chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Did you/the patient previously receive a COVID-19 Vaccine?: Yes; Did you/the patient previously receive a COVID-19 Vaccine?: Yes; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Dec2020 at 16:00 as dose 1, single (Lot number: EK9231), on 20Jan2021 at 14:30 as dose 2, single (Lot number: EL3249), in left arm, on 11Oct2021 as dose 3 (booster), single (Lot number: 30135BA), in left arm and on 14Apr2022 at 13:00 as dose 4 (booster), single (Lot number: FU98-94) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin, ampucilkin; "Osteoarthritis" (unspecified if ongoing); "Known allergies: ampucilkin" (unspecified if ongoing), notes: Known allergies: Penicillin, ampucilkin. Concomitant medication(s) included: ADVAIR. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovering" and all described as "Did you/the patient previously receive a COVID-19 Vaccine?: Yes". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Medication Advair diskus 100/50 were in 2 weeks after vaccine. received 3rd does on 11Oct2021 at 12:00 AM. Paxlovid started on 31May2022 and stopped on 05Jun2022 for treatment of COVID-19. On 13Jun2022 at 12:00PM, she had recurrent nasal symptoms, cough, fatigue for which no treatment was given and event were recovering.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
After about 7 days she looked at it and it was a quarter or larger area that was red, raised, inflamed area.  Around it had some little smaller redness, not raised that were blotchy all over.  It was a little itchy and when she touched it it was a little warm.  It was not a real bad reaction, but did not feel sick just the redness.  The next day it itched more and took a Benadryl, and about 2 days later it started to fade, but did merge together and got lighter and lighter in color and is almost completely gone.  it is not itching anymore and is light pink.
Redness around throat but no trouble breathing. No fainting. Notified primary MD already and followed up with pt at home: pt was instructed to use Benadryl OTC for few days per primary MD.
Two lumps (maybe swollen lymph nodes) in neck, one in arm pit, one in elbow. I believe my kidneys have an ache to them as welll. Lower back on both sides is hurting more than normal, tired.
Swelled throat; rash; Feeling cold; mucus along with swollen neck and throat; mucus along with swollen neck and throat; This is a spontaneous report from a contactable consumer (patient). A 15-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: ER8731, patient was not pregnant at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 04Jun2021 at 08:30 (at the age of 15-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included vitiligo. There were no concomitant medications. No other vaccine received in four weeks, no other medications received in two weeks, no covid prior vaccination, no covid tested post vaccination, no Known allergies were reported. On 04Jun2021 at 12:00, the patient experienced swelled throat, rash, feeling cold, mucus along with swollen neck and throat, mucus along with swollen neck and throat. No treatment was received for events. Reported that event swelled throat still not gone to normal after 48 hours. The outcomes of events (swelled throat, feeling cold, mucus along with swollen neck and throat, mucus along with swollen neck and throat) were not recovered and the outcome of event (rash) was recovered on 05Jun2021 (after 24 hours).  Follow-Up (19Jul2021 and 05Aug2021): Follow-up attempts are completed. No further information is expected.
had a rash on the site of inj (lt shoulder) which didn't irritate pt, but felt very tired & weak
5:35PM PT BECAME 'DIZZY' AT CHECK OUT - PLACED IN CHAIR.  A/O, PINK, W/D, RESP WITH EASE.  5:37PM STATES HE FEELS 'FINE NOW AND OK TO GO HOME'. NO ACUTE DISTRESS.  5:40PM AMBULATORY - GAIT BRISK AND STEADY. 3-31-21 8:52AM TC:  PT STATES HE 'FEELS BETTER. NOT DIZZY'.
Systemic: Blood Disorder  (diagnosed by MD)-Severe, Systemic: Joint Pain-Severe, Systemic: Seizure-Severe
Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient has a PMH significant for AF, Mitral Regurgitation, Prostate Cancer, hyperlipidemia, OSA on Bipap. No death certificate noted.
