chrisvoncsefalvay/vaers-outcomes huggingface dataset:
temperature of 103.8/running low fever; body aches/pain all over; chills; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at the age of 37-year-old) at single dose for COVID-19 immunization. The patient medical history and  concomitant medications were not reported. The patient stated she got the Pfizer COVID 19 vaccine on Tuesday and ever since that evening, she had  been running low fever and body aches. Now she had a temperature of 103.8.  It had been two days since vaccine and stated she had had severe body aches, chills and pain all over. She was wondering if she should go to the hospital or should she continue to take Ibuprofen rotating with Tylenol. She was  taking 1000mg of Tylenol and 800mg of  ibuprofen, every 4 to 5 hours, clarifying it would help for only three hours maybe. The outcome of the events was unknown.  The lot number for BNT162B2, was not provided and will be requested during follow up.
Information has been received from a physician concerning his daughter, an approximately 14 year old female patient who on 11-MAY-2007 was vaccinated with the first dose of GARDASIL in deltoid. The patient received the second dose on 31-OCT-2008, the third dose on 30-DEC-2008 and the fourth dose on 26-JUN-2009. The patient experienced pain and redness at injection site post vaccination. The patient had sought unspecified medical attention. At the time of report, the patient had recovered. This is one of several reports from the same source. Additional information has been requested.
The pt experienced outbreak of less than 50 lesions. Onset 10/29/00 and was itchy.
Mild arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Mild arm soreness) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included LINACLOTIDE (LINZESS) and LISINOPRIL for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (Mild arm soreness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Mild arm soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-068799 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-068799:crosslinked to Dose 2
Swollen around the injection site; redness around the injection site; Tender arm; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Tender arm), VACCINATION SITE SWELLING (Swollen around the injection site) and VACCINATION SITE ERYTHEMA (redness around the injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced TENDERNESS (Tender arm). On 25-Feb-2021, the patient experienced VACCINATION SITE SWELLING (Swollen around the injection site) and VACCINATION SITE ERYTHEMA (redness around the injection site). On 19-Feb-2021, TENDERNESS (Tender arm) had resolved. At the time of the report, VACCINATION SITE SWELLING (Swollen around the injection site) and VACCINATION SITE ERYTHEMA (redness around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was reported.
WITHIN ONE HOUR OF RECEIVING VACCINATION DEVELOPED 102.6F FEVER, HAVE HAD RECURRENT FEVER EVERYDAY ALONG WITH BODY PAINS, CHILLS FOR 1 WEEK NOW AND COUNTING CURRENTLY TAKING MOTRIN & TYLENOL TO ALEIVE FEVER
loosing blood in his stool; feeling weaker and weaker; feeling weaker; A spontaneous report was received from a consumer who is also a 76-year old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced weakness worsened/ asthenia and loosing blood in his stool/ hematochezia.  The patient's medical history included blood disease, some type of anemia, and a heart condition.  09 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 025320-24) intramuscularly for prophylaxis of COVID-19 infection.   The patient was feeling weaker, which started before the vaccine, and he took iron and it got a little better. The patient was also loosing blood in his stool.  Action taken with the drug in response to the events were not reported.  The outcome of the event, asthenia, was improved. The outcome of the event, hematochezia, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Hands and feet itchy; Hands and feet splitting/cracking; This spontaneous case was reported by a non-health professional and describes the occurrence of SKIN FISSURES (Hands and feet splitting/cracking) and PRURITUS (Hands and feet itchy) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced SKIN FISSURES (Hands and feet splitting/cracking). On an unknown date, the patient experienced PRURITUS (Hands and feet itchy). At the time of the report, SKIN FISSURES (Hands and feet splitting/cracking) and PRURITUS (Hands and feet itchy) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Patient did not thought Skyrizi was working. He still experienced hands/feet splitting and cracking caused by the Moderna Covid vaccines and booster. His hands and feet still were itchy.  Concomitant medications were not reported.  No treatment information was provided by the reporter.  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.
