chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE reported; Customer reported 1 dose of GARDASIL 9 that was administered after experiencing temperature excursion which started on estimated date of 14Dec2022, ended on 20Feb2023.   Temperature: 63F for 1641 hours 0 minutes 0 seconds Date of administration: 20Fe; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies was provided.  On 20-FEB-2023, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) after experiencing temperature excursion which started on estimated date of 14-DEC-2022, ended on 20-FEB-2023, lot # U031056 expiration date of 16-JUN-2024, for prophylaxis (product storage error) (route of administration and frequency were not reported).    Temperature: 63F (Fahrenheit) for 1641 hours 0 minutes 0 seconds. Prior excursion: No-one continuous excursion of 1641 hours.  No additional event reported.   This is a non-valid report due to lack of patient's identifiers.  Follow-up information has been received from the nurse 02-MAR-2023. The reporter confirmed that the spontaneous report referred to an 11-years-old male patient who on 20-FEB-2023, was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), as previously reported, with a dose of 0.5 ml by intramuscular route. It was confirmed that no side effects were reported by the patient or his parents. No more medical information had been reported.  This report was prior considered to be non-valid due to lack of patient's identifiers; on 02-MAR-2023 the nurse confirmed the patient's demographics and the case became to be valid.
Information has been received from a licensed visiting nurse concerning a 6 year old male with no known drug allergies who on 12/15/97 was vaccinated at another facility with a dose of varicella virus vaccine live. On 4/14/03 the patient presented to the doctor's office with varicella with about 20-30 erythematous, macular 8-10mm vesicles and a central, 3mm vesicles, all over his body. The patient also developed posterior cervical adenopathy. He had minimal itching. Medical attention was sought and the patient was treated with acyclovir. Subsequently, the patient recovered. No further information is expected.
Patient described waking up 2 days after getting the flu shot with bilateral lower extremity weakness. Her symptoms have now improved to near baseline.
This spontaneous report was received from a nurse who is the wife of the patient concerning her 60 year old husband. The patient's concurrent conditions included pituitary tumor since 1990, which was under control with an unspecified medication, high blood pressure and thyroid, cholesterol and heart issues. On 14-MAR-2016, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot# not provided). On the same date, the patient also received a shot of PCV (manufacturer unknown). The patient's concomitant medications were not provided. The patient's wife reported that since receiving ZOSTAVAX, since approximately March 2016, the patient had experienced severe cramping in his legs, especially the calves and ankles, causing patient to stand up to obtain more relief. Cramping of the legs was worse in evening than daytime. The patient's wife reported that patient experienced spasms in his fingers, which lasted two hours, on 09-APR-2016. No treatment was given for the patient's adverse event. The patient had no contacted primary care physician. At the time of the report, the patient had not recovered. Additional information has been requested.
Fever for 48 hours, runny nose for approximately 10 days, eye irritation, decreased appetite, irritability, rash on face, neck, stomach, back (for 3 days)
Administered Booster Covid-19 vaccine when not indicated by patient age, 16 years old
Delayed cutaneous hypersensitivity (COVID-arm) on day 8 after the vaccination. Slight swelling, slight pain, itching and redness around the injection site persisted for 48 hours.
Immediately after the shot, had a metallic taste in her mouth. Around 10 day later, April 4, 2021, vision in right went blurry. Received 2nd dose Moderna on 4/22/2021. After 2nd dose, vision in left eye went blurry. Had two surgeries on right eye.
Crying & screaming over 17 1/2 period temp 104 range during this time;
Arm became sore at injection site, became weak in the legs trouble walking, lasted about  24 hours
Pfizer-BioNTech COVID-19 Vaccine EUA 1. Left side of face was numb for a few minutes, got better, then got numb again.  Numbness went away again.  Over the last few days, left side of face has felt weird. Kind of tingly near cheek bone and under eye.   2. Sore shoulder for ~ 36 hrs. 3. Headache for ~ 48 hrs.
Tinnitus in both ears with pressure in ears.  Started 2 days after shot.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated intramuscularly with dose 1, 0.5 ml of GARDASIL (lot # not reported) on 12-JUL-2011. On 19-JUL-2012 the patient was vaccinated with dose 2 of GARDASIL (lot #, dose and route not reported). No other co-suspect and no concomitant medications were reported. No adverse effects were reported. No treatment information was reported. Additional information is not expected.
