chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from medical assistant via company representative refers to approximately 60 year old patient of unknown gender. On an unknown date of September 2013 (5 months ago), the patient was vaccinated with ZOSTAVAX (strength, dose unit, lot# and expiry date unknown) subcutaneously. On an unknown date of February 2014 (within this past week), patient received second injection of ZOSTAVAX. No adverse event reported. The outcome of patient received a ZOSTAVAX injection 5 months ago and then received a second injection within this past week and no ae reported was unknown. No further information was provided. Additional information has been requested.
Pt received incorrect vaccine. Pt was supposed to received HIB, but received PENTACEL. Pt received two doses of DTaP and one unnecessary IPV.
Patient received Moderna vaccine at Pharmacy on 5-4-21 after filling out paperwork that he had not recieved a previous covid-19 vaccine.  Later discovered that he originally recieved the Pfizer covid-19 vaccine at hospital on 1-23-21.  Infectious disease doctors told him to restart his vaccine series with Moderna, will consult with them to see what steps to take.
Pt. states that after receiving the 1st dose Phizer 07/30/2021 (Noted 07/30/2021 MMR 1st dose received), started experiencing symptoms 08/01/2021 of pain throughout the right leg and shortness of breath. 08/02/2021 Primary visit and was determined to have a blood clot located in the PVT calf. Prescribed a blood thinner. (Previous history of DVT 13yrs). Recommendation to continue prescription with follow up to ER if continue or shortness of breath.
pt recv vax JUN95 & 2JUL96 pt devel chickenpox w/less than 50 lesions on the back, arms & face;pt was treated w/med;pt sibling also recv vax & devel chickenpox;
inadvertently administered an expired Boostrix(exp:7/15/23) dose to a patient today on 7/28/23; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 69-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number HF2YA, expiry date 15-JUL-2023) for prophylaxis.   On 28-JUL-2023, the patient received Boostrix (intramuscular, left arm). On 28-JUL-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: inadvertently administered an expired Boostrix(exp:7/15/23) dose to a patient today on 7/28/23). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 28-Jul-2023 The pharmacist called to inquired that the dose was valid or the patient would need to be revaccinated. The reporter did not consent to follow-up. The patient was inadvertently administered an expire dose of Boostrix on the day of reporting, which led to expired vaccine used.
Osteopenia; Arthritis; Parathyroid gland excision; Vaccination site pain; Fatigue; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program.  A 52 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 17Dec2021 (Batch/Lot number: unknown) at the age of 52 years as dose 3 (booster), single for covid-19 immunisation; upadacitinib (RINVOQ), oral (ongoing) (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (COVID-19 Vaccine, Dose 1, Manufacturer Unknown), administration date: Feb2021, for Covid-19 immunization; Covid-19 vaccine (COVID-19 Vaccine, Dose 2, Manufacturer Unknown), administration date: Mar2021, for Covid-19 immunization. The following information was reported: PARATHYROIDECTOMY (medically significant) with onset 16Feb2022, outcome "recovering", described as "Parathyroid gland excision"; OSTEOPENIA (medically significant), outcome "not recovered", described as "Osteopenia"; ARTHRITIS (medically significant), outcome "not recovered", described as "Arthritis"; VACCINATION SITE PAIN (medically significant) with onset Dec2021, outcome "unknown", described as "Vaccination site pain"; FATIGUE (medically significant) with onset Dec2021, outcome "unknown", described as "Fatigue". The action taken for upadacitinib was unknown. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality for PFIZER BIONTECH COVID-19: The reporter's causality for the event(s) of parathyroid glands excision, osteopenia, arthritis were not reported; for vaccination site pain and fatigue with PFIZER BIONTECH COVID-19 was possible. Causality for RINVOQ (UPADACITINIB): The reporter's causality for the event(s) of two parathyroid glands removed, osteopenia arthritis unknown onset and third covid vaccine caused sore arm and fatigue onset in Dec2021 with RINVOQ(UPADACITINIB) was no reasonable possibility.  Opinion is that there is no reasonable possibility that the events of two parathyroid glands removed, osteopenia arthritis unknown onset, third covid vaccine caused sore arm and fatigue onset in Dec2021 are related to RINVOQ(UPADACITINIB).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report, a possible causal relationship between the reported events: Parathyroidectomy, Osteopenia, Arthritis, Vaccination site pain, Fatigue and the suspect drug BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Patient stated that he broke out in a rash that mimicked bug bites all under the vaccination arm and then it spread across his chest to his other arm.  His armpit on the right arm (vaccination site) was red and swollen also.  It itched but did not hurt.  It cleared up after about 2 weeks.
