chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Engerix B instead of Twinrix third dose; Late 2nd dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 43-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis.   Previously administered products included Twinrix (1st dose of Twinrix received on 02 March 2018).   In NOV-2019, the patient received the 2nd dose of Twinrix. On 05-OCT-2023, the patient received Engerix B. In NOV-2019, an unknown time after receiving Twinrix and not applicable after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: Late 2nd dose). On 05-OCT-2023, the patient experienced wrong vaccine administered (Verbatim: Engerix B instead of Twinrix third dose). The outcome of the wrong vaccine administered and drug dose administration interval too long were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 01-NOV-2023 The physician assistant called to report a patient received a first dose of Twinrix 02 March 2018, a second dose of Twinrix in November 2019. Then on 05 October 2023 Engerix B was administered instead of third dose of Twinrix which led to wrong vaccine administered. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule. (Drug dose administration interval too long) plus 7 days. The reporter consented to follow up via mail. No lot number reported.
Customer reported on the day of vaccine, an egg sized swelling at the site of injection, it was painful, and she described it with a fever- meaning hot to the touch. She said it hurt to sleep on. She then said it developed into a rash around the area with red dots, not raised and all localized. It resolved in 2-3 days and now you cannot tell it was given on 9/3/18.
Bleeding at site, headache, dizzy, upset stomach, temp 99-100.  Headache and low energy level for appx 2 weeks.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 72 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing). Concomitant medication(s) included: EVENITY [ROMOSOZUMAB AQQG]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which is Paxlovid from 07Feb2023 to 11Feb2023.  The information on the batch/lot number for [BNT162B2, BNT162B2 OMI BA.4-5] has been requested and will be submitted if and when received.
Third dose of Moderna COVID vaccine given was 0.5 mL, instead of 0.25 mg for non-immunocompromised pts. Per CDC's definition, pt is not severely immunocompromised. Pt reported no adverse reactions.
Light Vertigo; Headache/a little bit of pain in the right part of his head, just above his right eye; Gait is off/his gait is off like he is not looking where he is walking; just very mild dizziness/got a little bit dizzy; This is a spontaneous report from a contactable consumer (patient wife).  A 76-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported (patient reported ENVZIO 10 OR 210, reporter was not sure), expiry date: unknown) via an unspecified route of administration on 17Feb2021 (at the age of 76-years-old) as dose 1, single for COVID-19 immunisation. Medical history included blood pressure from an unknown date and unknown if ongoing, cholesterol from an unknown date and unknown if ongoing, stroke (mild stroke many years ago) from an unknown date and unknown if ongoing, ongoing blood thinner from an unknown date. Concomitant medication included lisinopril taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid (BABY ASPIRIN) taken for anticoagulant therapy, start and stop date were not reported; amlodipine taken for an unspecified indication, start and stop date were not reported; atorvastatin taken for an unspecified indication, start and stop date were not reported. On 17Feb2021, the patient experienced light vertigo and headache. On an unspecified date in 2021, the patient experienced gait was off and just very mild dizziness/got a little bit dizzy. His gait was off like he was not looking where he was walking. But this was not the dizziness at all. He was just slightly imbalanced sometimes. Reporter stated that patient had his first dose on 17Feb2021 and then he had little bit of a headache in his right cerebrum, just above his right eye and it just lasted like for a couple of minutes, and about half hour after that he started to have light vertigo. However, half an hour later, he got a little bit dizzy. She said she was just concerned since her husband was still having a little vertigo even if it has already been 6 days since he received the vaccine. consumer said that she was worried that this might be an indication for something else. She wanted to know if this reaction was still associated with the vaccine, and if it was necessary that they contact their doctor. On the list that he got after he took the vaccine, it did not say anything about this being side effects or a problem. All she really needed to know, if patient needed to contact his doctor or it was just very mild dizziness and it was like a vertigo. The patient did not take anything for it because he said it was so mild that he was been you know he said even Encifer (further not clarified), one of the vertigo medications were offered to him. He would not think because he needed it because it was that mild. Outcome of the event was light vertigo was not recovered. Outcome of the event headache/a little bit of pain in the right part of his head, just above his right eye was recovered on 17Feb2021 and of other events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
patient called to report injection site redness which is increasing, hardness and heat to left deltoid.
