chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a patient that received 0.5mL for their 1st booster dose from a previous vaccinator, instead of 0.25mL.; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (a patient that received 0.5mL for their 1st booster dose from a previous vaccinator, instead of 0.25mL.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Apr-2022, the patient experienced ACCIDENTAL OVERDOSE (a patient that received 0.5mL for their 1st booster dose from a previous vaccinator, instead of 0.25mL.). At the time of the report, ACCIDENTAL OVERDOSE (a patient that received 0.5mL for their 1st booster dose from a previous vaccinator, instead of 0.25mL.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  It was reported that a patient received 0.5mL for their 1st booster dose from a previous vaccinator, instead of 0.25mL.  No treatment information was provided.
Hives, itching 2 weeks after vaccine.  Currently taking Zyrtec, hydroxyzine and triamcinalone cream. Steroid Injection of kenalog 60 mg
pt recv vax 27OCT97 & approx 20min p/vax pt exp focal numbness & paresthesia w/no motor deficit noted;
Vaccine administered 1030 am itching started at 1800 all over body. Started applying CALADRYL cream to affected area.
Immunization (DTaP), IPV, HIB, hep B, Prevnar. 10/7/02 pt febrile, gastroenteritis, seen 10/11/02. Siblings ill. Amoxicillin, cardiac DM, pedialyte prescribed. pt did well.
Overnight soreness in left arm; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8734), via an unspecified route of administration in the left arm on 29Mar2021 at 12:15 (at the age of 55-year-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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 COVID-19 vaccination. On 29Mar2021, the patient experienced overnight soreness in left arm. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not receive any treatment for the overnight soreness in left arm. The clinical outcome of the event overnight soreness in left arm was resolved in Mar2021.  No follow-up attempts are needed. No further information is expected.
Information was received from an attorney regarding a case in litigation concerning a female patient of unknown age. Medical history, concurrent conditions and concomitant medications were not provided. In or about April 2016, the patient was inoculated at a physician's office with ZOSTAVAX (lot number, dosage, and route of administration not provided), for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving ZOSTAVAX, the patient developed an intermittent, sharp throbbing pain and blisters on the lower back and legs of her body. Thereafter, she was diagnosed with shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. The patient sustained severe and permanent injuries. The patient suffered serious, progressive, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Persistent strain of herpes zoster was considered disabling. Additional information has been requested.
Just reporting the side effects I had from getting the 2nd injection of the Shingrix vaccine. I woke up at 4am, 12 hours after receiving the vaccine, feeling hot , like I was becoming sick. It took several hours before I was able to get back to sleep for a bit. When I woke, I could barely get out of bed. I felt very fatigued and tired. Once I got up I felt muscle aches , tired, and feverish.  I did eat breakfast, took Ibuprofen 400mg, and rested, then took my temperature and it was 100.5 degrees F about 11am.  I rested most of the day, my right arm was very sore.  By late afternoon, my fever went away. The site on my arm got red. The next day the arm was redder and painful, like a rash about the size of a baseball.  The day after that it was still red and painful, but a bit better. Today, day 3 the rash is about gone, but still is sensitive to the touch and feels somewhat painful. I think it will be okay by tomorrow.
Right arm swollen 1 1/2 times and having intense pain. Bruised at site.
2 min after the injection patient started to sweat and fainted for a few seconds, then 1 min later she passed out 2nd time for a few seconds and woke up again.  Patient then disclosed she has had passed out in the past with blood drawing, but didn't mention about vaccine issue.   She said she hasn't gotten the same issue for a long time and so didn't report on consent form.  Patient was fully recovered by the time paramedics arrived.  They checked on her and said everything was within normal condition.
Since I have had the shot I continue to feel like I have issues swallowing - like there is a lump in my throat. There isn't.  It just feels that way.   I have had strep three times since I got the vaccine.
