chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was given 0.2 mL, but due to age should of received a 0.3 mL on 11/19/2021 at 11:38 A.M. Per CDC guidelines, do not repeat the dose. Wait 21 days, then give adult (0.3 mL) dose to complete the primary series.
This case was reported by a physician via interactive digital media and described the occurrence of general body pain in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced general body pain, fever, pain in arm, flu syndrome, diarrhea, fatigue, injection site erythema, unwell and pharmaceutical product complaint. On an unknown date, the outcome of the general body pain, fever, pain in arm, flu syndrome, diarrhea, fatigue, injection site erythema, unwell and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the general body pain, fever, pain in arm, flu syndrome, diarrhea, fatigue, injection site erythema and unwell to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The physician purchased a dose of SHINGRIX and had a patient with bad side effects. The patient experienced sore arm, redness around injection site, flu syndrome, fever, fatigue, and diarrhea. The physician also posted on social media, SHINGRIX made the patient ill and he would not give SHINGRIX to another human. The physician was requesting reimbursement for these doses of SHINGRIX. The Vaccine Service Center (VSC) said that, they could only reimburse for a product complaint. His main thought was to get reimbursed. He would like to talk to someone. He was requesting to speak with the vice president of the company. He reached out to his sales representative who had not gotten back to him. The physician would like a call back to resolve this situation. The physician was not willing to provide more information about the adverse event's because he had already reported the events. This is 1 of 13 cases, reported by the same reporter for the patient's who experienced adverse events after receiving SHINGRIX.
Patient received 1/2 dose of vaccination (19 years old). Patient to receive full dose of vaccine since 6 months has passed since invalid dose was given.
Fever as high as 101.6, chills and shakes lasting almost 8 hours. Currently shaking has subsided and fever/chills starting to break after some rest and Advil
DID NOT TAKE THE FOURTH DOSE ON TIME; This spontaneous case (PVX2019-835) was received from a consumer on 08-Apr-2019. It describes a female consumer who "did not take the fourth dose on time", while taking of oral Vivotif (lot number: 3003242; one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer took the third dose of Vivotif on 05-Apr-2019 and did not take her last dose, which was due on 07-Apr-2019.  Action taken with Vivotif with the event "did not take the fourth dose on time" was not applicable.  The clinical outcome of the event "did not take the fourth dose on time" was unknown.  Company's Comment: The causality of the event "did not take the fourth dose on time" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "did not take the fourth dose on time" was considered as not applicable.
administered 11Jul2022, expiration date 05Jul2022; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 42-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 229AN, expiry date 5th July 2022) for prophylaxis.   On 11th July 2022, the patient received Boostrix. On 11th July 2022, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 11-Jul-2022 Reporter's comment: The nurse reported that the patient was administered a dose of Boostrix on the day of reporting, which had an expiration date of 5th July 2022. At the time of reporting, dose had not been repeated. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Boostrix, which led to expired vaccine used.
Slept for 9 hours after booster; light-headedness; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Slept for 9 hours after booster) and DIZZINESS (light-headedness) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 068H21A, 032L20A and 031L20A) for COVID-19 vaccination.     The patient's past medical history included Vertigo (lasted two years.) from 2014 to 2016 and Surgery (8 years ago got vertigo from the surgery.) in 2014. Concurrent medical conditions included Functional neurological symptom disorder (Basically, I had a functional neurological disorder (FND)).   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced HYPERSOMNIA (Slept for 9 hours after booster) and DIZZINESS (light-headedness). At the time of the report, HYPERSOMNIA (Slept for 9 hours after booster) and DIZZINESS (light-headedness) outcome was unknown.            No concomitant medication was reported.  No treatment medication use was reported.   This case was linked to MOD-2021-418599 (Patient Link).
Patient said her left arm where she received her flu shot was red, swollen, and itchy the day after getting vaccinated. She went to the ER the day after her flu shot late in the evening. The ER doctor said it was cellulitis and wrote an Rx for an antibiotic and instructed her to take Benadryl.
