chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe low back and leg pain down both legs to ankles resolved in 2-3 days.
Body wide hives, itching and throat tightening.  Patient reports taking Benadryl 25 mg PO @ 6 hours x 4 doses and pre-prescribed steroid injection x 2.
malaise; sore arm; This case was reported by a consumer via call center representative and described the occurrence of malaise in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included arthritis. Concurrent medical conditions included heartbeats irregular.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 1 day after receiving Shingrix, the patient experienced malaise and pain in arm. On an unknown date, the outcome of the malaise and pain in arm were recovered/resolved.   It was unknown if the reporter considered the malaise and pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the 1st dose of Shingrix (intramuscular) and expeienced soarness in arm and malaise,which was recovered in 2 days. The reporter consented to follow up. No further information was available. For further tolerance of 2nd dose refer case US2020221359.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020221359:same reporter
This spontaneous case was reported by an other and describes the occurrence of FATIGUE (fatigue) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product MACITENTAN for Primary pulmonary hypertension. Concurrent medical conditions included Primary pulmonary hypertension. Concomitant products included DILTIAZEM and RIOCIGUAT for an unknown indication. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and MACITENTAN (Oral) 10 milligram once a day. On an unknown date, the patient experienced FATIGUE (fatigue). At the time of the report, FATIGUE (fatigue) outcome was unknown. Treatment medications were not reported.
After the initial effects subsided, I developed a rash at the injection site on day 8. It is now day 9/10 and it is about 5 cm, red, swollen and firm, painful, hot and itchy. It stings and itches.  This sounds similar to the delayed cutaneous hypersensitivity Moderna has reported as a possible side effects. I received the Pfizer vaccine.
12:45pm: Pt c/o lightheaded, stated visual disturbances, skin color pale, and diaphoretic about 15-20 minutes after receiving the COVID 19 vaccine.  Juice given. B/P 60/30 and pt.'s head placed between her knees. Pt transported via W/C to the cot and placed in supine position. 12:50pm: Pt stated she felt better with improvement in skin color noted B/P  102/70. 1pm: Pt states she continues to feel better B/P 106/70. Pt discharged from post-vaccination site via  W/C with her husband (driver). Pt instructed to call her PCP to report this event.
Peripheral neuropathy in his feet/Tingling and burning sensation around the end of his fingertips; This is a spontaneous report from a contactable consumer from the medical information team. A 69-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), via an unspecified route of administration, on the left arm, on 27Jan2021 at a single dose (at the age of 69-years-old) for COVID prevention. The patient had no medical history and no concomitant medications. The patient had no other vaccines on the same day as his COVID vaccine. On 09Feb2021, the patient experienced peripheral neuropathy in his feet with a tingling and burning sensation and also reported a tingling and burning sensation around the end of his fingertips. The patient wanted to know if Pfizer has seen this as a side effect to the product and if he should get his second dose or not. The peripheral neuropathy has improved but it was also persisting and stated that it was persisting at a lesser level. The patient was recovering from the event.
I got the pfizer vaccine on wed 4/7, it's 4/11 tonight and in addition to the headache and too much sleep, my head feels different, i can't concentrate and after 5 days, i'm sleepy and have light pain on the left side of my head. my head feels fuzzy and i'm not myself. The severe headache went away after 24 hours but the rest of the symptoms are ongoing.
Tingling in feet and legs, lower arms; feels like subtle movement in limbs - very annoying;  thought it was a chiropractic issue so didn't report it;  symptoms moved around to other parts of extremities and in some cases got better (feet and arms) and others worsened (legs more annoying) after 2nd dose on 3/11; suspected vaccine reaction but still sought chiropractor opinion
Patient experienced an unprovoked leg DVT "sometime after the second dose" in primary series; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose:1, single, MANUFACTURER UNKNOWN), for COVID-19 Immunization.  The following information was reported: DEEP VEIN THROMBOSIS (medically significant), outcome "unknown", described as "Patient experienced an unprovoked leg DVT "sometime after the second dose" in primary series". Patient was asking if there was any reason for a patient not to receive the covid booster after the patient experienced an unprovoked leg dvt sometime after the second dose of the Pfizer covid vaccine. Asking if there has been any reports of dvt occurring post vaccine. She does not have time to complete report. Response received that Pfizer cannot make individual treatment recommendations for patients and deferring to HCP.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported event Deep vein thrombosis. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
R. arm (deltoid area) swollen, hard, warm to touch. Swollen/hard area 13x15 cm @ 1400.  Guardian reported that PMD prescribed Keflex x 7 days in AM of 07/21/05.
