chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fatigue; Nausea; Headache; Abdominal pain; Muscle soreness (spot of injection, it is better now); This is a spontaneous report from a contactable other healthcare professional, the patient. A 29-year-old female received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL0140), via an unspecified route of administration on 28Dec2020 at 04:00 PM (at the age of 29-years-old) as a single dose in the left arm for COVID-19 vaccination. The patient had no relevant medical history. The patient did not have any allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Prior to the vaccination, it was unknown if the patient was diagnosed with COVID-19. The patient's concomitant medications in the past two weeks included bupropion hydrochloride ER 200 mg and ritual vitamins. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 29Dec2020, the patient experienced fatigue, nausea, headache, abdominal pain and muscle soreness (spot of injection is better now). The patient did not receive any treatment for the events. The clinical outcome of fatigue, nausea, headache, abdominal pain and muscle soreness was recovering.  It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Gradual pressure about eyes and pain in temple along with eyelid twitching uncontrolled. , increasing continuously daily until the headaches cause vertigo.  Dec 1 lost vision in Rt eye from 2:00 to 7: 00 positions. visited Ophthalmologist 12/9, she reports cornea in tact and reports something is behind the lens of right. Made an appointment with Dr, he scheduled me for MRI on 12/14. headaches continue to present with nerve twitching of eyelids
Pt with trumenba on R deltoid on 10/28; noted redness with some itching 10/29. Seen 10/30 with 2x2 inch redness on deltoid
Information has been received from a nurse referring to a patient of unknown age and gender. On 19-MAY-2015, the patient was administered with improperly stored dose of M-M-R II (lot # K016153, expiration date 24-SEP-2015, dose was unknown) subcutaneously. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
EVENING OF 12/28/20, DEVELOPED HEADACHE, FEVER, CHILLS, BODY ACHES, FATIGUE, AND INJECTION SITE PAIN. RESOLVED BY 12/30/20.
sore arm; localized reaction, flared up three times; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of herpes zoster (received 1st dose on an unknown date, refer case US2021202241).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm and local reaction. The patient was treated with ibuprofen, paracetamol (Acetaminophen) and non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the pain in arm and local reaction were recovered/resolved.   It was unknown if the reporter considered the pain in arm and local reaction to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The pharmacist reported the patient experienced sore arm and localized reaction after dose two of Shingrix vaccine. The health care professional reported that sore arm and localized reaction lasted for approximately one day but flared up three times within that day.  The patient treated the sore arm and localized reaction with ibuprofen, acetaminophen, and ice. The sore arm and localized reaction completely resolved.  The health care professional could not provide lot numbers or expiration dates of the dose given. The reporter consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021202241:same reporter
Treatment of COVID-19; Treatment of COVID-19; 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), as dose 5 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Patient had no known allergies.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received paxlovid treatment from 5Mar2023 to 29Mar2023.  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.
12/12/2022 Started about 6:30 in the evening pinching in the throat. Initially thought it was acid reflux. Deep in throat, about collarbone level. Got up about 4 AM and took a lansoprazole and went back to bed. On 12/13 I woke up with a headache above my eyes and nothing I took could get rid of the headache. I also started getting congested and having body aches. 12/14 I tested with an at home rapid COVID-19 test, this was positive. I had a social gathering the week earlier, 12/9 and 12/10 I had an exposure to Covid. On 12/14 Tele-visit with doctor. Doctor recommended treating the symptoms. I took MUCINEX to help treat the symptoms along with TYLENOL. 12/16 I started experiencing tightness in chest with a pain on the right side. I had difficulty breathing and felt like I was getting bronchitis. I had another tele-visit with doctor who prescribed ZITHROMAX. Symptoms improved considerably, with just stuffiness and at time of reporting.