Hot and swollen leg. Happened overnight. Child sleeps in a sleep sack.  No exposure to other  elements. Child had fevers with previous dtap.
no additional adverse effect; a patient was administered a dose of RECOMBIVAX after its labeled expiration date. RECOMBIVAX expired on 08-NOV-2019; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported.  On 19-NOV-2019, the patient was vaccinated with an expired dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) thiomersal free (lot # N006321 and expiration date: 08-NOV-2019) via unknown route for prophylaxis (expired product administered). No additional adverse effects were reported. No product quality complaint (PQC) was involved.
This spontaneous report as received from a physician via field representative refers to a female patient of unknown age. The patient's pertinent medical history was none and drug allergies were unspecified. On an unknown date in March 2014 the patient was vaccinated with a dose of GARDASIL (reported as last dose of the series). Concomitant medications were unspecified. From an unknown date (reported as since the last dose), the patient developed fever when she gets her period. The outcome of the event was unknown. The relatedness of the event with GARDASIL was not reported. Additional information has been requested.
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 7/18/2022 ACUTE HYPOXEMIC RESPIRATORY FAILURE J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 7/18/2022 PARKINSONS DISEASE
VERY LOW IMMUNITY; FEVER; This spontaneous report received from a parent via a company representative concerned a 24 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced very low immunity, and fever.  Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and very low immunity was not reported. This report was non-serious.
Pts leg Rt swelled up to the size of a soft ball was red and hard, warm to touch around injection site.
Lt arm painful within jection That evening arm was swollen.seen 10/30/09 Lt upper arm shows signs of mild  edama, moderate erthema, ROM Normal and No axillary lympth nodes palp. TX Biaxin 500 mg Bid X 10 days and medrol 4mg dose pack taken as directed.
Ringing in the left ear. Pain, inflammation in the ear. Ear feels clogged.
dizziness; nausea; headache; hives; left arm was swollen all the way down to the elbow; left arm was red all the way down to the elbow; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA, PERIPHERAL SWELLING, ERYTHEMA, DIZZINESS, and NAUSEA in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PERIPHERAL SWELLING and ERYTHEMA. On 13-Mar-2021, the patient experienced URTICARIA. On an unknown date, the patient experienced DIZZINESS, NAUSEA, and HEADACHE. On 21-Mar-2021, URTICARIA had resolved. At the time of the report, PERIPHERAL SWELLING, ERYTHEMA, DIZZINESS, NAUSEA, and HEADACHE outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
High fever lasting 7 straight hours, extreme weakness, nausea, painful skin, next day lower fever lasting 8 hours, jaundice and weakness
"Patient was warm but afebrile and a little grumpy in the evening after 12mo WCC+imms today Then he vomited his dinner and as mom walked him upstairs he began to seize. Total activity about 1min, total body stiffening, BUE and BLE jerking, and eyes rolling back. Initially he did not gasp or make noises, but after 2 min cried out. No cyanosis. After 2 minutes, cried, breathed normally, and continued to shiver but not jerk. EMT evaluated and did not find fever or VS abnormality, to dad's understanding. They all agreed to monitor at home together and when patient's behavior was back to baseline, EMT left. Dad and I reviewed seizure first aid, plan to call 911 if seizure recurs tonight, and will schedule for appt tmrw morning." Patient has a history of febrile seizures. Immunizations were given at approx. 10:30 in the morning.
mild breathlessness; allergic reaction; runny nose; cold; feeling tired; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 16Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received 1st dose yesterday, then she experienced an allergic reaction, runny nose, cold, mild breathlessness, and feeling tired in Feb2021. The outcome of ethe events was unknown.  Information about lot/batch number has been requested.
While in a store with mom ? syncope OR ? slipped and fell hitting his head. Later started vomiting, was sleepy and difficult to awaken. Seen at Emergency Room. Concussion follow-up with our office on 11/15/13. On 11/20/13 was seen in ER for altered mental state. Follow-up with our office on 11/27/13. Referred to Neurology, consult pending.
Tightness in my chest, shortness of breath, woke up through the night. Shortness of breath the next day.
