chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient was incorrectly scheduled for and given the second covid 19 vaccine dose 2 weeks after the first dose (i.e. 1 week early).
This spontaneous report as received from a registered nurse refers to three unspecified patients of unknown age. Within the "last month or so", approximately in April 2013, the patients were vaccinated with a dose of PNEUMOVAX23 lot number H022062, expiring 28-FEB-2014 (dose and route not provided). On unspecified dates, in 2013, the patients experienced chills, fever and swelling at injection site after receiving the vaccine. The outcome of swelling at injection site, fever and chills was unknown. The causal relationship was not provided. Additional information has been requested.
fever of 100.8; pain across her chest; her breathing was horrible; immune system is so bad; pain across her chest and back; she was real sick; This is a spontaneous report received from a contactable consumer. A 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection Lot number and expiration was not provided) via unspecified route of administration as a single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. It was reported that patient was very scared to get the vaccine. Caller stated patient had symptoms after the first dose of the pfizer covid 19 vaccine. Caller stated that everyone she knows said they did not have any side effects to the first dose and that the side effects are worse with the second dose. Caller was concerned her symptoms will be worse after the second dose. Caller reported fever of 100.8, all this other stuff, pain across her chest and back and her breathing was horrible Caller stated she was real sick. Caller stated her immune system was so bad. The patient asked once you get the first dose, how important was it to get the second one. Patient underwent lab test and procedure which included body temperature 100.8 centigrade.The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
13 year old patient received the Pfizer Covid vaccine intended for 5-11 years old and received the 0.2 ml dosage. We are currently reaching out to patient to inform about the error, but per CDC patient is to come back at 21 days to receive the second dose of Pfizer but patient is to receive age appropriate Pfizer vaccine 12 and over.
Information has been received from the Registered Nurse. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had been administered a dose of GARDASIL on 18-DEC-2012 (lot number 672834/0131AE, expiration date 26-OCT-2014) (dose and route not reported). No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
BLOOD PRESSURE DROPPED AND NORMAL / LOW NORMAL NOW AND HAS REMAINED THERE A STEADY 115/70 BEFORE IT FLUCTUATES 150/100; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included atenolol. On MAY-2021, the patient experienced blood pressure dropped and normal / low normal now and has remained there a steady 115/70 before it fluctuates 150/100. Laboratory data included: Blood pressure (NR: not provided) 115/70 mmHg. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 150/100 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood pressure dropped and normal / low normal now and has remained there a steady 115/70 before it fluctuates 150/100 was not reported. This report was non-serious.
lab levels doubled/thin blood doubled; This non-serious case was reported by a consumer via call center representative and described the occurrence of blood test abnormal in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included warfarin.   In JUL-2023, the patient received the 1st dose of Shingrix. In JUL-2023, an unknown time after receiving Shingrix, the patient experienced blood test abnormal (Verbatim: lab levels doubled/thin blood doubled). The outcome of the blood test abnormal was unknown.   It was unknown if the reporter considered the blood test abnormal to be related to Shingrix.     It was unknown if the company considered the blood test abnormal to be related to Shingrix.   Additional Information: GSK Receipt date: 18-JUL-2023 The patient was reporter's sister. The patient received dose 1 of Shingrix about a week ago from reporting date. She stated patient labs doubled.  The reporter stated the patient was on warfarin and the labs she gets to determine how thin her blood was doubled. The reporter did not consent to follow up.
This spontaneous report was received from a medical assistance concerning a patient of unknown age and gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On 05-SEP-2018, the patient was vaccinated with one dose of improperly stored PROQUAD (which had a lot # of R002932 and an expiration date of 29-JUL-2019; however, dosage number and route of administration were not reported), for prophylaxis. The sterile diluent (manufacturer unknown) used to reconstitute the PROQUAD was not improperly stored. No adverse effects were reported. On an unspecified date, the vaccine experienced a temperature excursion of -14 degree C to -10 degree C for 16 minutes. Reportedly, there had been no previous temperature excursion and the aforementioned one was identified due to a data logger. Furthermore, no product quality complaint was involved.
Sore arm the 1st day, followed by redness, rash that she said was spreading by 2nd day, prednisone inj, Inj BENADRYL doing better gave her BENADRYL (not taken yet) advised ER visit (7 pm).
Patient received vaccine on 12/29. On 1/6/20 she developed a erythematous oval area at the site of injection on her right deltoid with mild pruritus and warmth and localized tenderness.
