chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She experienced severe pain in the head and in the foot its muscular; She experienced severe pain in the head and in the foot its muscular; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "She experienced severe pain in the head and in the foot its muscular".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
hives 2wk p/vax requiring ER visit;medrol dosepack given in ER;13JAN97 residuals of hives given pred;
Sudden onset of redness to the eyes with watery drainage, congestion and increase in SOB and congestion.
Within two hours after vaccine- muscle pain at injection site (left arm), within 20 hours fever (highest 101.1 F), chills, all over muscle/body aches, slight stomach upset, headache. Bed rest, ibuprofen and acetaminophen alternating- for about 36 hours.
This spontaneous report as received from a pharmacy technician refers to a 1 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 12-MAR-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source.; Sender's Comments: US-009507513-1802USA001558:
irritable, nervous, insomnia, rash on face, legs APAP given appears to stimulate pt; seen by MD stated pt has cold & dry skin;
Feeling crappy; Flu like symptoms; HEADACHE; FATIGUE; UPSET STOMACH; Injection site reactions; CHILLS; Arm is still red / redness; arm is still red and a little swollen; no appetite; This case was reported by a consumer via call center representative and described the occurrence of headache in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th February 2020, the patient received the 1st dose of Shingrix. On 15th February 2020, less than a day after receiving Shingrix, the patient experienced headache, fatigue, upset stomach, injection site reaction, chills, erythema of extremities and swelling arm. In February 2020, the patient experienced appetite absent. On 19th February 2020, the patient experienced influenza-like symptoms. On 20th February 2020, the patient experienced feeling bad. On an unknown date, the outcome of the headache, fatigue, upset stomach and chills were recovered/resolved and the outcome of the injection site reaction was not recovered/not resolved and the outcome of the erythema of extremities and swelling arm were recovering/resolving and the outcome of the influenza-like symptoms, appetite absent and feeling bad were unknown.   It was unknown if the reporter considered the headache, fatigue, upset stomach, injection site reaction, chills, erythema of extremities, swelling arm, influenza-like symptoms, appetite absent and feeling bad to be related to Shingrix.  Additional details were provided as follows: At 9:00 am, the patient received the vaccine in left arm.  The patient had headache, fatigue, upset stomach and injection site reactions presented that afternoon. The chills presented that evening. The symptoms resolved by Sunday evening except that the arm was still red and a little swollen. The redness was the size of an orange the first day and on 18th February 2020, the size of a 50 cent piece. The patient said that symptoms were resolving. On 19th and 20th February 2020, 4 days after receiving Shingrix, the patient had flu like symptoms. The patient did not like the side effect of Shingrix. The patient was not going to receive 2nd dose of Shingrix for another 6 months because the patient did not like the way it feels. On day 5, the patient was feeling good for couple of days but again feeling crappy.
4-5" itchy red rash with 1 1/2" raised welt at injection site. Patient noticed approximately 6/19-6/20. No fever. Patient took oral BENADRYL 6/22-6/26 and applied BENADRYL cream then hydrocortisone val 0.2% cream. Rash slightly present 6/27.
Several hours after receiving the flu vaccine his right upper arm began to swell and become reddened.
Severe tired for all of evening of shot and next day. Fatigue so bad unable to do much of anything. Pain at injection site.
Pain, there is a knot in her arm at the injection site, her shoulder to the neck is swollen but she has no difficulty breathing, her arms are now uneven.
The day after the injection I was extremely fatigued and had sore muscles/slight body aches. The injection site was tender and would hurt if I moved my arm in a certain way. Three days later I still feel tired but not as bad and I still have some body/muscle aches/soreness.
Woke up shaking and very cold with chills sometime after 12:00am. After layering up it took about 30 minutes for shaking to fully subside and maybe 2-3 hours for body temperature to feel hot. Had headache and dry mouth the rest of the night into the early morning.   Took 400mg ibuprofen after having a morning meal and experienced no other side effects going forward except some tiredness from not getting a full nights rest.
