chrisvoncsefalvay/vaers-outcomes huggingface dataset:
expired dose of Daptacel was administered, no adverse event; Initial information was received on 26-May-2020 regarding an unsolicited valid non-serious case from other health professional.  This case involves a 31 months old female patient who was administered an expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].   Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A)   On 21-May-2020, the patient received a 0.5 mL dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (5th dose in series, lot C5366BA, expiry date 07-Feb-2020) via intramuscular route in the left deltoid for prophylactic vaccination  It was a case of an actual medication error due to expired vaccine used.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
My son was born absolutely perfect, full term and healthy who weighted 7 pounds and had been meeting all his milestones prior to his 12 months' shots. He had perfect eye contact and would socialize perfectly. After MMR and other vaccines at his 12 months, he became silent. After his 15 months shots, more adverse effects appeared. He had a short nap and became diarrhea and was constantly vomiting. He lost his eye contact and stopped responding to his name. He started walking on a tip toe and spinning and had been showing severe hand flapping. He would put everything into his mouth like his 8 months. He was staring at lights for several minutes and showed many repetitive behaviors like opening and closing doors for several minutes. He would eat only puree food. He had loved fruits prior to his 12 months but he stopped even touching them. He would hate new textures. Generally what happened after the vaccination he suddenly and immediately showed all the Autism symptoms.
pt stated 9 days after her covid vax, her left arm started to itch, was red, swollen and hot to touch around the injection site.  Pt stated she contacted her PCP and they told her this was a reaction of taking the vax.  She said it is better now with just a little itching.
Upset stomach; Slight fever; Headache; Tiredness; Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8734) via an unspecified route of administration in the left arm on 21Apr2021 at 14:00 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to pineapple and walnuts. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included citalopram hydrobromide (CELEXA), trazodone (MANUFACTURER UNKNOWN), loratadine (CLARITIN), fish oil (MANUFACTURER UNKNOWN) and unspecified birth control medication; all for unknown indications from unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 31Mar2021 at 14:00 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. On 22Apr2021 at 07:00, the patient experienced slight fever, headache, upset stomach, tiredness and sore arm. The events did not result in doctor or other health care professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events slight fever, headache, upset stomach, tiredness and sore arm were resolving at the time of the report.  No follow-up attempts are needed. No further information is expected.
Broke out in hives - abdomen/trunk; circumferential to back 4-6 inch wide band on 11/9. Also, had flu-like symptoms from evening of injection through hives. On 11/9 have note saying joints hurt, head felt spacey, body achy, chills. Took motrin & Tylenol with some relief. Spoke with allergist, prescribed prednisone 20mg daily x 2 days. Also took dose of Allergra. Hives lasted roughly 36 hours, but resolved with prednisone dosing. Also, had nausea for several days & had to take Zofran the morning of 11/8 to avoid vomiting.
Woke up the morning following the second dose of Moderna vaccine with a fever of 100.0, chills, body aches, and pain and swelling of the injection site.  Ibuprofen was taken and resolved symptoms shortly after.  The rest of the day I was lethargic.
Day after vaccine, left arm felt very weak and sore, and could not raise arm from the shoulder. Symptoms resolved by the third day. One week from the vaccine, slight soreness returned at injection site. On the 8th day, slight soreness/sensitivity continues and a pink, slightly raised area has appeared (approx 3? x 3? irregular patch or rash) at the injection area. No itching  at this point.
This spontaneous report was received from a physician via a company representative concerning to a patient of unknown age and gender. No concurrent conditions, medical history or concomitant medication were reported. On 09-APR-2014, the patient was vaccinated with an improperly stored dose of ROTATEQ orally, 2 ml, which had a lot # of H017721 and an expiration date of 14-APR-2014 (dose number was not reported). The vaccine had two temperature excursions, the first of 408 hours with the lowest recorded temperature reported was 33 Fahrenheit (F) (0.555555556 Celsius (C)) and the second of 256 hours with the lowest recorded temperature reported was 34 Fahrenheit (F) (1.111111111 Celsius (C)). The storage criteria and the storage type were reported as "Refrigerator (R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor product Quality Complaint (PQC) was involved. This is one of several cases received from the same reporter. Additional information has been requested.
