chrisvoncsefalvay/vaers-outcomes huggingface dataset:
just got one dose , unknown if was 2nd or 3rd; This case was reported by a consumer via interactive digital media and described the occurrence of extra dose administered in a 73-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 13-DEC-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient just got a Shingles shot. The patient was not sure if she had 2nd or if this was the 3rd dose. Additional Supportive Information: The patient received 3rd Shingles vaccine, which led to extra dose administered. The follow-up could not be possible as no contact details were available. On conservative basis the case was kept valid for the 3rd dose.
Patient received her second dose of the primary doses on 5/27/21. On 11/12/21, patient received her Pfizer booster shot.  Patient received her booster shot two weeks earlier. Patient was to receive her booster shot on 11/24/21 at the earliest per CDC guidelines.
Headache; Slightly elevated fever; This is a spontaneous report from a contactable consumer. A 17-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: 301358A), via intramuscular route of administration, administered in Arm Left on 12Sep2021 17:15 as dose 2, single for COVID-19 immunization (at the age of 17-year-old). The patient medical history included known allergies to Penicillin. Concomitant medications included Ibuprofen (ADVIL (IBUPROFEN)). Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0198), via an unspecified route of administration on 18Aug2021 (at the age of 17-year-old) as dose 1, single for COVID-19 immunization. It was stated that, patient did not receive any other vaccine in four weeks prior COVID vaccine. The concomitant medication (Patient took other medications in two weeks) include Advil. Patient was not diagnosed with COVID-19 prior to vaccination, and not been tested for COVID-19 since the vaccination. On 13Sep2021 07:00, the patient experienced headache and slightly elevated fever. The patient underwent lab tests and procedures which included fever: slightly elevated on an unspecified date. No therapeutic measures were taken as a result of events. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected
This spontaneous report was received from a pharmacist and refers to an unspecified number of patients of unknown age and gender. No patients' medical history or current condition were reported. In August 2015, reported as on 04-AUG-2015, through 26-AUG-2015, an unspecified number of unspecified patients were administered an unspecified number of improperly stored PEDVAXHIB (dose, route of administration were not reported) (lot number: K025002, expiry date: 20-JUL-2017 and lot number: K025005, expiry date: 21-JUL-2017). No concomitant therapy was reported. No adverse effect or experience was reported. Additional information has been requested.
Information has been received from a company representative concerning a pediatric male patient who on an unspecified date was was vaccinated with the 1st dose of  Hepatitis B vaccine recombinant. Within 15 minutes post-vaccination, the patient passed out and was sent to the hospital for testing. No abnormalities were found. It was noted that the patient is "fine" now. Additional info has been requested.
rt elbow pain x 1wk p/vax;26NOV  to family MD p/sx worsened got med;sx subsided for about 2-3wk;16JAN98 lt thumb & elbow started swelling w/pain & heat;27JAN went to see orthopedic MD:on inflammatory;upset stomach;diff carrying things;
Had a random red bump appear beside my ear. I initially thought it was an infected hair, It did not hurt to touch, but as the day progressed, it started shooting stabbing pains into my eyes and the side of my head that made me nauseous and dizzy. The frequency of the stabbing increased to once every 10 minutes. The ER doctor guessed that it was a swollen lymph node, prescribed an antibiotic, and said to follow up with a dermatologist to see about cutting it off. In two days of antibiotics, the bump disappeared as quickly as it appeared.
At 1615, patient reported tightness in shoulders and back of neck. Patient reported similar episodes when he is nervous. Patient assisted into anti-gravity chair. Patient stated he "feels like I'm going to throw up" and reported "feels like I'm going to black out". Patient offered emesis bag and water. Patient denied itchiness, rashes, hives, difficulty swallowing and difficulty breathing. At 1620, RN assessed patient vital signs: 122/78 mmHg and pulse 72 beats/minute. Patient reported history of being "borderline hypertensive", no chronic conditions, and no current medications. At 1621, patient stated his symptoms were "going away". At 1635, RN reassessed patient vital signs: blood pressure 118/80 mmHg and pulse 75 beats/minute. At 1639, patient denied nausea, vomiting, and reported less tension in shoulders and back of neck. At 1644, RN reassessed patient vital signs: blood pressure 124/80 mmHg and pulse 73 beats/minute. Patient reported he is feeling "good" and "okay" to drive. RN educated patient on signs/symptoms of when to seek emergency care, to follow up with primary care provider and to sign up on v-safe. At 1646, patient left facility with unlabored respirations and steady gait.
