chrisvoncsefalvay/vaers-outcomes huggingface dataset:
4-5 days after TDAP vaccination was given. I develop a stiff arm like it is paralyze. from my shoulder to my hand specifically 4 and 5th finger. pain is worst at night time. wake up every night even until now because of pain.  at first, i was given toradol shots and oral steroid but only last for 3-5 days.I am now taking Gapabentin 300mg twice a day and an occupational therapy to have my range of motion back.
After my second vaccine shot my period was four days late / The bleeding has now lasted 10 days; Lasted for 10 days of very heavy bleeding, and then I had medium to low amounts of bleeding for the next 30 days after that / My next cycle was 40 days long which is almost 2 weeks longer than it normally; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3246) via an unspecified route of administration in the arm left on 25Jan2021 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included etonogestrel (NEXPLANON) for birth control from an unknown date and ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3246) via an unspecified route of administration in the left arm on 04Jan2021 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. On 28Feb2021, after her second vaccine shot, the patient experienced her period was four days late. It then lasted for 10 days of very heavy bleeding, and then she had medium to low amounts of bleeding for the next 30 days after that. On an unknown date in 2021 the patient experienced her next cycle was 40 days long which was almost 2 weeks longer than it normally was. The bleeding had then lasted 10 days. The patient went and had an ultrasound done of her uterus, she was not pregnant and nor was ever pregnant. The patient did not have a miscarriage, no ovarian cyst, and no fibroids in her uterus. It was also reported that the gynaecologist cannot describe to her why her periods had changed in that way. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measure was taken as a result of the events included ultrasound of uterus. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event 'after my second vaccine shot my period was four days late / the bleeding has now lasted 10 days' and 'lasted for 10 days of very heavy bleeding, and then I had medium to low amounts of bleeding for the next 30 days after that / My next cycle was 40 days long which is almost 2 weeks longer than it normally' was not resolved.  No follow-up attempts are needed. No further information is expected.
This initial spontaneous report was received on 19-JAN-2017 from a female licensed practical nurse (LPN) who reported that multiple unspecified patients over 14 years of age received either dose 2 or dose 3 of GARDASIL 9 one to two years after receiving the previous dose of GARDASIL 9 (unspecified dates) which is outside of the recommendations in the GARDASIL 9 prescribing information. The vaccination(s) route, site, Lot #, expiration date and indication were not reported. No adverse effect reported. No further information was reported. Additional information received on 20-JAN-2017, from the same female licensed practical nurse (LPN) reported the date of the administration of GARDASIL 9 for this patient (gender not specified) was reported to be 1) 11-AUG-2016. [Date as reported.] No further information was reported. Additional information has been requested. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1701USA009269: US-009507513-1701USA009269: US-009507513-1701USA009269.
Swelling  around the point of injection; Redness around the point of injection; itching; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: ER8731) via an unspecified route of administration in the left arm on 10Apr2021 at 11:00(at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and insulin resistance. Concomitant medications included liothyronine (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN) and oneadayvitamin. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER7534) via an unspecified route of administration in the left arm on 20Mar2021 at 16:15 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 11Apr2021 at 12:00, the patient experienced swelling and redness around the point of injection in a circle about 1inch diameter associated with itching started 24 hours post vaccination of 2nd dose, persisted after 72hour at the time of reporting. Therapeutic measures were taken as a result of event and included treatment with anti-histamine(unspecified) from unspecified start date to unspecified stop date. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event swelling around the point of injection, redness around the point of injection and itching were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
About 40 hours after shot a large itchy rash broke out on arm where shot was given. Arm was swollen, red patches were puffy and itchy. Kept spreading throughout the day even with Benadryl and allergy meds and ibprofen, was a little worse the next day and then disappeared by the following day. But throughout the course from the moment I got the shot I had weird flittering itches that would come on rapidly in a spot and disappear before I could even reach to itch it. They were popping up all over my left side neck, arm, and leg but happening so fast I couldn?t tell what was going on.
