chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administration error. There was an error discovered that the Pediatric Covid vaccine was mistakenly not diluted prior to administration of vaccine to child resulting in higher than authorized dose (0.2 mL of undiluted vaccine administered).  Upon discover of error, management consulted local Health Department pharmacist, Medical Director, Administration, and Pfizer. Parent was notified on 03/22/22 of error and given guidance based on CDC and manufacturer's recommendation to not repeat dose and inform recipient of the potential for local and systemic adverse events.  Mother states child has not has any adverse effects after her vaccine. States she had a mild to moderate arm pain, but she was able to go to school today.  Questions answered.  Informed to seek medical care and inform us immediately if child experiences adverse effects. Health Department to follow-up with family over the next days and week.
got firm sickness; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got firm sickness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included Wasp sting on 21-Aug-2021 and Sickness (stung by a wasp then week after that the wasp site also got firm sickness.).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (got firm sickness). At the time of the report, ILLNESS (got firm sickness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       the concomitant medications and treatment information's ware not provided.
Asthma/almost every night she has attacks; This is a spontaneous report from a contactable consumer (patient's father). A 13-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: Unknown), dose 2 via an unspecified route of administration on 18Jun2021 (last Friday) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included history of genetic asthma which she got from caller and has not had any recent attacks. No concomitant medications were reported. Caller stated since the second dose, almost every night she has attacks and the medicines Advair she is using daily and Albuterol does not seem to help, the attacks are more constant. Caller stated he does not hear hissing when he listens to her back/chest. Caller wanted to know if this is a reported side effect. Therapeutic measures were taken as a result of Asthma. Outcome of the event was not recovered.  Information about lot/batch number has been requested. Additional information has been requested.  Follow-up (20Aug2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Information has been received from a pharmacist referring to a 64 years old male patient. The patient had no pertinent medical history and no known drug allergies. The patient had no concomitant medication. On 06-AUG-2016, the patient was vaccinated with a dose of ZOSTAVAX (0.65 ml once, lot # unknown) subcutaneously. On 07-AUG-2016, the patient developed an itching, painful, raised rash, and redness and warmth around the injection site in an area of "3 inches by 2 inches." Pharmacist described the rash as "hives, severe dermatitis, raised area like it was going to start weeping or form blisters." The redness had spread from the patient's shoulder to her elbow, a defined region of light red all the way around the tricep area. No treatment was given for the adverse events. The patient had no recovered from the events. The causal relationship between the events and ZOSTAVAX was unknown. Additional information has been requested.
EE flushed, diaphoretic, rapid response team called, sent to emergency department for evaluation.
fever, chills, body aches, nausea, cough, COVID-19 tested on 1/02/2021 and came back Positive
Abnormal taste 5 days after 2nd dose of covid vaccine.  Not loss of taste.  Certain foods no longer taste good.
Blood sugar 436, admitted into hospital 8/12/13, Diabetes, after release started noticing eye tics, depression, forgetfulness, hard time focusing and has since been diagnosed Type 2 diabetes, Juvenile Myoclonic Epilepsy, ADHD, Premenstrual Dysphoric Disorder, Sleep Apnea, and depression.
Patient complains of having a sore arm and some minor loss of function since about a week after injection. This was reported to the facility in late Feb, 3 months post injection. She has yet to have physician look at her arm, she believes that the injection was made into the bursa of the shoulder.
Patient initially was seen in ED and treated with ibuprofen, sling and ice pack which patient reported resolved the adverse reaction. Myalgia and Right shoulder muscle pain, inability to lift arm.
Supraventricular tachycardia (SVT) episode 50 hrs after vaccination.  Resolved on its own with vagel maneuvers .  I had SVT three times during pregnancy for the first time.  7.5 months postpartum now.   Also I am lactating and I had three days of reduced breast milk production.
