chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 17 month old female with a history of eczema and coeliac disease who on 08-JAN-2009 was vaccinated with the first dose of VARIVAX (Merck) (subcutaneous, 0.5 ml, lot # 660669/1381X) in her right leg.  On the same day the patient also received VAQTA (MSD) (lot # 658172/0800U) and MMR II (MSD) (lot # 661724/1365X).  Five months after receiving the vaccine the patient presented with a varicella like rash on her right leg that spread up her thigh (the rash was not itchy).  The physician did a scratch test and it came back positive for varicella and negative for herpes.  The physician prescribed acyclovir and followed-up with the patient about a week ago and the patient was doing better.  The laboratory tests included PCR and DSA tests and it indicated positive for VZV. Additional information has been requested.
I had a skin rash on my body. Light red and the rash spread all over my body. It lasted for about a month, I was prescribe some  cream.
Immediate reaction of flushing; Itchiness on right shoulders; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Immediate reaction of flushing) and PRURITUS (Itchiness on right shoulders) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced FLUSHING (Immediate reaction of flushing) and PRURITUS (Itchiness on right shoulders). The patient was treated with CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) at an unspecified dose and frequency and HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, FLUSHING (Immediate reaction of flushing) and PRURITUS (Itchiness on right shoulders) outcome was unknown. Not Provided          Concomitant product use was not provided by the reporter. Action taken with mRNA-1273 in response to the events were not applicable.   This case was linked to MOD-2021-016712 (E2B Linked Report).; Sender's Comments:  MOD-2021-016712:First dose case
This spontaneous report as received from a nurse refers to a patient of unknown age. On 03-NOV-2014 the patient was vaccinated with a dose of 0.5 ml PNEUMOVAX 23, (lot # unspecified, expiration date 26-SEP-2014), intramuscular. No adverse effect was reported. Additional information has been requested.
Patient given FLUZONE HD at 10:50AM. At 3PM pt called stating headache/body ache, uncontrolled shaking. Temp 100.5 degrees. After taking aspirin 1 hr prior. Pt went to primary care MD for supportive care. Per pt rest, fluids, ice and TYLENOL given - reduced fever.
his face is a little numb; This is a Spontaneous report from a Pfizer-sponsored program. A contactable male consumer (patient) reported that a male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient had his 1st dose today 15Apr2021 and his face was a little numb asking if it was normal. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a female patient who received BEXSERO. On 1st November 2017, the patient received BEXSERO. In November 2017, 1 day after receiving BEXSERO, the patient experienced injection site erythema, injection site pain and injection site induration. The patient was treated with ibuprofen, BENADRYL and medication unknown (Ice Pack (NOS)). On an unknown date, the outcome of the injection site erythema, injection site pain and injection site induration were unknown. It was unknown if the reporter considered the injection site erythema, injection site pain and injection site induration to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient was given BEXSERO vaccine 24 hours ago and was complaining of pain at injection site. The patient was seen today for pain and redness at the injection site with a harden area measuring four and a half by six centimeters. The reporter also mentioned that a second patient experienced the same symptoms 2 weeks ago. There were no additional details regarding that patient. The reporter had limited details and also attempted to file this adverse event online but got a message to call the Governance risk compliance. All questions asked and details provided were documented.
Developed syncope within a few minutes of receiving vaccine. Taken to the ED for treatment.  given IV fluids, Benadryl, famotidine, methylprednisolone,  IV fluid bolus and 02 along with reglan and Zofran.  Total ED stay approximately 4 hours
gen pruritus rash resolving over 7-10days; rx w/DPH- to dec itching;
Pt recvd vax on 1JUL92 & w/in 24 hrs of vax exp angioedema of face w/swelling & puffiness around the eyes & a diffuse redness to face; also exp blurred vision & arthralgia; MD felt pt may have exp serum sickness;
Vision problem. My son has been a homeschooled student for many years, using computer for his schooling without any problems. He had a minor injury to one eye shortly before the vaccination (scratched with hand), but after the shot, he complained of vision problems in both eyes. Redness, dryness, pressure, uncomfortable. Unable to concentrate and stay reading for more than a few minutes at a time. His primary doctor is now treating with antibiotic drops, but will take him to the eye doctor if he does not get better by Thursday as he will be done with the eye drops. We have also added allergy medicine, which seems to help a little. He is due for his second shot on 4/29. I still need him to get the shot to be protected from Covid, so hopefully, he will be better.
