chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tiny purple spot; Bruising; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION and CONTUSION in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included GABAPENTIN, PROBIOTICS, CALCIUM CARBONATE, VITAMIN D, and CALCIUM for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced SKIN DISCOLOURATION and CONTUSION. At the time of the report, SKIN DISCOLOURATION and CONTUSION outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Headache, Myalgia, Fever very sore arm, sore lymph nodes Narrative:
The patient is a 19-year-old girl, brought into the ER, apparently she was getting ready to go to a trip and had multiple vaccinations done including a yellow fever vaccine and apparently soon after this, the patient started developing a lot of weakness, nausea, fever, chills. She was having a lot of headaches and neck stiffness and eventually saw Dr, our infectious disease specialist and he was concerned about the reaction to the vaccine and possible yellow fever progressing to meningitis, so the patient was sent to the ER. At the time of she does have a lot of neck stiffness, some fevers and chills at home, and otherwise no vomiting or diarrhea. No abdominal pain. No neurologist complaints. No numbness or tingling in her extremities. 10/22/07-records received for DOS 10/8-10/10/07-DC DX: Viscerotropic reaction with aseptic meningitis secondary to yellow fever vaccination. C/O headache, body aching and skin hypersensitivity for about 5 days into her vaccination. Unable to study or concentrate, neck stiffness, neck rigidity, photophobia and blurred vision. Unable to life her head or turn her head, multiple joint inflammations.  1/31/08-records received-Patient stated she has arthritis. Patient cancelled subsequent appointment.
lump at the injection site; slightly sore; This spontaneous report was received from a physician assistant via a company representative and refers to a 15-year-old female patient. Her concurrent conditions, medical history and concomitant medications were not reported.  On 23-JUL-2020, the patient was vaccinated with the first dose of human papilloma virus (hpv) rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, intramuscularly (dose, anatomical location, lot # and expiry date were not provided) for prophylaxis.  In the evening of 23-JUL-2020, the patient's father noticed a lump at the injection site. He applied ice to the site and it relieved it a bit. On 24-AUG-2020, the patient returned to healthcare provider's office for a second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). The healthcare provider noticed that the lump was still present and it was slightly sore since an unknown date in 2020. The second dose was given at that time.  The outcome of the events was not reported. The relatedness between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.
DIARRHEA, DOUBLE VISION, HYPERTHYROIDISM SYMPTOMS AS WELL.
Systemic: Brain aneurysm-Severe, Systemic: Headache-Severe
BARD Power Port clogged with blood clot; cellulitis; Severe headache; abdominal pain; arm pain; chest pain; dose 1 administered in Leg Left; dose 1 and dose 2 on the same day; dose 1 and dose 2 on the same day; This is a spontaneous report receive from a contactable consumer (patient). A 38 years old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration as single dose, dose 1 administered in Leg Left on 19Mar2021 14:45 (Batch/Lot Number: EP7534), and dose 2 administered in Arm Right on 19Mar2021 (Batch/Lot Number: ER8729) for covid-19 immunisation. Medical history included myasthenia gravis, natural killer cell deficiency, gastroparesis, connective tissue disease, postural orthostatic tachycardia syndrome (POTS), known allergies: Gluten, dairy, xanthan gum, antibiotics, beta blockers, pain medication, latex. No other vaccine received in four weeks. It was unknown if the patient diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication(s) included escitalopram oxalate (LEXAPRO); montelukast sodium (SINGULAIR); diphenhydramine hydrochloride (BENADRYL); sumatriptan succinate (IMITREX); promethazine (PHENERGAN), all taken for an unspecified indication, start and stop date were not reported. The patient experienced Severe headache 1.5 days, abdominal pain 3 days, arm pain and chest pain 7 days, BARD Power Port clogged with blood clot and subsequent cellulitis from many attempt to flush the clot (22Apr2021 04:00 PM). The adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the adverse event: Home nursing visits and admitted to Emergency Room (ER). Outcome of the events was recovering/resolving.
Vaccine given on 5/27/14 had expired on 5/14/14.  No adverse events noted.  Patient re-vaccinated the same day.
