chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was accidentally administered the bivalent booster instead of the 2nd dose of the primary series.; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient was accidentally administered the bivalent booster instead of the 2nd dose of the primary series.) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Patient was accidentally administered the bivalent booster instead of the 2nd dose of the primary series.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient was accidentally administered the bivalent booster instead of the 2nd dose of the primary series.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medications were reported. On unknown date patient received 1st dose of Moderna COVID-19 vaccine. No treatment information was provided.   Reporter did not allow further contact
This spontaneous report as received from a consumer, via company representative, refers to an unspecified patients of unknown age and gender. She reported that her husband (unspecified physician) mentioned that unspecified vaccines that may have been improperly stored on unspecified dates and may have been administered to unspecified patients on unspecified dates. No adverse effects were reported. Additional information is not expected, due to lack of contact details. It has been determined that the case 1608USA005743 belongs to a batch of reports that are not being processed by the DMC. Therefore, case # 1608USA005743 is being deleted from our files on generic Hepatitis B Vaccine (Recombinant). All information from this case was was consolidated in case 1610USA004920.
Severe headache, body aches, low back pain, tingling in feet, ankle and foot pain.
Blisters all over left chest left arm left shoulder and up my neck into my hairline one blister on rt shoulder.
I wanted to report an incident that happened today at a pharmacy when my daughter was receiving the COVID vaccine.   I brought my 7 year old to the local pharmacy today at 1 pm. The nurse who administered the vaccine wasn't wearing a mask or gloves. She put on one glove when she actually injected my daughter, but wasn't wearing any when handling the vial or the syringe.   When she found out my daughter's age, she unnecessarily commented, "oh she's so young." After my daughter received the vaccine, and we were waiting, I overheard the pharmacist and nurse disagreeing about the amount of vaccine that had been given to my daughter, and the other children that day. The pharmacist felt the nurse hadn't given enough in the syringe, neither was going to tell me, but luckily I overheard them and confronted them.  The pharmacist felt the nurse had used too much saline (1.85 ml) to dilute the vaccine, and as a result the nurse should have given a larger amount. The nurse disagreed, and they told me they were waiting for a "higher up" at the pharmacy to weigh in.  The nurse said many times that I should not worry about the amount, and just to watch my daughter for side effects.  I now feel that she purposely administered a lower dose. I'm not sure if my daughter received a correct dose, and am quite frustrated that this has happened.   I want to report this so that someone can help me determine if she received a correct dose, and what our next steps should be. And also, to have someone look into the nurse and the incident, so that this doesn't happen to any other children and families.   I have reported this to the pharmacy, and am awaiting a response from the District Manager. I'm not sure if you can help, or if this is relevant to you, but someone provided your contact info and suggested I share as you are researching a similar incident at another pharmacy.   I'm happy to answer any questions you might have. Thank you!
Sudden debilitating dizziness and nausea 1 week after 2nd dose of Moderna vaccination.  Unable to stand or walk. Vomited 8 hrs until dehydrated.  Went to emergency room and received IV fluids with Zofran.  Emergency room doctor prescribed  Meclizine and Zofran. The nausea subsided the next day however a only a slight improvement in dizziness. After 5 days of significant dizziness and not able sand or walk very well, I then visited the a health care Center. After several Dr diagnosed me with Vestibular Neuritis (permanent nerve damage) in the right ear after several diagnostic tests.  Dr. thinks  a virus caused inflammation and damaged my nerve in my inner ear.  I was put on a 10 day prednisone and my condition improved by about 50%.  I am doing physical therapy to retrain my brain to compensate for the balance that my inner ear provided.  I am improving but this may take up to 3 months.  I have never had a problem like this in the past. I have read several other cases like mine on the website where people got the vaccine and all the sudden Vestibular Neuritis set in.
Pt appeared to have fainted after the nasal vaccine was administered. Pt was placed on floor with feet elevated, vitals checked, pt was feeling better juice given, pt went to be observed and was playing games upon observation pt's color was very pale, rescue called, vitals checked 92/62, P64 6:05pm. Pt bumped chin, ice applied BP 94/62 P64 at 6:20pm.