Nausea & vomiting x 1 week; fever; blurred vision; dizziness; pain in head radiating to neck, shoulders, arms & legs; legs aching & cold;
Headache, feverish, chills, sick feeling with fatigue.  Slept much of day.  Didn't feel like doing anything.  Loss of appetite. Feeling of unease in my stomach.  Was nauseous right before bedtime.  Next day (on the 27th) I felt much better in the morning.  Didn't have the sick feeling.  Didn't seem to have the headache.  Had some appetite again.  So, I had a really bad day the day after the vaccination.
sore throat, low grade temp, tightness in chest 2 days p/recvd vax; 3rd day lt eye swelled shut;
vaccine administered to 16 year old; A spontaneous report was received from a physician assistant concerning a 16 year-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccine administered to 16-year old.   The patient's medical history was not reported. No relevant concomitant medications were reported.  On an unknown date, 0 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.    On an unknown date, the 16 year old patient was administered the vaccine.  No treatment information was provided.     Action taken with mRNA-1273 in response to the events was not reported.    The event, vaccine administered to 16-year old, was considered resolved on an unknown date.; Reporter's Comments: This is a case of 16-year-old female patient who was administered mRNA-1273 (Inappropriate age at vaccine administration) (Lot #: unknown). There was no associated adverse event reported for the event of Inappropriate age at vaccine administration.
This dose makes the 5th dose the patient has received; This dose makes the 5th dose the patient has received, 2 year old; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old male patient who received DTPa (Infanrix) (batch number 7KM94, expiry date 10th June 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Infanrix (completed booster dose of series on an unspecified date).   On 31st March 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 31st March 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and drug dose administration interval too short. On an unknown date, the outcome of the inappropriate age at vaccine administration and drug dose administration interval too short 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: 5-APR-2022 Reporter's Comment: Office manager reported that the patient came in to clinic for wellness visit and the medical assistant thought the patient was missing DTaP (Infanrix) booster dose, so it was administered.  Afterward it was discovered that the patient had already received the booster dose. This dose made the 5th dose the patient had received. The HCP (Health Care Professional) gave permission for follow-up. Additional supportive information:  The 2 years old patient received another booster dose i.e. 5th dose of Infanrix but too early, which led to inappropriate age at vaccine administration and drug dose administration interval too short.
Anxiety; Aching muscles; low energy; Fatigue; Nausea; This is a spontaneous report from a contactable other healthcare professional (medical assistant). A 64-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number: AA7118, expiry: 31May2021, NDC: 00005197101), intramuscular in the left deltoid at the clinic on 16Sep2019 15:39 at 0.5 ml, single for immunization. Medical history included autoimmune disorder. There were no concomitant medications. On 20Sep2019, the patient experienced anxiety, aching muscles, low energy, fatigue and nausea. Outcome of the events was unknown. Events anxiety and aching muscles were reported as serious due to medically significant; for the other events were reported as non-serious. The patient was advised to go to the emergency room if any of her symptoms worsened.; Sender's Comments: A possible causal association between administration of PREVNAR 13 and the onset of aching muscles cannot be excluded, considering the apparent temporal association and the known adverse event profile of the suspect vaccine;  anxiety more likely represents an emotional tension arising from immunization.  The impact of this report on the benefit/risk profile of the Pfizer product 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.
This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 63-year-old female patient who received FLUARIX QUADRIVALENT (batch number 4GX4F, expiry date 30th June 2017). On 17th November 2016, the patient received FLUARIX QUADRIVALENT 0.5 ml. On 23rd November 2016, 6 days after receiving FLUARIX QUADRIVALENT, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unchanged. It was unknown if the reporter considered the injection site pain to be related to FLUARIX QUADRIVALENT. Additional details were received as follows: On the day of reporting the patient came to reporter and was still having pain in the right arm after receiving FLUARIX QUADRIVALENT in the right deltoid. No other information was provided nor any other adverse event was reported.
It started as my left shoulder and arm having an aching pain radiate down and some stiffness and then it become constant. Once it became a 24/7 occurrence I started getting weekly migraines which i have never had before, my lymph nodes on my left side filled with fluid and there was numbness/tingling from my forearm into my hand and in my leg from the calf down  into my foot. I also get pressure and pain in the left side of my face mostly behind my eye and my jaw. It has now moved into my right side as well, all the same symptoms just different side, but it will also move back to the left I never know where it will be when I wake up . I have never had symptoms like this at all before the vaccine.