This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Redeveloped symptoms of Covid-19 five days after completion of course of Paxlovid) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 93990S, 032L204 and 0ilh2uA) for COVID-19 vaccination. The patient had no drug allergy. The patient had previously received a COVID-19 vaccine. Concomitant products included ROSUVASTATIN from October 2021 to 13-May-2022 and ESTRADIOL from January 2022 to an unknown date for an unknown indication. On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-May-2022, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Redeveloped symptoms of Covid-19 five days after completion of course of Paxlovid). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 15-May-2022 to 19-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Redeveloped symptoms of Covid-19 five days after completion of course of Paxlovid) was resolving. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. It was reported that the patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. Device date was reported as 26-May-2022. Company Comment: This is a spontaneous case concerning a 71-year-old, female patient with no relevant medical history, who experienced the unexpected non-serious AESI event of Covid-19. The event occurred on May 23, 2022 day after the third dose of mRNA-1273 COVID-19 Vaccine which was administered on November 1, 2021. Patient was treated with nirmatrelvir and ritonavir at an unspecified dose and frequency. Patient re-developed symptoms of Covid-19 five days after completion of course of nirmatrelvir and ritonavir (Paxlovid). The event was reported as resolving. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report. Sender's Comments: Company Comment: This is a spontaneous case concerning a 71-year-old, female patient with no relevant medical history, who experienced the unexpected non-serious AESI event of Covid-19. The event occurred on May 23, 2022 day after the third dose of mRNA-1273 COVID-19 Vaccine which was administered on November 1, 2021. Patient was treated with nirmatrelvir and ritonavir at an unspecified dose and frequency. Patient re-developed symptoms of Covid-19 five days after completion of course of nirmatrelvir and ritonavir (Paxlovid). The event was reported as resolving. The benefit-risk relationship of mRNA-1273 COVID-19 Vaccine, is not affected by this report.
This is a spontaneous report received from a non-contactable reporter. A 33-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: COUGH (non-serious), outcome "unknown", described as "Constant cough for 6 months".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Rash developed on left shoulder in July,  close to injection site, size of a fist, red, hot, squishy, tiny blisters. Appeared to be bruised with white center, itching and burning sensation. Extreme fatigue at the same time as the rash occurred. Went to ER, given steroid cream, went to dermatologist, inconclusive but they advised to continue steroid cream. Has continued to subside. Name of steroid cream is Kenalog.
Original side effect was pain at the injection site followed by pain in the left portion of my chest.  Nine days after the injection I was eating lunch and started to have acute pain above my teeth in my gums and below my right eye radiating from my nose to my ear. Although I had no specific pain in any of my teeth, because of the location, I thought it was from my teeth. The pain would come and go and subsided with ibuprofen. I went to the dentist the same day and he found cavities in the molars in the same area. Over the course of five days, he fixed the cavities. After the cavities were fixed the pain did not subside. Three days ago, I noticed what seems to be an ulcer between my gum and my cheek at the point where the pain is centered. Today I noticed a new smaller ulcer on my bottom inside lip on the same side. Speaking to my doctor he thought it could be shingles. When he mentioned shingles, the light bulb went on regarding my recent vaccine.
THE ENTIRE UPPER ARM (TILL ELBOW) HAD A SEVERE REACTION AFTER ABOUT 24 HOURS. THE INJECTION SITE WAS HARD, PAINFUL, HOT. THE NEXT DAY THE RASH BECAME MORE PROMINENT, SWELLED, ARM WAS MORE PAINFUL TO TOUCH AND ARMPIT WAS SORE - ALL OVER HER UPPER ARM. PATIENT TOOK BENADRYL 25 MG AS A SINGLE DOSE ON 11/29/2017 AND IBUPROFEN 200 MG TOOK 2 DOSES ON 11/28/17 AND 11/29/17. (JUST A SUGGESTION: THERE SHOULD BE A WAY TO UPLOAD PICTURES OF THESE OUTCOMES - IT WOULD MORE CLEARLY BE ABLE TO DEPICT THE REACTIONS OBSERVED).