My first dose of the Covid 19 vaccine was Moderna and was in the system at the pharmacy. Both doses were scheduled at the same time.  I even offered if she needed my card before we did the vaccination and she stated that it could be filled out afterwards.  They administered the shot and then realized they gave me the Pfizer vaccine.  The pharmacist then called me over and said they never had Moderna and only carried Pfizer however it clearly showed in the system that the shot was the Moderna version.  They were pretty panicked and basically said we don't know what to do we will have to call you later.  They later called and said there is not a lot of information about this cross vaccination and that i should report any adverse reactions.  They also said they were sending in an error report.  I am assuming through this portal.  I called, trying to get some more information and they recommended i fill out this form as well.  Physically i feel fine but i have concerns about effectiveness and long term affects.
Information has been received from a physician and a female in a physicians office concerning a 34 month old female child who on 6/30/2003 (at 1 year of age) was vaccinated with her first dose of varicella virus vaccine live. Concomitant vaccinations given on the same day included the first dose of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) given subcutaneously and the third dose of hepatitis B virus vaccine rHBsAg yeast + Hib conj vaccine IMPC given intramuscularly. There was no illness at the time of vaccination. On 5/4/2005 (previously reported as 5/6/2005) the patient experienced herpes Zoster of right leg in the L-2 dermatome distribution with 4 clusters of vesicles. The patient required a doctor visit and was treated with PO acyclovir, no laboratory or diagnostic test were performed. It was reported that the patient had a response within 3-4 days with characteristic scabbing. The patient recovered as of 5/12/2005. Additional information is not expected.
It was more painful than the 1st time; This is a spontaneous report from a contactable nurse (patient herself) via a medical information team. A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), via an unspecified route of administration in arm on an unspecified date as dose 1, single for COVID-19 immunization. The patient's medical history included chronic pain. Concomitant medications were not reported. The patient previously received influenza shot (FLU) shots for immunisation and experienced reactions to flu shots, pethidine hydrochloride (DEMEROL) and experienced allergic reactions to Demerol, OCPs (oral contraceptive pills). She mentioned that she had prior reactions to flu shots where she got the flu afterwards, allergic reactions to Demerol where her through closed up, and reactions to OCPs. Patient mentioned that it was more painful than the 1st time. She mentioned that she initially did not want to get vaccinated due to her complications but was convinced by her doctor. She was calling to report this event and to see if this has been reported as a side effect because she did not see this as a side effect. She also had chronic pain, that was why she was unsure with associating the pain to the vaccine. The outcome of the event was unknown.  Information on lot/batch number has been requested
approx 2 hours after receiving vaccination, child began to scream, unconsolable x 30+ minutes.  Her left leg (site of immunization) became grossly swollen and she developed hives over most of her body.  Parents applied cold compresses, gave Tylenol and brought her directly here.  By the time they arrived symptoms were subsiding.
Patient received expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  On 31-Mar-2022, patient received the First booster dose which got expired on 24-Mar-2022.  No treatment information was provided by the reporter.
Patient states she noticed her right arm slightly red on the evening of 10/12/12.  When she woke up on 10/13/12, she states it was bright red, hot and swollen.   Pt. states it was swollen from the upper arm to the elbow.  Pt. used ice packs and took Benadryl.  She states her arm was back to normal on 10/15/12.
Expired dose administered to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 077C21B) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient). On 19-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   It was reported by Health care professional  that they administered 7 doses of an expired vial of Moderna COVID-19 Vaccine to 7 patients on 19-Jan-2022.  It was further stated by the Health care professional that no adverse events were observed in the patients. Health care professional stated no treatment was given and patients were not under any concomitant or regular medication. The date of vaccination of 1st dose and 2nd dose was unknown. The expiration date of 1st dose and 2nd dose was unknown. The vial was initially stored into refrigerator on 19-Jan-2022. The vial did not undergo any temperature excursions.
