chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided. Vaccine expiry date was on 02 January 2022. Reporter stated that 63 patients received expired vaccine. She also stated that some patients had reported flu like symptoms after receiving the vaccination but she did not have any details on that.
Patient lost range of motion in left arm where vaccine was administered and is still feeling pain in said arm.
Spoke w/ pt and she stated that she was dizzy w/ a H/A, muscle px and stomach ache.  She advised that the sx were worse yesterday and better today, but still present.  Pt stated that she also has redness and swelling on the R arm where she got the vaccines.  Pt was advised to take Benadryl, Anti-Inflammatory and ice the swollen area to see if that helps w/ the sx.  Pt was also advised that if sx get worse or continue to go to ER or Urgent care to be evaluated and treated.
Severe headache, severe body aches/pain, continuous vomiting for 12+ hours, muscle tremors/shaking. Up all night getting sick 12 weeks pregnant- due October 2021
injection site got extremely; injection site got extremely itchy; injection site got extremely red; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (injection site got extremely), VACCINATION SITE PRURITUS (injection site got extremely itchy) and VACCINATION SITE ERYTHEMA (injection site got extremely red) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jan-2021, the patient experienced VACCINATION SITE WARMTH (injection site got extremely), VACCINATION SITE PRURITUS (injection site got extremely itchy) and VACCINATION SITE ERYTHEMA (injection site got extremely red). At the time of the report, VACCINATION SITE WARMTH (injection site got extremely), VACCINATION SITE PRURITUS (injection site got extremely itchy) and VACCINATION SITE ERYTHEMA (injection site got extremely red) outcome was unknown.        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.   No concomitant medications were provided No treatment information provided; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Injection site pain first 24 hours extending across shoulders and neck to other arm. At about hour 38 developed parasthesias of the left arm and complex migraine
Near-immediate left-sided neck pain.  Then noticed left-sided facial numbness.  Mild, left-sided headache.  Also, left lateral aspect of tongue numb.  Pruritus of left hand and arm.  A few hives on left wrist, with scratching.  Did not have wheeze or respiratory difficulty.  Later in the day, felt tired.  Very mild stomach upset and slightly loose stool (once.) Numbness of left side of my face seemed to very gradually improve over several hours.  Nearly resolved by next day.   I would love to better understand these symptoms as I am very hesitant now to get the second dose.   I am a doctor and wonder if I had covid last winter.  Curious about possible blood work, crossing over to a different vaccine for booster, or any advice.  I?ve reached out to other doctors, but no one is sure about these symptoms or the best course of action from here.  Thank you very much.
This spontaneous report as received from a nurse refers to a 22 year old female patient. There was no information about the patient's concurrent conditions, medical history or concomitant medications. On 19-JAN-2018, the patient was vaccinated with the first dose of GARDASIL 9, for prophylaxis (dose, route of administration, lot number and expiration date were not reported). Later on 19-MAR-2018, she would receive the second dose of GARDASIL 9 dose 2 for prophylaxis (dose, route of administration, lot number and expiration date were not reported); however, the reporter was not sure if the patient received DEPO-MEDROL (dose, route of administration, lot number and expiration date were not reported) instead of GARDASIL 9. No adverse effect reported.
Missed the second dose more than 3 months a go; Sick with her other medical conditions after first dose; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick with her other medical conditions after first dose) and PRODUCT DOSE OMISSION ISSUE (Missed the second dose more than 3 months a go) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced ILLNESS (Sick with her other medical conditions after first dose). On 26-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed the second dose more than 3 months a go). At the time of the report, ILLNESS (Sick with her other medical conditions after first dose) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Missed the second dose more than 3 months a go) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medication was provided.
10 minutes afer vaccine, I felt light headed, sweating a lot, and  lost vision and hearing. I fell on the ground. I never lost consciousness and did not hit my head. No injuries. I was helped to a chair and given an ice pack and something to drink. Paramedics were called and examined me. 15 minutes after I fell, I was feeling completely better.
