chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 23 year old female with no pertinent medical history or drug reactions/allergies who on approximately 02-JUL-2007 was vaccinated with a dose of Gardasil (lot3 656050/0245U) 0.5mL IM. Concomitant medication included amphetamine aspartate (+) amphetamine sulfate (+) dextroamphetamine saccharate (+) dextroamphetamine sulfate (ADDERALL). On approximately 03-JUL-2007 "within 24 hours" the patient experienced fever, chills and cold sweats. Medical attention was sought. At the time of reporting it is unknown if the patient had recovered. Additional information has been requested.  01/07/2008 This is in follow-up to report(s) previously submitted on 8/14/2007. Initial and follow-up information has been received from a physician concerning a 23 year old female with no pertinent medical history or drug reactions/allergies who on approximately 02-JUL-2007 (also reported as 28-JUN-2007) was vaccinated with a first dose of GARDASIL (lot# 656050/0245U) 0.5mL IM in the deltoid. Concomitant medication included ADDERALL. On approximately 03-JUL-2007 (also reported as 29-JUN-2007) "within 24 hours" after the injection the patient developed a fever of 101, chills, body aches, nausea and cold sweats. Medical attention was sought. At the time of reporting it is unknown if the patient had recovered. The patient recovered on 30-JUN-2007 in "48 hours". Additional information is not expected.
Severe breathing problems, never before experienced, began after booster. Treatments have included inhalers and steroids but the problem continues. It began after receiving the booster.
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history, current condition and concomitant therapy were not reported. On unknown dates, the patient was vaccinated with 3 doses of GARDASIL (dose, route, lot # and expiration date not reported). The doses were not following the recommended schedule, across a period of 2 years. On 18-AUG-2016, the patient was administered a dose of GARDASIL 9 (lot # L048459, expiration date 28-FEB-2018, dose and route not reported). No adverse effect was reported. Additional information has been requested.
RRT called and and patient bagged with 100% O2 changed to code blue with compressions  for 15 minutes until patient s pulse returned and patient placed on vent for a few minutes then patients pulse and waveform dictated to continue CPR until NP called the code and CPR stopped.
Initial report received on the 25 Nov 2008. An 86-year-old male patient had received a dose of flu vaccine (trade name, manufacturer, lot number and route/site of administration not reported) two months ago. The next day, the patient's arm turned black at the injection site and was painful. Two months later, the patient still has the pain, which is now extending into the armpit. The patient saw an orthopedic doctor who took x-rays that were negative. The doctor administered a cortisone injection that only relieved the pain for two days. The black color went away after two weeks. Documents held by sender: None.
Passed out in my kitchen and hit the hardwood floor. This was within 24 hours of the shot.
She says her daughter got her second dose yesterday, August 9th; feels tired like she has been walking too much; redness at the  injection site; soreness at the injection site; some aching behind the bends of her knee; her own voice is shaky from anxiety; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for a 26-year-old female patient.  A 26-year-old female patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered in left arm on 09Aug2021 (at the age of 26-year-old) as dose 2, single for COVID-19 immunization. Patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered in right arm on Jul2021 (at the age of 26-year-old) as dose 1, single for COVID-19 immunization and patient experienced pain in extremity. The patient medical history was not reported, and concomitant medications were Ascorbic Acid, Herbal, Levoglutamide, Lysine, Magnesium, Manganese, Retinol, Riboflavin, Selenium, Tocopherol, Zinc, ELDERBERRY, VITAMIN D. On an unspecified date in Aug2021, after the vaccination, the patient experienced some aching behind the bends of her knee and feels tired like she has been walking too much. Caller wants to know if this is normal. Caller also asking what should she do for the pain and soreness at the injection site. The ache or tired like feeling just started around 3:30PM afternoon. She says she kept checking on her and last night to make sure she was not feverish or feeling bad, and in the morning, she had soreness to her arm like the first, which she had gotten in her right arm, then got the second in her left arm since they told her she couldn't take both shots in same arm. Patient was fine when she left here outside of the soreness of the arm, then she told her an hour ago she had aching to the bend of her knee like a tired feeling like she has been walking too much. The patient hasn't treated the ache or tired feeling because it just started about an hour ago. She says she thinks patient's first dose was in July, she knows it was like a two-week period between them, so she thinks it was on 30th of July or 26th of July. She says her daughter got her second dose on August 9th. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.  Follow-up (20Sep2021), This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Fever 101.5 F, chills, headache, throat ache, joint pain, general fatigue
Red, warm, fever of 105 degrees, put on steroids, (entire upper arm). Turned to Cellulitis and is on Antibiotics now.
Right arm became very swollen and sore. Felt very dizzy and weak and temp suddenly shot up to 102. Stayed between 101 and 102 until the following evening. Every joint became achy and sore. Leg cramps all night. Overall, pretty miserable. This morning feeling weak but no fever. Arm is still very swollen and sore.