No adverse event noted during office visit and injection time. Patient was given Hep A adult vaccine instead of HPV vaccine.
pfizer bivalent booster for 12yrs+ was given to 9yr old patient, no adverse symptoms
Initial Side effects were swelling at the site and fatigue for several hours. 17 hours later I woke up at 6 AM feeling tingling and swelling on my tongue. Tongue swelled significantly down towards back of throat. No signs of difficulty breathing. Took 75 mg of Benadryl and waited as my breathing was fine. Benadryl started to work called my physician who then filled an RX for EpiPen.
Slumped over while sitting about 2 hours after receiving injection. Difficult to rouse, complained of head and neck pain. Became very pale and shaky. Was feeling somewhat better by evening.
Information has been received from a registered nurse concerning an 8 year old female with no known medical history or allergies who on 12-SEP-2003 was vaccinated SC with Varivax (lot # 644796/0336N). Concomitant therapy included melatonin. On 03-JUL-2006 the patient presented with breakthrough chickenpox. The patient had approximately 60 pus marks in different stages. Some of the rashes consisted of small red bumps, some were fluid filled, and some were scabbed over. The rashes were very itchy. The patient was afebrile. It was reported that the patient was exposed on 28-JUN-2006 to an older sibling who had shingles. Medical attention was sought. No laboratory diagnostic tests were performed. There was no product quality complaint involved. Additional information has been requested.
Four raised plaques about 1.5 cm across each, in square pattern on left upper arm - two with puncta in middle. Spots developed on 4/14/10, five days after vaccines.  Diagnosed skin rash, possible bug bite.  BENADRYL 25 mg every 6 hrs PRN.
UNSPECIFIED REACTION TO THE VACCINE; This spontaneous report received from a patient concerned multiple patients. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch number. No concomitant medications were reported. On an unspecified date, the subject experienced unspecified reaction to the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unspecified reaction to the vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210355323.
No additional adverse effect reported; A patient was administered a dose of improperly stored ROTATEQ; This spontaneous report was received from a physician concerning a patient of unknown age and gender. The patient's concurrent conditions, concomitant drug, medical history and historical drug were not provided.  On 24-JUN-2020, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), lot number S005875, expiration date 30-NOV-2020 administered orally for prophylaxis. Strength, dose and frequency were not provided.   The temperatures involved were: below 36 degrees farenheit (34.8 degrees F) for 25 minutes. A previous temperature excursion was reported, the temperatures involved then were: below 36 degrees farenheit (34.5 degrees F) for 1 hour and 24 minutes. A data logger was involved. No additional adverse effect was reported.  This is one of several reports received from the same reporter.
Patient stated that she has redness, swelling and discomfort at injection site one day after receiving immunization.
Started on Monday: tired, body aches, chills, called out from work.  neg test results yesterday . Today symptoms are getting better today.
I experienced an immediate reaction within minutes of getting the shot. Symptoms were a flush through my abdomen and then dizziness, lightheadedness. Felt like my motor skills were shutting down and was getting weakness like I was about to pass out. Although I have a lot of allergies to medication, I have NEVER had a reaction to a vaccine before. I was taken in for observation and this was reported. The day after the shot I woke  up with a excruciating  headache that last all day intermittently for five days with no relief from ibuprofen.  Right leg throbbing pain and hot on second day. Third day had very severe pain in the abdomen like a lot of gas early in the morning while sleeping.
nurse stated she just gave a pentacel vaccine that was 1 day expired, with no reported adverse event; Initial information received on 08-May-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 7 months old female patient and it was reported nurse stated she just gave a diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (vero)] that was 1 day expired, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included rotavirus vaccine; hepatitis B vaccine; and pneumococcal vaccine CONJ all for Immunisation.  On 28-APR-2023, nurse gave 0.5 mL (dose 2; 1x) of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (vero)] Suspension for injection (batch/lot number: UJ673AAA and expiry date: 27-Apr-2023; frequency: once; strength: standard) that was 1 day expired via unknown route in the left thigh for immunization, with no reported adverse event (expired product administered) (latency: same day).  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Electrical shocks and buzzing sensation in lower arms and legs- severe at onset, now mild. Lightheaded, heat intolerance, nausea, pain in maxilla and gums, ear fullness, excessive thirst, neck pain, and moderate to severe headache, all of which still persist. Pain treated with stretching, meditation, hot baths, ice, lidocaine gel to gums, hydration, OTC meds and supplements without great result. Headache has improved after a visit to the urgent care where a shot of toradol was given.