Felt blah; Shoulder got sore; This is a spontaneous report from a contactable consumer (brother-in-Law) reporting same events under the same suspect product for 6 patients and this is one of 6 reports. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reportedly, the reporter was calling to report side effects for himself and reported about family members, report for family member number 5. The reporter was calling about the Covid Shot; verified Pfizer Covid Vaccine. The reporter got the shot, he had talked to several people, he had a sister who was a CNA, a niece who was a RN and another niece that was a nurse practitioner. Reporter stated his brother-in-law and mom also thought he should get this shot. Reporter stated they said their shoulder got sore the next day (on an unspecified date) and they felt blah on an unspecified date but that was it. Outcome of events was unknown. Follow-up attempts have been completed and no further information is expected.
Admitted to the hospital with hypertensive basal ganglia bleed, had a head bleed; This is a spontaneous report from a contactable consumer. A male patient of unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in 2020 at single dose for COVID-19 immunization. Medical history included hypertension. The patient's concomitant medications were not reported. After vaccination, the patient was admitted to the hospital with hypertensive basal ganglia bleed, had a head bleed in 2020. The outcome of event was unknown.  Information on the lot/batch number has been requested.
Patient experienced dull chest pain/tightness, anxiousness, and lightheadedness which happened 1 hour after receiving the vaccine. Patient was alert and oriented but did have some delayed speech responses. Patient's vitals were monitored before being transported to ER via EMS. Vitals stable, however, patient was still dizzy and lightheaded.
Within 5 minutes of receiving vax, the pt experienced a 3mm wheal and a 2 cm area of erythema at the injection site. No respiratory distress was noted after 45 minutes in the waiting room. Ice was applied and the pt was sent home. The most recent information received reports the condition of the pt as ongoing.
Immediately after immunization, Pt reported feeling "light-headed, strange, having an out of body experience". Increased heart rate (134/m). A&O x 3. Warm, dry.  Adult Emergency called and team responded within 2 mins. Pt states symptoms improving rapidly. Transported to ED w/o delay.
This spontaneous report was received from a registered nurse and refers to unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with doses of PROQUAD (lot # M012986, expiration date 12-SEP-2017, dose and route of administration were not reported) which were improperly stored. The administered doses of vaccine experienced a temperature excursion of 35.4 Fahrenheit degrees for 19 hours and 22 minutes. There were no previous temperature excursions. The temperature excursions were detected by a data logger. No adverse effects were reported. Additional information has been requested.
On 01/09/2021 client had fever, chills, shortness of breath, difficulty breathing, fatigue, muscle aches, sore throat, congestion & runny nose.  All symptoms lasted several days. Patient still does not feel well. Still is fatigued.
Admitted to Hospital on Date of Adverse Event for treatment of Covid-19 Positive following completion of Covid Vaccine Series
Information has ben received from a certified medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients received improperly stored RECOMBIVAX HB (lot # L006231, expiration date 06-OCT-2016, lot # reported as L0136959, expiration date 12-MAR-2018, lot # L045117, expiration date 06-OCT-2018, lot # M001578, expiration date 21-NOV-2018, lot # L027733, expiration date 13-SEP-2017; dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
6-21-13 reports (L) arm sore and now developed warm, hive-like welts on arm.
both sites reddened, firm size of baseballs;t104 x 5 days;saw MD who ordered APAP, warm soaks & neosporin to site;Zithromax;11 days later still has big knot on rt thigh;
Pain in injection site; tiredness; headache; muscle pain; chills; joint pain; fever; nausea; feeling unwell; weakness; fast heartbeat; This is a spontaneous report from a non-contactable consumer reported for herself. A 42-year-old non pregnant female patient received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot Number: EN6206) via an unspecified route of administration in arm left on 10Mar2021 09:45 as dose 1, single (age at vaccination: 42 year) for COVID-19 immunisation. Medical history included thyroid, known allergies: sulfa, all from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine (LEVOTHYROXINE); duloxetine (DULOXETINE), all taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. No COVID prior vaccination and did not tested COVID post vaccination. On 10Mar2021 at 09:15 PM, the patient experienced pain in Injection site, tiredness, headache, muscle pain, chills, joint pain, fever, nausea, feeling unwell, weakness, fast heartbeat. No treatment was received. The clinical outcome of the events on an unspecified date Mar2021 was resolved.  No follow-up attempts are possible; No further information is expected.