Pt recvd 1st dose of vax 14JUL92 & approx 2 days later on 16JUL92 pt exp a brief episode of numbness on the tip of tongue, almost passed out;
vaccine given without diluent; vaccine given without diluent; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.       Additional Information: GSK receipt date: 8-Aug-2022 Reporter comment: The reporter stated that needing to ask about a vaccine administration error and a vaccine was given without the diluent.  The reporter want to know if patient could come back in right away for revaccination. Additional Supportive Information: The vaccine was given without the diluent which leads inappropriate preparation of medication and inappropriate dose of vaccine administered
On June 10 got HPV shot on Tues woke up with left arm in pain from elbow all the way down to middle finger it was numb and to hold it close to her body, use pain, ice, heat till 13th she went to the doctor. Hand and arm was swollen. Hand shaking and hurt to move fingers.
After the flu shot I became short of breath, throat was tight, and I was developing hives on my chest and neck.  I took Benadryl 1 hour after the shot.  Over the course of the next few days I was seen several times in the er for anaphylactic reaction to the flu vaccine.  I was also seen in the dr office for the same symptoms.  My lips and eyes were swollen and throat was tight.  My oxygen levels were in the low 80'sat times.  On December 6th I was admitted to the hospital for difficulty breathing my oxygen level when I went in was 76.
Patient went on 4/14/2021 and got 1st dose of Moderna at pharmacy, came to our pharmacy on 5/14/2021 and was accidentally given Pfizer vaccine
all of a sudden a pain shot through knee; he can't put any weight on it; This is a spontaneous report from a contactable consumer. A 64-year-old male patient (reporter's boyfriend) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 24Mar2021 at single dose for COVID-19 immunization. Medical history included his weight is too much, maybe 210 pounds or something around there. The patient's concomitant medications were not reported. The patient experienced all of a sudden a pain shot through knee in Mar2021, he can't put any weight on it in Mar2021. Clinical course as reported: Reporter is a consumer reporting her boyfriend received the first dose on 24Mar2021 and is reporting pain in his knee. Reporter said the boyfriend's knee pain 'comes and goes really quickly'. Her boyfriend went golfing and he was getting ready to swing and getting set and all of a sudden, a pain shot through his knee and he couldn't put any weight on it. Patient said this knee pain was happening every one in a while but not often. Patient is running around like crazy person, he never sits still. Reporter stated she would have to check with her boyfriend to say when the pain began, she thought boyfriend stated it was the same day he received the first dose of Pfizer Covid 19 Vaccine on 24Mar2021. Also said it was the same day boyfriend received first dose of Pfizer Covid 19 Vaccine or the next day, within a couple days. Happened again the other day and it seemed to be sporadic and not as intense. Reporter reported her boyfriend received his vaccine at the same place as the reporter. He got his vaccine at the same place as reporter at a different time of the day around noon. Reporter said boyfriend was supposed to go back for the second dose of Pfizer Covid Vaccine the same day the reporter was scheduled to do so. The outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Rash on ring and small finger of left hand. Small blisters that turned into rough skin after a few weeks (current condition). Itching in the area.
Administered a 1st dose of the Moderna Covid-19 Vaccine from an expired vial (8-Feb-2022); This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered a 1st dose of the Moderna Covid-19 Vaccine from an expired vial (8-Feb-2022)) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939909) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered a 1st dose of the Moderna Covid-19 Vaccine from an expired vial (8-Feb-2022)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered a 1st dose of the Moderna Covid-19 Vaccine from an expired vial (8-Feb-2022)) 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.  The reporter stated that their clinic administered a 1st dose of the Moderna Covid-19 Vaccine from an expired vial (08-Feb-2022) to a patient on 10-Feb-2022. The date the vial was initially stored in the refrigerator was 10-Feb-2022. It was also reported that the vial didn't undergo any temperature excursions.  No treatment information was provided.
Chest pain, shortness of breath, tightness in chest, breathlessness, pounding heart, heart beat skipping, PVC's, irregular heart beat, fatigue, swelling of right leg, cough, hoarse voice. Symptoms started within 2 days of receiving second dose of Moderna vaccine.  Went to multiple doctor's who claimed that the vaccine does not cause these side effects so received inappropriate or no treatment.   Symptoms still persist months later, went to a different doctor who ordered a Holter monitor, Holter monitor test results came back abnormal so was referred to cardiology in May.  Ended up in the ER, ECG flagged abnormal, heart monitor alarm kept going off.  ER doctor stressed the importance of seeing a cardiologist as soon as possible. Cardiologist prescribed multiple medications to reduce inflammation in hopes that symptoms would resolve themselves over time including abnormal heart beat.  Still in treatment, chest pain still present but not as severe.
