chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After first dose, there was a very sharp, deep pain at injection site.  When I went to leave office I felt dizzy, nauseous, and vision started blurring and going black.  Nurse brought me back into room and I fainted.  I awoke a few minutes later and vomited.  My vision and steadiness had still not returned for about 30 minutes.  A month later, the arm of the injected site was still sore and a deep muscular ache was constant.  A very sharp pain would be felt if tried to raise my arm higher than horizontally in front of me.  -Parallel to ground. - After two months, I still have discomfort while raising it or moving it up and down, but the pain is less intense.  I feel like after the vaccination, I've had a weaker immune system - more susceptible to illnesses- than I've ever been in the past, and a lack of energy.  I've had an increase of headaches that are reoccurring.  There is still a scar on my arm and a raised bump from the injection. I don not feel safe getting the second or third dose, because I am afraid more serious side effects may likely occur.
STARTED RASH ON ONE ARM, BACK, NECK, OTHER ARM; ITCHING; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025, and batch number: 1805025 expiry: UNKNOWN) .5 ml, administered on 08-MAR-2021 17:30 to left arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced itching. On 09-MAR-2021 02:00, the subject experienced started rash on one arm, back, neck, other arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the itching and started rash on one arm, back, neck, other arm was not reported. This report was non-serious.
Diagnosed with cellulitis; This is a spontaneous report from a contactable nurse (patient).  A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient was diagnosed with cellulitis on an unspecified date. Therapeutic measures were taken as a result of the event and included treatment with KEFLEX for 10 days. The patient outcome of the event was unknown.  The information on the batch number has been requested.; Sender's Comments: The information currently available is limited and does not allow a meaningful case assessment. Based solely on an implied temporal association causality between event cellulitis and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The case will be reevaluated should additional information become 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.
Employee received the over 65 flu vaccination on 10/11/17. He was seen in Employee Health on 10/12/2017. Reported having flu-like symptoms and feeling ill after receiving the vaccination.  However, he also reported being woken up in the middle of the night feeling  bilateral eye pain - like razors were in his eyes, and that his vision was impaired. On 10/12/17, at the Employee Health Office his eyes were red with bilateral peri-orbital edema. Employee was examined, no foreign body was noted in either eye. At that time, as vision was still impaired, employee was sent to ED for further evaluation where he was treated and received prescritpions for prednisone, zyrtec, and pepcid. Issues have since been resolved.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 02-APR-2013 the patient was vaccinated with M-M-R II (lot # 0447AA, expiration date 28-MAR-2013) (route and dose unspecified). On 02-APR-2013 the patient was inadvertently administered M-M-R II that had expired on 28-MAR-2013. No adverse effects reported. Additiona information is not expected.
Patient was in the 15 minute review time after the immunization and briefly fainted. He was slouched in his chair.  I ran out to make sure he was ok.  He came to immediately and I sat him on the floor. We gave him a water bottle and observed him for another 15 minutes.  He said he was feeling ok and his wife/significant other drove him home.  I called him on 5/19/21 to check on him.  He said that he was feeling fine.
Stroke; A spontaneous report was received from a consumer who was also a 66-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced stroke.  The patient's medical history was not provided by the reporter.   Concomitant medications included Lisinopril, Rosuvastatin, Montelukast, Hydrochlorothiazide, Sertraline, Metoprolol, and Zyrtec.  The patient received their first of two planned doses of mRNA-1273 (Batch number: 029L201A) on 12 Feb 2021, approximately one day prior to the onset of the symptoms in the left non-dominant arm for prophylaxis of COVID-19 infection.   The patient experienced a stroke on the night of 13 Feb 2021- 14 Feb 2021. The patient could not speak properly due to being drowsy. On unspecified date the patient was hospitalized for the event of stroke and released on 16 Feb 2021.   Treatment for the event included double cholesterol med (from 10 to 20 mg) and baby aspirin.   No relevant laboratory details were included.   Action taken with the drug in response to the event was not reported.  Outcome of the event  was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event of stroke, a causal relationship cannot be excluded.
