chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Achiness; Soreness at site of vaccination; Shivering; Headache; Fever; Vomiting; Diarrhea; This case was reported by a consumer via other manufacturer and described the occurrence of pain in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced pain, injection site pain, shivering, headache, fever, vomiting and diarrhea. On an unknown date, the outcome of the pain, injection site pain, shivering, headache, fever, vomiting and diarrhea were recovered/resolved.   It was unknown if the reporter considered the pain, injection site pain, shivering, headache, fever, vomiting and diarrhea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 56 or 57 years old. The patient received the first vaccination round of Shingrix in July and felt some of the listed reactions like achiness, soreness at site of vaccination, chills ,shivering, headache, fever, vomiting, and diarrhea. The reporter had consented to follow-up but was unable to contact reporter after corresponding phone attempts, hence follow-up is denied.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR245362:same reporter, same suspect, same patient, 2nd dose
Case number PHEH2013US018849, is an initial spontaneous report received from a pharmacist on 05 Sep 2013, with a follow-up received on 04 Nov 2013. This report refers to an 18 years old male patient. He received only Men C, Y, W-135 liquid conjugated component of MENVEO (batch number: X12009), intramuscularly into left deltoid without being reconstituted with Men A lyophilized conjugated vaccine component on 14 Aug 2013 at 11:45 am. No adverse event was reported following this administration error. He was not returned to the hospital for revaccination. Follow-up was received on 04 Nov 2013: Vaccination site, vaccination time and information that patient not returned for revaccination were updated.
On July 12, 2022, I started having flu-like symptoms. Tested positive for COVID on July 13, 2022 and began taking Paxlovid. On July 15, 2022, I received a chest X-ray and blood work.  Both were normal. By July 18, 2022, I was getting some relief from the symptoms. As of now, July 21, I still have a slight cough and minor fatigue.
First shot on April 6 caused lymph nodes to swell up on left side of collar bone. Second shot on May 20 caused lymph nodes to swell MORE. They never went down even after first shot. Same evening of second shot felt nauseous, body ache, tired, no appetite,
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 13-JUL-2017, the patient was vaccinated with the improperly stored (in -11 degrees Celsius for 13 full days) dose of VARIVAX (for prophylaxis, lot # reported as M0048200, expiration date 07-DEC-2018; route of administration was not reported) that was reconstituted with the properly stored sterile diluent. No adverse effects and no previous temperature excursion were reported. Digital data logger was involved. Additional information has been requested.
onset of inc fever 103, chills, fatigue, redness & swelling & tenderness @ site of inj;macular lesion lt arm 6x51/2cm;
Patient's mother inadvertently gave both son's consent forms to pediatric vaccinator. Brother is 11y/o, pt in this report is 13y/o and should've received an adult dose. The RN then inadvertently gave the 5-11y/o pediatric Pfizer vaccine 0.2mL to the 13y/o for their second dose in series instead of giving the Pfizer adult dose at 0.3mL. Mother was made aware of the error and was educated on s/s to report, follow-up. that report with VAERS was being filed, and encouraged to contact clinic or EMS services if s/s or medical concerns arrive. Writer spoke with mom approx 5hrs after pt administration and mom said pt was "doing fine" stated she would monitor pt through the night and update clinic with any questions or concerns. Mom stated she felt "guilty" "I knew he was supposed to get an adult dose I just wasn't thinking" and was assured this was not her error or fault and clinic would address error with staff. Mom was educated that no additional dosing is needed and clinic would continue to follow-up.
Covid19 breakthrough. 1st vaccine received on 01/07/2021. 74 y/o PMH Multiple myeloma, immunocompromised host on Revlimid, BPH, HLD, HTN presents to ED 1/14/2022 after calling 911 for progressive weakness, SOB, Fever, sore throat and room air SATS of 80%. Patient had tested positive for Covid on 01/13/2022 at Local Care Center. CXR-Bibasilar PNA.  Started on IV ABX, IV Steroids and Remdesivir.
Staff administer the vaccine that was expired, Pt was vaccinated with no reactions, Pt was monitored for the 15 min and had no shortness of breath no visible reactions.
Pain, site of injection persisted 2 mos. General malaise 4 days. Vomiting 1 day. Large mass of sl tender soft lymph nodes neck, same side as injection.
