chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hard, immovable on back of head behind ear. Changes shape and size approximately every two days. Only on left side.; Dose number: 3; This is a spontaneous report from a contactable reporter (consumer or other non hcp). The reporter is the patient.  A 20-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 03Nov2021 at 12:00 (Lot number: FF8841) at the age of 20 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medications included: LEXAPRO; VITAMIN B12; VITAMIN D NOS and LOJAIMIESS. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: ER8737, Anatomical location: Left Arm, Vaccine Administration Time: 14:15), administration date: 02Apr2021, when the patient was 20 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: EW0171, Anatomical location: Left Arm, Vaccine Administration Time: 12:00), administration date: 23Apr2021, when the patient was 20 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 03Nov2021 at 12:00, outcome "unknown", described as "Dose number: 3"; NEOPLASM (non-serious) with onset 18Nov2021 at 10:00, outcome "not recovered", described as "Hard, immovable on back of head behind ear. Changes shape and size approximately every two days. Only on left side". It was unknown whether any therapeutic measures were taken as a result of the NEOPLASM.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Shingles appeared on left arm from injection site down to thumb.   Not claiming that the vaccine caused it, but hopefully this data point can help if any others are having same experience.
10/21/08:  Visual aura lasting approximately 20-30 minutes beginning 18:20.  Minor headache, only 2-3 on scale of 10.  Diagnosed as classical migraine by ER Neurologist.  Isolated event, no treatment recommended (no prior or family history of migraine).  10/22-25/08:  Mild headache, no treatment sought, took Ibuprofen with some effectiveness.  10/25/08:  Dizziness upon waking, 08:00.  Mild headache, feels like fever but temp normal (98.6 dF).  No treatment sought.
After administration, patient leaned back with eyes rolled towards the back of his head. He began to convulse for a few seconds, then fainted. Moments later he regained consciousness and appeared pale and complained of being tired.
1st day... Left arm-Swollen, red and warm to touch 2nd day...  left arm swollen, warm to touch, left breast swollen, firm warm to touch and ER doctor stated that lymph nodes are also swollen on left arm 3rd-5th day- arm swollen 3rd-present- left breast swollen
After my second Moderna vaccine ,  I developed Bells Palsey on the  right side of my face, and some on the left. I went to Medical Center and saw one of the providers  (it was a Saturday) who did a neurological exam and was 99% sure it was Bells but wanted more testing and caution. He sent me to Hospital where I went into the ER and they were expecting me. I was there about 4 hours or so, and had a bunch of tests. I left with a prescription for Prednisone and Valacyclovir, which is an anti-viral.
Shortness of breath started 4 hours after vaccine. It has continued, and Friday developed a cough. I had been dealing with seasonal allergies prior; however, shortness of breath was and never has been a symptom for me.
Approximately 5 minutes after administration of vaccination, child broke out in red hives on bilateral arms and cheeks, assessed by PA-C, and RN.  Benadryl 30 mg given intramuscular in right deltoid.  Patient observed for 30 minutes after injection with no further complications.  Educated father to give child Benadryl if worsened and if life threatening to seek treatment at a local emergency room.  Verbal understanding noted by father.
The Covid vaccine 0.3ml dose was prepared on 10/22/21 at around 2PM.  The dose was sent to the patient unit, but was administered the following morning around 09:17AM.  The dose was stored at room temp and would have expired after 6 hours in the syringe.    There were no adverse effects.  This was the 3rd dose in the series due to this patient being immunocompromised.   Her physician has notified the patient and family and plans to test for antibodies and may re-dose
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Oct2022 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 77 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Anti-hypertensive" (unspecified if ongoing), notes: Other medication in 2weeks product=Anti-hypertensive (beta blocker), last dose day before Paxlovid ,. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tests strongly positive again; Positive, notes: tests strongly positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19; received Paxlovid as COVID 19 Treatment from 14Oct2022 to 18Oct2022.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Swelling; Redness; Tiredness; Itching; redness at injection site the size of an orange; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling), ERYTHEMA (Redness), FATIGUE (Tiredness), PRURITUS (Itching) and VACCINATION SITE ERYTHEMA (redness at injection site the size of an orange) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PRURITUS (Itching) and VACCINATION SITE ERYTHEMA (redness at injection site the size of an orange). On an unknown date, the patient experienced SWELLING (Swelling), ERYTHEMA (Redness) and FATIGUE (Tiredness). At the time of the report, SWELLING (Swelling), ERYTHEMA (Redness), FATIGUE (Tiredness), PRURITUS (Itching) and VACCINATION SITE ERYTHEMA (redness at injection site the size of an orange) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment medication were reported.
Patient was given an expired dose of MMRV. There were no noted adverse reactions. Reported to Merck, they advised that the vaccine was supported but Immunization Coalition recommends revaccination.
