chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PT WOKE UP OM 6/19/21 WITH 102.6 DEGREE FEVER. FEVER LASTED FOR ABOUT 2-3 DAYS. PT ALSO REPORTS SOB, HA, BODY ACHES. PT TOOK TYLENOL AND IBUPROFEN PRIOR TO BEING SEEN IN CLINIC 6/24/21. SHE WAS GIVEN 30 MG OF TORODOL IM AT THIS VISIT.
Pt came to ER c/o left side flank pain, fall 5 days prior, SOB, cough.
Had Covid after first dose; Past 42 days after first dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Had Covid after first dose) and PRODUCT DOSE OMISSION ISSUE (Past 42 days after first dose) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Had Covid after first dose) and PRODUCT DOSE OMISSION ISSUE (Past 42 days after first dose). At the time of the report, COVID-19 (Had Covid after first dose) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Past 42 days after first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Ban Therapy for COVID.  Concomitant information not provided
Expired Havrix administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 13-month-old female patient who received HAV (Havrix) (batch number LY35X, expiry date 16-FEB-2023) for prophylaxis.   On 27-FEB-2023, the patient received the 1st dose of Havrix. On 07-FEB-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Expired Havrix administered). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 02-MAR-2023  A medical assistant asked how they should proceed if an expired dose of Havrix was given to a patient. Information about the patient and vaccine was provided.  The medical information was accepted and they asked to receive it via e-mail. The vaccine administration facility was the same as primary reporter. The reporter interrupted whilst giving the information. The patient received expired dose of Havrix, which led to expired vaccine used. The reporter did not consent to follow up.
patient came in on 02/17/23  and reported a side effect of pain on the injection site *(Right Arm)that has been ongoing since 10/4/2022. According to patient she has tried ibuprofen, tylenol and lidocaine patch but the pain did not subside.
Fever 100-101.4 developed approx. 18 hours after vaccine. Had the fever for 2 days. Muscle and joint aches for 2 days. Slept an unusual amount for 3 days. Right arm, fire red area about 5 inches long around the vaccine site and extreme soreness and pain in the area, unable to raise the arm due to the discomfort. Red area has taken about four days to decrease and now the red area is the size of a quarter. The area is still very tender to touch and there is a golf ball size lump around the injection site. Also, diarrhea and cramping for 5 days. Only treatment was Tylenol.
Pt stated that subsequent to MMR #1 and #2, she experienced significant swelling from knee down bilaterally. She stated that the swelling started 3 days post each vax and lasted for 3 days.
Patient present to office on 9/25/19 with Redness, swelling and pain to Left upper arm.
Arthritis in lower back; Arachnoid web of spine; Felt like hit by truck/slept; Fever; This spontaneous case was reported by a physician and describes the occurrence of SPONDYLITIS (Arthritis in lower back), ARACHNOID WEB (Arachnoid web of spine), FEELING ABNORMAL (Felt like hit by truck/slept) and PYREXIA (Fever) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection, solution for Hidradenitis suppurativa.    No relevant medical history was provided.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In 2021, the patient experienced ARACHNOID WEB (Arachnoid web of spine), FEELING ABNORMAL (Felt like hit by truck/slept) and PYREXIA (Fever). On an unknown date, the patient experienced SPONDYLITIS (Arthritis in lower back). The patient was treated with HYDROCORTISONE (CORTIZONE [HYDROCORTISONE]) for Adverse event, at a dose of 2 dosage form. In 2021, FEELING ABNORMAL (Felt like hit by truck/slept) and PYREXIA (Fever) had resolved. At the time of the report, SPONDYLITIS (Arthritis in lower back) had not resolved and ARACHNOID WEB (Arachnoid web of spine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This report was received via another manufacture which had received an solicited adverse event report from a consumer enrolled in clinical study, unknown type.  Concomitant medication information was not provided.  Additional treatment medication included a nerve block, unknown location.    The patient also reported that he slept.  Case is getting automatically downgraded as the SD states the case is other medically important condition and events were not IME listed.