Two days post-vaccine, large blotchy rash, raised & itchy. Started on arm and spread to back, stomach, shoulders and other arm. Seen by MD on 12/3/99 and given Benadryl for allergic reaction, duration 18 days.
Swelling of Rt arm above crease of elbow. Painful to touch. (Not at same site as vaccine).
HPV vaccine administered in pts left deltoid. While attempting to lie down to rest, pt convulsed briefly for 2-3 seconds, passed out for a few seconds. Pt then came to and responded appropriately. Pt rested for 15 minutes with mom at bedside. Pt given granola and a drink, rested 5 more minutes then dismissed in stable condition.
Patient developed red-popular areas about 3 in x 3in. No warmth. Patient c/o itching.
received an expired vaccination; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received an expired vaccination) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received an expired vaccination). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received an expired vaccination) outcome was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Vial was initially stored in the refrigerator on 31 Aug 2021 and it was reported that the vial did not undergo ay temperature excursion.  Treatment medication was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2022: Patient initials, date of birth, suspect start date and expiration date of vaccine were added.
10/06/2021 began having pain in the vulvar region approximately with redness and some linear breaks in the skin.  Pain was much worse with contact, and limited to the external genital region, I.e. not involving the vaginal canal. Pain felt like burning and there was also itching. No discharge, pus, odor, or bleeding.  Was prescribed diclofenac (VOLTAREN) 1 % Gel, Apply 2 g topically 4 (four) times daily (Patient not taking: Reported on 10/26/2021), Disp: 50 g, Rfl: 3 ?  estradioL (Estrace) 0.01 % (0.1 mg/gram) vaginal cream, Place 1 g vaginally At Bedtime Start off nightly for 1wk and then transition to twice a week., Disp: 1 each, Rfl: 3. Symptons got better but never fully went away. At the present time I am still experiencing the same symptoms.
Sciatic nerve pain, burning, numbness, muscle cramping - started 2/20/21 in lower left back, traveled across left buttocks on 2/22/21, continued to left outer thigh on 2/23/21, continued to left lower leg and foot on 2/24/21.  Loss of ability to walk properly due to left leg/foot pain and numbness which resulted in loss of contorl of left leg and foot on 2/24/2021. No prior history of injury or problems of this nature.
Rash at neck and lower back. It appears onset of shingles, varicella type symptoms.
don't feel well; feel little bit nauseous; Feeling bad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old male patient received bnt162b2 (BNT162B2), administration date 05Mar2021 (Lot number: EN6198) at the age of 68 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "bad prostate" (unspecified if ongoing); "wearing hearing devices" (unspecified if ongoing). The patient took unspecified vitamins as concomitant medications. The following information was reported: MALAISE (non-serious), outcome "not recovered", described as "don't feel well"; NAUSEA (non-serious), outcome "not recovered", described as "feel little bit nauseous"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Feeling bad". Therapeutic measures were taken as a result of nausea; patient was given Aspirin.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No information on the patients' concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (lot # M027879 with expiration date on 24-JAN-2018; lot # M022924 with expiration date on 24-JAN-2018; lot # M018644 with expiration date on 20-SEP-2017; lot # M033611 with expiration date on 02-MAR-2018 and lot # reported as M036458 with expiration date on 02-MAR-2018; dose and route of administration were not reported). No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion of 33 degrees Fahrenheit for 30 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA009358: US-009507513-1701USA009359: US-009507513-1701USA005323.