Vaccines received Monday, 9/23/08. On 10/1/08 mother noticed swelling at injection site on R leg. Pt. c/o itching but denies pain
Needle and syringe were not fully screwed together in packaging.  Vaccine was successfully withdrawn from vial.  However, while depressing the plunger, a significant portion of the vaccine was observed to escape from the syringe near the needle attachment point.  Due to observed quantity of vaccine loss, it was determined appropriate to re-administer the dose.  Manufacture recommended reporting incident to VAERS.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with ROTATEQ, lot # L042216, expiration date: 13-JUN-2017, 1 ml, orally (strength and frequency were not provided). There were no concomitant medications reported. The reporter stated that on an unknown date, the ROTATEQ was improperly stored. It was exposed to a temperature of 30.79 Fahrenheit for 31 minutes, before being administrated to the patient. No adverse event was reported. This is one of two reports from the same reporter. Additional information is not expected as the reporter did not consent for follow-up attempts.
Initially had chills, myalgia, and weakness.  Symptoms worsened with fever and ongoing headache that lasted for 2 weeks.  Developed visual disturbances.  Was admitted twice and ultimately diagnosed with giant cell arteritis
So I had swollen lyphnodes, in the back of my head and in my neck and in my jaw an under my arm.  I felt like they were on fire and burning, I was aching in all my joints, my skin hurt all over and was very painful to touch and very sensitive to everything.  I had general feeling of illness, symptoms escalated more and more as the day went on.  I felt sicker than I had ever felt.  My processing was slowed down, and I just pretty much hurt all over, and my lymphnodes was swollen all over and my skin was just burning, and my eyes felt like the were burning and on fire.  I went to Urgent care, they did a COVID+-19 test was negative, Blood Panel and it came back normal, and to continue the pain meds I was on and it should subside in a few day which it did.  I am having ongoing fatigue, and brain fog and having problems  with word retreival.  I still have aching joints and my lymphnodes are still swollen under one armpit. I am not sure if this is still a result of the COVID that I had in July 2022 or from the vaccine.  I am now going to sports medicine and they fill as though I have multi symptom inflamatory syndrome
Slight headache; Slight chills; Minor body aches; A little light headed; Tired; This is a spontaneous report from a contactable consumer (patient). A 66-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EM9810), via an unspecified route of administration in right arm on 12Feb2021 at 13:15 at single dose for COVID-19 immunisation. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL8982), via an unspecified route of administration in right arm on 22Jan2021 at single dose for COVID-19 immunisation. Medical history included intrahepatic cholangiocarcinoma. Concomitant medications included amlodipine 5 mg, atorvastatin 40 mg. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. The patient did not receive any other vaccine in four weeks. On 14Feb2021 08:00, the patient stated 43 hours after the second shot she got a slight headache, slight chills, minor body aches, a little light headed and tired. She took two tylenol and a nap and was fine within 5 hours. The outcome of the events was recovered.
Case number PHEH2015US026875, is an initial spontaneous report received from a nurse on 22 Dec 2015. This report refers to a 64 year old female patient. Medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501, expiry date: May 2016) into left deltoid on 06 Oct 2015. It was reported that before administration the FLUVIRIN had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day when she arrived the next day and the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information provided. Follow up information received from the nurse on 26 Jan 2016: Reporter's comment updated.
Information has been received from a consumer concerning her 5 year old daughter with gluten allergy and penicillin allergy who on 23-AUG-2010 was vaccinated with the second dose of MMR II (lot number not provided). The consumer reported that the arm in which MMR II was administered was uncertain. Secondary suspect therapy included a dose of VARIVAX (manufacturer unknown) (lot number not provided), the arm in which it was administered was uncertain. There was no concomitant therapy. The consumer reported that on 23-AUG-2010 her daughter experienced a raised bumpy rash with lines in it on her right arm. The consumer reported that her daughter's arm was heated, had mild swelling, and blisters. The consumer also reported that her daughter's left arm presented a red oval rash at the injection site which was also heated. The consumer reported that the rash on her daughter's left arm had begun to fade, but that the rash on her daughter's right arm was still present. At the time of the report the patient had not recovered. No laboratory tests were performed. The patient sought unspecified medical attention. No further information is available.
