chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received vaccine at another facility and experienced fever, Tmax 103.5 the night of the vaccine, onset of cephalocaudal rash and nonblanchable lesions 9/25/17. Rapid strep test neg, CBC with diff pending. Instructions to avoid public places, non-immunized persons or persons with immune deficiency for at least 7 days. Patient not ill appearing at time of visit. Parent instructed to notify provider, PCP, who gave vaccine of reaction.
The error was that the patient was just injected with the diluent, I didn't realize it had to be reconstituted. Then afterwards I explained this to the mother, they said I could inject the patient again, reconstituting the medication in front of them, the patient stated she was ok.  Basically she was just injected with the diluent, then the vaccine was prepared properly and the patient was then given the vaccine.
pt recv vax 5MAY95 & pt exp fever w/in 4 day;no further details were provided;
Injection site is swollen, red, & tender to the touch.  Also itches. No treatment planned. Just wanted the adverse action to be recorded for study.
Soreness in injection arm; Stiffness in injection arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in injection arm) and MUSCULOSKELETAL STIFFNESS (Stiffness in injection arm) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced PAIN IN EXTREMITY (Soreness in injection arm) and MUSCULOSKELETAL STIFFNESS (Stiffness in injection arm). At the time of the report, PAIN IN EXTREMITY (Soreness in injection arm) and MUSCULOSKELETAL STIFFNESS (Stiffness in injection arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided Treatment information provided as heat, pain relievers
Hives following vaccination; This is a spontaneous report received from contactable reporter(s) (Nurse) from a sales representative.  A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, 0.5 ml single (Lot number: FX0078, Expiration Date: 30Nov2024) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: URTICARIA (non-serious), outcome "unknown", described as "Hives following vaccination".  Additional information: Description of Event: Hives following vaccination. Name of Product: Prevnar 13, 0.5 mL, FX0078, 30Nov2024. Event took place after use of product.
nervous; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program. This (age: 78 units: unspecified) female consumer (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient stated that she got first dose of the Covid vaccine by Pfizer today (22Jan2021) and they gave her next appointment about 4 weeks later. She stated she was nervous (22Jan2021), so did not see that its 4 weeks apart instead of 3 weeks apart until she got home. She was scheduled to get the 2nd dose of the Covid vaccine 4 weeks from date of 1st dose instead of 3 weeks and patient was wondering if this was ok. Outcome of event was unknown.   Information on the lot/batch number has been requested.
reports feeling like she was getting a UTI, back pain on  day 3 & 4 - resolved without treatment   Narrative: reports feeling like she was getting a UTI,  back pain on day 3 & 4 - resolved without treatment
Patient's age and DOB were falsified so patient could receive Adult dose of Pfizer covid shot
feeling flushed and faint; her blood pressure went up as well as her heart rate; her blood pressure went up as well as her heart rate; brain fog; slurring her words; lethargy/ lethargic for 2-3 hours; hands were so cold it was like they were stuck in a snow bank and wasn't able to get them warm; feeling flushed and faint; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on unspecified date as a SINGLE DOSE for COVID-19 vaccination.  The patient's medical history and concomitant medications were not reported. The consumer reported her daughter had a bad reaction and is concerned about getting the second dose since it is said people could have more severe reactions. The patient's heart rate was up, blood pressure was up, feeling flushed and faint. Since her daughter works at the hospital and was next to the emergency room they kept an eye on her and everything. When she was okay to go back to her department she had brain fog, lethargy/ lethargic for 2-3 hours, and slurring of her words and that lasted 2-3 more hours. A few days later her hands were so cold it was like they were stuck in a snow bank and she wasn't able to get them warm. Not sure if that was a late reaction since it has never happened before. The patient underwent lab tests and procedures which included blood pressure: blood pressure was up on unknown date, heart rate: heart rate was up on unknown date.   Outcome of the feeling flushed and faint, her blood pressure went up as well as her heart rate, brain fog, slurring her words, lethargy/ lethargic for 2-3 hours were unknown.  Information on the lot/batch number has been requested.
Left leg swollen and sore, seen at Clinic received injection instructed PMD that was reactions.
This case was reported by a other health professional via call center representative and described the occurrence of fever in a adult male patient who received SHINGRIX for prophylaxis. Co-suspect products included Influenza vaccine Quadrivalent unspecified season for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose and Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving SHINGRIX and Influenza vaccine Quadrivalent unspecified season, the patient experienced fever. On an unknown date, the outcome of the fever was unknown. It was unknown if the reporter considered the fever to be related to SHINGRIX and Influenza vaccine Quadrivalent unspecified season. Additional details were received as follows: The age at vaccination was not reported. The reporter stated that, the patient received SHINGRIX and flu vaccine together. The patient presented with fever and the reporter wanted to know whether it was normal.
Welts/rash that itched broke out on patient's skin, beginning on both arms and progressing to rest of body.
received first dose of SHINGRIX in January 2021 and has not received her second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in January 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter was rushing towards the end of the call. Therefore, was unable to collect the following information: lot/exp date and the dosage of first dose of shingrix, route and date of administration, and an email address. The reporter gave a consent to follow-up with himself.