constricted throat approx 8/30/99;hair loss approx 7/14/99;sleeplessness approx 7/5/99;
High fever (103F) starting 3/14pm. Continued  into early 3/17. Temp responded to Tylenol but did not return to normal. Fussy and lethargic. Was better during the daytime 3/17 but then became very fussy and cried most of night on 3/17 (early am of 3/18.) 3/18am had a macular rash. Seen in Health District Clinic.  PNP felt child had a viral illness unrelated to vaccine at that time. Attributed rash to viral illness. Child had rhinorrhea and possibly developing otitis media.  Mother feels the fever on 3/14 was from vaccine and then child got a cold.   Mother reports two siblings ran a fever after 12month shots. Mother does not remember what vaccines or other details.
she had chills, headache like she never experienced before, and fever.; she had chills, headache like she never experienced before, and fever.; she had chills, headache like she never experienced before, and fever.; This is a spontaneous report from a non-contactable consumer reported for female friend. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were unknown. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. On 27Feb2021, after 2nd dose of COVID vaccine, the patient had chills, headache like she never experienced before and fever. The event took place after use of product. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Initial information received from a healthcare professional (physician) on 26 August 2013. A 30 year old female patient was vaccinated intramuscularly on 08 August 2013 with ADACEL batch C4426AA, into the right deltoid. On 10 August 2013 the patient experienced unspecified pain and swelling initially and within the first week, developed numbness and tingling in her arm and cheek, but no weakness. The patient also had muscle spasm and twitching, joint pains and arthralgias on a date not reported. The patient was diagnosed with serum sickness by a travel MD on an unreported date. Laboratory tests were not reported. The patient's medical history was reported as having an unspecified allergy to Sulfa. The patient was not ill at the time of vaccination. The patient is to be seen by an allergist reported as tomorrow. The patient outcome was reported as not recovered. Documents held by sender: None.
A week later on dec 31, 2020 I began to feel fatigued, loss of appetite, chest and back burning. On Jan 4 2021 my bp and pulse were elevated, I had increased chest burning, headache and was admitted to the hospital to rule out MI.  The ct scan showed mild pancreatitis, endoscopy negative. I didn?t have a period for the month of Jan and I am neg for pregnancy. I continue to have esophageal, chest and back burning. I feel better now. I am scheduled to have my second vaccine Thursday Jan 21st and I am nervous. Not sure if this is an adverse reaction or coincidence.
pt c/o of SVT. She is an MD.  She c/o of tickling  & lump in throat, refused Epi. Transferred to ER.
shaking, chills, fever, nausea, dizziness, felt terrible, arm soreness;
patient received dose 1 and shortly after receiving fainted.  Patient was very pale and pulse was very slow...Lasted a few minutes and patient started to recover. Recovered color within about 10 min
Patient's mom called 01/05/2021 @1106 to report that "she developed fever Sunday 12/27/20 of 102 gave Tylenol for fever and would only go down to 101, took her to the Dr. (Pediatrician) 12/28/20 and then continued Tylenol to treat fever" "Thursday 12/31 fever decreased to 100 and stayed down after that"  "and then last night (01/04/21) she got a rash "pinkish dots not really raised and were on her upper torso" Mom also reports, "she has decreased appetite and drinking in the last week" Mom denies any history of a vaccine reaction in the past. No complaints of nausea, vomiting or diarrhea; Mom also reports, "I called her doctor today but haven't heard back yet" 01/05/21 @1303 called Pediatrician Dr. regarding mom's concern "could she have reaction to measle vaccine?" LVM for the "Dr.'s nurse" @ 1330 Dr. Office nurse reports, "viral illness 12/28" they will follow up with mom.
