chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse and refers to a small amount (unspecified total) of patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL lot # K005881, expiration date 14-JAN-2017 (dose and route of administration were not reported. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 13-MAR-2013 at 09:20 am, the patient was vaccinated with RECOMBIVAX HB (lot # H018689 and expiration date 07-NOV-2014) (dose, therapy route and anatomical location unspecified). The physician reported that on an unknown date, RECOMBIVAX HB was exposed to multiple low temperature excursions. The excursion time at -1 was 124.50 hours (also reported as 17 hours -1, then 291, 2 admin). The patient was not experiencing any known symptoms. This is one of several reports from the same source. Additional information has been requested.
Having a little bit of queasiness; Her lymph node was swollen; cannot move left arm at all - the arm she got her shot in.; Knot in her left arm; excruciating pain in her left arm, so bad she can't even lift her arm; Her left arm was swollen at the site; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Having a little bit of queasiness), VACCINATION SITE LYMPHADENOPATHY (Her lymph node was swollen), VACCINATION SITE MOVEMENT IMPAIRMENT (cannot move left arm at all - the arm she got her shot in.), VACCINATION SITE MASS (Knot in her left arm) and VACCINATION SITE PAIN (excruciating pain in her left arm, so bad she can't even lift her arm) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced NAUSEA (Having a little bit of queasiness), VACCINATION SITE LYMPHADENOPATHY (Her lymph node was swollen), VACCINATION SITE MOVEMENT IMPAIRMENT (cannot move left arm at all - the arm she got her shot in.), VACCINATION SITE MASS (Knot in her left arm), VACCINATION SITE PAIN (excruciating pain in her left arm, so bad she can't even lift her arm) and VACCINATION SITE SWELLING (Her left arm was swollen at the site). At the time of the report, NAUSEA (Having a little bit of queasiness), VACCINATION SITE LYMPHADENOPATHY (Her lymph node was swollen), VACCINATION SITE MOVEMENT IMPAIRMENT (cannot move left arm at all - the arm she got her shot in.), VACCINATION SITE MASS (Knot in her left arm), VACCINATION SITE PAIN (excruciating pain in her left arm, so bad she can't even lift her arm) and VACCINATION SITE SWELLING (Her left arm was swollen at the site) 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.   The patient was taking concomitant medications including medicines for blood pressure and thyroid  Treatment details included Tylenol, Asper cream, Heating pad.   Reporter did not allow further contact
On 10/15/21, the patient received her second dose of Moderna COVID 19 vaccine.  The vaccine was given before the expiration date was checked and the vaccine expired on 10/14/2021.  No adverse events have been reported by the patient.
Patient reported feeling dizzy within 5 minutes of receiving vaccine, she was placed in clinic chair with legs elevated, her blood pressure remained stable and was taking every 5 minutes, she then reported feeling tightness in her chest.  50 mg IV Benadryl was administered per allergic reaction protocol and medical director was notified.  IV line connected to slow NS drip.  After administration of IV Benadryl she reported that chest tightness was no longer there but she still felt dizzy, lightheaded and now cold.  Continuing with protocol 100mg solumedrol was administered via port in IV saline line. Continued to take BP every 5 minutes.  She began to feel better/normal, we continued to monitor for roughly 20 minutes after all symptoms resolved.  Left clinic and had no more reported symptoms throughout the day.
Soreness to injection site, fatigue, fever, chills, body ache and nausea.
The patient received a lower than authorized dose of Moderna. They were supposed to receive a full dose of Moderna to complete their primary series but were given a booster dose of Moderna instead. They were informed of the administration error immediately and rescheduled to repeat their dose.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported.   Follow up information has been received on 22-JUL-2014 from a receptionist. The reported stated that there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot#J016188, expiration date: 02-OCT-2016 and lot #J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share.   Follow up information has been received from the registered nurse who provided patients details. This report refers to a 11 weeks old infant patient of unknown gender. On 23-JUL-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported, lot# J015437, expiration date 09-OCT-2016) that was improperly stored. No adverse effects were reported. This is the one of several reports received from the same reporter. Additional information is not expected.
