 (High) Fahrenheit at 4:15pm.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
pt recvd vax & 24 hrs p/3rd dose of vax exp red lt arm (inject site); 2 days p/dose exp swollen red, hot upper lt arm/deltoid (inject site); 3 days p/dose the swollen area was bullseye shape (8.5 cm); 5 days p/dose sx was resolving;
On Friday the 1st of October 2021 I woke up with a head ache and a sore arm so I took 2 Tylenol extra strength 500 mg for the pain.   The head ache persisted but the soreness in the arm eventually subsided through out the day. By the evening my head ache got worse and I took 2 more Tylenol 500mg.  On Saturday October 2 2021 I woke up with a worse headache with what felt like a tooth ache, I took 2 Advil since the Tylenol was not working and went about my day. By Saturday night the head ache became unbearable, blurred vision and throbbing in right jaw. I took 3 Aleve as the Tylenol and Advil wasn't working.   I was not able to sleep the night and woke up Sunday morning with a swollen face and sever pain. I spent the next day icing my face and taking pain killers. I went to my dentist and to the emergency room both who could not determine the cause. I was referred to a oral surgeon who found an abscess developing above my right jaw. I was immediately placed on antibiotics (amoxicillin) and 800 mg ibuprofen to reduce my fever, pain and inflammation.  And went under for surgery  A week later I'm still experiencing chills, head aches and neausea, loss of appetite and fatigue.   I am due for the second shot soon
Initial information received on 24-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves patient of an unknown demographics who experienced severe latex allergy last year to a flu product, while he/she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported (dose, expiry date, route and site of administration were unknown). On an unknown date, the patient developed a non-serious severe latex allergy last year to a flu product following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Other relevant tests included no lab data. Final diagnosis was having a severe latex allergy last year to a flu product. It was not reported if the patient received a corrective treatment. The outcome of the event was not reported. List of documents held by sender- none.
This spontaneous report received from a patient concerned an adult male of an unspecified race and ethnic origin. The patient's height and weight were not reported. The patient's concurrent conditions included non infectious intermediate posterior and Panuveitis. The patient previously received Spikevax (elasomeran) (dose number in series was 1) (form of administration was not reported, intramuscular, batch number: unknown and expiry: unknown) dose was not reported, start therapy date were not reported for prophylactic vaccination for prophylactic vaccination. No adverse events were reported following vaccination with Spikevax (elasomeran). The patient received Covid-19 vaccine ad26.cov2.s (dose number in series was 2) (suspension for injection, intramuscular, batch number: unknown and expiry: unknown) dose was not reported, 01 total start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. Non-company suspect drugs included: Humira (adalimumab) (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for non-infectious intermediate posterior and Panuveitis. On an unspecified date, the patient experienced inflammation (dose number in series was 2). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of inflammation was not reported. This report was non-serious.
Vaccine given at noon. By 8 p.m., pt was having chills and shaking, then felt hot. Headache, dizziness, nausea, no vomiting. Vaccine site sore. No problems with urination, no sore throat, no cough or wheezing, hoarseness or body aches. Pt told to rest, take BENADRYL, lots of fluids, rest, call us PRN.
Administered expired vaccine to patient, after the manufacture date of expiration.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient, after the manufacture date of expiration.) in a 63-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient, after the manufacture date of expiration.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient, after the manufacture date of expiration.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  It was reported that total of 173 doses were administered having Lot number has 070H21A. No information was reported on date of the storage of vaccine in refrigerator. The vial did not undergo any temperature excursions.  Treatment information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received contains non-significant information: additional patient identifier was added.
Initial unsolicited report received from a consumer on 17 November 2016. This case involves a four-year-old male patient who was vaccinated with a dose of Fluzone Quadrivalent (batch number: unknown, expiration date, dose, site and route of administration were not reported) intramuscularly in the left leg on 15 November 2016. Patient's Illness at time of vaccination was reported unknown and Pre-existing physician diagnosed allergies, birth defects and medical conditions included no known allergy and gets big red areas from mosquito bites. It was reported that patient required emergency room or doctor visit. Concomitant medications were not reported. On 15 November 2016, same day following the vaccination, the patient developed localized swelling with redness which was warm and hot which progressed over two days (was now 6 inches in diameter) and started to limp. Lab data and corrective treatment were not reported. Outcome of the event was reported as not recovered. List of documents held by sender: none.
Evidence of hives-fever of 102 F - "face blew up"- throat "closed".
I got a call from this woman who I was on a trip with who had COVID on 11/21/2022 and I tested positive same day, but I had no symptoms. I was on PAXLOVID for 5 days and I felt like I was putting a poison in my body and had the metallic taste while I was swallowing the pill but no other real symptoms. Also, after I tested negative, I saw my doctor about ear, and he put me on regimen of prednisone.
patient developed rash on legs and arms the same night as the vaccines, rash is warm to touch
My son got varicella to his groin, buttocks and legs about two weeks after inoculation. He started running fevers and then erupted into pustules on 2/17/20.
