chrisvoncsefalvay/vaers-outcomes huggingface dataset:
noticed an itch around that area (site of vaccine); heart started beating very fast; could not breathe/difficulty breathing; light headaches; some soreness on the vaccine site; swelling on the area where she was vaccinated; This is a spontaneous report from a contactable consumer (patient).  A 47-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL0142), via an unspecified route of administration in left arm on 30Dec2020 at single dose for Covid-19 immunisation. Medical history included high cholesterol (it was under control. Diagnosed a couple years ago). There were no concomitant medications. She did her first dose of Pfizer COVID vaccine on 30Dec2020, and she had a little experience, she didn't tell the nurse at that time, but she went through her paperwork and decided to call Pfizer. When she got the shot, she was told to go to the next room to sit down for 15 minutes. When she went to the next room, 1 minute later, her heart started beating very fast, then she started to feel like she could not breathe/difficulty breathing for that moment. So, she tried to calm herself down and she focused on her phone to play games and to not think about it. After a couple minutes, it had gone. it was probably gone maybe about 10 minutes later. After 15 minutes, she went back to her office, everything was ok. Her heart was beating but not that fast, it was calmer than before, and she had a light headache, then some soreness on the vaccine site, on the left side, 'she thinks that is normal, right?' Clarifies soreness as swelling and painful on the area where she was vaccinated. She wanted to know, was she able to go back for the second shot, she was scheduled for 20Jan2021. Regarding light headache, she took some paracetamol (Extra Strength Tylenol, strength: 500mg, expiration date: Jun2024, lot number: SJC214). Soreness outcome: It went away, maybe the third day (02Jan2021), it was completely gone. The third day it was ok to completely sleep and lean on that side. She has recovered completely. The third day (02Jan2021), she noticed an itch around that area (site of vaccine), but she was not scratching it. The itching had gone, she had recovered completely. The outcome of heart started beating very fast and could not breathe was recovered on 30Dec2020, light headache was not recovered, soreness at vaccine site was recovered on 02Jan2021, itching at vaccine site was recovered on an unspecified date of Jan2021, and swelling on the area where she was vaccinated was unknown.
Pt exp inject site rxn consisting of redness, swelling, & warmth p/recvd DT (ped);
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients were administered a dose of the Moderna COVID-19 bivalent vaccine after more than 12 hours of vial puncture), POOR QUALITY PRODUCT ADMINISTERED (The date vial was initially stored in the refrigerator: 14DEC2022. The date and time vial were first punctured: 15DEC2022, 2:00 PM) and NO ADVERSE EVENT (No adverse event) in a 41-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 061F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 2.5 milliliter. On 16-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients were administered a dose of the Moderna COVID-19 bivalent vaccine after more than 12 hours of vial puncture) and POOR QUALITY PRODUCT ADMINISTERED (The date vial was initially stored in the refrigerator: 14DEC2022. The date and time vial were first punctured: 15DEC2022, 2:00 PM). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients were administered a dose of the Moderna COVID-19 bivalent vaccine after more than 12 hours of vial puncture), POOR QUALITY PRODUCT ADMINISTERED (The date vial was initially stored in the refrigerator: 14DEC2022. The date and time vial were first punctured: 15DEC2022, 2:00 PM) 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 NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (patients were administered a dose of the Moderna COVID-19 bivalent vaccine after more than 12 hours of vial puncture) and POOR QUALITY PRODUCT ADMINISTERED (The date vial was initially stored in the refrigerator: 14DEC2022. The date and time vial were first punctured: 15DEC2022, 2:00 PM).    No concomitant medication was provided by reporter. The date vial was initially stored in the refrigerator: 14DEC2022. The date and time vial were first punctured: 15DEC2022, 2:00 PM and time of administration of vaccine: 16DEC2022, 9:42 AM How was the vial stored post puncture. The vial did not undergo any temperature excursions. No treatment medication was provided by reporter.
