chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 006B21A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Asthma and Allergy (Name of Drug was not Reported).   On 22-Mar-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021 at 2:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jan-2022 at 4:45 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.            No concomitant medication was reported. The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. The patient had previously received a COVID-19 Vaccine. The patient had sore throat returning 9 days later. Device date mentioned as 30-May-2022 No treatment medication was reported.  Company comment: This spontaneous case concerns a 60-year-old female patient, with concurrent asthma, who experienced the unexpected non-serious adverse event of special interest COVID-19, which occurred at an unspecified date after receiving a dose of mRNA1273. The patient was initially diagnosed with COVID-19 and was started with Nirmatrelvir/Ritonavir (Paxlovid) for 5 days. Patient reported sore throat returning 9 days later. Further details regarding the diagnostic test done and clinical course of the patient were not provided. The patient's elderly age and concurrent asthma may be considered as risk factors for the event COVID-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 60-year-old female patient, with concurrent asthma, who experienced the unexpected non-serious adverse event of special interest COVID-19, which occurred at an unspecified date after receiving a dose of mRNA1273. The patient was initially diagnosed with COVID-19 and was started with Nirmatrelvir/Ritonavir (Paxlovid) for 5 days. Patient reported sore throat returning 9 days later. Further details regarding the diagnostic test done and clinical course of the patient were not provided. The patient's elderly age and concurrent asthma may be considered as risk factors for the event COVID-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
This spontaneous report was received from a physician who is also the grandfather of the patient, regarding a 13 year old female patient with no pertinent medical history reported. Approximately in April 2009 (reported as about 5 years ago), the patient was vaccinated with the third dose of GARDASIL (lot number and expiration date not reported) (dose and route not specified). The dates of the first two doses were not specified. On an unknown date the patient experienced persistent headaches for a couple of weeks after receiving the third dose of GARDASIL. The patient recovered on an unspecified date. No treatment information was reported. It was reported that the patient sought unspecified medical attention. Additional information has been requested.
Awoke with pounding headache, fever 102 and felt breath catch (like when you breath in cold air).  Given Advil by Mother.  Symptoms gone by 12p-1p.
A female consumer reported that a male person (birthdate not identified) received smallpox vaccine (manufacturer unknown) in 1950 (exact date of immunization not specified). Subsequent to immunization, he experienced abdominal pain, neck pain and back pain. The consumer also reported that this person experienced adverse events following receipt of an influenza vaccine in 1995. See related case HQ5595503DEC2002. This information was received from manufacturer research laboratories. No additional info was available as of the date of this report.
Information has been received for the Merck Pregnancy Registry Gardasil from a 26 year old female who in April 2007 and June 2007 was vaccinated with a first and second dose of Gardasil 0.5 mL injection.  The third dose of Gardasil was administered on 03-DEC-2007.  Subsequently the patient found out she is 4 weeks pregnant on 03-JAN-2008.  The patient's LMP date was 12-DEC-2007.  Unspecified medical attention was sought.  On 06-MAR-2008 the patient had a miscarriage.  At the time of reporting it was unknown if the patient had recovered.  No additional information was provided.  Upon internal review miscarriage was considered to be an other medical event.  Additional information is not expected.
pt recv vax 10MAR99 & in mid morning of 11MAR99 mom called stating child rt leg (site of vax) had just devel rash the rash (red pimple like) was also seen on stomach & back;tops of feet swollen seen in ER;dx allerg rxn;
Information was received from a nurse who reported that on 10-JUL-2017, an unspecified patient (unknown age or gender) was administered a dialysis formulation of RECOMBIVAX HB, 40 mcg (lot #N007395, expiration date 13-OCT-2019; route of administration not provided). No adverse effects reported. No further details provided. Additional information has been requested.
Nausea, abdominal cramps, diarrhea, fatigue, vomiting, shortness of breath, dizziness, headaches (severely for 24 hours, mildly for an additional 24 hours).  On the 3rd day of symptoms (6 days post-vaccine) - shortness of breath, fatigue, headaches, dizziness.
pt recv vax 24MAR95 & pt exp neuropathy, neuralgia & deep muscle bone pain;27MAR95 pt exp swollen lymph nodes;APR95 pt devel hoarseness, sore throat & felt achy all the time;pt noted  has undergone several tests to r/o CMV, meningitis, EBV
extreme hives / welts; rash; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (extreme hives / welts) and RASH (rash) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (extreme hives / welts) and RASH (rash). At the time of the report, URTICARIA (extreme hives / welts) and RASH (rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   ? No treatment information was provided.
