chrisvoncsefalvay/vaers-outcomes huggingface dataset:
25 year old Male with no significant PMH presented to the vaccination clinic for his first dose of the covid-19 vaccine. Patient recieved the dose at 6PM and around 6:10pm the nurse saw the Patients eyes roll back and began to shake all four extremities "jerky movements". Patient lost consciousness for about 15-30 seconds. Once Patient regained consciousness he began to say "What happened to me?". EMS was present and PA's. Patient reported that he had no symptoms prior to experiencing the seizure. Patient denies history of seizures, shortness of breath, chest pain, dizziness, blurry vision, abdominal pain,  numbness/tingling, weakness and headache. Of note Patient has syncopized previously from blood draws. Patient was place on a 12 lead ekg: ekg unremarkable with no ST elevations, no inverted t waves, normal rate, intervals within normal intervals and no peaked t waves. Patients blood glucose was taken initially reading 54 and then Patient was given oral orange juice and the second blood glucose reading was 103. Patients initial vitals were HR: 62 RR:14, BP:117/82 with a SPO2: 100% on RA Second vital readings after 20mins there HR: 65 RR:15 BP:133/94 SPO2: 100% on RA. Patients physical exam revealed  neurological exam within normal limits, Patient alert and oriented x4. Cranial nerves 2-12 intact, steady gait, ambulatory, normal finger to nose, no romberg, sensation intact in all fours extremities, all fours extremities reveal a strength of 5/5 and normal coordination. Patient was in no acute distress, alert and oriented. Cardiac exam: regular rate, rhythm, no rubs, murmurs, or gallops. Pulmonary: lungs clear bilaterally, no wheezing or rhonchi and airway patent. HEENT: Pupils equal round and reactive to light, EOM intact, airway patent, moist mucosa, no tongue lacerations, uvula mid-line. Patient was transported to the hospital via ambulance by Paramedic and EMT. Patients Mother was informed of what occurred at the vaccination site and was informed that her son was being transported to the hospital given Patients first seizure and no history of seizures.
Mild pain in the arm of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Mild pain in the arm of the injection) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included MELOXICAM, ATORVASTATIN and OMEPRAZOLE for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced VACCINATION SITE PAIN (Mild pain in the arm of the injection). At the time of the report, VACCINATION SITE PAIN (Mild pain in the arm of the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications also included Blood pressure medication, Medicine for his cold.  No Treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Follow-up information received and contains No NewInformation.
Muscle and joint stiffness and soreness that continued to increase for weeks, until on 5/24/21, my primary care physician saw me and prescribed a rapid prednisone taper.  When that had not worked (temporary mild improvement that didn't last) by 6/1/21, he referred me to Rheumatology. Based on CRP values of 6.0 (inflammation) and symptoms, Dr. diagnosed me as having Polymyalgia Rheumatica, and first did a longer slower taper of the Prednisone, and finally a very long, very slow taper, with the addition of Methotrexate (4 mg once a week).
Lungs filled up with phlegm within two hours of receiving injection. Wheezing, trouble breathing, inflammation in lungs-slight burning feeling. Exacerbation of asthma symptoms.
Injection site, Left upper arm, swollen red and itchy 20mm x 20mm of redness. Rt eye swollen.
SENSITIVE ARM, ALMOST LIKE A SUNBURN WITH NO REDNESS OR SWELLING; ARM HURTS,  FROM ELBOW TO WRIST; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported. As per procedure no follow-up will be requested for this case. No concomitant medications were reported.  On MAY-2021, the subject experienced sensitive arm, almost like a sunburn with no redness or swelling. On MAY-2021, the subject experienced arm hurts, from elbow to wrist. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from arm hurts, from elbow to wrist, and the outcome of sensitive arm, almost like a sunburn with no redness or swelling was not reported. This report was non-serious.
Minor received third dose of Pfizer Vaccine on 8/29/2022 Then received a fourth dose of Pfizer Vaccine on 9/2/2022
1 week after receiving vaccine, pt reports approximately 2 x 4 in area of red, hard itching to back of right arm where she received the vaccine. Pt  also reported arm pain with movement. These symptoms lasted 2 weeks and resolved on their own. Pt did not seek medical attention.
no adverse event; patient was inadvertently administered the second dose less than 2 weeks after the first one; This spontaneous report was received from a certified medical assistant (CMA) referring to a patient of unknown age and gender.   No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.   CMA reported that on 03-DEC-2020, the patient was inadvertently administered a second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (dose, route and site of administration, lot number and expiration date were not reported), less than two weeks after the first dose (inappropriate schedule of product administration). No adverse effects were reported.  The outcome of inappropriate schedule of product administration and no adverse event was unknown.
This spontaneous report was received from a healthcare workers referring to a 30 to 40 patients of unknown age and gender. Since an unknown date in September 2015 (the vaccinations occurred within the past 2 weeks) the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (dose and frequency were not reported, lot # L004655 with expiration date: 11-FEB-2017, lot# L013067 with expiration date: 14-APR-2017). No adverse effects reported. This is one of the several reports received from the same reporter. Additional information is not expected. Reporters did not wish to be contacted.
