chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Woke up, felt tired even after 8+ hours of sleep, and body ached all over.  I normally have a good appetite in the morning, but was not feeling hungry and slightly nauseous.  I ate 2 scrambled eggs, 1 piece of toast and some weak coffee. Despite feeling a general malaise with body aches and some lethargy, I went for a 2 mile run at a slow pace at 10:30 AM.  Upon stopping from the run at 11:00 AM, I felt weak and my muscles and joints were in pain.  At 12:00 PM I had to lay down, took my temperature and had a fever of 101.3.  I felt like I might vomit at any minute, but did not.  I slept until 1:30 PM at which time my temperature was now 102.8.  I took 200 mg of Advil at this time.  The fever went down to 101.  I drank a lot of water, had some orange juice, fruit, and carrots and 5.5 oz of yogurt.  I felt a bit better until about 5pm at which time my fever returned, the body aches and lethargy returned, and I took more Advil (400mg).  At 11:15 PM I am feeling slightly better.  I did not have a cold or any signs of ill health prior to the TDap vaccination.
Headache; Fatigue; Chills; Fever; ache moving down through neck,; Joint pain; Weakness in knees, ankles, arms; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 21Apr2021 at 11:45 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history included Barrett's esophagus and food allergies (Zucchini and seafood/fish). The patient did not receive any concomitant medication within two weeks of vaccination. 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 took BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 31Mar2021 at 10:45 as a single dose for COVID-19 immunisation. On 21Apr2021, the patient had sudden onset of headache and fatigue after approximately 10 hours sudden onset of chills approximately 11 hours. Fever and constant shivering and ache moving down through neck, shoulders, and lower back after approximately 12.5 hours. Joint pain and weakness in knees, ankles, arms after approximately 13 hours. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events headache, chills, fatigue, neck pain, shoulders pain, lower back pain, joint pain and  weakness in knees, ankles, arms was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
"Saw PCP Monday and he (a) started metformin and (b) ordered TDAP and Pneumovax. The Pneumovax swelled up spectacularly and patient had chills;  awoke him from sleep.  In the AM he awoke with significant lightheadedness and a feeling of fullness in his head; this lasted most of the day, this AM he is better with only on-and-off fullness.  + HA, mild.  Chronic conditions are CHF with low EF, prior cardioembolic CVA, DM, HTN.  NO LOC, no weakness or numbness, no chest pain."
RED BLOTCHES (FIRST ON ARM AND THEN  SPREAD TO THE BODY); This spontaneous report received from a pharmacist concerned a female of unspecified age. The patient's height, and weight were not reported.  No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number:Unknown ,expiry: unknown) dose, start therapy date were not reported for prophylactic vaccination.  The batch number was not reported and has been requested.  No concomitant medications were reported.  On an unspecified date, the subject experienced red blotches (first on arm and then spread to the body). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of red blotches (first on arm and then spread to the body) was not reported. This report was non-serious. This case, from the same reporter is linked to 20210730843.
This spontaneous report was received from a nurse and refers to a 13-year-old male patient. No information regarding the patient's concurrent condition, medical history, concomitant medications and drug reactions or allergies was provided. On 28-AUG-2017, the patient was vaccinated with the 1st dose of GARDASIL 9 (dose, lot number and expiration date were not provided) intramuscularly for prophylaxis. On 27-MAR-2019, the patient was vaccinated with the 2nd dose of GARDASIL 9 (dose not provided) lot number R009614, expiration date 30-NOV-2020, intramuscularly for prophylaxis.  No adverse effect reported.
Have severe eye pain that have persisted for 2 years.  Have developed many styes and infections in both eyes as after Moderna vaccine.  Constantly battle what appear to be dry eyes at night but it feels like pepper in my eyes and something is crawling in my eyes and nose. Artificial tear drops, nighttime gels, and antibiotic are only temporary solutions. I have changed sheets, mattress, pillows, detergent and worn masks to bed but the pain continues mostly at night. Eyes are red, lids are puffy, blurred vision, sensitive to light, eyelashes have fallen out, I have seen two Ophthalmologists and an eye surgeon (eye infections).  The pain is persistent and severe was occurring at night but now it is starting to occur in the daytime. Nothing is working. (No cataracts or glaucoma) and its affecting both eyes.
