chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Woke up in the middle of the night 2/10  around 1:00 a.m. with headache, nausea, body aches, and chills.  Went to work that morning 2/10 late & ended up leaving early because of the body aches, dizziness, and nausea.  The day after vaccine 2/10 when I was feeling poorly I took tylenol, excedrin, and ibuprofen.
Pt vomited shortly after hepatitis A vaccine then developed intermittent crampy abdominal pain, with transient heme positive stools and elevated LFT's. DC DX: Viral Hepatitis/Diarrhea Seen several years ago with chronic intermittent abdominal pain, questionable functional abdominal pain syndrome v. abdominal migraine. Chronic abdominal pain, mild non-localized peri-umbilical, some anxiety relation, ex: had before therapy visit Wednesday and before this visit this am. Also intermittent severe abdominal pain, screens, rolls on floor, often relieved by bowel movements. no distention, vomiting, hard abdomen, clear obstructive symptoms; did happen after peanut/pad Thai meal. Some headache diarrhea with eating, 1 test positive C diff, diarrhea with mucus, little blood; fever resolved spontaneous, subsequently treated with Flagyl. Weight loss concerning lost 5# but has regained 2-3#., appetite never high but baseline again, bowel movements in general daily, no chronic constipation, hard strain, wide, pain, blood no chronic diarrhea. Always thin. Note given Hep A vaccine prior to illness, Impression: C. diff, diarrhea, ALT all resolved but some concern poor weight gain and acute abdominal pain episodes on top mild chronic abdominal pain. IBS may be significant component also abdominal migraine component, questionable possible Crohn's disease is concern with Omp-C Ab positive. Family HX of GI problems.
I am feeling light headed and dizzy. I have been diagnosed with vertigo by my doctor. Rapid eye movement.
12 hours post vaccination spiked fever 103.9.  dizzy, heart pounding with palpitations, chest heaviness, shortness of breath.  moderate soreness at injection site. no nausea, body aches or stomach upset.  drinking fluids. B/P 159/93. heart rate 87.  18 hours post injection temp 101-102. heart rate 130"s with palpitations and shortness of breath and dizziness. O2 sat 92% at rest. chest heaviness, aching. B/P 91/63. no nausea or body aches, minimal injection site soreness. drinking fluids.  24 hours post injection temp 99.0. heart rate 108. O@ sat 96% .  mild chest  heaviness, shortness of breath with exertion.  36 hours post injection temp 97.8. 134/74.  74.  sat 99%.
No adverse event; 7 doses of Moderna monovalent lot number 038A22A, expiration date 10.30.2022, was administered to patients/Date(s) of administration of vaccine*: 24Feb2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (7 doses of Moderna monovalent lot number 038A22A, expiration date 10.30.2022, was administered to patients/Date(s) of administration of vaccine*: 24Feb2023) and NO ADVERSE EVENT (No adverse event) in a 41-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 038A22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 24-Feb-2023, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 24-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (7 doses of Moderna monovalent lot number 038A22A, expiration date 10.30.2022, was administered to patients/Date(s) of administration of vaccine*: 24Feb2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (7 doses of Moderna monovalent lot number 038A22A, expiration date 10.30.2022, was administered to patients/Date(s) of administration of vaccine*: 24Feb2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (7 doses of Moderna monovalent lot number 038A22A, expiration date 10.30.2022, was administered to patients/Date(s) of administration of vaccine*: 24Feb2023).    Concomitant medication was not reported. The patient received vaccine at 12:11 PM. Patient received expired Moderna monovalent dose. The vaccine had been frozen with no known temperature excursion before being thawed today for administration. Vial was initially stored in the refrigerator on 24-Feb-2023. Vial did not undergo any temperature excursions.  Treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-712705, US-MODERNATX, INC.-MOD-2023-712698 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Feb-2023: Live non significant follow up received.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712705: US-MODERNATX, INC.-MOD-2023-712698:
No redness at site of injection. Immediately after receiving the PNEUMOVAX vaccine felt like it was going down the nerve, within 5 min of shot. C/o painful muscles, increased swelling in upper arm exterior to interior to the elbow. Red/hot to touch and blanching. Upper arm numb due to swelling. C/o heavy pressure like h/a x 2 days. Swelling began on Weds and lasted 5 days later swelling began to decrease.
