chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a Registered Nurse refers to multiple unspecified patients of unknown ages and gender. On an unspecified date the multiple unspecified patients were administered VAQTA (Lot# unspecified) (dose, frequency, route and location unspecified) that was stored improperly (first exposed to 9C for 30 minutes and then exposed to 8.3C for 1 hour). No adverse effects were reported. Follow up information has been received from the registered nurse via telephone call indicating that she did not have the information available at that time and she might be able to fax it early the following week. This is one of several reports received from the same source. Follow up has been received from the registered nurse. The nurse provided lot numbers, expiration dates and a list of patient identifier representing patients given affected vaccine from 16-APR-2014 through 23-APR-2014. On unspecified date in April 2014, 11 (eleven) patient were given affected VAQTA (lot # J011629, epiration date: 20-SEP-2015). The 11 patients included: MARRS# 1404USA014966, MARRS# 1405USA013228, MARRS# 1405USA013233, MARRS# 1405USA013234, MARRS# 1405USA013235, MARRS# 1405USA013236, MARRS# 1405USA013232, MARRS# 1405USA013231, MARRS# 1405USA013237, MARRS# 1405USA013229, MARRS# 1405USA013230. Additional information is not expected.
Friday afternoon joints were severely hurting and couldn't sleep that night due to joint and arm pain. Saturday morning  temperature of 99.9, no energy, upset stomach, and could hardly walk. Sunday morning temperature was normal and joints were back to normal aches and upset stomach was gone. Arm that injection was in still hurts bad and feels weak.
"has pounding headache"; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 16Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset Apr2021, outcome "unknown", described as ""has pounding headache"".  Additional information: Patients wants to know if it's okay to take aspirin. No unaddressed medical questions referred or forwarded to Medical Information.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
**Administration Error** Patient stated that she was not feeling well and that she received a large knot and rash at the injection site. Patient went to the ER on 8/16/2021. Patient was told that she received a staph infection where the vaccination was inserted. Patient stated that pharmacist did not clean the site before inserting the injection. Patient stated that she has long red streaks of red going down her left arm. Patient is very dizzy and feels Nauseated. She also has a headache and lightheaded.   Vaccination Flu Hd 65plus pf 2021-22 Inj 0.7ML Lot# UJ689A8
Member complains headache, arm swelling at injection site with heat and tingling to right elbow, and aching joints to right arm. Also states started having diarrhea 12/9/07 morning. Member self-medicated with Tylenol and anti-diarrheal medication (OTC) with little relief.
Temp excursion/beyond use date excursion I called about on1/21/22.; Temp excursion/beyond use date excursion I called about on1/21/22.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Temp excursion/beyond use date excursion I called about on1/21/22.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temp excursion/beyond use date excursion I called about on1/21/22.) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Temp excursion/beyond use date excursion I called about on1/21/22.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temp excursion/beyond use date excursion I called about on1/21/22.). On 20-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Temp excursion/beyond use date excursion I called about on1/21/22.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temp excursion/beyond use date excursion I called about on1/21/22.) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient took booster dose.  Concomitant information was not provided.  Treatment information was not provided.
Vaccine was not diluted before administration at 0900. Staff realized vaccine needed to be diluted at 0921. Dr. Patient has no adverse signs or symptoms at this time.
5-6 hours post vax, the pt developed convulsions. She also had some blood in diarrheal stools in hospital which persisted for 3-4 days.
17Dec90 pt vax w/ hepta B; exp rash on trunk & became worse.  24 hrs postvax exp shortness of breath.  Seen in ER. Tx w/ epinephrine & benadryl.
Swelling of upper arm. Redness, soreness. Whole upper arm became red and splotchy and was warm to touch. Placed on antibiotics by physician.
Information has been received from a 51-year-old female consumer with attention deficit disorder and a "drug reaction to almost every vaccination" who on 07-DEC-2007 was vaccinated with a dose of Zostavax (Oka/Merck). Concomitant therapy included RITALIN. The patient experienced swelling at the injection site right after receiving the vaccination. Unspecified medical attention was sought. There were no laboratory or diagnostic studies performed. The patient reported that the swelling was gone within a week. No product quality complaint was involved. Additional information has been requested.
