chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received 1st shot on 2/26/21 and on April  18 I became aware of a few small, flesh colored bumps on my forearms, about 1/8" in diameter, didn't think too much of it.  Moving forward from that day , the bumps slowly became red, some of them turned into white heads, no itch to a few being mildly itchy.  They came and went and still I just didn't think too much of them.  On April 23, 2021 I recieved 2nd shot and I had zero typical side effects, I felt completely normal.  By evening of 4/25/21 I had small, almost sand paper like, flesh colored bumps on my forehead, temples, neck, shoulders, etc.  From that day until today, 4/29/21 the rash got worse, all bumps are red, mildly itchy, white heads come and go,  I have them along and in hairline, forehead, temples, sides and back of neck, entire back, upper arms many, a few on forearms, my chest, a few on belly and not a single one below my waist.  I'm very intune with my body and I am 100% sure this is a side effect of the vaccine and not anything I eat, drink or put on my body because nothing in these categories has changed in my life during this time.  I have examined it for weeks.
developed severe body aches and joint aches. Pt describes not being able to get out of bed. Site was swollen and hard. Body hot to touch. Pt took tylenol. Did not see a doctor. Pt states today is the first day she has been feeling better, but still having flank discomfort.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 37 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Mast Cell Activation Syndrome" (unspecified if ongoing); "Chronic Lyme Disease" (unspecified if ongoing), notes: Chronic Lyme Disease; "Known allergies: Pennicilin" (unspecified if ongoing), notes: Known allergies: Pennicilin; "Known allergies: Dairy" (unspecified if ongoing), notes: Known allergies: Dairy. The patient's concomitant medications were not reported. Past drug history included: Lanolin, reaction(s): "Allergy_Lanolin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Antiviral COVID-19 Treatment Paxlovid from 12Jan2023 to 17Jan2023  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received first Pfizer Covid vaccine at 3PM on 8/11/2021. About 5 minutes post vaccination, patient felt faint while seated in the waiting area and loss consciousness for a few seconds and body was cold. Loss control of body movements for few seconds. Felt better while waiting for emergency services. patient was transported to hospital for further evaluation. Patient was released from hospital and came home around 7PM.
ECG confirmed septal infarct, age undetermined.; This is a spontaneous report from a non-contactable consumer (patient). A 19-year-old non-pregnant female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration, administered in left arm on an unspecified date of 2021 at 13:00 hours as dose 2, single (at the age of 19-years-old) for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 09Apr2021 at 13:15 as dose 1, single (at the age of 19-years-old) for COVID-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior to vaccination and had not been tested for COVID-19, since the vaccination. On 07Jun2021, at 09:00 hours, electrocardiogram (ECG) confirmed septal infarct, age undetermined. Cardiologist running a series of new tests. Patient had doctor or other healthcare professional office/clinic and emergency room/department or urgent care visit for the event. The event was reported as non-serious by the reporter. Patient received no treatment for the event. The outcome of the event was not recovered.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained. No further information is expected.
a little bit of a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a little bit of a sore arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A)) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (a little bit of a sore arm). At the time of the report, PAIN IN EXTREMITY (a little bit of a sore arm) outcome was unknown. Not Provided          Concomitant medication not provided.   Treatment medication not provided  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD21-071658 (E2B Linked Report).; Sender's Comments:  MOD21-071658:2nd dose of vaccine-MOD-2021-071436
It started with a really bad sore throat and a bad cough. I had also had fatigue. I completed a COVID-19 home test on January 12, 2023. I treated my symptoms with NYQUIL, MOTRIN, MUCINEX, saltwater gargles. It took about 2 weeks before I felt better and then I relapsed 5 days later because I developed a real bad cough this time. They gave me a Z-PAK and my doctor gave me steroids and TESSALON PEARLS. It took a week to feel better and it in total of 2 weeks.