Mild headache, which occurs when she bends down; nausea; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Mild headache, which occurs when she bends down), NAUSEA (nausea) and PYREXIA (low grade fever) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced HEADACHE (Mild headache, which occurs when she bends down), NAUSEA (nausea) and PYREXIA (low grade fever). At the time of the report, HEADACHE (Mild headache, which occurs when she bends down), NAUSEA (nausea) and PYREXIA (low grade fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Continuing soreness from shot two days prior, low-grade fever (99.7) for almost two weeks, with certain movements still have pain around injection site, sometimes migrating to joint. Intensity seems to be increasing.
I received the shot at 2 o?clock. By 2:05 my tongue and the back of my throat started tingling and burning like it had been scolded. It was reported after 30 minutes.  25 mg of Benadryl was given PO at 2:35. I started to develop a cough and was clearing my throat but had no difficulty breathing. At 3:05 another 25mg of Benadryl po was given. I was monitored until 4:30 PM. I was sent home. By 630 the sensation had started to increase again. I took 25 mg of Benadryl PO again. By 7 PM I was not having any relief so I spoke with my physician and he advised me to take 25 mg of Benadryl PO and the first row of a steroid dose pack. By midnight the symptoms had started to reoccur. I took another 50 mg of Benadryl. I finished the medrol dose pack on Wednesday, January 13th but still have the raw sensation on my tongue.
Developed large red  swollen area at injection site about 6 inches in diameter that occurred about 16 hours after injection.  Also  experiencing joint pain all over the body that is described as an 8 out of 10 on pain scale that occurred at same time as injection site reaction.
vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 07Jul2022; No adverse event; Administered the vaccine to patient after the 30 day by used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 07Jul2022) and NO ADVERSE EVENT (No adverse event) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 07-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 07Jul2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 07Jul2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 07Jul2022).    No concomitant medications were provided by the reporter.  The number of doses/vials administered were 35 vials. Date the vial was initially stored in the refrigerator was 04-Jun-2022. The vaccines were administered from the 04-Jun-2022 until the 26-Jul-2022. The vial did not undergo any temperature excursions.  No treatment medications were provided by the reporter.
An 11y/o female patient who received an undiluted dose of the Pfizer COVID-19 Vaccine Orange Cap.; An 11y/o female patient who received an undiluted dose of the Pfizer COVID-19 Vaccine Orange Cap.; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  A 10-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Lot number: FL8095, Expiration Date: 28Jun2022) at the age of 10 years, in right deltoid for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL] taken for asthma. The following information was reported: OVERDOSE (non-serious), PRODUCT PREPARATION ERROR (non-serious), outcome "unknown" and all described as "An 11y/o female patient who received an undiluted dose of the Pfizer COVID-19 Vaccine Orange Cap.".  Additional Information: Reporter stated there was no other medication taken only albuterol was taken as treatment drug for asthma. Reported stated it looked like she had albuterol pump. It was documented patient was not taking everyday it's when she needed. Reported stated that there were no prior vaccination (with 4 weeks) of suspect vaccination.
Valley fever; This spontaneous report was received from a currently 79-year-old female patient, concerning to herself. The patient's medical history, previous drug reactions or allergies and concomitant medications were not reported.     On and unspecified date in 2009, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (reported as pneumonia) for prophylaxis (strength, dose, route of administration, anatomical location, lot # and expiration date were not provided).  On an unknown date, the patient developed valley fever (coccidioidomycosis).   The outcome of coccidioidomycosis was not reported. The reporter considered coccidioidomycosis to be related to Pneumococcal Vaccine, Polyvalent (23-valent)(manufacturer unknown).     Upon internal review, coccidioidomycosis was determined to be a medically significant event.  This is one of two reports received from the same patient.; Sender's Comments:  US-009507513-2001USA002937:
Patient with throat itchiness and tounge swelling. Took Benadryl but that did not seem to help with symptoms. Went to ED for further observation . She was given steriods and famotidine for treatment.
ED to Hosp-Admission Discharged  5/4/2021 - 5/10/2021 (6 days)  Treatment team COVID-19 Principal problem   Hospital Course     HPI: Please see H&P for details   Hospital Course:   76-year-old gentleman was admitted to hospital because of COVID-19 pneumonia and respiratory failure with hypoxemia secondary to it.  He was placed on oxygen which was titrated.  He was started on remdesivir and finished the course.  Initially his condition got worsened and ID was consulted and he was given Tocilizumab.  He also was started on dexamethasone from day 1.  His condition has improved significantly.  He is requiring 2 L of nasal cannula.  At this point he is going to finish his course of dexamethasone as outpatient and he will be discharged home with oxygen.  He was also educated about proning and he is very good at this.  He also had remote patient monitoring arranged.  He is going to follow-up with his PCP.  Admission Diagnosis      Medical Problems     Hospital Problems        POA   * (Principal) COVID-19 Yes       Depressive disorder Yes       Type 2 diabetes mellitus (CMS/HCC) Yes       Chronic lymphoid leukemia in remission (CMS/HCC) Yes       Pneumonia Unknown       Acute respiratory failure with hypoxia (CMS/HCC) Yes
Myalgia Fatigue for 48 hours; Subjective fever and chills; feeling of fogginess Narrative:
J96.00 ACUTE RESPIRATORY FAILURE 3/6/2023 ATRIAL FIBRILLATION, UNSPECIFIED
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. In July 2014 the patients were vaccinated with M-M-R II (dose, route of administration and lot # were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
According to her husband, patient developed chill, fever and diarrhea and she was afraid to get the second dose.  I tried to call the patient but she did not respond
Patient had common adverse reactions with Shirgrix: Injection site soreness, redness, swelling.  Patient also felt tired.  Patient contacted pharmacy back within 24 hours and said the injection site was still sore and red.  Advised her to take NSAID or APAP to help.   Cotacted patient back within 24 hours and she stated welling had gone down but area was still red.
