chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe throbbing in entire arm, intense back aches, neck pain, insatiable thirst, fever, extreme weakness, easily winded, sneezing, runny nose, exhaustion, brain fog, flush, abdominal bloating, substantial gas, body aches, lack of appetite, increased blood pressure, headaches, bruising and swelling around left eye; almost all of these symptoms lasted a little over one week; other symptoms persist currently, including headaches, abdominal bloating, significant gas, out of breath easily, increased blood pressure, occasional unexplained bruises, neck pain
Slight fever & pain at area, hardness at area about 1 inch in diameter. Hardness persisted at 1 inch diameter.
Vomiting and hives 1-2 hours after receiving vaccines. No respiratory distress.
vial was initially stored in the refrigerator on 6-Oct-2022 and was administered on 7-Nov-2022; No adverse event; Fridge BUD 11/5/22, used on 11/7/22 (lot: 030G22B); This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Fridge BUD 11/5/22, used on 11/7/22 (lot: 030G22B)), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 6-Oct-2022 and was administered on 7-Nov-2022) and NO ADVERSE EVENT (No adverse event) in a 54-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Shingrix (Lot number 557B3 on right arm  intramuscular.) and FluBlok (Lot number QFAA2238 on right arm  intramuscular.). Past adverse reactions to the above products included No adverse reaction with FluBlok and Shingrix.   On 07-Nov-2022, 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 07-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Fridge BUD 11/5/22, used on 11/7/22 (lot: 030G22B)). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 6-Oct-2022 and was administered on 7-Nov-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Fridge BUD 11/5/22, used on 11/7/22 (lot: 030G22B)), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 6-Oct-2022 and was administered on 7-Nov-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (Fridge BUD 11/5/22, used on 11/7/22 (lot: 030G22B)) and NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 6-Oct-2022 and was administered on 7-Nov-2022).    No concomitant medications were reported. Patient received 0.5 mL of Moderna COVID-19 vaccine as dose 1 on 24-Apr-2021 on right arm with Lot/Batch number 008C21A. Patient received 0.5 mL of Moderna COVID-19 vaccine as dose 2 on 22-May-2021 on right arm with Lot/Batch number 026C21A. Patient received Moderna COVID-19 vaccine as dose 3 on 03-Jan-2022 on right arm with Lot/Batch number 060H21A. The pharmacist stated that she had a Moderna vaccine that had been punctured and used. The vial size was 2.5 mL. It was in their fridge for 32 days. Patient was administered a Moderna vaccine from a vial with a fridge BUD of 05-Nov-2022 (removed from freezer and put in fridge on 06-Oct2022) on 07-Nov-2022. Patient had reported no issues and was just waiting to hear back about re-vaccinating.  The patient did not experience a similar event in the past. The vial did not undergo any temperature excursions. No treatment drugs were reported.
6-18-2019 to 6-21-2019 I was feverish, had chills, was fatigued, felt pain in the arm, and had a headache. On 6-24-2019 I awoke with dizziness (4 am) that lasted for 9-10 hours and fatigue that lasted for 4 hours after arising at 9 am.  I also felt pain in my shoulders and had a headache.
after injection on 12/23 had red, raised, warm area lasting 3 days. On friday 1/1/2021 noticed that area came back, warm , red, raised and tender to touch. This lasted until Sunday 1/3/2021. On monday 1/4/21 the is a small amount of redness.
Moderna 1/21 and 2/25 Doing well and ready to proceed with physical rehab so he can return home
A 30-year-old female patient refers, at the end of her post-vaccination waiting time, feeling dizzy. The patient is guided on the importance of not abandoning treatment and maintaining its consistency to avoid incidents caused by not adhering to the indication of daily medications.
Severe tightness in throat & chest, coughing. Took 25 mg of BENADRYL got a little better, took another 25 mg and it went away within 45 min to 1 hr. After 2nd dose O2 sat had dropped to 86% then came back up to 98-100.
Pt complained about blurry vision, nausea & sweating . was able to talk/ Breath , Pt B.P was dropping , had to call EMT & pt was hospitalized.
