chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt called 2 days after he got the PNEUMOVAX 23 in his left arm, stating that the arm was warm, red and swollen. He is resting the arm and applying a cold compress. He also marked the outline of the area in order to monitor if it is getting bigger or improving. After 4 hours he said he felt better and that it had not gotten bigger at this time.
This spontaneous report as received from a pharmacist refers to a unspecified number of patients. On an unknown date the patients were vaccinated with ZOSTAVAX (Lot # not reported) (dose and route not reported) for shingles vaccines. No other co suspects were reported. No concomitant therapy was reported. On an unknown date the patients developed redness, swelling and tenderness at injection site. The outcome of the patients had developed redness, swelling at injection site and tenderness at injection site was unknown. Additional information is not expected.
I received my second vaccine yesterday. Approximately half an hour after receiving the vaccine, I developed numbness in my left cheek. It subsided within about 90 minutes. I had a more intense reaction after my first vaccine, when my left cheek, jaw, left arm and leg felt numb. When I got the first vaccine it felt like the needle hit the bone and like the injection was into the shoulder joint. The second vaccination as a little bit lower down.
Urinary tract infection; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (Urinary tract infection) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URINARY TRACT INFECTION (Urinary tract infection). The patient was treated with SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) for Urinary tract infection, at a dose of 1 dosage form. At the time of the report, URINARY TRACT INFECTION (Urinary tract infection) outcome was unknown.            Concomitant medication was not provided.   This case was linked to MOD-2021-231269 (Patient Link).
side effects; This spontaneous case was reported by a consumer and describes the occurrence of   in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 21-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
doses administered after 30-day Use By Date and expiry date; doses administered after 30-day Use By Date and expiry date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered after 30-day Use By Date and expiry date) and PRODUCT STORAGE ERROR (doses administered after 30-day Use By Date and expiry date) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     It was reported that Patient did not have COVID positive or negative  within last month.  The patient's past medical history included Anemia. Concurrent medical conditions included Diabetes, Drug allergy (Allergy to Glipizide) and Drug allergy (Allergy to Novolin 70/30). Concomitant products included METFORMIN and LISINOPRIL for an unknown indication.    On 06-Apr-2022 at 3:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2022 at 3:00 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered after 30-day Use By Date and expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (doses administered after 30-day Use By Date and expiry date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses administered after 30-day Use By Date and expiry date) and PRODUCT STORAGE ERROR (doses administered after 30-day Use By Date and expiry date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Other Concomitant medication included Lantus Solostar The number of doses/vials was 36. The vial was initially stored in the refrigerator on 25-Feb-2022 The vials did not undergo any temperature excursion. The healthcare professional (HCP) wanted to know how to proceed with 36 patients that received a vaccine past the 30 day storage on the refrigerator. HCP confirmed that the patients were not experiencing any side effects yet. No treatments were reported
When she took her Pfizer vaccine on 5/29/2021, she had a feeling of pressure around her heart that made her anxious on Day 2 and Day 3,  Lymph node under her left arm was swollen the size of a credit card for Days 3 & 4 post vaccine.  Had a fever on Day 4 & 5 after the Covid Vaccine.  Would wake up in the night with her bed soaked with sweat and she would have to change her clothes.  She had a horrible smell in her nostrils.  Had diarrhea.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 11-JAN-2017, the patient was vaccinated with an improperly stored dose of VARIVAX, lot number M033906, expiration date 20-JUL-2018 (dose, route and anatomical location were not reported) for prophylaxis (incorrect product storage). The vaccine was exposed to temperature of -5 Fahrenheit (F) (-20 Celsius (C)) and to the lowest recorded temperature of -14 F (-25C) during 4 hours and 5 minutes. The storage type was reported as "data logger". There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1701USA012890: US-009507513-1701USA013083: US-009507513-1701USA013084: US-009507513-1701USA013085: US-009507513-1701USA013086: US-009507513-1701USA013087: US-009507513-1701USA013088: US-009507513-1701USA013089: US-009507513-1701USA013090: US-009507513-1701USA013091: US-009507513-1701USA013092: US-009507513-1701USA013093: US-009507513-1701USA013094: US-009507513-1701USA013096: US-009507513-1701USA013097: US-009507513-1701USA013098: US-009507513-1701USA013099: US-009507513-1701USA013100: US-009507513-1701USA013101: US-009507513-1701USA013102: US-009507513-1701USA013103: US-009507513-1701USA013104: US-009507513-1701USA013105: US-009507513-1701USA013106: US-009507513-1701USA013107: US-009507513-1701USA013108: US-009507513-1701USA013109: US-009507513-1701USA013110: US-009507513-1701USA013082.