approx 3 hr p/vax pt was febrile to 103 & unresponsive; unresponsive period lasted 60-90mins; BP, 02 saturation & glucose documented, all nl; pt slept 19 hr the following day;
This case was reported by a nurse via sales rep and described the occurrence of injection site warmth in a adult female patient who received FLULAVAL QUADRIVALENT (batch number Y7X9Z, expiry date 30th April 2017). In September 2016, the patient received FLULAVAL QUADRIVALENT. In September 2016, 1 day after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site warmth, injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site warmth, injection site erythema and injection site swelling were recovered/resolved. It was unknown if the reporter considered the injection site warmth, injection site erythema and injection site swelling to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced warm, raised and red area around the injection site. The area was noted to be approximately 2 to 3 inches in diameter. In about 2 days all events were resolved without further medical attention. The health care professional stated that no other vaccines were administered on the same day. The reporter lot number (Y7X92) for FLULAVAL QUADRIVALENT season did not exist and was updated to Y7X9Z, according to sales database. No further information was provided. This case was one of the 4 cases, reported by the same reporter.
Shooting pain and weakness in legs bilaterally, tingling around mouth, right knee is swollen and painful/stiff in the joint, Generalized muslce and joint pain/aching, headache, lightheadedness, nausea, vomit x 1, temp of 99.9, Low BP 88/60
We received the following literature report on 15 JUN 2009: 15 children between 6 and 59 months of age were vaccinated for the first time with an influenza vaccine (batch no. and manufacturer unknown) at the start of each influenza season (defined from 01 NOV to 30 APR) from 1999-2000 through 2006/2007. The children received a total of two doses (fully vaccinated). Vaccine effectiveness among fully vaccinated children as compared with unvaccinated children was 86% (95% confidence interval: 29-97%) for medically attended, laboratory-confirmed influenza illness. Vaccine effectiveness for the partially vaccinated group was 73% (95% confidence interval: 3-93%) as compared with the unvaccinated group. This case refers to one child (for other children, please refer to reference cases MA2009-1692, MA2009-1708 to MA2009-1710, MA2009-1712 to MA2009-1719 and MA2009-1721 to MA2009-1722). Laboratory-confirmed influenza illness was reported (date?). Request was sent on 22 JUN 2009, no follow-up information received.
DTaP, IPV, HIB, Hepatitis B given on 9/17/02. Infant cried unconsolably for 4 hours 3PM to 7PM on 9/17/02. Acetaminophen was administered by mom but did not alter screaming/crying behavior.
Significant local reaciton. ? Cellulitis vs. panniculitis and fever. Reaction measured 2 x 1 cm. Localized on right thigh. Antibiotics given with eventual resolution.
At 53 hours after injection experienced piercing headache throughout different parts of  head, face and neck accompanied by nausea though no vomiting or fever.  Tylenol did not touch it.  Slept on and off.  Lasted 24 hours and then disappeared.
Pt died; Meningococcal meningitis; Culture proven Neissera;
Onset of symptoms 12-24h after vaccination of fever 102 degrees F, chills, rigors - swelling, erythema, pruritus at vaccination site progressively worsening - emergency room visit - treated with antibiotic.
flu- feverish for 3 days; bed ridden, severe head & body aches; lethargy- lack of energy
Case number PHEH2012US010530 is an initial spontaneous report received from a nurse on 18 May 2012. This report refers to a male patient whose age, medical history, past drugs, current conditions and concomitant medications were not reported. It was reported that on 18 May 2012 he was vaccinated only with MenA lyophilized conjugate component of MENVEO (batch number: M11071) reconstituted with a sterile diluent; intramuscularly on to unspecified site and did not received the MenCYW-135 liquid conjugate vaccine component. No adverse reaction was reported following the maladministration.
weakness; Headache; metallic taste in her mouth; This is a spontaneous report from a contactable consumer (patient) via Pfizer Sales Representative.  A female patient of an unspecified age received second dose of bnt162b2 (BNT162B2), lot number not reported, via an unspecified route of administration from an unspecified date as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced headache, metallic taste in her mouth, weakness after 2nd dose of vaccine. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Mom states child had behavioral changes after vaccines. She states child cried, very unreasonable and argumentative for 2 hours. After 2 hours the child fell asleep and when woke was fine and acted normal. Both injection sites were painful x 48hrs.
