chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID ARM; Red rash that lingers on for a while/ Red big rash; Itchy; Hurting; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headaches) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced HEADACHE (Headaches). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.    This case was linked to MOD-2021-094117 (Patient Link).
I exp chills low grade fever not to exceed 100, fatigue and body aches.I also had a cough that developed after the first dose.
right vision got more blurry; stroke on the left side of brain; felt weird; tongue started to go numb; Right side of face went numb; Headache; CBCT scan found nothing but calcification; overall cholesterol was 221; LDL was 124; triglyceride was 156; This is a spontaneous report from a contactable consumer (patient). A 57-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 09Apr2021 (lot number: EW0162), as 1st dose, single dose, at age 57 years old, for COVID-19 immunisation. Medical history included asthma, arthritis, environmental allergies, and allergy to grass ragweed, mold, tree pollen which triggers the asthma. Concomitant medications included celecoxib (CELEBREX) taken for arthritis from an unspecified date and ongoing; nicotinamide (VITAMIN B3); vitamin C; and vitamin b complex, taken for unspecified indications, start and stop dates were not reported. On 19Apr2021, between 19:30 to 20:00, the patient had a stroke on the left side of brain. It was also reported that on an unspecified date in Apr2021, the patient felt weird, tongue started to go numb, right side of face went numb, right vision got more blurry, and had headache. These events resulted to hospitalization on 20Apr2021 for 2 and a half days (as reported). In Apr2021, when the patient was in the hospital, laboratory tests were performed which included activated partial thromboplastin time (APTT), blood thyroid stimulating hormone (TSH), Hemoglobin A1C, lipid panel, basic metabolic panel, comprehensive metabolic panel, CBC platelet with automated differential, prothrombin INR, prothrombin time, i-STAT Troponin and Sonogram of carotid bilateral vascular in neck which were all normal; Triglycerides was 156, High density lipoprotein (HDL) was 53, Low density lipoprotein (LDL) was 124, Total cholesterol (overall cholesterol) was 221. On 10Apr2021, the patient underwent CBCT scan of the whole body which showed no aneurysm, no cancer, found nothing but calcification. The outcome of the events was unknown.  Follow-up attempts are needed. Further information is expected.
vomiting last night but has resolved, still presents with sore throat referred to primary provider if symptoms worsen
Injection site swelled to size of a softball - told her to take BENADRYL and ice it.
No adverse effects reported.; an unspecified number of patients received improperly stored dose of RECOMBIVAX, GARDASIL 9, MMRII, or PROQUAD; The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify.  Follow-up information has been received from the practice manager on 18-SEP-2018.  This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided.       On 26-APR-2018, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (recombinant Human albumin) (strength and route were unknown) (lot#  N020620 and expiration date 22-JAN-2019) for prophylaxis (Incorrect product storage). The sterile diluent (MERCK STERILE DILUENT) was properly stored. No adverse event was reported.  The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001959:
Patient came to ED with nausea, vomiting, and epigastric pain.  Patient admitted to hospital with Covid and leukocytosis.
Gastrointestinal symptoms beginning approximately 20-24 hours post vaccination and lasting approximately 14 days.  Colitis-like symptoms with cramping, diarrhea, mucous, urgency.   No prior GI dysfunction, no infectious contacts.
Information has been received from a physician concerning a 22 year old female patient with no previous medical history reported who on an unknown date, when she was child, was vaccinated with a dose of MMR II (Lot number was not available). In September 1993, October 1993 and in 1995 the patient was vaccinated with the first, second and third dose of RECOMBIVAX HB (manufacturer unknown) (Lot numbers not available) respectively. Subsequently, in the past few weeks, the patient had negative titers for MMR and hepatitis B. Recently, titers were performed. The patient sought unspecified medical attention and may be referred to an allergist or an immunologist. The patient's outcome was not recovered. Additional information has been requested.