This is a spontaneous report from a contactable consumer (calling on behalf of her son) and a contactable physician. An 11-year-old male patient received TURMENBA (Lot # J29203, expiration date01JUN2016), intramuscular at 0.5 ml single in left upper arm, on 19FEB2015 at 04:10 PM. Relevant medical history was none. The patient was not ill at the time of vaccination, had no adverse event following prior vaccination. Concomitant medication included a vaccine for subtype A, injection unknown manufacturer, in the left arm on 13FEB2015. The patient complained of left upper arm pain on 19FEB2015 (right after injection of a few hours later). The pain lasted for about one week and then recovered. In the early morning of 20FEB2015 the patient was feeling tired. The reporter still sent him to school, b ut by lunch time the school called and said the patient had high temperature at 100.3 degrees F. The patient didn't want to eat anything, had no appetite. Treatment received for high temperature included Tylenol every 4 to 6 hours. When the Tylenol wore off, his temperature went to 102.3 degrees F. High temperature, feeling tired and no appetite recovered on 22FEB2015. The physician described the event fever at 102 degrees F. x2 days and also reported the event soreness at injection site on 19FEB2015 with outcome of recovered. The physician assessed the events as non-serious and possible related to suspect product. Follow-up (17MAR2015): New information received from a contactable physician includes: Lot # and expiration date, dose and time for TRUMENBA, additional event (soreness at injection site) and details of fever, outcome and physician's assessment.  Follow-up (14MAY2015): Follow-up attempts completed. No further information expected.
Soreness in the arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received bnt162b2 (BNT162B2), as dose 1, single (Lot number: EK4176) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Hypertension. The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Soreness in the arm".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300367340 same patient, different vaccine dose number/different event;
24 hours later- uncontrollable sneezing, blowing nose, eyes watery and swelling, the white of my right eye swelled, the roof of my mouth swelled. It did not block airway, but was substantial. My concern is that I?m getting the booster this Friday 10/8/21. Please advise.  I was with a friend and she gave me Benadryl.  I took one, then 15 min took another.  Came home and took another.  My doctor said it was my choice to get the booster and I asked her to give me an epi pen.
Patient received Moderna for first dose and given Pfizer for second dose. No apparent injury noted.
Burning  and metallic taste in my mouth.  Started 3 days after my first shot.  Went to the doctor about 4-6 weeks later and was told that it was stomatitis, but there was no real explanation as to why.  Other than the vaccine 3 days prior to the symptoms, there were no changes in my lifestyle or diet.  There are no visual blisters or redness, just a  burning in my mouth (cheeks and tongue) has not gone away and continues still.
vaccines that were stored out of range for 3 months at a temperature of 33°F, administered to three patients/no AE; Based on additional information received on 02-MAR-2020, this case initially considered as non-valid was upgraded to valid.   Initial information received on 28-Feb-2020 regarding an unsolicited non-valid non-serious case received from a non-health care professional.  This case is link to 2020SA063065 (same reporter).  This case involves three patients (demography not reported) who received vaccine IPV (VERO) [IPOL] that was stored out of range for 3 months at a temperature of 33°f, administered to three patients/no ae, while he/she received vaccine IPV (VERO) [IPOL] (Product storage error).  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, three patients received a dose of IPV (VERO) lot number: P1E701M, Expiry date: 09-Nov-2020, via unknown route and site of administration for prophylactic vaccination.  It was a case of actual medication error due to Product storage error temperature too low.  Case details: Office manager called to check the stability of their ActHIB, Tenivac, Menactra, Fluzone Quad (0.50mL) and Ipol MDV (punctured) vaccines that were stored out of range for 3 months at a temperature of 33°F. Caller stated the vaccines were stored out of range for so long due to the refrigerator being set too cold. Caller also stated the Ipol was not administered during the time the 3 month excursion but it was administered to 3 patients after being placed back into recommended temperature range.  At the time of reporting, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Follow-up information received on 02-MAR-2020 regarding an unsolicited valid non-serious case received from a non-health care professional (office staff.  Case validity changed from non-valid to valid. Number of patient added.
Hives and swelling of injection site (R) thigh and (L) thigh. Given Benadryl 3 ml q 7 hours PRN.
12 hours after receiving the first dose I started having chills. Shortly after that I begin to experience nausea vomiting bodyaches dizziness headache and arm soreness. This lasted for approximately 24 hours. After that symptoms went away except for arm soreness which lasted for a few more days.
received a 3rd dose of Shingrix in her left arm, on 18-SEP-2023 from her pharmacy; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number 3B2YJ, expiry date 16-AUG-2025) for prophylaxis.   Previously administered products included Shingrix (received 2 doses  on an unknown date).   On 18-SEP-2023, the patient received the 3rd dose of Shingrix (intramuscular, left arm). On 18-SEP-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: received a 3rd dose of Shingrix in her left arm, on 18-SEP-2023 from her pharmacy).  The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 2-Oct-2023 The pharmacist calling on behalf of a patient that received a 3rd dose of Shingrix from her pharmacy.  Patient received all 3 doses over the course of a year and a half (no information provided about previous doses). Consent to follow up with the reporter that called in the adverse event was obtained. The patient received 3 doses of Shingrix, which led to extra dose administered.