Agitation, dizziness, vertigo, loss of concentration, hypothyroidism, memory loss, irritable mood, runny nose, nausea, nervousness, vision problems Received and reviewed records DX: hypercholesterolemia, arrythmia, hypothyroidism, Diabetes Mellitus Type II, conjunctivitis, allergic, proteinuria, generalized anxiety disorder, sleep disturbances.
pt broke out in hives the next day and still today is still having hives. He believes it is due to vaccine
Initial report received from a reporter on 24 OCTOBER 2013. A female adult patient had received FLUZONE MDV (lot # UH900AD and expiration date unknown) right/left deltoid on past two weeks. On 24-OCT-2013 within 24 hours, the patient had reported about a knot in her arm. At the time of the report, the outcome of the event was unknown. No further relevant information reported.
Vial might been used after 12hs of being punctured; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vial might been used after 12hs of being punctured) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vial might been used after 12hs of being punctured). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vial might been used after 12hs of being punctured) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Caller had a question regarding the application of the moderna covid-19 vaccine after the vial was punctured for 12hs. Treatment medication was  not reported. Relevant concomitant medications were not provided by the reporter.
Headache, Myalgia, Arthralgia, chills Narrative:  chills, headache, mayalgia, arthralgia, 1/25 - feeling better, slight headache
fever; palpitations; heart disease, unspecified; allergy; asthma; dizzy; wrong injection technique; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PALPITATIONS (palpitations) and PYREXIA (fever) in a 68-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.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 17-Mar-2021, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (wrong injection technique). On an unknown date, the patient experienced PALPITATIONS (palpitations) (seriousness criterion hospitalization prolonged), PYREXIA (fever) (seriousness criterion hospitalization), CARDIAC DISORDER (heart disease, unspecified), HYPERSENSITIVITY (allergy), ASTHMA (asthma) and DIZZINESS (dizzy). At the time of the report, PALPITATIONS (palpitations), PYREXIA (fever), CARDIAC DISORDER (heart disease, unspecified), HYPERSENSITIVITY (allergy), ASTHMA (asthma) and DIZZINESS (dizzy) outcome was unknown and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (wrong injection technique) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 104 °F (High) 104 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  The patient received Covid-19 vaccine the same day as she did her first Humira (adalimumab) injection. The patient reported that they told her at the hospital that the symptoms were due to the Covid-19 vaccine.  Treatment medication included Benadryl (diphenhydramine).  Based on the current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Nausea, vomiting, headache, muscle aches, chills, fever, sore arm, pain in left breast
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 01-FEB-2017  at 13:22, the patient was vaccinated with improperly stored VARIVAX injection (lot # M035142) (expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA008441: US-009507513-1704USA000389: US-009507513-1704USA000390: US-009507513-1704USA000391: US-009507513-1704USA000392: US-009507513-1704USA000393: US-009507513-1704USA000394: US-009507513-1704USA000395: US-009507513-1704USA000396: US-009507513-1704USA000397: US-009507513-1704USA000398: US-009507513-1704USA000399: US-009507513-1704USA000400: US-009507513-1704USA000401: US-009507513-1704USA000402: US-009507513-1704USA000403: US-009507513-1704USA000404: US-009507513-1704USA000405: US-009507513-1704USA000406: US-009507513-1704USA000407: US-009507513-1704USA000408: US-009507513-1704USA000409: US-009507513-1704USA000410: US-009507513-1704USA000411: US-009507513-1704USA000412: US-009507513-1704USA000413: US-009507513-1704USA000414: US-009507513-1704USA000415: US-009507513-1704USA000417: US-009507513-1704USA000418: US-009507513-1704USA000419: US-009507513-1704USA000420: US-009507513-1704USA000421: US-009507513-1704USA000422: US-009507513-1704USA000423: US-009507513-1704USA000424: US-009507513-1704USA000425: US-009507513-1704USA000426: US-009507513-1704USA000427: US-009507513-1704USA000428: US-009507513-1704USA000429: US-009507513-1704USA000430: US-009507513-1704USA000431: US-009507513-1704USA000432: US-009507513-1704USA000433: US-009507513-1704USA000434: US-009507513-1704USA000435: US-009507513-1704USA000436: US-009507513-1704USA000437: US-009507513-1704USA000438: US-009507513-1704USA000439: US-009507513-1704USA000440: US-009507513-1704USA000441: US-009507513-1704USA000442: US-009507513-1704USA000443: US-009507513-1704USA000444: US-009507513-1704USA000445: US-009507513-1704USA000446: US-009507513-1704USA00047: US-009507513-1704USA000448: US-009507513-1704USA000449: US-009507513-1704USA000450: US-009507513-1704USA000451: US-009507513-1704USA000452: US-009507513-1704USA000453: US-009507513-1704USA000454.