I had mild headaches since the day after the vaccination - but on April 18 it was severe - from 1 to 10 it was  a 10. I went to the hospital as I was concerned about the news reports. ER on April 18. They gave me an IV with a couple of meds in it - I got better with that. There was Benadryl in it and I don't know the other med.
extreme fatigue; joint pain; muscle pain; nerve pain; hives; large red skin blotches on arm where vaccinated; Swelling in limbs; Headache; head pressure; This is a spontaneous report received from a contactable consumer (patient). A 43-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW6208), in left arm on 18Mar2021 04:30 PM (at the age of 43-year-old) at single dose for COVID-19 immunization. The patient's medical history included post-traumatic stress disorder (PTSD) and seborrhea. No allergies to medications, food, or other products were reported. Prior to vaccination the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported, no other medications were received by the patient within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 18Mar2021 06:30 PM the patient experienced extreme fatigue, joint pain, muscle pain, nerve pain, hives, large red skin blotches on arm where vaccinated, swelling in limbs, headache and head pressure. The events were reported as serious since resulted in disability or permanent damage. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment was received for the adverse event as steroid pills, ibuprofen, aspercreme rubs and ice pack. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not resolved.
I got severe headache; difficult breathing; chilling; shaking symptoms after 20 hours I was vaccinated; I have asthma background; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 58-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 13Apr2021 at 12:15 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included tuberculosis (TB background), asthma (Having asthma). The patient had no known allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 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 experienced I got severe headache, difficult breathing, chilling, shaking symptoms after 20 hours I was vaccinated and I have asthma background on 14Apr2021 at 07:30. No treatment was received for the events. Outcome of all the events was recovering.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
the leg veins are more prominent than before.; tingling sensation in the right leg; pain in the right leg, the leg veins are more prominent than before; lightheadedness; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), HEADACHE (Headache), DIZZINESS (lightheadedness), PAIN IN EXTREMITY (pain in the right leg, the leg veins are more prominent than before) and VARICOSE VEIN (the leg veins are more prominent than before.) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Restless leg syndrome and Varicose veins. Concomitant products included NYSTATIN (STATIN [NYSTATIN]) for Cholesterol, ANTIHISTAMINES and CLARITHROMYCIN, OMEPRAZOLE, TINIDAZOLE (OTC-HP) for Hypersensitivity.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced FATIGUE (Fatigue). On 21-Apr-2021, the patient experienced HEADACHE (Headache). On 22-Apr-2021, the patient experienced DIZZINESS (lightheadedness). On 23-Apr-2021, the patient experienced PAIN IN EXTREMITY (pain in the right leg, the leg veins are more prominent than before) and PARAESTHESIA (tingling sensation in the right leg). On an unknown date, the patient experienced VARICOSE VEIN (the leg veins are more prominent than before.). At the time of the report, FATIGUE (Fatigue), HEADACHE (Headache), DIZZINESS (lightheadedness), PAIN IN EXTREMITY (pain in the right leg, the leg veins are more prominent than before), VARICOSE VEIN (the leg veins are more prominent than before.) and PARAESTHESIA (tingling sensation in the right leg) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information were reported.   This case was linked to MOD-2021-089051 (Patient Link).
Crying; Chills; This spontaneous case was reported by a consumer and describes the occurrence of CRYING (Crying) and CHILLS (Chills) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CRYING (Crying) and CHILLS (Chills). At the time of the report, CRYING (Crying) and CHILLS (Chills) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was reported. Action taken with mRNA-1273 in response to the events was not applicable.
10mm secondary lesion accured at vacation site after the scab fell off on day 34. Pt. received anthrax vaccine 4th dose on 08/31/2004
About 5 hours after I got the SHINGRIX shot, I started getting chills and also had a low grade fever. Later that night I had one of the worst headaches of my life and also became quite nauseous.
No issues during vaccine administration. Patient reported pharmacist did not inject too high or too low. 12 hours post injection reported a topical reaction of redness and injection site pain. 72 hours post injection reported increase pain and weakness and decreased range of motion. Symptoms have continued and worsened since injection on 9/19. Symptoms are interfering with job as nurse practitioner and daily life. Patient describes injury as bursitis from to long of needle/injecting in to far- a standard 25g 0.5 inch needle was used and appropriate based on patient size.
VIRAL SHEDDING/COVID-19 VACCINE SHEDS; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced viral shedding/covid-19 vaccine sheds. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of viral shedding/covid-19 vaccine sheds was not reported. This report was non-serious.