I started to get hives on my arm and within a day or 2 it spread down both arms and onto my torso and eventually up ,my leg. It kept spreading. I went to my PCP and they gave me Medrol steroid dose packs. When it continued to spread. My PCP advised me to go to the dermatologist. She advised me it was a drug reaction and gave me a steroid injection which helped to stop the spreading. I used Caladryl gel topically to stop the itching. Overall my symptoms lasted 6 weeks. I had an COVID 19 antibody test completed. My Antibody test results indicated my numbers were much higher than other participants that had been tested. Specifically I tested at a 17 and most participants average around 6 or less with a positive result.
Persistent headache for approximately 1 week. It was not responsive to any pharmacologic or non-pharmacologic interventions to reduce the pain.
Fever; Headache; Body ache; Chills; The third I got the booster, 2 days ago.; The third I got the booster, 2 days ago.; This is a spontaneous report from a contactable other HCP. A 72-years-old female patient received bnt162b2 (Pfizer- Covid-19 Vaccine, Formulation: Solution for injection, Batch/Lot Number: FC3183), dose 3 via an unspecified route of administration, administered in Arm Left on 23Sep2021, as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization (At the age of 72 years old). Medical history included hypertension from an unknown date and unknown if ongoing high blood pressure, diabetes mellitus from an unknown date and unknown if ongoing, renal disorder from an unknown date and unknown if ongoing kidney disease, adverse event from an unknown date and unknown if ongoing, I can't take NSAIDS. The patient's concomitant medications were not reported.  The patient previously took bnt162b2 (Pfizer- Covid-19 Vaccine, Formulation: Solution for injection, Batch/Lot Number: (Pfizer- Covid-19 Vaccine, Formulation: Solution for injection, Batch/Lot Number: FC3183) for covid-19 immunization and experienced no adverse event, bnt162b2 (Pfizer- Covid-19 Vaccine, Formulation: Solution for injection, Batch/Lot Number: EL8982) for covid-19 immunization and experienced no adverse event, motrin (ibuprofen) and experienced adverse event. On 23Sep2021 patient got the third dose (booster), 2 days ago, Nurse stated, "The first two Pfizer shot, I had no problem with. The third I got the booster, 2 days ago. I was fine for 2 days, now I have a fever, headache, body ache, chills I just want to report it. Nurse stated, No, I cannot take NSAIDS (Unspecified Medication) because of my kidney so I canot, they consider and it helps but I cannot or a Motrin but I cannot. On 25Sep2021 patient experiences fever, headache, body ache, chills. The outcome of the events was unknown on an unspecified date.  Follow-up attempts are completed. No further information is expected.
I have a cold; I'm sick as a dog; Sore throat; Loosing  my voice; I didn't feel good"; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 29Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "I have a cold"; ILLNESS (non-serious), outcome "unknown", described as "I'm sick as a dog"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "Sore throat"; DYSPHONIA (non-serious), outcome "unknown", described as "Loosing  my voice"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "I didn't feel good"".  Clinical Course: I have a cold, I'm sick as a dog, have a sore throat and loosing  my voice. I can't reach my doctor. How do I cancel the appointment I have today for my second dose and reschedule".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
side effects after recieving vaccine; A spontaneous report (United States) was received from a Consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  side effects .  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the event the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection and experienced side effects.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event was considered as unknown. .; Reporter's Comments: Very limited information regarding the event has been provided at this time and is insufficient for causality assessment. Further information has been requested.
his upper lip swollen; hives on his upper leg/hives on his arm/hives on his shoulder/hives on his belly/hives on his thighs; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives on his upper leg/hives on his arm/hives on his shoulder/hives on his belly/hives on his thighs) and LIP SWELLING (his upper lip swollen) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No treatment medication was provided.  The patient's past medical history included No adverse event (No medical history reported.). Concurrent medical conditions included Crabs NOS.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced URTICARIA (hives on his upper leg/hives on his arm/hives on his shoulder/hives on his belly/hives on his thighs). On 16-Mar-2021, the patient experienced LIP SWELLING (his upper lip swollen). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) ongoing from 13-May-2021 for Hives, at an unspecified dose and frequency and OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) ongoing from 17-May-2021 for Hives, at an unspecified dose and frequency. At the time of the report, URTICARIA (hives on his upper leg/hives on his arm/hives on his shoulder/hives on his belly/hives on his thighs) had not resolved and LIP SWELLING (his upper lip swollen) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood immunoglobulin E: 92 (Low) LOW.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. The patient took cetirizine (Zyrtec) as corrective treatment. Patient preferred contact method was email. Patient wanted to know if he should receive the 2nd dose and if this is common.   This case was linked to MOD-2021-146178 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: VAERS and Hypersensitivity form with significant info
Patient received varicella vaccine at ages 19 months and 10 years -on 5/12/08-.  The vaccine was administered in the left arm at 10 years of age, location of injection at 19 months not available in current medical record.  On 2/23/09, patient presents with URI and rash.  The rash is described as papulovesicular lesions and clusters to left back, side and abdomen- appears to follow T-10 or T-11 dermatome.  Treated with CAPSAICIN cream.