Approximately 8 days after first shot I started to feel strange feelings in chest after spending multiple hours outdoors. It was a pressure like feeling.  Occasionally when I swallow it will feel uncomfortable, but not every time.
heaviness in chest-dx w/bronchial asthma-dx pneumonia;diff breathing;
Patient received expired dose of the Moderna vaccine/ The vials were in refrigerator for over 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine/ The vials were in refrigerator for over 30 days) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine/ The vials were in refrigerator for over 30 days). On 27-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine/ The vials were in refrigerator for over 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications or treatment details were reported.   This case was linked to MOD-2021-338604 (Patient Link).
Information has been received from a Licensed Vocational Nurse referring to an unspecified number of patients of unknown age and gender. There was no medical history or drug reaction/allergies reported. On unknown dates the patients were vaccinated with doses of improperly stored VARIVAX (lot # L012038 with expired date 07-APR-2017, dose and route were unknown). No concomitant medication was reported. No adverse effect was reported. This is one of several repots received from the same reporter. Additional information has been requested.
3 days after receiving Yellow Fever meningococcal and injectable Typhoid vaccine, patient developed fever, chill, anorexia, swollen and painful joints, fatigue which persisted for 6 1/2 weeks.
rapid heart rate, difficulty breathing, dizziness, pressure in chest and chest pain. Currently being treated with Metoprolol 25mg daily, Ibuprofen twice daily and Albuterol inhaler every 4-6 hours.
Chest pain, worsening over 2 - 3 days after his booster dose. Presented to ED, found to have elevated troponins. Admitted to the cardiology service.  Troponin peaked on 2/21/22. IVIG given on 2/21/22, and troponins have fallen since. Chest pain resolving. Hemodynamically stable with normal cardiac function by echo and cardiac MRI throughout observation in hospital.
Severe Diarrhea, started in the evening and extended through the night. 5-7 episodes.
Pt's lips and tongue swelled up and pt had trouble breathing. Was drooling, pt had shots about noon, then took nap. Awoke 1630 with symptoms.
PATIENT EXPERIENCED NUMBNESS ACROSS HIS ENTIRE BODY WITHIN 5 MINUTES OF RECEIVING THE VACCINE. PATIENT DESCRIBED IT AS IF HE HAD A NUMBING INJECTION BEOFORE A PROCEDURE, ALONG WITH FEELING AS IF HE WAS INTOXICATED. PATIENT WAITED FOR 45 MINUTES, AND IT CONTINUED.  VITALS WERE COLLECTED.  BLOOD PRESSURE 167/96 (150/86 AT PROVIDER'S OFFICE THURSDAY). PULSE OF 93. WEIGHT 325LBS. PATIENT FELT GOOD ENOUGH TO GET UP, WALK AROUND AND GO HOME. WE WILL FOLLOW UP WITH PATIENT LATER TODAY, AND PATIENT WAS TOLD TO CALL HIS PROVIDER ON MONDAY TO BE EVALUATED.
FEVER, HEADACHE, STOMACHACHE, VOMITING EAR ACHE
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 11-SEP-2015, the patient was vaccinated with a dose of PNEUMOVAX23 0.5 ml once, lot # L014876, expiration date 13-JAN-2017, subcutaneously in the area "just below" the deltoid. On an unknown date in September 2015, the patient returned to the pharmacy and stated that "it was more painful than he or she thought it should have been". The reporter stated that she (the pharmacist) visualized the injection site and found area to be "perfectly normal, not red or warm or anything like that". The reporter stated that no other effects were reported. The patient did not receive any treatment. The outcome of the event was unknown. The patient sought medical attention via visiting the pharmacy. The relatedness between the event and PNEUMOVAX23 was not reported. Additional information has been requested.
Parent called 7FEB indicated pt had vomited 5-6x since 6AM w/elevated temp; referred to MD; t102 PC to parent 19FEB pt taken to MD @ 2PM on 7FEB but stopped vomiting by then no sx since then;
Had a sore arm a few days that went away no prob. Suddenly today around noon, I developed severe itching, redness and inflammation. I have a scheduled appt. for PE tom. with doctor and will have her check me out. This was my 1st dose. I've just taken benadryl to help so I can sleep.