DAY FOLLOWING SHOT:  SEVERE BONE AND MUSCLE PAIN, FEVER 102F, SHORTNESS OF BREATH, DIARRHEA, NAUSEA, VOMITTING, BLURRY VISION, DEPRESSED ATTITUDE SINCE SHOT.
20 minutes after ZOSTAVAX - Anaphylaxis. EMT transport to hospital overnight observation.
ErythemaMultiform Narrative:  arm sore/swollen, came back one week later; resolved with tylenol
Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: left lower extremity numbness and tingling
I had a fever and upset stomach overnight the night of the vaccination.  It is now the next day and I have a headache, but I also didn't sleep well with the fever shivering.  I have a sore vaccine site as well.  I'm not seeking care.  The symptoms are manageable.
PRURITIC RASH, COUGH, MILD WHEEZE, TINGLING LIPS
Diarrhea; runny nose; chills; became deathly ill; Nausea; fatigue and wiped out, drained; bordering dehydration; vomiting; three horrendous headaches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 78 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Mar2021 08:30 (Lot number: EL9261, Expiration Date: 05Aug2021) at the age of 78 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diarrhea", start date: Dec2016 (unspecified if ongoing), notes: in hospital for three weeks, treated with a bunch of diarrhea, dehydration. drinking pedialyte; "Hiatal hernia" (unspecified if ongoing); "Restless legs" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL taken for hypertension; PANTOPRAZOLE taken for hiatus hernia; ATENOLOL taken for hypertension; MONTELUKAST, start date: Oct2020; ROPINIROLE taken for restless legs syndrome; SIMVASTATIN taken for hypertension. Vaccination history included: Bnt162b2 (dose 1, Lot number: EL9261, Expiry date: May2021, left arm), administration date: 18Feb2021, when the patient was 78 years old, for COVID-19 Immunization, reaction(s): "no adverse event"; Flu shot (gets the flu shot every single year for 40 years, seldom have a reaction), for immunisation. The following information was reported: MALAISE (non-serious) with onset 20Mar2021, outcome "unknown", described as "became deathly ill"; VOMITING (non-serious) with onset 19Mar2021, outcome "unknown", described as "vomiting"; DIARRHOEA (non-serious) with onset 20Mar2021, outcome "unknown", described as "Diarrhea"; RHINORRHOEA (non-serious) with onset 20Mar2021, outcome "unknown", described as "runny nose"; CHILLS (non-serious) with onset 20Mar2021, outcome "unknown", described as "chills"; HEADACHE (non-serious) with onset 19Mar2021, outcome "recovered" (21Mar2021), described as "three horrendous headaches"; NAUSEA (non-serious) with onset 20Mar2021, outcome "unknown", described as "Nausea"; FATIGUE (non-serious) with onset 20Mar2021, outcome "unknown", described as "fatigue and wiped out, drained"; DEHYDRATION (non-serious) with onset 20Mar2021, outcome "unknown", described as "bordering dehydration". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of malaise, vomiting, diarrhoea, rhinorrhoea, chills, headache, nausea. Additional information: Patient had no prior vaccinations within 4 weeks.  No follow-up attempts are possible. No further information is expected.
immobilizing pain in my left hip; full body muscle spasms; hip pain was almost unbearable; 101.5 temp; blood preassure was 155/110 / my blood pressure was 168/130, 165/128, and 171/130; swelling at injection site; soreness at injection site; pain muscle of my right hip; major night sweating; a bit of fatigue late in the afternoon; This case was reported by a consumer and described the occurrence of fever in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th February 2021 14:00, the patient received the 1st dose of Shingrix. In February 2020, less than 2 weeks after receiving Shingrix, the patient experienced fatigue. On 9th February 2021, the patient experienced mobility decreased and muscle spasm. In February 2021, the patient experienced fever, increased blood pressure, injection site swelling, injection site pain, muscle pain, sweating and pain in hip. The patient was treated with tramadol and ibuprofen (Advil). On an unknown date, the outcome of the fever, increased blood pressure, injection site swelling, injection site pain, muscle pain, sweating, mobility decreased, muscle spasm, pain in hip and fatigue were recovered/resolved.   The reporter considered the fever, increased blood pressure, injection site swelling, injection site pain, muscle pain, sweating, mobility decreased, muscle spasm, pain in hip and fatigue to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm at around 2:00 pm and five hours later had a 101.5 temperature, blood pressure was 155/110, swelling and soreness at injection site. The patient had a 10 level pain in the muscle of right hip.  These symptoms persisted for four days and included major night sweating, continued immobilizing pain in left hip and full body muscle spasms. The patient reported after each of these spasms blood pressure was 168/130, 165/128 and 171/130 and the hip pain was almost unbearable.  The patient took two 50mg Tramadol and Advil and went to sleep.  The patient when woke up on Saturday and it was like nothing ever happened.  The hip pain was completely gone, blood pressure was normal (128/90), the swelling at the injection site was gone and the fever was down to 99. The patient had X-rays of hip that showed no ortho problems and did not had any lingering effects except a bit of fatigue. The doctor was not convinced that the issues are related to Shingrix, but there were no underlying issues and the symptoms all showed up on the day of the vaccination and all pretty much went away on the same day. The patient experience was less than perfect and wanted to share it in hopes that the patient at least confirm that my health issues side effects are related to vaccination.