This spontaneous report was received from a consumer (patient husband) refers to a female patient of unknown age. On an unknown date in November 2013, the patient was vaccinated with ZOSTAVAX. Concomitant medications included blood pressure medicines. On an unknown date, the patient experienced chicken pox like rash on face and chest. The patient sought medical attention and spoke to the physician. The patient reported that she noticed three very small rashes on her face that were little bit red which faded away in 2-3 days. Then she got another rash on her chest which also went away in 2-3 days. Patient mentioned these rashes to physician but physician thought that these rashes were not related to ZOSTAVAX. No treatment was given to the events. It was reported that VZVIP packet faxed to physician. Additional information has been requested.
Watery diarrhea starting day vaccine administered, u 5x/d x 1 wk afebrile, no vomiting TX: supportive care, oral hydration. Illness in progress.
vomiting 24hr p/vax;@ 48hr had severe h/a & body pains, not relieved w/APAP, felt weak & faint;@ 72hr pain intense, went to Er had shots for pain 15OCT97;went back to ER same sx MD said rxn to vax 8DEC97;recovered;
Information has been received from a physician concerning a 11 year old female patient who was vaccinated with a dose of Gardasil. Concomitant therapy included varicella virus vaccine live. Concomitant therapy included MENACTRA and BOOSTRIX. The physician reported that the patient developed nausea, vomiting and severe headache. She was taken to the emergency room (ER) and admitted in the adult "hospital where she was given intravenous (IV) fluids and meperidine hydrochloride ("DEMEROL")". Later she was transferred to another hospital where she was given IV fluids again and "TRUODOL". She was admitted overnight. No further information was provided. The patient was released the next day and was recovered. The reporter indicated that the patient getting intravenous (IV) fluids was to prevent a serious criteria and it was reported as an other medical event. Additional information has been requested.
PATIENT RECEIVED JANSSEN VACCINE ON 4/9/21. 10 HOURS POST-DOSE PATIENT REPORTS FLU LIKE SYMPTOMS AND 4 EPISODES OF SYNCOPE. SHE THEN REPORTS PAIN IN LEGS AND ABDOMEN. ULTRASOUND OF LEGS WERE NEGATIVE FOR BLOOD CLOTS. TODAY 4/14/21 SHORTNESS OF BREATH HAS NOT IMPROVED AND PAIN IN LEGS IN ABDOMEN HAS NOT IMPROVED. PATIENT IS GOING TO ER FOR EVALUATION.
Vaccines were kept frozen until they are ready for administration; Administered moderna vaccines beyond the use date and/or expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered moderna vaccines beyond the use date and/or expired) and PRODUCT STORAGE ERROR (Vaccines were kept frozen until they are ready for administration) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered moderna vaccines beyond the use date and/or expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were kept frozen until they are ready for administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered moderna vaccines beyond the use date and/or expired) and PRODUCT STORAGE ERROR (Vaccines were kept frozen until they are ready for administration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter.  Vaccines were kept frozen until they were ready for administration which meant they would be in the fridge about one to three days. They tend to store one to three bottles in the fridge to thaw out and was ready for the patients when needed. At worst case scenario they would have been in the fridge for about week if no one came in to be vaccinated.  No treatment medication was provided by reporter.
The patient experienced weeks of pain in her left arm and decided to go see her doctor. The doctor told her it would take 6 months to heal.
MD diagnosed as serum sickness.  She had hives on the inside of legs.  She has prickly sensation on lower extremities, severe pain in lower back, hips, right shoulder, knees and ankles.  Following that, her blood pressure went up extremely high.  She had trouble breathing.  There was an increase in acid reflux.  Due to Covid 19, she didn't realize that they were all related to Shingrix.  She tried Benadryl, amongst other things, and it made it slightly better.  When she went into the cold, all of her side effects were heightened.  She didn't get to the doctor until the first week of May.  She was having trouble all during that time.  When she saw the doctor, she said her breathing was bad, so she was prescribed Prednisone, and the MD gave her a sample of Triamcinolone.
stating he feels "funny. "He endorses throat fuzziness and itchy feeling, and just feeling overall strange Narrative:
Patient tested positive for COVID week of 05Aug2021 and is symptomatic.; Patient tested positive for COVID week of 05Aug2021 and is symptomatic.; This is a spontaneous report from a contactable consumer or other non hcp. An adult female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot no: EP7534) via intramuscular route of administration, administered on 21Mar2021 as single dose for covid-19 immunisation. The patient was not pregnant at the time vaccination. The patient medical history and concomitant medications were not reported. Prior to vaccination the patient was diagnosed with covid-19 was unknown. The patient receives any other vaccines within 4 weeks prior to the covid vaccine was unknown. It was reported that the patient was symptomatic to covid in the week of 05Aug2021. On an unspecified date in Aug2021 the patient tested positive for covid. On an unspecified date in Aug2021 the patient underwent lab tests and procedures which included Covid-19 test which was resulted positive. The patient was recovering from the covid.   No follow-up attempts are needed. No further information is expected.
