chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vials that was put in the fridge and after that refrozen and thawed again for adult male patient; No Adverse Event; Bivalent booster was given yesterday from vials that were put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Bivalent booster was given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (Vials that was put in the fridge and after that refrozen and thawed again for adult male patient) and NO ADVERSE EVENT (No Adverse Event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, 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 11-Jan-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Bivalent booster was given yesterday from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vials that was put in the fridge and after that refrozen and thawed again for adult male patient) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Bivalent booster was given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (Vials that was put in the fridge and after that refrozen and thawed again for adult male patient) 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 POOR QUALITY PRODUCT ADMINISTERED (Bivalent booster was given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (Vials that was put in the fridge and after that refrozen and thawed again for adult male patient).    Concomitant product use was not provided by the reporter. This case is for 3rd patient out of 100 patient's case. Patient received additional booster dose. 100 male patients were received bivalent booster dose. Moderna COVID19 vaccine bivalent, dosage given was in ml but was unknown to the healthcare practitioner. Also, lot number was unknown to the healthcare practitioner. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:Master case
Heart palpitations, light-headedness, feeling of being unable to get a full breath of air
Home bound 660+ # patient chronically ill with conditions listed elsewhere including Lupus vs. undifferentiated connective tissue disease on Hydroxychloroquine;  COVID vaccines: J+J given 4/7/21; Moderna booster given 11/19/21;  COVID infection 4/17/2022;  Took Molnupiravir and she was recovering at home - EMS visit on 5/1/2022 with cardiac arrest and death.
This spontaneous report was received from a pharmacist via a company representative referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, (route, dose, dose number, lot number, expiration date and frequency were not reported). Concomitant medications were not provided. On an unknown date, the patient experienced herpes zoster. The outcome of herpes zoster was unknown. No product quality complaint (PQC) was involved. The primary reporter did not provide the causal relationship between ZOSTAVAX and herpes zoster. Additional information has been requested.
Patient's arm formed a knot at the injection site immediately after giving injection. Asked patient to stay & put ice at site, but he did not. Told him to put ice on it & get emergency help if any more rxn. occurs. Saw patient next day & reaction had subsided.
Headache around sinus area (under eyebrows and teeth), slight fever of 99.1, nausea and vomiting.
local soreness that day-woke up the following day w/tender lymph nodes under lt arm-no nodule noted;took advil-cont to be lt underarm soreness
Local reaction 2" X 1 3/4 inch. Fever of 100.5.
Started on right leg then to the left leg, with an itch, red spots, burning rash. Now on back of hands and arms. Tender to the touch.
Left the Dr office right after immunization shots Pediarix & Pedvax. My son passed out, then started throwing up a lot as he was sleeping. He became unconscious and unresponsive. My hubsand, and my father could not wake him up or get him to respond. He was still breathing but we rushed him to the ER. He was unconscious for about 20 minutes.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received dose after its beyond use date), PRODUCT TEMPERATURE EXCURSION ISSUE (Received dose which was previously affected by a temperature excursion for less than 1 hour), PRODUCT STORAGE ERROR (Vaccine previously affected by a temperature excursion) and NO ADVERSE EVENT (No adverse event) in a 5-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 vaccination. No Medical History information was reported. On 16-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received dose after its beyond use date). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Received dose which was previously affected by a temperature excursion for less than 1 hour), PRODUCT STORAGE ERROR (Vaccine previously affected by a temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received dose after its beyond use date), PRODUCT TEMPERATURE EXCURSION ISSUE (Received dose which was previously affected by a temperature excursion for less than 1 hour), PRODUCT STORAGE ERROR (Vaccine previously affected by a temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Received dose after its beyond use date), PRODUCT TEMPERATURE EXCURSION ISSUE (Received dose which was previously affected by a temperature excursion for less than 1 hour) and PRODUCT STORAGE ERROR (Vaccine previously affected by a temperature excursion). No concomitant medication was reported by reporter. Vial was initially refrigerated and thawed on 26-Jun-2022. No treatment medication was reported by reporter. This case was linked to US-MODERNATX, INC.-MOD-2022-638955, US-MODERNATX, INC.-MOD-2022-638952 (E2B Linked Report). Sender's Comments: US-MODERNATX, INC.-MOD-2022-638955: US-MODERNATX, INC.-MOD-2022-638952.
