chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a other health professional via sales rep and described the occurrence of injection site swelling in a patient who received FLUARIX QUADRIVALENT. Previously administered products included Flu vaccine with an associated reaction of adverse reaction (for tolerance refer case US2016GSK169625). On an unknown date, the patient received FLUARIX QUADRIVALENT at an unknown dose. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT, the patient experienced injection site swelling, injection site warmth and injection site erythema. On an unknown date, the outcome of the injection site swelling, injection site warmth and injection site erythema were unknown. The reporter considered the injection site swelling, injection site warmth and injection site erythema to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient's age at vaccination was not provided. The reporter had limited details regarding vaccination. This was the 4th case of 6 cases reported by the same reporter. This case was linked with US2016GSK169625, for same patient.
bruising on legs, arms, breasts, feet, hands; petechiae all over body; thrombocytopenia-dx;
First 24 hours (Fri - Sat): extreme fatigue; full body pain/aching; tenderness at shot area on arm; low grade fever off and on over 24 hours; swollen lymph nodes/glands under right arm and both sides of neck. Second 24 hours (Sat - Sun): extreme fatigue; full body pain/aching; tenderness at shot area on arm; swollen lymph nodes/glands under right arm and both sides of neck.
Nausea, dizziness, vomiting, headache, fatigue, chills, shaky. This lasted about 24 hours.
Shortness of breath.; pain in left shoulder/arm/breast; pain in left shoulder/arm/breast; pain in left shoulder/arm/breast; This is a spontaneous report from a contactable consumer (patient). This 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 25Feb2021 14:30 (Lot Number: EN6200) as single dose (at 82 years old) for COVID-19 immunisation.  Medical history included complex regional pain syndrome, scoliosis, primary biliary cholangitis, hypersensitivity. On 26Feb2021 00:30, the patient experienced shortness of breath, pain in left shoulder/arm/breast with outcome of not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
sweaty and chills about 3am after vaccine then for the next 48-72 hours sneezing, runny nose, very fatigued - almost flu like symptoms
Covid/ BA.5 started with sore throat and really tired, to worse the second day and called the dr on call who ordered a PCR test. Next day checked my medical portal and saw it was positive .  I called back and an order for Paxlovid was called into the Pharmacy.
Redness and swelling of left upper arm at site of injections. Some blistering 2-3 days post vaccination.
Body aches; Slight stomach pain; Sweats; Excruciating headache; Fever 101.7; Chills; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 31Mar2021 at 10:45 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient had no known allergies to medications, food or other products. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 12:00, the patient experienced body aches, slight stomach pain, sweats, excruciating headache, fever, chills. On 31Mar2021, the patient underwent lab tests and procedures, which included body temperature which was 101.7. It was reported that the events had not resulted in doctor/other health care professional office/clinic visit and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of body aches, slight stomach pain, sweats, excruciating headache, fever, chills was not recovered at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Left thigh 2cm x 2cm induration, 7cm x 7cm redness with slightly increased warmth, can move left lower extremity with problems - no other discoloration. No numbness and significant tenderness. No history of trauma. She had no problems with Varicella for vaccine.
Sore Arm, Headaches, Dizziness, Bloody Nose (12), Fatigue
Received MMR vaccine on 7/23/07.  DN 7/29/07 woke up at 6 PM with high temperature, hot diaphoretic clinov.  No walk, no appetite, no drinking.  Gave Tylenol.  Doctor's appointment 7/31/07, low fever, negative strep.  8/2/07 roseola rash, no doctor's appointment to diagnose.  8/3/07 better.  29th to the 2nd clingy, quiet, no appetite, no drinking and no energy.
3:30am woke up feeling nauseous, within seconds of standing up lost vision and balance, ran to the bathroom and fell. Woke up in a different spot with a bit of black eye from falling. Woke up and felt very out of it and not sure of things. Drank a lot of water but a few hours later, got up and felt nauseous again like I was going to pass out again. Fever of 101.8 F. Lots of body aches and chills. Sweating like no other.