Vaccine administered to a patient younger than minimum age range. No adverse event was observed following vaccine administration.
Red hard lump where vaccine was administered, Swelling from injection site up into my shoulder, itches where red spot is, headache
she mixed ACTHIB with the wrong diluent and administered it to a patient WITH NO REPORTED ADVERSE EVENT; Initial information received on 06-Jan-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 12 months old male patient who experienced she mixed acthib with the wrong diluent and administered it to a patient with no reported adverse event while receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE); MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR); and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE).  On 05-Jan-2022, the patient received a  dose of suspect HIB (PRP/T) VACCINE lot UJ584AAA via unknown route in the right thigh for prophylactic vaccination.  On 05-JAN-2022 the patient developed a non-serious event "she mixed acthib with the wrong diluent and administered it to a patient with no reported adverse event" (incorrect product formulation administered) following the administration of HIB (PRP/T) VACCINE.  Action taken with HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) was not applicable.  It was not reported if the patient received a corrective treatment for the event (she mixed ACTHIB with the wrong diluent and administered it to a patient WITH NO REPORTED ADVERSE EVENT).  At time of reporting, the outcome was Unknown for the event she mixed acthib with the wrong diluent and administered it to a patient with no reported adverse 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 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.
Day 2- slight red rash on chest.  Day 3 - severe vomiting, Day 5 - called 911 taken to the Emergency Room for supraventricular tachycardia, Heart Rate of 158.  Day 9 - had an additional SVT, Heart Rate 171.  Day 10 - additional SVT, Heart Rate 150.  Have not been able to engage in pre-vaccine regular life activities without my heart rate severely rapidly increasing.  I had to quit my job.  Saw my doctor on Day 9 who examined blood levels from ER visit on Day 5, and ordered an echocardiogram.   I have an echocardiogram scheduled in the next 3-4 weeks, which was the soonest I was able to be seen.
Starting in January 2022: Tinnitus, Dizziness/Vertigo, severe pressure in head and sinus congestion (prescribed prednisone and meclizine)  February 2022: high blood pressure at Dr office read 160/100  elevated cholesterol (prescribed lisinopril and Lipitor) May 2022: right facial numbing/tingling/temporary paralysis (prescribed prednisone 3 times and 10 day antiviral valtrex for suspicion  of internal shingles) Facial numbing has lasted from May 2022 thru present. Diarrhea and weight loss. Ongoing numbness in tongue since receiving 2nd covid-19 shot on 5/14/21
Patient presented to the  Emergency Department complaining of chest pain, pale, cool diaphoretic, and hypotensive. The patient was discovered to have a large saddle pulmonary embolism, went into cardiac arrest and expired. Of note, the patient received her second Moderna COVID vaccine on 1/23, which would place her first one approximately 12/25 if she received them at the appropriate interval. This information is from the patient's daughter and the ED record, the information is not available in CAIR. Per the daughter, the patient started feeling ill on 1/21, improved on 1/25, and then acutely worsened on 1/27, resulting in the ED visit.
NO ADVERSE EVENT OCCURRED. MEDICATION ERROR. INFLUENZA 0.5 ML GIVEN INSTEAD OF 0.25 ML.
Information has been received through the pregnancy registry from a nurse practitioner concerning a 14 year old female with a history of anaemia and no allergies, who on 07-NOV-2007 and 09-JAN-2008 was vaccinated intramuscularly with the first and second 0.5 mL dose of Gardasil (Lot # 658490/0802U same Lot# for both doses), respectively. Concomitant therapies included HAVRIX, influenza virus vaccine (unspecified), MENACTRA, hormonal contraceptives (unspecified) and Varivax (MSD) (Lot# 658574/1269U). On 05-MAR-2008 the nurse practitioner reported that the patient is pregnant. It was reported that the patient had consistent bleeding so she didn't think she was pregnant. "It was believed that the patient was 26 weeks pregnant on 09-JAN-2008." The patient sought unspecified medical attention. Diagnostic studies performed included ultrasound ("everything is normal"), blood work-results unknown and urine pregnancy testing in February 2008. At the time of this report the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested. 02/17/2010 It was reported that the patient moved out of state in her third trimester and the nurse practioner has had no further contact with the patient. This patient is lost to follow up. No further information is available.