Reported fever of 103. Pain, redness, swelling and warmth in right arm from shoulder to elbow. Called patient 10/16/2012 08:00 AM and he stated fever gone and arm better. He took Tylenol and did a "home remedy" but did not explain what the "home remedy" was.
Hearing loss; Vertigo; This is a spontaneous report from a contactable consumer or other non hcp.  A female patient of an unspecified age received bnt162b2 (BNT162B2;solution for injection), via an unspecified route of administration on May2021 (Batch/Lot number was not reported) as unknown single for COVID-19 immunisation. The patient medical history and concomitant was not reported. The patient experienced hearing loss, vertigo on an unspecified date. It was reported that, While the caller was telling his experience with the Covid 19 vaccine with the hearing loss and vertigo he states his friend's mother received her Covid 19 vaccine and is experiencing the same thing as he done.She had her Pfizer Covid 19 vaccine 3 weeks ago. He's going to encourage his friend to have their mother call and report her experience. Outcome of the event were unknown.    He declines to provide any more information. He declines to file safety report for his friend's mother. No further information is provided or obtained.  Information on the lot/batch number has been requested.
Soreness at injection site; fever; rash; heart palpitations; headache; fatigue; chills; swollen eye.
Problems with speech , numbness to right side of body , fever , shortness of breath , shaking/jerking on right side
This spontaneous report as received from a pharmacist, refers to multiple, unspecified patients of unknown age and gender. The Pharmacist reported that multiple unspecified patients were administered improperly stored PROQUAD (dose and route of administration were not reported). It was a case of a digital data logger. Following batches were involved: Lot# M002055, expiration date 11-JUL-2017, time frame for temperature excursions were as follows: -2 degrees Celsius for 1 hour 36 minutes, 2.9 degrees Celsius for 3 hours 42 minutes, -8.1 degrees Celsius for 1 hour 36 minutes. It was reported that there were previous temperature excursions, as follows: -11.5 degrees Celsius for 30 minutes,  -7.4 degrees Celsius for 2 hours 12 minutes, -7.5 degrees Celsius for 48 minutes. Albumin status for Lot# M002055 has been verified as recombinant human albumin (rHA). Lot # M007965, expiration date 15-AUG-2017, time frame for temperature excursions: -2 degrees Celsius for 1 hour 36 minutes, 2.9 degrees Celsius for 3 hours 42 minutes. It was reported that there were previous temperature excursions, as follows: -8.1 degrees Celsius for 1 hour 36 minutes,  -7.5 degrees Celsius for 48 minutes, -13.4 degrees Celsius for 18 minutes, -13.7 degrees Celsius 12 for minutes. Albumin status for Lot# M007965 has been verified as recombinant human albumin (rHA). Follow-up information has been received on 28-NOV-2016 from the pharmacist via phone call, providing new stability data and an additional lot number to add to the case. Names of vaccines involved: PROQUAD, (lot# M007961, expiration date 15-MAY-2017, therapy type: rHA), subjected to following temperature excursions: 2.9 Celsius, time frame: 1 hour. Reported cumulative time frame was 11 hours 24 minutes. The time frames and temperatures were double checked with the pharmacist. Albumin status for Lot# M007961 has been verified as recombinant human albumin (rHA). No adverse effects were reported by patients. No further information provided. Follow up information was received on 17-FEB-2017. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.; Sender's Comments: US-009507513-1611USA013319:
Approximately 30 hours after receiving the vaccine, I experienced Fever, Chills, and severe pain throughout my body. Pain was centralized in areas where previous pain/injuries have occurred. Right and left knees, shins, lower back/hip, right and left shoulders. Pain was extreme, I would guess 3-4X what I would typically feel on a bad day.
ONE OF 3 PTS WHO EXPERIENCED AND INJECTION SITE REACTION(I.E. ERYTHEMA,SWELLING,TENDERNESS AND HOT TO TOUCH)WITHIN 24 HRS AFTER IMMUN. UNABLE TO WALK DUE TO REACTION,TREATED WITH TYLENOL AND ICE PACKS AT SITE OF INJECTION.