Reporting administration error as per state immunization system. We contacted Pfizer for expiration dates, Pfizer vaccine specialist advised expiration dates and deemed vaccine viable at the time of vaccine administration. Pfizer vaccine vials only include manufactuarer dates on the box and vials. Therefore, we contacted Pfizer to attain expiration dates directly from them.  No adverse reaction reported from the patietn at the time of the vaccination and no adverse reaction reported since given vaccine.
Patient came in for a scheduled appointment for their first dose of the primary series (monovalent) COVID vaccine. The technician who took in the patient failed to check what the appointment was for in the appointment scheduler and failed to verify which vaccine the patient was expecting to receive. She then entered the Bivalent booster instead of the monovalent and administered it. Patient came back 21 days later for their second dose and a different technician noticed and investigated the error. The CDC was contacted and upon their guidance the patient was given the monovalent as a completion to the initial series.
COVID breakthrough. Patient recently returned from vacation and began having symptoms for COVID on 9/5/21 such as cough, chills, and fatigue. He presented to the hospital on 9/14/21 with ongoing symptoms and decreased oxygen saturation. He tested positive in the hospital on 9/15/21.. He is currently on 5L of Oxygen.
Dizziness, Seizures, Myalgia & Syncope Narrative:  Employee had vaccine on morning of 1/26/21 and by 11:00 pm she felt dizzy/ears ringing and had tingling in her arms. Pt reports her 7 year old son witnessed her fall face down, "grunted", "soiled" herself and was not able to respond to him verbally. She reports she was able to hear him eventually and not able to answer. She reports she stayed home till this am when she could get help with her two young children. She was seen by her primary care team and is having a work-up for seizure vs syncope
I started feeling really sick on Christmas evening, lots of cough, productive cough. My lymph nodes on my left were very sore, I also had a sore throat, body chills, joint pain, mainly in my hands and fingers, extreme fatigue and it lasted through Wednesday and Thursday. My cough got really bad and I had to start on an albuterol nebulizer because of my cough/wheezing.
85 recruits were vaxed w/Td & yellow fever @ the same time; pts exp swelling & erythema surrounding vax site to a greater extent than was previously exp;
Took second dose shot at 9am on 1/13/21 - by 5pm the same day I started to experience flu like symptoms - no fever but had muscle aches, chills, jittery/restless/insomnia, fatigue - these symptoms continued until 10pm on 1/14.  Took four doses of ibuprofen between 6pm on 1/13 through 6pm on 1/14.  The ibuprofen was eith ineffective or slightly effective for a short period of time but all symptoms returned within 3-4 hours after taking ibuprofen. All symptoms resolved upon waking at 6am on 1/15/21.
Only minor side effects if any; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Only minor side effects if any) 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 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Only minor side effects if any). At the time of the report, VACCINATION COMPLICATION (Only minor side effects if any) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Antibody test: inconclusive (Inconclusive) unknown.          For mRNA-1273 (COVID 19 Vaccine Moderna)(intramuscular), the reporter did not provide any causality assessment. action taken with mRNA-1273 (COVID 19 Vaccine Moderna)(intramuscular),was unknown No concomitant medication details was reported. No treatment medication details was reported. patient had a infusion in Nov, 2020
sz worsen; weak, motionless, lifeless, no eye contact; med taken to control sz; in and out of ER- brain damage