Patient reports a persistent tingling sensation and slight pain at injection site still to this day (almost 1 year later). Patient has a visible mark on his left shoulder area that he reports is where he received the immunization. He notified his physician shortly after receiving the immunization, and his physician told him to not get the 2nd dose of Shingrix. He is awaiting an appointment with dermatologist to have the mark on his arm inspected again by a specialist.
coughing; Sore throat; congestion; pressure behind eyes; Chills; Fever; COVID-19 positive; coughing with a yellow mucus; Cramps in stomach muscle pain; Itching on arm/Itchy red spot; Red sopt on my arm; sore arm; my neck was hurting like a pulled muscle; I felt tired my arm hurt the next two days after the vaccine/tiredness; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing), OROPHARYNGEAL PAIN (Sore throat), NASAL CONGESTION (congestion), OCULAR DISCOMFORT (pressure behind eyes) and CHILLS (Chills) in a 43-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.     Concomitant products included MULTIVITAMINS [VITAMINS NOS] and VITAMIN D NOS for an unknown indication.    On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, the patient experienced PAIN IN EXTREMITY (sore arm), NECK PAIN (my neck was hurting like a pulled muscle) and FATIGUE (I felt tired my arm hurt the next two days after the vaccine/tiredness ). On 19-Aug-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red sopt on my arm) and PRURITUS (Itching on arm/Itchy red spot). On 22-Aug-2021, the patient experienced COUGH (coughing), OROPHARYNGEAL PAIN (Sore throat), NASAL CONGESTION (congestion), OCULAR DISCOMFORT (pressure behind eyes), CHILLS (Chills), PYREXIA (Fever), COVID-19 (COVID-19 positive), SPUTUM DISCOLOURED (coughing with a yellow mucus) and MUSCLE SPASMS (Cramps in stomach muscle pain). The patient was treated with ALOE VERA, BERBERINE HYDROCHLORIDE, BISMUTH CITRATE, DEGLYCYRRHIZINISED LIQUORICE (PEPTI GUARD) at an unspecified dose and frequency. At the time of the report, COUGH (coughing), OROPHARYNGEAL PAIN (Sore throat), NASAL CONGESTION (congestion), OCULAR DISCOMFORT (pressure behind eyes), CHILLS (Chills) and PYREXIA (Fever) had not resolved and COVID-19 (COVID-19 positive), VACCINATION SITE ERYTHEMA (Red sopt on my arm), PAIN IN EXTREMITY (sore arm), NECK PAIN (my neck was hurting like a pulled muscle), PRURITUS (Itching on arm/Itchy red spot), SPUTUM DISCOLOURED (coughing with a yellow mucus), MUSCLE SPASMS (Cramps in stomach muscle pain) and FATIGUE (I felt tired my arm hurt the next two days after the vaccine/tiredness ) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: higher (High) 100.1 degree Fahrenheit.. On an unknown date, COVID-19: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       she was diagnosed with COVID-19 after 14 days of first dose vaccination.
Left deltoid area red, warm to touch and slightly indurated x24 hours. Advised to apply ice intermittently to site x24 hours, given Tylenol and Motrin for age/wt and see PCP as ordered
Rash distal to injection site on right lateral deltoid, spread about 5cm diameter, was warm to touch and itchy. Rash remained for two days, decreasing in intensity of itching and heat. Oral BENADRYL was taken over-the-counter, topical anti-itch cream was applied. Symptoms disappeared four days after onset of rash.
Around 2:00pm the day after my shot my top lip stated to swell. Throughout the day it got bigger. Two days later and it?s still swollen and a little bit bigger. I haven?t gone to the doctor but if it doesn?t get better then I will.
This spontaneous report as received from a pharmacy technician refers to a 1-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported. On 16-FEB-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry date: 23-AUG-2019) (dose, frequency and route were not reported) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1802USA001558.
This spontaneous report was received from a licensed practical nurse and refers to a 8-week-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 30-SEP-2016, the patient was vaccinated with improperly stored doses of ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. No symptoms were reported. Administered dose of vaccine experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1608USA012908: US-009507513-1608USA012916: