chrisvoncsefalvay/vaers-outcomes huggingface dataset:
He can't even hold a bottle of water; Excruciating pain, hasn't spent a moment without pain; His arm was on fire; He can't lean on his arm, it hurts more than anything; He is sleeping on a chair because he can't lean on his arm; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (He can't even hold a bottle of water) and PAIN (Excruciating pain, hasn't spent a moment without pain) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Nerve block (Patient had a block nerve at birth; this condition was similar to cerebral palsy).   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced MUSCULAR WEAKNESS (He can't even hold a bottle of water) (seriousness criteria disability and medically significant) and SLEEP DISORDER (He is sleeping on a chair because he can't lean on his arm). 15-Mar-2021, the patient experienced PAIN (Excruciating pain, hasn't spent a moment without pain) (seriousness criterion medically significant), BURNING SENSATION (His arm was on fire) and PAIN IN EXTREMITY (He can't lean on his arm, it hurts more than anything). The patient was treated with Physical therapy for Muscular weakness; Physical therapy for Pain; Physical therapy (It did nothing) for Burning sensation and Physical therapy (It did nothing) for Pain in extremity. At the time of the report, MUSCULAR WEAKNESS (He can't even hold a bottle of water), PAIN (Excruciating pain, hasn't spent a moment without pain), BURNING SENSATION (His arm was on fire), PAIN IN EXTREMITY (He can't lean on his arm, it hurts more than anything) and SLEEP DISORDER (He is sleeping on a chair because he can't lean on his arm) had not resolved.            Concomitant product use was unknown. The patient stated he experienced excruciating pain that still going on more than a month now and his pain level is 100 (one hundred) on a scale of 0 to 10 (zero to ten). The patient also reported that he received his second dose on his right arm and did not experience any single side effect. Treatment for the events included Gabapentin, Percocet, Fentanyl.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Patient's medical history of a neurological disorder may be contributory to the elevated intensity of the events.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Patient's medical history of a neurological disorder may be contributory to the elevated intensity of the events.
achy and tired; achy and tired; This is a spontaneous report from a contactable consumer. A patient of an unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 29Mar2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), as a single dose for COVID-19 immunization. It was reported that, got my second Pfizer shot yesterday (29Mar2021) and patient was achy and tired today (30Mar2021). The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Narrative:  COVID infection following COVID vaccine series 12/31/2020, Pfizer, dose #1 01/25/2021, Pfizer dose #2 09/22 pt cc: chills, cough, diarrhea, fatigue, loss of taste or smell, myalgias, rhinorrhea, dyspnea exposure: unknown 09/23 COVID swab, result: detected 09/23 COVID-19 Ag: not detected 09/23 SARS-COV-2 Variant Sequencing result: pending
My eye lids got red spots almost like styes, but not quite the same amount of bump and pain - didn't get to that final stage of white bump like a stye.  Got on both upper and lower lids, and both eyes. This was a few weeks after the first vaccine and they hadn't gone away by the second and returned to same size and color and additional added. Now 2 months after 2nd shot eyelids still have some bumps and red color
This spontaneous report as received from a health care professional refers to a multiple unspecified patients of unknown demographics. On an unspecified dates the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (dose and route unspecified). These were the possible lots/expiration involved: (L005299, 17-FEB-2017), (L001335, 13-JAN-2017), (L011083, 1-APR-2017), (L016127, 6-MAY-2017). No adverse effects reported. Additional information has been requested.
This spontaneous report was received from a physician refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. On unknown dates, the patients were vaccinated with doses of ROTATEQ (route, lot number and expiration date were not provided). On unknown dates, there was an incorrect product storage as the multiple unspecified patients were administered improperly stored ROTATEQ. No adverse events were reported. It was unknown if the patients sought medical attention. The outcome of incorrect product storage and no adverse event was unknown. This is one of several reports received from the same source. Additional information has been requested.
Quizzie about 20 minutes after vaccination,then more nuaseated, burning in chest, light headed, HA and cold Sweat.  Seen in ED                           States had similiar reaction 8-9 years ago.