Mom noticed she experienced tremors last night after 2nd dose and it has gone away this morning. When she woke up, she had a 102.5 F fever and a massive migraine. Mom just gave her Advil 200mg one dose after she measured the fever. Pharmacist recommended mom to give her another 200mg Advil and to seek prompt medical attention if her fever does not break or she begins to experience any other symptoms.
Information has been received from a physician concerning a 17 year old female with an empty stomach who was vaccinated with Gardasil. Subsequently the patient fainted immediately after receiving the Gardasil. Subsequently, the patient recovered from fainting. This is one of several reports received from the same source. Additional information is not expected.
Dose administered from a vial that was more than 30 days on the fridge; vial that spent more than 30 days on the fridge; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered from a vial that was more than 30 days on the fridge) and PRODUCT STORAGE ERROR (vial that spent more than 30 days on the fridge) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Aug-2021, the patient experienced PRODUCT STORAGE ERROR (vial that spent more than 30 days on the fridge). On 20-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered from a vial that was more than 30 days on the fridge). On 20-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered from a vial that was more than 30 days on the fridge) had resolved. At the time of the report, PRODUCT STORAGE ERROR (vial that spent more than 30 days on the fridge) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-326226, MOD-2021-326421, MOD-2021-326307, MOD-2021-326468, MOD-2021-326218, MOD-2021-326226, MOD-2021-326383 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Patient demographic details, Vaccine facility information and suspected drug ROA was updated.
Lightheadedness approx 5 minutes after receiving vaccination, patient remained alert, given 1 carton of apple juice and monitored in lying position for 20 minutes prior to discharge in stable condition.
hit my blood vessel and I bled a little bit; lingering soreness; nasty looking bruise; immediately had swelling at the injection shot,at least a half inch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (hit my blood vessel and I bled a little bit), PAIN (lingering soreness), CONTUSION (nasty looking bruise) and VACCINATION SITE SWELLING (immediately had swelling at the injection shot,at least a half inch) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE HAEMORRHAGE (hit my blood vessel and I bled a little bit), PAIN (lingering soreness), CONTUSION (nasty looking bruise) and VACCINATION SITE SWELLING (immediately had swelling at the injection shot,at least a half inch). At the time of the report, VACCINATION SITE HAEMORRHAGE (hit my blood vessel and I bled a little bit) and PAIN (lingering soreness) outcome was unknown and CONTUSION (nasty looking bruise) and VACCINATION SITE SWELLING (immediately had swelling at the injection shot,at least a half inch) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No Relevant concomitant medications was reported.  Treatment information included ice pack.   This case was linked to MOD-2021-114432 (Patient Link).
received shot 11/18/03 - 11:30                  Received  pnuemonia shot 11/18/03 - 11:30  AM -  about 1 hr later noticed arm was itching/didn't check it until about 5 hrs later - was swollen,painful,beet red from below shoulder to elbow - saw doctor next afternoon - Took antihistamine and pain pill / took a couple days for symptons to disappear  Not sure of the correct vaccines are listed below, know it was a pneumonia shot and the flu vaccine, but not which ones.
Patient received flu shot. Prior to vaccination Nurse asked if patient had any problems in past with flu shots or if she was allergic to eggs she said no. 5 minutes after giving flu shot patient complained of arm feeling funny and tingling noted. When I assessed patient her right arm it was extremely swollen. She denied any shortness of breath. I immediately placed an icepack on it and it still appeared to be extremely swollen , at 12:36pm 50mg of Diphenhydramine IM(lot#026327 expires 02/2018 was given directly into Right deltoid(location of flu shot). Patient was monitored by Nurse until 1:10pm. Swelling had decreased and patient denied any shortness of breath or any other symptoms. Patient was told to let her doctor know what had happened and to not have another flu vaccine again without having her doctor/allergist evaluate her and that she would have to have it done through her doctor if they feel she is safe to have it.