PATIENT STARTED SWEATING WITHIN FIRST 3 MINUTES OF RECEIVING VACCINE. MONITORED HER IN STORE FOR 15-20 MINUTES. NO OTHER ADVERSE EVENTS NOTED.
The patient noticed redness that persisted for a week and went away.  She also noticed itching at the injections site.  The itching has persisted after the redness has resolved.  She notes sporadic itching at the injection site a week and a half after the injection was given.
Developed swelling and pain 2 days post vaccine in (L) knee. Evaluated by PCP x-rays and blood work NEG Dx "Reactionary Arthritis" Took Tylenol for pain.
Rash and hives on neck/around chin and middle of back; Rash and hives on neck/around chin and middle of back; This is a spontaneous report from a non-contactable consumer, the patient. A 15-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0198) via an unspecified route of administration in the left arm on 27Jul2021 at 11:15 (at the age of 15-year-old) as a single dose for COVID-19 immunisation. Medical history included eczema. The patient did not have any allergies to food, medications, or other products. 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. Concomitant medication included unspecified birth control medication from an unknown date for an unknown indication. On 27Jul2021 at 19:00, the patient experienced rash and hives on neck/around chin and middle of back. The events did not result in doctor or other healthcare professional office or clinic visit, emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event rash and hives on neck/around chin and middle of back was resolved on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
A couple days after my vaccine I noticed I had trouble breathing deep breaths- Shallow breaths were ok. Called the doctor I had a phone visit 05/14/2021 asking if it was asthma or seasonal allergies and thought it was seasonal allergies and prescribed an inhaler Flovent to use as needed. I continued to have this and I developed Chest pain. Over the weekend it got really bad and I went to the ER the following weekend roughly the 22nd or 23rd of May. ER provider suggested to continue using the inhaler as needed and f/up with PCP. I continued to have trouble with deep breathing and coughing. June or July it went away. It went away after a month.
On 11/10/21, I received the Pfizer vaccine at 10:00 am. Later that day I experienced a headache. 11/11/2021, I was achy, had a headache, and mild fever/chills. 11/12/2021 I felt better, but later that afternoon around 5:00 pm I started to get achy again. By 6:00 pm, I had strong chest pains, and had my wife take me to the ER. At the ER, I had severe chest pain that hurt more with respirations and movement. The doctors/nurses put in an IV and administered   NARCAN, morphine, sodium chloride, oxyCODONE, ZOFRAN ODT, REGLAN, melatonin, aspirin and famotidine . They completed a physical exam.  I had the following tests: comprehensive metabolic panel, d-dimer quantitative, troponin 1, c-reactive protein (inflammation), complete blood count with differential. They also completed a CTA Chest X-Ray, EKG, TTE, Telemetry monitoring, and an echocardiogram. The diagnosed me with Pericarditis, Myocarditis due to the Pfizer vaccine. This resulted in taking the following medications  at home:  975 mg of Aspirin (3 times a day), 0.6 mg colchicine (daily), and 20 mg Pepcid (daily).
Chest trauma adenopathy, left axillary adenopathy, continued left arm myalgias continued onset since 2 days after vaccination
Running nose past one day; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 27Apr2021 at 08:15 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included hemorrhoids. Concomitant medication included conception vitamins (MANUFACTURER UNKNOWN) for male taken for an unknown indication from an unknown date and unknown if ongoing. The patient previously 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 06Apr2021 at 08:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. 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 COVID vaccine. On 01May2021 at 04:00, the patient experienced running nose in the past one day. The clinical outcome of the event running nose past one day was not resolved at the time of the report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous case reported by a consumer, describes the occurrence of injection site pain  (arm is really sore) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 004M20A) for COVID-19 immunization. No medical history reported. On Jan 26, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jan 26, 2021, patient experienced injection site pain (arm is really sore). At the time of the report, injection site pain (arm is really sore) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No relevant concomitant medications or treatment information reported.
numbness on her left side of her face on and off.; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness on her left side of her face on and off.), HEADACHE (Headache) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced HEADACHE (Headache) and CHILLS (Chills). On 30-Mar-2021, the patient experienced HYPOAESTHESIA (numbness on her left side of her face on and off.). At the time of the report, HYPOAESTHESIA (numbness on her left side of her face on and off.) outcome was unknown and HEADACHE (Headache) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was unknown.
My left upper arm the site of the injection started to be itchy on Friday Feb. 12, 2021, six days after the shot.  It has a rash of about an inch and a half radius. I put some cortisone on it and took a quarter of a Benadryl tablet today Sunday Feb 14, 2021 because the itch becoming more irritating.  The itch did decline .
