chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient came in for Moderna Bivalent Booster (0.5mL). It was discovered the next day that the patient had received the Primary Series Moderna product (0.5mL) instead. They had already received their first two doses and booster. Patient was notified that day. The MD office was notified and per CDC guidance, the patient will wait 60 days and then receive the Bivalent Booster.
Patient presented 2 days post immunization to pharmacy with swollen hands and fingers that appeared to be bruised as well.
Pt had meningococcal vaccine yesterday at well visit, broke out in hives last night.  Had welts covering him from his head/hairline, down his torso, and on his arms.  Mom called nurse on call and was told to give Benadryl.  Seemed to help a little, this morning still had the hives.
getting more frequent nosebleeds from my left nostril/blood usually dripping on the floor; dose 3 (booster), single; This is a spontaneous report from a contactable consumer (patient). A 24-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in left arm on 23Oct2021 at 15:15 (Batch/Lot Number: FF2589) (at the age of 24-years-old) as dose 3 (booster), single for COVID-19 immunisation. Vaccination facility type was Pharmacy or Drug Store. The patient has no medical history that would interfere with vaccine efficacy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received nothing within 2 weeks of vaccination other than OTC cold medicine. Historical vaccine included first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) on 31Mar2021 at 11:00 AM (Batch/Lot Number: ER8730) (at the age of 24-years-old) as dose 1, single; and on 21Apr2021 at 11:15 AM (Batch/Lot Number: EW0164) (at the age of 24-years-old) as dose 2, single both via an unspecified route of administration in left arm for COVID-19 immunisation. The patient also has previous allergy to unknown drug. On 25Oct2021 at 12:00 PM, the patient had noticed that he had been getting more frequent nosebleeds from his left nostril. They usually only last for 15-20 minutes maximum, but they always start rather suddenly, with blood usually dripping on the floor. The patient received no treatment. The patient was not diagnosed with COVID-19 prior to vaccination. The patient been tested for COVID-19 since the vaccination. The event was considered serious by reporter. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Adverse Event; This spontaneous case was reported by a patient and describes the occurrence of ADVERSE EVENT (Adverse Event) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Adverse Event). At the time of the report, ADVERSE EVENT (Adverse Event) outcome was unknown.            Concomitant medication included blood thinning medication which the patient takes.  According to the reporter, the patient had 6 Covid vaccinations and one of them might be a Moderna shot.  No treatment information was reported.
- 9/19/2021 - tingling in bilateral hands/fingers - 9/23/2021 - left hand/ulnar nerve numbness - In the days following - Then tingling in left and right feet. Then right hand/ulnar nerve numbness. Then muscles spasms in right and left calves. Then muscle spasms throughout body. - 9/25/2021 - chest pain. Seen in urgent care. Cardiac work up negative. Provider advised pain could be due to inflammation, chostocondritis. - 10/6/2021 - primary care provider visit. Referred to neurology for EMG. - 10/9/2021 - chest pain. Seen in Emergency Room. Cardiac workup negative.  Advised to follow up with PCP and neurology. - 11/29/2021 - seen by neurology. EMG done. Showed nerve entrapment in left elbow, confirmed muscle spasms, nerve damage in right lower extremity.  - Sporadic numbness/tingling, muscle cramps/twitches in limbs continues.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient administered with expired vaccines) and PRODUCT STORAGE ERROR (Vial was stored on 17-Feb-2022 , expired on 01-Apr-2022 and administered on 07-Apr-2022) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination. No Medical History information was reported. On 07-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient administered with expired vaccines). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored on 17-Feb-2022, expired on 01-Apr-2022 and administered on 07-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient administered with expired vaccines) and PRODUCT STORAGE ERROR (Vial was stored on 17-Feb-2022, expired on 01-Apr-2022 and administered on 07-Apr-2022) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not reported. The vial was initially stored in refrigerator on 17 Feb 2022 10:00 am. The vials did not undergo any temperature excursions. It was reported that no patients have come out with adverse events. Treatment information was not reported. Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2022: Non Significant Follow up received analysis updated.