tested positive for Covid19; tested positive for Covid19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Batch/Lot number: unknown), on 31Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 04Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01Sep2022, outcome "unknown" and all described as "tested positive for Covid19". The patient underwent the following laboratory tests and procedures: Body temperature: (Sep2022) 101-103.1, notes: Caller states starting on 01Sep2022 through 04Sep2022, she ran a really high fever 101-103.1; SARS-CoV-2 test: (01Sep2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Tested positive for Covid 19 on 01Sep2022 after receiving 3 doses of the Covid 19 Vaccine. Reporter stated she tested positive for Covid19 on Thursday 01Sep2022. Reporter stated she doesn't know how she got it, she wasn't even working at the school at the time, and she wears a mask everywhere and to the grocery store. Reporter also stated she has been vaccinated with the original Pfizer Covid Vaccines and the Booster Dose. There were no other conditions, other products and investigations.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the Vaccination failure (LOE) and Covid-19 cannot be ruled out.
I read that the ZOSTAVAX can cause issues, I am reporting mine which seems to be possible side effects. At injection site after 24 hours some redness, warmth and swelling. After 48 hours swelling, redness approximately 4 inches by 2 inches, tenderness, very warm to the touch. I have applied ice a couple times and taken an anti-inflammatory  but I cannot tolerate BENADRYL. It has been about 51 hours and continuing to worsen. No tongue swelling or difficulty breathing or hives.
no adverse events reported. vaccine was administered 2 weeks after the first instead of recommended 3 week interval
Injection site reaction 4" x 2" sized red, raised hot injection site. Continued to grow for 2 days.
Patient described an increase of vaginal bleeding similar to menstruation she had not had for 2 years, although patient had vaginal spotting prior to May and June Moderna vaccines leading to pelvic  ultrasound and endometrial biopsy by her gyn in Feb 2021 (benign path). However, endometrial stripe was 6mm and she had a fibroid, it is therefore possible the increase in bleeding after the vaccines was coincidental and I referred her back to gyn for re-evaluation as she remains at increased risk for endometrial cancer
Within weeks of getting the second dose of Pfizer covid vaccine behavior and depression became severe. My spouse became agitated and delusional..  experienced burning sensations and and became highly paranoid. She was hospitalized in May for 18 days.. She was released to home for about a month and placed on medications for depression and abnormal thinking.   She was not happy with her medications due to side effects. She starting sleeping all day and not eating. She was then rehospitalized for another 15 days. Medications were changed.  She is not the same person. Even the smallest task seems too large..
small hernia; extremely enlarged fibroids in uterus, biopsy non-cancerous; horrible pelvic/abdominal pain, emergency CT scan; horrible pelvic/abdominal pain, emergency CT scan; small rash on lower arm; Shingrix seemed to wake-up the fibroids,  surgery scheduled 18Aug2022; This case was reported by a consumer via call center representative and described the occurrence of hernia in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included uterine fibroids.   On 10th May 2022, the patient received the 1st dose of Shingrix (intramuscular). On 13th May 2022, 3 days after receiving Shingrix, the patient experienced hernia, uterine fibroid, pelvic pain, abdominal pain, rash and condition aggravated. The patient was treated with baclofen. On an unknown date, the outcome of the hernia, uterine fibroid, pelvic pain, abdominal pain and condition aggravated were not recovered/not resolved and the outcome of the rash was unknown.   It was unknown if the reporter considered the hernia, uterine fibroid, pelvic pain, abdominal pain, rash and condition aggravated to be related to Shingrix.     Additional Information: GSK receipt date: 03-Aug-2022 Reporter's comment: The patient reported she experienced side effects after receiving her first Shingrix vaccine, in the right arm. On 13th May 2022, 3 days after the Shingrix vaccine she experienced horrible pelvic and abdominal pain on her right side and a small rash on her lower right arm. The reporter reports the pain subsided after a few days. (She did not mention the rash). On 23rd May 2022, the pelvic and abdominal pain came back, and the doctor taken urine sample and started her on Baclofen, which helped. On 5th July 2022, her daughter had to drive her to the doctor because of the abdominal and pelvic pain and she was sent for an emergency CT scan. The scan showed a small hernia and extremely enlarged fibroids in her uterus. On 12th July 2022, her gynecologist did a fibroid biopsy which cam back non-cancerous. On 18th August 2022, she scheduled for surgery to remove the fibroids. The reporter states she was fine until she had the Shingrix vaccine, It seemed to wake-up the fibroids. The reporter reports she knew she had uterine fibroids before she received the Shingrix vaccine but never had a problem or pain. The reporter did not consent to follow-up. Additional supportive information: On 5th July 2022, the patient experienced hernia, uterine fibroid and condition aggravated. However, the onset date was captured as 13th May 2022 as per the sign and symptoms.
arm soreness; This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected adult as per vaccine indication.  The patient experienced arm soreness after receiving Shingrix. The nurse did not have any of the patient information available at the time of the report.  The reporter would provide that information when the (2nd line) agent called her back. Consented to follow up was provided. This case has been linked with case  US2020AMR009401, US2020AMR009402 and US2020009080, reported by the same reporter.