This consumer report (initial receipt 24-Feb-2014) concerns a female patient. On an unspecified date, the patient received an unspecified flu vaccine (manufacturer and batch number not reported). On an unspecified date, the patient developed a reaction which included getting the flu after vaccination. Outcome was not reported.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 04-JUN-2017, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB intramuscularly in the right upper leg (lot number and expiration date were not provided) for prophylaxis. There was no adverse effect reported. Administered dose of RECOMBIVAX HB experienced the temperature excursion of 55 degrees Fahrenheit for 3 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1706USA002776: US-009507513-1706USA006114:
INJECTION SITE HARD; INJECTION SITE ITCHY; red around the injection site; INJECTION SITE SWOLLEN; swollen arm; Inflammed arm; itchy arm; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Inflammed arm), PRURITUS (itchy arm), VACCINATION SITE NODULE (INJECTION SITE HARD), PERIPHERAL SWELLING (swollen arm) and VACCINATION SITE PRURITUS (INJECTION SITE ITCHY) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergic reaction to antibiotics (Quinilones) and Drug allergy (sulfa). Concomitant products included ATORVASTATIN for High cholesterol.   On 24-Jan-2021 at 2:20 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jan-2021, the patient experienced INFLAMMATION (Inflammed arm). 25-Jan-2021, the patient experienced PRURITUS (itchy arm) and PERIPHERAL SWELLING (swollen arm). On 27-Jan-2021, the patient experienced VACCINATION SITE NODULE (INJECTION SITE HARD), VACCINATION SITE PRURITUS (INJECTION SITE ITCHY), VACCINATION SITE ERYTHEMA (red around the injection site) and VACCINATION SITE SWELLING (INJECTION SITE SWOLLEN). On 02-Mar-2021, INFLAMMATION (Inflammed arm), PERIPHERAL SWELLING (swollen arm) and VACCINATION SITE SWELLING (INJECTION SITE SWOLLEN) had resolved. At the time of the report, PRURITUS (itchy arm) had resolved and VACCINATION SITE NODULE (INJECTION SITE HARD), VACCINATION SITE PRURITUS (INJECTION SITE ITCHY) and VACCINATION SITE ERYTHEMA (red around the injection site) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not reported.   This case was linked to MOD-2021-240838 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow up received 29-jun-2021: Patient demographic information updated.Second dose information updated, reporter demographic information updated, allergies, concomitant medications updated.events recovered and event dates updated.
Vaccine on fri 1pm. Sat had 102 fever, headache. Sun 7pm had possible heart attack symptoms? pain in jaw and from throat to sternum. It went away  after giving aspirin so I did not call 911. Monday night  10:30 pm SEVERE headache and severe nausea . Pain on top of head. She said it was unlike any headache in her life. After asprin and tylenol  it subsided but she was up for hours with the pain. NOT NORMAL!
Polyarthralgias-symptoms increased 4 days after Anthrax #3. Anthrax 3 given on 3/30/03 in left arm. A report was filed on this pt in August 2003 for polyarthralgias and chronic urticaria. Two separate reports were filed by the vaccine healthcare center. The pt continues to experience multiple symptoms and has had an extensive evaluation. He was exempt from receipt of further anthrax vaccines. Enclosed is the clinical summary update covering pt symptoms and evaluation through Sept 2004. Pt has been off steroids since early June and off all medications since late July. He reports a few isolated incidents of 1-10 red, non-raised, mildly pruritic lesions since then; most lesions have been on upper extremities. No recent episodes of angioedema involving eyes, lips or throat, but has had episodes involving hives on his hands with associated myalgias/arthralgias in fingers. Joint pain is primarily affecting fingers, but also affects feet after prolonged weight-bearing and knees after increased bending and weightbearing. Mood changes may be improving since off Prednisone, but still not back to his usual self. Headaches are less frequent since all medications discontinued; has taken Tylenol 1-2 times for headaches over last 2 months. Family has voiced concerns regarding changes in personality over the past 15 months-moody, withdrawn; some improvement noted since off Prednisone.
Large localized reaction, HOT, baseball sized welt and rock hard swelling.  Within a few hours started vomiting. Mild vomiting for no more than a few hours.  Severe injection site swelling and itching continued for 5 days with itching continuing into day 6.