Large rash at injection site; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the right arm on 29Apr2021 at 14:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included magnesium (MANUFACTURER UNKNOWN), vitamin b complex (MANUFACTURER UNKNOWN), cyanocobalamin (VITAMIN B12) and calcium (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EW0158) via an unspecified route of administration on right arm on 08Apr2021 at 14:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01May2021, the patient experienced a large rash at injection site. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event large rash at injection site was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
Urticaria, angioedema High dose antihistamines (Allegra), Pepcid, steroids Outcome is TBD
ON 10-5-2011 DIZZY, ARMS SORE, FEVER OF 101-104 DEGREES, WITH TYLENOL 2 DEGREES LESS. ON THURSDAY 10-06-11 FEVER OF 104, BODY ACHES AND BONE PAIN, DIZZY, HEADACHE, NAUSEA, AND VOMITING BEGAN THURSDAY NIGHT. WENT TO ER ON FRIDAY OCT 7TH, 2011 AT 5PM.
Heavy menstrual bleeding for over 3 weeks starting 72 hrs. after vaccine. Had follow up bloodwork and ultrasounds which showed no indication why I bleed so heavy for so long. Had another heavy cycle after hormone pills. I now have not had a period in over 40 days and not pregnant.
Child had Varivax vaccine 2/97 in Kansas. Became ill with varicella disease the week of 11/25/01. Child broke out with rash all over body, hair,eyelids, mouth, ears, etc. She also had fever and sore throat. Dr diagnosed child having varicella. younger sibling didn't become ill - had Varivax vaccine 6/26/00 at hlth dept. Several children in the area had varicella also.
Vial was stored in refrigerator on 17-Feb-2022,expired on 1-Apr-2022 and administered on 05-Apr-2022; administered with expired vaccines; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with expired vaccines) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 17-Feb-2022,expired on 1-Apr-2022 and administered on 05-Apr-2022) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with expired vaccines). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 17-Feb-2022,expired on 1-Apr-2022 and administered on 05-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with expired vaccines) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 17-Feb-2022,expired on 1-Apr-2022 and administered on 05-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.  It was reported that 21 vials were initially stored in refrigerator on 17-Feb-2022 and doses were administered 30 day use by date or after manufacturer date of expiry.  The vials did not undergo any temperature excursions.  Treatment details were not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2022: Follow-up document contains no additional information.
Redness at the injection site; Swelling at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 61-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th May 2019, the patient received the 2nd dose of Shingrix. In May 2019, less than a week after receiving Shingrix, the patient experienced injection site erythema and injection site swelling. The patient was treated with ibuprofen and non-drug therapy (Cold Compress). On an unknown date, the outcome of the injection site erythema and injection site swelling were recovered/resolved.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. On 6th May 2019 Monday from the reporting date, the patient received 2nd dose of Shingrix The patient experienced redness and swelling at the injection site. The patient was treated with cold conpress and ibuprofen.
almost comatose/couldn't get a response; really really hot/took her temperature it was 101.8/fever; This is a spontaneous report from a contactable consumer (patient's husband). This consumer reported for two patients. This is the first of two reports. A 73-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EN5318 and expiration date 31May2021), via an unspecified route of administration in the right arm on 02Feb2021 at a single dose for COVID-19 immunization. Medical history included ongoing Type 1 diabetic; Alzheimers from 2014 and ongoing, about 7 years ago; and covid-19 from Dec2020 to Dec2020. There were no concomitant medications. At 4 am yesterday morning (03Feb2021), she developed side effects. The patient's husband woke up at 4 am and touched the patient to make sure she was okay like he does every night. When he did, patient was really really hot. He took her temperature it was 101.8. She was almost comatose, and he couldn't get a response from her. He gave her fluid with a straw on her lips. At 7:30 am, 3.5 hours later, she was still hot. He was putting cold compresses on her. He called the hospice nurse, and she came and checked her vitals. She had a fever of 101.5 that time. He continued cold compresses. Her vitals were stable. Then about afternoon, her fever broke, and she became coherent. The rest of yesterday, and today she seems to be fine. She had a side effect that caused her to have a fever and be out of it. He couldn't get a response from her until noon yesterday. When the fever broke around noon, that is when she became more responsive and back to normal. Outcome of the events was recovered on 03Feb2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021156644 same reporter/drug, different patient/event
Pediatric dose given in error. Per CDC guidelines, correct adult booster dose given immediately in opposite arm. Patient given opportunity to ask questions, verbalized understanding.