(LD) reaction 20 inches width x 14 1/2 inches length. Red pt seen by provider. Instructed pt to put ice packs and take BENADRYL. If not better to come back.
Paralysis of facial muscle.  Tongue does not function properly causing me difficulty speaking. Lips do not close properly, loss of upper and lower lip strength, no longer able to whistle or blow balloons as well as purse my lips.  Tongue  and cheek have continuous muscle spasms. bruising on lower lip since April.  All symptoms continue to get worse as time goes on.
Injection site was red, warm/hot, slightly itchy.; Injection site was red, warm/hot, slightly itchy.; Injection site was red, warm/hot, slightly itchy.; Patient received dose 4: Moderna; dose 5: BNT162B2, BNT162B2 OMI BA.4-5; Patient received dose 4: Moderna; dose 5: BNT162B2, BNT162B2 OMI BA.4-5; CSL vaccine given on same day as Bivalent vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Nov2022 at 19:45 as dose 5 (booster), single (Lot number: GJ2524) at the age of 55 years, in right arm for covid-19 immunisation; influenza vaccine (CSL), on 03Nov2022 as dose 1, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. Concomitant medication(s) included: DIFLUCAN; XYZAL; PEPCID [FAMOTIDINE]. Past drug history included: Demerol, reaction(s): "Known allergies: demerol". Vaccination history included: moderna (DOSE 4 (BOOSTER), SINGLE, Lot number: 001M21A, Anatomical location: Arm Right), administration date: 16Apr2022, when the patient was 54-year-old, for Covid-19 Immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Lot number: FF2587, Anatomical location: Arm Right, ), administration date: 08Oct2021, when the patient was 54-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Lot number: EW0158, Anatomical location: Arm Right, Vaccine Administration Time: 15:00), administration date: 09Apr2021, when the patient was 53-year-old, for COVID-19 immunization; BNT162b2 (DOSE 1, SINGLE, Lot number: EN6024, Anatomical location: Arm Right, Vaccine Administration Time: 15:00), administration date: 19Mar2021, when the patient was 53-year-old, for COVID-19 immunization. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 03Nov2022 at 19:45, outcome "unknown", described as "CSL vaccine given on same day as Bivalent vaccine"; OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious) all with onset 03Nov2022 at 19:45, outcome "unknown" and all described as "Patient received dose 4: Moderna; dose 5: BNT162B2, BNT162B2 OMI BA.4-5"; VACCINATION SITE WARMTH (non-serious), VACCINATION SITE PRURITUS (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 04Nov2022 at 08:00, outcome "recovering" and all described as "Injection site was red, warm/hot, slightly itchy.". The event "injection site was red, warm/hot, slightly itchy." required physician office visit. Therapeutic measures were taken as a result of vaccination site warmth, vaccination site pruritus, vaccination site erythema.  Additional information: The patient did not receive other vaccine in four weeks. Post covid, the patient had not tested. Treatment included Corticosteroid cream, benadryl and ice for the reported events.
I had vaccination on 07/14/2022. I started to experience sore throat and slight headache on 09/13/2022. I had a COVID-19 negative test at home. My husband was COVID-19 positive so I took a PCR test at my PCM the following day. I was COVID-19 positive 09/14/2022. I decided not to take the PAXLOVID. My nose is still burning and my legs are still week on 09/16/2022.
Itching legs/arms/back. Given Benadryl 25 mg PO
No additional AE details.; administered to patient during the excursion; This spontaneous report was received from a registered nurse referring to  a patient (age and gender unspecified) .There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 23-DEC-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)prefilled syringe, dose:0 .5 milliliter, lot # 1637651, expiration dste:09-JUN-2022 for prophylaxis (dose number, and  route of administration were not reported) during the excursion. The administered dose of the vaccine experienced a temperature excursion was below 2 degrees Celsius 1.3, and 1.6 degrees Celsius for 24 minutes, as recorded by a data logger. No product quality complaint reported combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.devicelotnumber: 1637651; expirationdate: 09-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
About 3 hours after the vaccine I started having nausea, headache, chills, diarrhea, body aches a horrible muscle pain. Took 2 Tylenol and slept it off.  Woke up next morning with no symptoms.