I received the latest Pzifer covid vaccine and now I have chills or I feel extremely hot all the time- almost like menopause; I feel extremely hot all the time; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A female patient (unknown if pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "I received the latest Pzifer covid vaccine and now I have chills or I feel extremely hot all the time- almost like menopause"; FEELING HOT (non-serious), outcome "unknown", described as "I feel extremely hot all the time".  Follow-up attempts are completed, information about lot/batch number cannot be obtained. No further information is expected.
History of seizures. Complained of dizziness, nausea, photosensitivity to light, spasm and anxiety. Provided water; symptoms resolved; no transport.
body aches/ Body continues to feel very achy; slight fever/occasional low fever; chest pain; difficulty taking a deep breath; inability to exercise; sleep disturbances; Body continues to feel very achy like the flu; shooting pains in limbs; occasional tremor in hands and feet; This is a spontaneous report from a contactable consumer (reported for himself).   A 20-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0178/Batch number was not reported), dose 2 via an unspecified route of administration on 25May2021 (at the age of 20-years-old) as dose 2, single for covid-19 immunisation at Pharmacy. Medical history included pectus excavatum from an unknown date and unknown if ongoing (Other medical history: Medical history includes Nuss procedure to correct pectus excavatum), mite allergy from an unknown date and unknown if ongoing (Known allergies: only dust mites). The patient's concomitant medications were not reported. The patient did not receive any other vaccines on the same day of vaccine vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0176/Batch number was not reported), dose 1 via an unspecified route of administration on 04May2021 (at the age of 20-years-old) as dose 1, single for covid-19 immunisation at Pharmacy. On 26May2021 at 10:00, the patient experienced body aches/ body continues to feel very achy, slight fever/occasional low fever, chest pain, difficulty taking a deep breath, inability to exercise, sleep disturbances, body continues to feel very achy like the flu, shooting pains in limbs and occasional tremor in hands and feet. The case assessed as serious disability. The reporter stated the events result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date in Jun2021 (Nasal Swab). Therapeutic measures were taken as a result of events included treatment with Diagnostic tests and trial of medicines. The outcome of the events was not resolved.  Follow-up attempts are completed. No further information is expected.
No additional AE's reported; Pharmacist called stating that a patient was accidently administered either PNEUMOVAX 23 or PREVNAR 13 via their intravenous port. Reporting pharmacist only has information that she has received via email. Vaccine was administered via the wrong route; This spontaneous report was received from a pharmacist and refers to a 48-year-old female patient. There was no information about the patient's concomitant therapies, drug reactions, allergies or medical history provided.  On 13-JAN-2023, the patient was accidently vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, or pneumococcal vaccine conj 13v (crm197) (PREVNAR 13), administered via intravenous (IV) port for prophylaxis (dose, dose number, lot #, and expiry date were not provided). The staff was not sure if it was pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, or pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) administered to the patient. The vaccine was administered via the wrong route in an outpatient infusion center at the hospital. Per medical records, the patient has had no adverse side effects. No additional adverse events (AE's) were reported. At the reporting time, there was no further information provided.
This spontaneous report as received from a pharmacist, via Sanofi, refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, strength, indication not reported). The reporter stated that his colleague witnessed, on an unknown date, the patient experienced adverse reaction (swelling) int he arm. The patient ended up in the emergency for treatment. The outcome of adverse reaction (swelling) int he arm was reported as recovered/resolved. The relatedness between event and ZOSTAVAX was not reported. Additional information has been requested.
Tightness in chest, ache radiating through chest, lightheaded and disorientation. Symptoms eased and passed within about an hour.
Was giving bath on evening of 11/4/22 and noticed rash at the site of the injection site where varicella was given. Decreased appetites and loose stools as well. Has had some URI symptoms. Avoidance of others until rash resolves and probiotic for diarrhea.
soreness; warmness; redness around the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (soreness), VACCINATION SITE WARMTH (warmness) and VACCINATION SITE ERYTHEMA (redness around the injection site) in a 75-year-old female elderly exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) , while the parent received the product for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.). Concomitant product exposures included LEVOTHYROXINE, ATORVASTIN (ATORVASTATIN), BETAXOLOL, HYDROCHLOROTHIAZIDE and IRBESARTAN for an unknown indication.    On 11-Jan-2021, the parent received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the elderly was diagnosed with VACCINATION SITE PAIN (soreness), VACCINATION SITE WARMTH (warmness) and VACCINATION SITE ERYTHEMA (redness around the injection site). The Elderly was exposed to mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  At the time of the report, VACCINATION SITE PAIN (soreness), VACCINATION SITE WARMTH (warmness) and VACCINATION SITE ERYTHEMA (redness around the injection site) outcome was unknown. 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.   No Treatment.