My son complained of left arm pain, deltoid muscle soreness with both doses of the vaccine, which resolved in 3 days for both doses. Only ibuprofen was given for comfort.However, with the 2nd dose; My son complained of left arm pain, deltoid muscle soreness with both doses of the vaccine, which resolved in 3 days for both doses. Only ibuprofen was given for comfort.However, with the 2nd dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 11 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Dec2021 13:00 (Lot number: 5-11 Fk5618) at the age of 11 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: IBUPROFEN. Vaccination history included: Bnt162b2 (lot number=5-11 Fk5618,, dose administration date=18Nov2021 , dose administration time=13:00 , dose number=1,, vaccine Location=Left arm), administration date: 18Nov2021, when the patient was 11 years old, for Covid-19 Immunization. The following information was reported: AXILLARY PAIN (non-serious), TENDERNESS (non-serious) all with onset 10Dec2021 19:00, outcome "recovered" (2021) and all described as "My son complained of left arm pain, deltoid muscle soreness with both doses of the vaccine, which resolved in 3 days for both doses. Only ibuprofen was given for comfort.However, with the 2nd dose". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of axillary pain, tenderness.  Additional Information:  Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine was reported as no. List of any other medications the patient received within 2 weeks of vaccination was reported as no. Prior to vaccination, was the patient diagnosed with COVID-19 was reported as unknown. Since the vaccination, has the patient been tested for COVID-19 was reported as yes.  No follow-up attempts are possible. No further information is expected.
temperature went up to 60 degrees; This case was reported by a consumer via interactive digital media and described the occurrence of incorrect storage of drug in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 05-Aug-2022 Reporter's Comments: The case was received from the patient via interactive digital media. The refrigerator door did not seal overnight and the temperature went up to 60 degrees. Follow-up could not be possible as no contact details were available. Additional supportive information: The Boostrix vaccine temperature was exposed upto 60 degrees, which led to incorrect storage of drug.
Pt came into office 3 days after vaccine administered wheezing. Wheezing subjective fever and vomiting started the evening after the HPV vaccine.
The nurses gave a booster Pfizer COVID vaccine to the patient using the leftovers of a vial and another new vial.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 16-DEC-2015 at 15:12, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperatures were 8.3 (for 6 hours 50 minutes) and 5.8 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
upset stomach; low grade fever; tired; sleep for several hours; This case was reported by a consumer via call center representative and described the occurrence of upset stomach in a 83-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingels vaccine (received 1st dose on an unknown date).   On 1st July 2020, the patient received the 2nd dose of Shingles vaccine. In July 2020, less than a week after receiving Shingles vaccine, the patient experienced upset stomach, low grade fever, tiredness and sleepiness. On an unknown date, the outcome of the upset stomach, low grade fever, tiredness and sleepiness were not recovered/not resolved.   It was unknown if the reporter considered the upset stomach, low grade fever, tiredness and sleepiness to be related to Shingles vaccine.  Additional details were provided as follow: The reporter was patient's mother. The patient received 2nd shingle shot yesterday. She had a low grade fever and had a very upset stomach. She was very tired and had sleep for several hours. The reporter wanted to know how long do the side effects last with a second shingle shot.
A little soreness in the VAC shoulder for one day; This is a spontaneous report from a contactable consumer (Patient). A 58-years-old male patient received first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration, administered in Arm Left on 24Feb2021 12:00 (Batch/Lot Number: EN6203) (at the age of 58-years-old) as SINGLE for covid-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing. The patient did not have any allergies to medications, food, or other products. 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 COVID-19 vaccine. Concomitant medication(s) included hydrochlorothiazide 25mg, amlodipine 10mg and carvedilol (CARVEDI); all taken for an unspecified indication, start and stop date were not reported. On 24Feb2021, 17:00, the patient experienced a little soreness in the vac shoulder for one day. The patient did not received any treatment. The reporter considered the event as non-serious. The outcome of event was recovered in Feb2021.   Follow-up attempts completed. No further information expected.
hardly got sore; Chills; Nausea/Nauseated; This is a spontaneous report from a contactable consumer, the patient. A 88-years-old female received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number:  EL1283), via an unspecified route of administration  in left arm on 11Jan2021 at 14:00 (at the age of 88-years-old) as a single dose for Covid-19 immunisation. Medical history included Covid-19 from Dec2020 to an unknown date ('quarantine was over a few days before Christmas'.), Heart attack, Had four stents placed, ongoing Blood pressure high , ongoing blood cholesterol , drug hypersensitivity ('allergic to lots of medications'). Concomitant Medication include 'blood thinners, blood pressure, cholesterol, that sort of thing'. No additional details provided. No other vaccines were given within 4 weeks. On 12Jan2021, The patient experienced chills all day long.  She never ran a temperature. She got nauseated around 9:00 PM-9:30 PM and on an unspecified date reported she hardly got sore, no additional details provided. She drank ginger ale, went to bed. She got up the following morning and was fine. By 13Jan2021 she felt fine and no longer had chills or nauseated. The adverse events did not require a visit to the emergency room or physicians office. Consumer inquired if she can use antipyretics before or after vaccination of the covid-19 vaccine. The patient is scheduled to get the second dose on 01Feb2021. The clinical outcome of the event is chills and nausea were recovered on 13Jan20201 while hardly got sore was unknown.