Patient presented to Ra local Hospital via EMS after being found down in bathroom at Skilled Nursing Facility. Coumadin reversed with Vitamin K and FFP.  CT head 6/24 showed Subarachnoid Hemorrhage in bilateral frontal lobes and right parietal lobe.  He also had left eye conjunctival hemorrhage, suborbital hematoma and orbital wall fracture.   6/24: Head CT: showed new intraventricular hemorrhage. 6/24:  repeat Head CT in evening was stable.
About 10 minutes after injection, patient came to pharmacy counter, clutching his chest and bent over, saying it felt like a balloon was inflating in his chest wall and asked if that was normal.  911 was called and he was escorted to sit down and given some water.  By the time the paramedics arrived, he was already feeling better.
Significant swelling, redness, throbbing both at injection site and involving upper 1/3 of arm.  There is a space which is uninvolved between the injection site and the most significant portion of erythema, warmth and swelling.  It has expanded from inked margins since it was first noticed by the patient.
About 24 hours after my second dose I started having symptoms similar to seasonal allergies, though I had been nowhere new and have no history of having allergies. I also grew a cyst (about 2 inches in diameter) under my left collar bone 24 hours after the second dose (I have no history of anything like this).
Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 08-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the vials were stored in the freezer and taken out of the freezer and placed in the refrigerator on the date of administration where the vials did not undergo any temperature excursions.  No concomitant medication was reported. No treatment medication was reported.
Pin Pricking sensation; Redness; Rash; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Pin Pricking sensation), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE RASH (Rash) and VACCINATION SITE PAIN (Soreness) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A71A and 032L20A) for COVID-19 vaccination.     Concomitant products included APIXABAN (ELIQUIS), METOPROLOL SUCCINATE (TOPROL) and PROTON PUMP INHIBITORS for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced PARAESTHESIA (Pin Pricking sensation), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE RASH (Rash) and VACCINATION SITE PAIN (Soreness). At the time of the report, PARAESTHESIA (Pin Pricking sensation), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE RASH (Rash) and VACCINATION SITE PAIN (Soreness) outcome was unknown.            Treatment information included, cortisone cream was provided.
Headache, Diarrhea, NauseaVomiting,  congestion, chills Narrative:
Limp developed eight days after vaccine, Motrin given. Gradual improvement over 4-5 days.
I woke up less than 24 hours later feeling very achey and fatigued. My body ached all day the day after and I had a bad head ache. My arm that the shot was in, hurt to move but was bearable. The injection spot is inflamed and raised and the arm muscle still had a deep ache almost a week later.
Painful shoulder for about 3 days after shot. Tired and achy day of and day after shot.  Red arm (3-4" in diameter) around injection site starting 6 days after shot.
Upper right arm edema starting from the right elbow and extending to the right shoulder (humeral area)
" Per site and proclamation of moratorium on use of mRNA monovalent vaccines and as booster doses after 31 AUG 2022, and instruction to enter doses administered as such into VAERS; this report was entered for documentation purposes".
A consumer report has been received concerning a 7 year old female patient. The patient received nasal FLUENZ TETRA on 02-NOV-2015. It was reported that patient experienced headache and tummy ache on 02-NOV-2015. The patient recovered from headache and tummy ache on 03-NOV 2015. The company physician considered headache and tummy ache to be non-serious. Corrected report on 19-NOV-2015: coding of suspect drug corrected. Manufacturer corrected. Reporter details updated. Narrative updated.
8 days after immunization, L deltoid began to swell, becoming very sore and firm overnight, accompanied by mild fatigue and body aches; no fever. Well-demarcated area of light erythema noted the next morning. Swelling eventually subsided, although mild swelling still present today (2/3/2021), 8 days after onset. Erythema has faded slightly, although still present, and skin mildly pruritic. Application of 0.2% hydrocortisone valerate twice a day (begun 1/31/2021) seems to be helping. No further systemic symptoms. I still plan to take the second dose as scheduled 2/15/2021, but in the opposite arm.
Information has been received on 23-NOV-2016 from a registered nurse referring to a 1 year old patient (gender unknown). The patient's concurrent conditions, medical history and concomitant therapy were not reported. On 23-NOV-2016, the patient was inadvertently administered a dose of ZOSTAVAX (lot number and expiration date not reported) instead of VARIVAX. No adverse effects were reported. No further information was provided. Additional information has been requested.