I63.9 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 10/27/2022 DEHYDRATION J96.10 CHRONIC RESPIRATORY FAILURE 10/13/2022 DEHYDRATION I63.9 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 10/27/2022 SUBCLINICAL HYPOTHYROIDISM J96.10 CHRONIC RESPIRATORY FAILURE 10/13/2022 SUBCLINICAL HYPOTHYROIDISM
It was reported to this writer, RN that 11 year-old male minor patient accompanied by his mother was vaccinated on 11/08/2021 for Pfizer COVID-19 vaccination by LPN at 03:58pm. Patient and his mother reported patient initially tolerated vaccination well and was stable when escorted to clinical site. Around 4:04pm when patient was sitting in post-vaccination observation area with mother, his mother noticed that he was not feeling well while both were sitting in chairs. Mother reports she noticed that her son became disoriented and per her report ?began bobbing his head back and forth with his eyes closed?. It was reported to this writer that RN who was assisting in supervising patients in the post-vaccination observation area responded while patient was seated and assessed that he was pale and drowsy. RN reported she gave the patient apple juice. Shortly after the patient stated that he felt better and was escorted by RN with mother present to private medical cot area to lie down. This writer immediately responded to the medical incident to support clinical staff and observed the patient was stable but still pale. RN took serial vitals for patient that were within defined limits. Patient was given more apple juice and said he felt better at 04:09pm and told his mother with clinical staff present that he only had a small snack after school and 1 hour before his mother had picked him up from school. Patient also stated that when clinical staff in post-observation area began talking again about possible vaccine side effects with mother that patient said he got scared and anxious. After 10 minutes of resting on the medical cot with mother and RN staff present and another round of stable vital signs noted by RNs, patient stated he felt good and slowly stood up at the side of the cot. Patient denied any dizziness or feelings of weakness. Patient skin color returned with defined limits, no paleness noted. Patient ambulated in the care of his mother who was driving them both home at that time out of the clinic without any issues or adventitious findings at 04:21pm.
10 x 10 cm large pink area with center more brownish color noted next day after injection, warm to touch, temp. 99.1, no drainage or fluctuance.
soreness in arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 60 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 22Mar2021 (Batch/Lot number: unknown) at the age of 60 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID], start date: 2011 (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 22Mar2021, outcome "recovered" (23Mar2021), described as "soreness in arm". Therapeutic measures were taken as a result of pain in extremity. Additional information: Clinical course: The patient wanted to know when can he safely resume his aspirin maintenance therapy after receipt of the Pfizer-BioNTech COVID-19 Vaccine. The patient has been on aspirin 81 mg for many years (at least 10 years) as maintenance therapy. He has many health issues (unspecified). The patient stopped aspirin on his own, on either Friday or Saturday (19Mar2021 or 20Mar2021) in preparation for receipt of the Pfizer-BioNTech COVID-19 Vaccine. He got his first dose of the Pfizer-BioNTech COVID-19 Vaccine on Monday, 22Mar2021 and took a couple of paracetamol (TYLENOL) that same night because of soreness in his arm. The next day he was okay. The patient has not resumed his aspirin yet and planned to speak further with provider.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Received Pfizer vaccines on  1/27, 2/17, 11/18/21 COVID-19 positive by PCR on  1/18/22 admitted to hospital on 1/19/22 d/t bacteremia, fever, dyspnea, bilateral pleural effusions
Joint aches, shortness of breath, 4" redness at injection site, 1 1/2" knot. Generalized malaise. Eval. by MD-Dx as "allergic rxn." TxZ: Atarax pan. No hospitalization req'd.
Information has been received from a nurse referring to a patient of unknown age and gender. Concomitant therapies included sterile diluent. Information about concurrent condition, drug reactions/allergies and medical history was not provided. On 19-JUL-2018, the patient received one dose of improperly stored (-9 Celsius (C) degree to 8 C degree for 68 minutes; previous temperature excursion: -9 C degree to 8 C degree for 76 minutes) PROQUAD (rHA, lot # R002931, expiration date 29-JUL-2019; strength and route were not reported) for prophylaxis; reconstituted with properly stored sterile diluent (as reported lot# M039639, expiration date 28-MAY-2019). No adverse effects reported. The reporter called because of a data logger. Sender's Comments: US-009507513-1809USA005628: US-009507513-1809USA011283: US-009507513-1809USA011743: US-009507513-1809USA011745: US-009507513-1809USA011746: US-009507513-1809USA011747: US-009507513-1809USA011748: US-009507513-1809USA011749: US-009507513-1809USA011750: US-009507513-1809USA011751: US-009507513-1809USA011752: US-009507513-1809USA011753: US-009507513-1809USA011754: US-009507513-1809USA011755: US-009507513-1809USA011756: US-009507513-1809USA011757: US-009507513-1809USA011758: US-009507513-1809USA011759.