Headache, nausea,  muscle and joint pain, low grade fever,  swelling and pain at injection site, fatigue, weakness
This spontaneous report was received from a physician refers to a female patient of unknown age. The patient's concurrent condition, concomitant medications, medical history, past drugs, allergies and reactions were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX for prophylaxis (dosage schedule was not reported). On an unknown date, the patient experienced drug allergy to ZOSTAVAX (drug hypersensitivity). The drug allergy reaction was reported as kidney transplant (renal transplant) and immunosuppression. The reporter considered renal transplant, drug hypersensitivity and immunosuppression to be related to ZOSTAVAX. Upon internal review, the event immunosuppression and renal transplant was considered to be medically significant. This is one of the two reports.
Mild cellulitis around vaccine site, L arm, day #9. Pt had prior history of MRSA cellulitis.
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: injection may have been given too low
chicken pox; 2 blisters, one on forehead and one on upper right arm; itchy spot; skin is peeling; This case was reported by a consumer via call center representative and described the occurrence of chickenpox in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th November 2021, the patient received the 1st dose of Shingrix (intramuscular) 50 µg. In November 2021, 24 hrs after receiving Shingrix, the patient experienced chickenpox, blister, pruritus and skin peeling. On an unknown date, the outcome of the chickenpox, blister, pruritus and skin peeling were not recovered/not resolved.   It was unknown if the reporter considered the chickenpox, blister, pruritus and skin peeling to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient. The patient had received the Shingrix vaccine in her upper left arm.  The reporter reported that 24 hours after the vaccination, she developed 2 blisters (one on her forehead and one on her upper right arm).  The reporter stated that both her PCP (primary care physician) and her dermatologist told her it was chicken pox.  The caller stated the two spots were still itchy and the skin was peeling and they had not resolved over the past 2 months. The reporter was given consent to contact her and her healthcare professional but she did not had her physician's information available during the call. The reporter did not have the lot or expiration date of the vaccine administered. The reporter consented to follow up.
Client  received the COVID vaccine (Pfizer, lot # EW0182, expiration date 5/13/2021) at 1455. The client complained of feeling hot, nausea, spotty vision at. EMT and RN responded at this time. The client was offered a bottle of water. He appeared pale and clammy, and was speaking in 1-2 word sentences. The client denied chest pain or shortness of breath. At 1506, the client stated that he was feeling "weak and faint" and was transferred to the zero gravity reclining chair at that time. The client denied any medical history, stated he takes no medications, and has no allergies. The client stated he ate breakfast at 1000 and hadn't had anything to eat or drink since then. At 1509, the client's vital signs were as follows: blood pressure 100/60, heart rate 52, respiratory rate 20, O2 97%, temperature 96.3 (the client was still quite sweaty at the time.) The client's pulse was thready but regular. The client continued to appear diaphoretic but his color was improved. He was alert and oriented. The client stated his arms were tingling but his vision had returned to normal and his nausea had resolved. The client refused benadryl at this time. At 1517, the client's heart rate was 84, respiratory rate 14, pulse strong and regular. The client's skin color had returned to normal and he was no longer diaphoretic. The client stated that his symptoms had all resolved and he was feeling "back to normal." Education provided regarding v-safe, primary care follow up, symptom management, AMR activation and emergency management. At 1530, the client's vital signs were as follows: blood pressure 100/82, heart rate 72, pulse strong and regular, O2 96%. The client was able to stand up from the reclining chair without any dizziness, and ambulated with a steady gait to his car, where he drove himself home.
For the 1st 48 hours Ice packs ,BENADRYL and Aleve And the redness and pain went away.   Headaches coming and going since shot and never got them much before shot.   One week later a bright hot rash circle back on my arm  Call Teladoc and told Ice Packs, Benadryl , Aleve and Doxycycline for the infection.
