chrisvoncsefalvay/vaers-outcomes huggingface dataset:
numbness in both arms for 48 straight hours after her second injection; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number and Expiration Date was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date, the patient experienced numbness in both arms for 48 straight hours after her second injection. Outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Post third dose of vax, the pt's mother stated that pinkness developed at the injection site which was hot and swollen for two days.
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine to a patient after the written BUD.), PRODUCT STORAGE ERROR (Moderna COVID-19 vaccine to a patient after the written BUD.) and NO ADVERSE EVENT (No Adverse Event) in an infant patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 24-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine to a patient after the written BUD.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna COVID-19 vaccine to a patient after the written BUD.) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine to a patient after the written BUD.), PRODUCT STORAGE ERROR (Moderna COVID-19 vaccine to a patient after the written BUD.) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.          Moderna 6m-5y Given to child of proper age. Beyond Use Date was reported as 21-Jan-2023. Expiration: date was reported as 19-Aug-2023.    Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jan-2023: Non-significant follow up added include AE-00010537 number. On 25-Jan-2023: Follow up included no new information.
3 days after my vaccine i started my period. It wasn't a normal period it was extremely early and very very heavy.  I have never bled so much in my life.  At one point I thought I should go to the hospital I was losing so much blood.  I didn't want to go because the amount of covid patients.  I continued to bleed for weeks.  I just had blood work that had results consistent with heavy blood loss. I have been abnormally dizzy upon standing. I still have horrible cramps that do not go away.
Information has been received from a health professional concerning a female who was vaccinated with IM with a 0.5 ml dose of Gardasil (yeast) (lot 654885/1424F # or lot # 655619/1427F). Subsequently within a few minutes the patient experienced dizziness and felt as if she was going to faint. The patient did not faint and was not sent to the hospital. The patient laid down for a few minutes and had something to drink. The patient recovered on an unspecified date. Additional information has been requested.
STARTED TODAY WITH RASH ON MY NECK, WHICH GOT PROGRESSIVELY WORSE THROUGH THE DAY  RASH STARTED EARLY MORNING AROUND 1030 AM   GOT SOME FACIAL FLUSHING, BUT NO FEVERS
Hives developed of day after vaccines administered.  Rash present on entire body for two days.  No fever or any other symptoms noted.
This spontaneous report was received from a nurse referring to unspecified patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates, the patients were inadvertently administered vaccinated with RECOMBIVAX HB (lot # N002202, expiration date 04-NOV-2019, lot# N002914, expiration date 04-NOV-2019) that had been improperly stored for prophylaxis. The temperature was 1 centigrade degree (°C), and the time frame was 2 hours 23 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA007035: US-009507513-1708USA007006.
Case number PHEH2014US006389 is an initial spontaneous report received from a nurse on 28 Mar 2014. This report refers to an 18 year old female patient. The patient's past medical history and concomitant medications were not reported. The patient received only Men CWY liquid conjugate component of MENVEO (batch number: X11076) without reconstitution with Men A lyophilized component intramuscularly on 28 Mar 2014. No adverse events were reported following this medication error (inappropriate preparation of medication).
Information has been received from a registered nurse concerning a 68 year old male with allergy to penicillin and shellfish who in 1997 was vaccinated with first dose of Pneumovax 23 and on 15-NOV-2006 was vaccinated with greater than third dose of Fluvirin (Chiron) (lot # 72008) IM in the right deltoid at 4:40 PM.  The patient had no acute illness at the time of being vaccinated.  On 01-DEC-2006, the patient was vaccinated with a second dose of 0.5 mL dose of Pneumovax 23 (lot # 651437/0899F) IM in the right deltoid at 10:40 AM.  Subsequently, the same day, the patient developed "unusually high swelling of the arm at the shot sight."  Two days later, the patient was recovered.  Additional information was received from the registered nurse.  The patient's wife called the office and reported that on 01-DEC-2006, in the evening, her husband experienced swelling and tenderness in his right arm, temperature was below normal.  The patient "felt very bad" and stayed in bed most of the day on 02-DEC-2006.  The patient did not remember the exact date of recovery but had recovered by 05-DEC-2006.  No additional information is expected.