Having muscle and I would say joint pain; Having muscle and I would say joint pain; Numbness continue in my right arm where I received the vaccine; Tingling in my upper arm and it still continues; They are still there and actually worsening; I started feeling the pain and the numbness and tingling in my upper arm; This is a spontaneous report from a contactable consumer (patient reported for himself). A 59-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0164), via intramuscular route of administration, administered in deltoid right (right shoulder) on 22Apr2021 at 12:30 PM (at the age of 59-year-old) as dose 2, single for COVID-19 immunization. Medical history included disability (patient stated, well I am on disability. I am disabled). The patient's concomitant medications were not reported. the patient did not receive any other vaccine 4 weeks prior to COVID shot. The patient previously took gabapentin and neurontin, both drugs for disability; first dose of bnt162b2 for COVID-19 immunization. The patient experienced having muscle and I would say joint pain, numbness continue in my right arm where I received the vaccine, I started feeling the pain and the numbness and tingling in my upper arm was reported as worsened, they are still there and actually worsening on an unspecified date in 2021. Patient stated, I was calling because I received the vaccine in May and I am still having muscle and I would say joint pain and numbness continue in my right arm where I received the vaccine. I am calling, its about 2 months 3 months now should those effects be feeling. When probed whether these adverse events took place after the first Pfizer COVID shot or Second. Patient stated, Second. When probed for the exact date for the onset of adverse events, Patient stated, Well I had the second dose on 22Apr2021. I would say two weeks later I started feeling. The day I had the injection I felt it. It was two days then it kind of went away but then like almost I would say 7 days later I started feeling the pain and the numbness and tingling in my upper arm and it still continues. Date and time for second COVID shot: Patient stated, 22Apr2021 (22Apri2021). I would say 12:30 pm. Patient stated, they are still there and actually worsening. I feel like its worsening because its happening more. (confirmed as worsening). The patient did not receive any treatment for the events. Outcome of the events was not recovered.
Itching at age injection site started 7 days after the first shot. Redness and hardness at the injection site more apparent on day 8, with still Slight itching.
* RECEIVED X3 VACCINES (SEE ABOVE) ON 10/17/2023 AROUND 1:15PM AT MY PHARMACY.,  * ON 10/18/23 AROUND 3PM, I WAS FEELING PAIN TO MY UPPER/LOWER RIGHT ARM OF THE ONE INJECTION SITE, HOT TO     TOUCH, VERY DISCOMFORT, BODY ACHES, FEVER 102-F (BY MOUTH TEMP) AND A INDURATION OF 70MM X80MM WITH     REDNESS ALL AROUND. VERY PAINFUL TO TOUCH (I HAVE PICTURES IF NEEDED AS PROOF)* * STAYED HOME BED RIDDEN X2 DAYS * TOOK TYLENOL 1000MG  EVERY 12 HOURS
Warm inflammation 5cm around injection site of right upper arm Benadryl. Cool compress.
Patient received fluad instead of fluarix, although patient is only 63y/o. Patient was made aware but did not report any additional side effect from the fluad.
4 year old male received DTaP, IPV left leg on Tuesday 5/9/2006 and developed local erythema, mild swelling at injection site. Area of erythema 6 cm Diameter. no F/C no neurovascular compromise.
Moderna COVID-19 Vaccine EUA - pulmonary embolism with mild to moderate infarction in right lung
@7:08 p.m 05/28/2021; Patient became very stiff and weak unavailable to move around like normal, after that   Fever began to start and I gave him Tylenol he went to sleep a little while after then when he woke.. he began to cry and had a seizure, arm twitching while slob came out his mouth bubbly while he laid on the ground for 13 to 15 mins. After he was hospitalized where he continue to have seizure, and he had to be put into a medical induced coma. Hospital flew him 2 hours away to be further treated.