Patient has a raised area of redness that measures 10 cm long and 6.2 cm high. She reports having this reaction the night of her vaccination.
Ringing in my ears; This is a spontaneous report from a non-contactable nurse, the patient. A 49-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 23Sep2021 (at the age of 49-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. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Sep2021 the patient experienced ringing in ears. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event ringing in ears was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Rapid heart beat, dizziness, headache, vomited. Transported to ER.
LIMITED ARM MOBILITY; ARM PAIN AND SORENESS; This spontaneous report received from a patient concerned a female of unspecified age. 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: Unk) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced limited arm mobility. On MAR-2021, the subject experienced arm pain and soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm pain and soreness, and limited arm mobility. This report was non-serious.
Breakthrough case: My symptoms included sore throat, cough, exhaustion, headache, and stomach pain.   I was seen at the hospital for low oxygen. I was given an inhaler and was kept there for 8 hours. They give me a lot of fluids. Then I was released. The second time I was there, I was told I was a long hauler and I'm still dealing with coughing, low oxygen, and exhaustion.
Fever for 48 hours after injection, intense chills, shivering and body aches.
First 12 hrs, normal arm soreness/redness. Second 12 hrs, severe upset debilitating  equilibrium, bedridden. Third 12 hrs, mild headache.
It had been refrigerated but past the recommended time; No adverse event; Administered a vaccine that was drawn 21 hours prior./Dose was given on 19MAY2023 8:45 AM after being initially punctured on 18MAY2023 11:13 AM; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered a vaccine that was drawn 21 hours prior./Dose was given on 19MAY2023 8:45 AM after being initially punctured on 18MAY2023 11:13 AM), PRODUCT STORAGE ERROR (It had been refrigerated but past the recommended time) and NO ADVERSE EVENT (No adverse event) in a 57-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7170B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-May-2023 at 8:45 AM, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 19-May-2023 at 8:45 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered a vaccine that was drawn 21 hours prior./Dose was given on 19MAY2023 8:45 AM after being initially punctured on 18MAY2023 11:13 AM). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (It had been refrigerated but past the recommended time) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered a vaccine that was drawn 21 hours prior./Dose was given on 19MAY2023 8:45 AM after being initially punctured on 18MAY2023 11:13 AM), PRODUCT STORAGE ERROR (It had been refrigerated but past the recommended time) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered a vaccine that was drawn 21 hours prior./Dose was given on 19MAY2023 8:45 AM after being initially punctured on 18MAY2023 11:13 AM) and PRODUCT STORAGE ERROR (It had been refrigerated but past the recommended time).    No concomitant medication information was provided.   Patient didn't receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient didn't report any symptoms.  Treatment medication information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-May-2023: Follow-up received, updated patient demographics and suspect drug information.
DEATH; BLOOD CLOTS; This spontaneous report received from a consumer via a company representative via social media (Johnson and Johnson Corporate) concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient was vaccinated with covid-19 vaccine ad26. cov2. s (manufacturer not specified) (dose number series 1) (suspension for injection, route of admin not reported, batch number and expiry were unknown) dose was not reported, 1 total, administered for prophylactic vaccination. No adverse events were reported following vaccination with covid-19 vaccine ad26. cov2. s (dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2), (suspension for injection, route of admin not reported, batch number, and expiry: unknown) dose was not reported, 1 total, administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. Following booster administration, the patient came home and died (captured as death). On an unspecified date, an autopsy was performed and according to the autopsy result the patient had developed blood clots. On an unspecified date, the patient died (cause of death unknown) (dose number in series: 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on an unspecified date, and the outcome of blood clots was not reported (dose number in series 2). This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0: 20211247547-covid-19 vaccine ad26.cov2.s -Death, blood clots. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH; Autopsy-determined Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Myalgia, Fever, FEVER 101.3, SHAKING, CHILLS, SORE ARM. FEELS LIKE WHEN I HAD COVID Narrative:
Fever to 99,  chills,  muscle aches, arthralgias Severe headache insomnia twitching extremities at night difficulty concentrating
Patient completed Moderna COVID vaccine series by different vendor on 2/5/2021 and 3/5/2021.  Patient then received 3rd dose of Moderna vaccine by us as documented on this report on 8/14/2021.