the seal of a Prevnar 13 syringe is broke at the top and that it "came that way"; the seal of a Prevnar 13 syringe is broke at the top and that it "came that way"; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) (Batch/Lot number: unknown) as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYRINGE ISSUE (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious) and all described as "the seal of a Prevnar 13 syringe is broke at the top and that it "came that way"". Additional information: Caller is a Pfizer Territory Manager. Caller shared that that a HCP reported to him the seal of a Prevnar 13 syringe is broke at the top and that it "came that way". Caller reports the HCP is seeking a replacement.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Left arm had slight red /  small amount of swelling to site.   Pt complains painful to site,  unable to move arm.  Father stated  Pt.  unable to eat, and   is very tiered.     Woke up x2 ,  last night  9-1-20  got up to go see eye M.D. and did school work.
Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about concurrent condition and medical history of the patient was not provided. Concomitant medication included properly stored sterile diluent (manufacturer unknown). On 28-JUN-2017, the patient was administered a dose of improperly stored VARIVAX (lot # N001528, expired date 13-JAN-2019; dose and route were not provided) for prophylaxis (incorrect product storage). The vaccine was exposure to  temperature excursion (range of 6 Fahrenheit degrees to 14 Fahrenheit degrees) for 12 hours. There was no previous temperature excursion. The dose of VARIVAX was reconstituted with properly stored sterile diluent (lot and expiration date not reported). Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA009098: US-009507513-1707USA008903: US-009507513-1707USA009099: US-009507513-1707USA009100: US-009507513-1707USA009102:
Developed COVID 19 infection 2+ months after completion of Moderna COVID vaccine series. First vaccine received on 1/7/2021
developed chest painsl along with increased blood pressure which approached dangerous levels in early April (199/120).  ER visit, followed by blood pressure medication and statins.
This spontaneous report as received from a physician refers to an 18-month-old female patient with no pre-existing physician-diagnosed allergies, birth defects or medical conditions. The patient was not ill at the time of vaccination. On 16-NOV-2018, the patient was vaccinated with the first dose of VARIVAX lot # R007695, subcutaneously for prophylaxis in unspecified thigh (exact dose was not reported). She was concomitantly vaccinated with HAVRIX A and RECOMBIVAX. During the administration of VARIVAX, the needle was not attached to the syringe properly and as a result some VARIVAX inadvertently squirted out of the syringe and into the physician's face and eyes. The physician felt the patient received the full dose of VARIVAX because "it was such a small amount" of VARIVAX that squirted out of the syringe (also reported as "the patient was unaffected and received the full dose of vaccine minus a small spray"). No adverse effect was reported for the patient. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1811USA007762:
Suspected Covid-19; Feeling bad; Loss sense of smell.; Diarrhea; Muscle ache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (Suspected Covid-19), FEELING ABNORMAL (Feeling bad), ANOSMIA (Loss sense of smell.), DIARRHOEA (Diarrhea) and MYALGIA (Muscle ache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Type 2 diabetes mellitus since 2010 and Cardiomyopathy since 2020. Concomitant products included METFORMIN HYDROCHLORIDE (METFORMIN XR), DULAGLUTIDE (TRULICITY), ROSUVASTATIN CALCIUM (CRESTOR), CARVEDILOL (COREG) and VALSARTAN (DIOVAN) for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Jun-2021, the patient experienced FEELING ABNORMAL (Feeling bad) and ANOSMIA (Loss sense of smell.). On 19-Jun-2021, the patient experienced SUSPECTED COVID-19 (Suspected Covid-19). On an unknown date, the patient experienced DIARRHOEA (Diarrhea), MYALGIA (Muscle ache) and FATIGUE (Fatigue). At the time of the report, SUSPECTED COVID-19 (Suspected Covid-19), FEELING ABNORMAL (Feeling bad), ANOSMIA (Loss sense of smell.), DIARRHOEA (Diarrhea), MYALGIA (Muscle ache) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Jun-2021, SARS-CoV-2 test: positive (Positive) Positive (Rapid Molecular Nasal Swab).         After getting suspected for COVID-19 the patient was quarantined for 10 days.  Treatment medication was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Significant follow up, patient demographics, medical history, concomitant and treatment medications and new events were updated.