04-27-09 patient came for a well child check, immunizations given at 9:30AM at around 1:30PM patient woke up from sleep cried and turned limp, called 911. 5/13/09 hospital records received DOS 4/27/09 to 4/30/09 FINAL DIAGNOSIS: Apnea, status post immunization Post vaccination crying, limp, vomiting, apnea, fever, nasal congestion, pupils dilated, tachycardia. Agitated, irritable. TM dull. Erythema diaper area.   5/18/09 Discharge summary received DOS 4/27/09 to 4/30/09. FINAL DIAGNOSIS: Apnea resolved, sepsis ruled out Post vaccination cried and became limp, febrile, nasal congestion.  Follow-up states - Pt recovered.
Pt noticed itching at injection site several hours after receiving vaccine. The next day, he noticed hives around injection site and on arms and spreading to hands. His hands started to swell and this increased in severity the following day. He called for advice, who told him that "it will probably get better in a few days." There was no improvement in a few days, so he went to the emergency room on 10/13/17 where he was given a prescription for hydroxyzine HCL, which he filled at a pharmacy. The hydroxyzine didn't provide much relief, so he went to his primary care provider, Dr. on 10/16/17. He prescribed a prednisone taper and his symptoms improved greatly within 2-3 days.
Nodules developed under the skin at both injection sites   They both turned bright red with the bump and itched a little. The COVID shot had a bigger nodule than the flu. I?m worried it could mean the shots did not make into the muscle and the vaccine built up in my tissue. They are still there but have not grown in size
IMMEDIATELY AFTER IMMUN., ONSET OF FLUSHING, PROFUSE PERSPIRATION, SHARP HEADACHE.  LOW FEVER, ACHING, OCCURRED SEVERAL HRS POST-VAX. PT NOT SEEN BY PHYSICIAN.
30JAN92 short stiffening arms & legs few seconds; 1FEB92 several seconds of body stiffening & arching, turned blue, eyelids fluttered;
Bleed when she injected me. She did not draw the needle back to see if it was in a vein. That evening fever of 100.7. Horrible headache all weekend nothing helps even prescription headache medicine!  Left arm site of injection hurts very bad even to lift!  Put ice on it did not help. Saturday fever of. 101.1 even with medication, arm still in pain.  Iced again, Tylenol again fever still there pain did not go away. Sunday morning woke with  red spots half way down my warm, hit to touch still in pain. Took Benadryl it did not help.  Went to health clinic they gave me topical steroid and prescription for antihistamine.
fever; sweats; chills; aches and pains; weakness; This case was reported by a consumer via call center representative and described the occurrence of fever in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2020, the patient received the 1st dose of Shingrix. In August 2020, less than a day after receiving Shingrix, the patient experienced fever, sweating, chills, pain and weakness. On an unknown date, the outcome of the fever, sweating, chills, pain and weakness were recovered/resolved.   It was unknown if the reporter considered the fever, sweating, chills, pain and weakness to be related to Shingrix.  Additional details were provided as follows: The patient developed fever, sweats, chills, aches and pains, and weakness.  The patient states that these symptoms resolved after 2.5 days.  The patient did not have additional information for this case. The reporter did not consent to follow-up. For the tolerance of 2nd dose of Shingrix, refer linked case US2020226615. This case has been linked to US2020226621, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020226621:same reporter (husband´s case) US-GLAXOSMITHKLINE-US2020226615:SAME PATIENT (2ND DOSE)
Pt. received 2nd dose of Pfizer, waited 30 minutes in observation and went to leave. After walking approx 100 yrds, pt. developed hoarseness and tongue tingling, mild difficulty with breathing- contacted clinic staff. Pt. reported this was how her last anaphylactic reaction started >16yo ago. She was escorted to a private location, given 50mg liquid diphenhydramine. Pt. evaluated by medical staff, intermittent hoarseness noted with mild diaphoresis, HR 62, BP 176/90, RR 20. Pt. able to maintain airway and manage secretions, no acute distress. Pt. verbalized feeling of plateau of sxs 15 minutes after diphehydramine admin. EMS staff on scene and pt. transported to local hospital.