Bad shortness of breath following mild cold. Treated with Prednisone, Albuterol, Montelukast and Spiriva. Now improving.
pt recvd vax;high pitched noise since vax;27feb95 eats & sleep ok, however spit-up 4 times; sxs resolved by am;
patient is pregnant and has already received both doses of the vaccine; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of EXPOSURE DURING PREGNANCY (patient is pregnant and has already received both doses of the vaccine) in a 34-year-old female patient (gravida 3) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 028L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 11-Jun-2021. On 29-Dec-2020, the patient experienced EXPOSURE DURING PREGNANCY (patient is pregnant and has already received both doses of the vaccine). On 28-Jan-2021, EXPOSURE DURING PREGNANCY (patient is pregnant and has already received both doses of the vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  No concomitant medication was provided.  The patient previously had two miscarriages.
Lt upper arm with 10 cm round raised plaque.  Like lesion war to touch, red, swollen, tight; No pain, able to use arm.  No fever.
body/muscle aches; muscle aches; headache; chills; tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 at 17:00 as dose 4 (booster), single (Lot number: GH9694) at the age of 49 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Factor V Leiden blood clots" (unspecified if ongoing). Concomitant medication(s) included: ELIQUIS. Vaccination history included: BNT162b2 (DOSE 1), administration date: 27Jan2021, when the patient was 48-year-old, for Covid-19 immunization; BNT162b2 (DOSE 2, Lot number : EL3247), administration date: 17Feb2021, when the patient was 48-year-old, for Covid-19 immunization, reaction(s): "Flu-like symptoms", "muscle aches", "fatigue", "injection site soreness", "fairly severe chills", "body aches", "headache"; BNT162b2 (DOSE 3, Lot number : EW0217), administration date: 29Sep2021, when the patient was 48-year-old, for Covid-19 immunization, reaction(s): "mild injection site pain began approx 4-6hrs post dose and lasted 1-2days", "chills", "shaking began approx 14hrs post dose and lasted 3-4hours", "flu-like body aches", "general ill-feeling began 14hrs post does and lasted 1.5days", "headache began 14hrs post dose and lasted 2.5days". The following information was reported: PAIN (non-serious) with onset 13Sep2022 at 05:00, outcome "recovering", described as "body/muscle aches"; CHILLS (non-serious) with onset 13Sep2022 at 05:00, outcome "recovering"; HEADACHE (non-serious) with onset 13Sep2022 at 05:00, outcome "recovering"; MYALGIA (non-serious) with onset 13Sep2022 at 05:00, outcome "recovering", described as "muscle aches"; FATIGUE (non-serious) with onset 13Sep2022 at 05:00, outcome "recovering", described as "tiredness". Therapeutic measures were not taken as a result of pain, myalgia, headache, chills, fatigue.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021177906 same reporter/patient, different product/dose/AE;US-PFIZER INC-202101311721 same reporter/patient, different product/dose/AE;
pt recv vax & devel a fever of 105 & a very large inj site rxn;pt recovered;
pain/severe pain all the way on my left side; severe pain in my arm - left; severe pain moves to the neck - left side; severe pain moves to the ear - left side; I can barely move around; it's been very difficult; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain/severe pain all the way on my left side), PAIN IN EXTREMITY (severe pain in my arm - left), NECK PAIN (severe pain moves to the neck - left side), EAR PAIN (severe pain moves to the ear - left side) and MOVEMENT DISORDER (I can barely move around) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 09-Feb-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 PAIN (pain/severe pain all the way on my left side), PAIN IN EXTREMITY (severe pain in my arm - left), NECK PAIN (severe pain moves to the neck - left side), EAR PAIN (severe pain moves to the ear - left side), MOVEMENT DISORDER (I can barely move around) and DISCOMFORT (it's been very difficult). At the time of the report, PAIN (pain/severe pain all the way on my left side), PAIN IN EXTREMITY (severe pain in my arm - left), NECK PAIN (severe pain moves to the neck - left side), EAR PAIN (severe pain moves to the ear - left side), MOVEMENT DISORDER (I can barely move around) and DISCOMFORT (it's been very difficult) outcome was unknown. Not Provided      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.   Reporter did not allow further contact
tested positive; arm soreness; headache; minor chills; cough; This is a spontaneous report from a contactable consumer. A 24-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration on the left arm on 10Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient asked if he was eligible to get the second vaccine dose if he tested positive and had COVID. The patient reported that he got his first COVID vaccine dose on 10Jan2021 and experienced arm soreness, headache and minor chills the day after getting the vaccine, on 11Jan2021. Then on Wednesday into Thursday, he began having a cough which prompted him to get tested and he tested positive on Thursday 14Jan2021. The patient underwent lab tests and procedures which included COVID test: positive on 14Jan2021. Outcome of the events was unknown.   Information of lot/batch number has been requested.