Pt recvd 3 doses of Hep B vax 6 yrs ago & it was determined that pts titer was neg; booster dose & re-titer is planned;
Psoriasis aggravated; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis aggravated) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriasis.    Concurrent medical conditions included Psoriasis (Moderate to severe chronic plaque psoriasis).   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, Citrate Free. On an unknown date, the patient experienced PSORIASIS (Psoriasis aggravated). At the time of the report, PSORIASIS (Psoriasis aggravated) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       There was no reported medical history.  Concomitant medications details were not reported.  It was reported that plaque psoriasis was coming back slowly for the patient.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter's causality for the event of psoriasis aggravated was not provided for Humira.  No treatment information was reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
Pt 6w pregnant was mistakenly given Flu Mist. Pt advised to go to her GYN and to call us if any symptoms occur Pt shows no signs of adverse reaction at this time.
no additional AE; given PROQUAD and VARIVAX in error simultaneously; This spontaneous report was received from an office manager, referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, previous drug reactions, or allergies were not reported.  On 08-FEB-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and varicella virus vaccine live (oka/merck) (VARIVAX) in error simultaneously (exact doses, sites of vaccination, routes of administration, lot numbers and expiration dates were not reported) for prophylaxis (overdose). The reporter wanted to know about any vaccine adverse interactions. No additional adverse events (AEs) were reported (no adverse events).
PPD 0.5 mL IM administered by RMA instead of Tdap per orders.  Primary provider notified; patient assessed and observed.  Follow up call made 11/4/2016 by RN; no adverse reactions noted.
Started at 2:00 AM with severe chills, and then throwing up and diarrhea and no appetite, and I couldn't do anything, so I slept. I wasn't able to hold down any fluids. And about 2:00 in the afternoon that day, I was feeling better.
missed the third dose of Twinrix at appropriate time and is 2 months late; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose received on an unknown date) and Twinrix (2nd dose received on an unknown date).   On an unknown date, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. Till the time of reporting ,the patient did not receive the 3rd dose ,which led to incomplete course of vaccination.  The  reporter consented to follow up via call.
Breakthrough case after three vaccines Janssen Lot# 1805020;  Pfizer 11/9/21 Lot# FH8030;  Moderna 4/29/22 LOTt# 004M21A
>Vaccination given- Janssen  03/14/2021 c/o onset of headache  03/15/2021 lasted 3 wks, resolved and started again 04/13/2021,  pain to bilateral temporals radiates to occipital area, current pain 7/10, best pain 5/10, worse 10/10, pain is continuous, improves with Acetaminophen, exacerbated with activity,  no Hx of chronic headaches not described as "worse headache of my life"  >denies pain, swelling to injection site, fever, chills, fatigue, body aches, abdominal pain, leg pain,  hives, trouble breathing, n/v, diarrhea, neurological deficits, change in level of consciousness, seizure activity, visual disturbances
Patient developed extreme pain in both feet, progressing up both legs, extreme headache, depression, episodes of crying,mental confusion, states symptoms lasted 1 week began to subside 11/16/06. Reported symptoms to MD, was seen 11/16/06 referred to neurologist, but did not keep appointment. Patient reported symptoms to family pediatrician, will attempt to/ heal of flu vaccine.
Bright red skin with hives, very itchy, located on both sides and small area on  abdomen Started this afternoon with hives. But Skin  itchy all over since early morning
This spontaneous prospective pregnancy report as received from a registered nurse refers to a 24 year old female patient. The patient did not have pertinent medical history, drug reactions or allergies. The patient became pregnant with Last Menstrual Period of 06-JUN-2016. On 14-JUN-2016, the patient was vaccinated with her second dose of GARDASIL, intramuscularly, (dose was not provided), lot # was reported as "m02659" with expiration date on 20-SEP-2017. Concomitant therapies included SPRINTEC and cefdinir. On 06-JUL-2016, the patient had a positive urine pregnancy test when she went to visit a health care professional office. The patient did not receive any treatment for the event. The outcome of the positive pregnancy test was reported as not recovered. The Estimated Date of Delivery would be 13-MAR-2017. The relatedness between the positive pregnancy test and therapy with GARDASIL was not stated. Additional information has been requested.
burning sensation in feet; Felt very weak; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A male patient received BNT162b2 (BNT162B2 NOS), 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: BURNING SENSATION (non-serious), outcome "unknown", described as "burning sensation in feet"; ASTHENIA (non-serious), outcome "unknown", described as "Felt very weak".  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-202300272957 Different patient/drug, different dose/events (Dose 3);US-PFIZER INC-202300273026 Different patient/drug, different dose/events (LOE);US-PFIZER INC-202300273025 Different patient/drug, different dose/events (DOSE 2);
When pt came in for CPE on 6/16/06, grandmother reported reaction to vaccines given 1/10/06. States that evening she witnessed a mild convulsion with pt shaking all over and eyes rolled back. States she doesn't think he lost consciousness. She did not report incident at that time or have pt seen because it didn't last long and he was fine afterwards. States maternal aunt had seizure after DTP. Pt was afebrile at time of seizure
Pt received his first Pfizer vaccine on 4/13/21 and developed prostatitis with possible abscess on April 23, 2021. Pt recovered after ER and clinic visits, antibiotics and the fact that the abscess seemed to spontaneously drain at one point.  It may not be related to his vaccine but pt wanted it reported since it happened 1.5 wks after his first dose of the COVID-19 vaccine