Central Nervous System Inflammation; This case was reported in a literature article and described the occurrence of central nervous system inflammation in a patient who received HPV 16-18 (HPV vaccine) for prophylaxis.  On an unknown date, the patient received HPV vaccine. On an unknown date, unknown after receiving HPV vaccine, the patient experienced central nervous system inflammation (serious criteria GSK medically significant). On an unknown date, the outcome of the central nervous system inflammation was unknown.   The reporter considered the central nervous system inflammation to be related to HPV vaccine.   Additional Information: GSK Receipt Date: 13-JUL-2022 Author Comment: The patient was a part of study was aimed to determine the prevalence and clinical characteristics of iatrogenic CNS inflammation associated with vaccinations at a tertiary neuroimmunology clinic and compare the frequency of these events before and after the COVID-19 pandemic. The study analyzed 419 consecutive patients seen over 4 years (2017-2021) at a tertiary neuroimmunology clinic who were screened for iatrogenic CNS inflammation secondary to vaccinations. In patients with suspected iatrogenic events, the Adverse Drug Reaction Probability Scale was used to score the probability of vaccine-related events as doubtful, possible, probable, or definite. The patient received HPV vaccine and experienced central nervous system inflammation. In conclusions, Post-vaccination iatrogenic CNS inflammation is a rare but distinct neuroimmunological disease spectrum mostly involving spontaneous recovery or responsiveness to corticosteroids. We did not identify an excess of SARS-CoV-2vaccine-related events. The rare occurrence and predominantly favorable prognosis suggest the benefit of vaccination outweighs the neurological risks, especially during the COVID-19 pandemic.
Developed persistent crying/unusual behavior immediately; fever and loss of appetite within 1-12 hours of vaccination; vomiting after 36 hours.  This was our childs FIRST vaccine which occurred at 9 months of age.
hearing loss; tinnitus; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: Unknown) via an unspecified route of administration on an unspecified date as  Dose 2, Single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: Unknown) via an unspecified route of administration on an unspecified date at Dose 1,Single for COVID-19 immunization. Patient really felt tinnitus was related to COVID vaccine. It started on an unspecified date about 3 weeks after the second dose. Patient went to ear specialist. She noted patient had mild hearing loss which patient have never had before. She said the tinnitus was related to the loss of hearing. She could not confirm or deny any vaccine cause. She did say she sees hearing loss and tinnitus with the Covid infection. Patient would just like you to add it to our studies. It was not going away. Adverse events resulted into physician's office visit. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Next day 24 hours later/10/23/20 - Pain, oval shaped swelling extending completely across the top half of my arm and extending approximately half and  inch outward, with redness, and a thick lump in the center of my top  arm at the injection site. Used ice on 10/22/20-10/23/20.  Used ice and Extra strength Tylenol Days 2 and 3. 10/24/20  Same appearance but  now with bruising (a thin bluish line) under the complete half of the oval shaped swelling. An increasing feeling of being unwell. Not able to compare it to any other feeling. Have been resting as much as possible to help with lightheadness and sick feeling. 10/25/20  Same appearance with a slight lessening of the swelling and bruising  is disappearing. Now warmth is felt to the touch only at the injection site where the lump is.  Pain is continuing. 10/26/20  Requested an urgent care Follow up with the Doctor.
pt recv vax 16JAN98 & exp inconsolable crying x 4hr;re- evaluated @ 4PM irritable & crying w/handling quiet w/o manipulation;T99.9R;otherwise nl;
Pain, Burning, Stabbing, shooting pain since time of administration.   The pain is Limiting my range of motion without causing severe pain.