Patient was given pediatric vaccine instead of adult vaccine.  Had no side effects.  Informed patient and she then received adult dose per recommendations on 10/22/23.
Pt. was seen 3 days ago with GM and received TDap. HPV in right arm and Flu and MENACTRA in left arm. She has some redness in the areas but no swelling. Nontender. She developed a blister on each arm, that is nontender. She is OTW well. No fever, cough or R/N. She has had the Flu vaccine in the past with no reaction. She has never had a reaction like this in past to Dtap. Patient presents with a diagnosis of local reaction to vaccines.
experiencing tinnitus since receiving my vaccine in Dec/Jan; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (experiencing tinnitus since receiving my vaccine in Dec/Jan) 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 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 TINNITUS (experiencing tinnitus since receiving my vaccine in Dec/Jan). At the time of the report, TINNITUS (experiencing tinnitus since receiving my vaccine in Dec/Jan) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. On 06-FEB-2015 the patient was vaccinated with a dose of ROTATEQ oral (dose and lot # not reported) that had undergone temperature excursions. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Swelling, redness, pain. Patient given antibiotic, allergy medication and labs were taken at time of visit.
Kawasaki disease complete vascular system swollen his body attacks itself he was in the hospital for 2 weeks he received two treatments of IVIG treatment he was on high-dose aspirin to control the swelling in his heart he couldn't walk he couldn't talk he couldn't eat his urine look like orange juice he had started off with a rash and it started for me very quickly throughout his whole body even his testicles were peeling off skin and feet peeling off layers of skin his tongue was extremely swollen lips swollen can it started the beginning of February of 2015 and we got him in the hospital but it was a very long process he suffers extreme anxiety because obviously he was young when he started it it was a very traumatizing event for him and for I especially when not much is known about Kawasaki disease his vaccines were received in December and he started getting sick like I said about the beginning of February the high fevers cause them to have rheumatoid arthritis he has bad sleeping patterns it's just been very bad he still goes for echograms of his heart he can't do a lot of activities because his legs begin to hurt and his heart begins to pound because he was going to have an aneurysm in his heart these magazines are filled with poisons that are killing our children.
Pt called stating that she had a mild rash to her right arm, antecubital area. States she 1st noticed the rash in the morning of 8/15/00 but has had similar rash to bilateral legs, prior to receiving Hep-B. Has used Benadryl lotion for itching and has not seen a doctor. Is taking Tegretol 200mg 2 X a day and is unsure if rash is secondary to Tegretol or Hep-B vaccine. Had received 2 prior Hep-B vaccines with no reaction.
No additional AE reported; The vaccine was administered after it expired; This spontaneous report was received from registered nurse (RN), concerning a patient of unknown age and gender. No information was provided regarding the patients' pertinent medical history, concomitant medications and previous drug reactions or allergies.  On 28-JUN-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant Human albumin (rHA) (M-M-R II) 0.5 milliliter (ml) (lot number R031628 has been verified to be valid, expiration date reported and validated as 01-NOV-2020)) (vaccination scheme frequency, route and anatomical location of administration were not reported) as prophylaxis. Concomitant therapies included the sterile diluent at a dose of 0.5 milliliter (ml) (lot number S008564 has been verified to be valid, expiration reported and validated as 05-AUG-2021). No additional adverse event (AE) reported.
