chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PATIENT COMPLAINED OF NUMBNESS IN RIGHT ARM 15 MINUTES AFTER RECEIVING VACCINE. NO DIFFICULTY BREATHING, WHEEZING, OR STRIDOR NOTED. NO ITCHING, REDNESS, OR HIVES NOTED. NO SWELLING IN RIGHT ARM OR INJECTION SITE. 2 SECOND CAPILLARY REFILL OF RIGHT HAND AND FINGERS NOTED. PATIENT ALERT, ORIENTED, AND RESPONDING APPROPRIATELY. VITAL SIGNS STABLE. CONTACTED CLIENT'S OB PHYSICIAN, AND INSTRUCTED TO HAVE CLIENT TRANSPORTED TO HOSPITAL FOR FURTHER EVALUATION. EMS CONTACTED AND PATIENT TRANSPORTED TO HOSPITAL VIA STRETCHER AT 1351.
Patient with right shoulder pain since injection. Seen in PCP office today. Limited ROM, significant pain.
pt recv vax & pt devel hives & SOB;pt was seen in ER;
Redness, tenderness, lump, fever. No treatment except ice and Tylenol.
Last 2 doses administered were stored incorrectly; A spontaneous report was received from a patient on 07NOV2022. It described an elderly female patient (height: 66 inches) for whom the "last 2 doses administered were stored incorrectly" (PT: Product storage error) of Vivotif (Typhoid vaccine live oral Ty21A) (lot number: 3003785) for immunisation. On 26OCT2022, the patient received the first dose of Vivotif. It was reported that the last 2 doses administered to the patient were stored incorrectly at a room temperature of 60 degrees Fahrenheit for about 36-48 hours. Reportedly, the patient did not face any side effects. The outcome of the reported event was not applicable.  Action taken with Vivotif with respect to the reported event was not applicable.  The medical/surgical history and the concomitant medications of the patient was reported as none. The patient was allergic to Sulpha.  No additional information was reported.  Company comment: It was reported that the last 2 doses administered to the patient were stored incorrectly (product storage error). Vivotif should always be stored in the refrigerator at the recommended temperature, and the causality of product storage error is assessed as not applicable to Vivotif due to the nature of the event which was due to human error. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that the last 2 doses administered to the patient were stored incorrectly (product storage error). Vivotif should always be stored in the refrigerator at the recommended temperature, and the causality of product storage error is assessed as not applicable to Vivotif due to the nature of the event which was due to human error. The case is considered non serious as per medical assessment.
Sore arm as expected; Sore ovaries unclear exactly, but feels like same position as ovaries (i.e. on both sides of uterus); Sore uterus; Low ache, feels a bit like the aches/; Cramps I might get during the early days of my period (but my period finished last week, so can't be that); Pain woke me in the night. Has lasted the last 12 hours; This is a spontaneous report from a non-contactable consumer, the patient. A 40-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the arm left on 13Apr2021 at 11:15 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma as a child. Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021 at 21:30, the patient experienced sore arm as expected. Sore ovaries or uterus, unclear exactly, but feels like same position as ovaries (i.e. on both sides of uterus). Low ache, feels a bit like the aches/cramps she might get during the early days of her period (but her period finished last week, so can't be that). Pain woke her in the night, has lasted for 12 hours. 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 these events. The clinical outcome of the events pain in arm, ovarian pain, uterine pain, ache and abdominal cramp was not recovered however the clinical outcome of the event pain was recovered after a duration of 12 hours.  No follow-up attempts are possible. No further information is expected.
C/o anxiety, shaking of head, did not eat breakfast. B/P 122/71, HR 82, O2Sat 98, T 98.
Dizziness, light headed, sore arm.  Dizziness and light headedness began after first shot on March 5, 2021 and persisted for 3-4 weeks.  Second shot received June 1, 2021 and onset of dizziness and light headedness began within 15 hours.
Fever LAD TO LEFT AXILLARY, FATIGUE Narrative: CALL TO PCP AND WAS TREATED WITH DEXAMETHASONE
I wanted to report what is being called Covid arm, this was not a adverse side effect but read online it should be reported so they can keep track of how many people it is happening to.  On 4-12-21 had my 1st vaccine on left arm, then on 4-21- 21 felt a little itchy tingle in left arm, 4-22 had a raised rash and swollen around injection area, not very bothersome but was a delayed reaction, lasted little over 2 weeks before fading. Then went for my 2nd vaccine  lot # 022C2IA  on 5-13-21 since I had a delayed rash on left arm the nurse at the hospital decided to give me the shot in the right arm,  this time I had the raised rash and swollen with in 2 days on 5-15-21 when I woke up in the morning, same as other time around injection site but appeared quicker,  this time it faded within less than 5 days,  little itchy but not to bothersome. I did use cortisone each time when it itched a little depending on what shirt I was wearing, but did not need to put the cortisone on every day was not to much of a bother,  was sore when swollen but once that went down it was ok.