This spontaneous report was received from a Registered nurse regarding a 12 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 07-AUG-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Starting 04/10/2022, I developed soreness in the injection area and a general feeling of lethargy. This lasted for about 24 hours and then it resolved on its own.
Information has been received from a health professional concerning an adult male patient who in 2006 ("recently") was vaccinated IM with a 0.5 mL dose of Pneumovax 23 (possibly Lot# 655501/1035F).  Subsequently, (2006) the patient developed an injection site reaction to include local pain, redness, general malaise and fever up to 102 F.  At the time of the report, the reporter indicated that the patient was recovering.  The patient sought unspecified medical attention.  Additional information has been requested.
Pfizer monovalent was given instead of Bilvalent Dose.  NO adverse effects.
Severe headache, body aches, fever 104.8 at highest and lowest for 3 days was 102, brain fog, fatigue, shortness of breath
Less than 2 yrs p/initial series completed pt not immune to HBV B according to test results; Given 3 doses  2NOV88, 7DEC88, 19MAY89 lot #1893P 1 & 2nd dose not recorded To be given 4th & 5th dose;
After 1 full week, the pt had a fever of 99.8F max, lethargic (mom had to wake baby up to feed). Mom took her outside in the sun to wake baby up.
1500 Noted (R) upper arm swelling, hot, aching, location upper arm to elbow - iced area, ibuprofen, no temp. 1630 Noted throat feeling swollen & had difficulty swallowing, denies difficulty breathing. On daily med for seasonal allergies / asthma - loratadine - used albuterol inhaler without change symptoms, no wheezing. On 12-4-12 difficulty swallowing subsided 12-5-12 slight swelling (R) upper arm & less pain today.
Breakthrough case admission after 4 vaccines Moderna 3/9/21 Lot# 030A21A;  Moderna 4/7/21 Lot# 025B21A;  Moderna 12/6/21 Lot# 045F21A;  Moderna 4/14/22 Lot# 005M21A
Patient had severe diarrhea and the left side of her jaw began hurting the night she received the vaccination
After vaccination on way home mom said lips got swollen and child broke out in fine whelps. Gave TYLENOL and BENADRYL. On 5-7-09 left arm at top raised area warm to touch. Not broke out all over on 5-7-09. Concern due to past flu shot making knot
7:00 pm feeling tired 8:30 pm forehead warm to touch but thermometer said temp normal. Went to bed. 10:40 pm, cannot sleep, 99.7 temp,  headache, chills, warm, nausea. Brain constantly active therefore unable to distract to go to sleep 2 am head cool to touch,  no covers, very warm 3 am started getting little bursts of sleep 4 am slept, not soundly, until 8 am
Patient came in with right arm swollen from midarm down to below the elbow. The area was red, hard, and swollen. Patient also complained of pain in the area.
Confirmed with caller the patient did not experience any other adverse event; The caller said the patient received a dose of MMRII on 7/7/2023, after the product was involved in a temperature excursion.; This spontaneous report was received from a Registered Nurse concerning a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, and drugs reactions and allergies were not provided.  On 07-JUL-2023, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) 1 dose as prophylaxis (Lot number w039699 has been verified to be a valid lot number, expiration date reported and validated as 25-MAY-2024) (strength, dose, frequency, route of administration, and anatomical location were not reported).  The vaccine was exposed to a temperature excursion of 48.8 degrees Fahrenheit (F) during a time frame of 7 hours and 45 minutes (product storage error). It was unknown if there was a previous temperature excursion. It was confirmed with caller that the patient did not experience any other adverse event (no adverse event).
Miscommunication in the pharmacy resulted in the dose being administered greater than 12 hours after the vial had been punctured. Moderna was contacted regarding how to proceed. They said not to re-dose, but it was up to our judgement  to contact patient. Patient was contacted. Voicemail was left, encouraging patient to call us if any side effects had occurred. No call back from patient as of yet.
Severe headache and dizziness, to the point like I feel I'm going to pass out
Rash, erythema, itching, burning face left eye swollen shut. Rash extending to throat and scapula by 12/14/09. Relieved partially by Benadryl PO.