This spontaneous report as received from a other health professional refers to13 patients of unknown age and gender. The patients' pertinent medical history, current conditions and concomitant medications were not reported. On unspecified dates (reported as "between 09-SEP-2016 and 06-OCT-2016"), the patients were vaccinated with improperly stored dose of PNEUMOVAX 23 lot # M000592 and expiry date: 12-OCT-2017 (dose and route were not reported). The vaccine was exposed to temperature of 49 Fahrenheit for 30 minutes. No previous temperature excursion was reported. No adverse effects and no product quality complaint (PQC) was reported. No further information provided. This case was cross referenced with # 1610USA003097, 1610USA004376 and 1610USA004378 (same reporter link). Additional information has been requested.
Case number PHEH2015US023066, is an initial spontaneous report received from a health care professional on 06 Nov 2015. This report refers to a 36-year-old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was administered expired FLUVIRIN (batch number: 1414101) intramuscularly at a dose of 0.5 ml on 28 Oct 2015. The case was reported as non-serious. No adverse event was reported.
Client had received flu vaccination. Health Dept had gone there to immunize staff.  Client noticed blister at injection site that was the size of "a pencil eraser" on 9/22/12. States blister broke open 9/25/12.
PT REPORTED A LARGE BUMP AT VAX SITE WITH REDNESS AND SOME RED BUMPS FURTHER DOWN ARM. PT SAW DERMATOLOGIST AND RECD RXS FOR TAC AND CLINDA TOPICAL SOLN.
Patient developed a red, sore, itchy, and inflamed area around the injection site several hours after injection was given. It was the injection site that the SHINGRIX vaccine was given. Patient was given the shot on Friday and she came back in on Saturday where I observed the reaction.  The area was very red and warm to the touch. She complained of it being itchy. I advised her to try taking some naproxen. She was already on an antihistamine and could not tolerate BENADRYL She also used cold compresses overnight. She came back to the pharmacy on Sunday and the area had grown in size and remained itchy and inflamed due to a reaction. She said the soreness had diminished but it was still itchy. It was warm and hard to the touch in the area. Patient went to the urgent care and was diagnosed with cellulitis. She was given a steroid shot while there and prescribed prednisone, KEFLEX, and ibuprofen and went home to monitor.
No Adverse Event Vaccination Administration Error: We received Moderna Vaccine on 9/2/2021 from our local health department. The expiration date for Lot # 005C21A was 10/22/2021.  We were under the impression that we had until 10/22/2021 to use the vaccine.  The vaccine was properly stored in the refrig. with a data logger attached to ensure temperatures remained within required range. No excursions occurred.  We learned today  (10/27/2021)  from  the local health department, that we should have discarded the vaccine (Lot # 005C21A) on 10/2/2021 (30-days after receivership with refrig. storage). We were instructed to contact Moderna Tx, LLC. this was done today.  During this call this writer was informed that we would hear from the Medical Affairs Team to obtain further instructions regarding how to handle this issue.
Tested positive for Covid; Tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: EL3247), in left arm, on 22Mar2021 as dose 2, single (Lot number: EL3247), in left arm, on 18Nov2021 as dose 3 (booster), single (Lot number: EW0196), in left arm and on 21Apr2022 at 09:00 as dose 4 (booster), single (Lot number: FL3197) at the age of 55 years, in left arm, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ATORVASTIN; CITALOPRAM; OMEPRAZOLE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 16May2022, outcome "recovered" and all described as "Tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16May2022) Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19. It was reported the patient tested positive on 17May2022 via nasal swab.
Pt received vaccine at 0936. At 0941 pt c/o dizzyness, nausea, light headedness and had syncopal episode lasting approximately 30 seconds. 0942 EMS called pt had not eaten, BP 105/63 P- 65 RR -20. 0955 EMS arrived care transfered to them
Very painful arm. Swelling and heat at injection site. Painful through the arm and down the top part of body under armpit.  I have been taking Tylenol.  Did not go to dr.  I was told I should report.
Dizziness 12 hours after vaccine - didn't report until 9-27-11. Patient said dizziness went away shortly.