No adverse event; Patient had been administered with the Moderna vaccine which were beyond the 30day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient had been administered with the Moderna vaccine which were beyond the 30day beyond use date) and NO ADVERSE EVENT (No adverse event) in a 36-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 042J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Mar-2022, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 09-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient had been administered with the Moderna vaccine which were beyond the 30day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient had been administered with the Moderna vaccine which were beyond the 30day beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient had been administered with the Moderna vaccine which were beyond the 30day beyond use date).    No concomitant medication was reported.  No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Non significant Live Follow up; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
pt recv vax 6JAN96 & 9JAN96 pt devel rash & exp tiredness & achy joints;f/u info from the nurse practitioner was indicated that the rash resolved on 12JAN96;
I experienced mild to moderate fatigue and headache on the day of, and day after the injection. No other adverse reactions until 4/15/21 (day 9). At approximately 6:00 am on 4/15/21 I noticed pain, hardness and swelling at the injection site. The skin around that area was warmer than the rest of my arm. I did not look at my arm until approximately 10:00 pm. At that time, I visibly observed redness and swelling at/around the injection site, approximately the size of a golf ball. The adverse reactions that began on 4/15/21 are ongoing at the time of this submission, with no noticeable change in severity of the symptoms.
Information has been received from a registered nurse referring to 3 patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates, the patients were vaccinated with improperly stored RECOMBIVAX HB (dose and route were not reported; lot # L033343, expiration date 13-SEP-2017; Temperature: 34 Fahrenheit (F), Time frame: 14 hours; no previous excursion). No adverse effects were reported. Additional information has been requested.
Starting on the day of the vaccine 1st dose, that night I had severe throbbing headaches, right arm soreness and pain.   I slept most of the day.  I took Astelin nasal spray to help with the headache.  A week later, my upper right arm still had swelling and a rash appeared.  I had these symptoms for 3 to 4 weeks and I called the doctor to notify them about my symptoms. The doctor basically advised me to give it time and lots of rest.   I was well enough by week 4 to get the second dose of the vaccine.
On the 19th I woke up with a sore throat; next morning it was even worse. I was tested for COVID and Strep at Health clinic - both came back negative. Dr prescribed an antibiotic and that helped resolved the sore throat. But I wasn't feeling better with my other symptoms and so the doctor said it was a sinus infection a few days later and he prescribed another antibiotic for that (runny nose, cough, pressure in my sinuses and my face). I have a lingering cough but the rest of me feels much better.
COVID-19; This spontaneous report received from a patient concerned an adult male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, 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 numbers.  Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for ankylosing spondylitis. No concomitant medications were reported.  On an unspecified date, the patient experienced covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient was recovering from covid-19. This report was non-serious.
patient fell, hit head.  reason for falling unknown.  lost consciousness, treated at ER, observed for 48 hours, released with no restrictions.
Violent attack of diarrhea lasting approximately 2-3 hours.  Took 2 anti-diarrhea pills then 1 and sometime later another 1 which brought it under control.
I got my period on 7/20 and was vaccinated on 7/22. On August 2nd, less than two weeks after the first day of my last period I started bleeding heavily. That lasted about 4 days. However, I have not stopped bleeding completely as of today8/11/21.. I have been like clockwork with my cycle since I was 17. Unless I was pregnant, I have not missed a period or had a cycle shorter than 23 days. Once I got my period back after having a baby, it was never erratic, ever.  It always went straight back. I have so many questions and think it?s completely unfair to not mention this would happen , and to not give me any explanation at to why. As far as I know I?ve completely messed up my hormones.   Also, around the same time I started bleeding vaginally I developed 7 bruises on my left leg. 4 on my left foot, one on my left ankle  and two on my left calf. I have no recollection of hurting myself. Also, I never bruise.  I was also foggy for about 3 weeks, but that?s the least often side adverse side effects.
Facial tics (no motor).  Rapid progression of clenching of the neck muscles so that the neck tendons are visible, opening his moth wide open, and a lifting of his eyebrows. This happens about 4-5 times consecutively. These tics occur frequently throughout the day.