May 16 started with scratchy throat. Progessed to congestion aches, fever, drainage, coughing, sneezing, lethargy.  Later, after Paxlovid, headaches.
Injection about 1:00 pm, next morning woke with HA, fever of 102 and site of injection was swollen, red & itchy. When pt came to pharmacy 3 days after shot the red area was about 6 inches diameter. Pt still had HA. Didn't feel well but was unsure if had a fever still. Slowly, swelling is decreasing.
Pt. was in clinic to receive her 4 y/o vaccines, she was not very happy about it and resisted quite a bit so mother had to hold down her top half and I secured her legs and gave the vaccines, the patient cried during but was quick to get up and let me give her a lollipop and some stickers which ended the tears. Patient was talking and cutting up with her sister who was also present while mother was getting all of her copies together and then they left to go and complete pts school registration process. A few minutes later the school nurse who was participating in the school registration event came and asked me to come check on the patient because she felt her color was "not right" and her lips were very pale. Pt. was sitting up at a table with her head down on her arms when I arrived, she talked to me but her skin color was very pale and her lips in fact had no color either. Mother carried patient to the nurses office where we laid her down and I elevated her feet and put cool wet towels on her forehead, because she felt very warm. After approx. 2 minutes the patients lip color started to return and shortly after that he color was just about back to normal. Pt. denied any pain or difficulty breathing, and her pulse ox was 99%, the school nurse took her other vitals (which I didn't get before we left) and stated other than her pulse being a little low they were normal. Pt never lost consciousness and was able to talk to me throughout the whole process, and her pulse rate also increased after a few minutes. Pt sucked on her lollipop and finished it as we sat together and also started playing with her sister again before they were discharged.
Fatigue, muscle aches, dizziness, headache, chills for a day after. 2nd days just fatigue and left arm is sore.  Only arm was sore after first shot.
Steady headache in the front of forehead; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 09Apr2021 at 09:15 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included citalopram (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 17Mar2021 at 10:30 (at the age of 35-year-old) as a single dose for COVID-19 immunisation.  On 09Apr2021 at 12:00, the patient experienced steady headache in the front of forehead, not all day, but it was pretty much every day for a few hours. It was also reported that the patient was never been the one who suffered from headaches. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the reported event. The clinical outcome of the event steady headache in the front of forehead was not resolved at the time of report.   No follow-up attempts are needed. No further information is expected.
Starting on 10/3/21 patient right arm developed redness, tenderness to touch, warm to touch, limited range of motion and headache. As of 10/5/21 patient is still experiencing symptoms and came to the pharmacy to report them. Patient was advised to contact the physician. Pending outcome from physician.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 66-year-old female patient who received SHINGRIX. On 2nd March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. In 2018, the patient experienced left arm achiness, which lasted for 2 days after injection. This is 1 of the 2 cases reported by same reporter.
Information has been received from a health professional concerning a 12-month-old male who on 28-MAR-2007 was vaccinated PO with the first dose of Rotateq. Unspecified medical attention was sought. No problems were reported. Additional information has been requested.
Redness, 2-3" area of swelling, itching. Ice & BENADRYL
5/20 /21 started to feel rash on both her forearms and wrists. It was itchy and red, and has little circles.   It lasted 2 days and went away. Then today the rash showed up again. The circles are slightly different. It is more itchy today. She has been taking Zyrtec for 4 days because of seasonal allergies. She was not taking Zyrtec when rash first started.