Sudden vertigo episode. Long lasting for 1 week. Followed by dizziness still ongoing 8 months later. Symptoms have improved but have not disappeared.
Swollen arm that was hurting; Swollen arm; shoulder blade and hip pain; very fatigue; Diarrhea; Difficult breathing; Headache; Stomachache; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th June 2021, the patient received the 1st dose of Shingrix (intramuscular). On 14th June 2021, 7 days after receiving Shingrix, the patient experienced pain in arm, swelling arm, arthralgia, fatigue, diarrhea, difficulty breathing, headache and stomach pain. On an unknown date, the outcome of the pain in arm and swelling arm were recovered/resolved and the outcome of the arthralgia, fatigue, diarrhea, difficulty breathing, headache and stomach pain were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, swelling arm, arthralgia, fatigue, diarrhea, difficulty breathing, headache and stomach pain to be related to Shingrix.   Additional details were reported as follows: This case was reported by the patient. The patient reported that patient received Shingrix vaccine and after one week experienced stomachache, headache, difficult breathing diarrhea and very fatigue, shoulder blade and hip pain all of which were continuing to affect her. The patient also stated that a swollen arm that was hurting at the time of these other symptoms, but has resolved at the time of the call. Consented to follow up.
1st dose given 29Jan2021, because facility closed down, second dose not schedule til 24April2021, going to schedule second vaccine outside the 35 day time frame; 1st dose given 29Jan2021, because facility closed down, second dose not schedule til 24April2021, going to schedule second vaccine outside the 35 day time frame; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (1st dose given 29Jan2021, because facility closed down, second dose not schedule til 24April2021, going to schedule second vaccine outside the 35 day time frame) and PRODUCT AVAILABILITY ISSUE (1st dose given 29Jan2021, because facility closed down, second dose not schedule til 24April2021, going to schedule second vaccine outside the 35 day time frame) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported). Previously administered products included for an unreported indication: COVID-19 VACCINE (Patient received 1st dose intramuscularly in left deltoid muscle (Batch: 027620A)) on 29-Jan-2021.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (1st dose given 29Jan2021, because facility closed down, second dose not schedule til 24April2021, going to schedule second vaccine outside the 35 day time frame) and PRODUCT AVAILABILITY ISSUE (1st dose given 29Jan2021, because facility closed down, second dose not schedule til 24April2021, going to schedule second vaccine outside the 35 day time frame). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (1st dose given 29Jan2021, because facility closed down, second dose not schedule til 24April2021, going to schedule second vaccine outside the 35 day time frame) and PRODUCT AVAILABILITY ISSUE (1st dose given 29Jan2021, because facility closed down, second dose not schedule til 24April2021, going to schedule second vaccine outside the 35 day time frame) outcome was unknown. Not Provided          No Treatment information was reported.   This case was linked to MOD21-076258 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Patient Birth date, Previous COVID-19 vaccine dose details added, event verbatim information updated; Sender's Comments:  MOD21-076258:Birth date of patient and verbatim updated
administered with vaccine that experienced more than 1 temperature excursion; administered with vaccine that experienced more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (administered with vaccine that experienced more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (administered with vaccine that experienced more than 1 temperature excursion) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021 at 11:02 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-Feb-2021 at 11:02 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (administered with vaccine that experienced more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (administered with vaccine that experienced more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (administered with vaccine that experienced more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (administered with vaccine that experienced more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 56.18.  Concomitant medication of the patient was not reported.  Batch number 031L20A underwent temperature excursion on 14-Feb-2021 with temperature of 32 degrees Fahrenheit at 09:00 AM, 32 degrees Fahrenheit at 10:00 AM, 32 degrees Fahrenheit at 11:00 AM, 35 degrees Fahrenheit at 02:00 PM and 35 degrees Fahrenheit at 03:00 PM. These vials were moved to fridge on 09-Feb-2021 and beyond use date for the vials was reported as 10-Mar-2021. The vaccines moved to clinic on 13-Jan-2021. Storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination. Vials were only punctured right before administration. Vaccines were not frozen at time of administration and prior to administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. The reporter reported that, no data logger reports were available and traceable temperature monitor was used to record hourly temperatures.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-566976 (Patient Link).