Generalized urticarial rash, rhinorrhea, cough, wheeze, w/in 1 hr of vax adm. Tx:SQ Epi > all s/s resolved
After the patient had waited her 15 minutes she got up to leave; on the way to the door she said she began to feel weak, have slow reaction, dizziness, and felt warm to the touch. She cam back in side the room and we had a nurse assess her, her BP and heart rate were a  little elevated. We gave her some water and had her sit for some extra time while we talked to her. She has a child hood trauma regarding vaccine and had just had a major panic attack before and during her vaccination. We were all  pretty sure she had just worked her self up and was not feeling well because of that and she said as much herself. After about 15-20 more minutes her BP and heart rate were back to normal and although still feeling a little weak she was ready to go home with her mother.
Sedation, Myalgia, Arthralgia, NauseaVomiting, Tachycardia,  Chills, swollen glands   Narrative:
ROUGH PATCH, RED DOTS, ITCHY AND SCRATCHING AT INJECTION SITE; RASH AT INJECTION SITE; This spontaneous report received from a patient concerned a 33 year old male. 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, batch number: 211D21A, expiry: 11-APR-2022) dose was not reported, administered on 07-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-NOV-2021, the patient experienced rough patch, red dots, itchy and scratching at injection site, and rash at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash at injection site, and rough patch, red dots, itchy and scratching at injection site. This report was non-serious.
Pt developed fever of 101 degrees F on day of vaccine and over 2 days fever increased to over 102 degrees F. On 2/16/11 pt developed redness to entire left arm. TYLENOL & MOTRIN given. Redness decreasing.
screaming intermittently for 5 hrs; fever 103-15 off & on for 5 hrs; tempera given 910AM immun @ 930AM; another dose 1130AM, 330PM then fever came down appt 5PM;
Loose stool; Vomiting; Fatigue; Headache; Booster; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2590) via an unspecified route of administration in the left arm on 28Oct2021 at 14:00 (at the age of 51-year-old), as a single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), fibromyalgia, restless leg syndrome, post laminectomy syndrome and allergy to nausea medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included naloxone hydrochloride/buprenorphine hydrochloride (SUBOXONE), pregabalin (LYRICA), pramipexole (MANUFACTURER UNKNOWN), lamotrigine (LAMICTAL) and meloxicam (MELOXICAN); all for unspecified indication from unknown date and unknown if ongoing and also included influenza vaccine (MANUFACTURER UNKNOWN) via unspecified route of administration in left arm on 15Oct2021 for immunization. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Mar2021 at 15:00 (at the age of 50-year-old) and received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO170) via an unspecified route of administration in the left arm on 30Apr2021 at 18:00 (at the age of 50-year-old); both as a single dose for COVID-19 immunisation. On 29Oct2021 at 02:30, the patient experienced loose stool, vomiting, fatigue and headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events loose stool, vomiting, fatigue and headache were resolving at the time of this report.
Moderna COVID-19 Vaccine EUA 2 1/2 inch round swelling around injection site that was very hot, red, and itchy for approximately 2 days exactly one week following the injection.
7.5 cm by 8 cm area of erythema inferior to Right Deltoid, No other skin lesions noted.
Large hives on most of body but not face. Started about 4 hours after vaccine. Increased over next several days.
perforated appendicitis with appendectomy; Abdomen pain; diarrhea; acute gangrenous, perforated appendicitis; minimal nausea; This is a spontaneous report from a contactable consumer (patient). A 54-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 19Mar2021 16:00 (Lot Number: EN6204) (at the age of 54-year-old) as single dose for covid-19 immunisation. Medical history included hypertension. The patient did not have covid prior vaccination. Concomitant medications included ascorbic acid (VIT C); zinc; ergocalciferol (VIT D); vitamin K2 (menaquinone); vitamin b complex (B COMPLEX) and multivitamin, all taken for an unspecified indication, start and stop date were not reported. The patient had known allergies: sulfamethoxazole, trimethoprim (SEPTRA), clindamycin, rabeprazole sodium (ACIPHEX), esomeprazole sodium (NEXIUM). The patient previously took the historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in arm left on 26Feb2021 14:30 (lot number: EN6200) (at the age of 54-year-old) as single dose for COVID-19 immunisation. The patient experienced abdomen pain, minimal nausea, diarrhea, acute gangrenous, perforated appendicitis with appendectomy on 20Mar2021 14:00. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). The patient hospitalized from an unspecified date in 2021 to an unspecified date in 2021 for 3 days. The patient received treatment included appendectomy. The patient underwent lab tests and procedures which included covid test (blood test) date on 22Mar2021 with result of negative. The outcome of the events was recovering.