no adverse event; Received Moderna Covid 19 Monovalent as a booster dose; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received Moderna Covid 19 Monovalent as a booster dose) and NO ADVERSE EVENT (no adverse event) in a 53-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 057A22A, 036CZIA and 016CZIA) for COVID-19 prophylaxis.     Concurrent medical conditions included Bee sting hypersensitivity (Bees allergy) and Allergy to animal dander (Cat hair allergy).   On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Received Moderna Covid 19 Monovalent as a booster dose). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Received Moderna Covid 19 Monovalent as a booster dose) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Received Moderna Covid 19 Monovalent as a booster dose).    No concomitant medications were reported.  The reporter stated that one of her colleague had accidentally administered Moderna Covid-19 vaccine as a booster dose instead of providing the Moderna Covid-19 Bivalent booster dose.  On 04-Nov-2022, the patient received first booster dose of Moderna COVID-19 Vaccine.  No treatment information was reported.   This case was linked to MOD-2022-669141 (Patient Link).
Patient presented to ED 12/27/22 with shortness of breath. Patient reports positive COVID diagnosis 12/20/22. Positive result upon admission to the ED. VS on admission 36.4C Resp 42, Pulse 66, BP 130/58, SpO2 54%. Admitted to ICU on 6l NC oxygen. Started on doxycycline, decadron, barictinib, remdesivir, trend troponins. 12/29/22 2300 changed to Bipap FiO2 60. 12/30 2200 increasing respiratory effort, patient agreed to intubation which was tolerated well.  FiO2 50 in VC/AC mode. FiO2 increased to 60, 70 then 100 at one point before starting to come back down. 12/31/22 Central venous line was placed. Patient was extubated 1/6/23 and placed on 8l nc, titrated down to 2lnc. Discharged 1/9/23 to short term rehab.
p/vax pt devel diarrhea;pt stool specimen tested positive for rotavirus antigens;
Sleep disturbance; Fatigue; Pain; Low back pain; Mobility decreased; Osteoarthritis; Spinal osteoarthritis; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (Sleep disturbance), FATIGUE (Fatigue), PAIN (Pain), BACK PAIN (Low back pain) and MOBILITY DECREASED (Mobility decreased) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis and Plaque shift.    Concurrent medical conditions included Rheumatoid arthritis and Plaque shift.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced SLEEP DISORDER (Sleep disturbance), FATIGUE (Fatigue), PAIN (Pain), BACK PAIN (Low back pain), MOBILITY DECREASED (Mobility decreased), OSTEOARTHRITIS (Osteoarthritis) and SPINAL OSTEOARTHRITIS (Spinal osteoarthritis). At the time of the report, SLEEP DISORDER (Sleep disturbance), FATIGUE (Fatigue) and PAIN (Pain) had resolved, BACK PAIN (Low back pain), MOBILITY DECREASED (Mobility decreased) and OSTEOARTHRITIS (Osteoarthritis) had not resolved and SPINAL OSTEOARTHRITIS (Spinal osteoarthritis) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: Pending.         This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Concomitant products were not provided. Treatment medication were not reported.  It was reported that the patient could not sleep when taking Rinvoq at night hence currently she was taking it during the day. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of COULD NOT SLEEP WHEN TAKING RINVOQ AT NIGHT with RINVOQ(UPADACITINIB) was a reasonable possibility. The reporter's causality for the event(s) of FATIGUE WITH SORENESS FOLLOWING SECOND COVID VACCINATION unknown onset, FATIGUE WITH SORENESS FOLLOWING SECOND COVID VACCINATION unknown onset, SHARP PAIN AND DIFFICULTY RISING WITH ISOLATED PAIN IN THE LOWER BACK unknown onset, SHARP PAIN AND DIFFICULTY RISING WITH ISOLATED PAIN IN THE LOWER BACK unknown onset and OSTEOARTHRITIS with RINVOQ(UPADACITINIB) was no reasonable possibility. The reporter's causality for the event(s) of EGENERATION IN FACET JOINT was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Mar-2022: Significant follow up appended. Current condition was updated. Indictaion was added for cosuspect drug. Dosage details were added for suspect product.
