chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE; Caller reporter improperly stored and administered vaccines for MMR-II, PROQUAD, and VARIVAX to multiple patients since May 2023 (TE occurred 5/9/2023). No symptoms reported. Caller did not have specific AE information available regarding patient inf; This spontaneous report was received from other and refers to a 7-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 07-JUL-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #W008712, expiration date: 14-MAR-2024, administered for prophylaxis (strength, and route of administration were not provided).This vaccine underwent temperature excursion before administration in 58.65 degree Farenheit (F) for 25 hours 45 minutes (Product storage error). No additional adverse event was reported.
Multiple  swollen lymph nodes under both underarms and  right groin. Also noticed flare up of arthritic pain in left knee
The same day I received the shot I began to feel tired, light headed and fatigued.  The next day I also began to feel sinus pressure and began coughing.  When I returned home on 1/27/08 I took otc medication to relieve my symptoms but got no relief.  On 1/29/08 I went to see my doctor and she prescribed antibiotics believing that I had a sinus infection however, I have now finished that treatment and still have the same symptoms.
3 hours after vaccine developed generalized arm swelling, redness, tenderness, 25 hours temp 100.2 and headache sore throat, diarrhea, muscle aches which lasted 3 days and was taking tylenol. this subsided after 3 days. large knot at injection size and felt like skin was pulling. reports gumball area as of today. Reports skin feels hypesensitivity. no respiratory issues reported.
The night of vaccination I had a fever of 100 degrees, chills, body aches, and headaches that lasted for 2 days. I was also vomiting. I wasn't able to eat. I was feeling nauseas and dizzy. I was also experiencing a faster heart rate at night, but by the next day it stopped. I called the Student Health Center, and they prescribed me with ibuprofen 400mg, Tylenol 650mg, Pantoprazole 20mg, and Domperidone 10mg. I was fine 2 days later.
Rash on hands and feet. Swelling of feet ( edema).  Rash on right shin.   Rash on right hand got worse is very painful.  Went to ER on 3/23. They say I have Vasculitis.   Condition still getting worse after 8 days. Treatment is steroid  ( Prednisone).
Heart hurts feels really tight; Heart hurts feels really tight; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 03Sep2021 11:00 at the age of 41 years old (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced heart hurts feels really tight on 03Sep2021 13:00. The outcome of events was recovering. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment given for the events.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Patient was given DTaP instead of Tdap. He had left the office before this was discovered. Message left for parents to call our office. Parent called back same day and reports no adverse event yet.
Big rash over shoulder extending to left elbow/Rash over left arm; fever 99.3; headache; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Big rash over shoulder extending to left elbow/Rash over left arm), PYREXIA (fever 99.3) and HEADACHE (headache) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced RASH (Big rash over shoulder extending to left elbow/Rash over left arm), PYREXIA (fever 99.3) and HEADACHE (headache). At the time of the report, RASH (Big rash over shoulder extending to left elbow/Rash over left arm), PYREXIA (fever 99.3) and HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       she experienced rash on Left shoulder, left arm and up to left elbow. 2 days later 16 march she developed big rash 10 inch by 10 inch on left shoulder and left arm with fever 99.3 and headache, she consulted her HCP. She is using anti hist lotion for that. She take aspirin and thyroid medicine as concomitant medication.
This was a cancer patient and they would need a third dose; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE, and on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The pharmacist reported that this was a cancer patient and they would need a third dose with outcome of unknown. Patient had a negative antibody test following Pfizer vaccine series. Serious: No.   Information on lot/batch number has been requested.; Sender's Comments: Based on no temporal relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be assessed for the reported event of neoplasm malignant. 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
1) sweating, chills, some difficult to describe feelings, dizziness, light headache, light nausea 2) difficulty in going to sleep, abnormal dreams, nightmares, hallucinations, unusual/bizarre images, preoccupied, day dreaming 3) Occasional hyperventilation 4) Unable to focus. I am slow to understand/comprehend/react. 5) Sometimes when I wake up, I find myself crying. 6) During the day, sometimes I find myself talking to myself when there is nobody else in the room but me.
