chrisvoncsefalvay/vaers-outcomes huggingface dataset:
bilateral sharp leg muscle pain; difficulty to move around; severe fatigue; This is a spontaneous report from a non-contactable Other Healthcare Professional reporting for herself   A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 04Jan2021  at single dose via an unspecified route of administration  for COVID-19 immunization. The patient didn't have medical history. Concomitant medications included ibuprofen 1 dose of over the counter Ibuprofen a day prior to vaccination. On an unspecified date in Jan2021 after the 1st dose patient experienced bilateral sharp leg muscle pain causing difficulty to move around and severe fatigue. The events lasted daily for more than 1 week. Treatment received included Tylenol. It was informed that 2nd dose should be administered the week of 25Jan2021. The patient recovered from the events on an unspecified date.   Information on the lot/batch number has been requested.
Left arm and facial numbness starting 2/14/21 and lasting 10 min. I had two episodes one week apart.
CRAMPS IN LEFT LEG; FEEL DIZZY; HURT; HARD HEADACHE; MUSCLE PAIN IN BACK (COVERS WHOLE BACK); This spontaneous report received from a patient concerned a 26 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient did not had fever or cough. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 17-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced feel dizzy. On SEP-2021, the patient experienced hurt. On SEP-2021, the patient experienced hard headache. On SEP-2021, the patient experienced muscle pain in back (covers whole back). On 18-SEP-2021, the patient experienced cramps in left leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cramps in left leg, hard headache, feel dizzy, hurt and muscle pain in back (covers whole back) was not reported. This report was non-serious.
Increased temp (103.9), swelling, redness (L) deltoid area - injection site extending down to elbow.
Grand mal seizure at 11:30 a.m. Continued having seizures until 2:00 a.m. 3/29/21 He had not had a seizure for 3 weeks. He had not had seizures for this long a period of time for as long as we have on record. His neurologist stated to give him Ativan each time they were becoming constant,
Fever, lump in leg, lethargy, bumps on face and body, diarrhea, dehydration, lack of appetite.
ELEVATED BLOOD CLOTTING; LONG LASTING HEADACHES; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: Unknown) frequency 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.   On MAR-2021, patient had been to GP (general practitioner) in hospital 3 times as she was experiencing long lasting headaches. On an unspecified date, the patient experienced elevated blood clotting, and was hospitalized. Patient was inquiring whether PF4 should be considered as a part of tests for people experiencing long lasting headaches. Patient had elevated bloods clotting but platelets were normal and scan clear.  Patient still had persistent headache 4 weeks on and had been referred to neuro. Laboratory data (dates unspecified) included: Coagulation factor (NR: not provided) Elevated, Platelet count (NR: not provided) normal, and Scan (NR: not provided) clear. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from long lasting headaches, and the outcome of elevated blood clotting was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:  This patient of unspecified age and gender reported to have "elevated bloods clotting" and "long lasting headache" after an unspecified duration from receiving COVID-19 VACCINE AD26.COV2.S for the prevention of symptomatic SARS-CoV-2 virus infection.  The patient reported to "have been to GP, hospital 3 times" with "platelets normal and scan clear".  No other details reported. The information available precludes a complete and meaningful assessment.  However, considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded.  Additional information was requested.
Started feeling pain in right temporal region; the next day temporal vein was swollen and protruding on forehead; Had a telehealth appointment and was told it was probably just a Superficial Phlebitis and to contact my Dr. if it didn't subside. After 4 days it seemed to resolve itself.
Tested PCR positive for COVID 8/9/21 after being fully vaccinated. Symptom onset 8/8/21.
pt says she got a feeling in left leg like something was sitting there between her knee and ankle.  She had a couple of episodes of this.  Her left ankle and foot started swelling and hurting and she began having trouble walking.  On the edge of the bottom of her left foot she found two knots that were there a couple of days.  She had two lumps develop on the back of left arm that were only there for a couple of days.  She continues to have pain and swelling in her left foot and having episodes of pain in the left leg.  On 6/4/21 she went to the ER.  She was prescribed some Tylenol and ibuprofen.  She still has inflammation and pain today.  She has a appt w/ her PCP next week. She will ask to have test to rule out blood clots.
This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with GARDASIL (dose1, 1 dose, route reported as vaccine and lot# unknown) as recommended by the CDC (Centers for Disease Control). On an unknown date, the patient was diagnosed with "TOTS" (Tip-of-the-Tongue Syndrome) and did not complete series of GARDASIL. She only received the first dose. On an unknown date, therapy with GARDASIL was discontinued. The outcome of the events were considered as unknown. Causality assessment was not provided. There was no product quality complaint (PQC) involved. Additional information has been requested.