Narrative:  COVID infection following COVID vaccine series 03/17 COVID vaccine dose #1 04/07 COVID vaccine dose #2 09/22 admitted through ED for EtOH detox, tested positive for COVID-no COVID symptoms 09/23 no respiratory symptoms 09/26 discharged from hospital 09/27 c/o fatigue, occasional headache 09/28 reports fatigue improving 09/29 reports continued fatigue, myalgias, rhinorrhea, and congestion 09/30 reports fatigue, myalgias 10/01 symptoms resolved
serious pain in arm; neck and shoulder pain; stomach pain; serious headache; heavy panting; in a panic; neck and shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of   in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient take Extra strength Tylenol as a Treatment drug
One week later the patient received a third dose of Menveo in error; This non-serious case was reported by a physician via call center representative and described the occurrence of extra dose administered in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Concomitant products included MENVEO and MENVEO.   In MAY-2023, the patient received the 3rd dose of Menveo. In MAY-2023, an unknown time after receiving Menveo, the patient experienced extra dose administered (Verbatim: One week later the patient received a third dose of Menveo in error). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 10-JUL-2023 The Medical Director of a research study reported a patient was given two doses of Menveo 8 weeks apart per guidelines. One week later the patient received a third dose of Menveo in error. The healthcare professional did not have any details about lot's expiry dates etc. (it was a blind study) and he said follow up was ok with him and he could get some details about the patient such as sex and age. The reporter consented to follow up. The patient received a third dose of Menveo in error, which led to extra dose administered.
This spontaneous report was received from the patient's daughter via Pfizer (manufacturer control # 2015130287) concerning to her mother a currently 68 years old female patient with asthma and chronic obstructive pulmonary disease (COPD). Medical history and allergies were not reported. In April 2013, the patient was vaccinated with a dose of PNEUMOVAX 23, (strength, dose, frequency, route, anatomical location, lot number and expiration date were not reported0. Other suspect and concomitant therapies were not reported. On an unspecified date in September 2013, 5 months after the vaccination with PNEUMOVAX 23, the patient experienced pneumonia. The reporter was wondering if the patient should receive PREVNAR 13 and what would be the time interval required between both vaccines. The outcome of pneumonia was unknown. The relatedness between pneumonia and therapy with PNEUMOVAX 23 was not reported. Additional information has been requested.
Per internal reported event - Pt experienced swelling at the location of the injection immediately after receiving the vaccine. Area swelled to 3 cm. Pt was given 100 mg Benadryl and water and was observed for 30 min. He was in no acute distress, HR and BP normal, no CP,  no difficulty swallowing or breathing. Pt opted to go home after additional observation. Staff called pt at 1450 and the patient said the swelling had improved.
This spontaneous report was received from an office manager, referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # R013565, expiration date: 13-MAY-2020) for prophylaxis (dose, frequency and route of administration were not reported). The vaccine was stored at a temperature of 31.6° C during a time frame of 6 hours and 16 minutes. A data logger was used. No previous temperature excursion had occurred and no adverse effects were reported.
Severe Headache that has lasted almost continually since about 6 days after receiving vaccine. have seen numerous doctors . ahve had blood tests supposedly normal has had 2 Catscans  both according to doctors they were normal. my husband has mentioned to the doctors about having head pain shortly after getting vaccine shot they seem to ignore him or just say okay.
SORENESS UNDER NECK WHICH MIGHT BE THE LYMPH NODE ON THE SAME SIDE AS THE INJECTION SITE WHICH IS THE LEFT SIDE. ALSO SORE AND SWOLLEN ON COLLAR BONE AS WELL AND REDNESS. AS I TRIED TO EAT IT WAS TO SORE TO SWALLOW FOOD AND PAINFUL TOO.
Got breakthrough Covid infection. Lasted a week, sore throat, very tickly nose, clogged ears, headache, nasal congestion, periodic sharp pain in my lower left side front stomach area, diarrhea.
felt faint & dizzy p/vax;skin pale & cool, BP 82/50, HR 72;vasovagal response to immun;