Patient received first dose of Moderna COVID-19 vaccine today at approximately 07:30 hours. Approximately 5-7 minutes after receiving vaccine patient experienced a brief wave of nausea. Denies any additional symptoms and said that the nausea passed within about a minute.  Disposition:  Patient has a history of anxiety and verbalized that she was feeling anxious to receive the vaccine and hadn't sleep well. Patient stated that she does experience waves of nausea when she is feeling anxious and stated that the brief episode of nausea had passed and continued to deny any additional symptoms. Patient ambulated out of the vaccine clinic.
I received ZOSTAVAX vaccine with no problems, but 2 days later I began having 1 or 2 mouth blisters per day for about 2 weeks. Then I also had a sore tonsil for 1 day. After that everything is OK.
This spontaneous report as received from a licensed practitioner nurse refers to a patient of unknown age and gender. The nurse reported that on 23-DEC-2011 the patient was vaccinated with the first dose of GARDASIL (dose, route, lot number and expiration date not reported). On 25-JUL-2013 the patient was vaccinated with the second dose of GARDASIL (dose, route, lot number and expiration date not reported). No adverse event was reported. Additional information is not expected.
Patient experienced an episode of syncope followed by a full tonic-colonic seizure which lasted about 3 min. Patient was assisted to the floor, loosened all restrictive clothing ensuring not to cause further injury . Notified Ambulance services to transport to Emergency Department . Continued to treat and monitor until transport arrived.
pt recv vax 30NOV98 & w/in 12hr exp flu like sx including sore throat, h/a & myalgia;
p/vax pt exp a fever,pressure in ears, runny nose, hallucinations, uncontrolled diarrhea, pain in joints, hands & knees & was tired;pt sough unspecified med attention & was tx w/biaxin;sx subsided but still feels tired & head hurts per pt;60 day follow-up dated 10/25/00 provided no additional data.
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 23-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided. Concomitant medication was not provided.
Day after vaccine: headache, nausea, low grade fever, "pinching feeling in chest", decreased appetite.  Felt better for a few days, then 4 days after vaccine, low grade fever returned, pt developed rash/swelling on 75% of body, itching, little nausea, elevated diastolic blood pressure when measured at urgent care. pt was given steroids for swelling/rash.
Student became pale, clammy.  After rest and hydration student continued to feel "off."  His vital signs were WNL.  Parents were called and he went home to rest.  Parents reported he felt fine all day and night.  The following AM student woke with swollen eyes.  The parents were unclear if this was due to cat exposure and student's allergy to cats or a flu shot reaction.  Student referred to MD and was seen 22.5 hours after receiving the vaccine.   Parent reported there was no swelling, redness at site of injection, no malaise felt.  MD suggested Benadryl and monitoring at home.
Only liquid portion given; Only liquid portion given; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a female patient who received Herpes zoster (Shingrix) (batch number JN93X, expiry date 07-JUL-2024) for prophylaxis.   On 27-MAR-2023, the patient received Shingrix. On 27-MAR-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Only liquid portion given) and inappropriate dose of vaccine administered (Verbatim: Only liquid portion given). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 28-MAR-2023 The reporter reported that the patient was administered only with the liquid portion. The patient received only adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter asked how to proceed. The vaccine administration facility is the same as primary reporter. The reporter did not consent to follow up.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 09-JAN-2015 the patient was vaccinated with a dose of GARDASIL (lot# was unspecified, 0.5 ml, intramuscular) which underwent a temperature excursion. No adverse effect was reported. This is one of several reports received from same reporter. Additional information has been requested.