Patient presented with heavy bleeding under the skin around the injection site. Strange circular marking at the injection site. Whole arm bluish/purple.
injection site swelled on day 7. Still swollen and red and itchy. hurts  .. itches..swollen the size of baseball ... red... Hurts down the arm ... sweating....toes are numb...  both feet...leg cramps are  terrible both legs.. headache little white bumps on belly.  When I lay down my heart beats fast. leg cramps keep me awake at night.
overdosed with the Covid 19 orange cap Bivalent booster they received, it was undiluted; overdosed with the Covid 19 orange cap Bivalent booster they received, it was undiluted; sore arm/arms were sore (more than with previous doses); sore arm/arms were sore (more than with previous doses); felt tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (159558). The reporter is the parent.  A 6-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 as dose 4 (orange cap; booster), single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization, reaction(s): "sore arm"; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization, reaction(s): "sore arm"; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunization, reaction(s): "sore arm". The following information was reported: FATIGUE (non-serious) with onset 2022, outcome "not recovered", described as "felt tired"; PAIN IN EXTREMITY (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 2022, outcome "not recovered" and all described as "sore arm/arms were sore (more than with previous doses)"; PRODUCT PREPARATION ERROR (non-serious), OVERDOSE (non-serious) all with onset 28Oct2022, outcome "unknown" and all described as "overdosed with the Covid 19 orange cap Bivalent booster they received, it was undiluted".  Additional information: The caregiver reported that her two kids were overdosed with the Covid 19 orange cap Bivalent booster they received on 28Oct2022, it was undiluted. It's been 2 weeks and their arms were sore (more than with previous doses) and they felt tired. She had seen on the news that this happened to other kids. She was wondering why Pfizer was not doing the single dose of the vial already diluted and was concerned about that. She wanted to make sure her kids have no adverse effect from that. She was told by the HCP that it should be fine; just more reactogenicity. They got in touch with the CDC.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201300448 same reporter, events and suspect product; different patient;
01/30/07 mother did not report but states her son had following: fever, Abd pain discomfort, joint aching, and swollen left upper arm. Was given Tylenol and preventive measures. 01/31/07 8am called to report yesterdays S/S and was told to bring child for an assessment, Upon arrival 1/31/07 child verbalized no problems. Assessment of L deltoid area was localized upper arm with some redness and minimal edema. Denied any pain.
The initial spontaneous case was received from other health professional (nurse) on 06-Nov-2017, concerning a patient of unspecified gender and age. This case refers to 12th out of 18 reports. The patient's medical history and concomitant medications were not reported. It was reported that most of the patients received the vaccine on 09-Oct-17 (as reported), the patient was administered with FLUVIRIN (dose, route of administration, anatomical location, batch number, expiry date: not reported) (explicitly coded to expired vaccine used). It was reported that, the patient had no reaction/had not experienced any adverse event after vaccination. The reporter assessed the events as non-serious.
About 6 hrs after shot - temp 101.7 and 90 pulse - tachycardia. Pt went home - took Ibuprofen - woke up next morning - temp resolved - HR still elevated - rested several hrs later pt recovered.
Developed warts on hands after HPV vaccine...has been treated in office and now using over the counter remedies.
Post vax, the pt experienced fevers of approximately 102 and a flu-like sickness. Unspecified medical attention was sought.
Facility had a temperature excursion in the freezer; Patient received the Moderna COVID-19 Vaccine Bivalent after a temperature excursion; No Adverse Event; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Facility had a temperature excursion in the freezer), POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna COVID-19 Vaccine Bivalent after a temperature excursion) and NO ADVERSE EVENT (No Adverse Event) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 049D22A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Facility had a temperature excursion in the freezer), POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna COVID-19 Vaccine Bivalent after a temperature excursion) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Facility had a temperature excursion in the freezer), POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna COVID-19 Vaccine Bivalent after a temperature excursion) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Facility had a temperature excursion in the freezer) and POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna COVID-19 Vaccine Bivalent after a temperature excursion).    No concomitant medications were reported.   The facility had a temperature excursion in the freezer. They had an inspection and saw that their DDL was not recording the temperatures.  At the time of the excursion, the vaccine was in frozen storage. The vaccines were in broken cartons with vial size of 2.5 ml and 5.5 ml.  Because only manual recording was done twice a day, the maximum and minimum temperatures reached by the vials were unknown.  The excursion duration was unknown. The vaccine was returned to the freezer.   The visual inspection showed the vaccine state as still frozen.  The vial underwent temperature excursion for the first time.  No treatment information was provided by the reporter.
states she developed a temp on 11/16/2022- tested positive for covid on binax rapid antigen test 11/17/22- has had 1 dose of Moderna 12/30/2020 and 1 dose of Janssen as listed above
Beginning within a few weeks post-vaccination, pt has noticed tingling & pins & needles sensation. Sx are intermittent. Have progressed such that it can occur anywhere on his body, including trunk/face.