No adverse side effects; Pharmacist states she accidently gave an expired dose of MMR-II because she looked at the lot and expiration for sterile diluent but not MMR-II.; This spontaneous report has been received from a pharmacist, referring to a 30-year-old female patient. The patient's concurrent conditions, medical history, and concomitant medications were not provided.   On 20-OCT-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (recombinant human albumin) (M-M-R II) 0.5 milliliter subcutaneously (lot number T034380 has been verified to be a valid lot number, expiry date 08-OCT-2022) (expired product administered) concomitantly with the sterile diluent, indicated as prophylaxis.  No additional adverse events were reported.
Pt presented w/ chest pain, pulmonary embolism confirmed via CTA Chest on 4/15/2021 1 week after J&J vaccination (4/7). Also tested positive covid on 4/15. Being treated with heparin infusion
Chicken pox disease diagnosed by myself on 11/13/02. She had received chicken pox vaccine.
Diahrea, abdominal pain, hemmoroids, bowel infection, fluid surrounding my bowels
Temperature of 100; Right shoulder swollen; Bruised on the injection spot; Inflammation on lymphatic nodules on the right side, from neck to hip.; Headache; No appetite; Brain fog; Lethargy; This is a spontaneous report from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in right arm, administration date 29Nov2021 at 11:45 (Lot number: FH8027) at the age of 40 years as dose 2, single for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: FH8030, Anatomical location: Right arm, Administration time: 11:45), administration date: 08Nov2021, when the patient was 40 years old, for COVID-19 immunisation.  The following information was reported: PYREXIA (non-serious) with onset 30Nov2021 at 01:00, outcome "recovered" (an unknown date in 2021), described as "Temperature of 100"; JOINT SWELLING (non-serious) with onset 30Nov2021 at 01:00, outcome "recovered" (an unknown date in 2021), described as "Right shoulder swollen"; VACCINATION SITE BRUISING (non-serious) with onset 30Nov2021 at 01:00, outcome "recovered" (an unknown date in 2021), described as "Bruised on the injection spot"; LYMPHADENITIS (non-serious) with onset 30Nov2021 at 01:00, outcome "recovered" (an unknown date in 2021), described as "Inflammation on lymphatic nodules on the right side, from neck to hip"; HEADACHE (non-serious) with onset 30Nov2021 at 01:00, outcome "recovered" (an unknown date in 2021), described as "Headache"; DECREASED APPETITE (non-serious) with onset 30Nov2021 at 01:00, outcome "recovered" (an unknown date in 2021), described as "No appetite"; FEELING ABNORMAL (non-serious) with onset 30Nov2021 at 01:00, outcome "recovered" (an unknown date in 2021), described as "Brain fog"; LETHARGY (non-serious) with onset 30Nov2021 at 01:00, outcome "recovered" (an unknown date in 2021), described as "Lethargy". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, joint swelling, vaccination site bruising, lymphadenitis, headache, decreased appetite, feeling abnormal and lethargy.  Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. 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 events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  No follow-up attempts are possible. No further information is expected.
On 8/6/2018 the I.M. injection of Meningitis B (BEXSERO) was given in right deltoid at 7:50 a.m. and within 3 seconds, patient closed his eyes and his head went back fainting. This lasted 5 seconds before he eventually responded and opened eyes.
Patient reported that her arm feels "three times its normal size" two days after receiving a booster dose of COVID-19 shot. She was in clinic for an unrelated follow up for chronic disease state management when she shared this information. I did visualize a roughly quarter-sized area of erythema and swelling on her left upper arm. She also reported that since the injection "my whole arm is numb down to my fingers." She felt very ill for 2 - 3 days post-injection, skipped most/all of her medications during this time, spent most of the time in bed. Fasting blood sugar increased from 100s to 300s mg/dL over these 2 - 3 days.
Patient was given the Moderna COVID-19 vaccine as an additional dose instead of the Pfizer COVID-19 vaccine as a booster. Patient received the Pfizer Covid-19 as her 1st and 2nd doses on 01/28/21 and 02/23/21. Patient is doing well as at 09/24/21
BODY WEAKNESS; HEADACHE; DIFFICULTY SLEEPING; This spontaneous report received from a patient concerned a 19 year old male. The patient's weight was 155 pounds, and height was not reported. The patient's pre-existing medical conditions included the patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered to right deltoid on 28-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-MAR-2021, the subject experienced difficulty sleeping. On 29-MAR-2021, the subject experienced body weakness. On 29-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, difficulty sleeping, and body weakness. This report was non-serious.