Patient was given KINRIX on 06/03/2016 but had received PENTACEL on 10/19/2015. He was already 4 years old when he received the PENTACEL so did not need any further doses of DTaP or polio. Spoke with patient's guardian who states he is fine and had no reaction to the vaccines given.
My dad is going to die; has developed lymphedema on his legs; they are extremely swollen and sore; they are extremely swollen and sore; This is a spontaneous report from a contactable consumer (patient's daughter). An 84-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), dose 2 via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE, and dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation; pemetrexed disodium (ALIMTA) and pegfilgrastim (NEULASTA), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history included mesothelioma (Her father was diagnosed with Mesothelioma 6 months ago and has been on chemo for 5 months). The concomitant medications were not reported. Caller stated that the day his father got his vaccine, he also received his chemotherapy and now has developed lymphedema on his legs. Caller is asking if this is advisable. Patient (reporter's father) had the COVID vaccine, and he was on Alimta and Neulasta which was a patch that they put on them that injects so many hours after chemotherapy stops. It was a time release patch (filgristam). He had developed lymphedema in his legs and they were extremely swollen and sore. Reported that Alimta does not caused lymphedema and he was been on it for several cycles on Alimta and had no problems. Reporter had a feeling that giving these drugs together with the COVID vaccine caused lymphedema. Reporter's dad was going to die. Mesothelioma had no cure. Lymphedema only happens when there was an injury to the lymph nodes. Now her dad who had these drugs that he was getting for several months, never had any problems, now had lymphedema. The doctors were lying (as reported). Now he can't have his chemo because of the lymphedema. 100 percent reporter believe that the vaccine caused this. The outcome of the events was unknown.  Information on the batch/lot number has been requested.
REDNESS AT AREA OF INJECTION; HOT TO TOUCH; ITCHING TO AREA.
After vaccination, sight was red. Within 5 days became redder, hard and itched. It then proceeded to crust and upon presentation on 8/4/12 lesions had dried up.
Pt exp pain in the shoulder p/Td vax; described as a severe & prolonged local reaction which lasted about 4 wks; pt also had pain in the lt deltoid;
Weak and Not feeling well; Achy; Headaches; very weak; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (very weak), PAIN (Achy), MALAISE (Weak and Not feeling well) and HEADACHE (Headaches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced ASTHENIA (very weak), PAIN (Achy) and HEADACHE (Headaches). On 22-Jan-2021, the patient experienced MALAISE (Weak and Not feeling well). At the time of the report, ASTHENIA (very weak), PAIN (Achy), MALAISE (Weak and Not feeling well) and HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD21-11364 (Patient Link).
Patient received vaccination at site and came to pod as elevate employee Patient reported feeling lightheaded and right hand pain with mild rash Patient provided with water and seen by medical team Patient refused medical transport and signed form Patient stated symptoms improved, Patient is an elevate employee and will be sent home early
Patient received second dose of Covid19 Pfizer-BioNTech. A few minutes later, my pharmacy technician, was informed that patient had collapsed in front of the pharmacy. I was in the immunization room with another patient. I grabbed an Epinephrine 0.3mg auto injector and went to the patient. He was unconscious and unresponsive. I told him to call 911 and to send for paramedics. I administered one dose of 0.3mg epinephrine and patient woke up within a few seconds. He stayed sitting with me assisting as this was his most comfortable position. He later transferred to a chair and paramedics/emt took over when they arrived.