In the evening of the shot  pt c/o of being tired, frustrated, red parts on the body, blurring eye sight, rx w/DPH; c/o spasms of the muscles; pt seen @ ER;
Patient received vaccine then briefly fainted after about 30 seconds. Lost consciousness for about 20-30 seconds. Pharmacist began moving patient toward floor then patient regained consciousness. Given Juice and instant cold pack monitored in clinic for 30-40 minutes then released.
Patient received Pfizer COVID vaccine on 3/13/21 (lot # EN6208), 4/3/21 (lot # ER8737), and 11/6/21 (lot # FH8028). On 1/20/22, patient admitted to our inpatient facility (med/surg unit) with acute hypoxemic respiratory failure and pneumonia due to COVID-19 and acute encephalopathy. As of today (1/22/22), patient is still admitted in our med/surg unit.
This spontaneous report as received from a nurse who refers to multiple unspecified patients of unknown age and gender. The multiple patient's medical history and concurrent conditions were not reported. On an unspecified date in January 2016, multiple patients were vaccinated with improperly stored doses of ROTATEQ lot # L027067 expiration date; 06-APR-2017, lot # L029617 expiration date 19-MAY-2017, lot # L027076 expiration date 25-MAY-2017, lot # L033545 expiration date 30-MAY-2017, lot # M004508 expiration date 29-JUN-2017, lot # M014318 expiration date 30-SEP-2017. Dose, route and anatomical location were not provided. No other concomitant medications were reported. Excursion details: The vaccine was exposed to 9 degrees F for 9 hours, as well as to 0.3 degrees F for 837 hours and as to 30 degrees F for 542 hours. Digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
About two months after receiving the Moderna Bivalent Booster, I tested positive for COVID. I started experiencing symptoms while in Germany before I headed home. I was on a trip with my spouse and 4 of our friends. Five out of Six of us tested positive for Covid-19. My symptoms included sneezing, body aches, fever, headache and a runny nose. After experiencing these symptoms, I woke up the next morning with just sneezing and a runny nose. I performed two home tests once I got home and they were both positive. I contacted my PCP and he prescribed Paxlovid for me. I took Paxlovid and I feel like it definitely helped me.
Developed mild lip and ear swelling (R>L) and mild redness of upper chest about 10min after receiving vaccine. VS table.   Given 50mg IM Benadryl., within 15 min symptoms resolved. Did c/o mild nausea and drowsiness afterwards. Developed hoarse voice which she stated was a common reaction she has after exposure to allergens due to her "reactive ariway disease."  Monitored for 30 min; no further symptom developed, VS remain normal.  Left with husband; ED precautions given.  Lot# 042L20A Moderna
pediarix was administered to a 7 yr; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number j953n, expiry date 11th May 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th October 2021, the patient received the 1st dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 27th October 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: Adose of pediarix was administered to a 7 yr patient, which led to inappropriate age at vaccine administration. No vaccination history available for the patient. The reporter consented to follow up. This case has been linked to US2021223563, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021223563:same reporter
This spontaneous report as received from a healthcare worker refers to multiple unspecified patients of an unknown age and gender. Medical history and drug reactions were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored PROQUAD (Merck) (lot# reported as 1005292, expiration date reported as "08/17/201" dose and route of administration were not specified). Concomitant medication was not reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Severe h/a, nausea 2 days p/1st dose in post-exp series;
No adverse event. Reporting vaccine administration error. DTAP was administered and patient was above the allowable age range for DTAP. Patient was over the age of 7yrs at the time of administration which is the age cut off for DTAP. Pt. was 9 years old at time of receiving this DTAP vaccine.
Approx at 5 pm on 5-19-15 patient started experiencing dizziness and shaking. Required visit to urgent care. Was treated w/ BENADRYL and sent home. Patient reports experiencing symptoms for 2 days.
Client in for clinic, pregnancy test indicated positive per doctor's orders. Administration of shot was already given, although client reported not pregnant et last menses 2.18.12. No adverse effect currently present.