~7 to 8 days ago, my left arm precisely where the Covid vaccine injection site was located started to hurt again.   It has progressively got worse especially when my arm is raised,  area is touched or today when trying to swing a golf club my left upper  arm  was painful. My Left arm had hurt for about 5 to 6 days after the vaccination but the pain had almost diminished but it has come back now. I'm trying OTC aleve  and now heat.  If. It better soon will go see doctor.
Patient received vaccine after allowed expiry time; Patient received vaccine after allowed expiry time; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after allowed expiry time) and PRODUCT STORAGE ERROR (Patient received vaccine after allowed expiry time) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after allowed expiry time) and PRODUCT STORAGE ERROR (Patient received vaccine after allowed expiry time). On 07-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after allowed expiry time) and PRODUCT STORAGE ERROR (Patient received vaccine after allowed expiry time) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Pt became dizzy, vomited, passed out for "5 seconds" per mother. Heart rate elevated. Injection site swollen.  Pt "feels funny". Mother pushed fluids, gave BENADRYL.
Patient states she developed pain in left armpit and around left breast that started the evening she received vaccination about 9:30 PM.  Next day developed left sided torso pain and extreme fatigue over weekend.  Noticed today, 3/8/2021, she has a small rash on left side torso that is itchy.
This spontaneous report as received from a physician via a company representative refers to unspecified patient(s) of unknown age. On unknown date(s), unspecified patient(s) were vaccinated with GARDASIL (lot # not reported) (strength and total daily dose not reported). It was reported that unspecified patient(s) did not complete series or take a long time to complete. No adverse events were reported. It was unspecified whether the patient(s) sought for medical attention. The outcome was unknown. Additional information has been requested.
Pt received both Pfizer vaccines. On August 31st, 2021, pt tested positive for COVID-19. Presented to ED with complaint of finger swelling and diarrhea. Pt. is asymptomatic in regards to COVID.
Left deltoid warm, swollen, tender from shoulder and elbow induration 1mm site.
Nausea   , weakness,  faintness ,stomach pain  , headache, aches
A few days after the vaccine I was at work and began to get hives on the inside of both elbows and my neck. I was diagnosed with chronic hives and it gets triggered by heat or stress. It is now developed into full body hives all over my face arms and chest when I get hot/stressed/anxious.
L arm erythema, warmth, and tenderness to palpation measuring 6x9 inches
20 min after administration of vaccines developed SOB, lip swelling, difficulty swallowing and returned to office in respiratory distress c/o itchy rash, Albuterol/ATROVENT nebulizer. BENADRYL po 1 1/2 tsp, ORAPRED 15/5 2 tsp po, Epi Pen Jr (1.5mg) given IM; transported to ER by EMS.
Potential AE due to doses administered from vials that may have been compromised; Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion; Administered vaccine from vials that may have been compromised; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised). At the time of the report, IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Reporter stated that, they had a group of 13 pharmacies and have administered the Moderna vaccine. Their digital data loggers and freezers expired before they were re-calibrated. They were aware in some of the freezers there was a temperature excursion that their data logs showed. The vaccines have never reached a temperature that was considered outside of frozen recommended range. The data loggers had laps where they were not considered calibrated, so they had a paper-logs to monitor those temperatures. This was in several different freezers and the vial temperatures never went out of range when they were using the paper log. The reporter was concerned that the vials have been compromised. Further reporter stated that, vaccines administered at their pharmacies that were stored in an unapproved freezer and thus, might have been compromised.  The beyond use date for vial was reported as 01-Dec-2021 to 15-Dec-2021.  No treatment medication was reported.
Allergic reaction; itching and rash on scalp, neck, ears, and shoulders; swollen lymph nodes; aches; eye pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 7 year-old female patient received bnt162b2 (BNT162B2), administered in arm right (Lot number: FK5127) at the age of 7 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing), notes: Relevant past drug history:, Name of Drug as Reported: No, Reaction: Allergy. There were no concomitant medications. The following information was reported: HYPERSENSITIVITY (non-serious) with onset 19Nov2021 12:00, outcome "recovering", described as "Allergic reaction"; RASH PRURITIC (non-serious) with onset 19Nov2021 12:00, outcome "recovering", described as "itching and rash on scalp, neck, ears, and shoulders"; LYMPHADENOPATHY (non-serious) with onset 19Nov2021 12:00, outcome "recovering", described as "swollen lymph nodes"; PAIN (non-serious) with onset 19Nov2021 12:00, outcome "recovering", described as "aches"; EYE PAIN (non-serious) with onset 19Nov2021 12:00, outcome "recovering", described as "eye pain". Therapeutic measures were taken as a result of hypersensitivity, rash pruritic, lymphadenopathy, pain, eye pain.  Additional information: The patient had Benadryl and Tylenol as a treatment for all the events. The patient did not have any other vaccine in four weeks. The patient did not have any other medications in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient has not been tested for COVID-19 since the vaccination. Vaccine facility type was pharmacy or Drug Store. Reporter did not have idea who this patient was, they will have to provide additional information so that they may identify whether the patient was seen in this office.  No follow-up attempts are possible. No further information is expected.  Follow-up (01Dec2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported in response to HCP telephonic follow-up activity that included: Updated information: Reporter address and occupation.  No follow-up attempts are possible. No further information is expected.  Follow-up (20Dec2021): This is a spontaneous follow-up report received from a contactable consumer. This consumer reported in response to HCP letter sent that included: Updated Information: New reporter information. Additional Information: Comments/ Narrative.   No follow-up attempts are possible. No further information is expected.