Child awoke parents at 4:20 AM (7/8/03) with a piercing scream. Parents say she was burning up with fever and arms and legs were flailing. They rushed her to the ER. She was treated with 350 mg Tylenol suppository, which reduced the fever. No further seizures noted. Saw family MD same day.
Experiencing some aches; some temperature; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received 2nd dose of COVID Vaccine(UNSPECIFIED TRADE NAME) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose on an unspecified date for covid-19 immunization. The patient experienced experiencing some aches and some temperature. The outcome of the event was unknown.   Information about lot/batch number has been requested.
Subsequent to two doses of varicella virus vaccine live, the pt failed to seroconvert.
I became weak all over....sick to my stomach, and extremely dizzy.  I went to bed and stayed throughout the remainder of the day (Jan. 15th)  and next morning (Sat. Jan 16th).  I had no fever, nor headache.
tongue swelling; neck to jaw rash; chills; being tired; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (tongue swelling), RASH (neck to jaw rash), CHILLS (chills) and FATIGUE (being tired) in an 86-year-old female patient who received mRNA-1273 (M oderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced SWOLLEN TONGUE (tongue swelling), RASH (neck to jaw rash), CHILLS (chills) and FATIGUE (being tired). At the time of the report, SWOLLEN TONGUE (tongue swelling), RASH (neck to jaw rash), CHILLS (chills) and FATIGUE (being tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment medication was not provided.
Unable to reach patient yet.  Patient received 3 doses of pfizer covid vaccine.  Patient received 1st dose 12/22/20 at a different provider then was covid positive on 1/4/21.  Patient received 2nd dose on 4/29/21 and a 3rd dose on 5/20/21
pneumonia; cardiovascular issues; Information has been received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age or gender. The pt's concurrent conditions, medical history and concomitant medications were not reported. On or about 22-SEP-2016 (at approximately 65 years old), the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, anatomical location, lot number and expiration date were not provided) at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequently, the pt was treated by a health care provider for the following injuries resulting from the zoster vaccine live (ZOSTAVAX) use: pneumonia and cardiovascular issues. The outcome of the claimed events was not provided, and causal relationship was reported as related to zoster vaccine live (ZOSTAVAX).  Upon internal review, pneumonia was determined to be medically significant event.
inflammation on her collarbone; paining on her collarbone; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution of injection, Lot Number was not reported) via an unspecified route of administration on 10May2021 (at the age of 27 years old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution of injection, Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date, the patient experienced inflammation on her collarbone and paining on her collarbone. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Double vision or diplopia; This case was reported by a consumer via call center representative and described the occurrence of diplopia in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 month after receiving Shingrix, the patient experienced diplopia. On an unknown date, the outcome of the diplopia was recovered/resolved.   It was unknown if the reporter considered the diplopia to be related to Shingrix.     Additional Information: GSK Receipt Date: 5-APR-2022 Reporter's Comment: The patient self-reported this case. The patient received first dose of Shingrix about a year ago from the date of reporting (exact date unknown) and about a month or so after, she stated she began experiencing double vision or diplopia. At the time she consulted her physician who advised her not to take dose 2 due to the side effect. She did not take dose 2 within the recommended interval of 2-6 months after dose first. Provided information per clinical trial data on PI (package insert). Referred to HCP (health care professional). Provided medical advice disclaimer. The reporter gave permission to contact HCP (health care professional). The reporter consented to follow-up.
This spontaneous report was received from a physician (also reported as registered nurse) who was also the patient. The patient was a female of unknown age. The patient's pertinent medical history and drug reactions/allergies were not reported. On an unspecified date in 2015, patient was vaccinated with the first dose of PNEUMOVAX 23 (dose, route, lot # and expiration date were not reported) and on 21-OCT-2015, with a second dose of PNEUMOVAX 23 in the left arm. Concomitant medication included an unspecified flu shot, administered on 21-OCT-2015 in her right arm. On 21-OCT-2015, the patient developed a welt on the left arm and felt "sick, achey and tired". The outcome of the events was reported as not recovered. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information is not expected as the physician did not consent for further contact.