Dr advised the parents the patient received a vaccine approved as a combo vaccine for 4-6 yrs of age. Pt tolerated the vaccine with no adverse affects post event. Dr gave the parents all the current information and documentation showing vaccine was same as if given separately.
Unexpected therapeutic outcome; A spontaneous report was received from a consumer concerning a 81 year old , female patient .  The patient's medical history included backache in her kidneys for 2 weeks.  Products known to have been used by the patient, within two weeks prior to the event, included medications for Thyroid and water pills to make you urinate.     The patient received her planned dose of mRNA-1273 (Batch number:unknown) on 02-feb-2021 intramuscularly for prophylaxis of COVID-19 infection. .She also reported that her back pain in kidney went away after the administration of covid-19 vaccine.     The outcome of the event(s) was reported as resolved.
Arm was sore (1st dose); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore (1st dose)) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced PAIN IN EXTREMITY (Arm was sore (1st dose)). At the time of the report, PAIN IN EXTREMITY (Arm was sore (1st dose)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  Treatment medications were not provided.   This case was linked to MOD-2021-029199.
Received FLUZONE HD afternoon of 9/2. Evening 9/2 fever, diarrhea, vomiting. Became dehydrated. Patient taken to hospital treated and released.
developed the sensation of eyelid swelling, throat tightness and lateral tongue swelling within an hour of the vaccine.
Upon receiving vaccinations, patient became dizzy and lightheaded. Lasted approximately 5 minutes.  Treated with juice, and rest Outcome: patient recovered without incident
Severe chills began at 2:00am about 12 hours after injection. Lasted for about 6 hours. Severe muscle aching lasting about 12 hours began at 2 am as well. The main issues and reactions which as of the posting of this report are still very much active are: Feeling of a "pit in my stomach" which was present for about 24 hours after the FIRST injection (1/28/2018) after the second injection returned at about 2 am and continues to this day. An odd rash appeared on 04/07/2018 in two places: on my right forearm and my right calf. Raised and red and itchy. They are still present at this reporting. The itchiness tends to travel down the forearm to the hand and all up and down the right calf. When heated while exercising a red flushing appears on my forearm and travels down to my right hand. In fact there has been an overall worsening of generalized urticaria.
Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 11-Apr-2022; Expired vaccine administered to 155 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 11-Apr-2022) in a 77-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 11-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 11-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 11-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.  Vaccine expiration date was 01-April-2022. On 04-April-2022 vial was initially stored in refrigerator. The vial did not undergo any temperature excursion.  Treatment details was not reported.
On the morning of Saturday, August 14, 2021, I lost my sense of taste and smell, was tired and had a headache.  I went to the walk-in clinic and saw a Dr, who believed I probably had COVID-19.  He called later that afternoon with a negative CPT test result but prescribed azithromycin anyway which I took for 10 days as directed.  He also told me to get a follow-up test.  My symptoms gradually went away and were gone by Friday, August 20.
trouble breathing; severe body aches; fevers and chills; extreme fatigue; headaches; passed out/ when trying to return to bed, passed out a second time; This is a spontaneous report from a non-contactable physician.  A 52-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 07:30 at a single dose for COVID-19 immunization at the workplace clinic. The patient's medical history was not reported. Patient has no known allergies. Concomitant medication included venlafaxine hydrochloride (EFFEXOR). Patient previously had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date. On 15Jan2021 04:00, patient had severe body aches, followed very quickly by fevers and chills. At 4:45am started to have trouble breathing. Patient was concerned about respiratory symptoms, and woke his spouse, then stood up to try and breathe better, took a couple steps, and passed out. When the patient woke, when trying to return to bed, passed out a second time. Over the next few hours respiratory symptoms improved. Remainder of day characterized by extreme fatigue, body aches and headaches. Patient had an unspecified over the counter anti-inflammatory medication. The patient has a negative COVID 19 test via a nasal swab on an unknown date. Patient was recovering from the events.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported passed out and the administration of the COVID 19 vaccine, BNT162B2, based on the reasonable temporal association.   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 RA, IEC, as appropriate.