15 minutes after vaccine- itchy all over-  took benedryl severe fatigue starting the next day vaccine  and lasting for 7 days Arm tender for first 48 hours 9 days AFTER vaccine- area where vaccine given very red, swollen , hot to touch and itchy
This case was reported by a other health professional via call center representative and described the occurrence of needle injury in a adult female patient who received RABAVERT (batch number 584011A, expiry date December 2018). This case was associated with a product complaint. On 23rd May 2016, the patient received RABAVERT. On 23rd May 2016, immediately after receiving RABAVERT, the patient experienced needle injury and puncture site hemorrhage. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the needle injury, puncture site hemorrhage and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the needle injury and puncture site hemorrhage to be related to RABAVERT. Additional details were provided as follows: This case was previously reported to a manufacturer. The age at vaccination was not reported. The patient (medical assistant) successfully opened up the RABAVERT vaccine packaging, while attempting to take the cap off the needle (cap was hard to remove). The patient jammed herself in the finger and drew blood. The dose of RABAVERT vaccine was not administered to the one whom it should have been administered and GlaxoSmithKline was replacing to the pharmacy. The reporter did not know the date of birth of the patient.
8 hours after the shot, my son got arm pain and his arm was hard to move. This lasted for 21 hours, then it came back 24 hours after the shot and that lasted for three more hours. 16 hours after the shot, he got nausea, low fever, belly pain, and change in taste. This lasted for 12 hours. 17 hours after the shot, he had pain in his chest while he peed. This happened again 12 hours later. 26 hours after the shot, he felt lightheaded and dizzy. This lasted 7 hours. 33 hours after the shot, he got a headache. This came and went for 36 hours. 48 hours after the shot, he got belly pain.  This lasted for 24 hours, and this was worse when he peed.48 hours after the shot, he got a sore throat which lasted for 24 hours.
Patient reports arm is red, raised, and swollen after 1 week. Patient also said area is warm to touch.  Patient said that symptoms started the day of the vaccination and are still present.
a day after patient received the fluzone high-dose quad vaccine she came into the pharmacy and said she had requested the covid vaccine instead of the flu vaccine and that she had already received the flu vaccine at a hospital several weeks before.  she said she had no ill effects from the vaccine she had received the previous day.
Heart palpitations; This is a spontaneous report from a contactable consumer or other non-HCP (Patient herself).  A 43-years-old non- pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL0140), dose 2 via an unspecified route of administration, administered in Arm Left on 20Jan2021 11:45 (at the age of 43-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history included migraine headaches. The patient had no known allergies. The patient's concomitant medication included botulinum toxin type a (BOTOX), sertraline hydrochloride (ZOLOFT), zolmitriptan (ZOMIG), montelukast sodium (SINGULAIR), magnesium and ribof. The patient had no other vaccine in four weeks. The patient had no Covid prior vaccination and post vaccination. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL1283), dose 1 via an unspecified route of administration, administered in Arm Left on 30Dec2020 11:45 (at the age of 43-years-old) as DOSE 1, SINGLE for covid-19 immunisation. On 02Feb2021 at 04:00 PM, the patient experienced heart palpitations that started after the second injection and have not subsided. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. The patient did not receive the treatment for the adverse event. The outcome of the event was not recovered.   No follow-up attempts are possible. No further information is expected.
Patient received dose #2 of Moderna vaccine on April 1, 2021. The patient reported that the shot felt like a bee sting and she had fever and chills for 2-3 days. The patient stated that by "day 3," she had swelling and redness of her right arm which continued to get worse, despite using ice. By 4/7, the patient's arm was 2.5 times larger than the other one, swollen down the entire arm and hand. It was red, splotchy, had lesions, and was painful. The patient went to the ER and was admitted to the hospital. The patient was diagnosed with cellulitis. The providers told the patient the vaccine did not go all the way into the muscle but "ran into the tissue." The patient received IV cefazolin x3 days then switched to cephalexin. She was hospitalized for 3 days. The patient is healing and doing better at the time she reported this adverse event to us.