Younger than 18 years of age received Moderna Covid-19 vaccine; A spontaneous report 7was received from a consumer concerning his son who was 17 years of age (Product administered to patient of inappropriate age) at the time of administration of Moderna's COVID-19 vaccine (mRNA-1273).   There was no medical history. Concomitant medications included vitamins.   On 10 Mar 2021, the patient received their first dose mRNA-1273 ((Lot number : 014M20A) intramuscularly in left arm for prophylaxis of COVID-19 infection.  It was reported that patient who was younger than 18 years of age received Moderna's COVID-19 vaccine.  Action taken with m-RNA 1273 in response to the event was not applicable.; Reporter's Comments: This report refers to a case of Product administered to patient of inappropriate age for mRNA-1273, lot# 014M20A, with no associated adverse events.
Child examined by nurse.  Redness to abdomen and back, red raised rash with hives noted.   Was sent to primary care physician.
It is harder than normal skin around the inoculation site; Itchy around the inoculation site; Noticed a red spot around the innoculation site; It has a rash texture; A little tender to the touch, but not painful at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (It is harder than normal skin around the inoculation site), VACCINATION SITE PRURITUS (Itchy around the inoculation site), VACCINATION SITE PAIN (A little tender to the touch, but not painful at injection site), VACCINATION SITE ERYTHEMA (Noticed a red spot around the innoculation site) and VACCINATION SITE RASH (It has a rash texture) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma since 01-Sep-2020. Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) from 01-Sep-2020 to an unknown date, MONTELUKAST SODIUM (SINGULAIR) from 01-Sep-2020 to an unknown date and BUDESONIDE (PULMICORT FLEXHALER) from 01-Sep-2020 to an unknown date for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE PAIN (A little tender to the touch, but not painful at injection site). On 02-Feb-2021, the patient experienced VACCINATION SITE INDURATION (It is harder than normal skin around the inoculation site), VACCINATION SITE PRURITUS (Itchy around the inoculation site), VACCINATION SITE ERYTHEMA (Noticed a red spot around the innoculation site) and VACCINATION SITE RASH (It has a rash texture). At the time of the report, VACCINATION SITE INDURATION (It is harder than normal skin around the inoculation site), VACCINATION SITE PRURITUS (Itchy around the inoculation site) and VACCINATION SITE PAIN (A little tender to the touch, but not painful at injection site) outcome was unknown and VACCINATION SITE ERYTHEMA (Noticed a red spot around the innoculation site) and VACCINATION SITE RASH (It has a rash texture) had resolved with sequelae.            On 02 Feb 2021, eight days after the vaccination, patient noticed a red spot. Patient was recovered with slight discolororation on arm which was approximately 2" by 4". No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Added reporter information, patient demographics, historical condition, vaccine information, outcome of the events vaccination site erythema and vaccination site rash and causality was updated.
Starting 48 hours after receiving the Janssen Covid-19 vaccination: -- 3rd day after the vaccination -- -- while at my home -- 1) persistent coughing 2) tightness in the middle of my chest 3) wasn't able to sleep that night  remedial actions on my part: 1) I drank several glasses of lime juice and grapefruit juice over a period of 12 hours 2) I took 500 mgs. of aspirin over 4 hours  -- 4th day after the vaccination -- 1) persistent coughing 2) tightness in the middle of my chest 3) I slept for only 2 hours  remedial actions on my part: 1) I drank several glasses of lime juice and grapefruit juice over a period of 12 hours 2) I took 500 mgs. of aspirin over 4 hours  -- 5th day after vaccination -- 1) no more coughing 2) reduced tightness in the middle of my chest 3) I took 250 mgs. of aspirin and I slept normally  No more problems after that, other than some loss of head hair.
started to feel extreamly hot,then dizzy, then fainted....co workers there to catch my fall. not 100% sure ont the type of influenza shot.
12 hours after  2nd shot severe chills, shivering fever nausea sweating pain all over body.  next day 8/10 couldn't get out of bed slept all day body pains fatigue  headache.  8/12 nausea and diarrhea . I didn't know about this site and with the first shot I lost a day of work due to headache and body pain too/
Information has been received from a physician concerning his 5 year old grandson with a history of eczema (outgrew) and no known allergies who in May 2008, was vaccinated with the first dose of VARIVAX vaccine (Oka). There was no concomitant medication. On an unspecified date the patient was not feeling well. The patient sought unspecified medical attention. Additional information has been requested.