Brain fog; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) and CONFUSIONAL STATE (Brain fog) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Aug-2021, the patient experienced VACCINATION SITE PAIN (Sore arm). On 01-Sep-2021, the patient experienced CONFUSIONAL STATE (Brain fog). At the time of the report, VACCINATION SITE PAIN (Sore arm) and CONFUSIONAL STATE (Brain fog) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication were not reported Treatment medication were not reported
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with a dose of properly stored M-M-R II therapy type rHA, lot # N013868, expiration date 04-MAY-2019 (dose and route of administration were not reported) for prophylaxis. The vaccine was reconstituted with improperly stored sterile diluent (manufacturer unknown) (lot # and expiration date were not provided). No adverse events were reported. The sterile diluent had been improperly stored at a temperature of -1 degree Celsius or colder (-10 degrees Celsius) for 6 days, through unknown number of cycles. There had been no previous temperature excursion. Digital Data Logger was involved. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1711USA003734:
This case was reported by a consumer via call center representative and described the occurrence of rash in a 67-year-old female patient who received SHINGRIX for prophylaxis. On 25th June 2018, the patient received the 1st dose of SHINGRIX. On 27th June 2018, 2 days after receiving SHINGRIX, the patient experienced rash, muscle pain, fatigue and headache. The patient was treated with ALLEGRA. On an unknown date, the outcome of the rash, muscle pain, fatigue and headache were recovering/resolving. The reporter considered the rash, muscle pain, fatigue and headache to be possibly related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left deltoid. The patient developed a rash on her trunk, back, stomach and shoulder that was creeping down to her elbow. She would send a picture of the rash via email.
Red feverish welt at site of injection and swollen lymphnodes in armpit same side as injection.
A patient getting over 2nd bout with the flu; Initial information was received on 18-Feb-2021 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional (patient).  This case involves a patient (unknown demographics) who getting over 2nd bout with the flu (influenza), while he/she received INFLUENZA VACCINE.  The patient's past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   The patient had no medical history, concomitant disease or risk factor.  In October 2020, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (batch number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient getting over 2nd bout with the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as non-serious.  It was unknown if the patient experienced any additional symptoms/events.   The details of medication and reason for taking the medicine was not reported.   There were no lab data/results available.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the patient was recovering from the event.  There will be no information on batch number for this case.
soreness in upper arm site of inject 24 hrs only some redness & warmth @ site only;
Information has been received from a registered nurse referring to unspecified number of patients of unknown age and gender. There was no medical history or concurrent condition reported. On unknown dates the unspecified patients were vaccinated with doses of improperly stored VARIVAX (Merck) (lot # L013827, expiration date 21-APR-2016) (dosage, strength and route were not reported). There was no concomitant medication reported. No adverse effect was reported. This is one of several report from the same reporter. Additional information has been requested.
PATIENT 1 DAY AFTER VACCINATION STARTED TO DEVELOP HIVES TO BILATERAL KNEES, WHICH PROCEEDED DOWN LEGS TO ANKLES AND PEAKED AFTER DAY 2 (7/18). AS OF DAY 4 (7/20), HIVES ARE STILL PRESENT BUT NOT GETTING WORSE. NO OTHER SYMPTOMS REPORTED
Patient observed to become unresponsive and slumped over in chair during observation at appros 15 minutes.  He remained unresponsive to verbal and physical stimuli for approx 5 minutes.  Once responsive, he c/o pain all over, abdominal pain with curling up as if cramping.  no muscle spasms observed.  Skin with mild tenting.   vitals monitored,  NS IV given, ~150 cc given prior to transfer to EMS. Lorazepam 0.5mg IV given for muscle spasms.   Diphenhydramine 25mg IV administered  Labs drawn.  Oxygen saturation 99% initially with NRB, changed to NC and remained  >94% on 2 lpm.  patient remained somnolent, not answering questions, though conscious.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Mar2021 at 08:00 as dose number unknown, single (Batch/Lot number: unknown), in left arm and on 26Mar2021 at 08:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 43 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 20Aug2021 at 11:45 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing); "GERD" (unspecified if ongoing); "thrombocytopenia" (unspecified if ongoing); "Known allergies: mushrooms" (unspecified if ongoing); "Known allergies: sulfite" (unspecified if ongoing); "PFO closure" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Vfen, reaction(s): "Known allergies:VFen"; Anastrazole, start date: 26Nov2014. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: Low; 77/45; SARS-CoV-2 test: Unknown results.  Clinical information: Despite completing the treatment with Paxlovid, still feel COVID-19 symptoms. Additionally, I have felt super dizzy and right-side numbness. I ended up in the hospital. Since treatment, my blood pressure kept dropping too low (77/45) causing me to pass out. Before diagnosed with Covid and took Paxlovid, I was healthy. During treatment, I felt weak, nauseous, dizzy, and unable to stand up. It reminded me of an awful chemotherapy drug called Adriamicin. I was as sick now as I was then. Frankly, I have not been able to return to work since treatment. How long would these symptoms last and if there was anything else to fix me.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
One of twenty-one cases: A non-serious, spontaneous event of a half dose to FLUMIST administered was received from a registered nurse. The event occurred in an eighth grade adolescent male. Now medical or drug history was reported for this adolescent. FLUMIST was inadvertently administered in on nostril to 21 children during a flu clinic  at an elementary school. The nurse administering the doses had been trained on administering FLUMIST but forgot to take off the divider clip; 21 children received only half a dose. No adverse effects were reported the event is considered resolved.
