chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She had seizures, very high fever, 2 times once on 1-10-08 lasting approx 12 min, 2nd time 1-12-08 lasting approx 5 min with low grade fever.
I showed up to work in an office setting. I developed a persistent cough. I figured it was allergies. That afternoon at about 4:00PM, I received a phone call from a friend who was COVID-19 positive. I went home and called the clinic, who told me to come in so I could test. By the time I showed up to the clinic I developed cough, body aches, chills and fever of 101. I also lost my sense of smell and taste as well as a persistent headache. My vision was blurred and had heavy fatigue and drowsiness, low energy. This lasted 2.5 days. I started to regain strength and my cough went away after about 1.5 weeks.
Covid19 breakthrough.  1st Vaccine received on 03/08/2021.  63 y/o with PMH Asthma, HTN, TIA comes to Ed with c/o worsening SOB over past 24 hours.  Pt states she tested + for Covid on 1/4/22, took full course of antibiotics for PNA and had been feeling better.  Now SOB returned and also c/o weakness, cough, mild rhinorrhea.  Denies fever, chills, N/V/D or HA.
Woke up with large headache and nausea, chills and hot flashes. Severe throat pain and fatigue with chills throughout the day, arm pain and lymph node swelling, joint pain
was noticed falling out of his chair in the 15 min waiting area. At that moment I  surrounded him and noticed he had passed out. It looked as if he had slightly hit shoulder first with no obvious head injuries. He came to in about 5 seconds in which he mentioned the fact passing out had happened to him before and was common with shots. The paramedics quickly attended to him and took blood pressure which came back normal. He denied transport by ambulance.
Fever, rash, refusal to eat - vaccine given 2/12/14. Symptoms started 2/22/14.
My first booster also made my armpit swell but not as severe as this; Tested positive for COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested positive for COVID-19) and LYMPHADENOPATHY (My first booster also made my armpit swell but not as severe as this) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066H21A, 011J20A and 011J20A) for COVID-19 prophylaxis.     Patient had no chronic or long-standing health conditions.  Concurrent medical conditions included Allergy to animal.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jan-2022, the patient experienced COVID-19 (Tested positive for COVID-19). On an unknown date, the patient experienced LYMPHADENOPATHY (My first booster also made my armpit swell but not as severe as this). At the time of the report, COVID-19 (Tested positive for COVID-19) outcome was unknown and LYMPHADENOPATHY (My first booster also made my armpit swell but not as severe as this) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jan-2022, SARS-CoV-2 test: (Positive) Positive.         Patient had an Moderna distributed COVID-19 test on 05-Jan-2022.  No concomitant medication reported. No treatment medication reported.   This case was linked to MOD-2022-658670 (Patient Link).
I started with a very sore throat; for about 3 days then I started to have a fever with congestion I felt better, then I felt very sick again; I feel like my muscles hurt and my body hurts and I feel very miserable I went I went to the doctor she said it's a respiratory infection.
Narrative:  COVID INFECTION AFTER COMPLETION OF COVID VACCINE SERIES 01/28 COVID vaccine dose #1 02/18 COVID vaccine dose #2 05/08 COVID testing for pre-op for TKA, COVID positive, reports being around coworkers that were known or suspected positive; no symptoms
A physician reported that a 6 year old male received Prevnar vaccine on 12/05/2001. He has a past medical history of heart transplant, meningitis, and reactive airway. Concomitant medication included prednisone, Tacrolimus, ranitidine hydrochloride and iron. The child's mother reported that he developed upper respiratory congestion and cough for 5 days; however, in the last 2 days he developed "high" fevers with tachypnea, and back and chest pain. He was evaluated in the ER and found to have a "RUL and retrocardiac infiltrate consistent with a community-acquired pneumonia." The child was admitted to the hospital on 02/04/2002. No additional info was available as of the date of this report. follow-up information received on 02/22/2002 from reporting physician. Pt's medical history and concomitant medication provided. The lot number of Prevnar vaccine was provided.
