chrisvoncsefalvay/vaers-outcomes huggingface dataset:
6 Doses administered beyond the expiration date/ 2 days expired Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (6 Doses administered beyond the expiration date/ 2 days expired Moderna vaccine) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Nov-2021 at 1:00 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (6 Doses administered beyond the expiration date/ 2 days expired Moderna vaccine). On 08-Nov-2021 at 1:00 PM, EXPIRED PRODUCT ADMINISTERED (6 Doses administered beyond the expiration date/ 2 days expired Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.  No side effects experienced or reported by the patient.   Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2021: Non-significant follow up- contact info. and Fax no. added On 12-Nov-2021: Updated reporter's address and patient demographics.
inadvertently administered expired doses of adacel/No AE; Initial information received on 24-Aug-2021 regarding an unsolicited valid non-serious case received from other health professional .  This case involves a 12 years old female patient who received expired dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  Medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) and HPV VACCINE (HPV VACCINE) for Immunisation.  On 11-Jun-2021, the patient received first 0.5 mL dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6321AA, expiry date- 7-Jun-2021 via intramuscular route in the right deltoid for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine administered (latency same day).  It was reported, "Nurse reporting two patients were inadvertently administered expired doses of ADACEL."  At time of reporting, 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 the 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.
The evening of Feb. 8th after receiving the shot and the next day, my injection site on left arm was sore. The surprise was that my left arm injection site felt itchy  on  Feb. 15th and in the  early a.m. of the 16th I woke up feeling chilled and having a headache.  I took an ibuprofen, water and  was eventually able to sleep again. I had an inflamed red patch about 4 inches by 3 inches on my arm that I saw in the morning when I got up at about 6:00 a.m.. I felt a little fatigued in general, took another ibuprofen because I still had a headache. I was okay by about 2 or 3 p.m. that afternoon.
This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 62-year-old female patient who received SHINGRIX for prophylaxis. On 24th September 2018, the patient received the 2nd dose of SHINGRIX. In September 2018, less than a day after receiving SHINGRIX, the patient experienced poor quality sleep. On 25th September 2018, the patient experienced joint pain, muscle pain and tiredness. On an unknown date, the outcome of the joint pain, poor quality sleep, muscle pain and tiredness were unknown. It was unknown if the reporter considered the joint pain, poor quality sleep, muscle pain and tiredness to be related to SHINGRIX. Additional details were provided as follows: This case was reported via a live click to chat. The patient had terrible night sleep, awoke with muscle aches, joint pains and general tired feeling. The call center representative transferred the call to product specialist who works closely with this product and who was the pharmacist. The patient's husband said that the side effects reported by the pharmacist were pretty common, they seemed to be fading with exercise and general movement, but they both awoke with a SHINGRIX hangover. The patient's husband was going to see his doctor on Wednesday and the patient had immediate access to her doctor as well, they just wanted to touch base to see if this was a normal reaction, which it appeared to be. This case was linked with the case US2018GSK174204, reported for her husband.
I am having adrenal surges or adrenaline surges when I'm not doing anything I had one last night 13Apr2021 in the evening while I was sitting watching TV.  I'm having one now; I am having adrenal surges or adrenaline surges when I'm not doing anything I had one last night 13Apr2021 in the evening while I was sitting watching TV.  I'm having one now; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Apr2021 08:15 (Lot number: Ew0164) at the age of 56 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: EPINEPHRINE INCREASED (non-serious), ADRENAL DISORDER (non-serious) all with onset 13Apr2021, outcome "unknown" and all described as "I am having adrenal surges or adrenaline surges when I'm not doing anything I had one last night 13Apr2021 in the evening while I was sitting watching TV.  I'm having one now". Therapeutic measures were not taken as a result of epinephrine increased, adrenal disorder.  Additional information: The patient did not receive other vaccine in four weeks. The patient did not receive any medication in two weeks. The patient had not covid prior vaccination and she had not been covid tested post vaccination. She had no known allergies. Patient reported that she was having adrenal surges or adrenaline surges when she was not doing anything, she had one last night on 13Apr2021 in the evening while she was sitting watching TV. She was having one now and the patient was in esthetician working in a spa environment which was very relaxing.  No follow-up attempts are possible. No further information is expected.