Injection site felt like someone punched; Initial information was received on 17-Nov-2021 regarding an unsolicited valid non-serious case from a Social Media via a consumer/non-health care professional.  This case involves a patient (unknown demographics) whose injection site felt like someone punched (vaccination site pain) after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date (in November 2021), the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination.   On an unknown date (in November 2021), the patient developed a non-serious injection site felt like someone punched (vaccination site pain) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, outcome of the event was unknown.  The reporter did not report the causality of event with suspect.  There will be no information available on the batch number for this case.
Red & hard & hot to the touch. Pain on site (on right deltoid) up to (Rt) side of neck. Fever.
Seizure lasting 10 minutes followed by second seizure 3 hours later and high fevers lasting days.
RED, TENDER, SWOLLEN AND WARM AREA AT SITE OF polio or DTaP.
Vaccinated 10-24 3PM  with PNEUMOVAX 23 (also receive  FLUZONE HD in other  arm). By 12PM  on 10-25 visited doctor and they gave her BACTRIM DS for suspected cellulitis in left arm (PNEUMOVAX 23). By 4PM  on 10-25 sx worse and went to hospital and received vancomycin around 8PM  on 10-25 and again Thursday am on 10-26. She was allowed to go home and has completely recovered  from cellulitis infection.
10 hours after receiving shot - low grade fever, sore arm, extreme fatigue, no smell or taste.
Patient reported feeling "fuzzy". Pallor in appearance. She vomitted once. This lasted 30 minutes.
Woke up during night with severe chills, entire body was shaking, could hardly walk, slight headache and arm hurt. and sore joints.   Was a little better several hours later but very fatigued.  Felt normal the following day (11/6/21) but still a little fatigued.    Had no reaction after my second Moderna vaccination in March 2021 except two days after vaccination was very fatigued for a day or two.
Nausea, some vomiting, fever <101.0, aches, chills, sweating
First symptom was flu-like the following day of the 2nd vaccine. That went away the following day.   Eight days later I had dry cough, congestion and itching (first with large welts).  Welts went away the net day, but the itching still exists and i am taking Cortisone cream 2.5% every day.  Since I have experienced the itching from two previous occasions years ago, I knew exactly what I was in for long term.  I had previously, about 15 years ago, itching that would not go away and had been prescribed the medication Predizone by a dermatologist.  The itching was not as severe after taking the meds, but continued itching for another 3-4 months.  It finally went away.  My new experience with this side effect from the Moderna Vaccine with the second dose, was very similar to the itching experiences I've had in the past.   I am also still experiencing congestion when I get up in the middle of the night and bring up a lot of mucas. If you need any additional information on my symptoms, but call or email me.  I have not contacted a doctor yet at urgent care, but if the itching continues, I will go to urgent care next month.  Meanwhile I thought my symptoms should be reported to you.
This spontaneous report was received from a Registered Pharmacist (R. Ph) concerning a 59 year old male patient. The patient's pertinent medical history and concurrent conditions were not reported. On 05-JUL-2017, the patient was vaccinated with a dose of PROQUAD (dose, frequency and route were not reported) (Lot # reported as N013268; expiration date 25-OCT-2018) for prophylaxis instead of M-M-R II. No adverse effects. There was no product quality complaint involved.
Experience severe nausea with vomiting and diarrhea. Called fire department ambulance and was taken to Hospital. Adm. 11/2 to 11/4/10 for monitoring and fluids IV.
headache; chills; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiration Date not reported) via an unspecified route of administration as 1st dose, single dose on 18Feb2021 for COVID-19 immunisation and varicella zoster vaccine rge (cho) (SHINGRIX) (Batch/Lot number was not reported) via an unspecified route as 2nd dose single dose on 22Feb2021 for immunisation. The patient medical history and concomitant medications were not reported.  The patient wanted to know should he get his second dose of the covid vaccine in 2 weeks when it was due or start over. On 23Feb2021 experienced headache and chills. The outcome of events was unknown.   Follow-up (24Feb2021): This is a follow-up spontaneous report from a Pfizer sponsored Program. A contactable consumer (patient) reported event information.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
no adverse events noted; patient received Pfizer bivalent booster instead of 2nd dose of primary series of Pfizer.