This spontaneous report as received from a healthcare worker via a field representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot # J001010, expiration date 24-APR-2014) (dose not reported). The healthcare worker reported that the patient contact they physician's office by phone on 08-JUL-2013 to report that she was experiencing "significant" redness and blistering of her arm at the injection site, after receiving ZOSTAVAX. The healthcare worker also reported that the patient took a photograph of her arm and sent it to the physician's office. At the time of reporting, the outcome of the events was not reported. Additional information has been requested.
1 YO received Kinrix; extra dose of Kinrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 1-year-old male patient who received DTPa-IPV (Kinrix) (batch number H9FM5, expiry date 7th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis and dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 2nd dose of Kinrix, Kinrix Pre-Filled Syringe Device, the 1st dose of Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix, Kinrix Pre-Filled Syringe Device, Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and extra dose administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and extra dose administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 23-Aug-2022 Reporters comment: A nurse reported that a 1 year old patient received an extra dose of Kinrix. The reporter reported that the extra dose was not administered on the same day, it was administered months after the 1st dose. The reporter consented to follow up. Additional Supportive Information: The patient received an extra dose of Kinrix at inappropriate age, which led to inappropriate age at vaccine administration and extra dose administered.
Patient had redness around the site for 7 days, was scabbed & warm to the touch.
On a 4th day after injection - my troat become inflamed and next day bad caugh  started to the point that I was not able to work, experienced body chills,  was not able to talk as voice got very harsh, was choking when talked and vomited a bit exactly as COVID symptoms. On May 9 had to go to urgent care to do COVID 19 PCR . Prednisone and benzoate were prescribed.
Nausea, vomiting, chills/sweats, headache, 101.6 fever that caused dehydration, low blood pressure with high heart rate, passing out and a type two heart attack while pregnant.
Headaches, nausea, side pain and body aches - symptoms started the day after receiving vaccine.
This spontaneous report as recovered from a healthcare worker (also reported as Certified Medical Assistant (CMA)) refers to unspecified patients (less than 5) of unknown age and gender. Concomitant medication and pertinent medical history were not provided. On an unknown date, the unspecified patients were vaccinated with improperly stored LIQUID PEDVAXHIB (lot#, dose, route and frequency were unknown). The reporter was at the early stage of identifying how many patients were involved, so she was unable to provide further details at this time. No adverse symptoms reported. The outcome of the events was unknown. This is one of several reports received from the same source. Additional information has been requested.
0.2cc undiluted Pfizer 5-11 administered in Left Deltoid on 12-30-21 at 1030. the error was noted after administration and the mother was notified at 1200 that day. At that time, the client had no side effects. On 1-5-22 the mother was interviewed. She reported that the client had "a little soreness" at the site of administration and "a little headache". No fever, No redness, No swelling. the mild symptoms lasted one day.
Mild to moderate hives and rash all over body; Mild to moderate hives and rash all over body; This is a spontaneous report from a contactable consumer (patient's husband). A 34-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on 05Jan2021 at a single dose for COVID-19 immunization. Medical history included allergy to penicillin as a child, high blood pressure. The patient has no known food allergies. Concomitant medication included unspecified high blood pressure medication for a month and half. The patient experienced mild to moderate hives and rash all over body on 13Jan2021. She was prescribed with cetirizine (ZYRTEC), diphenhydramine hydrochloride (BENADRYL) and unspecified steroid. The outcome of the events was unknown. She is scheduled for her to take the second dose on 25Jan2021, the reporter was asking if the patient can still take it.   Information about batch/lot number has been requested.
Began w/headache and chills approx. 10 PM, no fever.  Chills continued till approx 2:30 AM; headache finally subsided approx 9:30 AM after taking 600 mg OTC ibuprofen at 8:30 AM.