ALL S&S OCCURED WITHIN 48 HRS OF INJECTION, SWOLLEN ARM, ACHES, CHILLS, FEVER, MALAISE.
Shingles, painful rash on torso, started 5 days after second dose.
Tender, painful & hot at injection site.  I just waited.  I'm sorry of I'm reporting too minor of a reaction.
The child was given the vaccination and within minutes they developed hives on face, torso, and upper arms.  They also had lip and eyelid swelling.  The nurse gave EpiPen 0.3mg and the lip swelling decreased.  The parents were not able to be reached immediately.  911 was called and child was transported via ambulance to Hospital.  The child was given Benadryl 25mg IM in transport.  The child was alert through the entire event.  At the ER child's symptoms resolved and was discharged home.
Chills, aches, mild nausea and fever up to 100.8 for 6-8 hours. Headache and fatigue  for 20 hours.
pt recvd vax; periorbital swelling, urticaria on arms & body;
Patient felt dizzy, hot, and developed rash on arms and chest within 15 minutes of vaccination.  Benedryl given, IV started, and transported to ER by EMS.
This spontaneous report was received from a nurse practitioner refers to a patient of unknown age and gender. The pertinent medical history, drug reactions or allergies and concomitant medications were not reported. It was reported that, on an unspecified date the "plunger rod would not push" while administering a dose of GARDASIL 9 to the patient (lot # L048459, expiry date 22-FEB-2018, dose, strength, dose number, vaccination site, route not provided). No adverse effect was reported. A product quality complaint was filed. No further information was provided. Additional information has been requested.
This spontaneous case was reported by a consumer and describes the occurrence of LEUKAEMIA (leukemia) in a female patient of an unknown age who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received third dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced LEUKAEMIA (leukemia) (seriousness criterion medically significant) and FEELING ABNORMAL (changed them very much). At the time of the report, LEUKAEMIA (leukemia) and FEELING ABNORMAL (changed them very much) outcome was unknown. No concomitant medication was reported. The reporter stated that after the vaccination with the mRNA, it changed them very much. It was like not only mental and they were not as toxic and stuff but they had this now. They got them to take a booster. That's when everything really took a nose dive. Now it was really an urgent situation because the cutting edge type information that if it was caused by the vaccine, but the reporter thought it's leukemia because they were talked about chemo. It was stated that it might not be a good idea to use chemo and it might be a better idea to use since they know. The genes were inserted and not, that someone could possibly fix the leukemia with a gene. Company comment: This spontaneous case concerns a female patient of unspecified age with no medical history reported, who experienced the unexpected serious(medically significant) event of Leukaemia that occurred unknown days after receiving the third dose (booster ) of mRNA-1273.222 vaccination in COVID-19 vaccination series. No further details on risk factors, medical history, clinical course, additional vaccination details, concomitant medications and treatment details were provided. The outcome of the report was unknown at the time of report. The benefit-risk relationship of mRNA-1273.222 Vaccine is not affected by this report. This case was linked to US-MODERNATX, INC.-MOD-2022-642151 (E2B Linked Report). Sender's Comments: This spontaneous case concerns a female patient of unspecified age with no medical history reported, who experienced the unexpected serious (medically significant) event of Leukaemia that occurred unknown days after receiving the third dose (booster ) of mRNA-1273.222 vaccination in COVID-19 vaccination series. No further details on risk factors, medical history, clinical course, additional vaccination details, concomitant medications and treatment details were provided. The outcome of the report was unknown at the time of report. The benefit-risk relationship of mRNA-1273.222 Vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2022-642151: parent case.
Knee pain, left knee, appeared within 2 days of shot, and has persisted for two weeks.  Knee previously received arthroscopic surgery in 2015 for meniscus but has not been problematic since.