No adverse effects; one separate dose of an improperly stored vaccine, PEDVAXHIB was administered to one separate patient.; Information has been received from a medical assistant, referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.    On 11-JUN-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 0.5 milliliter (one dose, lot# R021077, expiration date: 11-JUN-2021, frequency was unknown) intramuscularly for prophylaxis (incorrect product storage). No adverse effect was reported.  The vaccines were exposed to temperature of 34.2 Fahrenheit (F) for 4 hour 54 minutes. The temperature excursion was detected by a data logger. No previous excursions were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674:Original Case : 1906USA011674
I felt great all day but around 10pm I started having sharp pain above my eyes. Decided I was just tired and went to bed. Almost immediately intense pain started in my legs and traveled up my body. I started having chills. I curled up in fetal position and thought I was dying. I could not even turn over to reach for my cell phone on the night stand. I felt someone sit on my bed however I was alone in the house. I saw a young girl of about 10, I asked who she was and she said, "I'm here to help you. You're going to be okay. Now go to sleep". I did sleep in spite of the pain and chills. When I woke in the morning, I no longer had pain or chills but I was very tired. After a cup of coffee, I decided to go back to bed. I slept for 24 hours. After that, I was back to normal. I did have my Moderna booster on 10/28/2021. Except for a few hours of pain, no other problems.
Tingling in torso, arms and legs almost like pins and needles sensation; This is a spontaneous report from a contactable healthcare professional (patient). A 33-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN9581, expiry date not reported), via an unspecified route of administration at the left arm on 05Feb2021 10:15 at single dose for COVID-19 immunization. Medical history included hyperlipidaemia, COVID-19, and sulfa drugs. The patient was vaccinated at a hospital. Concomitant medications included atorvastatin (LIPITOR) and fish oil. Historical vaccine included first dose of bnt162b2 (lot number: EK9231, expiry date not reported) in the right arm on 15Jan2021 08:00 at single dose for COVID-19 immunization. The patient experienced tingling in torso, arms and legs almost like pins and needles sensation on 05Feb2021 16:00 with outcome of unknown. No therapeutic measurement was given as a result of the event.
This spontaneous report was received from a nurse regarding a patient of unknown age and gender. There was no information on medical history and drug reactions or allergies. On an unknown date, the patient was vaccinated with a dose of (Merck) VARIVAX (dose, route reported as in prescribing information, product lot#, expiry date not reported) that was improperly stored. No adverse effects were reported. There was no product quality complaint involved. The outcome of the events was unknown. Additional information has been requested.
Tested positive for COVID; Tested positive for COVID; This is a spontaneous report from a contactable consumer. A 67-year-old male patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date, at 67-year-old, as single dose(Batch/Lot number was not reported) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to vaccination the patient had not been diagnosed with COVID-19. It was unknown if the patient had received any other vaccines within 4 weeks prior to the COVID vaccine. On 10Aug2021, the patient was tested positive for COVID. This event resulted in emergency room/department or urgent care and hospitalization, and the patient died. The patient got hospitalization for 7days from 10Aug2021 to 17Aug2021. The patient was on a ventilator for 5 days and died last night( on 17Aug2021). The outcome of events was fatal. It was unknown if an autopsy was performed.  The lot number for BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: COVID; COVID
On day of adverse event patient presented to ER with acute dyspnea and chest pain.  Cardiac arrest in waiting room.  Deceased.  CT PE negative.  Troponin elevated.  Did not have cardiac cath as he died.  Previously had normal coronary Calcium score  1/4/23, so shocked if this was acute coronary syndrome from Pre existing heart disease.  While has risk factors, we had just done this reassuring calcium score of zero (low risk).  No autopsy done.  Ultimate cause of cardiac arrest not determined.