2 Hep B shots at same time!! No reaction yet - should not had gotten 2 hep b shots at one time.
Tingling/numbness on left side of head and face soon after administration, subsided within a few hours but returned six days later. Still have residual sensation, no paralysis.  Fever beginning 7 pm (9 hrs post vaccination) and continuing through next day, 99-101 degrees; no fever on third day. BUT six days later, when facial symptoms appeared again, temperature 99 degrees. Now normal again.
pt recv vax 26AUG96 & 28AUG96 area to lt upper arm red & sl edema from shoulder to 2 inches above elbow, t99.1 o;
In the evening it felt like I swollen something funny and I was trying to clear my throat and get it out. The next day I still had a tickle that turned into a productive cough. So that evening I was getting worried. We were on a cruise getting ready to get off and my husband told me to get test. I got a rapid test done it was negative. Because I had symptoms she did a PCR and it was positive. And they told me to stay in my room and they would put us in the hotel. We were there for 5 night I had night sweats and a cough. I called my doctor who ordered a prescription to the hotel room. The Paxlovid did help but I had a nasty taste in my mouth. I had to stop taking the statin so I could take the Paxlovid. When i got home I was still testing negative. I am feeling better but still have a small cough.
Got slight pain in armpit and little swelling found next day of first shot. And that went of couple of days.  Next day after second shot, got a lemon sized swelling and pain in under arm - armpit where the shot taken (left hand). Got slight fever but not bad. Still having armpit pain and swelling. But pain is reduced slightly
Woke up sick; Couldn't sleep; Mouth and lips were very dry; Mouth and lips were very dry; Cold chills; Nausea; Really bad fatigue; Joint hurting; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Woke up sick), INSOMNIA (Couldn't sleep), DRY MOUTH (Mouth and lips were very dry), LIP DRY (Mouth and lips were very dry) and CHILLS (Cold chills) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included METFORMIN, GLIPIZIDE, LIRAGLUTIDE (VICTOZA), LOSARTAN, FELODIPINE, HYDROCHLOROTHIAZIDE, LEVOTHYROXINE, BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and SALBUTAMOL SULFATE (PROAIR [SALBUTAMOL SULFATE]) for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced INSOMNIA (Couldn't sleep), DRY MOUTH (Mouth and lips were very dry), LIP DRY (Mouth and lips were very dry), CHILLS (Cold chills), NAUSEA (Nausea), FATIGUE (Really bad fatigue) and ARTHRALGIA (Joint hurting). On 18-Mar-2021, the patient experienced ILLNESS (Woke up sick). At the time of the report, ILLNESS (Woke up sick), INSOMNIA (Couldn't sleep), DRY MOUTH (Mouth and lips were very dry), LIP DRY (Mouth and lips were very dry), CHILLS (Cold chills), NAUSEA (Nausea), FATIGUE (Really bad fatigue) and ARTHRALGIA (Joint hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information reported included ibuprofen.
Narrative: 65yo male patient with PMHx of DMII, ESRD on DIALYSIS T/TH/S, anemia, PVD, CAD with prior CABG and B/L BKA with (R side BKA in 2020 non-healing wound & L side BKA in 2019 2/2 osteomyelitis) died on 11/13/2021. Pt had received covid vaccines on 2/17/21 & 4/8/21. No information provided on pt's cause of death. This death is likely not related to the vaccinations due to the patient's comorbidities, advanced age, and length of time from vaccine administration.
Case number PHEH2014US024348, is an initial spontaneous report received from a nurse on 02 Dec 2014 and with a follow-up from a nurse received on 21 Jan 2015. This report refers to a 77 year old female patient. Past medical history and concomitant medication were not reported. The patient had tolerated vaccines (no further details provided) well in the past. The patient was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar 2015) into left deltoid intramuscularly at a dose of 0.5 ml on 12 Nov 2014. The nurse reported that before vaccination the prefilled syringe (PFS) of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. No adverse event was reported following this maladministration. No further information was provided. Follow-up from a nurse received on 21 Jan 2015: Site of vaccination (left deltoid) and other clinically relevant information on previous vaccinations in the narrative was updated.