I have had bad anxiety attacks since having the first covid shot; This is a spontaneous report from a contactable consumer. A 50-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration at the age of 50 years old, administered in right arm on 13Jul2021 15:00 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included allergies. Concomitant medication included amlodipine. The patient had nasal swab on 16Jul2021 which showed negative result. The patient experienced bad anxiety attacks since having the first covid shot on 19Jul2021. No treatment received. The outcome of the event was not recovered.  Information about lot/batch number has been requested.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 23-JUL-2014 the patient was vaccinated with VAQTA (50/1.0 U/ML) (dose: 1.0 ml, route: intramuscular). Pertinent medical history and concomitant medications were not reported. The reporter stated that VAQTA was administered after being exposed to 48F for 30 minutes. No adverse effects reported. The outcome of the event was unknown. No further information reported. Additional information has been requested.
after 48 hours, pain, redness, swelling, and subjective fever.  pain progressed to limiting range of motion and pain radiating down to the left hand.  By the Jan 6th, there was a 7 cm diameter patch or erythema consistent with cellulitis.  Patient was started on clindamycin with improvement by 01/11/2021
24 hours after vaccine DTaP. Left deltoid area red, swollen, warm to touch, moderate tender bnt, not C/O pain unless arm is bumped. Afebrile, sl cough, Tylenol, Robitussin DM. Red, swollen 2/28 6.5 x 8 cm
Felt 'rush' throughout the body after 15 minutes of injection. Drank lots of water. Chills 50 minutes after injection. Took Tylenol. Day 8, arm itchy and red around the injection site.  Warm to the touch. Day 9, more redness and larger area. Size of a silver dollar.  Talked to the nurse at a local gym. Suggested a clinic. I Saw a Nurse Practioner at a clinic. She thought perhaps it was an insect bite as the red area was about 4 inches below where a 'normal shot' would be given. Prescribed cream and antibiotic. I didn't take it.  Took Benadryl (pill). Improving after 1 hr of taking Benadryl.
Given High Dose vaccine when he should have received regular dose.  Side effects: Headache, night swear, fatigue, nausea, body aches. Lasted for two days.
I went to urgent care on 9/28 with bilateral foot swelling and redness. I was then sent to the ER at  Hospital. They diagnosed me with cellulitis and sent me home with antibiotics. Over the weekend the swelling and redness moved up my legs and to my arms and hands. I went to Medical Center ED and was admitted on Oct. 3-4. A central line was placed and a biopsy taken of my arm. I was discharged on prednisone. On Oct 12 I followed up with dermatology and had another biopsy taken in my doctor's office. My pain and swelling had spread. On Oct. 17, I passed out with a high fever, increased redness, swelling and pain. I was again admitted to Hospital 17-18.
This initial spontaneous case, was received from other non-health professional (consumer) on 23-Oct-2017, concerning a 29-year-old adult female pregnant patient. The patient had no relevant medical history. The patient had no relevant maternal and paternal medical history relevant to pregnancy. The patient had no previous pregnancies. The patient received unspecified birth control medications prior to pregnancy. The infant's father received unspecified vitamins prior to conception. The patient's concomitant medications during the pregnancy included PNV (prenatal vitamins). The patient did not receive any contraceptive methods. The patient's  last menstrual period was an unspecified date in May/Jun-2017, it was patient's first pregnancy. The gestational age of the fetus was 20-weeks and gender of the fetus was male. There was no evidence of any defect/adverse finding from a prenatal test. The patient gave the permission to enroll in the pregnancy registry. On 23-Oct-2017, at gestational age of 20-weeks (second trimester), the patient was administered with FLUCELVAX QIV (route of administration: Intramuscular, dose, batch number, expiry date, anatomical location: not reported). The patient received the vaccine during pregnancy (explicitly coded as vaccine exposure during pregnancy) and no adverse event was reported in pregnant woman and fetus. The estimated delivery date was 13-Mar-2018. The reporter assessed the event as non-serious.
Pt presented with bright red raised distorted area (approximately 4 -5 in) directly below the band-aid injection site. Pt reported no pain, fever, or itching. The application area of the circular "Inject-Safe" covering was also reactive, though not at all red.  I directed the patient to take a picture of the area and report the reaction to Family Physician, watch for changes or no improvement. Patient may be directed to take antihistamine prior to the 2nd Shingrix if no further complications. Pharmacist will also notify the FP  of this report
headache; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (vomiting) and HEADACHE (headache) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced VOMITING (vomiting). On 14-Apr-2021, the patient experienced HEADACHE (headache). On 14-Apr-2021, VOMITING (vomiting) had resolved. On 15-Apr-2021, HEADACHE (headache) had resolved.            Concomitants were not provided. Treatment was not provided.
HYPERtension, Tachycardia, Patient stated she was not feeling well and c/o chest pain and left arm numbness. vitals were obtained and a Condition C was called. Narrative:
After receiving Tdap and Tb skin test she said she broke out in a rash around neck and to/around eye (R) eye.