Patient said she had a really bad cold for about 7-10 days after she had the high dose vaccine. She said the "flu" and wanted us to report the incident.
Pericarditis - went to the Emergency Room, advised to take NSAIDs for the next two weeks until the chest discomfort went away. It never did, and it's been three months since my vaccine.
SLEPT A LOT; FEELING VERY TIRED; This spontaneous report received from a consumer concerned an 89 year old male. The patient's height and weight were not reported. The patient's past medical history included artificial valve surgery, and pacemaker surgery, and concurrent conditions included non smoker, sepsis, cancer on shin bone and radiation burn and other pre-existing medical conditions included no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A  and expiry: 23/JUN/2023) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. Concomitant medications included amoxicillin for sepsis. On APR-2021, the subject experienced slept a lot. On 13-APR-2021, the subject experienced feeling very tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling very tired on 15-APR-2021 and the outcome of slept a lot was not reported. This report was non-serious.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 31-MAR-2014, the patient was vaccinated with an expired second dose of ROTATEQ (lot # H016259, expiration date 26-MAR-2014), strength: 2 ml (dose and route not reported). The healthcare worker mentioned the ROTATEQ in question did not have any previous temperature excursions. No adverse symptoms reported. It was unspecified if the patient sought medical attention. Additional information has been requested.
Shot given, 5-10 minutes became dizzy c/o HA, stomach, legs shaky.  When tried to walk, almost fell because legs weak & shaky.
This spontaneous report has been received from a registered nurse. The reporter stated that improperly stored doses of VAQTA (strength, dose number, route not reported, lot number L028666 expiration date 04-NOV-2016) were administered to an unspecified number of unspecified patients on unspecified dates. No adverse effects were reported. No further information was provided. This is one of several reports from the same source. Additional information has been requested.
gave a adult patient an expired Daptacel instead of Adacel, no advesre event; gave a adult patient an expired Daptacel instead of Adacel, no advesre event; gave a adult patient an expired Daptacel instead of Adacel, no advesre event; Initial information was received on 05-Feb-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 57-year-old female patient who was vaccinated with a 0.5 ml dose of expired DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot C5367AA and expiration date 30-Jan-2020) via an intramuscular route in the left deltoid on 03-Feb-2020.  Medical history was not reported and the patient did not receive any concomitant medications.  It was an actual medication error case due to expired vaccine used, wrong vaccine administered and inappropriate age at vaccine administration.  No adverse event was reported at the time of reporting.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
joint pain in left arm; pain initially in the right arm which seemed to the at the joints; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (joint pain in left arm) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 11-Jan-2021, the patient experienced ARTHRALGIA (joint pain in left arm). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 13-Jan-2021, ARTHRALGIA (joint pain in left arm) had resolved.            Reporter did not allow further contact
Patient came to pharmacy 6/19/17 stating she was diagnosed with a cellulitis due to the ZOSTAVAX immunization given on 6/16/17. I am unsure of the timing of the symptims.
burning  + itching sensation and large hives on back of right buttock and thigh.  It started 24 hours after vaccination.  It may have something to do with the Botox.  I had many bad side effects from the Botox.  I put Benedryl and cortison creams on leg and buttocks . It is still there 26 hours later.  It has reduced in size and intensity
This spontaneous report as received from a licensed practical nurse (also reported as registered nurse) refers to an unknown number of patients of unknown age and gender. Since 02-JAN-2015, an unknown number of doses of ROTATEQ (dose, route, anatomical location, lot # and expiration date were not reported), which underwent supported temperature excursions, have been administered to an unknown number of patients. No adverse effect reported. This is the one of several reports from the same reporter source. Additional information has been requested.
At injection site visible bruising surrounded by red splotchy rash appearance. Palpable lump and swollen left bicep and arm pit. Day after muscle aches in neck, sore throat, fatigue, fever and headache.
After shot #1 my lower legs and forearms started itching, not on the surface of the skin, but itching just below the surface. The itching area slowly increased over time. After #2, the itching grew much worse. I'm now 7 days past shot #2, and the itching really bothers me. There isn't any swelling or redness, but I keep scratching, which makes it red. I've never had these symptoms before. Perhaps it is a reaction to the Pfizer vaccine?
large clot in his great saphenous vein identified today when he saw Dr. on ultrasound
She got the vaccine, had some soreness, but nothing much.  Yesterday had some pain, but not too bad.  Woke up this morning with pain and swelling of her hand.  There is a knot at the injection site, and about 2.5 cm in circumference, and itching, and the knot is brown and discolored.  She has not taken anything for it, and is going to call her doctor for recommendations.