Presented to the ER approximately 14 days after vaccination with chest pain consistent with myopericarditis. 02/28/07-records received from facility for DOS 12/13-2/21/07. DX: acute myopericarditis. adverse effect of drug therapy vaccines small pox. Ventricular septal defect.
A few minutes after receiving the vaccine, patient reported 1/10 chest pressure to left chest, to left shoulder, improving after 15 minutes.  No nausea, light headedness.  Non-smoker, no HTN or DM.
Lips/face tingly and numb within a hour. Extreme fatigue for 2 days. Baseball size lump in arm for 1 week. Reduced to half, hive/rash/pain/itch on injection arm nearly 3 weeks later, despite otc allergy medicine.  Day 4 included throat squeezing sensation.
I had abdominal pain for a few weeks (that happens to me with all vaccines, celiac disease related), then memory loss and amnesia episodes that had me visit my primary doctor and then referred to a neurologist for testing.  I had brain, cervical and thoracic MRI's, and  an EEG, resulting in the diagnosis of Non convulsive seizures that I never had prior to vaccine.  I now take anti-convulsive medication.
Nausea that started around 3:15am that led to vomiting. It came in waves about ever 15-20 minutes until 6am.
pt recvd 4 doses of Engerix-B; Anti-HBSAG titer drawn 10 months p/1st dose & 1 yr p/4th dose were neg;
Information has been received from a physician concerning a 13 year old female patient who on an unspecified date was vaccinated with a dose of GARDASIL. Subsequently, the patient developed headache and fever. Her outcome was not reported. Additional information has been requested. This is a consolidation of two reports concerning the same patient. WAES# 0610USA01349 was previously submitted on 13-Oct-2006.
SYNCOPE  +LOC, -FALLS, +NAUSEA, +DIZZINESS  ALL SYMPTOMS RESOLVED W/I 10 MINS OF SYNCOPE
The first round of the vaccine she only had a super mild sore arm and a slight headache.; The first round of the vaccine she only had a super mild sore arm and a slight headache.; sore; This is a spontaneous report from a contactable nurse. A 38-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL1284, expiry date: 30Apr2021), intramuscularly on 28Dec2020 at SINGLE DOSE at left deltoid for covid-19 immunisation. Medical history included ongoing pernicious anaemia, a b12 deficiency. She gives herself B12 shots. She was diagnosed 2-3 years ago. She also had a Myomectomy, 15 cm uterine fibroid , removed this past summer. Concomitant medication included ongoing cyanocobalamin (B12 [CYANOCOBALAMIN]) for pernicious anemia. The first round of the vaccine she only had a super mild sore arm and a slight headache. She was a little suspicious because of the headache after the first one. She hasn't been around anyone in a couple of weeks. She has been working from home. She has not been exposed to people. She keeps feeling like she needs to stretch because she is sore. The patient underwent lab tests and procedures which included COVID 19 test on an unspecified date: negative, COVID-19 antibody test on an Unspecified date, Result: negative. The outcome of the events was unknown.
Nausea, itching, arm, torso & leg rash (Fri AM) 11-19-10 (Sat Noon 11-20-10 thru Sunday 11-21-10) - ER visit 11-21-10 for Prednisone, BENADRYL, ZANTAC.
Throat became sore, nasal congestion, eyes felt like there was serious sand/debris in them a then quickly became goopy, chest tightened with the constant need to clear my lungs, then the onset of the cough to try and clear my lungs. Ar about 4:30 AM I felt exhausted, worn out; however, I felt significantly better.
Patient called the pharmacy on 10/25/19 and said she had a reaction to the vaccine. Her arm was warm and swollen around the injection site. The redness was about 4 inches surrounding the site of injection.