A report has been received from a health professional. The report concerns a 15 year old female patient. The patient's medical history included acne. Concomitant medications included salbutamol and ibuprofen. The patient received nasal FLUMIST on 28-Sep-2012. The patient started experiencing flu like symptoms on 29-Sep-2012. The patient's symptoms were sore throat, body aches, fatigue, and trouble getting out of bed. It was reported that physicians notes stated cough, acute pharyngitis, possibly strep. It was reported that patient was not given antibiotics, but she was given albuterol nebulizer Q4H and was told to take MUCINEX or MUCINEX D. It was further reported that the patient has sore throat and cough. The reporter also reported that the patient was not allergic to eggs or egg proteins, had no long term aspirin therapy, no previous Guillain-Barre Syndrome, no reactive airways disorder or asthma, not taking TAMIFLU or other related medications, not pregnant or lactating, no heart, kidney or lung disease, no seizure disorder, no cerebral palsy, and would not be in contact with anyone with a weakened immune system. The outcome of the events was unknown. The report was considered to be non-serious by the reporter. Summary of follow-up information received by AstraZeneca/MedImmune 01-Nov-2012 from health professional: Non-serious event of cough acute pharyngitis possibly strep was added. Reporter information was added. Suspect Vaccine Information was added. Concomitant medication and medical history was added. Narrative was updated. Summary of follow-up information received by AstraZeneca/MedImmune 02-Nov-2012 from health professional: Events were added as sore throat and cough. Reporter's details were updated.
Edematous, erythematous, large local reaction to nearly entire right thigh extending to knee. Pruritis developed 1 day later. Refusal to walk on initial day of symptoms. No fevers. Treated at home with Ibuprofen and hydrocortisone. Prednisolone added 10/23/2021.
some arm soreness in the injected arm; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on arm, via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported he had already received his first dose of the Pfizer covid-19 vaccine and tolerated it well, but he did experience some arm soreness in the injected arm. The outcome of event was recovered.  Information on the Lot/Batch number has been requested
tested positive for a Sars-Cov-2 infection; tested positive for a Sars-Cov-2 infection; This is a spontaneous report from a contactable consumer (patient).  This 38-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EK5730) intramuscular in the left deltoid on 18Dec2020 at the age of 38-years-old at single dose for COVID-19 immunisation. There were no relevant medical history and concomitant medications. On 05Jan2021, the patient tested positive for a SARS-COV-2 infection. The patient was asking how to proceed with getting his second dose; at the time of the report, he was 2 weeks post diagnosis and he was 32 days since his first shot. At the time of the report, the outcome of the event was unknown.
Information has been received from a registered nurse (R.N.) concerning a 9-year-old Asian female with no pre-existing allergies, birth defects or medical conditions who on 25-AUG-2999 was vaccinated subcutaneously in the left arm with a first dose of Varivax (lot # 631073/0450J). There was no concomitant medication. There was no illness at the time of vaccination. On 08-JUL-2006 the patient was seen in the physicians office by a pediatric nurse practitioner with a 10 day rash, a few spots on her abdomen and arms, vesicles and papules at various stages. She was treated with BENADRYL and AVEENO BATH. There were no diagnostic or laboratory tests performed. The patient recovered. Additional information is not available.
pt reported Atrial Fibrillation within hours of having his Pfizer booster dose. Hospitalized for cardioversion then released to home. Reported via VAERS. Pt did NOT wish to be contacted regarding this event or have his prescribed contacted. Pfizer vaccine not dispensed or administered by this pharmacy so have no information on that.
Redness and significant swelling of left thigh surrounding PREVNAR injection site. Swelling has occurred with each injection in this series and gotten progressively worse each time. Swelling is starting to go down on day 5 after injection but appears still hard and painful to the touch. Fever and irritability started 12 hours following injection and resolved around 72 hours later.