In June I started with joint pain and swelling, to the point where I wasn't able to walk outside my apartment.
Papular rash on arm, torso. BENADRYL and topical steroid.
Seringue broke while being administered the second Maderna Covid Vaccine, so I was given a second dose in order to receive full dose.  Following day I had 102.8 fever and swollen lymph node under armpit.  Fever broke but armpit is still swollen two days after receiving the second dose of the vaccine
This medically confirmed spontaneous report (initial receipt: 27-Sep-2012) concerns a 24-year-old female patient, who had no pertinent medical history or drug reactions / allergies. She was not taking any concomitant medication. On 25-Sep-2012 the patient received AFLURIA (batch number: P59207) injection at a dose of 0.5 mL once intramuscularly. On 26-Sep-2012, after receiving a dose of AFLURIA, the patient's skin turned light pinkish color about the size of a baseball at the injection site. The patient sought medical attention by calling the pharmacist. No treatment was given for the event. No lab diagnostics study was performed. The event outcome was not recovered.
within 30 seconds I had a cooling sensation rush across the tip of my tongue, then a sweet taste, then more identifiable as bubble gum flavored.  By 12:45 I noticed I was scratching several areas of my body. Arms, legs, chest, neck, back and scalp and kept clearing my throat.  I looked down at my arm and seen a red welt from my elbow to my wrist in my left arm and a fine red rash beneath skin on right arm.  I looked up at the pharmacist and he said at 12:40 he had already placed a call to have another pharmacist come to look me over.   I then noticed that my heart seemed to be racing and feeling winded.  I figured this was my anxiety and just tried to relax.  The second pharmacist arrived and we walked to the ER.  I was very winded. They took me to a room and checked stats.  after 3 attempts taking my BP and using two different cuffs, she said my BP was 190/90 where it is typically 120/70. I drank lots of water and they monitored me for almost an hour and gave me another Benadryl.  My BP came down to 180/82 , breathing was easier and itching was decreasing so I chose to return to my station and I took one more Benadryl.  The following day: woke up with head ache in rt eye and fuzzy vision all day, mild sore throat, mild body aches, queasy stomach, fatigue and runny nose.  Took a Pepcid for stomach, Tylenol/Advil duo for sore throat, headache/body aches, drank lots of water and rested.  Following day most symptoms resided, still  slight sore throat, rt eye blurred vision, coughing, sneezing and runny nose.  everyday since, symptoms continue to decrease.
This case was reported by a physician via sales rep and described the occurrence of loss of vision in a adolescent patient who received BEXSERO (batch number 146101, expiry date April 2016). On 9th April 2015, the patient received BEXSERO .5 ml. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced loss of vision (serious criteria GSK medically significant). On an unknown date, the outcome of the loss of vision was unknown. It was unknown if the reporter considered the loss of vision to be related to BEXSERO. Additional details were provided as follows: The patient was 11 or 15 years old. The patient experienced loss of vision in left eye. This case was linked to case US2015GSK173020 (same reporter).
Erythema/minor pain at injection site. Bump (4 inches x 2 inches), itching.
Pt vacc. w/Engerix-B developed acute pancreatitis, amylase & lipase levels were elevated, epigastric pain & lt upper quad pain continue.
Pt recv vax on 8/3/98; 45 min later pt exp headache &emesis for 2 hr.