Redness and pain at injection site, area is swollen to a flattened golf ball and painful to touch and warm that was Tuesday. By Wednesday the pain was a 5 on the pain scale of 1-10. I couldn't raise my arm above my waist and I tried taking meds for relief.
This spontaneous report as received from a licensed practical nurse (L.P.N.) refers to a female patient of unknown age. On 13-AUG-2010 the patient was vaccinated with GARDASIL (lot # not reported) (dose 1, strength and total daily dose not reported). On 05-SEP-2012 the patient was vaccinated with GARDASIL (lot # not reported) (dose 2, strength and total daily dose not reported). On 01-AUG-2013 the patient would receive GARDASIL (lot # not reported) (dose 3, strength and total daily dose not reported). No adverse effect was reported. It was unspecified whether the patient sought for medical attention. The outcome was unknown. Additional information has been requested.
Nausea and Vomiting this morning at 8:30 am on 1/26/21. Slight headache yesterday.
got Covid -19; got Covid -19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-MODERNATX-MOC20230504000126 (Moderna).  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "got Covid -19". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a patient who received BEXSERO (batch number 149001A, expiry date 30th September 2016). On an unknown date, the patient received BEXSERO. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced severe arm pain after vaccination. The representative did not have any patient identifiers.
Dizziness; Body aches; Severe diarrhea; Vomiting; Headache; Joint pain; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 19-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Apr2021 at 10:30 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history reported. The patient did not have any allergies to medications, food, or other products. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) and LOGESTERON taken for unknown indications from unknown dates and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 06Apr2021 at 21:00, the patient experienced severe diarrhoea and vomiting, headache, body aches, joint pain, dizziness and fatigue, all for over 24 hours. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events severe diarrhea, vomiting, headache, body aches, joint pain, dizziness and fatigue were not resolved.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Chronic shoulder pain near injection site, left arm. Elbow pain one month later followed by wrist. Pain equivalent to toothache, sharp and continuous. Patient is right handed with no previous left shoulder, elbow or wrist injuries.
Fatigue; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 14Apr2021 at 09:45 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included oxybutynin (MANUFACTURER UNKNOWN) and sertraline (MANUFACTURER UNKNOWN); both for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the right arm 24Mar2021 at 10:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. On 14Apr2021 at 20:00, the patient experienced fatigue and diarrhea. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fatigue and diarrhea was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
A week post 3rd vaccination My Blood Pressure was no longer mitigated by medication and swelling in my feet became uncontrolled.  Creatinine levels elevated on blood work that was done as well around 2.4-2.6. The doctor wanted to check my kidneys during a visit after seeing swollen feet. My medication changed however there was no change in my blood pressure initially. I stopped HTZ and was changed from Lisinopril to Amlodipine BESYLATE 10mg. After my change in medication. During my second blood test my creatinine levels dropped to a normal level.   These symptoms have been notated in Europe as well post getting second blood test results. I took a PCR test 6 weeks ago coming back negative. My wife tested positive around 2.5 weeks ago and 5 days post her positive test I still tested negative with no symptoms.
Received 2nd dose of Pfizer COVID vacccine 1/21/2021.   on 3/31/21 patient developed cough and congestion.  Tested positive for COVID.  No previous COVID positive test.  First dose of COVID vaccine gven 1/2/2/021.
First dose I felt go to my heart 20 min after getting it. Second dose day after receiving had very rapid heart rate and hard pounding
A pharmacist reported that a female, now 66 years of age, received an injection of Tetanus toxoid in 1953. Immediately post-immunization, she developed a fever and an injection site reaction characterized by swelling and pain that extended from her fingertips up through her arm. She recovered after 5 to 6 days.
Information has been received from a nurse concerning a male who on an unknown date, was vaccinated with ZOSTAVAX (Oka/Merck) (lot# not provided). Subsequently the patient broke out with cold sores on his lips. He had never had cold sores before. The patient's symptoms persisted. Unspecified medical attention was sought. This is one of several reports received from the same source. Additional information has been requested.