Patient received her 2nd dose of the COVID-19 maderna vaccination on February 4, 2021. By the evening of February 4, 2021 her husband reported her health to decline rapidly. Her symptoms and complains included overall generalized body weakness and fatigue. She was reportedly unable to get out of bed on February 5, 2021. She continued to decline and became short of breath in the early morning hours of February 6, 2021. She went unresponsive and was pronounced deceased at 0615 by (medicolegal death investigator).
At about 1AM on October 4th, I woke up with severe hot sweats. I noticed that I had 2 spots on my neck that looked like blisters. I went back to bed, and then I woke up the next day and realized that those 2 spots turned into clusters of blisters, that looked like chicken pox. It had spread to the other side of my neck and all over my stomach. On October 5th, it started spreading from my thighs down to my kneecaps. I was taking over the counter Benadryl for it. The spots didn't itch, but they felt like a burning sensation. That whole week I was down in the dumps with flu like symptoms. I visited the ER on October 10th, because I had woken up and felt extremely sick. I couldn't breathe so the EMS came and took me to that hospital. They ran some tests, and they diagnosed me with an unspecified rash. My oxygen level was low, so they gave me oxygen before I left the hospital. Then they sent me home with steroids to take for the rash. I went to the ER about 5 times within a 3-week span because of the rash I had that continued to spread up my back and in my hairline. My hair was coming out. They had given me steroids, a steroid injection, Atarax, Zyrtec, and Cipro for the rash to help clear it up, but none of the medications, or injections worked. On 10/25/2021, I was able to see my PCP. He said that he wants me to see an allergist since the medicines have not helped the rash. He thought it was an allergic reaction due to the vaccine. I haven't changed anything with my body or hair products except only taking the shot. I have been sick ever since taking that shot. I keep losing train of thought. I have been off work because of this. I am so exhausted and tired. I sleep for 12 hours a day. I am off work until 11/3/2021 or it may be continued if I am still sick. My job mandated the shot, so I had to take it. I feel like I am dying, and I am scared to go to sleep at night because of that. I have never been sick or had a rash for this long going over a month.
Soreness at the injection site; Fatigue; Headache; A little nausea; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Soreness at the injection site), FATIGUE (Fatigue), HEADACHE (Headache) and NAUSEA (A little nausea) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced INJECTION SITE PAIN (Soreness at the injection site), FATIGUE (Fatigue), HEADACHE (Headache) and NAUSEA (A little nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INJECTION SITE PAIN (Soreness at the injection site), FATIGUE (Fatigue), HEADACHE (Headache) and NAUSEA (A little nausea) outcome was unknown. Not Provided          No relevant concomitant medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.
Within 15 minutes of receiving the vaccine, some mild redness and slight itching was reported by the patient at the injection site. She said it was mild, and I advised her that those were possible side effects, and that she should monitor their progression and treat with Benadryl if they become uncomfortable. She called me at around 1pm on 6/6 to report that the injection site had remained red and slightly warm, and that an area she described as the size of a deck of playing cards around the injection site was slightly firm and raised and that it was still itching slightly. She said the needle site was unidentifiable, and that there was no soreness, weeping, oozing or fever. She said the reaction responded to Benadryl, but she didn't like the drowsiness. I told her to treat again with Benadryl if it remained bothersome, or she could use cetirizine if she wanted a non-drowsy option. I advised her that if it continued to progress, or if she showed any signs of an allergic reaction to call her doctor or go to the ER. I called her primary care doctor and made them aware of the situation for their records.
acute onset of right shoulder pain after vaccine receipt , worsened over the subsequent 3 weeks, clinically acute tendonitis of the right shoulder on office visit 8/31/22
A physician reported that a 9 month old female received Prevnar and Hep-B vaccines on 10/24/00 and subsequently, developed a "strange" rash. The rash was described as red and papular rash over her body and a confluent, bright red rash over her entire face. She also developed an injection site reaction characterized by a "1/2 dollar-sized" area of induration and erythema at the injection site of the Prevnar injection. She was treated with diphenhydramine. As of 10/26/00, the rash persisted.