ILLNESS; This spontaneous report received from a parent concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced illness. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from illness. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as Non serious
Hospitalized 01/08/2022-still currently admitted; COVID-19 positive 01/08/2022; fully vaccinated plus booster  Pneumonia due to COVID-19 virus Assessment & Plan Will perform procalcitonin. If procalcitonin elevated, will give prophylactic antibiotic. Will give Decadron, vitamin- C, zinc, and Pepcid. Remdesivir considered however patient symptoms have been present for 13 days.  Lovenox prophylaxis.  Follow-up chest x-ray Monday morning.    1/9...  Continue bronchodilator, zinc, ascorbic acid and steroid Remdesivir was not started because patient has had symptoms for up to 2 weeks However this morning patient's oxygen has been weaned off to room In view of the fact that patient is not requiring oxygen today with continued to hold off on remdesivir   1/14 continue bronchodilators zinc aspirin dexamethasone.  Patient was not started on remdesivir as she had symptoms for 2 weeks.  Patient requiring 15 L of oxygen does feel that she is breathing some better today.  CTA yesterday showing bilateral diffuse COVID pneumonia no PE patient did have upper and lower extremity Dopplers no DVTs   1/15 patient continues with bronchodilators zinc dexamethasone.  Patient was not started on remdesivir as she had symptoms for 2 weeks.  Patient is requiring increased O2 Ms. On nasal cannula at 15 L and non-rebreather.  Repeat chest x-ray unchanged from the 13th where she had had a CT scan showing diffuse bilateral pulmonary infiltrates consistent with COVID pneumonitis.  Patient has a poor prognosis.  Patient's case was discussed with her daughter was unable to come in as she has COVID also.  Did address code status did not want CPR but still would like intubation.  Will check EKG troponin D-dimer CRP continue Lovenox at therapeutic doses.   1/16 patient continues with bronchodilators and dexamethasone.  Patient is on high-flow oxygen.  Repeat chest x-ray unchanged from the 13th where she had a CT scan showing diffuse bilateral pulmonary infiltrates consistent with COVID pneumonitis.  Patient does have poor prognosis.  Patient's case discussed yesterday with her daughter was unable to come in as she does have COVID.  Did address code status does not want CPR but still would like intubation.   1/18...  Chest x-ray on 01/16/2022 does not show any worsening of the pulmonary opacity Patient remains on high-flow oxygen 40 L Continue bronchodilators and steroids Procalcitonin is 0.8 lactic acid 1.0 and patient has remained afebrile with no leukocytosis Hence I do not think there is any superimposed bacterial infection
guillain barre syndrome/paralyzed from neck up; paralyzed from waist down and neck up; Getting the vaccine almost killed me; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome 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 guillain barre syndrome (serious criteria GSK medically significant), paraplegia (serious criteria GSK medically significant) and near death experience (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome, paraplegia and near death experience were unknown.   It was unknown if the reporter considered the guillain barre syndrome, paraplegia and near death experience to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient self-reported this case. The patient received the Shingles vaccine and ended up with Guillain-Barre syndrome. The patient was paralyzed from the waist down and the neck up. Getting the vaccine almost killed the patient. The follow-up would not possible as no contact details were available.
Worked all night, vaccinated at 8:15, went to bed at 8:30. Woke at 11 am, ,body sore, chilling, weakness, (unable to pick up 20 lb child). excruciation headache, Temp 101, symptoms still present at 24 hours past immunization.
administered with expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049C21A, 045B21A and 033B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 10-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine). On 10-Jan-2022, EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported. treatment medications were not reported.  Pharmacist reported that they inadvertently administered an expired Moderna Covid-19 vaccine to 14 patients.
Right after the vaccination my arm was sore and I had fatigue. On April 12, 2022 my throat lymph nodes were swollen and I could not swallow. My right elbow was also swollen and I could not bend my arm.
Pt's caregiver described the reaction as a "huge, red welp and bad bruising"
Patient received Immunizations, went to the parking lot - and returned with facial swelling, vomiting, coughing, wheezing, SOB. BENADRYL 25 mg po, SOLUMEDROL 40mg IM, 0.2 cc EPI, Albuterol Neb. After-Neg. Lungs clear, face more red, playing with toys, continued observation x 30 minutes. Had peanut butter the night before.
Injection was painful and initially caused swelling and redness when received.  The following morning, the swelling was much worse, increased redness along with severe itching.  Two days after the injection, the swelling continued to get worse and the itching is severe even though I have been icing the area and taking Benedryl.  The size is the size of a baseball.  I will see Dr. tomorrow (Monday) and ask what additional treatment I need.   I did not have this reaction to the first injection - it was painful but no lasting redness, swelling or itching.