Week-long fevers, 101.7 highest. 6 days Fever All. Lethargic, sleeping and crying excessively. Vomited once, decreased appetite. Speech reduced. Physician was called several times,  no in-person visit.
Diarrhea; This case was reported by a physician via call center representative and described the occurrence of diarrhea in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th February 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced diarrhea. On 7th March 2022, the outcome of the diarrhea was resolved with sequelae.   It was unknown if the reporter considered the diarrhea to be related to Shingrix.  Additional details were provided as follows: The reporter stated that the patient developed diarrhea after 1st dose of Shingrix and might not receive 2nd dose of Shingrix. The reporter enquired about effectiveness of 1 dose of Shingrix and stated that it was not the time for 2nd Shingrix vaccine yet. The reporter did not consent to follow-up. Note: Outcome was captured as resolved with sequelae as per clarification mail.
patient stated that her arm became very warm and turned red with a knot and swelling occuring that started at her injection site and moved down her arm. It started two days afer her injections.
Chills, fever, severe joint pain, heart palpitation, fatigue,  dizziness
A week after the vaccine my son developed a rash on the arm that he received his COVID vaccine.
Flu and Pneumovax given on Dec 7 2005.  Since vaccine running increased fever, malaise, myalgias.  And testing CRP, bloodwork etc negative, fever on and off about 6 weeks.  Had redness, swelling, tenderness to R arm site 2 days after inject given. Still running on and off fever, malaise, myalgias.
soreness of arm day of inject; swelling, hot to touch, itchy, soreness area around inject site the following day; some rash around this area @ 1 inch lasting for 4 hrs;
Initial report received from nurse on 16 Feb 2010: The patient received 0.5 ml of FLUVIRIN on 03 Dec 2009 (Batch no. 102040P1). On 20 Jan 2010, again he received same vaccine. No adverse events were reported after administration of either dose.
Arm became soar and has gotten worse over time. Has not gotten any better since last injection.  Became very sick after second dose and was so for 3 days. Have continued to be extremely fatigued since.
Rash on stomach/chest/arms, non-pruritic, day after 4th dose x3d; no associated symptoms.
This spontaneous report as received from a pharmacist refers to a 1 year old patient of unknown gender. On 07-APR-2015, the patient was vaccinated with VARIVAX (Merck) (dose, route and lot# were not reported) which had expired on 05-APR-2015. Potency was supported. No adverse effects reported. Additional information has been requested.
17-year-old patient received the first dose of Moderna COVID-19 vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old patient received the first dose of Moderna COVID-19 vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old patient received the first dose of Moderna COVID-19 vaccine). In March 2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old patient received the first dose of Moderna COVID-19 vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.
FLUZONE HIGH DOSE vaccine administered by mistake instead of administering the FLUARIX regular dose. Patient experienced no adverse reaction at the time of vaccination and no reported complains or reaction in the days to weeks following the vaccination.
pt recv vax & about 72hr p/vax pt exp 6 inch area of erythema & warmth @ the site of vax;
Feeling weird, didn't feel normal until morning 6:30AM; Laying down with chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling weird, didn't feel normal until morning 6:30AM) and CHILLS (Laying down with chills) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Nov-2021, the patient received third 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 an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, the patient experienced CHILLS (Laying down with chills). On 03-Nov-2021 at 9:30 AM, the patient experienced FEELING ABNORMAL (Feeling weird, didn't feel normal until morning 6:30AM). On 04-Nov-2021, FEELING ABNORMAL (Feeling weird, didn't feel normal until morning 6:30AM) and CHILLS (Laying down with chills) had resolved. Not Provided          No concomitant medications were provided. No treatment medications were reported.   This case was linked to MOD-2021-375339, MOD-2021-375333 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: Follow-up contains outcome and end date of the event (Chills) and  Reporter Causality
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On 22-JUN-2017, the patient was vaccinated with an expired dose of ZOSTAVAX (dose and route of administration were not reported) (lot # K026365 and expiration date 15-MAR-2016) and a DILUENT MRK (dose and route of administration were not reported) (lot # L014261 and expiration date 21-JAN-2018) for prophylaxis. No adverse effects reported.