Severe rash throughout body and conjunctivitis  starting 2 days after injection . Flu vaccine 10/12/2021
full body hives; 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 (full body hives) 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) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced URTICARIA (full body hives). At the time of the report, URTICARIA (full body hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Disseminated shingles - first lesions appeared hours after vaccine - painful, itchy rash over L inner thigh,  which progressed to include additional lesions on her left foot and right trunk.  When she had first lesions on thigh, was prescribed oral acyclovir. When she developed additional lesions on other parts of body, was admitted to hospital for IV acyclovir, infectious disease consult, ophthalmology consult.
Information has been received from a medical assistant concerning a 8 year old male patient who on 12-MAY-1998 was vaccinated with a dose of varicella virus vaccine live. On approximately 28-DEC-2005, the patient developed chickenpox. Unspecified medical attention was sought. There was no product quality complaint involved. No further information was available. Additional information has been requested.
Pt vaccinated with OPV and screamed for two hours on two occasions also developed a rash on the upper half of torso and around neck area. Rash disappeared after two days.
We held off on getting my daughters shots until she was 3. Originally we were just going to hold off for the first year of her life to let her body build up its own immunity. So in Nov. 2004, she received her second shot of Dtap,polio, and HepB. She showed signs of a fever of 104.0, and I called her nurse and they said that was normal. She had a raised red mark about the size of a nickel on her leg where they injected the medicine. Its not NORMAL for a body to reject the medicine to where it puts the body in danger.
redness and warmth to touch below injection site; redness and warmth to touch below injection site; This is a spontaneous report from a contactable physician via a Pfizer sales representative. A male patient of an unspecified age (reported as 63 without unit) received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced redness and warmth to touch below injection site on an unspecified date with outcome of unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
HCP called to report a TE with MMR II, PROQUAD, VARIVAX, GARDASIL 9, ROTATEQ, VAQTA, VAXELIS PFS. VAXELIS PFS and ROTATEQ were administered; This spontaneous safety report, with reference number 02385069 (Interaction # 02385061) was received by the partner on 08-MAY-2023 and forwarded to agency on 09-MAY-2023, from a health professional.    Due to the nature of the event, the causality between the event "HCP called to report a TE with MMR II, PROQUAD, VARIVAX, GARDASIL 9, ROTATEQ, VAQTA, VAXELIS PFS. VAXELIS PFS and ROTATEQ were administered" and Vaxelis was not applicable.  Further information is expected.  Significant Follow-up information was received by the partner on 16-MAY-2023 and forwarded to agency on 17-MAY-2023, from a health care professional. This case is maintained as non-serious.  This case continues to be considered non-valid.   The causal relationship between VAXELIS and the reported event of "HCP called to report a TE with MMR II, PROQUAD, VARIVAX, GARDASIL 9, ROTATEQ, VAQTA, VAXELIS PFS. VAXELIS PFS and ROTATEQ were administered is not applicable."  Further information is expected.
This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. In approximately January 2015, reported as since the first stability assessment on 07-JAN-2015, the patients were vaccinated with doses of VARIVAX (Merck) (dose, lot numbers, expiration dates were not reported) that were exposed to a maximum -11.3 Celsius degree for a total time of 2.5 hours, due to defrost cycles. No adverse effects were reported. Additional information has been requested.
pt states she was fine for the first day after taking the vax. On 4/4/201 when she got up around 2:30 AM she was dizzy and was light headed.  Her head was spinning causing her to fall.  She went back to bed her but head was still spinning.  She was finally able to get some sleep which helped her to feel better.  Her blood sugar has been higher than usual since taking the vax.  On 4/6/2021 blood sugar was normal in the morning but spiked up to 325.  she was cold and felt chilled.  she was getting dizzy and started throwing up.  This lasted a couple of hours.  On 4/7/2021 her blood sugar is still a little high but she feels better today.
This spontaneous report was received from a healthcare worker concerning an unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with (Oka/Merck) VARIVAX, lot # M010484, expiration date: 01-MAR-2018, (strength, dose and route of administration were unknown), which were improperly stored. No adverse effects were reported and no product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Pain on armpit; Swollen lymph nodes/swollen armpit; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (Pain on armpit) and LYMPHADENOPATHY (Swollen lymph nodes/swollen armpit) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, the patient experienced AXILLARY PAIN (Pain on armpit) and LYMPHADENOPATHY (Swollen lymph nodes/swollen armpit). At the time of the report, AXILLARY PAIN (Pain on armpit) and LYMPHADENOPATHY (Swollen lymph nodes/swollen armpit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.