I am the epidemiologist reporting on behalf of 60 year old male patient. The patient received two doses of the Moderna vaccine on 5/17 and 6/14. On 8/9/21, the patient tested positive via a PCR test for COVID-19 (vaccine breakthrough). The patient died on 8/26 and the cause of death is listed as ?Cardiac arrest, myocardial infarction, gangrene LLE, Covid pneumonia.? Pre-existing conditions are listed as DIABETES MELLITUS, CARDIOVASCULAR DISEASE.
Pregnant -- EDD 5/28/21  Cough  Shortness of Breath  Difficulty breathing  Headache  Congestion or running nose  Nausea or vomiting
Strong Body aches, mild fever,  nausea and dizziness  for 24 hours  8 weeks pregnant
Patient called 2 days after injection complaining of pain in arm all the way down to her hand.  Said her hand was swollen and sore and she could not close it.  Pharmacist suggested Tylenol or nsaids.  12-9 patient called again same symptoms and said she had a doctors appointment on 12/12.  On 12-18 patient called said doctor told her to take Tylenol and that wasn't working, pharmacist suggested naproxen or ibuprofen.
Initial report received on 05 August 2013 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 23-month-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received the following 4 doses of PENTACEL vaccinations: lot C3663AA received on 19 September 2011, lot C3663AA received on 23 November 2011, lot C3747AB received on 18 January 2012, and lot C4131AA received on 18 July 2012. The subject developed a cough on 10 July 2013, approximately 1 year after the last dose, and a paroxysmal cough without a whoop on 15 July 2013. The subject also developed cold like symptoms on 15 July 2013, and posttusive vomiting and sleep disturbance (start dates not reported). Laboratory testing included positive PCR on 19 July 2013. Chest x-ray findings were negative. Corrective treatments consisted of azithromycin starting on 19 July 2013 for 5 days. The subject was not hospitalized. At the time of final contact on 01 August 2013, the subject's cough was still persisting. The duration of the cough was reported at that time as 22 days. Investigator causality assessment is not required as per protocol. This is one case out of a cumulative total of 205 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 05 August 2013. These 205 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not captured as per study protocol. Documents held by sender: None.
The patient had complaint of "itching throat", denies shortness of breath. Vitals obtained at 1530. BP=118/68, P=89, O2=98%, R=18. Patient provided with 50 mg Benadryl per her request. Vital taken at 1550=BP=108/66, P=83, O2=98% The patient stayed until 1630 waiting for ride due to fatigue from Benadryl. Was able to walk out on her own.
Within 5 minutes of receiving his first PCV13 immunization, mom reports that the patient "went limp" and called for help. Assessed by CNA and RN in the office who noted that pt's "respirations [were] even and unlabored ... and [his] eyes [were] closed." Pulse ox 100%. I was called to see the patient who was drowsy-appearing but responsive to pain and mom with pulse 145, pulse ox 100%, Lungs CTA. No evidence of respiratory distress. No hives/erythema/induration/bleeding at site of injection or otherwise. During the exam, pt became more awake and interactive. He was able to open his eyes and make good eye contact with mom and respond to her. Good muscle strength and tone. Moved all extremities well.
Smallpox site inflamed causing a dark, red, bumpy appearance around it.  Approximately 1 to 2 inches around the site.  Small, red bumps appeared about 3 weeks after the vaccination.  They appeared on my face, arms, legs, and starting of the back.
This spontaneous report as received from a nurse practitioner refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) injection (lot # K010338, expiry date 22-JUL-2016; dose and route of administration were not reported). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint (PQC) involved. Additional information has been requested.
On 3/8/2016 patient developed a rash on his left thigh. 3/11/2016 at 1100 patient developed a fever. Patient seen 3/11/2016 at Urgent Care where he presents with fever of 101.7. Advised to take ibuprofen and Tylenol alternating to control fever and follor up if worsening or not better.
Entire leg swollen x3 days, pain upon movement of leg x1 week, unusual crying x3 days, fever x3 days.
This was an administration error with the incorrect second dose Pfizer vaccine given to someone who had received a Moderna first dose. Provide on Duty was called, patient was called, he reported no adverse effects, he returned to site to have his CDC card updated with the correct information.