chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The vial was initially stored in the refrigerator on 11-Jan-2022 and administerd on 02-Mar-2022; Patient received expired dose after the 30 day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose after the 30 day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and administerd on 02-Mar-2022) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 044B21A and 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose after the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and administerd on 02-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose after the 30 day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and administerd on 02-Mar-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The patient received expired booster 1 dose. It was reported that the staff were not dating the boxes of vaccine when placing them in the fridge for storage. The vial was initially stored in the refrigerator on 11-Jan-2022. The dose administered more than 30 days after 11-Jan-2022 was not in accordance with a Regulatory Authority. The vial did not undergo any temperature excursions. The patient had not reported adverse reaction to the HCP knowledge. No treatment information was reported.
Body aches; chills; headache; fatigue; This is a spontaneous report from a contactable nurse (patient).  A 50-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration at right arm on 11Jan2021 at 10:45 at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration at left arm on 23Dec2020 at 17:30 at single dose for COVID-19 immunization. On 12Jan2021 at 02:00, the patient experienced body aches, chills, headache and fatigue. The patient outcome of the events was recovering.
Rather than rabies immune globulin being administered at a different location than the imovax rabies injection, they were administered at the same location (deltoid muscle) with no reported adverse event; Initial information received on 01-Jul-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age male patient in whom rather than rabies immune globulin being administered at a different location than the imovax rabies injection, they were administered at the same location (deltoid muscle) with no reported adverse event while receiving vaccines rabies vaccine and rabies (HDC) vaccine [Imovax rabies].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect rabies (HDC) vaccine Injection (strength, dose, lot number and expiry date not reported) via intramuscular route in deltoid muscle and a dose of suspect rabies vaccine produced by unknown manufacturer (formulation, strength, dose, lot number and expiry date not reported) via intramuscular route in deltoid muscle, both for Post exposure immunization.  On an unknown date, the patient was rather than rabies immune globulin being administered at a different location than the imovax rabies injection, they were administered at the same location (deltoid muscle) with no reported adverse event (product administered at inappropriate site) following the administration of rabies (HDC) vaccine rabies vaccine.  Action taken was not applicable.  Outcome: 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 guidelines. 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.; Sender's Comments:  01172953:
Pain at injection site. Fever/chills, night sweats, all over achy, fatigue. On 4/29/21 a large lump appeared on my collar bone on the same side as my injection.
Patient developed hives 6 hours after immunization without difficulty breathing, cough, or voice changes.  Patient with no known prior exposure to eggs.
Patient said while she was waiting the required 15 minutes after vaccine that she had some chest pains (which she claims she had on and off before she came in for the vaccine) and a burning sensation in her vaginal area.
Pt had MMR and Varicella vaccine administered. and in the afternoon the pt developed macular, erythematous rash on trunk and extremities. No fever. Happy and playful.
This case was reported by a healthcare professional (nurse) via sales representative and described the occurrence of injection site pain in a female subject of unspecified age who was vaccinated with FLUARIX (GlaxoSmithKline). On 23 or 24 October 2013 the subject received unspecified dose of FLUARIX (unknown). In October 2013, within days of vaccination with FLUARIX, the subject experienced injection site pain, injection site redness and swelling injection site. The nurse reported that she has seen an increase of pain, redness and swelling at the injection site after FLUARIX in five female subjects; no other details were provided. The vaccine was administered between 23 and 24 October 2013. At the time of the report no other information was provided. The outcome of the events were unspecified. For the other cases please see A1048965A-A1048968A.
24 hrs after injection redness, itchiness, and rash right and left hands and around inject site.
Patient got first dose of COVID vaccine today and approx 10 minutes later he went to restroom and felt "like I was suffocating and could not catch my breath". denied any swelling, itching, or rash. patient has hx of COPD and wears home O2 at 3L.EMS was called and transported him to the Emergency room. He was given 3L oxygen and monitored for 2 hours. He was then discharged with the diagnosis of Dyspnea ( difficulty breathing)
chills; shivers; feel very cold on the inside; No sleep at all; feel very warm on the outside; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), on 16Jul2022 at 13:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Prostate Cancer" (unspecified if ongoing), notes: Other medical history: Prostate Cancer. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1, Unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 3, unknown manufacturer), for COVID-19 Immunization. The following information was reported: FEELING HOT (non-serious) with onset 16Jul2022 at 21:15, outcome "recovering", described as "feel very warm on the outside"; INSOMNIA (non-serious) with onset 16Jul2022 at 21:30, outcome "recovering", described as "No sleep at all"; CHILLS (non-serious) with onset 16Jul2022 at 21:30, outcome "recovering"; NASOPHARYNGITIS (non-serious) with onset 16Jul2022 at 21:30, outcome "recovering", described as "feel very cold on the inside"; CHILLS (non-serious) with onset 16Jul2022 at 21:30, outcome "recovering", described as "shivers". Therapeutic measures were not taken as a result of feeling hot, chills, chills, nasopharyngitis, insomnia.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt recv vax on 1/26/99; on same day pt exp vax site pain, red, swelling, fingers numb, cold lips; tx=cool compress, Ibuprofen/Tylenol, Benadryl
Initial report received from a patient who is a health care professional in the USA on 13/Oct/2005. A 37 year old female patient developed a metallic taste in her mouth, her BP was 120/101 and she felt "fuzzy" approximately 10-15 minutes after receiving the injection of Fluzone, lot number U1754AA in the right deltoid on 12/Oct/2005. Patient denied dizziness. Stated BP normalized 10-15 minutes later. Duration of the metallic taste and fuzzy feeling was two hours. No other signs or symptoms were reported. As per reported the patient recovered. Follow-up information received on 21/Feb/2006 from a health care provider. The case was reviewed, and the reported has no additional information.