I got my first shot, and then I had extreme trouble breathing/chest discomfort/pain where I could not walk for longer than three minutes and could not partake in any sort of physical activity without those pains and trouble for a whole month, I went to the emergency room and they took a photo of my heart, did an xray, blood tests, but they could not find exactly what was happening to me, i luckily recovered in a month (atleast to not feel as terrible as before), they also gave me a ton of painkillers
Hip surgery; Numbness in hand;   This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program.  A 73 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Aug2021 (Batch/Lot number: unknown) at the age of 72 years as dose1, single for covid-19 immunisation. Relevant medical history included: "MODERATE TO SEVERE RHEUMATOID ARTHRITIS" (ongoing). Concomitant medication(s) included: HUMIRA taken for rheumatoid arthritis. The following information was reported: HIP SURGERY (medically significant), outcome "recovered", described as "Hip surgery"; HYPOAESTHESIA (non-serious) with onset Aug2021, outcome "recovered" (2021), described as "Numbness in hand".  Clinical course: The patient had a hip surgery which was successful. The vaccine caused her hand to lose feeling for about two to three months. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Company's opinion is that there is no reasonable possibility that the events of hip surgery and vaccine caused Hand to lose feeling are related to Humira (adalimumab).  The reporter considered "hip surgery" and "numbness in hand" related to bnt162b2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on a positive temporal relationship, causal relationship between the reported events the suspect BNT162B2 cannot be excluded.
Severe camping and bloating leading to menstruation.; Very heavy bloating; Severe camping and bloating leading to menstruation. First period since December 2019 with very heavy bloating and severe cramping.; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 24Apr2021 at 18:00 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, Ehlers danlos syndrome and allergy to pecans. The patient did not receive any medication within four weeks of vaccination. Concomitant medications included albuterol sulfate (MANUFACTURER UNKNOWN) from unknown date for an unknown indication and ethinylestradiol; norethisterone acetate (JUNEL) for birth control from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received clindamycin (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 22Mar2021 at 18:00 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. On 26Apr2021 at 00:00, the patient experienced severe cramping and bloating leading to menstruation. First period since Dec2019 with very heavy bloating and severe cramping. The patient have not experienced cramping or bloating related to menstruation since 2011. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe cramping and bloating leading to menstruation was not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Erythematous, itchy rash over deltoid and spread to distal arm.  Improved overnight with Benadryl and Triamcinolone.                                                                        Anthrax
Began 29MAY w/elevated temp; 30MAY & 31MAY t101.6 & above; 01JUN afebrile; 4JUN had sz (extremity upper) & facial twitching x 1 1/2min @ 810AM; gave CPR as pt lips cyanotic & apneic spell;
I started to get muscle twitching in my left arm, it moved to my breast bone and around to the upper portion of my rib cage. I also experienced quite a bit of deep muscle pain around the injection site and extreme tiredness. I spoke to my doctor and he prescribed cyclobenzaprine for the twitching
Mild pain at injection site for 1 1/2 days; This spontaneous case was reported by a health care professional and describes the occurrence of INJECTION SITE PAIN (Mild pain at injection site for 1 1/2 days) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced INJECTION SITE PAIN (Mild pain at injection site for 1 1/2 days). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INJECTION SITE PAIN (Mild pain at injection site for 1 1/2 days) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.     This case was linked to US-MODERNATX, INC.-MOD-2021-064258 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-064258:2nd dose case
Patient received vaccine and was impatient to get to front of store to shop for puzzle books.  Approximately 15 minutes, as she was leaving the store, she got dizzy and fell. Her companion said she was having a seizure. EMS was called and responded approximately 5 minutes later and checked blood sugar and pulse ox-reported normal. Patient said she no longer felt dizzy and did not want to be transported.
On day 2 there was soreness. The soreness returned on day 7, approx 2-3 inches around the injection site is hard to the touch, warm, and there is some redness.  The soreness was first noticed when I woke up and had continued and gotten worse through the day.