Headache, body aches like I have never had before, nausea, elevated temp 100.2, and extreme tiredness. These lasted for about 24 hours
Patient fully vaccinated inclucing a booster on 11/15/2021 for COVID.  COVID positive 11/20/2021.Patient presented with respiratory failure due to COVID. Admitting dx:  COVID-19, taychycardia, hypogycemia, hypoxia, UTI, hypomagnesemia, elevated troponin, CHF exacerbation, repiratory failure,  acute respiratory failure with hypoxia.   Treated with lovenox, remdesivir, baricitimib and decadron with continued deterioration.  Patient intubated, and discharged to hospice care. Patient expired.
I started noticing red rashes and pustuals on my hands.  I have had this in the past but not in about 6 years and my actions had not changed.
She has abdominal pain every time she eats; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number, and Expiration date not reported), via an unspecified route of administration on 12May2021, as second dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced she has abdominal pain every time she eats on an unspecified date. Patient stated she is afraid to eat because she has abdominal pain every time she eats. Patient wanted to know how long symptoms last. Patient stated she has a call in to her HCP. The outcome of event was unknown.   Information on the lot/ batch number has been requested.
right arm swollen; itchy; fever; bruised; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the arm right on 02Apr2021 at 10:00  (at the age of 42-year-old) and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the arm right on an unknown date, both as a single dose for COVID-19 immunisation. Medical history included stroke, blood pressure high and high cholesterol. Concomitant medications included too many unspecified drugs (as reported). The patient previously took Peroxide and adhesive. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Apr2021 the patient experienced two spots covering the top right arm swollen, itchy, fever and bruised. They looked like a bullseye as reported. The clinical outcome of the events arm swollen, itchy, fever and bruised were not recovered at the time of the report.  No follow-up attempts are needed. No further information is expected.
Fever up to 102 degrees; Headache; Pain in the left arm; Severe itchiness on the left side of the body (head to toe); Body aches; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP69SS) via an unspecified route of administration in the left arm on 29Apr2021 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included VITAFOL, VITAMIN D3, VITAMIN B-12, and IRON, all for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP69SS) via an unspecified route of administration in the left arm on 08Apr2021 at the age of 38-years-old as a single dose for COVID-19 immunisation. On 29Apr2021, the patient experienced fever up to 102 degrees (units unspecified), pain in the left arm, severe itchiness on the left side of the body from head to toe, body aches, and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the events and included treatment with TYLENOL, every six hours. The clinical outcome of the events fever up to 102 degrees (units unspecified), pain in the left arm, severe itchiness on the left side of the body from head to toe, body aches, and fatigue was resolved on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Covid-19 vaccine (unknown manufacturer) 2 days prior to pulmonary embolism and sudden death
17AUG92 pt recvd 1st dose of ENgerix-B & w/in 24 hrs devel inject site redness, swelling & a local pruritic reaction;
low-grade fever; Body aches; back ache; This case was reported by a consumer via call center representative and described the occurrence of fever in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis.   On 6th August 2021, the patient received the 1st dose of Shingrix. In August 2021, less than 2 weeks after receiving Shingrix, the patient experienced general body pain and back pain. On 18th August 2021, the patient experienced fever. On an unknown date, the outcome of the fever and general body pain were not recovered/not resolved and the outcome of the back pain was unknown.   It was unknown if the reporter considered the fever, general body pain and back pain to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient. The patient had past medical history of Rheumatoid Arthritis (RA).  The patient received 1st dose of Shingrix in the right deltoid and experienced side effects from the vaccine, which includes body aches and low-grade fever.  The reporter was unable to differentia l whether the body ache was coming from the vaccine or RA, but had back ache which was a different (new) location than usual location where she experiences aches due to RA.  The reporter was unsure whether the back ache was due to vaccine or RA. The patient also had a low-grade fever, which was experienced almost 2 weeks post the vaccination. The patient normal body temperature was 97-degree F and mentioned that she had fever (did not provide fever temperature).  However, she mentioned that her temperature had not crossed 100F. The body ache and fever were not completely resolved, and the severity had been the same from the day they experienced the side effects. The reporter consented to follow up.