Arm was itchy and sore after immunization, soreness moved down the arm into the forearm and elbow area, pt could not pick up or support weight with arm that shot was administered in. Pt has not seen MD about ruling out other diagnosis.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE NEUROPATHY STABLE ANGINA CHRONIC HYPOXEMIC RESPIRATORY FAILURE
nurse administered an expired dose of FLUZONE QUADRIVALENT HIGH DOSE with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via Medical Information (Reference number- 00787284) and transmitted to Sanofi on 27-Sep-2021.  This case involves a 67 year old female patient to whom a nurse administered an expired dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (lot number and expiry date: not reported) for prophylactic vaccination.  On 27-Sep-2021, the patient received a dose (0.7ml) of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number: UJ512AB; expiry date: 30-Jun-2021) via intramuscular route in unknown administration site for prophylactic vaccination.  It was the case of actual medication error due to expired vaccine used (latency: same day).  It was reported "Pharmacist states that a nurse administered an expired dose of FLUZONE QUADRIVALENT HIGH DOSE to a patient on 27SEP2021; caller would like to know how soon the vaccine can be re-administered and any adverse effects to look out for"  Also, the reporter mentioned, the patient was given the dose from the last year's supply.  No adverse events were reported at the time of this report.  The outcome of the event was reported as unknown.  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 the 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.
Sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles and pain (extremely painful sores on butt).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 14-FEB-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported that she received her second dose of Shingles vaccine. The patient stated that she know that the vaccine was only 60 to 80 percentage effective due to health, but she took the vaccine on any percentage over having the shingles again. The patient stated that they really need to change the advertising they make it seem like shingles was a minor itchy rash. The patient reported that his/her shingles broke out along her sciatic nerve in her right leg and surrounding areas and hundreds of extremely painful sores on her butt, down the back of her leg and best of all his man parts. The patient stated that she wished for death until her physician prescribed pain killers that kept him/her unconscious for the more than week that it took to heal. Patient could do was wake up, pee, pop a pain killer and pass out. The patient hope she never experience these things again and she gladly dealing with her sore arm for a few days. Additional supportive information: Follow-up would not possible as no contact details were available.
no adverse effects to the patient; dose of VAQTA was administered on 07/28/2020 and expired on 07/26/2020; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.  On 28-JUL-2020, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) injection, lot # S009943 was confirmed to be valid, expiration date 26-JUL-2020 (exact dose, injection site and route of administration were not provided) for prophylaxis. No adverse effects were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. Devicelotnumber: S009943; expirationdate: 26-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
"She is a 28 year-old female calling today with a chief complaint of a rash. Her symptoms started about three days ago. She got her first Pfizer covid-19 vaccine last Thursday, 5 days ago. 2 days later she started to develop some itching on the bottom of her foot and then shortly after started to develop a blotchy rash on the foot. She woke up today and now has a rash over the majority of her body, it is under her arms, on her chest, her knees, her sides, upper back, inguinal area and legs. She is not having any trouble breathing or swallowing. There is no chance she is pregnant. The rash is not itchy except for the small area on her foot. She took Benadryl once the first night she had some itching which helps."
Case number PHEH2012US008739 is an initial spontaneous report received from a nurse on 20 Apr 2012. This report refers to an adult female patient. It was reported that this patient over the age of 55 years but under the age of 65 years was vaccinated with a dose of MENVEO (batch number: not reported) intramuscularly on to unspecified site on an unknown date. No adverse reaction was reported following this maladministration. No further details were provided.
The pt experienced a fever of 104.4 for 2 days with Tylenol, went to ER and told to use "tepid baths"; unconsolable crying for 2 days and then "became well".  Follow up:  According to MA who filled out the form, adverse event onset is unknown.
This spontaneous report was received from a nurse practitioner referring to unspecified patients of unknown age and gender. The concurrent conditions and medical history were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot #: K026533, expiration date on 07-AUG-2017 and lot #: L012837, expiration date on 11-MAR-2018 (route, dose and anatomical location were not reported). Concomitant therapies were not provided. No adverse events were reported. No product quality issue was involved. This is one of several reports coming from the same source. Additional information has been requested.
Patient was given a Pfizer Pediatric Dose that had not been diluted by mistake.  Per mother patient is not demonstrating any adverse side effects at this time.
Headaches; body aches; Injection site pain; This is a spontaneous report from a contactable Pharmacist (patient). A 37-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on left arm on an unspecified date at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were reported as none. The patient experienced headaches and body aches, injection site pain, on 29Dec2020 at 08:00 AM. The patient had Acetaminophen as the treatment for the events. The patient stated that no other vaccine in four weeks and no other medications in two weeks. No Covid prior vaccination and no Covid tested post vaccination. The outcome of the events was unknown.  Information about batch/lot number has been requested.