Patient reported that she went to medical doctor due to rash forming on both arms and waist approximately 1 month post vaccination. Was told by MD that it looks like shingles but unsure due to bilateral nature. I concured but advised her to seek medical attention by dermatologist sooner rather than later. She returned today, 6-11-18, with rash continuing and is perfuse. She states she has burning, itching, hot to touch, etc. She state her MD said he would bet it is shingles and/or advers reaction to vaccine.
Patient received second dose of Japanese Encephalitis. Pt states less than a month later her face broke out in a severe rash attended to in the ER. The patient continue to experience a noticeable and uncomfortable rash all over her face for over a year.  Rash has not responded to treatments from 2 different Primary Care Provider and 2 dermatologists.
Has a side effect on the arm at the injection site; All around injection site is red; It itches; Is painful; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Has a side effect on the arm at the injection site), VACCINATION SITE ERYTHEMA (All around injection site is red), VACCINATION SITE PRURITUS (It itches) and VACCINATION SITE PAIN (Is painful) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053E21A, 039K20A and 029K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Has a side effect on the arm at the injection site), VACCINATION SITE ERYTHEMA (All around injection site is red), VACCINATION SITE PRURITUS (It itches) and VACCINATION SITE PAIN (Is painful). At the time of the report, VACCINATION SITE REACTION (Has a side effect on the arm at the injection site), VACCINATION SITE ERYTHEMA (All around injection site is red), VACCINATION SITE PRURITUS (It itches) and VACCINATION SITE PAIN (Is painful) outcome was unknown.            No concomitant medications were reported.  No treatment information was provided.
30AUG94 pt recvd vax that noc & pt had severe swelling, redness, vomiting, t102 per mom; mom took pt to ER same noc localized react was to lt thigh;
The patient's arm swelled up and became very red.  It was warm to the touch and the spot was from the shoulder down to the forearm region of her right arm.  The patient went to her doctor's office on Saturday (11/02/19) and was give scripts of prednisone and keflex because to them it looked more like a case of cellulitis instead of an adverse reaction to the vaccine.  The patient wasn't convinced of their diagnosis and didn't take the antibiotic.  She did take the prednisone and when counseled asked for me to report the event.   Upon speaking with the patient today at 1pm, she stated that her arm was back to normal..
Monovalent doses administered after the BUD to patients; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (no adverse event) in a 61-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients).    No concomitant medication information was reported. 77 Monovalent doses administered after the BUD to patients 12 and up. Breakdown of doses is as follows- 37 doses from Lot 059H21, 26 doses from Lot 065K21A, and 12 doses from Lot 058A22-2A No treatment medication information was reported.
the patient felt faint and had to sit down about 5 minutes after receiving the vaccine.  He was found pale, but awake and coherent but groggy.  He was able to call a ride, and get a ride home, so EMS was not activated.  He did seem better after drinking a glass of water
soreness and warmth on her arm; soreness and warmth on her arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "multiple sclerosis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), FEELING HOT (non-serious), outcome "unknown" and all described as "soreness and warmth on her arm".  Additional Information: Patient had multiple sclerosis prior to the vaccine.-Stents put in November. She enquired that would there be any particular side effects she should be concerned about with the second dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Child developed fever to 104 four days after getting HIB and Varicella vaccine followed by status epilepticus.
C/O leg pain following immun and throughout next day. Did not take Tylenol or any pain med. C/O most pain in left leg, wouldn't let mother assess leg. 2 days later vomited 9 times but no fever, no headache, no sore throat. Felt all better by Sunday morning 3/26/06.