Patient started with symptoms of asthma. she has asthma but doesn't need to use nebulizer or any other medication for it. But since the first dose, patient has been going through daily asthma attacks; This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (Patient started with symptoms of asthma. she has asthma but doesn't need to use nebulizer or any other medication for it. But since the first dose, patient has been going through daily asthma attacks) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.    On 17-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, the patient experienced ASTHMA (Patient started with symptoms of asthma. she has asthma but doesn't need to use nebulizer or any other medication for it. But since the first dose, patient has been going through daily asthma attacks). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Asthma, at an unspecified dose and frequency. At the time of the report, ASTHMA (Patient started with symptoms of asthma. she has asthma but doesn't need to use nebulizer or any other medication for it. But since the first dose, patient has been going through daily asthma attacks) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported by the reporter.  Within 30 minutes of administration, patient started with symptoms of asthma.  Patient has also seen a doctor and was prescribed with corticoids too. She was better now than at the beginning, but still not good.
Body rash (not at injection site) 2 days after injection. Trying Benadryl to relieve. Injection date 3/24/21, rash appeared 3/26/21
hypoxia, severe dyspnea, dx with bilateral PE Narrative:  Severe dyspnea, hypoxia with sats in 80. Hospitalized 2 days, heparin, DOAC to continue until Sept 2021
Patient complained of a red, swollen area and muscle pain at injection site following the vaccination. Redness and swelling lasted several days. Patient used rubbing alcohol to alleviate symptoms. Patient stated on 11/23/21 that symptoms were almost completely resolved. Patient denied fever, hives or additional symptoms. Patient did not visit primary care physician.
"hurt arm"; fever; felt tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY ("hurt arm"), PYREXIA (fever) and FATIGUE (felt tired) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced PAIN IN EXTREMITY ("hurt arm"), PYREXIA (fever) and FATIGUE (felt tired). At the time of the report, PAIN IN EXTREMITY ("hurt arm"), PYREXIA (fever) and FATIGUE (felt tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
The day following the vaccine  c/o tactile fever, headache, stomach ache and fatigue (on 5/2).  On 5/4 developed chest pain and shortness or breath.  Reported to the ER with concerning EKG and troponin levels and therefore transferred where he has been admitted for myocarditis.
Patients mother states he developed a large reddened area on Friday, 08/04/17 and she took him to the local ER where she was told it was cellulitis from a vaccine. Was given Bactrim and a steroid cream. The induration has continued to get larger and now has peticchae around the area. Mom is taking child back to ER today.
Information has been received from a physician concerning a 16 year old female with no medical history and an allergy to naproxen, who on 17-JAN-2008 was vaccinated IM in one arm with a dose of GARDASIL (Lot# 6596553/1448U) and a dose of MENACTRA, administered in the other arm. On approximately 01-FEB-2008, fifteen days post vaccination, the patient developed a rash. The rash was predominantly on the neck and the face. The rash was diffuse, macular, itchy, and was hive-like in some areas. The patient complained of a marked lack of energy and several episodes of wheezing and respiratory discomfort. On 05-FEB-2008 the patient went to the emergency room because she was experiencing difficulty breathing, headache, and a swelling sensation in the throat. The patient was diagnosed with allergic reactions and/or exercise-induced asthma. The patient was treated with albuterol and an unspecified steroid. On 07-FEB-2008 the patient went to the emergency room because she experienced difficulty breathing after taking her inhaler  for two days and the steroid for one day. The patient was diagnosed with atypical pneumonia and treated with ZITHROMAX. On 15-FEB-2008 the patient was seen for back pain and "cholerectic pain." The shortness of breath had resolved. The patient's chest x-ray had no change. The patient had positive convalescent mycoplasma. On 04-MAR-2008 the patient followed up at the office to recheck pneumonia and upper respiratory infection, which were resolved. It was reported that the patient's back pain was 80% better. The blood counts were normal. On 07-MAR-2008 the patient was seen by her primary pediatrician. It was reported that the patient may have used ALEVE during the week for relief of pain. It was reported that there was no wheezing, lungs were cleared, and the patient was referred to an allergist. The patient was started on FLOVENT. On 11-MAR-2008 there was a call to the office for an unspecified reason. The patient was prescribed an EPIPEN . On 12-MAR-2008 the patient saw an allergist who said that her pulmonary functions were normal. The allergist did not think that the patient required respiratory medications. On 10-APR-2008 the patient came back to the office due to a cold, and complained of a headache, dizziness, and vertigo. The patient had no other neurological conditions. The patient had experienced persistent malaise and fatigue since the onset of the rash. At the time of the report, the patient was not recovered from all events. No product quality complaint was involved. Upon internal review the allergic reaction, exercise induced asthma, difficulty breathing, headache, swelling sensation in throat, and atypical pneumonia were considered to be other important medical events. Additional information has been requested.