typical soreness of injection site in my Left Arm; This is a spontaneous report from a contactable consumer (Patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date, as 1st dose, single dose in left arm for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included evolocumab (REPATHA SURECLICK) and lorazepam (LORAZEPAM), taken for unspecified indications. The patient was hypertensive to these medications. On an unspecified date, after her first dose of vaccine, the patient experienced typical soreness of injection site in her left arm. The clinical outcome of the event was unknown.  Information on the lot/batch number has been requested.   Follow-up attempts are completed. No further information is expected.
Information has been received from a physician concerning a 19 month old female who on 28-JUL-2010 was vaccinated with the first dose of VAQTA. On 29-JUL-2010, the patient presented to the office with a fever of 102 degrees Fahrenheit. They were told to watch and wait regarding the fever. On 31-JUL-2010 the patient presented to the office again, and although afebrile, was irritable and had a swollen face. At this point, the patient was tested for strep which came back negative and was given ORAPRED and AUGMENTIN. This AE is recorded in regards to the VAQTA. At the time of the reporting, the patient's status was unknown. Additional information has been requested.
This spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown demographics. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unspecified dates, the patients were vaccinated with doses of improperly stored LIQUID PEDVAXHIB, lot # N000238 with expiration date on 25-OCT-2019 (dose and route of administration were not reported). The vaccine underwent a temperature excursion of 0 to 1 degree Celsius for 40 hours. Digital data logger was not involved. The vaccine did not undergo any previous temperature excursions. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA011819: US-009507513-1706USA001284: US-009507513-1706USA001282: US-009507513-1706USA001283: US-009507513-1706USA001279: US-009507513-1706USA001281:
I had a severe manic episodes with thoughts of ending my life. It lasted almost 5 hours.
past by 2 weeks for the second shot - second dose not administered within 35 days interval; 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 PRODUCT DOSE OMISSION ISSUE (past by 2 weeks for the second shot - second dose not administered within 35 days interval) in a female patient of an unknown age 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (past by 2 weeks for the second shot - second dose not administered within 35 days interval). At the time of the report, PRODUCT DOSE OMISSION ISSUE (past by 2 weeks for the second shot - second dose not administered within 35 days interval) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information was provided.
t103 4 hrs past immun, even w/use of APAP; sore x 30 mins; trembling x 2 hrs; would not sleep all noc; carried to MD questioned sz;MD did not feel pt had abn reaction to immun;
Received flu vaccination at around 1000 on 10/6/17. States "About 30-45 minutes later my arm started itching and I had hives on my upper arm. It progressed down my arm and my digits were swollen and itchy. I self-medicated with BENADRYL." On 10/7/18 he states both of his hands and upper lip were swollen and itchy so he went to ER where they gave him a prescription for Prednisone for 5 days. He states the prednisone worked well and he is asymptomatic at this time.
Erythematous swollen L upper thigh 15 cm area.  Tx with Keflex.
Initial case received from a consumer on 30 September 2014. A 70-year-old female patient, with a medical history of breast cancer with radiation treatment in 2001, received an intramuscular injection of FLUZONE HD (lot number not reported) on 25 September 2014. Within 30 minutes of vaccination, she experienced a difficulty breathing and increased heart rate. She was evaluated by a physician, and reported that vital signs, "blood enzymes", and EKG were all within normal limits. She was treated with CLARITIN and PEPCID. According to the consumer, she continued to have episodes of shortness of breathing lasting a few minutes. Outcome was not reported. Documents held by sender: none.