On 04/13/2018, during her annual physical, the donor reported to center medical staff: On 03/27/2018, the day after receiving her second Rabies vaccination, the donor experienced a rash on the right side of her neck. Two days after, she experienced an onset of swelling and itchiness on bilateral arms. Due to the symptoms, the donor took over-the-counter medication ? BENADRYL. The donor went to see her PMD, due to the swelling on her arms and the itching on her neck. She was prescribed Hydroxyzine Hydrochloride 50 mg (to be taken orally once every six hours) and Cetirizine Hydrochloride 10 mg (to be taken orally once daily). On 04/09/2018, the same day as her third Rabies vaccination, and a few hours afterward, the donor experienced the onset of itching and swelling on her neck, extending to her shoulders. No medication was taken at that time. The following morning, all symptoms had cleared. Due to the information provided by the donor on 04/13/2018 about the adverse events described above, she was removed from the Rabies immunization program.
Information has been received from an RN concerning a 21 year old female patient who on 23 Oct 2006 was vaccinated IM with her first dose of Gardasil, lot #654540/1162F. On approximately 27 Dec 2006 the patient was vaccinated with her 2nd dose of Gardasil. On 27 Dec 2006 the patient developed a painful injection site after vaccination and also developed a red rash going up and then down her arm and around the injection site. She was given Benadryl and advised to keep an ice pack on it for the rest of the day. As of the report date the patient was recovering. Additional information has been requested. Follow up information has been received concerning the female patient who on 05-DEC-2006 at 1:30 p.m. was vaccinated IM in Left arm with her second dose of GARDASIL, lot # 654540/1162F. On the same day (not 27-DEC-2006 as previously reported), after the vaccination, the patient's arm became red at the site of injection. Within 5 minutes the redness traveled up her arm and down to her elbow. A rash appeared. The area was warm to touch and painful. BENADRYL 25 mg PO was given. The patient's arm remained sor for seven days. Additional information is not expected.
Moderna first Dose Vaccine give 09/23/2021.  Lot later found to have expired 09/22/2021.   Moderna contacted, all handling details given,  Moderna tested viability of vaccine lot beyond expiration and found it maintained the activity necessary to protect against Covid 19 at the time of administration.  No adverse reation noted by client related to expiration
Pt rports having severe swelling of injection site arm and dispersed erythema that was roughly the size of a football.
High pitch screaming, screamed until his voice gave out, screamed between 6-8 hours. Per 60 day follow up:The pt has not recovered. Brain damage, eye problems, motor skills. They need to do away with the vac. program, it damages children and adults. Also talk to follow up nurse on 01/02/2003, they have all missing info.
Patient called around 12:00pm on 10/7/18 to report redness, warmth, and swelling around injection site which started about 12 hours after initial injection. She has had reaction to flu vaccine approx. 10-15 years ago, but has not had any problems since then. Says reaction is not as severe as she had in the past. Past reaction resulted in her going to ER, but she does not feel this is necessary at this time. Was recommended that patient go to urgent care or ER to have vaccination site checked out, but she declined at this time. Patient will be taking ibuprofen to help with swelling and will report back with any changes.
itching to both legs and back; This is a spontaneous report from a contactable physician via Self-Reporting.  A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular, administered in Arm Left on 16Feb2021 at 11:45 (lot number: EM9810; expiry date: unknown) at the age of 69-years-old, as dose 2, single for Covid-19 immunisation. Medical history included congestive heart failure (CHF), prostate cancer, and hypertension (HTN). The patient had no known allergies. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), for Covid-19 immunisation. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The patient was not diagnosed with COVID prior vaccination. The patient has not been tested for COVID-19 since vaccination. On 16Feb2021, the patient experienced itching to both legs and back. The patient did not receive treatment for the event. Outcome of the event was recovering.   No follow-up attempts are possible. No further information is expected.
Headache started 3 hours after vaccine was administered. Extreme fatigue, nausea, low grade fever (100.2), extremely sore arm  and slight shortness of breath followed. Symptoms lasted 3 days (missed a day of work) and I still have a sore arm 9 days later.  If my arm is bumped or touched at all still quite painful.
there was an excursion from freezer; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (there was an excursion from freezer) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (there was an excursion from freezer). On 08-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (there was an excursion from freezer) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.   No treatment information was reported.