Pt cried/screamed for 4 hrs parents unable to console; parents had used APAP since vax administered; pt taken to ER advised to continue w/APAP & to offer pt a salt water solution in bottle;
Migraine; Nauseous; Dizzy/ light headed; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Dec2021 08:30 (Lot number: 30130BA) at the age of 45 years as dose 1, 0.3 ml single and administered in arm left, administration date 10Jan2022 08:30 (Lot number: FL3198) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hashimoto's disease" (ongoing), notes: Hashimoto's disease, Diagnosed about 2018; "Fibromyalgia" (ongoing), notes: Fibromyalgia, Diagnosed about 2018; "Chronic urticaria", start date: 2016 (ongoing), notes: Chronic Urticaria; "Angioedema", start date: 2016 (ongoing), notes: Angioedema; "Alopecia", start date: 2018 (ongoing), notes: Alopecia; "Eczema", start date: 2016 (ongoing), notes: Eczema; "Covid", start date: Oct2020 (unspecified if ongoing), notes: had the Covid virus in Oct2020. Family history included: "Asthma", start date: 2016 (ongoing), notes: Asthma, Family Medical History Relevant to AE(s): Grandmother has Asthma; "COPD" (unspecified if ongoing), notes: Family Medical History Relevant to AE(s): Grandmother has COPD; "Heart disease" (unspecified if ongoing), notes: Family Medical History Relevant to AE(s): Grandmother has Heart disease. The patient's concomitant medications were not reported. Vaccination history included: Flu shot, administration date: 10Dec2021, when the patient was 45 years old, for Immunization, reaction(s): "angioedema", "swelling", "hives", "allergy to eggs"; Flu shot (She hadn't had one since 2014), administration date: 2014, for Immunization, reaction(s): "She hadn't had one". The following information was reported: MIGRAINE (non-serious) with onset 20Dec2021, outcome "not recovered", described as "Migraine"; NAUSEA (non-serious) with onset 20Dec2021, outcome "not recovered", described as "Nauseous"; DIZZINESS (non-serious) with onset 20Dec2021, outcome "not recovered", described as "Dizzy/ light headed"; FATIGUE (non-serious) with onset 20Dec2021, outcome "not recovered", described as "fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of migraine.  Additional information: She has several autoimmune diseases and is immune compromised. She addressed her migraines and prescribed Atenolol. After each injection the symptoms began within 15 to 20 minutes. After each injection the symptoms began within 15 to 20 minutes. After the first dose, she made the mistake of not eating prior to receiving the vaccine. She had to stay there for an hour after the injection because she was so lightheaded and dizzy that the room was spinning; they had her lay down. The second time they didn't have staff so they had her sit in the hallway in a chair, 15 to 20 minutes after each vaccine.   No follow-up attempts are possible. No further information is expected.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 08-DEC-2011 at 8:00, ZOSTAVAX (Lot # 671140/1266AA) was exposed to -13 degrees C for an estimated total time out of range of 10.5 hours. On 06-JAN-2012, the patient was vaccinated with an out of range dose of ZOSTAVAX (Lot # 671140/1266AA, expiration date 05-NOV-2012) (dose and route of administration were not provided). No adverse experience was reported. This is one of 182 reports received from the same source. Additional information has been requested.
24 hours post vax, the pt experienced a 6 " diameter area of redness and hardness at the injection site. The consumer stated that the injection site was as hard as a rock. No treatment was given.
The patient experienced a fever of 103F and severe myalgia for 3 days with malaise. The patient woke with these symptoms the morning after receiving the vaccine. The patient took time off work and still feels weak.
severe allergic reaction; Chest tightness; shortness of breath\ difficulty breathing; sever reaction happened for 7 mins/Anaphylactic reaction; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (sever reaction happened for 7 mins/Anaphylactic reaction) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anaphylaxis and Hives. Previously administered products included for Product used for unknown indication: Anesthesia (Patient threw up for several hours.) in March 1997, taxotere (chemo IV) ((chemo IV) Difficulty breathing, stridor, chest tightness) in April 2004, taxotere (chemo IV) ((chemo IV) Difficulty breathing, stridor, chest tightness) in April 2004, taxotere (chemo IV) ((chemo IV) Difficulty breathing, stridor, chest tightness) in April 2004 and Moviprep in July 2015. Past adverse reactions to the above products included Chest tightness with taxotere (chemo IV); Difficulty breathing with taxotere (chemo IV); Stridor with taxotere (chemo IV); and Vomiting with Anesthesia and Moviprep. Concurrent medical conditions included Hypertension since January 2021, Bradycardia (Pacemaker) since 01-Oct-2020 and Seafood allergy (Lobster allergy causes Hives) since 1986. Concomitant products included UBIDECARENONE (COQ10 [UBIDECARENONE]), MONASCUS PURPUREUS (RED YEAST RICE), MULTIVITAMIN [VITAMINS NOS], CALCIUM and LISINOPRIL for an unknown indication.    On 29-Jan-2021 at 4:50 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced CHEST DISCOMFORT (Chest tightness) and DYSPNOEA (shortness of breath\ difficulty breathing). 29-Jan-2021, the patient experienced ANAPHYLACTIC REACTION (sever reaction happened for 7 mins/Anaphylactic reaction) (seriousness criterion medically significant). On an unknown date, the patient experienced HYPERSENSITIVITY (severe allergic reaction). On 29-Jan-2021, CHEST DISCOMFORT (Chest tightness), DYSPNOEA (shortness of breath\ difficulty breathing) and ANAPHYLACTIC REACTION (sever reaction happened for 7 mins/Anaphylactic reaction) had resolved. At the time of the report, HYPERSENSITIVITY (severe allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    The patient went to the ER and got pumped with something (Unspecified).   Most recent FOLLOW-UP information incorporated above includes: On 18-Jul-2021: Updated patient demographics, medical history , allergies. Updated event , concomitant medications and treatment medications.