Initial large painful seroma at site of injection.  Several days later followed by the onset of severe polyarticular inflammatory arthritis unimproved with steroids, somewhat improved with adalimumab (Humira.)
loose stools; not feeling well; fever of 102.4; pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (loose stools), MALAISE (not feeling well), INJECTION SITE PAIN (pain at the injection site) and PYREXIA (fever of 102.4) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced INJECTION SITE PAIN (pain at the injection site). On 21-Feb-2021, the patient experienced DIARRHOEA (loose stools), MALAISE (not feeling well) and PYREXIA (fever of 102.4). At the time of the report, DIARRHOEA (loose stools), MALAISE (not feeling well), INJECTION SITE PAIN (pain at the injection site) and PYREXIA (fever of 102.4) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication and treatment medication was provided.   This case was linked to MOD-2021-032541 (Patient Link).
A healthcare professional reported that a 4 month old male received an injection of Prevnar on 10/18/02. Concomitant vaccines included Synagis, IPOL, Infanrix, and Comvax. On 10/18/02, the child developed fever *of 102 deg F*, bulging fontanelle, somnolence and anorexia. He was subsequently hospitalized. *A "septic work-up" and evaluation of the cerebrospinal fluid were performed which yielded negative results. A "culture" was reported as negative. He was treated with unspecified intravenous antibiotics.* On 10/19/02, he was discharged from the hospital. *A few days after discharge, the bulging fontanelle reappeared. A Dx of mild hydrocephalus was made. The MD indicated that the child was "doing well".* This infant's twin experienced the same event. The follow up received on 12/30/02 states that the physician indicated that the child recovered. The follow up received on 4/28/03 states
Heart Palpitations; headaches; severe body aches; tiredness; This is a spontaneous report from a contactable consumer (patient). A 62-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6203, Expiration date not reported), via an unspecified route of administration, administered in the right arm, on 03Mar2021 (at the age of 62-year-old) as single dose for COVID-19 immunisation at Health Clinic. Medical history included supra ventricular tachycardia's heart, epstein barr, obesity, high bp, hypothyroid, stomach issues with indigestion from an unknown date and unknown if ongoing. The patient received other unspecified medications with 2 weeks. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: EL9269, Expiration date not reported), via an unspecified route of administration, administered in the right arm, on 10Feb2021 at 11:30 (at the age of 62-year-old), as single dose for COVID-19 immunisation. The patient previously received codeine (MANUFACTURER UNKNOWN) and experienced allergy. No other vaccine received within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. On 05Mar2021 (reported as: 2 days after 2nd dose), the patient experienced heart palpitations, headaches, severe body aches and tiredness. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the adverse events. The outcome of all events was not resolved.   No follow-up attempts are possible. No further information is expected.
Mixed series vaccines (First Pfizer, second Moderna); This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Mixed series vaccines (First Pfizer, second Moderna)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 WRONG PRODUCT ADMINISTERED (Mixed series vaccines (First Pfizer, second Moderna)). At the time of the report, WRONG PRODUCT ADMINISTERED (Mixed series vaccines (First Pfizer, second Moderna)) 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 concomitant medications were provided.  No treatment details were provided.
got covid after receiving the first shot; got covid after receiving the first shot; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for two patients. This is second of two reports.   A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got COVID after receiving the first shot on an unspecified date. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021046083 same reporter/drug/event, different patient
Woke up with muscle aches.  While walking to get Advil I collapsed on the floor and was conscious but unresponsive for 15-30 seconds while my wife tried to get me to respond.  For the next hour or so I had waves of aches, nausea, dizziness, and muscle weakness.  I was then able to get back to sleep and following day, I had mild aches that subsided as the day progressed and was close to feeling normal by evening.
Myalgia and impaired speech, red, lump at injection site, pain at site, right leg weakness.