Improper booster dose administered of 0.5 ml booster dose/ Incorrect Booster Dose; Body aches; Chills; Tactile fever; This spontaneous case was reported by an other health care professional and describes the occurrence of MYALGIA (Body aches), CHILLS (Chills), PYREXIA (Tactile fever) and ACCIDENTAL OVERDOSE (Improper booster dose administered of 0.5 ml booster dose/ Incorrect Booster Dose) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012h21b) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. In November 2021, the patient experienced MYALGIA (Body aches), CHILLS (Chills) and PYREXIA (Tactile fever). On 19-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (Improper booster dose administered of 0.5 ml booster dose/ Incorrect Booster Dose). In November 2021, MYALGIA (Body aches), CHILLS (Chills) and PYREXIA (Tactile fever) had resolved. On 19-Nov-2021, ACCIDENTAL OVERDOSE (Improper booster dose administered of 0.5 ml booster dose/ Incorrect Booster Dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details were provided. No treatment medication details were provided.
right sided weakness; Patient also reported severe dizziness with 1st dose of vaccine.prolonged hypoglycemia; developed POTS (diagnosed by clinician); This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  An adult female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: (unspecified if ongoing); "inflammatory bowel disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ASTHENIA (non-serious), outcome "not recovered", described as "right sided weakness"; DIZZINESS (non-serious), outcome "not recovered", described as "Patient also reported severe dizziness with 1st dose of vaccine."; HYPOGLYCAEMIA (non-serious), outcome "not recovered", described as "prolonged hypoglycemia"; POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (non-serious), outcome "not recovered", described as "developed POTS (diagnosed by clinician)". The events "right sided weakness", "patient also reported severe dizziness with 1st dose of vaccine.", "prolonged hypoglycemia" and "developed pots (diagnosed by clinician)" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of asthenia, dizziness, hypoglycaemia, postural orthostatic tachycardia syndrome.  Additional Information : other vaccine in four weeks: Unknown . Ae resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Patient did not received covid prior vaccination. Known allergies: unknown  The lot number for bnt162b2 was not provided and will be requested during follow up.
I fell. I tripped over my friends' feet. I broke my elbow. I was getting on a cruise ship and had decided not to go to the hospital there. I returned home and went to the doctor the next day. I had surgery on 03/20/2023. I am now in a splint. I'm feeling okay. I had no side effects from my vaccine.
Patient was followed at medical center and screening prefomed there. Confirmed.  No problems 8/9/2021
Severe soreness on right arm, under arm and through to shoulder very painful to lift arm. Taking TYLENOL 1000 mg Q 4 hours. Severe headache, no fever.
Pt. received Hepatitis A vaccine, mom states patient had a seizure with fever.  Mom took patient to the emergency room.
Five hours after injection, sudden onset of itchy rash, tiny, slightly pink raised bumps on upper/inner right thigh. Spreading within a 15 minute period to upper/inner left thigh, arms and neck. Issue resolved in 30 minutes with 10 mg dose of Cetirizine Hydrochloride (Zyrtec). No ongoing rash symptoms. Soreness at injection site is only side effect remaining 17 hours after injection.
swollen arm & pain started the day after the injection. Taking ibuprofen every 6 hrs. cold compress applied without relieve
SEVERE ALLERGIC REACTION / TIRDNESS / LETHERGY / AND SITE REACTION
Patient with mild swelling and redness to LEFT upper arm. Patient advised to start Benadryl for 25 mg for site reaction.