4 cm erythemic wheal over injection site. Blanches to pressure, no drainage.
Itching on back of head first sign.  Occasional itchy still. Terrible hot spot on left shoulder blade which still hurts when I put pressure on it as in my recliner. Rash on left side of trunk and below knee.  Rash went away after 4-5 days. Slight fever and headache for 24 hours.
tiredness; light headache; This spontaneous case was reported by an other health care professional and describes the occurrence of FATIGUE (tiredness) and HEADACHE (light headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022m20a) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced FATIGUE (tiredness) and HEADACHE (light headache). At the time of the report, FATIGUE (tiredness) and HEADACHE (light headache) 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.   Concomitant product use was not provided by the reporter.  Treatment information was not provided. The patient stated that she is small and maybe the doses were too high for her.
Muscle aches started about 12hours after shot, fever started around 16 hours after shot ranging from 99.4 - 102.4. Took Tylenol at 7:30 am and 3:30 pm.  Fever subsided around 9 pm and fatigue is still ongoing
seizure; faint; feeling dizzy; drained again; his lips lost their color; difficulty hearing; nauseous; sweating profusely; This is a spontaneous report from a contactable pharmacist. An adolescent male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: Er8736), intramuscular, administered in Arm Left on 30Apr2021 20:30 as 1st dose, single for COVID-19 immunization. Medical history, none known. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient's concomitant medications were not reported. The patient reported no previous adverse events with prior vaccinations, specifically dizziness or fainting. After the shot he went to the bathroom, returned fairly quickly & reported feeling dizzy and quickly took a seat and thought he might faint. Soon thereafter he seemed to have a seizure. His eyes remained open but rolled back, he stayed upright but was unresponsive.  They removed his mask & his mother & they kept talking to him. It ended after about 10 seconds & he asked how long he had been out. His color was momentarily better, but drained again & his lips lost their color. They asked if he had any difficulty breathing and he did not. He reported that he had difficulty hearing (like he had headphones on) & was sweating profusely.  His mother kept encouraging him to take deep breaths, they got him some water & asked if he had a history of hypoglycemia- he did not. They asked if they could get him a candy bar& they asked for a granola bar which they acquired.  He was too nauseous to eat it & asked. The events started on 30Apr2021 20:30. No treatment was given. The outcome of the events was recovered.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the seizure and the other reported events  due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including EEG and head CT/MRI, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Left upper arm redness, warmth, swelling from below shoulder to elbow.  Perimeters marked by hospital ER.  Lab work done at hospital.  Report by patient WBC elevated.  Received injection about 2:40 p.m., 1st symptoms occurred at 4:40p.m.  Treated self for 24 hours then received medical care at ER.  Received IV antibiotic and prescription for Clindomycin po 300 QID.  Diagnosis from physician as reported by patient was cellulitis.
Patient presented to the pharmacy at approximately 3 pm 5/29/2021 to discuss what they believed was a reaction to the second dose of the Moderna COVID-19 mRNA vaccine. They showed me that their right arm where they got the vaccine on 5/24/2021 was red. Patient stated that they started to notice the redness and irritation the day after vaccination. They also stated that the area started as a small red area about a day after vaccination but has since started to spread. Additionally, patient went on to say that in addition to the redness of the skin around the vaccination site, that the area was warm to the touch and was itchy. Patient stated that they had begun taking Benadryl which has seemed to help reduce the redness somewhat in their opinion. My best estimation of size of the affected area is roughly 3 inches in diameter. I advised the patient that the Moderna vaccine has been known to rarely cause a delayed hypersensitivity skin reaction, but also there is a possibility that there may be the presence of cellulitis or other related skin infection. Due to the fact that the area has appeared to spread, has not shrunk in size and that it has now been 5 days since vaccination, I advised the patient to seek a physician's opinion to determine if there is an infection, or if it is merely a mild skin reaction to the vaccine.