Contacted the patient by telephone regarding possible reaction to the rabies vaccine that she received on 5/25/2021. Pt reports rash to bilateral chest, arms, and thighs and states that the rash is not itchy or swollen, and that she is not short of breath or having any difficulty breathing. Pt was advised that she could take benadryl and to please also report this to her PMD. Pt was advised that she should still try the benadryl but that she could also take a non-drowsy antihistamine for relief as well. Patient visited an urgent care where she received a steroid pack which cleared up the reaction
I received the J&J one-dose vaccine on Thursday, April 8, at approx. 1600. Within an hour I had a mild headache and was nauseous. I went to sleep around 2130. At 0030 (or 30 minutes past midnight) I was awoken to the sudden shock of feeling very cold. My temperature was 91, within 15 minutes I spiked to 100 degrees, and then 15 minutes later I was at 102. I was shivering but felt like I was on fire. I had intense pain throughout my entire body. Internally and topically (skin) my entire body felt like it was on fire -- a burning sensation. Clothes -- even a soft hoodie -- felt like a steel wool scrubber was brushing against my skin and my skin was very hot to touch. I continued to feel nauseous.  After 90 minutes of this, I was able to take acetaminophen (2 x 500 mg). After another 90 minutes, my temperature dipped to 99 and the horrible pain mostly subsided.   From 0530 to 1830, in three-hour increments, my temperature continued to spike and fall between 99-101 degrees and the pain came in the same waves. Nausea continued. So, I continued an acetaminophen regimen throughout the day to help with the symptoms and took a few tums to help too.  After 1830, I felt very weak and tired. My temperature stabilized at normal. Nausea continued.   On Saturday, April 10, I was mostly just tired and had minor body aches/soreness. My shoulder bruised where I was vaccinated. Food did not sit well and my stomach was quick to turn.   Sunday, April 11, mostly back to normal. Although, still fatigued. No major side effects or symptoms.   Monday, April 12, seems to be the same as Sunday.   Note: I had COVID the first week of February 2021.
blood work showed no immunity to the flu.; Initial information received on 19-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 36 years old female patient who showed no immunity to the flu (antibody test negative), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatments, vaccinations and family history were not provided.  No other vaccine was given.  On 10-Oct-2019, the patient received a dose of 0.5 ml suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT6654KA Expiry date- 30-Jun-2020 via intramuscular route in the left deltoid.  on 11-NOv-2019 and on 12-Nov-2019, one month one day and one month two days after, blood work was performed and patient showed no immunity to the flu (antibody test negative).  No other events was reported.  Lab data included antibody test negative.  No corrective treatment was reported.  outcome is not applicable.
no additional AE'S; improperly Stored; Administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and concomitant medication were not provided.  The previous temperature excursion of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) was reported as 30.28 Fahrenheit degrees (F) for 19 minutes and 34.81 F for 35 minutes. On 18-MAR-2021, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # T020616,expiration date 16-MAR-2023, dose was reported as 1 (unit unknown); strength and route were not provided) for prophylaxis (product storage error). Administered dose of vaccine was stored in the temperature of 28.34 F for 1 hour and 2 minutes. No additional adverse event was reported. Data logger was involved.  This is one of several reports received from same reporter.; Sender's Comments:  US-009507513-2104USA002463:Original Case : 2104USA002463
Red whelps noted to stomach, back, arms, lower legs, face, neck and ears. Ears and lips appear to be enlarged. Whelps started late last evening and worse this AM. Spoke w/guardian, saw private physician today - Dx'd as having allergic reaction to "something." To take BENADRYL 3x day.
Case number PHEH2014US019153 is an initial spontaneous report received from a nurse on 19 SEP 2014. This report refers to a male patient of an unknown age. Past medical history and concomitant medication was not reported. On 18 SEP 2014, the patient was inadvertently vaccinated with FLUVIRIN 2014/2015 (batch number: 1412001) intramuscularly at a dose of 1.0 ml instead of the recommended 0.5 ml does. No adverse event was reported following this medication error (overdose).
Information has been received from a registered nurse concerning a male patient whose mother on 13-AUG-2008 received the first dose of GARDASIL and on 05-DEC-2008 AM received the second dose of GARDASIL IM on deltoid. The patient was delivered on 15-AUG-2009, at 39 weeks from LMP. The patient weight 3628gm, length 51cm, Apgar score 8/9 and head circumference 33. Subsequently the baby developed tachypnea and presumed sepsis and was hospitalized. Course of IV antibiotics for 10 days. The baby was discharged on 25-AUG-2009. At the time of the report the outcome of the patient was unknown. No further information is available. The mother's experience has been captured in WAES0902USA02182.
Received flu shot and within one hour right foot began tingling and continues to tingle at time of completion of this report.  Tingling has not advanced up leg and feels the same as yesterday.