Full on anaphylaxis. Full body hives, swelling of hands and feet and lips, tightness in chest.
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 21-AUG-2020, the patient was vaccinated with an improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 0.5 ml orally as prophylaxis (lot # 1660991 with expiration date 27-APR-2021) (strength and frequency were not reported) and with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 ml as prophylaxis (lot # S036821 with expiration date 21-APR-2022) (strength, dose, frequency, route of administration and anatomical location were not reported).  The improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA006106:
Patient called on 9/14 and reported and said her arm started itching on Sunday right below administration site. Redness at admin site, hot to touch. No other symptoms. Getting more severe as of the date of this report. More itching, redness is spreading.
On 1/18/22 swelling started in the morning up to the neck and lymph nodes. On 1/19/2022 bruising and vomiting started in the evening. On 1/20/2022 mom took her to the urgent care in the morning.
Narrative: Vaccine administered without complications. The patient was advised to remain in the facility for 15 minutes post vaccination. The patient was given a completed COVID-19 vaccination record card, a copy of the Side Effects and Adverse Events Reporting Fact Sheet and instructed and instructed on how to report any adverse reactions. Vaccine administered by policy/protocol. on 12/22/21 patient reports: Patient report he had to go to ED after 2nd moderna Vaccine "my O2 sat was 78."
Patient received the vaccine at the age of 17and 10 months when the required age is 18 years old. She was 2 months short of the requirement and I have to report this.
I still don't feel good; Headache; Fatigue; Felt like crap again; Started feeling like a shit for 4 days; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (I still don't feel good), FEELING ABNORMAL (Started feeling bad for 4 days), FEELING ABNORMAL (Felt bad again), HEADACHE (Headache) and FATIGUE (Fatigue) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder.    On 29-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced FEELING ABNORMAL (Started feeling like a shit for 4 days). On 08-Feb-2021, the patient experienced FEELING ABNORMAL (Felt bad again). On an unknown date, the patient experienced FEELING ABNORMAL (I still don't feel good), HEADACHE (Headache) and FATIGUE (Fatigue). On 03-Feb-2021, FEELING ABNORMAL (Started feeling bad for 4 days) had resolved. At the time of the report, FEELING ABNORMAL (I still don't feel good), FEELING ABNORMAL (Felt bad again), HEADACHE (Headache) and FATIGUE (Fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-086720 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: NNI regarding Outcome: Not recovered
10-29-08 started with chills, fever and arm pain.  10-30-08 repeat of previous night.  10-31-08 pain in arm and neck.  11-1/11-2 rash with itching.  Treatment self medicated with Benadryl.
RECRUDESCENCE OF PRIOR POST-CONCUSSION SYMPTOMS, HAD BEEN WELL PRIOR TO BOOSTER. REMAINS SYMPTOMATIC AS OF 9/23/22
lost 20% of his body wake for starvation,; he had to force feed himself, look like he was  in a camp for loosing so much weight.; not going to take the booster because the vaccine  made him sick; having no apatite again/lost appetite, and no one as severe as him,  that lost for 5 weeks; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (having no apatite again/lost appetite, and no one as severe as him,  that lost for 5 weeks), WEIGHT DECREASED (lost 20% of his body wake for starvation,), FEEDING DISORDER (he had to force feed himself, look like he was  in a camp for loosing so much weight.) and ILLNESS (not going to take the booster because the vaccine  made him sick) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053C21A and 041B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FUROSEMIDE for Bladder infection, FINASTERIDE, TAMSULOSIN and CALCIUM for an unknown indication.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Jun-2021, the patient experienced DECREASED APPETITE (having no apatite again/lost appetite, and no one as severe as him,  that lost for 5 weeks). On an unknown date, the patient experienced WEIGHT DECREASED (lost 20% of his body wake for starvation,), FEEDING DISORDER (he had to force feed himself, look like he was  in a camp for loosing so much weight.) and ILLNESS (not going to take the booster because the vaccine  made him sick). The patient was treated with NITROFURANTOIN (NITROFUR) at an unspecified dose and frequency. On 22-Aug-2021, DECREASED APPETITE (having no apatite again/lost appetite, and no one as severe as him,  that lost for 5 weeks) had resolved. At the time of the report, WEIGHT DECREASED (lost 20% of his body wake for starvation,), FEEDING DISORDER (he had to force feed himself, look like he was  in a camp for loosing so much weight.) and ILLNESS (not going to take the booster because the vaccine  made him sick) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-408617 (Patient Link).