Immediate swelling around site. Decreased after 15 minutes. Called pt few hours later. He was fine.
Returned to vaccine clinic 35 minutes after receiving vaccine with having heat in her cheeks, clammy hands, chest tightness and feeling that her lips were swollen. BP  175/104, pulse 118, 02 sat 98% AXO x 3, anxious appearing, No cough or respiratory distress. Anxiety increased and continued hypertensive. EMS called and transported to ED. Observed for 2 1/2 hours with symptom resolution. Discharged home
Information has been received from an RN concerning a female patient who was vaccinated with her first and second dose of Gardasil and subsequently developed 'a bit of urticaria/rash on the body after getting both the first and second dose." It was reported that medical attention was sought and that "the rash was not bad enough to discontinue the series yet". The patient's outcome was unknown. Additional information has been requested.
Pfizer-BioNTech COVID 19 Vaccine EUA  LYMPH NODE SWELLING IN RIGHT ARMPIT and Pain.
3/18/2021 - Mild Nausea, Injection Site bruised, hematoma at site and very painful all around injection site for 2 weeks. 3/18/19/20/2021  - 3 days of extreme fatigue kept me from usual activities. Resumed activities on 4th day. Received no Dr. treatment.
Bottom left side of her lip, and right side of her upper lip, she broke out in 6 or 7 cold sores/lumps from the cold sores on one side of lower lip in the corner along the edge.; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (Bottom left side of her lip, and right side of her upper lip, she broke out in 6 or 7 cold sores/lumps from the cold sores on one side of lower lip in the corner along the edge.) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product HYALURONIC ACID (RESTYLANE) for an unknown indication.    The patient's past medical history included Dental cleaning. Previously administered products included for Product used for unknown indication: Flu shot; for Drug use for unknown indication: BOTOX. Past adverse reactions to the above products included No adverse event with BOTOX and Flu shot. Concurrent medical conditions included Seasonal allergy. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and VITAMINS NOS for an unknown indication.   On 11-Jan-2022, the patient started HYALURONIC ACID (RESTYLANE) (unknown route) at an unspecified dose. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2022, the patient experienced ORAL HERPES (Bottom left side of her lip, and right side of her upper lip, she broke out in 6 or 7 cold sores/lumps from the cold sores on one side of lower lip in the corner along the edge.). The patient was treated with CEFALEXIN (CEPHALEXINE) ongoing from 15-Jan-2022 at a dose of 500 microgram and VALACYCLOVIR [VALACICLOVIR] ongoing from 20-Jan-2022 at a dose of 1 gram (4). At the time of the report, ORAL HERPES (Bottom left side of her lip, and right side of her upper lip, she broke out in 6 or 7 cold sores/lumps from the cold sores on one side of lower lip in the corner along the edge.) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information include triple antibiotic ointment. The consumer received COVID Moderna vaccine year ago in January 2 shots, and last fall got the booster. Patient had no dental procedures in the past 6 to 12 months, other than a dental cleaning.
Information has been received from a licensed practical nurse concerning a four year old female patient with no pre-existing allergies or medical conditions and no illness at the time of vaccination who on 16-SEP-2009 was vaccinated with a fourth IM dose of PREVNAR (lot# B08657F) and on 19-SEP-2006 was vaccinated with a second SC dose of VARIVAX (Merck) (lot# 653516/0347F). On 25-FEB-2010 the patient developed 50-60 red papular lesions with a few purulent lesions and no fever; a large patch was first noted in her abdomen and then spread for three-four days. There was no fever. The patient did not seek medical attention. At the time of the report, the outcome of the patient was unknown. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a 64 year old patient of unknown gender. There was no information about the patient's pertinent medical history, drug reactions or allergies provided. On 28-MAY-2016, the patient was vaccinated with first dose of RECOMBIVAX HB (frequency, indication, lot #, expiration date and therapy type were not reported), intramuscularly for prophylaxis. On 22-AUG-2016, the patient was vaccinated with second dose of RECOMBIVAX HB (frequency, indication, lot #, expiration date and therapy type were not reported) intramuscularly for prophylaxis. No side effects were reported. Additional information has been requested.