Dizzy immediately following injection; Tired; Nauseous; Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the right arm on 29Apr2021 at 11:30 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history included scoliosis. The patient did not receive any medication within two weeks of vaccination. The patient previously received unspecified medication. Prior to the 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 29Apr2021, the patient experienced dizzy immediately following injection, tired, nauseous and sore arm. The clinical outcome of the events dizzy immediately following injection, tired, nauseous and sore arm was recovered on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport was refrigerated packaging tote to maintain a temperature of 36 F - 46 F.  However, that is not approved COVID-19 vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
Shortness of breath, Acute  systolic heart failure, GI bleed, anemia
7-21-15 8:30 am at site of injection, back of (L) arm very red, raised reaction, warm to touch, cold pack given. 7-21-15: 2:30 pm initial red raised area was unchanged, but a light pink color was spreading out/across arm-beginning to itch bad. 7-22-15: 8:30 the bright red had not changed, but the pink color had spread down the back of her arm, almost to the elbow and moved up and around toward the top of her bicep. Dr. told her to continue to use hydrocortisone on the pink/red area.
A physician reported that a 5 month old infant (gender unspecified) developed drug resistant Streptococcus pneumoniae meningitis on 02/27/2002. The infant received two doses of prevnar, two months apart. In November 2001, the infant (at age 2 months) received that both twins developed meningitis. The physician noted that the infants had no ddaycare experience, no immune deficiencies or drug sensitivitie. They were "resistant to all" except vancomycinand chloramphenicol. At the time of this report, the infants had no improved. No further info was provided. This event was considered medically important.
6 hours after vaccination symptoms started and lasted for 72 hours: fever (100 for 48 hours), headache, muscle and joint pain, nausea, fatigue. Fatigue lasted another 24 hours. I'm ok, day 5.
Dose 1 and 2 received on 19-JAN-2021 and 12-FEB-2021, 24 days apart; This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 and 2 received on 19-JAN-2021 and 12-FEB-2021, 24 days apart) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, GERD, Osteoporosis and Drug allergy (None. Unknown historical drug). Concomitant products included ROMOSOZUMAB (EVENITY [ROMOSOZUMAB]), FAMOTIDINE, LISINOPRIL, SERTRALINE, CALCIUM, COLECALCIFEROL (CALCIUM + D3 [CALCIUM;COLECALCIFEROL]) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 and 2 received on 19-JAN-2021 and 12-FEB-2021, 24 days apart). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 and 2 received on 19-JAN-2021 and 12-FEB-2021, 24 days apart) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were provided.   This case was linked to MOD-2022-581874 (Patient Link).
I woke up this AM with my face especially under my eyes and cheeks extremely swollen I went to the Urgent care facility and the doctor said it was an allergic reaction to something. The diagnosis he gave me was angioneurotic edema.  I got a shot of prednisone, a  prescription for 50mg tablets one tablet per day for 5 days, and a topical cream called Clobetasol propriate 0.05%.   I went to she Shindrex website and it mentioned that a severe reaction to the vaccine could be a swollen face.
It began with a headache and sleepiness, followed by chills, dizziness,  fever - first time at 6 p.m. 101.1, followed by other readings of 99.8, until 8:00 a.m. Wednesday morning, his temperature was 98.3.  He still has a headache.
pt had febrile sz the noc of 9NOV95;fever was 104.7;was given rx Advil
Information has been received from a physician concerning a 76 year old female patient who in approximately November 2006 was vaccinated in the arm with a first dose of Zostavax (lot #652966/0722F), Two weeks after vaccination, in December 2006, the patient developed shingles. Follow up information indicated that the patient was recovering. A product quality complaint was not involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 1/16/2007.  Information has been received from a physician concerning a 76 year old white female with allergies to mysoline and dilantin, and a history of hypertension, hyperlipidaemia, convulsion disorder, deep vein thrombosis recurrent, shingles (June 2006) and abdominal pain (hospitalization June 2006) who in approximately November 2006 was vaccinated in the arm with a first dose of ZOSTAVAX (Merck) (lot # 652966/0722F).  Two weeks after vaccination, in December 2006, the patient developed shingles.  Follow-up information indicated that the patient was recovering.  A product quality complaint was not involved.  Additional information indicated that the patient who on 22-SEP-2006 (previously reported as approximately November 2006) was vaccinated in the arm with a first dose of ZOSTAVAX (Merck) (lot # 652966/0722F).  On 26-SEP-2006 the patient developed injection site redness and inflammation which lasted 1 week.  The patient had a history of shingles in June 2006 and reported recurrent painful itchy spots in November 2006 which lasted for 2 weeks.  There has been no subsequent recurrrence.  No further information is expected.