Doctor has made a diagnosis of SIRVA; patient has not been able to work; This spontaneous case was reported by a consumer and describes the occurrence of SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (Doctor has made a diagnosis of SIRVA) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (patient has not been able to work) in a female patient of an unknown age who received mRNA-1273 (Spikevax) (batch nos. ASKU and ASKU) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine. Concurrent medical conditions included Diabetes.   In June 2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (Doctor has made a diagnosis of SIRVA) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (patient has not been able to work). At the time of the report, SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (Doctor has made a diagnosis of SIRVA) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (patient has not been able to work) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. It was reported that after the second dose the patient's arm was frozen. It was stated that patient had been going to physical therapy for the SIRVA. The patient was not home and does not had her information about previous vaccines with her. The patient did not reported any adverse reactions. The patient did not remembered any of the dates of when she received her vaccine. No treatment information provided.
Received my vaccine on March 8.  I had immediate sore arm which lasted for about 60 hours.  On March 14 my arm started to itch at the point of vaccination.  On March 16 I noticed the area around shot was swollen and red and warm to the touch.
bleeding like having her period, it was a very very irregular situation to her; D-dimer levels were too high; Blood clots in lungs; patient received first dose on 08May2021 and second dose on 11Jul2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), administration date 11Jul2021 (Lot number: FA9094) at the age of 45 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "period was approximately 7 years ago" (unspecified if ongoing); "ablation due to fibroids on uterus" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162B2 (Dose 1; Lot number: EW0193), administration date: 08May2021, when the patient was 45 years old, for COVID-19 immunization, reaction(s): "No adverse events". The following information was reported: PULMONARY THROMBOSIS (medically significant), outcome "unknown", described as "Blood clots in lungs"; MENSTRUAL DISORDER (hospitalization), outcome "recovered", described as "bleeding like having her period, it was a very very irregular situation to her"; FIBRIN D DIMER INCREASED (medically significant), outcome "unknown", described as "D-dimer levels were too high"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 11Jul2021, outcome "unknown", described as "patient received first dose on 08May2021 and second dose on 11Jul2021". The events "blood clots in lungs" and "d-dimer levels were too high" were evaluated at the physician office visit. The clinical course was reported as follows: The patient stated she received first dose of Pfizer vaccine on 08May2021 and second dose of Pfizer on 11Jul2021. She explained her last period was approximately 7 years ago, because at that time she got an ablation due to fibroids on her uterus. With Pfizer first dose there was no symptoms. With second dose, she experienced bleeding like having her period, it was a very very irregular situation to her; she ended up in the hospital. Doctors told patient her D-dimer levels were too high, and she experienced blood clots in her lungs. It was reported that after the second dose, both lungs had blood clots but heart was fine. Treatment of rivaroxaban (XARELTO) was given (a blood thinner medicine). The patient underwent the following laboratory tests and procedures: blood iron: low, notes: since always; electrocardiogram: normal; fibrin d dimer: too high; haemoglobin: low, notes: since always. Therapeutic measures were taken as a result of pulmonary thrombosis.  No follow-up attempts are possible. No further information is expected.
Soreness at end of first day, Next day arm pain mild, mild headache, fatigue and  nasea, 1/29/2021 mild pain , headache .moderate fatigue, with mild nasea. 1/30t/2021  wheezing, low grade fever of 100.8., moderate  pain.,  headache , redness and swelling in arm. Severe fatigue, moderate body aches ,mild abdominal pain and diarrhea. stuffy sinuses, 1/31/2021 no fever, arm pain, redness and swelling mild .Headache mild, fatigue moderate, 02/01/2021  no fever. pain ,redness or swelling in arm,.milf headache and fatigue.
On our scheduling portal 2 Pfizer kids 1st doses were scheduled. Mom brought her 2 kids into the pharmacy stating she had 2 children's vaccines scheduled. The pharmacy technician filled out the consent form and the vaccine card as a Pfizer kids 5-11 vaccine. The pharmacist failed to check the date of birth with the mom and injected the 12 year old with a Pfizer kids 5-11 vaccine.