chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine given beyound 30 days of refrigeration period; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy.    On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period). On 13-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) 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 considered EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) to be not related.    No treatment and concomitant medications were provided.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-313106 (Patient Link).
One day after vaccines my son experience a Seizure, that was not acknowledge by hospital because the time we got to hospital it was over. He got the 2nd one 3 weeks later.
Information has been received from a Post-Marketing Surveillance Study for PNEUMOVAX 23. A medical assistant reported a 56 year old female patient, who on 16-MAR-2010 the patient was vaccinated with a dose of PNEUMOVAX 23 (Lot # 663936/0508Y, expire date 17-JUN-2010, route not reported) as part of a study. On 02-OCT-2010 the patient was vaccinated with another dose of PNEUMOVAX 23 (Lot #, expire date and route not reported). No adverse effect known. On an unspecified date, the patient developed pneumonia and was hospitalized. At the time of the report the outcome of the patient was unknown. At this time, relationship of pneumonia to study therapy was unknown. Additional information has been requested.
My menstrual cycles are regular and never deviate from the rotation of my birth control due to me being meticulous about taking my Birth Control at the same time each day. They usually last 4 days and are light with little pain/discomfort and I typically have a stable mood. I was set to begin my cycle the day after getting my 1st COVID19 Vaccine Dose on Sunday 6/27/21, but it was delayed one full week and began on Sunday 7/4/21. It was unusually heavy/painful and lasted 6 days. After receiving the 2nd Dose of the Vaccine on Saturday 7/17/21 at 10:30am. I was set to begin my menstrual cycle on Sunday 7/25/21, but again it was delayed one full week and began on Sunday 8/1/21 and was unusually heavy/painful and lasted 5 days. For the month of August, my menstrual cycle was set to begin on Sunday 8/22/21, which it did, but it was still unusually heavy/painful and lasted 5 days. For the month of September, my menstrual cycle was set to begin on Sunday 9/19/21, which it did, but I was unusually moody.
Muscle pain, bone pain, tiredness, sleepiness, headache, throbbing sensation in the head.
(L) arm swollen, warm, non-tender. Erythema from shoulder to elbow.
This case was reported by a pharmacist (father of the subject) and described the occurrence of arm pain in a 17-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent vaccination included MENACTRA (Sanofi Pasteur MSD) given on 23 July 2012. There were no concurrent medications. On 23 July 2012 at 15:00 the subject received a booster dose of BOOSTRIX in the left arm. On 23 July 2012, less than one day after vaccination with BOOSTRIX, the subject experienced arm pain. On the afternoon of the following day, 24 July 2012, the subject experienced weakness, tiredness and sleepiness. At the time of reporting the event of arm pain was worse. The remaining events were unresolved. The reporter indicated that he advised his son to take MOTRIN to help his symptoms.
Information was received from a physician via an Internet article regarding cases in litigation concerning female patients of unknown ages, who were vaccinated with GARDASIL (lot numbers, dates, dosages, and routes of administration not reported). Between May 2009 and September 2010, there were reported to be 213 cases of permanent disability (unspecified) that occurred after GARDASIL vaccination. 213 cases of permanent disability was considered to be disabling. This is one of several reports from the same source. Additional information is not expected.
This case was considered medically important. Information regarding PREVNAR 7 was received from a nurse and an allergist regarding a 2-month-old male patient who experienced swollen cervical gland and fever of 103 degrees F. The patient received the first dose on 16-Mar-2009. The patient's mother reported to the allergist that 48 to 72 hours after receiving the first dose of PREVNAR 7 and other unspecified vaccinations, the patient experienced swollen cervical gland and fever of 103 degrees F in Mar-2009. The pediatrician treated the events with AUGMENTIN. The fever resolved in 10 days. The swollen cervical glands resolved on an unknown date. No additional information was available at the time of this report. See related case(s): US-WYE-H18409910 (adverse event, expedited).