Fever, L. arm pain described as burning in L. arm evening of the shot.  Started noticing difficulty moving L. shoulder.  Symptoms started October 1st evening of shot and she saw me in clinic with persistent L. shoulder pain on 10/26/2021 and it is still persisting up till now.  Concerned about SIRVA
mom observed sternal retraction (persistent) w/stomach flattened; appeared to have resp effort but no air movement; EEG 31AUG w/lateralized slowing; stiff; apneic like event;
Narrative: COVID infection following COVID vaccine series 06/11 Janssen, dose #1 08/17, pt cc: rhinorrhea exposure: unknown 08/16 COVID swab, result: detected
6/10/21 went to ER cause headache, dizziness, hoarse,fatigue. They took EKG, Chest Xray, blood 3 times cause first 2 clotted. Swabbed for Strep. all came back negative . ER doctor suggested rest, drink plenty of fluids and Ibuprofen also suggested flowwup with a primary care doctor.  6/18/21 saw ENT who send a tune up my nose to my throat where my vocals were the size of grapes. ENT prescribe Fluticasone spray 2 times a day. Still can't speak. Family Care doctor prescribe 7/2/21 Methprednisolone 21 pills
Itchy rash-started day of immunization, getting worse-very widely spread size varies (~5-30mm), irregular margins, not raised-location: first ones mid abd and bilat. arms, nowhere else. Arrived ~ 1wk ago. Recommended: Benadryl, anti-itch cream prn-to go to health clinic if not improved. 4/17 TC with pt and her rash disappeared ~ 3 days after vaccination.
Fever 101-99 degrees, Red patches of skin on (R) upper arm swelling, and unable to raise arm above head. Also c/o nausea, body aches. Pt. given promethazine 25mg / POTID x 5 days.
C/O bilateral hands tingling  Denies chest pain, SOB, dizziness, headache, blurred vision, palpitations.  Seen and cleared by EMS
Burning sensation in left leg; He was at the sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03May2021 14:00 (Lot number: EW0172, Expiration Date: Aug2021) at the age of 57 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Lot: EW0162, Expiry: Jul2021., Time:14:00 , Anatomical location: Left arm, No reaction), administration date: 12Apr2021, when the patient was 57 years old, for Covid-19 immunization, reaction(s): "No reaction". The following information was reported: BURNING SENSATION (non-serious) with onset 07May2021 03:00, outcome "not recovered", described as "Burning sensation in left leg"; PAIN (non-serious) with onset May2021, outcome "unknown", described as "He was at the sore".  Additional information: The patient was telling the other lady, this morning at 3, he had a burning sensation in his left leg for a couple of seconds that woke him up. He continued that when he got up it happened again. When he got in his truck, it did it again. Every half hour or so it happened. A burning pain near his ankle that he describes as someone got a match to one spot on his leg. And this has occurred since his 2nd dose of the Pfizer COVID vaccine. No visit of Emergency Room and Physician Office. No prior vaccinations within 4 weeks.  No follow-up attempts are possible. No further information is expected.
Deadly migraine headaches that never went away, weak, diarrhea and nausea for 1 wk. Full body weakness continues at least 2 xs a week since vaccinations, plus sweating.
Large red rash at injection site.  Itchy and it burned. Lasted 6 days.  On day four and five the rash was almost gone during the day but it reappeared at night although smaller in size. I took Attrix 3 times to relieve itching and put Cortisone cream on rash twice daily.
Resident woke up the next day with facial drooping. All vitals were stable and within normal limits.  Diagnosed by physician with Bell's Palset and treated with Valtrex 1mg every 12 hours for 10 days (started 1/28/21)  Resident has recovered from reaction.