Patient presented to clinic on 02/23/17 with two red pustule-like bumps at the site of vaccine administration. Mom reports patient not wanting to allow anyone touch the area. During examination by the provider, patient cried when area was touched. Seems to be painful. Slightly swollen. Not currently hot to touch. Mom reported fevers that started 2 days after vaccination.
No additional AE reported.; Nurse reported a dose of VAQTA was inadvertently administered after the labeled expiration date; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/ allergies was not provided.  On 28-NOV-2022 (also reported as yesterday), the patient was inadvertently vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) pre-filled syringe, dose of 0.5 mL, lot number: U026792, expiration date: 28-OCT-2022 (dose number, route of administration and anatomical location were not reported) for prophylaxis (expired product administered). The reporter confirmed that the suspect vaccine did not experience any temperature excursions. No additional adverse event (AE) was reported (no adverse event).
More trouble falling asleep since vaccine; Vivid bad dreams since vaccine; Hot flashes after 1st dose; Sore arm after 1st dose; Waking up more at night since vaccine; Fatigue after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (More trouble falling asleep since vaccine), NIGHTMARE (Vivid bad dreams since vaccine), HOT FLUSH (Hot flashes after 1st dose), PAIN IN EXTREMITY (Sore arm after 1st dose) and SLEEP DISORDER (Waking up more at night since vaccine) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Autoinflammatory disease. Concomitant products included COLCHICINE for Autoinflammatory disease.    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 INSOMNIA (More trouble falling asleep since vaccine), NIGHTMARE (Vivid bad dreams since vaccine), HOT FLUSH (Hot flashes after 1st dose), PAIN IN EXTREMITY (Sore arm after 1st dose), SLEEP DISORDER (Waking up more at night since vaccine) and FATIGUE (Fatigue after 1st dose). At the time of the report, INSOMNIA (More trouble falling asleep since vaccine), HOT FLUSH (Hot flashes after 1st dose), PAIN IN EXTREMITY (Sore arm after 1st dose), SLEEP DISORDER (Waking up more at night since vaccine) and FATIGUE (Fatigue after 1st dose) outcome was unknown and NIGHTMARE (Vivid bad dreams since vaccine) had not resolved. Not Provided          The co-suspect medication included antidepressants. The patient was taking them since Dec-2020. In Feb-2021, the dose was increased. Patient's doctor suspected that her symptoms were more likely due to antidepressants. The dose of antidepressants was decreased. Even after the dose was reduced,the patient still had some dreams.      Reporter did not allow further contact
After receiving 2 of 4 requested vaccines, pt. reported feeling faint. Lost consciousness x 1 min, pale, blood pressure 80/54. EMS called. Had a vasovagal reaction. Recovered and discharged home after 30 minutes.
patient received the Pfizer Covid-19 vaccine that was diluted and then left on a counter for 2 weeks at room temperature before it was administered to the patient.; patient received the Pfizer Covid-19 vaccine that was diluted and then left on a counter for 2 weeks at room temperature before it was administered to the patient.; patient was administered expired Pfizer COVID 19 vaccine; arm soreness; fever; This is a spontaneous report from a contactable Pharmacist. This pharmacist reported for a male patient that:  A male patient of an unspecified age (Age: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: Unknown, Expiry date: unknown) via unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient received the Pfizer Covid-19 vaccine that was diluted and then left on a counter for 2 weeks at room temperature before it was administered to the patient. Patient had complaints of arm soreness (unknown which arm per HCP) and fever of 102 degrees Fahrenheit after being administered the Pfizer Covid-19 vaccine. HCP looking guidance for revaccination. Additional Context: To get clarification on administration of expired vaccine. Clinical Pharmacist stated, "I do. Yeah, if it feels okay, I will give you a little more detail, ok so we had a situation where one of our patient was administered expired Pfizer COVID 19 vaccine. It had been out of the Refrigerator sitting on a desk for an extended period of time about 2 weeks from 01Jul till 15Jul, so it was administered after 14 days. I am looking at the CDC guidance for deviations for typical COVID 19 vaccination and they do know that if the dose has been administration past the expiration will be on new date to contact them for any guidance and if manufacturer can provide information or support or the dose should be repeated, and repeated dose can be given immediately with no minimal interval of after the arm. So, I am calling to call in terms of what the manufacturer guidance is for this particular case and should the second shot have administered and expelled. Clinical Pharmacist stated, "I do in about half an hour. I just want to make sure, I get them call and gave it wrap. I hope that's okay. Clinical Pharmacist was unwilling to complete the report hence further probing could not be done. Hence, limited information available over the call. The patient underwent lab tests and procedures which included pyrexia: 102 degrees fahrenheit on unspecified date. The clinical outcome of events was unknown.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On an unspecified date, the patient received an improperly stored dose of ZOSTAVAX (19400 plaque-forming units, PFU) (lot # M019646, expiration date: 18-JUL-2017) injected subcutaneously. The administered dose of vaccine was exposed to a temperature of 6.8 Fahrenheit degrees for 1 hour and 30 minutes. It was reported that the temperature was back in ranges. Data logger was used to track the temperature. There were no adverse effects reported. No product quality complaint (PQC) was involved. Additional information has been requested.