Vomiting, sore arm, fever, body ache, almost loss of conciousness
Patient is complaining of arm pain for over a year since vaccine.  She says she cant move her arm.
Patient was inadvertently given 1ml dose of influenza vaccine, instead of correct 0.5 dose. Patient reports no skin reaction and no adverse events.
This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. On 23-SEP-2013, the patient was vaccinated with GARDASIL (lot# J003727 and expiration date 07-NOV-2015 (also reported as 08-NOV-2015). It was reported that the vaccine was improperly stored and was exposed to below 31.6 Fahrenheit from 09-SEP-2013 to 23-SEP-2013. No further information was available at the time of the report. The case is linked to 1312USA001445, 1312USA008847, 1312USA008940, 1312USA008941, 1312USA008942, 1312USA008943, 1312USA008945 (Same reporter link). Additional information has been requested.
Patient developed hives over 90% of his body 4 days after receiving the vaccine. The doctor who treated him thinks it was an allergic reaction to the vaccine. He is currently being treated with steroids and reports being about 50% better at this time. He still has doses to take.
It started with body ache and then terrible headache, chill, nauseous, tiredness, and overall weakness. Not so much fever (about 100) but felt cold. I was Covid positive in November 2020, and felt the symptoms were very similar to what I had back then. It lasted two full days and especially the headache was persistent and went on the morning on the 3rd day. Spent two full days in bed. Took Advil on the 1st day and 2nd day but it took 3-4 hours to start feeling the effect. I switched to Tylenol on the night of the 3rd day, but didn't feel it worked.  Felt almost normal in the afternoon of the 3rd day, but the headache came back the same night and couldnt sleep. Finally felt recovered in the morning of the 4th day but minor headache. The 4th day afternoon was fine.
There was no adverse events reported by patient. Due the refrigerator temperature excursion on 8//2/16. Manufacture determined the vaccine is not viable and CDC recommend revaccinate.
Received vaccine at approx. 11am on 10-7-2022  at 9:45pm on 10-7-2022, resident was diaphoretic, B/P 118/84,  HR 125,  PSOX 98%, at 10:10pm, feeling better, at 10:45pm BP 90/50 diaphoretic , weak and pale, 911 was called, 11:29pm 911 arrived, talked to resident he was able to stand to transfer to stretcher and then became weak, dry heaves, and he stopped breathing, resident was a DNR, so breathing was assisted until pulse stopped, pronounced deceased by  911 at 11:45pm
Patient experienced lightheadedness and dizziness after 15 minute wait period upon standing up. Blood pressure was checked and was 150/90 then re-checked 15 minutes later which increased to 170/96. In house physician decided to call 911 for patient and blood pressure was re-checked 15 minutes later which showed another increase to 196/102. Patient was taken to hospital for evaluation and treatment at 1:17PM.
Dizziness within one hour of injection. approximately six hours after Injection fever, chills, body aches, headache and shakes. Relief from symptoms occurred approximately 26 hours after injection.  At the time of submission 29 hours after injection patient continues to have symptoms but not as severe
12 year old received Moderna COVID-19 booster; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old received Moderna COVID-19 booster) in a 12-year-old patient of an unknown 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) .25 ml. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old received Moderna COVID-19 booster). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old received Moderna COVID-19 booster) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Fascial numbness, and arm numbness. She reports she could not feel her neck being pinched. She also felt fatigue and as if her heart was beating slowly. She denies hurting herself today. Pt reports she is now feeling better.
Swollen breasts -used ice packs to cool down.. 2 days post vaccine they are still swollen Started menstrual cycle around 1am next morning.. I haven't had a cycle in 5 years. I'm on extended birth control.   Induced a migraine - used OTC Excedrin  Body aches, chills, aching skin, Sensitivity to light and sound