Patient said after receiving her second dose of Shingrix she started feeling flu-like symptoms (fever, chills, sweating) that afternoon after receiving the vaccine in the morning. She was feeling better the next day but still felt achy and tired.
No additional AE.; Caller reported that PNEUMOVAX 23(syringe) that underwent a temperature excursion was administered.    ?; This spontaneous report has been received from another reporter, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided.  On 05-JAN-2023, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (valid lot number U027357 [expiration date 25-MAR-2023]) (dose, vaccination scheme, route of administration, and frequency were not provided) for prophylaxis, after a temperature excursion and timeframe below 2 degrees Celsius (C) (-40.0C) for 22 hours (h) 0 minutes (min) and 0 seconds (sec). No previous temperature excursion was reported.  No additional adverse events (AE) were reported.
Patient received a dose of Pfizer vaccine. It was noted that the vaccine 5-day expiration date/time was 5/12/2021 @ 9:30 am. Vaccine was administered to patient at 9:53 am on 5/12/2021. No adverse reactions noted during observation period. MD and management team aware.
2 days after injections swelling, redness and warm to touch on right thigh. 5/10/2018 Patient is a 4 y.o. 1 m.o. male who presents in office today for evaluation of injection site reaction on right thigh. Dtap/IPV given 5/7/18. Swelling, redness and warm to touch noticed yesterday. Pain to touch this morning. Appetite and activity levels are normal. Sleep is normal. No ill contact. No other contributing factors.
Adm. vaccine that expired on 11-16-22 on 11-17-2022 not knowing the vial had expired at time of adm.  Realized same day after adm the vial lot number  was not in the registry and reviewed the time  vaccine was received to date  and noted the vaccine expired 1 day prior.   Notified state Vaccine program.  Also notified Pfizer of the incidence and was advised since within 2 days of expire time the vaccine would not have to be readministerd.  An email was sent from Pfizer with the following info to verify that there is 2 additional days for expire time but the vaccine over all expire date has not had any extension time.   Total Time: 72 days = [10 weeks (70 days) labeled time described in the Prescribing Information plus 2 days excursion time)] ? No additional excursion time is allowable for vials reduced to 1 week of storage at 2°C to 8°C (35ºF to 46ºF) due to excursions at -50°C to -15°C (-58°F to 5ºF). The vials do not have printed expire dates and when the shipment is received the staff have to determine the expire date and then COVID vaccines are constantly having extended  expire dates, making it very confusing for staff to monitor.    No treatment was needed, no injury occured  to the vaccine receipent (patient) and all staff have met and will place visible expire labels on each box upon recieving and monitor expire dates daily to prevent further occurances.
Pt. had NOB appt. with Dr. and at that time she stated that she received the MMR 8-4-17 at work when she was likely early pregnant. Per Dr. note, "no systemic symptoms". Patient will be meeting with maternal fetal medicine doctors for a detailed anatomy scan.
She cant move; She has high fever that doesn't want to break; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (She cant move) and PYREXIA (She has high fever that doesn't want to break) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 17-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, the patient experienced HYPOKINESIA (She cant move) and PYREXIA (She has high fever that doesn't want to break). At the time of the report, HYPOKINESIA (She cant move) and PYREXIA (She has high fever that doesn't want to break) outcome was unknown.            The action taken with mRNA-1273 in response to the event was not applicable.  Concomitant medications were not provided. Treatment information was not provided.
Intense , debilitating exhaustion (like the sensation one gets when fighting off an infection): 5 weeks so far since the vaccination. Sleeping 12 hours, waking fatigued, napping, having a hard time focusing, exhausted after a simple activity like walking or doing laundry. The first four weeks I felt a kind of sickness to the fatigue. Week 5 I feel absolutely exhausted but without the zombie yuckiness.  Also, there's still a warm red blotch on my arm at the injection site, 5 weeks later.
Fever & confusion starting "1 week after vaccine given. CSF WBC 79, prot 71, glucose normal. CSF HSV PCR (-) CSF Gram & culture (-). Resolved quickly (1-2d).