Caller reporting AE of improperly stored vaccine administered to patient; This spontaneous report was received from a nurse referring to a 23 years old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  On 20-AUG-2020, the patient was vaccinated with improperly stored of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # S008151, expiration date: 20-NOV-2021; 0.5 milliliter; route was not reported) for prophylaxis (product storage error).    The administered dose of the vaccine experienced a temperature excursion -48.39 Fahrenheit (F) for 1 hour and 45 minutes time frame. There was no previous temperature excursion. The digital data logger was involved.  No additional adverse effect details available. Device was not available for evaluation (obtain was reported as false). combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: S008151; expirationdate: 20-NOV-2021; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability.
PATIENT RECEIVED VACCINE AND SAT DOWN TO BE MONITORED, SHE THEN FAINTED AND APPEARED TO BE SEIZING, VACCINATOR MONITORED PATIENTS BREATHING WHILE STAFF CALLED 911. PATIENT HAD SEIZURE LIKE ACTIVITY FOR 10-15 SECONDS, WAS  UNCONSCIOUS FOR 30-45 SECONDS, MADE LABOR BREATHING SOUNDS WHILE UNCONSCIOUS, APPEARED FLUSHED AND SWEATING. AMBULANCE TRANSPORTED HER TO THE HOSPITAL, SHE WAS AWAKE AND ALERT WHEN SHE LEFT OUR FACILITY.
pt stated she went to her mother's office (Mom is an MD) after receiving immunizations.  Added she felt "hot" & "sluggish".  Shortly after ariving, she developed hives to both arms & tightening of her mouth.  Nurse in office administered Benadryl 25 mg IV.  According to pt & nurse, she immediately felt better.  No follow up recommended
burning sensation on left arm; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (burning sensation on left arm) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.No concomitant medication was reported.     On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced BURNING SENSATION (burning sensation on left arm). At the time of the report, BURNING SENSATION (burning sensation on left arm) outcome was unknown. Unknown   Treatment medication was not provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
breakthrough Covid; Breakthrough Covid; This is a spontaneous report from a contactable consumer or other non-HCP (daughters friends mother). A female patient of an unspecified age received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number-UNKNOWN) via an unspecified route of administration on 11Sep2021 as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced breakthrough covid on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: breakthrough covid on an unspecified date. The clinical outcome of the breakthrough Covid was unknown.  Description of Product Complaint: Caller relays his daughter (name) best friend told him, she was talking with his daughter and he heard them talking, and his daughter asked him if she could come over for a sleepover and he said sure and then found out that the friends mom had come down with Covid 3 weeks ago and he didn't ask at that time about vaccine and just said no she can't come over. Caller states he asked (name) if her mom got the vaccine and (name) said yes and he asked which one and her mom got the Pfizer Covid vaccine and that put him on the hook to report.  Caller states this was Saturday night that he got confirmation that she did have a breath through case. Caller has no further details or information to provide.  This lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Patient lost consciousness in his chair. He came around after about 20 seconds. His blood pressure was measured at 86/42 and his heart rate was 36. He was sweating profusely. Emergency services were called but patient refused to be evaluated.
Information has been received from a Doctor of pharmacy concerning an 81 year old female patient with no known drug allergies who on 07-APR-2011, was vaccinated subcutaneously in left arm with 0.65 mL of ZOSTAVAX (Merck) (Lot# 669590/1507Z, expiration: 02-FEB-2012). Concomitant therapy included LEVOXYL and DIOVAN. The pharmacist reported that on 08-APR-2011 the patient experienced complete hearing loss in her left ear after administration of ZOSTAVAX (Merck). The patient sought unspecified medical attention. No laboratories were performed. No treatment was given for this adverse event. At the time of reporting the patient had not recovered. The pharmacist considered the complete hearing loss in patient's left ear to be disabling. Additional information has been requested.
Loss of consciousness, probable cardiac syncope, prolonged QT to 628, last known prior QT in March of 2021 was 467.
Upon waking up my upper back muscles were very tight and spasming.  This also caused excrutiating pain in my lower back.  I also am having pain shooting up my neck on both sides from time to time and constant neck stiffness.  My hands are a little swollen and my fingers are very sore and it is very hard to grip things.  This has all been going on for about three weeks now.  I also feel fatigued, more than usual.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient's medical history and current condition are not reported. It was reported that on 07-JUL-2014 the patient was vaccinated with expired ZOSTAVAX (lot # J001007 and expiry date 24-APR-2014). Other co-suspects and concomitant medication are not reported. Also reported that the ZOSTAVAX did not have any previous temperature excursions. No adverse symptoms are reported. Product quality complaint was not reported. The outcome of the event is unknown. Additional information has been requested.