Symptoms were: 99.9F fever, swollen lymph nodes, arm pain, achy all over body, tired, headache. All symptoms occurred within 24 hours of the shot and lasted through 9/1/2021. Woke up feeling better 9/2/2021.
fluttering in chest, extremity weakness, fatigue, severe body aches and headache felt like pins and needles all over body heart pounding,  whole body felt numb and he had difficulty sleeping
I had a really sore arm, and I couldn't lift it. I ended up getting massages and it helped. I felt like I also had a fever and had a headache and felt nauseous as well and had a body ache. I rested for the weekend and took ibuprofen and was feeling normal the next Monday (except for my arm).
D69.6 - Thrombocytopenia (CMS/HCC) U07.1 - COVID-19 D72.819 - Leukopenia R77.8 - Elevated troponin I level J18.9 - Multifocal pneumonia U07.1, J12.82 - Pneumonia due to COVID-19 virus
This spontaneous report was received from a physician and refers to a 2 month old patient of unknown gender. Information on the patient's concurrent conditions, medical history or concomitant medications was not reported. On an unknown date, the patient was inadvertently vaccinated with a dose of MMR II (lot#, expiration date, dose and route were not reported). On an unknown date, the patient experienced low grade fever. The patient did not seek medical attention and no treatment was given. The outcome of the event was not reported. Causality assessment was not provided by the reporter. Additional information has been requested.
Developed (B) axillary pain, (L) SS > (R) ; and (L) axillary edema that started within 24 hours of vaccine.
This is a spontaneous report from a contactable Nurse (licensed practical nurse). This Nurse reported for a 80-year-old female patient that: An 81-year-old female patient of an unspecified age received PREVNAR 13 (Batch/lot # X70865, exp date 01Dec2020) intramuscular at 0.5ml to left deltoid once on 07May2019 15:30 for immunization, prescribed by the Family Practice HCP.  Medical history was unknown. There were no concomitant medications. History of all previous immunization with the Pfizer vaccine considered as suspect was unknown. Additional vaccines administered on same date of the Pfizer suspect were none. Prior Vaccinations (within 4 weeks) were none. On 08May2019 the patient experienced swollen at the site, hot to touch, blisters on upper forearm, itching, burning, induration possible phlebitis from shoulder to elbow. All events were considered serious as medically significant: the events require a visit to Physician Office (not to Emergency Room). The doctor ordered to use Benadryl cream and Tylenol and to follow up in 24-48 hours and to inform the doctor if she experiences worsening or difficulty. The blisters have dried up now. It was still lightly swollen. It was itching, burning and red but improved. The outcome of swollen at the site was not recovered, of all other events was recovering. Therapeutic measures were taken as a result of swollen at the site, hot to touch, itching, burning. The reporter considered there was a reasonable possibility that the events were related to the study medication. A Product Complaint was filed for Benadryl since it was still itching and Tylenol for it was still swollen at the site and hot to touch.; Sender's Comments: Based on the information currently available, a contributory role of PREVNAR 13 towards the occurrence of events vaccination site pain, swelling and warmth cannot be fully excluded. Blisters on upper forearm, itching, induration possible phlebitis from shoulder to elbow more likely represent intercurrent medical conditions unrelated to PREVNAR 13. 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.
Initial unsolicited report received from a pharmacist on 12 June 2015. A 43-year-old male patient, whose medical history and concomitant medications were not reported, had received a second dose of ADACEL (batch number- C4774AA, expiry date-15 July 2017, route and site of administration was not reported) on 07 May 2015. As patient received ADACEL vaccine within a few months of a previous dose of Tdap vaccine, it was an inappropriate schedule in drug administration. Patient had previously received a dose of Tdap vaccine. Illness at time of vaccination was not reported. On 08 May 2015, one day post vaccination, the patient was seen in emergency room for chills, myalgia, pain and hyperthesia. Laboratory investigations and corrective treatments were not reported. Patient required ER/doctor visit. At the time of this report, outcome of the events was unknown. Documents held by sender: none.
patient reports redness and swelling of toes on left foot after 1st vaccine,  this became intesified particularly after his booster (3rd) dose He has tightness of skin, redness in the arch and moccasin pattern on left foot.  Skin on toes are dry and pealing and now fissured. He is experiencing sensitivity on tips of toes and with pressure on naibeds.