Fever, arm soreness at injection site, chills, muscle aches, and extremely swollen lymph nodes at left clavicle
patient was brought to the emergency room after a non-witnessed syncopal event less than 24 hours after receiving her moderna covid booster she has not done this in the past she was found down and confused by her husband and brought in by ambulance she had what appeared to be bite marks on the right side of the tongue, consistent with a seizure and had a slow return to mentation baseline consistent with a post ictal state while we can't be sure at this time, it seems likely that she had an isolated seizure
Erythematous papules to face & neck with possible angioedema & urticaria as per parent description.  Seen at local hospital.  Reaction 6 hours post vaccines.
Employee states two days after Hepatitis B shot, she had a headache and her blood pressure was 140/108. She states that is better, but her arm remains sore. Sent to facility to be seen by MD.
PIAN, ERYTHEMA, HARDNESS, EDEMA INJECTION SITE PROGRESSED FROM INJECTION DATE TREATED 2 DAYS POST INJECTION WITH ANTIBIOTIC. RAPID RECOVERY RESPONSE
Covid Booster received on 10/29/2021 and dx with pneumonia on 11/01/2021--were told to submit in case this was a reaction to the booster
I have a rash on the sides of my arms and my legs and on parts of torso so it like raised bumps, red bumps; I have a rash on the sides of my arms and my legs and on parts of torso so it like raised bumps, red bumps; it was like dry skin and then the previous day it was the worst; This is a spontaneous report from a contactable consumer (patient). A 55-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: EL3248 and Expiration date: UNKNOWN), via an unspecified route of administration on 24Jan2021 as unknown, single dose for COVID-19 immunization (55 years old when vaccinated). Medical history of the patient included thyroid disorder. The concomitant medications included thyroid (ARMOUR THYROID) taken for thyroid disorder. The reporter stated that she had the vaccine on 24Jan2021 and everything was fine until the two couple of days, still persisting, she initially thought it was like dry skin and then the previous day it was the worst and it felt the same that morning. It was reported that the patient had a rash on the sides of arms and legs and on parts of torso so it like raised bumps, red bumps on 02Feb2021. Therapeutic measures were taken as a result of rash on the sides of my arms and my legs and on parts of torso so it like raised bumps, red bumps which included Allegra, allergy medication. The reporter stated she tried to get with Dermatologist, Allegra its Fexofenadine. The outcome of the event i have a rash on the sides of my arms and my legs and on parts of torso so it like raised bumps, red bumps was reported as not resolved and the outcome of the event it was like dry skin and then the previous day it was the worst was reported as unknown.  Follow-up attempts are completed. No further information is expected.
Chills, body shakes, fever, sore arm at injection site. swollen glands under left arm, body aches,  headache, tired.
Patient left message stating that she had a bad reaction, arm was red, really swollen, painful and vomiting. She told me she had taken BENADRYL-still a little painful but swelling had went down.
she had a fever; sore arm; tired; swollen tonsils with red/white spots; Within a couple days she had swollen tonsils with red/white spots; This is a spontaneous report from a contactable consumer. A 20-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EW0196) dose 2 via an unspecified route of administration on 21Jun2021 (at the age of 20-year-old) as single dose for COVID-19 immunisation at pharmacy or drug store. Medical history was none. No known allergies. Concomitant medications were unspecified. Historical Vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EW0180) dose 1 an unspecified route of administration on 30May2021 (at the age of 20-year-old) as single dose for COVID-19 immunisation and she was fine after 1st vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 22Jun2021, after the second dose she had a fever, sore arm, and tired. Within a couple days she had swollen tonsils with red/white spots. She has been on antibiotics for month, which has helped with spots, but still has swollen tonsils. She still feels more tired than usual but not as bad as day after the 2nd vaccine. She is going to an ENT on 30Jul2021. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests which included post vaccination bi-weekly at client in Jun2021: Negative. The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
sweating, dizziness, lightheadness, anxious, flushing, tingling, water given, observed, improved , sent home
I received the smallpox vaccination on 12 September 2019. On 12 October 2019, I started experiencing  temporary paralysis on the right side of my body. My right arm, my right leg, the right side of my face, and mouth were affected each time. Each "episode" would last no more than 20-30 seconds. Initially, these "episodes" would happen once a day however, some days it would occur twice. These happened an approximately 12 times in a one week period.