Became extremely ill about two days after receiving the vaccine. Was unable to keep down liquids or eat. Had severe stomach pain, diarrhea, and chills. Was so sick I was unable to check my temperature.
Started with headache, fatigue, sore throat, runny nose, neck stiffness 1 to 2 hr after 3rd rabies vaccination. This 3rd vaccination was at 12 noon. At midnight developed fever. Also had rash too 2 days after this vaccination.
Sore arm; This is a spontaneous report from a contactable consumer (patiet).  A 73-years-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL3248) in the Public Health Clinic/Veterans Administration facility, via an unspecified route of administration on 16Jan2021 09:15 AM at a single dose on the left arm for COVID-19 immunization.  The patient's medical history was not reported. The patient has not had COVID-19 prior to vaccination. The patient did not have any other vaccine in four weeks. Concomitant medication included losartan (manufacturer unknown), levothyroxine (manufacturer unknown), hctz (manufacturer unknown), montelukast (manufacturer unknown, also reported as 'monounsatu').  The patient experienced sore arm on 16Jan2021 at 09:45 AM. The patient did not receive any treatment for the event. The outcome of the event was recovering. The patient has not been tested for COVID-19 post vaccination.
2nd dose given on 2/24/2021, deceased on 3/2/2021
urticaria around eyes & face spread to arms & legs 2yr p/vax given DPH po x 2;urticaria again 5 days later 31MAR97 given DPH po again;pt was also on med;
Information has been received from a consumer concerning her son with reaction to all vaccines and medications he has received that contain gelatin who in 2001, was vaccinated with VARIVAX (Oka/Merck). The patient experienced vomiting after vaccination. The consumer stated that in 2007 her son had a reaction after he was given "a varicella vaccine". The reporter did not know if it was VARIVAX (Oka/Merck) or not. She said after he received the vaccine, he vomited "a slimy material and air. "This lasted for "a few hour". The patient also experienced an adverse event on MMR II (WAES#0901USA04120). Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent condition, medical history or concomitant medications were not reported. The nurse reported that on 16-FEB-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # K009953, expiry date 03-APR-2016 (dose and route of administration unspecified). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
GI: diarrhea/nasuea headache chills fever rash on site arm feeling miserable
Significant soreness at the injection site that persists now 2 months after the vaccination and does not seem to be going away.
Developed a rash around injection site about 2 hrs post injection. Rash spread up leg, around lower back and into groin area within 24 hours. Saw doctor and diagnosed with shingles. Oral antiviral prescribed, conditions is clearing up.
COVID-19; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known allergies. No relevant medical history reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 21-APR-2021 for covid-19 vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported. On 24-DEC-2021, the patient experienced covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient recovered from covid-19. This report was non-serious.
Headache; Body aches; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER9736) via an unspecified route of administration in the left arm on 28Apr2021 at 12:45 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. 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 COVID-19 vaccine. Concomitant medications included simvastatin (MANUFACTURER UNKNOWN), escitalopram (MANUFACTURER UNKNOWN), ascorbic acid (VITAMIN C), cyanocobalamin (VITAMIN B12) and colecalciferol (VITAMIN D3) all from an unknown date for an unspecified indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 07Apr2021 at 12:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. On 29Apr2021 at 22:30, the patient experienced headache, body aches, fatigue. Patient stated that he was in bed from 29Apr2021-30Apr2021. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, body aches, fatigue was not recovered.    No follow-up attempts are needed. No further information is expected.
PT STATED HE HAD RECEIVED COVID VACCINE IN PAST BUT DID NOT HAVE COVID IMMUNIZATION CARD. PT GIVEN MODERNA BIVALENT BUT PT HAS NOT HAD COVID PRIMARY IMMUNIZATION SERIES. ERROR FOUND WHEN CHARTING VACCINE. NO ADVERSE EVENT