After receiving the vaccination the patient had a lot of pain where she got vaccinated. She also developed a very large bruise that turned very dark.
7 hours after shot: Mild Headache 15 Hours after shot: Extreme Nausea (although I did not vomit), intense chills, moderate headache, slight fever
Very bad shakes, fever, rash, arm still hurts, doesn't want 2nd dose.
w/in 10-12 mins p/vax pt vomited, c/o SOB, turned red all over including palms of hands & soles of feet according to mom;mom feels seemed slow or sleepy;pvt MD advised DPH;mom states back to nl in 15-20mins p/DPH, redness gone, fully alert
I am having issues of bulging veins in my leg.  They surfaced about 3 weeks after the vaccination was received. They did not go away, have continued to get worse, and become painful during every day life.
Initial information received on 15-Oct-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a 52 years old female patient who was vaccinated with a dose of DIPHTHERIA AND TETANUS TOXOIDS On 11-Oct-2018 instead of ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient was not vaccinated with any other vaccines on that time. It was a case of actual medication error due to wrong vaccine administered. It was unknown whether the patient experienced any adverse events. 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "recovered", MALAISE (non-serious), outcome "recovered" and all described as "achy and was not feeling great for a brief period after the shot but it was not anything too bad; states someone else she works with had this same experience and got the shot and this went away"; FATIGUE (non-serious), outcome "unknown", described as "got maybe a little tired and thinks a fever 24 hours after the event then clarified it was not fever but achy and was not feeling great for a brief period". Additional information: It was reported that the patient herself got might be a little tired and thinks a fever 24 hours after the event then clarified that was not fever but achy and was not feeling great for a brief period after the shot but it was not anything too bad; states someone else she works with had this same experience and got the shot and this went away and that was all this person she works with got and this person had the Pfizer vaccine and everyone at the facility had the shot too and she has no patient details to provide or any lots, expiry dates or NDC numbers to provide for her coworker. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Employee  requested the vaccine be given in gluteal muscle and the nurse assigned to the vaccine clinic administered Covid-19 vaccine in the gluteal muscle. Nurse made aware that immunizations are to be given in the deltoid. Employee was notified by the nurse that the gluteal muscle was not studied and that the recommended site is the deltoid and advised that the next injection will be administered in the deltoid.
14 days after receiving the second dose, I experience gout like symptoms on my left foot (below big toe). This lasted for about 3 weeks which during  this time I received medical treatment from my doctor.  X-rays and blood work were conducted along with medication to reduce the swelling was prescribed.
Covid symptoms started in the morning but I blew it off, but when I didn't feel better I thought I was having a reaction to bleach. That afternoon I couldn't get off the couch. I tested positive on 02/01/22. I had a headache, fever, sore throat, and they swabbed me at urgent care and I went home and swabbed again and it was positive. The next day I went to the doctor and tested positive again and they gave me ivermectin and a steroid and sent me home. 2 days later I went to the ER again because I got worse and they pulled me off all the medicine from the first ER visit and gave me IV protonic and fluids and sent me home and I eventually got better and tested negative on 02/14. I also started throwing up and had low oxygen levels and body aches 3-4 days after testing positive. On the 6th day I loss sense of taste. After this I had 11 kidney stones since 02/18 and I was diagnosed with kidney failure this past Thursday.
Moderna Dose 2 adminster 4/30/21. Fever developed within 24 hours, bad flu-like symptoms. Hour 48:  Troubling symptoms after fever lifted. Brain fog, headache, chest tightness, light headedness, nausea, low energy. Neurological symptoms felt concussion like. Flu-like symptom resolved very rapidly after 36 hours. Headache persistent. Week 2: Brain-fog, lightheadedness, chest tightness, low energy, low ambition, insomnia. Took 20 hour sick leave. Visited two physicians. BP Normal. Blood work normal. Day 19: Persistent symptoms: Shortness of breath, chest tightness, headache, brain fog, low energy. Day 20: Symptoms persistent w/increasing severity.  SYMPTOMS RESOLVED FOLLOWING TREATMENT contact me for details
After receiving most recent injection throat swelled up within a couple of hours and had a headache. Next day became nauses with another headache.Throat still soar and swelled as of todays date.Injection site is still soar and red with a raised itchy bump.