PATIENT STATES THAT ARM FELT A LITTLE ITCHY ON LOWER FOREARM THAT WAS VACCINATED. AFTER WENT HOME ITCHINESS SPREAD ALL OVER. PATIENT DID TAKE SOME BENADRYL TO HELP. NO RASH JUST ITCHY. LASTED FOR ABOUT 36HOURS BEFORE TOTALLY GONE. PATIENT DEVELOPED RED CIRCULAR RASH ONRIGHT FLANK. STARTED ON MAY 8TH OR 9TH. IS NOT ITCHING OR RED AS OF TODAY, BUT STILL FADING. SKIN FELT BUMPY AND A LITTLE SCABBY BUT WAS NOT BLISTERED OR OOZING. USED A LITTLE HYDROCORTISONE ON IT FOR ITCHING AND SEEMS TO BE CLEARING UP.
back pain; This is a spontaneous report from a contactable consumer via medical information team. A 83-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route on 13Jan2021 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. patient started taking Celebrex about 5 days after the first dose on 13Jan2021of the vaccine for back pain. will be getting second on 03Feb2021. Stated that he has been on Celebrex which is an anti-inflammatory drug. Stated that he was told to get off of it if he wanted the vaccine to work. Stated that she got off it last Thursday. Wanted to know long he has to be off of it before the next shot and how long does he have to be off it after the next shot. Is for Pfizer Covid 19 vaccine. The outcome of the event was unknown.   Follow-up attempts are possible. No further information is expected.
Felt like she had the flu; Slept a lot; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Felt like she had the flu), HYPERSOMNIA (Slept a lot), PYREXIA (Fever) and CHILLS (Chills) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     The patient's past medical history included Sarcoma bone (sarcoma right femur), Cancer (blood cancer in left arm), Chemotherapy and Radiation therapy. Concomitant products included PIROXICAM (PAXIL [PIROXICAM]), ALPRAZOLAM (XANAX), ZOLPIDEM TARTRATE (AMBIEN) and VITAMINS NOS for an unknown indication.    On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (Felt like she had the flu), HYPERSOMNIA (Slept a lot), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, INFLUENZA LIKE ILLNESS (Felt like she had the flu), HYPERSOMNIA (Slept a lot), PYREXIA (Fever) and CHILLS (Chills) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment information was provided.   This case was linked to MOD-2021-240776 (Patient Link).
Chills, headache, fatigue, soreness for 3 days. Treatment = rest
20 y/o female with NO PMH recieved second Pfizer COVID-19 vaccine on 4/27/21. Pt had first dose of COVID-19 vaccine on 4/13/21. Pt arrived 8 days early for her appointment and recieved her second dose, she was scheduled for her second dose appointment on 5/4/21. Pt believed that her appointment was today and is not experiencing any symptoms. Pt was counseled on the unknown efficacy and potential lowered efficacy, she was advised to contact her PCP/911 if she begins to experience any symptoms due to the unknown effect of receiving the vaccine early. and clinical leads discussed with patient and
My stomach pain started a couple weeks after the vaccine. On May 8, I went to the ER because I had left side abdominal pain. I was prescribe antibiotics and given an IV of antibiotics. On the 12th, I called my doctor again and I was admitted me to the hospital. I still feel weak and have abdominal pain on and off. I am scheduled for a colonoscopy on July 23, 2021.
Breakthrough  Covid19 infection.  Symptoms: congestion, extreme fatigue, loss of smell, taste and + test on July 24. 2021.  temp 100 one day only. Husband ,also vaccinated developed symptoms 2-3 days before me. We had driven to , only around vaccinated family members from 7/15- 7/22. 4 other vaccinated family members in  area also contracted symptomatic covid. Still have some congestion and fatigue but better this week than last . Today is day 13 for me. Nobody from  or  reached out to me. I called them and they just said someone would call me. I also called the . no one called me back
COLD SORES; FEELING BAD; RETRO-ORBITAL PAIN; EYE PAIN; BRUISING; MALAISE; FEVERISH; SORENESS AT INJECTION SITE; This spontaneous report received from a patient concerned a male of unspecified age. 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: Unk) dose was not reported, administered on 15-MAR-2021 14:00 to Right Arm for prophylactic vaccination. The batch number was not reported. Concomitant medications included aciclovir. On 15-MAR-2021, the patient experienced soreness at injection site. On 16-MAR-2021, the patient experienced feverish. On 16-MAR-2021, the patient experienced feeling bad. On 16-MAR-2021, the patient experienced retro-orbital pain. On 16-MAR-2021, the patient experienced eye pain. On 16-MAR-2021, the patient experienced bruising. On 16-MAR-2021, the patient experienced malaise. On 18-MAR-2021, the patient experienced cold sores. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feverish, feeling bad, retro-orbital pain, eye pain, and malaise on 17-MAR-2021, and bruising, and soreness at injection site on 21-MAR-2021, and was recovering from cold sores. This report was non-serious.
