chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Missed approximately 14 days from work due to this event. FU info from MD states pt had localized edema and redness for approx 1 week and then symptoms resolved. MD saw him again 3 1/2 weeks later for mild upper respiratory tract symptoms, which was attributed to a viral bronchitis. Pt reports that for 2 weeks after he was seem by MD he was essentially bedridden with a fever, malaise, extreme body aches, weakness, anorexia and headache. He was back in MD's office on 11/8/99 due to his concerns about symptoms being related to anthrax vax. MD informed pt at that time this seemed unlikely to be related but was willing to report the possibility.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 68-year-old male patient who received SHINGRIX for prophylaxis. On 31st May 2018, the patient received SHINGRIX. On 28th June 2018, 28 days after receiving SHINGRIX, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was not recovered/not resolved. It was unknown if the reporter considered the injection site rash to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional (HCP) stated that the patient, a day before reporting, noticed a rash on his upper arm, which was the same arm he had gotten the SHINGRIX injection.
some back pain; Chills; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (some back pain) and CHILLS (Chills) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 021B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jun-2021, the patient experienced BACK PAIN (some back pain). 20-Jun-2021, the patient experienced CHILLS (Chills). At the time of the report, BACK PAIN (some back pain) and CHILLS (Chills) outcome was unknown.            No concomitant medications were mentioned. No treatment details were reported.
Arthrus reaction to Dtap (Daptacel). Mom says noticed red area at bedtime  on 09/02/05. Advised to use cool compresses and take Benadryl as needed.
muscular soreness on the upper arms; her symptoms got worse; exhausted; slept most of the time; symptoms of Covid-19; soreness on the injection site (right arm); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness on the injection site (right arm)), MYALGIA (muscular soreness on the upper arms), FATIGUE (exhausted), SOMNOLENCE (slept most of the time) and COVID-19 (symptoms of Covid-19) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Psoriatic arthritis.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) milliliter. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 11-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (soreness on the injection site (right arm)). On 21-Jun-2021, the patient experienced FATIGUE (exhausted), SOMNOLENCE (slept most of the time) and COVID-19 (symptoms of Covid-19). On an unknown date, the patient experienced MYALGIA (muscular soreness on the upper arms) and CONDITION AGGRAVATED (her symptoms got worse). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (soreness on the injection site (right arm)), MYALGIA (muscular soreness on the upper arms), FATIGUE (exhausted), SOMNOLENCE (slept most of the time), COVID-19 (symptoms of Covid-19) and CONDITION AGGRAVATED (her symptoms got worse) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jun-2021, SARS-CoV-2 test: Positive.
Local injection site pain, joint aches, chills, malaise, nausea and now vomiting
COAGULATION DEFECT IN PREGNANCY, THIRD TRIMESTER 5/30/2022 -- RECURRENCE OF SAME SYMPTOMS
pt recvd vax 10JUN92 beginning on 2nd day had fever of 104, lt leg swollen mid thigh to knee cap became fretful day of vax & remained fretful x 3 days; hx of mom having siezures prior to age 12; fever of 104 lasted 2 days; no immed MD visit
This spontaneous report was received from a health care professional refers to multiple unspecified patients of unknown demographics. In 2015 (also reported as multiple unspecified dates ranging from 01-OCT-2015 through 03-NOV-2015) the patiens were vaccinated with improperly stored multiple unspecified doses of RECOMBIVAX HB L004754; expiry: 10-NOV-2016, L018501; expiry: 22-JUN-2017 (dose, route and frequency unspecified). No concomitant medications were reported. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 21-NOV-2016, the patient was vaccinated with improperly stored dose of PROQUAD lot # M021731 with expiration date 29-OCT-2017 (dose and route of administration were not reported). The reason of the call was temperature alarm received via a Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 degrees Celsius for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA004113: US-009507513-1611USA011831: US-009507513-1705USA009742.
Pt became syncopal and fell off examination table; LOC x 30 seconds; struck head against wall; BP's checked, water given, sent to local ED for Eval.
Developed pain around the injection site but more around the backside of the shoulder and extending to the left side of her neck.  Pain is worse with movement. No swelling or redness or heat at injection site. Tips of fingers have felt numb at times with movement.  Resolves with rest.  Denies nausea, vomiting, shortness of breath or wheezing.  No weakness in this arm.
My daughter's hands and feet are red, purple, blue and white.   We took her to the clinic, they said she should go to the ER.  After running many tests and ruling out anything life threatening they said to follow up in the clinic.  She is thought to have Raynaud's.