Pain x 1 month then rash the pain started approx. 2 weeks after injection. Prednisone 20mg taper.
maybe swollen lymph nodes around neck; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (maybe swollen lymph nodes around neck) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced LYMPHADENOPATHY (maybe swollen lymph nodes around neck). At the time of the report, LYMPHADENOPATHY (maybe swollen lymph nodes around neck) outcome was unknown.            Reporter did not allow further contact
Ever since I received the first dose of vaccine, I have had elevated blood pressures and palpitations. I am slightly overweight but my weight has not changed in years. Prior to my vaccine, BP was consistently 1 teens / 70s. It is now consistently 130-140s/ high 80s to low 90s. I?ve also been experiencing palpitations and occasional lightheadedness.
Very sore and tender arm at site of injection, swollen lymphnodes under arm on that side 36 hours after injection, headache starting 4 hours after injection, fatigue, menstrual cycle much heavier than normal
My left arm became hot to the touch and red and was "itchy". By the next morning my arm near the injection site was a bit swollen. By the evening I had several patches of red, rough, itchy skin in other areas (on my hands, left ankle, lower leg, behind my right ear, etc). When I woke up the morning my arm was almost back to normal (still a bit sore but not red and itchy any more). The other patches of itchy skin are much better.
June 23, I started having sore throat, and body aches like the flu. I still have the cough today and I felt horrible. June 26, I went in the morning to visit the doctor because I was still feeling sick days later. The doctor said all my test were negative and he told me to take over the counter mediation. I took anything over the counter I could find to help with the cough. July 8, extreme fatigue.
This spontaneous report as received from a healthcare worker referring to unspecified number of patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date the patients received improperly stored doses of LIQUID PEDVAXHIB lot # L042836, expiration date 24-AUG-2018 (dose, route and frequency unknown) for prophylaxis. The temperature and time frame was reported as 32 degree Fahrenheit) (F) to 35 F for 10 days. There was no previous temperature excursion and it was not because of a data logger.; Sender's Comments: US-009507513-1708USA010211:
I got it at 35 weeks pregnant and my unborn son died less than 3 weeks after getting it - unknown stillborn. Doctors can?t determine the cause. This was my first pregnancy. I had no complications during it. I was due 10/29, gave birth on 10/20. Unknown when infant died in the womb. Birth weight was 5lb 8 oz
DVT LEFT LEG AND PULMONAEY EMBOLISM SHORTNESS OF BREATH ABOUT 6 WEEKS AFTER 2ND DOSE
1.0 ml administered IM, low grade temperature less than 24 hours. She did not measure her temperature, mild muscle soreness at site of injection.
An attorney reported that a male child received series of Orimune, DTaP, Hib, Hepatitis b, MMRII and Varivax vaccines from *Feb. 98 thru "at least" June 99.* birth through 15 months of age. It is alleged that *as a result of the mercury in the thimerosal-containing vax's," the child, now 4 years of age, developed *"toxic neurological effects of mercury poisoning... including injuries, illnesses, and disabilities." According to the legal complaint, the child's injuries are "severe", and he has "been injured permanently". Manufacturer's comment: The reporter indicated that the child received Orimune on 5/1/98 and Hib-Titer on 5/1/98; however, the lot #'s provided are not valid with the reported manufacturer.* No further information on available at the date of this report. Thimersol-induced mercury poisoning was considered medically important.
Swelling of the face, hot, red, rash, itching about 20 minutes after the vaccinations were given.  Patient called the pharmacy explaining her reaction that she was having. Patient was advised to take a benadryl and watch for worsening of symptoms and to go to the ER if anything worsens.
Patient experienced a very sore, red, and warm area around the injection site. The radius around the injection point was around 1 inch. Patient is fine and just wanted to let us know about her reaction. It appeared when she woke up the next morning after receiving the vaccination.