sticky; Chapped lips; so dry; peeling; sore; red like she had lipstick on; pieces were sticking out; This spontaneous case was reported by a consumer and describes the occurrence of CHAPPED LIPS (Chapped lips), LIP DRY (so dry), SKIN EXFOLIATION (peeling), PAIN (sore) and LIP ERYTHEMA (red like she had lipstick on) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included DIAZEPAM for Anxiety, IMIPRAMINE for Depression, MESALAZINE (PENTASA) for Ulcerative colitis.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced CHAPPED LIPS (Chapped lips), LIP DRY (so dry), SKIN EXFOLIATION (peeling), PAIN (sore), LIP ERYTHEMA (red like she had lipstick on) and ORAL DISCOMFORT (pieces were sticking out). On an unknown date, the patient experienced STICKY SKIN (sticky). At the time of the report, CHAPPED LIPS (Chapped lips), LIP DRY (so dry), SKIN EXFOLIATION (peeling), PAIN (sore), LIP ERYTHEMA (red like she had lipstick on), ORAL DISCOMFORT (pieces were sticking out) and STICKY SKIN (sticky) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MODERNATX, INC.-MOD-2021-114492 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2021-114492:Case for coworker
Began with itchiness at the injection site which shortly turned into a swollen and raised injection site, hot to the touch, then it got really painful.
Pt broke out with chickenpox rash that lasted about 1 week and is now scabbing.
Patient reports medicine taste in her mouth without associated difficulty swallowing, itchiness,sob. Patient given ER precautions and told to follow-up with pcm if persistent symptoms.
Pt describes "felt blood sugar drop and muscles tighten up/tingle/shaking in my jaw, unable to move extremeties.  Was tired with a headache for the rest of the day."  Patients reports that she stayed home with spouse and monitored after the event.  Muscles contracted for a bout 2 hours before she could get up.  She did not seek medical attention and assumed it was due to blood sugar dropping.  A co-worker mentioned that she experienced the same symptoms.
had a superficial blood clot in my left calf between the first and second vaccines; This is a spontaneous report from a contactable consumer (Patient). A 51-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 01Apr2021 16:00 (Batch/Lot Number: ER8733) at the age of 51-years-old as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medication was none, patient did not received other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had a superficial blood clot in his left calf between the first and second vaccines on 16Apr2021. Event resulted in Doctor or other healthcare professional office/clinic visit. Treatment received for the event included had a shot of enoxaparin sodium (LOVENOX) and am taking rivaroxaban (XARELTO). The patient underwent lab tests and procedures which included blood test: negative on 06May2021, Nasal swab covid-19 test: negative on 27Apr2021. The outcome of the event was not recovered.
Fever/temperature about 101 degrees; Sweating; chills; This is a spontaneous report from a contactable consumer (patient). A 70-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL3247) on 14Jan2021 at single dose in Left Upper Arm for COVID-19 immunisation.  Medical history was none. There were no concomitant medications. She had vaccine on Thursday 14Jan2021 and last night or probably Saturday into Sunday she experienced the chills and fever. She was fine now, but all day on 17Jan2021 she experienced a fever of a temperature about 101 degrees, she was now back to normal. She had chills and sweating. She took Tylenol. She had her first dose on 14Jan2021. Then the symptoms started either late Saturday on the 16Jan2021 or going into Sunday on 17Jan2021. All she knows was Sunday was when she woke up with the chills and the fever. She was sweating, which started after taking the Tylenol. She took the Tylenol Sunday morning. She stated that no symptoms are ongoing at the moment. She felt good right now, there are No symptoms at the moment. She has had No positive Test for Covid before the vaccine. She had a negative Antibody Test, but it was About a good 6 months ago in 2020. She has had No issues with vaccines in the past. The outcome was recovering.
Information has been received from a lawyer regarding a case in litigation concerning an approximately 78 year old female patient. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 08-AUG-2011, the patient was administered the ZOSTAVAX by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On an unknown date in 2015, the patient was treated by a healthcare provider for the following injury resulting from her ZOSTAVAX use: Shingles. The patient claims damages including: injury to herself and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
Patient complained of prolong adverse reactions including: Malaise, body aches, not feeling well. The symptoms would come and go over a period from time of vaccine 3/18/21 until 3/29/21.
immed p/vax pt became pale, circumoral cyanosis & limp almost non responsive;