Injection was on 02/19. On 02/22 injection site became red, 2" circle. On 2/24 it is still a 2" around circle. No heat or pain. Arm is a little sore. Told her to try BENADRYL.
BLAH; CHILLS; FEVER; HEADACHE; SIDE EFFECTS; This spontaneous report received from a patient concerned a 43 year old male. The patient's weight, height, and medical history were not reported. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 7/18O/U/V/8978 expiry: JUN-2021) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, Laboratory data included: Body temperature (NR: not provided) 103 F. On 12-MAY-2021, the subject experienced blah. On 12-MAY-2021, the subject experienced chills. On 12-MAY-2021, the subject experienced fever. On 12-MAY-2021, the subject experienced headache. On 12-MAY-2021, the subject experienced side effects. The action taken with covid-19 vaccine  was not applicable. The patient recovered from blah, chills, fever, headache, and side effects on 14-MAY-2021. This report was non-serious.
This case was reported by a consumer via call center representative and described the occurrence of nausea in a 84-year-old female patient who received Flu Seasonal QIV Dresden. On 26th September 2016, the patient received influenza vaccine Quadrivalent. On 27th September 2016, 1 days after receiving Influenza vaccine quadrivalent, the patient experienced nausea. On an unknown date, the outcome of the nausea was unknown. the reporter considered the nausea to be possibly related to influenza vaccine quadrivalent. Additional details were provided as follows: This case was not previously reported to anyone. the patient did not receive any other medications. the patient was given a quadrivalent flu shot but the brand was not known. the patient developed nausea in the next morning after her breakfast at 9:30.
APPROX 7 DAYS AFTER THE SHOT I EXPERIENCED VERY LOW BLOOD PRESSURE (92/71) HB OF 160 AND LATER TEST 96/80 HB OF 167
Hive like rashes on face, eyes, mouth, back, arms, legs.    Low fever 99.5, stuffy head.    Benadryl in higher doses and Tylenol.  Dr. prescribed a medication.
5 years old and is accompanied by the mother. Patient has redness and swelling of the right thigh for one day. Patient was given immunization yesterday. Patient got KINRIX vaccine on the right thigh and patient now has redness swelling and itching at the site of the injection. No history of drainage from the site of the injection.
Abdominal Pain; Leg aching; constipation; This is a spontaneous report from a non-contactable consumer (patient reported for herself) via a specialty pharmacy in the. A 69-year-old female patient received BNT162B2 (COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunization and naltrexone (VIVITROL, Formulation: Solution for injection, Lot number: 2020-3020T) intramuscularly from 25Dec2020 and ongoing at 380 mg monthly for opioid dependence. This patient's medical history included opioid dependence. Concomitant medications were not reported. On an unspecified date, the patient experienced abdominal pain, leg pain and constipation. It was reported that, "on December 2020, naltrexone for extended release VIVITROL for injection 380 mg intramuscular-glut monthly was initiated, for the treatment of opioid dependence. On an unspecified date, the patient received a COVID vaccine dose. On an unspecified date, after the COVID vaccine was administered, the patient experienced abdominal pain, leg aching and constipation, the symptoms were considered as mild. The status of VIVITROL was ongoing". Treatment for the events was not reported. Outcome of the events was not resolved. Causality was assessed as unknown to VIVITROL. No further details were provided at the time of this report.  No follow-up attempts needed. No further information is expected.
It was reported that a female patient (1 of 4) was vaccinated with Fluzone SV '01 -'02 vaccine, lot number UO682AA on 10/16/2001. Reportedly, the a patient developed a local reaction of redness and swelling at the injection site. Patient evaluated by a physician and no therapy was prescribed. The case is linked with reports U2001-01278, U200101279 & U2001-01280.