I waited the required 15 minutes for monitoring. (I was a passenger driven to the site by someone else.) Just a few minutes after exiting, my face, back of my head, and top of my head went numb. No other side effects noticed (breathing was fine and no swelling or pain). It was a sensation more severe than when a body part "falls asleep" but less severe than what a novocaine shot feels like.  It did not seem like something severe enough to turn around a return to the hospital. My face did not droop like with Bell's Palsy and was not tingly. It was just a numbness across my cheeks, under and above my eyes, across my jaw line into my ears, at the upper back of my head, and the top of my head. Effect lasted about three hours. Morning after still feel very slight effect, like a tightness feeling.
there is lump under my armpit; my arm feels really it's hurting hard, sort of not bad but it does hurts and I got a lump under it; body ache; headache; feeling kind of yelpy; I'm feeling yucky; This is a spontaneous report from a contactable consumer. This 40-year-old male consumer (patient) reported for himself that: A 40-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection, Lot Number: FF2537 or FF2587, Expiry date: unknown), dose 2 via an unspecified route of administration on 20Sep2021 (at the age of 40-years-old) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient had previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection, Lot Number: FC3180), via an unspecified route of administration, on 30Aug2021 (at the age of 40-years-old) as DOSE 1, SINGLE for covid-19 immunization. On an unspecified date in Sep2021 the patient experienced there was lump under my armpit, my arm feels really it's hurting hard, sort of not bad but it does hurts and I got a lump under it, body ache, headache, feeling kind of yelpy and feeling yucky. The patient reported that, he just got vaccine on Monday and in the last couple of days. Patient have been feeling kind of yelpy and then somehow today he got up this morning and his arm feels really It's hurting really hard really sort of not bad but it does hurts and he got a lump under it. So, patient don't know and he called the local pharmacy where got it done and they told him to call Pfizer and report it. Just to like he guess to you guys check on it or see if the side effects or you guys log in you side effects login or whatever. The patient stated that, lot number FF2587 or 37 I don't know. I can hardly read the number here. The patient did not received treatment. The outcome of the events was unknown at the time of reporting.  Follow-up attempts are completed. No further information is expected.
Site: Pain at Injection Site-Mild, Systemic: Tingling (specify: facial area, extemities)-Medium, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Information has been received from a medical assistant (MA) concerning a 4 year old male patient who on 24-MAY-2010 was vaccinated with a dose of PROQUAD (Merck upgrade process) (lot# 01862 was invalid) in a thigh. Concomitant therapy included DTAP (reported as "D-tap"). Subsequently the patient was brought back 2 days later (26-MAY-2010) experiencing rash and redness on the thigh that spread to the groin. The patient experienced no fever. The patient sought unspecified medical attention. At the time of the report, the patient's status was unknown. Follow-up information has been received from the MA. She reported that the patient was a 4 year old male with no illness or pre-existing conditions. On 24-MAY-2010 at 1:45 pm the patient was vaccinated SC into the right thigh with his first dose of PROQUAD (Merck upgrade process), and on the same time was also vaccinated IM into the left thigh with a second dose of DTAP (Sanofi Pasteur, lot# C3141AA). On 26-MAY-2010 at 12:00 pm the patient experienced redness and induration to right leg. On 27-MAY-2010 the patient was recovered. Additional information is not expected.
Received: 11/5/19, had flu shots before, no allergies to eggs Symptoms (occurred after 30mins): redness, itchinessareas: stomach, side of stomach & 1 spot in the calf Remedies: she used poison oak Ivy remedy yesterday and it helped with itchiness isolated incident? Possible, pt stated she did pet a dog yesterday (but to her knowledge, no allergies is known to dogs before)My Recommendations: take benadryl & use HC 1%will follow up with her in 2 days to see if she gets better, will notate in system & reference in our adverse reaction database
In afternoon two hours after appt where vaccines were given. Child woke up from nap with fever 101.3 crying about 3pm. She received return phone at 5 pm. Talked with nurse   about 2x crying persisted----stop began moving --arm, leg tremors. neck move to the---. Moaning. No appetite. Tremors lasted 2 days off and on for 2 days. He slept but awoke called back at 9 pm. Nurse told her to go to ER if wanted to or observe him. Sx lasted 2 days with fever 102.
Patient received the original Pfizer vaccine for patients 12 and older for a booster dose rather than the bivalent as intended.  No adverse effects noted.  The original monovalent version of the vaccine was given rather than the new bivalent.
fatigue, took ibuprofen, drank extra water, then woke up shivering sweaty vomitting, lasted 2 days, then cough , then fatigue that has lasted 5 days,