When I started taking the Tylenol per my doctor for the pain (most of the pain came from the right arm and I received my shot in  my left arm). I received a cortisone shot in my arm; however, after I received the shot things started to getting worse. I didn't have any redness or swelling. I went to the ER and was treated for my symptoms. I'm still experiencing extreme pain in both arms, wrists, and the knuckles of both hands along with swelling (taking Ibuprofen and Tylenol).
Initial information received on 23-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves 2 months old female patient who received dose of vaccine QUADRACEL (lot number and Expiry date unknown) via unknown route in the right thigh on Jan 2018. The patient's past vaccination(s) not reported. Patient received DTAP, IPOL Polio  Vaccine and PENTACEL at the age of 4 months and 7 months. It was a case of actual medication error due to inappropriate age at vaccine administration. (It was reported that QUADRACEL administered to a 2 months old female just discovered during a review of her record at a 10 months visit.) No reaction reported at the time of vaccination. 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 2001/83/EC and Module VI of the Good Pharmacovigilance 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. Documents held by sender: none. Addendum 15-Jan-2019.
Second dose of the vaccine was scheduled before vaccine was given. At the time that the appointment was scheduled, the guidance was that the 2nd dose could be administered 4 days before the 28 day mark. The guidance changed in between the time that the vaccinators had scheduled the 2nd dose and when the 2nd dose was administered. The vaccinator did not receive information about this guidance until after the vaccination was administered.
Thrombocytopenia  Now 2 aneurism in brain  Angio scheduled for 4/14/21
Pt. reported lead taste in mouth lasting approximately 5 minutes.  Similar taste to what is experienced on Chemo days.  Last chemo date was 12/9 per pt. Pt. kept in observation for 30 minutes without further s/s.  Pt. informed to seek evaluation is s/s develop post observation.
Pt recvd dose Engerix-B & the next day had h/a; As of 3JUN92 had tiredness, joint pain, rash (petechiae), elevated liver function tests; seen by MD; recvd Darvocet for h/a & joint pain;
This spontaneous report refers to 8 to 10 patients of unknown gender and age. Medical history is not provided. On an unknown date in July 2013 the patients were vaccinated with PROQUAD (Merck) which was improperly stored. No symptoms were reported. Additional information has been requested.
A 31 year old male with no previous medical conditions received the 2nd dose of Anthrax vaccine on 01/21/2001.  Concomitant medications at the time of the vent and the patients previous reactions to vaccines are unknown.  The patient was not ill at the time of the vaccination, but was exposed to a daughter with a strep infection prior to the immunization. On 01/21/2001, 8 hours after the Anthrax immunization, the patient noted symptoms of a flu-like syndrome; malaise, body aches, chills and a temperature of 104 degrees.  He was treated with Ibuprofen and Tylenol.  On 01/23/2001, he was seen in the clinic with a temperature of 99 degrees, bilaterally clear tympanic membranes, beefy red tonsils, swollen uvula, white patches on the tonsils, and bilateral swelling of the cervical lymph nodes.  The patient was diagnosed with strep infection of the tonsils and began treatment with Amoxicillin 500 mg.  On 01/31/2001, the patient stated he was asymptomatic.
little soreness on the arm of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (little soreness on the arm of the injection) in a 60-year-old male 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (little soreness on the arm of the injection). At the time of the report, VACCINATION SITE PAIN (little soreness on the arm of the injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided. Treatment information was not provided.
Rash Reynaud's distal fingers-self-limited, chills. No fever. All vaccine side effects experienced between 4-10 hours post- vaccination. Narrative: Called Employee Occupational Health report syptoms
10:50 am. Within 10 minutes of administration presented with itchy eyes, large inflamed itching area around site of injection - given Loratadine 10 mgs and BENADRYL 50 mgs po. 2nd dose BENADRYL given at 12:50 started to feel better 2:00p.
Information has been received from a registered nurse referring to a 11 year old patient of unknown gender. On 30-JUN-2015 the patient was vaccinated with GARDASIL (lot # K008931, intramuscular, expiration date and dose were unknown) which excursed the storage temperature. No reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Violent chills the evening of the day of vaccination followed by a day of extreme fatigue requiring bed rest.   Condition improved the next day
Per pt after getting shingles shot, one week past, started developing blisters on legs. Pt thinks she may of had a reaction to the shot. Large blister on rt calf/still being treated.
lips felt like they were sunburned; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (lips felt like they were sunburned) 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-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced RASH ERYTHEMATOUS (lips felt like they were sunburned). At the time of the report, RASH ERYTHEMATOUS (lips felt like they were sunburned) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medication reported. treatment medication steroid cream   This case was linked to MOD-2021-211739 (Patient Link).
Discomfort in chest/heart area. Inflammation of skull and back of neck. Feeling of disturbed blood flow in chest.