Pt's temperature was 103F and was not acting normal. He had vesicular-type lesions over face and extremities. (Rash onset 9/5/01) (temperature onset 9/6/01).
breast cancer; Retracted nipple; breast lump; This spontaneous case was reported by a consumer and describes the occurrence of BREAST CANCER (breast cancer) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BREAST CANCER (breast cancer) (seriousness criterion medically significant), RETRACTED NIPPLE (Retracted nipple) and BREAST MASS (breast lump). At the time of the report, BREAST CANCER (breast cancer), RETRACTED NIPPLE (Retracted nipple) and BREAST MASS (breast lump) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Mammogram: suspicion of malignancy (abnormal) Suspicion of malignancy. On an unknown date, Ultrasound breast: abnormal (abnormal) 95% likelihood of breast cancer.         Concomitant products were not provided. Treatment medication were not reported.  After vaccine the patient developed retracted nipple.   Later patient developed a small lump and went for an immediate mammography and its results stated suspicion of malignancy, ultrasound results shown 5 on scale indicating 95% likelihood of breast cancer. Doctor confirmed it as breast cancer and mentioned they need biopsy to go for the treatment option. Also stated that patient developed this mass after 4 months of vaccination.  Company Comment :  Very limited information regarding these events has been provided at this time. Additional information required.; Sender's Comments: Very limited information regarding these events has been provided at this time. Additional information required.
General malaise from day 2 through 4.  Severe sore throat day 5 through 7.  Sinus congestion  day 7 through 10. Treatment: Tylenol. No fever. No reaction at injection sight.
Patient reported to me via phone that her arm had a red rash spread over her arm. It was warm to the touch. She went to the ER and the ER gave her "a medication by mouth" but patient does not know what it was and they have prescribed her steroids, which she hasn't picked up from the pharmacy.
This spontaneous report was received from the mother of a female patient of unknown age. On an unknown date, the patient was vaccinated with dose 1 of GARDASIL (lot #, expiry not reported). On an unknown date, the patient received her second dose of GARDASIL (lot #, expiry not reported) 1 year after the first dose and would receive her third dose 4 months following the second dose. Additional information has been requested.
Initial phone voicemail contact on 10/14/13 at 4:18pm: Patient called stating her arm is sore due to a Tdap she received 10/11/13.  Nurse left message for patient to return call. On 10/15/13 patient "Returned call regarding arm pain from Tdap.  States she cannot use her arm at all.  OTC pain relievers offer no relief.  Transferred to scheduling for office visit. Office visit on 10/16/13 notes by provider:  Notes pain in right upper arm after Tdap 10-11-13, denies erythema, edema, numbness,  or weakness.  No fever or chills.  No SOB, throat tightness.  Has used Motrin X1 with minor relief. To use warm washcloth to right upper arm 15 min 5 X a day for 4 days.  Can take ibuprofen 200 mg tabs, 3 at a time 3X a day with food.  Do range of motion exercises with right arm 3X a day. On 10/31/13  I called patient and she said plan of care helped.  Arm completely back to normal on the 22nd.  It started about 5pm that afternoon of the shot and next day couldn't use her arm.
This spontaneous report was received from a physician via a company representative, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 18-SEP-2015, the patient was vaccinated with an improperly stored dose of inactivated VAQTA, "10pk 25U/0.5ml SD LLok wCap Ped" which had a lot number of L013324 and expiration date 24-APR-2017 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. No product quality complaint was involved. On an unspecified date, the inactivated VAQTA vaccine had one temperature excursion of 24 hours. The lowest recorded temperature was 33 F (0.555555556 Celsius) and the highest recorded temperature was not mentioned. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R). This is one of several cases received from the same source. Additional information has been requested.
possibly administered that adult vaccine to an 8 year old patient/administration of the Pfizer Covid19 vaccine grey cap to an 8 year old patient; The initial case was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on 12Jul2022, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team, Program ID: (159558).  An 8-year-old patient received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OVERDOSE (non-serious), outcome "unknown", described as "possibly administered that adult vaccine to an 8 year old patient/administration of the Pfizer Covid19 vaccine grey cap to an 8 year old patient".  Additional information: The caller called about the Pfizer Covid19 vaccine grey cap and a nurse possibly administered that adult vaccine to an 8 year old patient; caller clarified that he did not have patient information or date of birth.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Woke up on day 8 after getting vaccine with large warm lump on left arm all around the injection site  Warm to touch, red and looks irritated
lymph node swelling above right collarbone. started about 5 days after vaccination in right arm