02/16/22 presents to ED for "Respiratory Distress". PMHx of "COPD on chronic 15 L high flow nasal cannula therapy at home, right-sided heart failure"
28JAN92 pt felt warm; temp not measured; had convuls; some vomiting; taken to hosp ER; dx w/ear infection; tx w/ATB; no further convulsions following illnesses or vax;
pt recvd vax & left axillary was swelling progressing down inner aspect of left arm throughout nite approx doubling in size; pt used ice/heat on arm; discoloration fr internal bleeding occured; discoloration cleared up now;
This spontaneous report as received from an office manager via a company representative refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 (dose, route of administration, lot # and expiration date were not reported). On an unknown date, approximately 10 minutes after administration of the vaccination, the patient felt dizzy and fainted. It was also reported that the patient sought medical attention at the physician's office at the time of the occurrence. The outcomes of the events were unknown.  The relatedness between the events and GARDASIL 9 was not reported. Additional information has been requested.
Pt receive his 1st dose of COVID-19 vaccine today at approximately 0915.  At 0930, pt reported feeling "a rapid heart rate, like I have my A-fib again."     Pt was non-ill appearing upon complaint, spoke clearly and was a good historian.   Denied shortness of breath.  Denied N/V Denied dizziness Denied Blurry vision Denied Chest discomfort or chest pain --"I just have the palpitation feeling, but not any pain."   Pt reports a history of A-fib and needing Cardioversion in his past ("about 6 years ago I think."  Pt offered to be seen in ED and states, "yes, I think that would be a good idea.  This is what I felt like in the past when I had A-fib.  I feel it right above my heart."     Pt was moved via wheelchair safely to observation; vitals taken (see flow sheet). Charge RN called to give report; Charge RN arrived quickly to transport patient to ED.
Fatigue, weakness, aches and 101 fever, sore joints.  Rash covering body, tingling in hands and feet with weakness in lower legs. Low blood pressure 102/60 - 106/64. Pain/blood on urination
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sight of injection very painful for 3 days/Could not sleep on that arm) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sight of injection very painful for 3 days/Could not sleep on that arm). At the time of the report, VACCINATION SITE PAIN (sight of injection very painful for 3 days/Could not sleep on that arm) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication details were provided. No treatment medication details were provided.  While driving in the car 10-Oct-2021, patient mentioned that she received a vaccination and sight of injection very painful for 3 days. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Information has been received from a physician concerning a male with possible attention deficit disorder and delayed speech who on an unspecified date was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) rHA (lot # 654896/1180F), varicella virus vaccine live (Oka/Merck) (MSD) (lot # 659071/1475U) and hepatitis A vaccine (inactive) (MSD) (lot # 659186/1258U). While the patient was still in the office, within 1 minute of receiving all three vaccines, he experienced severe stomach ache, became flushed and lethargic. After a little while the symptoms resolved. In the evening of the same day the patient developed hives. The parents called an on-call physician but no treatment was required. It is unknown if this was the first vaccination with each vaccine. The patient sought medical attention via an office visit. The following day the patient recovered. A product quality complaint was not involved. Additional information has been requested.
A spontaneous report was received from a pharmacist concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) that was stored at -20 degrees F, so outside of the temperature range. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. The reporter stated the COVID-19 vaccine was stored at -20 degrees Fahrenheit; outside of the recommended temperature range. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, vaccine that was stored at -20 degrees F so outside of the temperature range, was considered resolved.; Reporter's Comments: This case concerns a patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product storage error without any associated adverse events.
A large raised, red welt at the injection site around 6 hours after the shot. Lasted around 4-5 days. Very hot and itchy. No treatment. Left a slightly discolored patch on my arm
After the first and second shot I have cold sores all over my lips and below my nose.. I have not had any cold sores in 5 years..
Sweating real bad, gotten 10 times worse since she got the shot; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on 01Apr2021 at single dose for COVID-19 immunization. The patient's medical history included ongoing menopause and ongoing sweating. Concomitant medications were not reported. The patient experienced real bad sweating in Apr2021, the patient was in menopause, but it seemed it was gotten 10 times worse since she got the shot. The patient asked whether the vaccine would have run its course and how long it would last. The patient mentioned that she did not think she was running a fever, but just sweating. The patient asked whether the vaccine would cause fever. The outcome of the event was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.