given Hiberix reconstituted with sterile water; given Hiberix reconstituted with sterile water; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Hib (Hiberix) (batch number 594CF, expiry date 13th July 2022) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, unknown after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. A nurse reported that, it was possible that, the patient was given Hiberix that might have been incorrectly reconstituted with sterile water instead of saline, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. Healthcare professional did not have specific patient information or dates administered at the time of report.  The healthcare professional stated that, the specific lot was administered over a range of a couple of months.  The reporter consented to follow up. This was 1 of 9 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022022662:Same reporter US-GLAXOSMITHKLINE-US2022AMR024235:Same reporter US-GLAXOSMITHKLINE-US2022AMR024236:Same reporter US-GLAXOSMITHKLINE-US2022AMR024238:Same reporter US-GLAXOSMITHKLINE-US2022AMR024239:Same reporter US-GLAXOSMITHKLINE-US2022AMR024240:Same reporter US-GLAXOSMITHKLINE-US2022AMR024241:Same reporter US-GLAXOSMITHKLINE-US2022AMR024237:Same reporter
Pt recvd 1 dose of Engerix-B & subsequently on 2OCT91 pt devel pain, joints hurting, neck & shoulder muscle strained & rt arm hurting even though the inject was given in lt deltoid;
Within one minute of AFLURIA injection - I had a severe metallic taste in my mouth, odd sensation in throat due to this taste, felt heat everywhere especially perineal area. "Felt odd" all over - several hours to 6 hours later all over itching - hives on trunk!
The vial and syringe were left out of the refrigerator for longer than the allowed time of 2 hours (3 hours and 37 minutes)
redness on his bicep that looked like a tourniquet; arm was heavy; his lymph nodes were the size of grapes on his arm, underarm, bicep, neck and chest; areas were hot to touch; pain level was a 10, like his arm  was going to explode; chills; Flu like symptoms; Just wanted to sleep; A spontaneous report was received from a consumer concerning a male of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced redness on his bicep that looked like a tourniquet/vaccination site streaking, arm was heavy/limb discomfort, lymph nodes were the size of grapes on arm, underarm, bicep, neck and chest/lymphadenopathy, areas were hot to the touch/vaccination site warmth, pain level at a ten, felt like arm was going to explode/pain in extremity, chills, flu-like symptoms/influenza like illness and just wanted to sleep/fatigue.  The patient's medical history included cellulitis and swelling with mosquito bite.  Concomitant product history was not provided.  On 20 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number:026L20a) for prophylaxis of COVID-19 infection. Two weeks after his first injection he had a small red circle the size of a half dollar at the injection site that lasted about three to four days. He notified his doctor and was told there was no issue with the red circle.   On 17 Feb 2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number:039K20a) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 17 Feb 2021 about 14 hours after his second shot he stated that he had flu like symptoms including chills, slept and had a sore arm. Then about a day and a half later in his left arm where he got the shot, his lymph nodes were the size of grapes on his arm, under his arm, bicep area, on the left side of his neck, and on the left side of his chest. The patient stated that the areas where hot to the touch and his pain level was at a 10.  He felt like his arm was going to explode. He also just wanted to sleep. His doctor thought it was cellulitis. On 20Feb2021, the patient went to urgent care because he developed redness on his bicep that wrapped around his arm like a tourniquet, and his arm was really heavy. The urgent care doctor put him on steroids. On 21Feb2021, he contacted his doctor again and was told to go to the ER. He was taken off the steroid and but on IV vancomycin every 12 hours for 3 days. He was admitted to the hospital from the ER. The patient had 2 Covid tests while in the hospital and both came back negative. His white blood cell count was 35,000 while in the hospital and was seen by an infectious disease doctor.  The patient was discharged on 23 Feb 2021.  Treatments of these events included doxycycline, IV vancomycin  Action taken with mRNA-1273 in response to the event  were not applicable.  The outcome of the event(s) were not provided.; Reporter's Comments: Based on the current available information, a temporal association between the use of the product and the start date of the events, a causal relationship with the events cannot be excluded.
7" area of induration, warmth, erythema, & TTP - Treated for possible cellulitis.
This case was reported by a pharmacist via call center representative and described the occurrence of itchy scalp in a 75-year-old female patient who received SHINGRIX (batch number EY93J, expiry date unknown) for prophylaxis. On 22nd October 2018, the patient received the 1st dose of SHINGRIX. On 23rd October 2018, 1 days after receiving SHINGRIX, the patient experienced itchy scalp, sunburn and raw skin. On an unknown date, the outcome of the itchy scalp, sunburn and raw skin were not recovered/not resolved. It was unknown if the reporter considered the itchy scalp, sunburn and raw skin to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine on Left arm at 12:07 PM. The patient received the Shingrix vaccine two days ago from the date of reporting. The patient called the pharmacy and reported that the following day she had a raw, itchy scalp and it feels like a sun burn on her head. The patient had not washed her hair and the symptoms had not resolved.