I received my first dose of Pfizer on 2/3/2021. When I went to bed at about 9:00PM on 2/5/2021, I noticed that whenever the bedcovers rubbed up against my beard, I experienced a burning sensation. On the morning of 2/6/2021, I couldn't feel anything on the right side of my face. I then sought medical care at a clinic, and I was just checked for an ear infection. Even though there was no sure sign of an ear infection, I was given medicine to treat any swelling that may have been present in the inner ear canal. The medication didn't help, and the numbness persisted for about 2 more weeks until it gradually began to dissipate.  Even though the right side of my face was numb, my facial muscle movements were unaffected. After much independent research, I have concluded that I likely had Bell's palsy.
Mother called 7/25/06 stated that child had hives a day after received vaccines listed on #, started on right arm 2-3 hives, a couple on left leg and 1 on right cheek. No other problems per mother 7/31/06 child doing well per mother hives resolved.
patient fainted in office approx 10 min. after injection. Patient rested a few minutes then went home. About 3:30pm mother reported child was feeling fatigued and was sleeping. Pt had ER visit later. 2-21-07 pt had a followup appt
Pt. rec'd vaccinations at WCE; s/s began next AM -> itchy, red rash to (Lt) arm and transient spreading to trunk. (Lt) deltoid area with approximately 5 cm diameter area erythema and warm confluent raised welts to inner (Lt) arm and (Lt) thigh. Tx- BENADRYL PRN.
The day following the vaccine I started having numbness/tingling in 1 hand, the next day on the other. 4 days later I developed Tinnitus on both ears. I  went to see  PCP and ENT but still have the Tinnitus which impairs my sleep greatly and some nights I can hardly sleep. The paresthesias in my hands continued. Then at the end of April I had paresthesias in my arms, legs and face. I had blood test and brain MRI which were negative. I went to see a Neurologist and I was diagnosed with Sensory Ganglionopathy. The Quality of my life has been greatly impacted since all of these started.
On 1/8/03 child broke out w/small whelps that developed into large whelps over a 2-day period. They spread from his flap to trunk then areas and a few small places on his face. Large whelps ?? dark in center. No fever, but did have a runny nose and diarrhea. Saw MD on 1/10/03 and was treated w/a 5 day course of Pediapred for allergic reaction. Whelps improved by 1/11/03 and completely resolved by 1/13/03.
huge bruise post tetanus vax-aches has fever in it-can not lay on the lt side-aches all;treated w/ice;
Discomfort at injection site; Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE DISCOMFORT (Discomfort at injection site) and INJECTION SITE PAIN (Pain at injection site) in a male patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE DISCOMFORT (Discomfort at injection site) and INJECTION SITE PAIN (Pain at injection site). At the time of the report, INJECTION SITE DISCOMFORT (Discomfort at injection site) and INJECTION SITE PAIN (Pain at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
This case was reported by a nurse via call center representative and described the occurrence of cardiac arrest in a 69-year-old female patient who received TWINRIX (batch number NZ3TA, expiry date 12th November 2018). On an unknown date, the patient received TWINRIX. On an unknown date, less than a minute after receiving TWINRIX, the patient experienced cardiac arrest (serious criteria GSK medically significant), respiratory arrest (serious criteria GSK medically significant), seizure (serious criteria GSK medically significant), nausea, diaphoresis and syncope. On an unknown date, the outcome of the cardiac arrest, respiratory arrest, nausea, diaphoresis and syncope were unknown and the outcome of the seizure was recovered/resolved. It was unknown if the reporter considered the cardiac arrest, respiratory arrest, seizure, nausea, diaphoresis and syncope to be related to TWINRIX. Additional details were provided as follows: Within a 1 minute after receiving TWINRIX, the patient became nauseous and diaphoretic followed by syncope. Within a few seconds, the patient went into respiratory and cardiac arrest. The cardiopulmonary resuscitation (CPR) was initiated, but only a few compressions were delivered before the patient had a seizure. The seizure lasted approximately 30 seconds. The patient was stabilized before emergency medical services (EMS) arrived. The patient transferred to the emergency room (ER) where the cardiac enzymes and chest X-ray (CXR) were found to be normal. The patient discharged to home from the emergency room.
saw MD 17APR96 AM;pt has throat & ear infect was running fever of 102, lethargic & upper body jerking 3x every 5min beginning 17APR96 4AM until seeing MD;MD felt pt rxn was d/t throat infect & being injected w/vax
patient was inadvertently administered the first dose of GARDASIL 9 on 8/27/2019, 2 minutes after her pregnancy test was resulted as positive; This spontaneous report was received from a nurse prescriber referring to a currently 24-year-old female patient, who had no pertinent medical history, drug reactions or allergies or concomitant therapies. Her pregnancy test was performed on 27-AUG-2019 and was resulted as positive.  On 27-AUG-2019, 2 minutes after her pregnancy test was resulted as positive, the patient was inadvertently vaccinated the first dose with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot# 1614897, expiration date 29-SEP-2021, upon internal validation established as 20-SEP-2021, dose not reported) intramuscularly for prophylaxis (vaccine exposure during pregnancy). The last menstrual period (LMP) and estimated date of delivery (EDD) was unknown. The pregnancy outcome was pending. At the reporting time, the outcome of the event was unknown.