Immediately following the vaccines, baby was lethargic and continued to be unusually extra sleepy all week. She had a head drop episode during that week and was fussy throughout. Acted unlike her usual very energetic self. 5 days post vaccines, she went limp for a brief period of time then 2 hours later she experienced a seizure during which she was limp. Called 911, she came around post-seizure, taken to ER, then was transferred to hospital. 2 weeks later she experienced another 3 seizures spaced out every other day. 2 weeks after that she experienced 6 seizures in a week (twice in one day on back to back days in addition to the other days).
Bump under his skin resembling marble at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Bump under his skin resembling marble at the injection site) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.  On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On an unknown date, the patient experienced VACCINATION SITE MASS (Bump under his skin resembling marble at the injection site).   At the time of the report, VACCINATION SITE MASS (Bump under his skin resembling marble at the injection site) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to MOD-2021-076842 (Patient Link).
No additional AE; Caller reporter improperly stored and administered vaccines for MMR-II, PROQUAD, and VARIVAX to multiple patients since May 2023 (TE occurred 5/9/2023). No symptoms reported. Caller did not have specific AE information available regarding patient inf; This spontaneous report was received from other and refers to an 1-year-old patient of unknown age.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 05-JUL-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, lot #W026315, expiration date: 18-FEB-2024, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration in 58.65 degree Farenheit (F) for 25 hours 45 minutes (Product storage error). No additional adverse event was reported.
Woke up with a case a vertigo that lasted 30-45 minutes, Headache that lasted around 6 hours that same day
Sore arm;  tiredness; itchiness at injection site Lasted for approximately 3 days.
Headache, Arm Swelling, Red Rash on complete upper arm, Severe Itching
Pt received vaccine @ 12:15 PM. Prior to vaccine pt warned nurse of Hx w/ passing out after injection/blood draw. Nurse administered vaccine and conversed w/ pt in an attempt to distract pt. @ about 12:30 PM pt c/o nausea & lightheadedness . Pt was laid down in trendelenburg position. Pt was still conscious and able to speak. Two sets of vitals were taken. Both were WNLs. Pt was observed for 30 mins and d/c home. No further medical f/u needed. - Healthcare Provider.
pain; swelling/ swelling of knuckles/ blueberry on knuckle; Joint pain/ pain on knuckles / knee pain/ Pain ankle; swelling of hand; swollen lymph node on the left side of neck (midway between the front and back); flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th December 2018, the patient received the 1st dose of Shingrix. In February 2019, less than a year after receiving Shingrix, the patient experienced influenza-like symptoms and enlargement of lymph nodes. On 10th March 2019, the patient experienced pain in hand, swollen joints, pain in joint involving hand and hand swelling. The patient was treated with prednisone and steroids nos (Steroids). On an unknown date, the outcome of the influenza-like symptoms was unknown and the outcome of the pain in hand, swollen joints, enlargement of lymph nodes, pain in joint involving hand and hand swelling were recovered/resolved.   The reporter considered the influenza-like symptoms to be related to Shingrix. It was unknown if the reporter considered the pain in hand, swollen joints, enlargement of lymph nodes, pain in joint involving hand and hand swelling to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient had 1st dose of Shingrix on left arm without any symptoms.  In late February 2019 she had flu like symptoms and a swollen lymph node on the left side of her neck (midway between the front and back) which resolved.   On 10th March 2019, 82 days after receiving Shingrix vaccine the patient experienced pain and swelling of her hand and knuckles.   The patient's knuckles looked liked she had a blueberry on each knuckle. The size of a blueberry not the color.   The color of her skin was normal. Later that day the pain and swelling traveled to her knee and ankles and then to all joints all over her body.  The patient was treated with prednisone for 10 days and the pain and swelling subsided.   As soon as the prednisone was withdrawn, the symptoms came back.  The patient was treated with steroids again and the symptoms resolved.   The patient took her last dose day before reporting. The reporter consented to follow up.