Had a really bad migraine for 3 days straight, extreme aching in arm from neck to fingertips, felt extremely tired for 5 days and on the 6th day, woke up with my armpit extremely sore, swollen lymph nodes in armpit and collar bone, have not gone down yet
pt recv vax & exp soreness & redness @ inject site; No further details were provided;
Pt devel hives and injection site warmth, redness and swelling after being vaccinated with pneumococcal vaccine 23 polyvalent.
Within 1 minute, patient complained of symptoms of lightheadedness, flushing, asked for water.  Symptoms persisted, reported vagal and "spacey", vitals were 117/91, HR 67,  O2 sat 99% on room air.  Reported chest heaviness, shortness of breath and within 5 minutes developed rigors and  urge to defecate. 911 called,  repeat vital 150/89 HR 113 O2sat 97%, continues to want to defecate.  1 loose BM, transferred to ED
Information has been received from a health professional concerning a 16 week old patient who on 16 Aug 2006 was vaccinated with a first oral dose of Rotateq (human bovine). It was reported that no adverse experience was related to this event. No other information was provided. Additional information has been requested.
L arm/deltoid pain  persisting  for 3 weeks after vaccination,  decreased ROM of L arm due to pain.  no redness or bruising at vaccine site. Unable to abduct arm past 40 degrees due to pain.
Varicella vaccine administered and one week later my daughter developed a fever which was followed by a varicella rash which started on abdomen and over the course of one day spread all over her body. She was very irritable and cried during the first day of symptoms . The small red spots covering her body lasted for the next 4-5 days following initial presentation . We gave pain medications to help with comfort .  We do have photographs of the rash to show if needed. We contacted the doctors office which advised to monitor and treat symptoms as they arose.
Covid Breathrough. First vaccine 03/06/21. On 1/5/22 Patient presents to ED c/o dizziness, syncope, and CP.  Patient tested positive for Covid 8 days prior to admission at outside facility.
Little tightness in his chest; Today it has been worse.; It was a little green this morning; He feels like he has a bad sinus infection; Nose has been running for almost 24 hours; Coughing; Sneezing; pain in the arm; This is a spontaneous report received from a contactable consumer (patient) reported for himself. A 62-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8737, Expiry date: not provided), via an unspecified route, on unspecified date (at the age of: 62-year-old) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Past drug event included Claritin which patient takes every day and took it before the shot. On 20May2021, patient nose started running on Thursday morning/nose has been running for almost 24 hours. It stopped during the day. He laid up in his recliner last night because he could not lay with his nose running so much. It fluctuates and will stop for an hour or so then he starts sneezing and it starts running again. It is clear now. It was a little green this morning (21May2021). He thought he had some kind of infection. It is ironic that it happened right after the shot. He takes Claritin every day and he took it before the shot, he does not have this problem during the day. He was taking Claritin and Ibuprofen like they said to take for pain in the arm or something like that yesterday and last night. Today (21May2021) it has been worse. He feels like he has a bad sinus infection (21May2021). He asks if that is possible after the Covid vaccine. His wife had it, but she did not have this kind of side effect. His nose is running, and it says nothing on the sheet about it. He was coughing. He hopes it is not getting into his chest. The coughing started on 20May2021. On 21May2021, his chest started feeling tight this morning/has a little tightness in his chest. He asks if he needs to call the doctor to get something to knock it out. From an unspecified date, he has been sneezing and sneezing as well for over 24 hours now. He will sneeze and it makes his nose run too. That was why he wanted to know if it is related or if there is something to take or if he needs to go to the doctor. He just wanted something he can take over the counter. He asked how long these questions will take. He just needs something to take to feel better. While reporting an AE, patient mentioned that he took Ibuprofen and Claritin for a running nose, cough, sneezing, and tightness in his chest and has not gotten better. The clinical outcome of nose has been running was not recovered, it was a little green was recovered on 21May2021 and for another events outcome was unknown.  No Follow-up attempts completed. No further information is expected.
Only one in series  - Breakthrough Case  COVID-19 (Moderna) 1 77 Years 9 Months 01/21/2021  Moderna 027L20A
Patient reported that her arm swelled up and became really hot the same day of the injection. She reported the event two days later, reporting that it did get better after applying ice and taking TYLENOL, however, it still remained a bit swollen.
Fever, abdominal cramps, vomiting with blood, diarrhea with blood, chest pain, shortness of breath, blurred vision, constant dizziness, dental pain, severe pain at injection site radiating to the neck and ear left side.