Muscle pain (not simply aches); Joint pain (not simply aches); 102 Fever; Extreme shaking chills; Extreme fatigue; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 01Apr2021 at 09:15(at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to two antibiotics and COVID-19. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medications included simvastatin (MANUFACTURER UNKNOWN), ergocalciferol (VIT D), biotin (MANUFACTURER UNKNOWN), acetylsalicylic acid (ASPIRIN) and krill (MANUFACTURER UNKNOWN); all for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 01Apr2021, the patient experienced muscle and joint pain (not simply aches), 102 fever, extreme shaking chills (fever not present at that time) and extreme fatigue. On the same day, the patient underwent body temperature test and the result was 102 (units unspecified). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not tested for COVID-19. The clinical outcome of the events muscle and joint pain, 102 fever, extreme shaking chills and extreme fatigue was resolved on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Dizzy; This spontaneous case was reported by an other health care professional and describes the occurrence of DIZZINESS (Dizzy) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizzy). At the time of the report, DIZZINESS (Dizzy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication not reported by reporter. Treatment information not reported by reporter
Presented to ED with 3 week history of increased fatigue, rib pain, 3 day history of cough.  Known COVID household exposure.  Positive COVID-19 result by PCR after >14 days vaccination completion.
around 3:30 -4pm  I started to feel dizzy and weak , swelling my  face and throat it felt like needles inside my throat also felt nauseated but did not vomit . I took Motrin 20   0mg and went to sleep for couple of hours .  2nd day took another Motrim did not got to work and rested the whole day drinking enough liquids .     3rd day I steel feel dizzy but it is on and off not constant as before  the swelling of my face  and throat are gone .
This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (my arm (inj site) was warm to touch), VACCINATION SITE SWELLING (my arm (inj site) was swollen), VACCINATION SITE ERYTHEMA (my arm (inj site) was bright red) and VACCINATION SITE PRURITUS (my arm (inj site) was itchy) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced INJECTION SITE WARMTH (my arm (inj site) was warm to touch), VACCINATION SITE SWELLING (my arm (inj site) was swollen), VACCINATION SITE ERYTHEMA (my arm (inj site) was bright red) and VACCINATION SITE PRURITUS (my arm (inj site) was itchy). The patient was treated with IBUPROFEN at an unspecified dose and frequency; DIPHENHYDRAMINE at an unspecified dose and frequency; AMMONIUM CHLORIDE at an unspecified dose and frequency and SODIUM CITRATE at an unspecified dose and frequency. At the time of the report, INJECTION SITE WARMTH (my arm (inj site) was warm to touch), VACCINATION SITE SWELLING (my arm (inj site) was swollen), VACCINATION SITE ERYTHEMA (my arm (inj site) was bright red) and VACCINATION SITE PRURITUS (my arm (inj site) was itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2021: No specific follow-up information recorded.
Initial information received on 19-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This was linked to case 2018SA393726 (same reporter). This case involves 700 number of patients (age and gender not reported) who received vaccines FLUBLOK QIV, FLUZONE HIGH DOSE and ADACEL. The patients past medical history, concomitant medication and family history were not provided. Between 30-Oct to 02-Dec-2018, the patients received injection of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number, expiry date not reported via unknown route in unknown administration site. Between 30-Oct to 02-Dec-2018, the patients received injection of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number, expiry date not reported via unknown route in unknown administration site. Between 30-Oct to 02-Dec-2018, the patients patient received injection of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number, expiry date not reported via unknown route in unknown administration site. It was a case of an actual medication error due to incorrect product storage as it was reporter by Nurse that according to their data logger, the refrigerator containing the vaccines (ADACEL, FLUZONE Ped/HD, and FLUBLOK QUADRIVALENT) reached 28F between 1800 on 30oct2018 - 0500 on 31oct2018. She believes that it is an erroneous temperature report because nothing was frozen and the probe was against a metal bar in the refrigerator. Approximately 700 people received vaccines that had been stored in that refrigerator  Some of the patients experienced events (link case: 2018SA393726 registered). This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender- none.