moderna vaccine  and then woke up with itchy swollen arm and some redness on neck  had mild itchy throat for one week no sob no cough no sweats or chills
Lymphadenopathy on same side of shot; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730), via an unspecified route of administration in the left arm on 24Mar2021 at 17:15 (at the age of 26-years-old), as a single dose for COVID-19 immunisation. Medical history included asthma. The patient did not have any allergies to medications, food, or other products. Concomitant medications received within 2 weeks of vaccination was reported as not applicable (N/A). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205), via an unspecified route of administration in the left arm on 02Mar2021 at 09:15 (at the age of 26-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021, the patient experienced lymphadenopathy on the same side of the vaccination. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of lymphadenopathy was not recovered.  No follow-up attempts are needed. No further information is expected.
dehydration and severe pain. PT got 2nd covid vaccine yesterday noon. Woke up w/ whole body pain around 0130. No fever. Reports nausea and x3 vomit w/o blood.No chest pain or SOB. Not taking medication per PT. HISTORY OF PRESENT ILLNESS: 19 yo F p/w headache, nausea, vomiting, body aches for 4 hours after receiving 2nd COVID vaccine yesterday. Acute onset of symptoms, mild generalized body aches with bitemporal pressure headache. Emesis x3 w/o blood. Denies fever, chills, chest pain, dyspnea, abdominal pain.
Flublok was administered to a pregnant patient, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health care profession via The Agency (Reference number- 00324247) and transmitted to Sanofi on 22-Oct-2020.  This case involves a 34 years old female patient received on (08-Oct-2020) 0.5ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot no: UJ446AA and expiry date: 18-Mar-2021 Strength = standard) once via intramuscular route in left arm for prophylactic vaccination and while she was pregnant (vaccine exposure during pregnancy).  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.  The estimation due date was 04-Apr-2021.  The patient was 14 weeks pregnant.   The date of last menstrual period was not reported.  Medical history, medical treatment(s), past vaccination(s) and family history were not provided.  The patient had no other vaccines.  It was also a case of vaccine exposure during pregnancy.  At the time of report, no adverse event was reported.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
Cough, sore throat, headache, runny nose, lethargy starting on 15 March 2022 and continuing through 25 March 2022.
4AM on 19APR96 pt awakened mom saying had severe h/a in rt temple area & it hurt so bad could not talk;had high fever but was not taken by thermometer;appetite dec but not vomiting;later c/o sl earache;
Sudden dizziness while standing outdoors; extreme chills; heavy breathing difficulty; Nearly fell over; This is a spontaneous report was received from a contactable consumer (patient). A 96-years-old female patient (Non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in left arm on 27Jan2021 11:30 as single dose for covid-19 immunisation. Medical history included allergies to medications, food, or other products maybe penicillin. Concomitant medications included lovastatin, thyroid patient received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 29Jan2021, at 11:00AM, the patient had experienced sudden dizziness while standing outdoors 48 hours after vaccine injection, extreme chills, and heavy breathing difficulty. Nearly fell over but son caught her. Treatment received for the adverse event are unknown. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up (15-Apr-2021): This follow-up is being submitted to notify that the batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
slightly sore arm, flu like symptoms including: fever, chills, nausea (had empty stomach and no throwing up), bad headache.  took two extra strength Acetaminophen every six hours. Stayed in bed and slept as much as possible.
Headache; Fever; This case was reported by a consumer and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th November 2020 08:00, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced headache and fever. On an unknown date, the outcome of the headache was unknown and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the headache and fever to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient received the 2nd dose of Shingrix experienced fever and headache. The reporter stated that had fever for 2.5 days and have headache on and off. The reporter inquired How long do side effects like headache and fever typically would last. The information regarding consent to follow was not reported.
mom called 21JAN97 & reported pt had sz 1115PM on 14JAN97 & was taken to Er;mom described sz as very rigid, eyes rolled, head back;hosp x 2 days Wednesday & Thursday;test done EEG -CXR-CAT Scan-blood work WNL;
Pt had generalized seizure, pupils dilated, non reactive, upper extremities contracted, diaphoretic, apneic.  Seizure activity lasted approximately 30 sec.  Pt attended by Rn clinic supervisor and NP.