Janssen COVID-19 Vaccine EUA Symptoms started April 7, 2021 (one day following vaccine): -8am body aches, chills and headache started, noticeable pain, swelling and redness of injection site -10am fever of 100, headache, chills and body aches persisted (took ibuprofen, which reduced fever), redness of injection site grew to nearly 2" diameter. -6pm fever of 102.5, nearly unbearable body aches and chills (took more ibuprofen, which brought fever down to 99.4 and took edge off body aches) April 8, 2021: -3:45am fever of 99.8, sweating until clothes were wet, chills and body aches. Pain at injection site worsened.  -7am chills, body aches lessened, dizziness started. After the chills, body aches, fever and headache subsided, I did not experience fever, but I still feel "hot flashes" and dizziness occasionally. Itchiness of the injection site. Redness still around 2" diameter.
100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; No adverse event; 100 bivalent boosters were 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 (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) 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 (100 bivalent boosters were 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 (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) 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 (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again).    This case contains information for the 58th of 100 adult male patients described by the reporter.  Concomitant Medication use information was not provided by reporter.  Nurse reported that an adverse event 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again. The 100 adult male patients were involved.  Moderna COVID-19 vaccine bivalent, dosage given in ml unknown to the HCP.   Treatment Medication use information was not provided by reporter.   This case was linked to MODERNATX, INC.-MOD-2023-697752 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2023-697752:Master case
This spontaneous report was received from a registered nurse (R.N.) concerning a patient of unknown age and gender. No concurrent conditions or medical history were reported. On 30-MAY-2015, the patient was vaccinated with improperly stored dose of VAQTA (Lot no. K001792 Expiration date: 22-OCT-2015) (dose, route and anatomical location of administration were not reported). No concomitant therapy was provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient was in bed for 2 days, no fever, extreme fatigue, and all of her upper body was extremely sore.
Patient has a known egg allergy, developed sensation of itchy, tight throat and persistent cough no wheeze oral or edema
Expired vaccine is stored in refrigerator on 08-Nov-2021 and then administered on 09-Nov-2021; Doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine is stored in refrigerator on 08-Nov-2021 and then administered on 09-Nov-2021) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine is stored in refrigerator on 08-Nov-2021 and then administered on 09-Nov-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine is stored in refrigerator on 08-Nov-2021 and then administered on 09-Nov-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that there was a confusion between the expiration date printed in the carton and the expiration date when the code was scanned. No adverse events were reported. Vial did not undergo any temperature excursion. Vial was placed in refrigerator on 08-Nov-2021.  No treatment medications were reported.
My health has a fairly deteriorated since vaccination; Severe inflammatory reaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 45-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GENERAL PHYSICAL HEALTH DETERIORATION (non-serious), outcome "unknown", described as "My health has a fairly deteriorated since vaccination"; INFLAMMATION (non-serious), outcome "unknown", described as "Severe inflammatory reaction". The events "my health has a fairly deteriorated since vaccination" and "severe inflammatory reaction" required physician office visit.  Additional information: 45-year-old female and long distance hiker and backpacker patient. Patient had a severe inflammatory reaction to the Pfizer vaccines. Patient health has a fairly deteriorated since vaccination. Patient have seen many highly rated doctors who are perplexed. Patient would like to offer her self as a subject. Patient seeking research that patient can participate in that might help illuminate what happened to patient and save others from such outcomes.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 31Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 20Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 21Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
excessive bruise right above her elbow; She also had shivering; This case was reported by a pharmacist via call center representative and described the occurrence of contusion of elbow in a 84-year-old female patient who received Herpes zoster (SHINGRIX) (batch number 4749N, expiry date 14th December 2021) for prophylaxis.   On 25th September 2020, the patient received the 2nd dose of SHINGRIX (intramuscular). In September 2020, less than a week after receiving SHINGRIX, the patient experienced contusion of elbow and shivering. On an unknown date, the outcome of the contusion of elbow was recovering/resolving and the outcome of the shivering was recovered/resolved.   It was unknown if the reporter considered the contusion of elbow and shivering to be related to SHINGRIX.  Additional information was provided as follows: The patient received the 1st dose of SHINGRIX and 3 to 4 days later she developed an excessive bruise right above her elbow. She also had shivering. The bruise symptom was getting better but had not been resolved yet. The reporter consented to follow up.
Severe edema, local heat, tenderness in site of administration , in excess of expected and usual reaction. No treatment.