Administered a vx after temperature excursion; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th September 2021, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that a Shingrix vaccine had a temperature excursion.  The lowest temperature that the vaccine reached was 22.5 degree F for 4 hours with a previous excursion for 1 hour. The pharmacist stated that a patient received a dose of one of these vaccines on 15th September 2021.  The pharmacist did not have the patient's demographic information. The reporter consented to follow up.
Temperature excursion that occurred several days ago in the Freezer; No adverse event; Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion that occurred several days ago in the Freezer), POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine) and NO ADVERSE EVENT (No adverse event) in a 39-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 18-Oct-2022, 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 18-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion that occurred several days ago in the Freezer) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion that occurred several days ago in the Freezer), POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion that occurred several days ago in the Freezer) and POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine).    Concomitant medication was not reported.  Reporter stated that a temperature excursion occurred several days ago in the freezer which was found in an audit. Multiple patients received vaccine from vaccine that underwent a temperature excursion in the freezer. Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question. Patient who received this vaccine did not report any adverse event. Treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-675735 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-675735:same reporter case/master case
Noticed large 2-3 inch knot at injection site, red and "hot". Developed symptoms 1 day after shot. Symptoms not noticeable the next day.
terrible constipation; stomach pains badly; This spontaneous case was reported by a consumer and describes the occurrence of CONSTIPATION (terrible constipation) and ABDOMINAL PAIN UPPER (stomach pains badly) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced CONSTIPATION (terrible constipation) and ABDOMINAL PAIN UPPER (stomach pains badly). At the time of the report, CONSTIPATION (terrible constipation) and ABDOMINAL PAIN UPPER (stomach pains badly) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
patient states he has pain and itching at injection site and a hives type rash of about 4 inch by 7 inch around injection site.
According to the patient, about 3 hours after receiving the vaccination she started to have a fever up to 102 degrees F, chills, body aches and rapid heart beat. The next day, the fever has subsided, but she still has some body aches and chills. She has never had this type of reaction after a vaccination  before.
The morning after the first dose of the Pfizer vaccine, my shoulders were incredibly tight. At 11 am that day, I had a muscle spasm on the lower left side of my back. I laid down and gradually throughout the day my entire back began to tighten up until I could barely move. At 4 pm I tried to stand and the pain was excruciating. I couldn't stand more than a few minutes without pain and laid back down. By 7 pm, I couldn't move at all. We called the paramedics to take me to the ER. At the ER, I was given medication to help manage the pain and prescribed pain meds at home. I was in bed and unable to move without help and excruciating pain for the next 5 days. I continued to have muscle spasms in my back while standing and sitting during that time. Since then, my mobility has begun to return slowly. I have seen a chiropractor several times, my doctor, had an x-ray done of my back (results were normal), PT several times, and request for an MRI was denied by Insurance. I continue to have soreness in my back and tightness in my shoulders almost 6 weeks after. 4 weeks after the vaccine, I had dizziness, nausea, and headaches. This lasted for 12 hrs and returned again 5 weeks after. I continue to have extreme fatigue halfway through my day doing way less than normal activities.
Resident received Pneumovax on 4/3/06 0.5cc IM in right deltoid. 7cm x 7cm area of injection became red, warm, swollen and resident complained of pain in area. Reaction reported on 4/5/06 by nurse.