"Paralyzed from flu shot given at work."  Flu shot given on 10/6/2016.  Just reporting this to us on 6/20/2017.
Information has been received from a physician concerning a patient who was vaccinated PO with the first dose of Rotateq. The physician reported that the patient developed bloody stool roughly 3-4 weeks after being vaccinated. it was unknown if medical attention was sought. At the time of this report, the outcome was unknown. Upon internal review, bloody stool was determined to be an other important medical event. Additional information has been requested.
Pt recvd vax & exp pain @ the inject site which lasted about 7 to 8 mins a/resolving; pt also c/o sore & heavy arm all day;
Vaccine administered past expiration date. Vial was moved from freezer to fridge on 10/7/21 with a 30 day expiration date of 11/6/21.
Numbness on the finger tips; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on an unknown date (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any allergies to medications, food, or other products. The patient had not received any concomitant medications within two weeks of the COVID vaccine. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 29May2021, the patient experienced numbness on the finger tips. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event numbness on the finger tips was unknown at the time of this report.  The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
About 2-3 hours following the injection, my arm was sore down to my wrist.  I could not raise my arm without pain. I've never had a poor reaction to vaccinations before. I couldn't get comfortable to sleep that night. I'm a dental hygienist and if I had to work chairside the next day I would not have been able to. By morning, my arm was very red, not at the injection site, but several inches below it - basically my biceps, including the underside of my arm and up into my shoulder. By day two, it was still red and swollen. The margins around the areas were very distinct and raised. But, the pain was greatly diminished and I was able to see patients. The muscles in my arm were sore for a few more days, but manageable.
My otherwise normal hormonal cycle has been completely disrupted.  After the first vaccine shot on March 4th, I had irregular bleeding following my period, but not heavy and because it was super light, I considered it unnoticed.  However, after the second vaccine on March 25, I had heavier cramping exactly during the time I would normally have my period, but no period came.  I am now 6 days late, which has never happened to me.  I had all of the cramping and symptoms of a timely cycle, but no period at all!  My cycle is normal, if not a day early.  Never late.  Additionally, the day after the shot, I had an enlarged lymph node under my arm pit for a few days that moved to a sensitive breast.   Something is definitely wrong.
Chest pain; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0168) via an unspecified route of administration in the right arm on 04May2021 at 11:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included obesity. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7533) via an unspecified route of administration in the left arm on 06Apr2021 at 15:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. On 04May2021 at 14:00, the patient experienced chest pain. The event chest pain did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event chest pain was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Back pain/back pain in her low back; Pain in the arm where she received the actual vaccine; The right arm pain shot down her arm, into her hand and pinky finger; Tingling in her right arm; Her throat became itchy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Apr2021 09:30 (Lot number: ER8737) at the age of 41 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for hypothyroidism (ongoing). The following information was reported: BACK PAIN (non-serious) with onset 15Apr2021, outcome "not recovered", described as "Back pain/back pain in her low back"; PARAESTHESIA (non-serious) with onset 14Apr2021, outcome "recovered" (14Apr2021), described as "Tingling in her right arm"; THROAT IRRITATION (non-serious) with onset 14Apr2021, outcome "recovered" (14Apr2021), described as "Her throat became itchy"; VACCINATION SITE PAIN (non-serious) with onset 15Apr2021, outcome "recovered" (15Apr2021), described as "Pain in the arm where she received the actual vaccine"; PAIN IN EXTREMITY (non-serious) with onset 14Apr2021, outcome "recovered" (14Apr2021), described as "The right arm pain shot down her arm, into her hand and pinky finger".  Additional information: She experienced back pain. Her experience started initially at that moment when she was being monitored after receiving her first dose. She experienced tingling in her right arm, but she had the injection in her left arm. The right arm pain shot down her arm, into her hand and pinky finger. Her throat became itchy. She wants to say 1 day later, she experienced pain in the arm where she received the actual vaccine. Her left arm. It lasted for only 2 and a half hours. A day later, she experienced back pain in her low back that lasted 4 days and came back on 29Apr2021, not as severe. The pain isn't as severe as it was on Thursday, but if she moves a certain way, she is back in pain. She has not been moving as she is used to and the pain has subsided, then clarifies her back pain is persisting and it comes and goes. No previous immunization with the Pfizer vaccine. No additional vaccines administered on same date of the Pfizer suspect. No prior Vaccinations (within 4 weeks). No illness at time of vaccination.  No follow-up attempts are possible. No further information is expected.
Sore Arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore Arm) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm). On 25-Jan-2021, PAIN IN EXTREMITY (Sore Arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no treatment and concomitant medication reported.   This case was linked to MOD-2021-044239 (Patient Link).
Headache shortness of breath, injection site pain Narrative: patient reports shortness of breath resolved with rest; no treatment needed for headache or injection site pain