Feeling pain on both arms/ all the arm is sore and pain; Stiffness and hurt remains; Hard time sleeping because the muscles hurts; After the second dose it just continuously got worst; Hard time sleeping because the muscles hurts; Severe knuckle pain/touches it's elbow the bone and hurts like crazy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Feeling pain on both arms/ all the arm is sore and pain), MUSCULOSKELETAL STIFFNESS (Stiffness and hurt remains), INSOMNIA (Hard time sleeping because the muscles hurts), CONDITION AGGRAVATED (After the second dose it just continuously got worst) and MYALGIA (Hard time sleeping because the muscles hurts) in a 72-year-old male patient 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 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-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 (Feeling pain on both arms/ all the arm is sore and pain), MUSCULOSKELETAL STIFFNESS (Stiffness and hurt remains), INSOMNIA (Hard time sleeping because the muscles hurts), CONDITION AGGRAVATED (After the second dose it just continuously got worst), MYALGIA (Hard time sleeping because the muscles hurts) and ARTHRALGIA (Severe knuckle pain/touches it's elbow the bone and hurts like crazy). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Feeling pain on both arms/ all the arm is sore and pain) and MUSCULOSKELETAL STIFFNESS (Stiffness and hurt remains) had not resolved and INSOMNIA (Hard time sleeping because the muscles hurts), CONDITION AGGRAVATED (After the second dose it just continuously got worst), MYALGIA (Hard time sleeping because the muscles hurts) and ARTHRALGIA (Severe knuckle pain/touches it's elbow the bone and hurts like crazy) outcome was unknown. Not Provided          Concomitant medications were not reported.  No treatment information was specified.
This spontaneous report, initially received on 04-Apr-2017, was reported by an other health professional (nurse) and concerns a patient of unspecified age and gender. The nurse reported that, the vaccine refrigerator door was left open at one of their sites from an unspecified date. The nurse said that, on 31-Mar-2017 at 5 pm, the refrigerator temperature was in range at 6 degree Celsius but on 03-Apr-2017 at 5 pm, the refrigerator temperature was found to be 10 degree Celsius and 9 doses of pre-filled syringes were affected (incorrect storage of drug). After follow up nurse reported that, the vaccine refrigerator door was closed when she got the vaccine. At 04:52 p.m., the temperature alarm triggers. At 05:00 p.m., the refrigerator door was found open. The manual temperature reading on 3 Apr 17 at 05:00 p.m. was 10 degree Celsius and data logger reading was 15 degree Celsius. The data logger also has the total time above the normal range as one hour and 58 minutes, with maximum temperature 16 degree Celsius. The data logger and manual temperature reading do not match exactly, but my information shows the excursion was less than 24 hours, an AE has not really occurred. Administration of Company suspect drug: On 03-Apr-2017, the patient had administered incorrectly stored AFLURIA [(drug administration error), influenza vaccine 0.5 ml, intramuscular, batch number: WT54607, Exp: 30-Jun-2017]. Action taken with AFLURIA was not reported. Outcome of incorrect storage of drug and drug administration error was not reported. Reporter's Assessment: The reporter did not provide the causality and company causality between AFLURIA and events (incorrect storage of drug and drug administration error) was assessed as not related. This case was not serious. Follow up received on 18 Apr 2017: The following information as updated, the nurse reported that, the vaccine refrigerator door was closed when she got the vaccine. At 04:52 p.m., the temperature alarm triggers. At 05:00 p.m., the refrigerator door was found open. The manual temperature reading on 3 Apr 17 at 05:00 p.m. was 10 degree Celsius and data logger reading was 15 degree Celsius. The data logger also has the total time above the normal range as one hour and 58 minutes, with maximum temperature 16 degree Celsius. The data logger and manual temperature reading do not match exactly, but my information shows the excursion was less than 24 hours, an AE has not really occurred.
Patient described an injection site reaction that has been progressively getting worse.  Started as a smaller red circle around injection site that has grown to about a 2 inch diameter.  Patient described it as being soft and now has gotten hard and itches.  Has been getting progressively worse over last 2 days since date of injection.
7-8 days after injection, right arm began to swell, become painful, and a raised reddened area measuring approximately 2" diameter developed. Site was hot to touch and was itchy. The swelling extended around the circumference of upper arm and into armpit. Benadryl and ice was administered. Approximately 4 hours later, the swelling and pain had decreased, however the redness had extended to approximately 3" and was splotchy, red, itchy, and warm to touch; GI discomfort (diarrhea, nausea) had also developed. More benadryl was administered. 2 days after onset of symptoms, GI symptoms, swelling, pain and redness has improved however, there is still itchiness and and mild redness.  PCP aware and advised to contact CDC for advisement on whether to continue with 2nd dose and continue with current treatment.