feels lazy; fatigue and gets easily tired; This spontaneous case was reported by a consumer and describes the occurrence of LAZINESS (feels lazy) and FATIGUE (fatigue and gets easily tired) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On an unknown date, the patient experienced LAZINESS (feels lazy) and FATIGUE (fatigue and gets easily tired).   At the time of the report, LAZINESS (feels lazy) and FATIGUE (fatigue and gets easily tired) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
81 yo man w/ HTN, T2DM, diagnosis of cough-variant asthma, presented after a week of cough, wheezing and chest tightness. He was treated for COPD exacerbation but also thought to be having heart failure exacerbation and his symptoms improved with diuresis. He developed atrial fibrillation and lateral TWI on ECG w/ very low level troponin elevations so underwent CTA to evaluate for underlying CAD which showed small amount of partially calcified plaque in multi vessel distribution. LA was very dilated w/ thick and small LV so there was concern for amyloid prompting CMR which was not c/w amyloid but did show mild LVH, basal inferolateral wall mid myocardia LGE which was thought c/w myocarditis; the same area was FDG avid on PET. He had no other evidence of extracardiac sarcoidosis. Likely he has a mild viral myocarditis, w/ very minimal biomarker elevation and no evidence of ventricular arrhythmias. He was started on beta blocker and will go out w/ MCT for further monitoring. He was also started on a standing diuretic, and bc of his AKI, his HCTZ and losartan were discontinued. These may need to be restarted in the outpatient setting if his blood pressure is not controlled and renal function is stable. He was also started on apixaban for his atrial fibrillation.
Within a minute after being given the vaccine I had a metallic taste in my mouth and my body became warm and tingly. This first wave passed quickly and I thought I was fine. About 13 minutes after injection my body became extremely hot and I was dizzy. I stood up to get the pharmacists attention and fainted to the ground. Upon awakening I was profusely sweating, nauseous, had stomach cramping and weakness.  I had to remove my mask and was having difficulty breathing. I was taken to the ER by ambulance where the doctor decided that I did not have an allergic reaction to the vaccine. I am convinced that I had a direct reaction to the vaccine whether or not it was anaphylactic in nature.
I am breastfeeding my baby. After receiving the vaccine I had a fever that kept going between 101-103.00. It stayed like this for about 24 hours. I had headaches, body aches, and chills. I didn't necessarily have a rashes but I did see a red area at the site I got the vaccine and noticed a lump. I also experienced nausea.
received the booster dose and his  annual flu shot in the other arm; received the booster dose and his  annual flu shot in the other arm; her husband tested positive after receiving the booster dose; her husband tested positive after receiving the booster dose; This is a spontaneous report from a contactable consumer or other non-HCP (consumer reported on behalf of her husband). A 63-year-old male patient received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in the arm on 09Oct2021 as DOSE 3 (BOOSTER), SINGLE (Age of vaccination: 63-year-old) for COVID-19 immunization. The patient had earlier received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration, on an unspecified date as DOSE 1, SINGLE and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration, on an unspecified date as DOSE 2, SINGLE (Age of vaccination: Unknown) for covid-19 immunization. The patient medical history was not reported. Concomitant medication included influenza vaccine (FLU) dose number unknown, single on an unspecified date. On 09Oct2021 patient received the booster dose and his annual flu shot in the other arm. That evening, he started with a cough and was quick tested 2 days after booster which came back positive, on the same day did drive-thru PCR test and Wednesday received positive results. He started with symptoms the same day as booster and his doctor said he was already infected prior to getting the booster on Saturday maybe 3-5 days prior to 09Oct2021 . Then he monoclonal antibody infusion on Thursday 5 days after booster. Is that going to negate the booster shot the reporter queried. The patient underwent lab tests and procedures which included PCR test (sars-cov-2 test): positive (drive-thru PCR test and Wednesday received positive results) on 11Oct2021. The outcome of all events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
30 minutes after vacine was given. I became severely nausated and vomited. Dizzy. Within the first hour to second hour I experienced moderate weakness and chills. By the 6th hour I had hives on the upper part of the arm that I recieved the shot in. The following day, I way just extremely weak and had mild flu-like symptoms. They had resolved by the 3rd day. I took 600mg og Motrin at the first signs of symptoms. 50mg of Benadryl with the hives. I never experienced any shortness of breath or cardiac issues.
Injection  site  reactions: pain,  tenderness  and swelling  in  the same arm of  the  injection,  swelling (hardness), and redness.