I got the pfizer covid vaccine on 1/18/21 my initial reactions were slight soreness at injection site and a mild headache for 2 days. I took some ibuprofen for the headache.  Prior to the vaccination I have not been ill. When I woke up on Sunday morning , 6 days after my initial injection I have a swollen gland on the left side of my neck about 2 " directly below my ear lobe. The swollen gland is mildly sore. Initially i think the size was about 1.75" by 3/4 ".  Now on day 4 after it first presented itself the swelling is slowly going down to about 1"x  1/2 ".
This spontaneous report was received from a pharmacist via company representative referring to a male patient of unknown age. Patient's medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml, subcutaneously (lot# and expiry date not reported). Other co-suspect or concomitant medications were not reported. Last week, in October 2015, the patient developed an injection site reaction. Patient's arm was red and it was swelling (arm not specified). The outcome of application site reaction site, injection site swelling and injection site erythema was unknown. Additional information is not expected.
I would say an hour or two after I had the vaccine I started feeling dizzy and very nauseous these symptoms have still not gone away and it?s five or so days later and at the end of the day probably from being busy I?m guessing I have a big headache
Fever (100.7) Severe body aches lasting 2-3 days Chills lasting several hours Nausea Extreme fatigue Headache Swollen and red arm lasting 4-5 days
Information has been received from a registered nurse concerning a female patient (age not reported) who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23. Concomitant medication was not reported. Subsequently on an unspecified date, the patient experienced a reaction on the injection site (unspecified). Unspecified medical attention was sought. The outcome of the event was not reported. No product quality complaint was involved. Additional information has been requested.
In bed two days, couldn't eat, missed my meds, severe arm and shoulder pain, upset stomach, nausea, dizziness, shortness of breath, unable to do my work-activities, not easy, missed morning exercises, couldn't lay on my side, etc.
Injection site pain, tiredness, headache, severe aches and pains throughout body joints and muscles, chills so bad that I was convulsing, injection site swelling, nausea, feeling sick for more than 2 days, swollen lymph nodes in left arm pit, chest feeling tight and lungs feeling heavy
RECEIVED PFIZER-BIONTECH MONOVALENT INSTEAD OF INTENDED BIVALENT.
w/in 24hr of vax pt devel lymphadenopathy, described a painful swelling in the lt axilla which radiated down the medial portion of the lt arm;
34 year old female G9P4043 at 36 weeks received Arexvy which is indicated for patients over 60 years of age and older rather than Abrysvo which is indicated for pregnant patients or 60 years of age and older. Likely a look alike sound alike error. Arexvy was ordered and verified instead of Abrysvo. No adverse effects identified.
shortness of breath, low oxygen level from COVID-19 1st week of November 2020.  After vaccination on 2/2/21, developed high temp (104.1F), severe dehydration, and pain at injection site
After the first dose: I noticed a lump  in the base of the neck and 2 other lumps around the neck. Another lump behind my right hear. A few days later I had another big lump in the right side of my groin.   I did not associate that with the vaccine and later I took the second dose of the vaccine.  After the second dose I realized that I have more lumps around my neck and there were other ones developing under my chin and on the left side of my groin but a little bit smaller than the one on my right side which had become bigger and more painful.
This case was reported by a nurse and described the occurrence of taste abnormality in a 34 year old male subject who was vaccinated with hepatitis B vaccine recombinant Engerix B. Medical history included smoker, allergy to prednisone, anaphylactic reaction bee sting, codeine allergy, Tequin allergy. On 9/7/2005 the subject received the 1st dose of Engerix B (lot AHBVB033BA0, the 1st dose of hepatitis A vaccine inactivated Havrix (lot AHAVB021AA) and a booster dose of tetanus toxoid. At an unspecified time following receipt of the immunizations, on 09/07/2005, the subject experienced a medicine taste in his mouth. The event resolved on an unspecified date on or after 9/7/2005 and before 11/1/2005. On 11/1/2005, the subject received a 2nd dose of Engerix B (lot AHBV171AA incorrect lot number). This is longer than the recommended interval of one month between the 1st and 2nd doses of Engerix B. Almost immediately following the administration of the 2nd dose of Engerix B, on 11/1/2005, the subject, again experienced a medicine taste that evolved to a rusty taste. The event resolved on 11/1/2005. The nurse considered the events to possibly be related to vaccination with Engerix B.