Body aches; heart palpitations; Low grade fever; five days post shot extreme fatigue/exhaustion to point I could not get out of bed; First and second day post shot a little tired;; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the arm right on 15Apr2021 at 11:15(at the age of 62-year-old) as a single dose for COVID-19 immunisation. Medical history included hashimoto's disease and reaction to preservatives(Preservatives in shots). Concomitant medications included levothyroxine sodium (SYNTHROID), cetirizine hydrochloride (ZYRTEC),famotidine (MANUFACTURER UNKNOWN) and Estrogen patch(Manufacturer unknown) from unknown dates for unknown indication. The patient previously received Biaxin, Sulfur and penicillin. The patient previously received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number:ER2613 ) via an unspecified route of administration in the arm right on 22Mar2021 at 13:15(at the age of 62-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 15Apr2021 the patient experienced little tired First and second day post shot. On 20Apr2021 at 08:00 five days post shot extreme fatigue/exhaustion to point she could not get out of bed, heart palpitations, low grade fever, body aches. The clinical outcome of the event First and second day post shot a little tired; was recovered. The clinical outcome of the event Body aches was recovered. The clinical outcome of the event heart palpitations was recovered. The clinical outcome of the event Low grade fever was recovered. The clinical outcome of the event five days post shot fatigue/exhaustion was recovered.  No follow-up attempts are needed. No further information is expected.
Rt. upper arm swollen & red 2 cm by 4 cm seen 3/28/11.
Felt like throat was closing and hands and wrist swelled up. Happened the evening after receiving the vaccines around 12:30 in the afternoon.
throbbing and pain in left arm; This is a spontaneous report from a contactable consumer. This consumer re-ported for 79-Year-old female patient (friend) received a dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in Arm Left, on an unspecified date (age at vaccination: 79 years), as unknown, single dose for COVID-19 immunization. The patient's medical history included ongoing diabetes. Concomitant medications were not reported. The patient experienced throbbing and pain in left arm on an unspecified date which she got her COVID 19 vaccine in. The patient thought she was still having arm pain because she has diabetes and with diabetic patient's it takes things longer to heal. She thought that was why her arm still hurts like she just got the vaccine. The caller was pretty sure the patient got the vaccines in her left arm because she was right-handed. Outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Severe left arm pain requiring ER visit. Treated with Diphenhydramine 50mg IM x1, Hydromorphone 2mg IM x1; then sent home.
Patient required hospitalization due to breakthrough infection. Patient received the Pfizer vaccine (2nd dose in series) on 04/13/21. Patient was hospitalized from 07/20/21, then discharged on 07/22/21, readmitted on 07/24/21 and then finally discharged again on 08/04/21. Below is copied from final discharge summary:  The patient presented to the ED with mild fatigue, in no acute distress, and pleasantly demented. Patient was recently admitted for syncope, and was discharged with home healthcare, but returned due to family concern of patient's inability to maintain self care. Patient was noted to have poor nutritional intake in the setting of dementia. Additionally, the patient was tested positive for COVID-19 on 07/20/2021 but remained free of severe symptoms. He has no past history of significant medical problems. He has been followed by case management for placement options, and has been authorized for placement at Nursing and Rehab. He is discharged at this time to this facility in stable condition.   All the above recommendations were discussed with the patient/family. Patient/family agreed with the plan as stated. All questions regarding diagnoses/medications/follow-up were answered. Following appointments already made as below. >30 minutes were spent for the entire discharge process.
Died after receiving the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "Died after receiving the vaccine". The patient date of death was unknown. The reported cause of death was "Died after receiving the vaccine". It was not reported if an autopsy was performed.  The lot number for bnt162b2 was not provided and will be requested during follow up. ; Reported Cause(s) of Death: Died after receiving the vaccine
Pain at injection site 2 days 101+ fever at 9 hrs post vaccination followed by chills & aches unresolved w 200mg ibuprofen.
Information has been received from a nurse practitioner concerning a now 36 years old male who on unspecified dates was vaccinated with two doses of MMR II as a child. Now the patient has a negative antibody titer for mumps. The patient was seen to visit the office. Additional information has been requested.