suffocating and sometimes needs air; sore left arm; This is a spontaneous report from a contactable consumer (patient). A 41-years-old female patient received second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number ER8731, expiration date unknown), via an unspecified route of administration, administered in Arm Right on 30Apr2021 as DOSE 2, SINGLE for COVID-19 immunization. No relevant medical history and family history reported. Concomitant medication included ongoing norethindrone acetate (NORETHINDRONE ACETATE, LOT: 548586A, Expiry date: Jul2023) 0.35gm 1 pill a day by mouth taken for contraception, from an unknown start date. Patient did not receive any other vaccine prior to 4 weeks of vaccination. Patient previously received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EW0158, expiration date unknown), via an unspecified route of administration, administered in Arm Left on 08Apr2021 (at the age of 41 years) as DOSE 1, SINGLE for COVID-19 immunization. On an unknown date in Apr2021 post vaccination, the patient had sore left arm. On an unknown date in May2021, the patient experienced suffocation and sometimes needed air. Patient was still having an uncomfortable feeling in the arm. It was reported that when she felt like she needed air, it felt like her arm felt a bit better. It was like it moved from her arm to her chest and she started to feel like she was suffocated. It has been about a month since she started to feel suffocated like that. The patient was treated with Diclofenac and she stated that it is not helping her. The outcome of the events was reported as not recovered at the time of report. Investigation Assessment: No.
Severe redness at site of injection with hard mass and pain, swelling of area and also swelling of face (not tongue or lips, and NO breathing difficulty)
Wasn't eating the night before very well, coughing, fussy, Seizure like symptoms, stiffened up then went limp and took a gasp for air about every 5 seconds.  Called 911 ambulance took to Hospital, then transferred to another Hospital by life flight.
I had flu like symptoms that lasted about 48 hours. I ran a fever of 102. The site of the vaccine on my left arm swelled up and wrapped all the way across my arm. Hot to the touch.
pt was found dead by mom-65hr p/vax;2hr prior to events the mom had fed child w/o problems;
Swollen lymph nodes in left armpit, sore lymph nodes, upper body (back, neck, shoulder, both arms) aches, low grade fever, chills.  Soreness in left arm and painful to lift left arm. Lasted 24 hours, then just sore lymph nodes/sore arm for another 24 hours after that.
Shoulder pain. Diagnosed with cervical radiculitis. Shoulder X-rays done and doctor felt that symptoms are unrelated to injection.
1 hour after shot left ear started ringing a piercing noise almost passed out from it, blurry vision immediately had vertigo after ear stopped screaming after a minute
On 3/10/2021 the patient presented to the ED with a fractured right clavicle after doing dips during workout. Per EUA, all ED visits must be reported after recently receiving a vaccine. This visit is likely not related to the vaccine.
Extremely high resting heart rate for the entire day 5/6/21. Average heart rate was 100. Highest rate was 154. It was over double my normal heart rate. No medications except the allowed amount of Advil every 6 hours. Other symptoms were fever, stuffy nose, body aches, skin soreness, and extreme fatigue.
A report has been received from a Health Professional concerning a 6 year old Female subject, who had been receiving Nasal FLUMIST (INTRANASAL) started on 25-Jan-2014. The outcome of the event of EXPIRED FLUMIST is unknown. The report was considered to be non-serious by the reporter.
Mother reports redness at site on injection. Pictures reveal improvement. No fever. Child does not appear bothered by signs. 8x11 cm area, redness & swelling, mildly indurated, medially & minimal tenderness; no red streaking.
Sudden Hearing Loss - left ear Ringing in ears,  'full' feeling in ears  Treatment - starting steroids
I received my 1st Pfizer BioNtech Vaccine July 7 2021 at a facility, no side effects.  I received this 2nd shot at the another facility on August 7th 2021. 8-10 hours after this 2nd shot my arm ached and I was exhausted.  I slept and woke at 3 a.m. with no feeling in my left arm, totally numb and unable to move it, and numbness in lower left leg.  I woke at 10 a.m. on August 8th with most feeling returned in arm, but very weak left arm, weak left hand, pain in injection site, left shoulder pain, left chest tightness and pain, numbness top of left foot.  August 9th my joints started to ache, as if/like I had developed inflammation or arthritis in both wrists and shoulders.  Most, but not all strength came back in arm/hand at 1 month, but the pain in left shoulder, ache in wrists, tightness / irregular pain in left chest remain, as does numbness in lower left leg/top of left foot.