Patient reported shoulder pain and hypotension on the following day. Stating his first BP was in the 90s and second in the 50s. He also stated he felt dizzy. Recommended he follow up with PCP as hypotension the following day is generally not a side effect of immunization. As for shoulder pain, patient had issues with that last year as well
This is a spontaneous report from a contactable other healthcare professional via a Pfizer sales representative.  A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (batch/lot number: EL9262) as 2nd dose, single for COVID-19 immunization. Medical history included polycystic ovarian syndrome (PCOS). The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 on an unspecified date as 1st dose, single for COVID-19 immunization. On an unspecified date, the patient experienced soft tissue swelling and erythema at injection site, elevated temperature, chills, headache, body aches, fatigue, mild abdominal cramping twice, bleeding/spotting in vaginal area, has not had a period in over 22 months. The patient underwent lab tests and procedures which included body temperature: elevated on an unspecified date, weight: 150 (unit unspecified) on an unspecified date. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.
Information has been received from a registered nurse concerning a 3 year old patient of unknown gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 16-NOV-2012 and 18-JUN-2013, the patient was vaccinated with the first and second dose of VAQTA (lot numbers, expiration dates and doses not reported) intramuscularly, respectively. On 22-JUL-2015 the patient was inadvertently administered a third dose of VAQTA lot # K018181, expiration date 04-JUN-2017, intramuscularly (dose not reported) (Extra dose administered). No adverse effects were reported. Additional information has been requested.
Patient had pallor, reported lightheadedness, felt jittery. Patient reports not having breakfast. Juice given and calming techniques provided, did not resolve symptoms. Denies throat swelling or difficulty breathing. Blood pressure elevated, denies history of hypertension. Other vital signs stable.
Based on document review of Influenza vaccination consent form, on 9/29/21 @ 1626, employee received a dose of Hepatitis B (engerix B) vaccine by her department flu champion instead of receiving a dose of Flulaval. Employee Health spoke with employee on 1/26/22 to disclose the discovery of the error. Employee denies having any adverse reaction/side effects from the vaccine. Employee is scheduled to receive an influenza vaccine by Employee Health on 1/28/22.
Pain, swelling, approx 3 hours after receiving vaccine worsening later in day. This AM arm more swollen and painful developing hives about noon.
Information has been received from a physician concerning an approximately 20 year old female, with no medical history, who on 11-JAN-2007 was vaccinated intramuscularly with a first dose of HPV vaccine (yeast). Concomitant therapy included hormonal contraceptives (unspecified). On approximately 21-JAN-2006 the patient developed bilateral tender lymph nodes and malaise.  Unspecified medical attention was sought.  At the time of the report, the patient's bilateral tender lymph nodes and malaise persisted. There were no laboratory or diagnostic tests performed.  Additional information has been requested.
Flu-like symptoms for the first 3 days: fever, chills, body aches, headache, itchy skin, pain in injection site (left arm). A few days later I started my period. It was irregular with severe PMS, panic attacks, anxiety and depression, severe cramping, more bleeding and blood clots than usual, period lasted longer than usual. Every day since I have been having PMS symptoms (anxiety, depression, panic attacks) and cramping. The cramping feels like period cramps but I am no longer on my period. The cramps last all day long and are not going away. I also had severe eye pain in my right eye about 1 week after the injection. The pain lasted for about 2 days, and was a throbbing pain behind my eyeball. I have never experienced any issues with my eyes before. I also had covid January 2021 and did not experience any of these symptoms then.