Vertigo; sleepy/feeling sleepy; flu like thing/flu like symptoms; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team, Program ID. The reporter is the patient.  A 75-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Aug2023 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 75 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 01, single), for COVID-19 Immunization, reaction(s): "flu like thing/flu like symptoms", "sleepy/feeling sleepy"; Bnt162b2 (Dose: 02, single), for COVID-19 Immunization, reaction(s): "flu like thing/flu like symptoms", "sleepy/feeling sleepy"; Bnt162b2 (Dose: 03, single), for COVID-19 Immunization, reaction(s): "flu like thing/flu like symptoms", "sleepy/feeling sleepy"; Bnt162b2 (Dose: 04, single), for COVID-19 Immunization, reaction(s): "flu like thing/flu like symptoms", "sleepy/feeling sleepy". The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 18Aug2023, outcome "recovered" (Aug2023), described as "flu like thing/flu like symptoms"; SOMNOLENCE (non-serious) with onset 18Aug2023, outcome "unknown", described as "sleepy/feeling sleepy"; VERTIGO (non-serious) with onset 21Aug2023, outcome "not recovered". Therapeutic measures were not taken as a result of somnolence, influenza like illness, vertigo.  Additional information: patient had a Pfizer booster on Thursday of last week which is about the seventeenth. The day following that patient was kind of sleepy and with a flu like thing for a little while which is pretty typical, patient've had that before with some of your earlier Pfizer vaccines. But yesterday morning, three days plus later, patient woke up with vertigo which patient still have, patient read online that maybe there is an association. Have you seen that reaction or not? Flu like symptoms: Started about 12 hours after the vaccine, the day after vaccine. Got vaccine 17Aug2023, symptoms started 18Aug2023. Outcome of event: Not still experiencing these symptoms, dissipated pretty quickly, in less than 12 hours. Vertigo: Started yesterday morning, 21Aug2023, when he woke up.  Outcome of event: Has stayed about the same.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
This non-serious spontaneous case, initially received from other non-health professional on 13-Nov-2018, concerns a 84-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius (explicitly coded as incorrect product storage). On 30-Oct-2018, the patient was administered FLUAD (TIV) [batch number: 250802, dose, route of administration, anatomical location and expiry date: not reported] which underwent temperature excursion (explicitly coded as drug administration error). At the time of this report, no adverse event was reported. This case 201805531 was crossed linked to original 201804863 due to same reporter.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Nausea-Mild, Additional Details: Patient felt lightheaded and nauseaus after vaccination. Had patient rest in chair. Asked if he needed to be evaluated and he said yes. EMS came and evaluated and he was then able to walk out of the store and refused to be brought to the hospital. Patient was completely fine and walked out.
The patient has a history of dementia. She was brought to the ED by EMS on 4/20/23 for evaluation of weakness. In the ED, she was noted to initially be hypoxic requiring 2L via nasal cannula. Ultimately, the patient was admitted 4/20/23 - 5/3/23. She developed a fever overnight into 4/22. A COVID test was performed on 4/22 and resulted positive. Discharge diagnoses included acute hypoxic respiratory failure in the setting of COVID-19, among other diagnoses. She was able to be weaned to room air prior to discharge. Of note, the patient has received the primary COVID vaccine and two boosters.
Patient had pain upon admission of FLUZONE QUAD. A prefilled syringe was used with a 1" needle. Pain and loss of arm function was reported. Patient saw her physician, 8 days after administration. She was diagnosed with SIRVA. She was treated with oral steroids and physical therapy. Pain is slowly getting better but still continues.
Apr 28th began noticing  right upper abdominal pain, from the sternum area, down and around base of right lower rib cage and toward my back.  A tightness feeling going also toward my back.  Interfering with breathing because pain increase with deeper breath but did not feel short of breath.  Area became tender to touch.  Felt like muscle spasms in "bread basket" area.  These cont'd off and on - affecting size of meals I would eat - too much increase the discomfort.  Self exploring lead me too exercising and deep breathing to advice via website.  Provided some relief and improved breathing ability. By May 2th things became more severe-  3 morning episodes of severe gripping pain, sweats, chills ,nausea, vomiting, weakness - Husband took me to Emerg May 4th. Bld in urine. Kidney scan - no stones; Bld work - normal.  Agan in Emerg June 29th. No medical reason given for the severe pain.  Sent home.
Patient presented to primary care physician with irritation to left deltoid and erythema presenting from deltoid to an area 3-4 inches above the elbow. Area is warm to the touch. Treatment- Patient prescribed KEFLEX by prescriber to be started today (09/21). Patient told to apply cool compresses and to take some BENADRYL. Outcome - Visited PCP. Final resolution of symptoms to be determined, will follow up with patient in 24 - to 48 hours, clinical effects expected to be minimal and are expected to resolve promptly.