Patient remained in the facility for 20+ minutes with medical support staff keeping a great eye on him. Within first 10 minutes of injection, patient could taste medication. He described it as the taste of alcohol. Support staff took Patient's vitals. Support Staff administered injection of what spouse believes was Benadryl (exact medication and dosage unknown to Spouse).  Between 4th through 6th hour after injection (2 p.m. through 4 p.m.), patient experienced nausea. He asked for otc antacid medication.    Seven hours after injection (about 5 p.m.), patient requested prescribed medication Pantoprazole 40mg.  Patient took 1 Pantoprazole 40mg.  At 5:30 p.m., Patient began chills, shaking from head to foot.  Warm blankets were given. He covered himself from his head down.  This lasted just under 10 minutes.
On 8/27/00, pt had a mild seizure at 4:30 am. She was rushed to hospital, where it was determined that she was having a seizure. The doctors at the hospital were unable to revive her from a comatose state. She was transported via ambulance to another facility. She remained non-responsive from approximately 5 am to 2:30 pm. They are treating this seizure as though it is epilepsy, but are unsure of the exact cause. The pt is currently taking carbamazepine every twelve hours.
This is a spontaneous report from a contactable other health care professional on behalf of a physician. A 66 years old male patient received the 2nd dose of PREVNAR 13 (Lot# M73332, Exp Date Jul 2017, NDC 0005-1971-01), intramuscular in the left arm, on 21Jul2016, at 0.5 ml single, for immunisation. Relevant medical history was none. Concomitant medications were not reported. The patient previously received 1st dose of PREVNAR 13 in 2001 for immunisation with no adverse effect. The patient experienced severe shoulder pain in Jul2016, 3-4 days after vaccination, with outcome of not recovered. The event was evaluated at physician office. The event worsened in the last 2 weeks. The patient underwent lab tests and procedures which included: blood work and x-ray of left shoulder on 20Oct2016.
Case number PHEH2012US012934 is an initial spontaneous report received from a consumer on 26 Jun 2012: This report refers to a 20-year-old male patient. He was given only the CYW-135 liquid component of MENVEO vaccine (batch number: M10126A) intramuscularly on 26 Jun 2012. No adverse reaction was reported following this administration error.
She says that after each shot she has experienced ringing in her ears,  the ringing was only in one ear; This spontaneous case was reported by a patient and describes the occurrence of TINNITUS (She says that after each shot she has experienced ringing in her ears,  the ringing was only in one ear) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939904, 010M20A and 013A21A) for COVID-19 prophylaxis.     It was reported that patient did not have COVID + test or diagnosis.  Concurrent medical conditions included Drug allergy (allergy to Meloxicam), Fruit allergy (allergy to Blueberries), Cholesterol and Macular degeneration (status such as improvement or worsening was reported as Stable.) since 2019. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for Cholesterol, BEVACIZUMAB for Macular degeneration, LEVOTHYROXINE SODIUM (SYNTHROID) and TRETINOIN for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TINNITUS (She says that after each shot she has experienced ringing in her ears,  the ringing was only in one ear). At the time of the report, TINNITUS (She says that after each shot she has experienced ringing in her ears,  the ringing was only in one ear) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: blood pressure was normal at 118/75..         Patient stated that she has received 5 doses of the Moderna COVID-19 vaccine so far, included the most recent Moderna COVID-19 bivalent booster. She stated that after each shot, she had experienced ringing in her ears, which she never had before. When the vaccine started to wear off, the ringing in her ears stop. With the first 4 doses, the ringing was only in one ear. But with the most recent bivalent booster, she had ringing in both ears. She read online that ringing could be caused due to high blood pressure but her most recent blood pressure was normal at 118/75. She also read that dehydration could be a cause, but she stated that she drank a lot of water so it could not be that.  Patient did not experience a similar event in the past. Flu shot was given 2 weeks before Moderna bivalent  Patient had been to the "hearing" doctor for her symptoms. Patient hearing had been reduced.  The symptoms improved over time between each shot but came back whenever she had another Moderna shot. No treatment medication was reported.    This case was linked to MOD-2022-661330, MOD-2022-661336 (Patient Link).