no further AE; temperature excursion; PROQUAD no longer viable; This spontaneous report was received from a nurse referring to a 13 months old male patient. The patient's medical history, concomitant drugs and drug allergies were not reported.   On 25-JAN-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T003714, expiration date was not reported, but upon internal validation established as 29-JUL-2021, strength was not reported) 0.5 milliliter subcutaneously for prophylaxis.   It was reported that the office was closed due to coronavirus disease (COVID), and the freezer had gone out of range. The temperature excursion of these vaccine was 47 degrees Fahrenheit for approximate 9 hours and 54 minutes without any previous temperature excursion. The digital data logger was involved for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). It was also reported that the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was no longer viable. No further adverse event was reported.
Vial was expired on 1-Apr-2022 and initially refrigerated on 4-Apr-2022; Expired vaccine administered/ Vaccine was expired on 01 Apr 2022 and was administered on 08 Apr 2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered/ Vaccine was expired on 01 Apr 2022 and was administered on 08 Apr 2022) and PRODUCT STORAGE ERROR (Vial was expired on 1-Apr-2022 and initially refrigerated on 4-Apr-2022) in an 83-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered/ Vaccine was expired on 01 Apr 2022 and was administered on 08 Apr 2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was expired on 1-Apr-2022 and initially refrigerated on 4-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered/ Vaccine was expired on 01 Apr 2022 and was administered on 08 Apr 2022) and PRODUCT STORAGE ERROR (Vial was expired on 1-Apr-2022 and initially refrigerated on 4-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided Treatment medication was not provided by the reporter  It was reported that they thought that the vaccine was expired in Jun-2022, however it was expired on 01-Apr-2022 Date the vial was initially stored in refrigerator was 04 Apr 2022. Vial had not undergone any temperature excursion.
3/26- small itchy spot in middle of forehead    3/29- Large red inflamed rash center of forehead and swelling on jaw at left ear,  3/30- appointment with VA. N.P. thought it to be Shingles w/ cellulitis and swelling from drainage. Prescribed 500MG Keflex 3 times daily.         4/2- rash and swelling have diminished, rash a little larger than 50 cent piece w/ a 1 inch vertical scab? in center.
fever; This case was reported by a nurse via call center representative and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced a fever after Shingrix vaccine. The dose number was not clear whether 1st dose of Shingrix or 2nd dose of Shingrix. The reporter did not provided any other details. The reporter did not consent to follow up.
Pt recvd series of Hep B vax 1FEB90, 1MAR90, 3AUG90; booster dose given 29COT90; titer 9OCT90-weakly pos; titer 12MAR91 pos;
Injection site pain; tiredness; headaches; muscle pain; chills; joint pain; nausea; feeling unwell; a fast heartbeat; off balance; This is a spontaneous report from a contactable consumer (patient). A 78-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: El1283), via an unspecified route of administration, administered in Arm Left on 09Feb2021 as dose 2, single for covid-19 immunisation from hospital. Medical history included Arthritis, Afib, high blood pressure, thyroid and allergy to opioids.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with covid prior to vaccination and patient was not tested for COVID-19 post vaccination. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL3249), via an unspecified route of administration, administered in Arm Left on 19Jan2021 as dose 1, single for covid-19 immunisation. Concomitant medications included Olmesartan, apixaban (ELIQUIS), metoprolol, levothyroxine all taken for an unspecified indication, start and stop date were not reported. The patient experienced Injection site pain, tiredness, headaches, muscle pain, chills, joint pain, nausea feeling unwell, a fast heartbeat, off balance on 09Feb2021 19:00. The patient did not receive any treatment in response to the events. The outcome of the event was recovering , headaches (headache) (non-serious) on 09Feb2021 19:00 with outcome of recovering , muscle pain.  No follow-up attempts are possible. No further information is expected.
I tested positive for Covid-19 on December 13, 2022 I experienced a fever of 101.5, chills, body aches, coughing, congestion, nausea,