Extensive swelling of left arm at injection site and diffuse erythema and swelling and rash from deltoid to just above the elbow. Hard and warm to touch. No joint involvement. Moderate pain. 3 days duration. Examined by medical doctor=no infection.
HIVES:  BACK, CHEST, SHOULDERS, GROIN, HIP, WAIST LINE
BUD Date 4/7/2022 administered 04/14/2022.Pfizer could not verify stability data beyond 4/9/2022 and advised to revaccinate.Booster administered 05/08/2022
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. There was no medical history or drug reaction reported. On unknown dates the patients were vaccinated with 4 doses of improperly stored ROTATEQ (lot # K010325 with expired date 10-MAY-2016, oral, dose was unknown). No concomitant therapy was provided. No adverse event was reported. Additional information has been requested.
ACUTE NON ST ELEVATION MI 5/29/2022 COMPLETE SMALL BOWEL OBSTRUCTION ACUTE NON ST ELEVATION MI 5/29/2022 LEFT PIRIFORMIS SYNDROME ACUTE NON ST ELEVATION MI 5/29/2022 METABOLIC ENCEPHALOPATHY
Swelling, redness, hives (for one day) and pain -> pt took Ibuprofen and BENADRYL.
Hospitalization: 2/28/2023 - 3/2/2023 (2 days) Presentation to the ED: weakness associated with altered mental status COVID + date: 2/28/2023  Treatment: none indicated.  Discharge to: home.  2/24/2021 EN6201 3/18/2021 EN6206
Bad pain up under rib cage; This case was reported by a consumer via interactive digital media and described the occurrence of rib pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included pruritus (itch time was over).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced rib pain. On an unknown date, the outcome of the rib pain was unknown.   It was unknown if the reporter considered the rib pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 15-Sep-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The patient got the vaccine from his/her nurse practitioner. The patient did not had itching and rash. The patient never itched in his/her life until he/she got an Intravenous in the hospital and then the patient itched like never in his/her life. Itch time was over for the patient. The patient was back to him/her that did not itch. The patient had a weird bad pain up under his/her rib cage on one side. Anyway, the patient took care before of some people who had shingles. They were in so much pain. The patient felt sad for anyone who had shingles. Additional supportive information: The follow-up would not possible, as no contact details were available.
pt. c/o light headache immediate after the vaccine.   Warmness of his face;  dry mouth;  symptoms resolved & patient went home.
Showed lymph nodes under both arms; Bad headaches; Chills; Very tired; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the arm left on 24Mar2021 at 03:00 (at the age of 67-year-old) as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus and overweight. Concomitant medications included metformin (MANUFACTURER UNKNOWN and vitamin d nos (VITAMIN D); both from an unknown for unknown indication. The patient had no known allergies to medications, food or other products. 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. On 25Mar2021 at 13:15, the patient experienced showed lymph nodes under both arms, bad headaches, chills and very tired. The patient reported that she had a mammogram 2D on 05Apr21. It was less than 2 weeks of vaccination and the result showed lymph nodes under both arms. Later she was informed that she should not have had done within 6 weeks of vaccine and then they explained vaccine causes lymph nodes to swell, with the vaccine everyone was showing lymph nodes who had done mammogram within 6 weeks. The patient stated that the tech did not tell her, she would have waited for 2 months if she was known. She would now wait till July because she was going to take dose 2 in April-2021. She stated that she also had a rash but she thinks they are insect bites (home had bed bugs, think red marks are bites). She further stated that she had bad headaches, chills and was very tired. On 05Apr2021, the patient underwent 2D Mammogram and the result was Showed lymph nodes under both arms. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the events showed lymph nodes under both arms, bad headaches, chills and very tired were not resolved.  No follow-up attempts are needed. No further information is expected.
Information has been received through the Merck pregnancy registry for GARDASIL from staff member at a physician's office (not the office that vaccinated) concerning her close friend a 17 year old female patient who on approximately 25-AUG-2008, one month ago, was vaccinated with the first dose of GARDASIL. On approximately 25-AUG-2008, after receiving the vaccine, the patient fainted, had a seizure and had headaches. The patient is pregnant. Date of last menstrual period was not reported. On an unknown date, the patient recovered from fainted and seizure. The patient sought medical attention at physician's office. Upon internal review, seizure was considered to be an other important medical event. Additional information has been requested.
I had no adverse reaction to the vaccine but on 10/20 I woke up with a runny nose which continued through 10/22.  I woke up with no sense of smell, so I went to the Urgent Care and got a COVID-19 test done and it came back positive. On 10/23 I developed a slight headache and on 10/24 I developed a slight cough. To date, I am still experiencing a dull headache but all other symptoms have since resided.
Information has been received from a pharmacist concerning a patient (age and gender not reported), who on 16-NOV-2012 was vaccinated with a dose of ZOSTAVAX, that had previously been exposed to 65 degrees F (dose, route and lot # not reported). No adverse effect was reported. Additional information has been requested.