Weakness in lower leg and arms; spinal issues,-grapefruit size tumor that moved up to base of brain
Jynneos Vaccine was administered  0.1 ml Intradermal instead of 0.5 ml subcutaneous since she is a minor below 18 years old. Administered on the left arm, created a wheal, patient did not present any respiratory complaints or weakness, Mother was present, provided information and health education regarding the vaccination given. Mother is a nurse  and verbalized understanding. Patient left with mother alert, ambulatory, in good spirit.
26 year old female receiving her first Moderna Covid vaccination. Immediately after receiving the shot, she felt her hands go numb, said she didn't "feel right", and stopped talking. Her husband and I lowered her to the floor and put her feet on a chair. 9-1-1 was called.  Immediately, the patient started talking again, saying she had "cotton" in her ears and felt "woozy".  Vital signs assessed: BP 100/72, P 62, respirations 16 non-labored. Upon discussion, patient admitted to having a phobia of needles where she sometimes faints when giving blood.  Patient had previously denied reactions following vaccination, NKDA.  Paramedics arrived 15 minutes later, assessed the patient, took vitals/EKG, cleared with a refusal to transport, instructed to consume water and gatorade. Patient reported feeling much better, was escorted out with her husband.
Temperature 101.8 for two days, then dropped to 99.7 for three days after taking some advil. Diarreah on days (about) 5 and 6. Headache, insomnia for several weeks, pressure on eyes with a slight decrease in visual acuity. Heavy feeling on the middle of my chest for several days as well as production of copious amounts of phlegm for about two weeks. After the first week I felt about 50% of normal. After the second week I was up to 70 to 75% of normal for about two weeks, inclusive. After three weeks I started to sleep better and was able to begin exercising again, lightly. After four weeks I was feeling about 90% normal and currently am about 97% of normal and still getting stronger.
"15mins post vaccination, pt c/o mild dizziness. Vitals: @15:40 BP 135/89, HR 78, RR 16, SPO2 99% -- > @15:55 141/93, 67, 18, 100%.  Pt stable and released from the vaccination site."
Janssen COVID-19 Vaccine EUA Headache within 45 minutes-treated with OTC medications; headaches have continued unresolved, intermittent as recently as today. Accelerated heartrate within 45 minutes-no treatment; symptoms have continued intermittently as recently as today.  Weakness and nausea within 1 hour, vomited x1-no treatment; nausea continued for 2 days. Extreme fatigue within 1 hour-confined to bed; symptoms lasted 3 days. Tightness in chest and throat and fine rash to arms and generalized itching within 1.5 hours-2 Benadryl at onset followed by Benadryl twice a day for next 3 days; continued for 3 days. Numbness in both arms within 1.5 hours-no treatment; continued intermittently for 3 days. Muscle and joint soreness/pain within 2 hours-no treatment; continued for 3 days.
2nd covid vaccine received 03/11/2021.   Tested positive for covid19 on a routine HCW screen after being fully vaccinated.  Asymptomatic.
Left leg DVT. Pain posterior calf/popliteal and pretibial edema onset Feb 2, 2022.
This is a spontaneous report received from contactable reporter(s) (Physician). Other Case identifier(s): 2022NVX-000002718 (NOVAVAX). A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 21Jul2022 as dose 1, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EYE SWELLING (non-serious), CONJUNCTIVITIS (non-serious) all with onset 2022, outcome "unknown" and all described as "eyes swelled shut and got all "pinky""; LIP EXFOLIATION (non-serious) with onset 2022, outcome "unknown", described as "lips were crusted and peeling". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
More than 36 days passed since the first dose without getting the second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 36 days passed since the first dose without getting the second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 36 days passed since the first dose without getting the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 36 days passed since the first dose without getting the second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
By 9/24 pt experiencing spreading red rash that was itching around the injection site. Pt given Benadry l1.5-25mg every 6 hrs, Loratidine 10 mg daily by mouth and Hydrocortisone 1% cream topical 3 time a day application at 9/24/12 10am.