2053: complained of flushing that progressed to lips tingling within 3-5 min BP:145/84, HR: 96, 02:99%, no SOB or respiratory distress, gave water and observed 2055: BP: 132/88, HR: 92, 02: 99%, no respiratory distress 2100: reports lips were less tingly, BP: 121/82, HR: 94, O2: 99%, no respiratory distress 2103: BP: 110/77, HR: 88, O2:98% 2105: BP: 149/70, HR: 90, 02: 99%, pt talking and moving 2107: BP: 126/73, HR: 77, O2:98%, stated feeling better 2110: BP:117/69, HR: 86, O2:97%, pt stated VS WNL, feeling better 2115: BP: 116/79, HR:87, O2:98%, no respiratory distress, no complaints, requested to go home
This spontaneous report was received from a nurse concerning to a 4 months patient of unknown gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 15-JUN-2015, the patient was vaccinated with an improperly stored dose ROTATEQ injection (lot # K023534, expiration date: 22-MAY-2016) strength and dose were unspecified), the route was defaulted to oral. No concomitant medications were reported. No adverse effect had been observed or reported. The outcome of th event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
About 3 hours after vaccine administration I experienced severe numbness and tingling in entire Right arm and hand, pain at very top of right arm.  Fatigue started the next day (3/3/2021), worsened each day through day 6.  Numbness and tingling also lasted 6 days.
Very sick all night long with aches, chills, fever.  Mouth, teeth, face hurt.  Fatigued the next day but no more symptoms. WHY am I logging this, you ask?  BECAUSE I have gotten flu shots for at least almost every year for the last 20+ years and NEVER HAD ANY SIDE EFFECTS BEFORE except for a sore arm.  So why all of a sudden is this vaccine giving me problems?  Also, I have had the senior shot before too.
pt recv vax 23SEP98 & myopathy/neuropathy lt arm w/overall weakness;arm was nl before onset sx;
RECEIVED LESS THAN 0.5ML (APPROXIMATELY AROUND 0.3ML) OF VACCINE AS A BOOSTER DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 25 year old. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient was previously treated with covid-19 vaccine ad26.cov2.s from unspecified manufacturer (suspension for injection, route of admin not reported, batch number: Unknown expiry: Unknown) dose was not reported (dose number in series 1), 1 in total administered for prophylactic vaccination. It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26.cov2.s. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A, expiry: 11-APR-2022) dose was not reported, 1 in total, administered (dose number in series 2) on 01-DEC-2021 for prophylactic vaccination which was an off label use as patient received less than 0.5 ml of the Janssen covid-19 vaccine as a booster dose (LLT: Vaccine underdose). No concomitant medications were reported.  As per the report, the HCP withdrew 8 doses of the Janssen Covid-19 vaccine from 5 vials and 7 doses from 1 vial which injected into 48 individuals. When the caller had a discussion with that HCP, mentioned that he/she injected 0.5 mL but the caller mentioned that the math (she arrived at that by dividing 2.5 mL by 5 doses) did prove that they received approximately around 0.3 mL."(dose number in series 2) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received less than 0.5 ml of the Janssen covid-19 vaccine as a booster dose (approximately around 0.3 ml) was not reported. This report was non-serious. This case, from the same reporter is linked to 20211210197, 20211209551, 20211210067, 20211210058, 20211210160, 20211209679, 20211209706, 20211209740, 20211209782, 20211209816, 20211209843, 20211210106, 20211210141, 20211210143, 20211210160, 20211210165, 20211210350, 20211209843, 20211209816, 20211209782, 20211209740, 20211209706, 20211209679, 20211210112, 20211209775, 20211209874, 20211210385, 20211210408, 20211210409, 20211210549, 20211210555, 20211210585, 20211210588, 20211210662, 20211210662, 20211210684, 20211210733, 20211210824, 20211212082, 20211212088, 20211210159, 20211210670, 20211210590, 20211210334, 20211210180, 20211210133, 20211210112, 20211210107, 20211210019, 20211209921, 20211209912, 20211209880, 20211209551, 20211209798, 20211209884 and 20211209976.
Pt was hospitalized and dx'd with bacterial meningitis. This occurred 10 days after receiving the new Prevnar vaccine. Symptoms included fever, vomiting and stiff neck. Pt was given various antibiotics for 14 days. Tests conducted on the cultures were unable to determine the exact strain of meningitis.
Rash at the site of injection approx 8-10 hrs to giving shot. Resolved the next day.
Delayed reaction, nine days after the injection: Fatigue, severe neck and head pain, headache, muscle aches, joint pain
Within minutes of receiving the injection, I had a headache. It is now 5 days later and I still have the headache. I have widespread muscle and joint pain. On Monday and Tuesday, I had severe chills, fever and diarrhea. I am most concerned about the headache and pain as nothing is alleviating these symptoms.
Mild Headache and a rash that started on my lip and spread to my cheek, my eye and forehead. The rash it blistery kind of looking, little bit blister and they would open and bleed and then close back up. It was also burning.  It start continually spread more. I went yesterday  02/09/2021to a Dermatologist he treated me for a contact kind of dermatitis as if he was unsure if it was linked to vaccine or not. He gave me two steroid injections in the office and prescribed a cream Elidel 1% .  The medications seem to be clearing up my face today.