Patient complained of lightheaded and feeling like her throat is swollen and tight.  ER gave pt dexamethasone and benadryl & to f/u with pcp.
mental fog; swollen gums; mouth irritation; weakness; nausea; Fever; chills; severe muscle pain; severe headache; This is a spontaneous report from a contactable consumer (patient). A 46-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EW0196) via an unspecified route of administration on 14Jul2021 at 18:00 (at the age of 46-years-old) in right arm as dose 2, single for COVID-19 immunization. The patient medical history was reported as none. No other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with covid-19. Post vaccination, the patient had not been tested for covid-19. No known allergies were reported. Concomitant medications received in two weeks included rosuvastatin (ROSUVASTATIN) and ezetimibe (EZETIMIBE) both taken for an unspecified indication, start and stop date were not reported. The patient's previously received BNT162B2 (COVID Pfizer vaccine; lot number: EW0168) on 23Jun2021 at 18:00 in right arm as dose 1, single for COVID-19 immunization. The patient experienced fever, chills, severe muscle pain, weakness, severe headache, mental fog, swollen gums, mouth irritation and nausea on 15Jul2021 at 06:00. The patient did not receive any treatment. The outcome of all the events was recovering.  Follow-up attempts are completed. No further information is expected.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Experiencing diarrhea; Fever; Being tired; Headache; This case was reported by a consumer via call center representative and described the occurrence of fever in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd January 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 23rd January 2022, 10 hrs after receiving Shingrix, the patient experienced fever, tiredness and headache. On 25th January 2022, the patient experienced diarrhea. On 24th January 2022, the outcome of the fever, tiredness and headache were recovered/resolved. On an unknown date, the outcome of the diarrhea was not recovered/not resolved.   It was unknown if the reporter considered the fever, tiredness, headache and diarrhea to be related to Shingrix.  Additional details were provided as follows: The patient self reported the case. The patient received a dose of Shingrix on Sunday and about 10 hours after receiving the vaccination the patient began to experienced fever, being tired, and a headache.   One day later these symptoms were recovered. Two days after receiving the vaccination, she experienced diarrhea. The patient was asking if this could be a side effect of the Shingrix. The reporter was informed as per package insert adverse events. The patient recommended follow up with health care professional if she was concerned.  No Lot number or Expiration date was known.  The patient provided health care professional contact information. The reporter consented to follow-up.
On 04/27 I felt pain, disorientated, nausea and fever. I took Tylenol for the pain and fever. At the time of the report, I feel a little better but not "myself". Pain in the arm at injection site.
Body temperature increased 1.1 degrees, aches and pains, lethargy. Took Advil. Recovered by next morning.
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (manufacturer unknown). On 01-SEP-2017, the patients were vaccinated with improperly stored PROQUAD (dose, frequency and route were unknown, lot # M044720, expiration date:07-MAY-2018, lot # N013863, expiration date:31-OCT-2018) for prophylaxis(Incorrect product storage). Administered vaccine experienced the temperature excursion of -14 celsius degree to -10 celsius degree (-14.2 celsius degree) for 6 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. No product quality complaint(PQC) was involved. All telephone attempts on 10-OCT-2017 to obtain follow up information have been unsuccessful. Follow up information has been received from an other reporter concerning a 4 year old patient. On 07-SEP-2017, the patient vaccinated with improperly stored PROQUAD (dose, frequency and route were unknown, lot # N016089, expiration date: 22-NOV-2019) for prophylaxis(Incorrect product storage). This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1709USA002186: US-009507513-1709USA002098:
getting COVID after being vaccinated; getting COVID after being vaccinated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male patient received BNT162b2 (BNT162B2), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "getting COVID after being vaccinated". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: getting COVID after being vaccinated. Clinical course: The reporter did not realize that getting COVID after being vaccinated was considered an adverse event until she received the postcard that was sent to colleagues today. Once she saw that she reported immediately. The same situation occurred for her husband and son which she was going to report tonight so she could gather all the relevant info (Vaccine dates and lots) from them.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202200797971 same reporter and drug, different patient
at 142pm reports moderate dizziness, left arm numbness and headache.  BP=125/82, P=96, o2 sat = 98% water and cookie given at 1;50pm BS=112, .  reports that she hasn't' eaten since 0700and got tired out from standing in line.  Denies left arm numbness. reports that the headache is gone, the dizziness is decreased and that she has bilateral le weakness. 205pmunsteady on feet, swaying back and forth and closing eyes when standing   Instructed  patient to try to keep her eyes open when she is standing.  Reports moderate dizziness.  At 230pm standing BP 139/86 p=96, T=98.2, 240pm remains unsteady on feet and states that her legs are weak bilaterally. reports that her left arm numbness has returned.  Lives with handicapped son  who is not able to help if needed.  Instructed patient on the need to try to get a family member to drive her home.  frequently seen holding her head in her hands.  reiterated with the patient on the need to keep her eyes open when standing.  reports that she has a hart time drinking any fluids.  instructed patient on the need to push fluids and to discuss her dizzy spells with her MD, discharged to the care of her son.
1 day after IZ given, child brought to clinic because of swelling at site of DTaP. Red, warm to touch, mild swelling. Temp 99.3 (oral). Tylenol prn pain recommended.