HEAD HURTS UNTIL AT THE BACK OF SKULL; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On APR-2021, the subject experienced head hurts until at the back of skull. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from head hurts until at the back of skull. This report was non-serious.
Caller received the first dose of the Pfizer-BioNtech covid-19 vaccine (she doesn't remember when) and one or two weeks later she got Covid-19.; Caller received the first dose of the Pfizer-BioNtech covid-19 vaccine (she doesn't remember when) and one or two weeks later she got Covid-19.; This is a spontaneous report from a Contactable consumer. A female patient of unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  The patient after received the first dose of the PFIZER-BIONTECH COVID-19 vaccine (she doesn't remember when) and one or two weeks later she got COVID-19 on an unspecified date. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on an unspecified date. The outcome of events was unknown.  Information about lot/batch number has been requested.
pt became very pale & c/o dizziness w/in minutes p/inject; denies any resp difficulty; pt reported dizziness p/5-10 mins; dx allergic to tetanus & instructed mom to give DPH or go to ER if resp difficulty;
Ears feel like they are burning, itching started going down right arm then left. Itching continued on head/face/scalp, down neck and back.  It felt like ants crawling under my skin. Started at 9:50 then continued to spread over the next hour.  I was back at work  as the symptoms  progressed. My CFO drove me to urgent care.
Shot is on left arm the reaction was red itchy, a little bit of pain, and a big bump.
whole body skin welting situation/hives; serious, serious itching/scratching my bearded area on my face/he was scratching his bearded area on his face. He realized it was on his arm, stomach, and shouldersarm, stomach and shoulders; Flu symptoms; Red welts that were shallow; Face broke out; lips are swollen; Rash; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (whole body skin welting situation/hives), PRURITUS (serious, serious itching/scratching my bearded area on my face/he was scratching his bearded area on his face. He realized it was on his arm, stomach, and shouldersarm, stomach and shoulders), INFLUENZA (Flu symptoms), URTICARIA (Red welts that were shallow) and FACE INJURY (Face broke out) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced URTICARIA (whole body skin welting situation/hives), PRURITUS (serious, serious itching/scratching my bearded area on my face/he was scratching his bearded area on his face. He realized it was on his arm, stomach, and shouldersarm, stomach and shoulders), INFLUENZA (Flu symptoms), URTICARIA (Red welts that were shallow), FACE INJURY (Face broke out) and LIP SWELLING (lips are swollen). 25-Oct-2021, the patient experienced RASH (Rash). The patient was treated with METHYLPREDNISOLONE on 25-Oct-2021 for Adverse event, at a dose of 4 milligram for 6 days and HYDROXYZINE HYDROCHLORIDE on 25-Oct-2021 for Adverse event, at a dose of 25 milligram three times a day. At the time of the report, URTICARIA (whole body skin welting situation/hives), PRURITUS (serious, serious itching/scratching my bearded area on my face/he was scratching his bearded area on his face. He realized it was on his arm, stomach, and shouldersarm, stomach and shoulders), INFLUENZA (Flu symptoms), URTICARIA (Red welts that were shallow), FACE INJURY (Face broke out), LIP SWELLING (lips are swollen) and RASH (Rash) outcome was unknown.            He states he had nothing after the first two shots of Moderna; his arm was a little sore. The patient received his first dose (lot number DIZAZIA) of Moderna COVID19 Vaccine on 01Mar2021 and second dose (lot number 025B21A) on 29Mar2021. Consent given for safety to contact the patient and his HCP.  No concomitant medications were reported.   This case was linked to MOD-2021-363693, MOD-2021-363695 (Patient Link).
This is an administration error.  Patient brought me in their Covid card today (12/5/2022) so we could fill out his info of his shot he received on 10/13/2022.  There was only 1 previous dose listed on the card.  He said the October vaccine was only his second.  I thought maybe he had a second card so I looked him up on our registry and that also showed that that was his second shot.  His second shot should have been a monovalent Moderna shot.
Information has been received from a licensed practical nurse, for GARDASL, a Pregnancy Registry product, concerning a 17 year old female patient who in February 2009, was vaccinated with the first dose of GARDASIL (lot# not reported). The patient subsequently became pregnant. Date of LMP not reported. On 18-MAR-2009 the patient had an elective abortion. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. Upon internal review, elective abortion was considered to be an important medical event. Additional information has been requested.