Patient presented and stated she had cellulitis from the vaccine. She began a 10 day course of cephalexin today. Her arm  was red and inflamed. The physician assistant drew a ring around the area to make sure it did not expand.
Abdominal pain/ She had severe, intermittent abdominal pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Abdominal pain/ She had severe, intermittent abdominal pain) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    The patient's past medical history included Kidney disorder.   On 01-Apr-2021, the patient started UPADACITINIB (RINVOQ) (Oral) 15 milligram. In 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced ABDOMINAL PAIN (Abdominal pain/ She had severe, intermittent abdominal pain). At the time of the report, ABDOMINAL PAIN (Abdominal pain/ She had severe, intermittent abdominal pain) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound abdomen: it was fine.         No concomitant medications were reported No treatment medications were reported Patients physician had thought that the vaccines caused the abdominal pain but he was stopping Rinvoq for one month to see if that might be the cause despite the pain commencing prior to initiating Rinvoq.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporters causality for the event(s) of SEVERE, INTERMITTENT ABDOMINAL PAIN with RINVOQ(UPADACITINIB) was no reasonable possibility.  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.
Vial was initially stored in the refrigerator on 25-Feb-2022/Patient received the vaccine which was past the 30-day storage on the refrigerator/ Doses were applied between the 01-Apr-2022 and 08-Apr-2022; Dose administered after 30-day Use By Date or after manufacturer date/Patient was vaccinated with the Moderna Vaccine after the expiration of 25-Mar-2022.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date/Patient was vaccinated with the Moderna Vaccine after the expiration of 25-Mar-2022.) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 25-Feb-2022/Patient received the vaccine which was past the 30-day storage on the refrigerator/ Doses were applied between the 01-Apr-2022 and 08-Apr-2022) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Patient has No known dug allergies (NKDA).  Concurrent medical conditions included Hypertension (HTN) and Type 2 diabetes mellitus (DMII). Concomitant products included LOSARTAN and METFORMIN for an unknown indication.    On 20-Apr-2022 at 10:07 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2022 at 10:07 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date/Patient was vaccinated with the Moderna Vaccine after the expiration of 25-Mar-2022.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 25-Feb-2022/Patient received the vaccine which was past the 30-day storage on the refrigerator/ Doses were applied between the 01-Apr-2022 and 08-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date/Patient was vaccinated with the Moderna Vaccine after the expiration of 25-Mar-2022.) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 25-Feb-2022/Patient received the vaccine which was past the 30-day storage on the refrigerator/ Doses were applied between the 01-Apr-2022 and 08-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the vial was initially stored on refrigerator on 25-Feb-2022. Number of doses/vial used were 36. The vial did not undergo temperature excursion.
Numbness, tingling, soreness of (L) arm that began one day after hepatitis B vaccination (1/3 of series). Seen in ED on 8/22/17 and diagnosed with (L) sided deltoid localized post injection site reaction.
This is a spontaneous report from a contactable consumer. A male patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on 09Apr2017 as a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient developed a reaction: welts and rash in Apr2017. The reaction started approximately 6 hours after getting the vaccine and had been ongoing for a couple of weeks. The consumer stated that the patient may have already received pneumococcal 13-val conj vac (dipht crm197 protein) when he got his flu shot 21 months ago. The consumer suspects that it may be a duplicate dose of Prevnar 13 but was not sure. Outcome of the events 'rash' and 'welts' was not recovered.
Swollen Lymph nodes under the jaw, has been going on for 6 weeks now
Two weeks after my second Pfizer COVID-19 vaccine, I began to experience burning in my feet and legs, occasional numbness and tingling in my lower extremities, and frequent muscle twitches, mostly in my legs. My chronic back pain became worse, and I developed pain throughout my body. Walking more than a few blocks became difficult due to the pain. I was seen by my internist and referred to a rheumatologist, Dr.  who I saw on 6/25/21. I was diagnosed with fibromyalgia at that time.  I started  a course of physical therapy. My pain and lower extremity symptoms have gradually been subsiding but are not quite gone. I am not at all sure the symptoms are related to the vaccine, but I am reporting them in case they are helpful in identifying a trend.
The day after receiving mandatory flu vaccine at Hospital (Sequirus, Afluria) she developed parasthesia down left shoulder, arm, upper back and facial fasciculations.