Fatigue; This spontaneous case was reported by a physician and describes the occurrence of FATIGUE (Fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical history was not reported).    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced FATIGUE (Fatigue). On 12-Feb-2021, FATIGUE (Fatigue) had resolved.        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 information were not provided. No treatment information was provided
This spontaneous report was received from a health care worker referring to a 11 year old patient of unknown gender. The patients' concurrent conditions and medical histories were not provided. On 08-SEP-2015, the patient was vaccinated with unspecified improperly stored doses of GARDASIL 9 (lot # L014415, expiration date 25-JUL-2017), (routes, doses and anatomical sites of vaccination were not provided). It was reported that the temperature of excursion were the following: 53.6 F for 392 hours, 58.5 F for 465 hours and 46.2 F for 15 hours, respectively. The outcome of excursion was not supported. Co-suspect therapies or concomitant medications were not provided. 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.
This spontaneous report as received from a pharmacist refers to a 52 year old female patient. The patient was on an unspecified biologic and kept getting urinary tract infections, but she had been off that biologic for 6 months and had not had an infection since. The patient did not have any known drug reactions or allergies. Concomitant therapies included a biologic for increased liver enzymes. On 07-APR-2017, the patient was vaccinated with ZOSTAVAX lot # M033910 (expiration date 19-OCT-2017) subcutaneously for shingles prevention (the strength, dose, and frequency were not provided) reconstituted with sterile diluent (lot # M022946 expiration date 17-DEC-2018). On 08-APR-2017, the patient noticed some redness around the injection site that was moving down toward the elbow. The area was very hot and tender, and the patient was also feeling nauseous and could not eat. On 09-APR-2017, the patient called the pharmacist and reported the symptoms and told her they were not getting away better. She also had chills, and still felt very nauseous. On the same day, the patient went to see the pharmacist, and the pharmacist reported that the redness around the injection site was about a 4-5 inch oval of redness and looked very hot and tender. Inside the 4-5 inch oval of redness was another different circular rash about 2 inches in circumference. The inner circle looked like a textured red rash, almost like a blistered burn and was very swollen. It was also informed that the patient could go to the hospital, but she declined it. On 11-APR-2017, the patient still had chills and was sweating profusely. She also reported that the inner circle rash was changing, it edges were were moving and becoming misshapen, it was not longer a circle. There was not treatment for the events  and no laboratory diagnostic studies were performed. At the reporting time, the patient had not recovered from the events. The relationship between the events and the suspect therapies was not provided. Additional information has been requested.
Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild
Information has been received from a registered nurse concerning a 9 year old male who on 15-Mar-2000 was vaccinated into his leg with the first dose of VARIVAX (Merck) (lot number 632276/145J). On 20-Mar-2008 the patient was vaccinated into his left low arm with the second dose of VARIVAX (Merck) (lot number 659937/1789U). There was no illness at the time of vaccination. On 02-Jul-2008 the patient had 10-15 lumps on body, abdomen, neck, face, back and around ankles and feet. The lumps just broke cut over weekend of holiday July 04. His mom thought it was mosquito bites, afebrile, itching at spots, lethargy. The patient sought medical attention and visited the physician. On 11-Jul-2008, the chicken pox completely cleared. No further information is available.
Pt with syncope a few minutes after event. Pt laid in recumbent position, recovered, continued observation with vitals, water, and cool compress. Symptoms resolves after 15-20 mins, discharged home. after 30 mins.
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 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 provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles 4 times. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Localized arm pain.  Systemic body aches followed by severe abdominal pain, hematochezia, palpitations.
Arm is little sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of   in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Hypertension and Gout. Concomitant products included METFORMIN, AMLODIPINE and VALSARTAN for an unknown indication.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not reported.
administered the Moderna vaccine about 36 hours after the use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered the Moderna vaccine about 36 hours after the use by date) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 26-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered the Moderna vaccine about 36 hours after the use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered the Moderna vaccine about 36 hours after the use by date) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   The reporter was a pharmacist.  Concomitant medication of the patient was not reported.  Date the vial was initially stored in the refrigerator was on 25-Jan-2022 and the vial did not undergo any temperature excursions. The reporter did not have more information about the patient.  No treatment information was provided by the reporter.