Fatigue started October 18th 2021 after the shot and I am still fatigue which has been a battle with my work schedule.  I have broken out into rashes on different places on my body including the site area. The area I received the shot at it is still sore , hard and red . I work for the Department of Homeland Security and I was forced to take this vaccine even though I have a religious exemption form and a medical note from my allergy and asthma specialist.  Before and after the shot I have been taking Tylenol and vitamin C . I am healthy with no health issues whatsoever so my health has nothing to do with this. Whatever is In this vaccine has cause many issues with ky body
Moderate Nausea, Vomiting and Diarrhea. Pt also had rash in the area of vaccination.
This spontaneous report as received from a registered pharmacist refers to a 62 years old female patient with no pertinent medical history and no drug reactions or allergies who on 06-JUL-2012, was vaccinated with a dose of ZOSTAVAX (lot # 672868/0239AE, Exp. Date: 26-APR-2012) (dose and route not reported). No other co-suspects were reported. No concomitant medications were reported. The pharmacist stated that the patient developed an injection site reaction following vaccination with ZOSTAVAX. The injection site reaction was described as a red area (no rash) with a "knot" (hard area) at the injection site. The pharmacist did not know the time of development of the injection site reaction other than it occurred shortly after the ZOSTAVAX was administered. No lab diagnostics studies were performed. Ice or cold compresses were given as a treatment for the experience. At the time of the report, the patient had not recovered. The patient sought medical attention by contacting the pharmacist. The relatedness for red area at injection site and "knot" hard area at the injection site was unknown for ZOSTAVAX. Additional information has been requested.
A sales representative reported that a 7 month old infant received a second dose of Prevnar vaccine and subsequently devleoped "streptococcus." No further information was available at the date of this report.
I got really cold, the first day and my eyes hurt pretty badly, Then the 2nd day I woke up from a nap in a puddle of sweat, Then the 3rd morning, I also woke up in a puddle of sweat.  I slept a lot and took tylenol.
This spontaneous report was received from a pharmacist refers to a 31 year old female patient with allergy to cantaloupe, pear, tree nuts, penicillin, cucumber, oxycodone, shellfish, lactose and latex. On 19-SEP-2013, the patient was vaccinated with a dose of PNEUMOVAX23 (lot# reported as J004061, expiry: 25-JUN-2014), intramuscularly in the left deltoid. On 19-SEP-2013, the patient developed a 4 inch in diameter red indurated injection site reaction. The patient also had chills. Patient sought medical attention. The patient was already hospitalized at the Medical Center for a vaginal hysterectomy and the PNEUMOVAX23 was given before discharge. The discharge was delayed due to this reaction and pain management post surgery. This was her first vaccination with PNEUMOVAX23. She has been treated with ice packs to the site and BENADRYL. The outcome of red indurated injection site reaction and chills was reported as not recovered. Additional information has been requested.
a little chilly; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (a little chilly) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032620A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (a little chilly). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form and IBUPROFEN for Adverse event, at a dose of 1 dosage form. At the time of the report, CHILLS (a little chilly) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Patient took second dose on 25-FEB-2021 (left arm) (lot no. 002A21A).   This case was linked to MOD-2021-323799
This spontaneous report was received from a pharmacist refers to a female patient approaching 80 with latex allergy. on 08-OCT-2013, the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX, subcutaneously. Patient reported to the pharmacist on 23-OCT-2013, that she had developed a vesicular bump near her injection site approximately on an unknown date in October 2013. The pharmacist stated that he had not seen the patient's bump. She told him that it was only one "bump", that it seemed to have a vesicle. He told her to go consult her physician. At the time of this call, the pharmacist was at home, and he did not have the patient's records with him. No treatment was given. Patient sought medical attention-consulted the pharmacist. He stated that she was "approaching 80." The pharmacist was agreeable to receiving the VZVIP, and it was faxed to the pharmacist's facility. The outcome of vesicular bump near her injection site was reported as not recovered. Additional information has been requested.
Extensive swelling below the injection site recommended 1-2 doses of diphenhydramine 25mg.