Patient had a metallic taste in the back of her throat. She has a history of several allergies and she felt like she was going to have an allergic reaction. She became anxious and had slight shaking in her hands and legs.  She removed her mask and jacket and sat calmly. We took her BP and Pulse Ox and she was normal. She sat for 1 hour and then felt better to leave.  I followed-up with her 4 hrs later and she was okay but just didn't feel right. I advised her to come to the ER if her symptoms worsened.
Child had a flu vaccination on 10/15/2014 and leg became red, swollen and irritated. Child was diagnosed with cellulitis and put on AUGMENTIN for 10 days. Left thigh was flu shot.
Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Approximately 4 minutes after receiving the vaccine, patient reported tingling of the left hand (left deltoid is the site of administration), left eye twitched once, left side of neck spasmed once and left hand tingling remained. Patient remained in the pharmacy in store clinic for 20 minutes. Patient was contacted via cell phone to follow up but no answering machine answered phone call.
adult patient received Infanrix; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 60-year-old female patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th March 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 15th March 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The pharmacist reported that, an adult patient received Infanrix instead of Tdap booster dose, which led to inappropriate age at vaccine administration.  The reporter stated that it was not done at her location. Lot and expiration date not available to share. The reporter consented to follow up.
Clientreceived vaccine, became progressively light headed, had approximately 10 second Loss Of Consciousness. Awoke and was able to ambulate to wheel chair without difficulty or residual light headedness. Brought immediately to treatment area by wheel chair and recovered fully
This case was reported by a healthcare professional and described the occurrence of injections site soreness in a 8 to 80 subject's of unspecified age and gender who were vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subjects received unspecified dose of FLUARIX (reported as 15 mcg, subcutaneous) and experienced inappropriate route of vaccination and injection site soreness. The nurse reported that between 8 to 80 healthcare workers at this institution received FLUARIX SC (subcutaneously). Subjects complained of injection site soreness lasting more than 5 days. No additional information is known at this time. At the time of reporting the outcome of the injection site soreness was unspecified. The nurse also reported a case of injection site redness, soreness and inappropriate route of administration (see Case ID A0809114A for more details). Follow up information was received on 20 October 2009 from the reporting nurse. Initially some flu vaccine may have been given SQ (subcutaneously). Since the initial report many of the subjects who were vaccinated by the administering staff member had said they did receive an IM (intramuscular) injection so she had no further follow up. The outcome of the events were resolved.
Pt c/o dizziness, nausea, headache and stomach ache and fell on her head to the floor 5 min after receiving Td and HAV. BP 10.  with SC swelling on rt upper side of ? ice pack applied.
Patient developed symptoms of Covid-19 pneumonia on 2/10/2021.  He was treated as an outpatient by his PCP.  On 2/15/2021 he was admitted to the hospital with Covid-19 pneumonia and hyponatremia.
Cognitive impairment for four days, felt concussed. Difficulty with language and "finding words."
Headache that started about 1 hour after the shot and lasted over night Severe arm pain that radiated down my arm and through my middle finger; started shortly after the injection and continued for nearly three days; discomfort that woke me from sleep The two and a half weeks after the shot my menstrual cycle started. This was 2 weeks early than expected.
(First COVID shot) Immediately (likely due to low glucose levels): Dizziness; muscle spasms; burning in neck and face; chills/chattering teeth (settled down after about an hour, drinking Gatorade and eating). About an hour after the shot: Nausea, lightheadedness, diarrhea. Afternoon of 4/9 to 4/11: Nausea, repeated vomiting, repeated diarrhea, chills, chattering teeth, headache, body aches, fatigue, unable to keep food down, fever. Morning of 4/11: Still feeling body aches, headache, and slight nausea; fever reduced; vomiting stopped.