had the shot and he get shingles/suspected vaccination failure; shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows; The case was reported by the patient's sister in law. The age at vaccination was not reported. The reporter said generally that shot did not prevent the shingles just help you had a lighter case of the shingles. The patient had the shot and he still got the shingles just not as often. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Information has been received from a physician, via a company representative, concerning a female patient who was vaccinated (date not specified) with the first dose of Gardasil. Subsequently the patient experienced prolonged pain at the injection site. The patient was scheduled for an evaluation visit at the physician's office. Additional information has been requested.
This spontaneous report was received from a healthcare worker refers to unspecified patients of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On an unknown date the patients were vaccinated with five doses of GARDASIL 9 (strength, dose, frequency and route were not reported) lot # K006960 with an expiry date of 19-FEB-2017. No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint. This is one of the two reports received from the same reporter. Additional information has been requested.
Swelling that increased in size over six days to form a rounded triangle. Bruising around injection site. On day six, brusing started to appear at edges of triangle. By day eight, brusing remains but swelling is now half the triangle's size and hard to the touch
Itching all over started on Mat 12th, turned to raised hives. Itching was on both legs, arms, and scalp.  Patient said a fever developed. Fever has resolved. Raised hives resolved, but skin still feels itchy.
MEDICATION PREPARATION ERROR.  PATIENT GIVEN UNDILUTED DOSE OF PFIZER 5-11 ORANGE CAP BIVALENT VACCINE.
I had a cough spell, very light slight throat, shortness of breath, headache, and fever of 101. By the third day everything was gone except for the cough. The cough lasted for a week. I tested positive for COVID-19 at home. I spoke a doctor and prescribed me Paxlovid. By the fifth day I tested negative.
1-6-21 Left arm numbness and tingling, 1-7-21 Headache, body aches and chills,
Case number PHEH2013US023974 is an initial spontaneous report received from a nurse on 12 Nov 2013 with a follow-up received on 16 Dec 2013. This report refers to a 17 years-old male patient. His medical history did not included any relevant underlying disease and his concomitant medications were not reported. His vaccination history was up to date with all inoculations. This patient under 18 years of age was vaccinated with a 0.5 ml intramuscular dose of FLUVELVAX (batch number: 0080011A, expiry date: 30 Jun 2014) on 07 Nov 2013. No adverse event was reported following the maladministration. Follow-up received from the nurse on 16 Dec 2013: Updated patient's demographic (male), medical history and vaccination history. Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 16 Dec 2013: The BPI labeling of the event "Inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
COVID19 as identified by home test kit morning of 6/11/2022. Initial symptoms: general malaise and sinus drainage. Saw telehealth doc and was prescribed Paxlovid the same day. Took 1st Paxlovid dose evening of 6/11. 6/12, developed mild fever (99.8 deg) and cough. Symptoms and fever (100.5) peaked on 6/13, then began to decline. By last Paxlovid dose on 6/16 (morning), fever was almost gone (99.0) and sinus drainage and cough were greatly diminished. On 6/17, tested negative with two different home tests. On 6/19, symptoms returned along with a positive home test. By 6/21, fever was up to 100.7, sinus drainage increased and cough was productive. Fever broke on 6/23 and all symptoms began to decline but did not go away. On 6/25 lost sense of smell. Fully recovered except smell by 6/30. Sense of smell returned on 7/9.  6/16 (am) last dose