This spontaneous reprot as received from a pharmacist refers to a patient of unknown age and gender. Concurrent or medical conditions were not reported. On 17-MAR-2015, the patient was vaccinated with PNEUMOVAX23 lot # J009689, expiration date 29-JAN-2015 (dose, strength and route were not reported). Secondary suspects and concomitant therapies were not reported. The pharmacist reported that the patient received an expired dose of PNEUMOVAX23. No adverse effects were reported. No product quality complaint was reported. Additional information has been requested.
No additional AE details available; stored outside of recommended range; This spontaneous report was received from an office manager in charge of vaccine storage, referring to a patient of unknown age and gender. The medical history and current conditions were not provided. The concomitant medication included sterile diluent (manufacturer unknown).   On 28-JUN-2022, the patient was administered with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) subcutaneous injection (lot #W006585, expiration date: 23-AUG-2023; strength, dose, frequency, lot# and expiration date were unknown) for prophylaxis, which was a frozen and refrigerated product and had been stored outside of recommended range (Incorrect product storage). The temperature excursion (TE) frame was 6 degree Fahrenheit up to 14 degree Fahrenheit for 0 hour 50 minutes 0 second, 14 degree Fahrenheit up to 46 degree Fahrenheit (15 Fahrenheit) for 0 hour 30 minutes 0 second. There was no previous temperature excursion. No additional AE details available.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2207USA000680:MSD US-009507513-2207USA000771:MSD US-009507513-2207USA000470:MSD US-009507513-2207USA000561:MSD US-009507513-2207USA000544:MSD US-009507513-2207USA000552:MSD US-009507513-2207USA000563:MSD US-009507513-2207USA000765:MSD US-009507513-2207USA000553:MSD
Patient experienced pain at site of injection the day following vaccine receipt. Two days following receipt of vaccine, patient noticed what felt like a nodule at site of injection.
PATIENT WAS VACCINATED IN TIMELY MANNER 3-12-21 AND 4-2-21 AND TESTED POSITIVE FOR COVID 9-28-21. PATIENT WAS ADMITTED 10-4-21 AFTER ED VISIT PRESENTING WITH FEVER, CHILLS, FATIGUE, PRODUCTIVE COUGH, DIARRHEA, LOSS OF APPETITE. PATIENT WAS MILDLY HYPOXIC--WAS ON 2 L O2 AND DEXAMETHASONE.
Fever, nausea, vomiting for nearly 2.5 weeks. Tachycardia began, 06/30/08. She also has episodes of syncope with no warning since 01/22/09, multiple episodes a day 2-3 days a week. Has generalized malaise as well, recurrent bladder infections.  11/03/09 Vacccine records received.  11/09/09 ICD9 Codes and medical records received for DOS 1/24/08 and 1/28/08. FInal DX: Gastroenteritis , dehydrartion.   Patient presented for IV fluids per NP orders. Vomiting. WBC WNL  D/C to home with parents.  Supportive care.   ICD9 Codes: 611.72 (lump or mass in breast), 276.51 (dehydration), 558.9 (noninf gastroenteritis NEC).
Systemic: eye and facial pain/pressure-Mild, Additional Details: patient had pressure in the right eye and right side facial and scalp pain.
allergies; This is a spontaneous report from a contactable consumer (patient) received from a Pfizer sponsored program COVAX US Support via medical information team. A female patient of an unspecified age reported for herself that she received bnt162b2 (Comirnaty, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date in 2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she had first dose of Pfizer vaccine less than month ago. Pharmacist had told her not to get the second dose of covid vaccine because of her allergies. She did not have any issues from first dose. They told her it would be the 2nd dose that she would have an issue with. The patient wanted to know if she would be able to get second dose of vaccine. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Covid Arm.  Infection at site of injection.  Red, itchy swollen rash.
mild case of shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a 70-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient got mild case of shingles after dose of Shingrix. The reporter wanted to know could a 70 year old get a mild case of shingles after 1st dose.
Hot sheet of pain from the base of my scull, down the back of my neck and spreading out on the top of my shoulders. Lasted for approximately 30 to 40 min.  Came on suddenly felt stiff and sore until it faded. I have never experienced a pain like that before. I wasn?t sure if I should report it or not, but then felt it might be significant.
severe fever,dizziness,drowsiness, weakness, vomiting bile, cough, nasal congestion, sore throat,
Excruciating pain in my feet; My left foot and right hand, around the ankle is swelling; I can't barely walk; Both my hands and feet are swollen; Both my hands and feet are swollen; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of PERIPHERAL SWELLING (Both my hands and feet are swollen), the second episode of PERIPHERAL SWELLING (Both my hands and feet are swollen), GAIT DISTURBANCE (I can't barely walk), JOINT SWELLING (My left foot and right hand, around the ankle is swelling) and PAIN IN EXTREMITY (Excruciating pain in my feet) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included Kidney disorder. Concurrent medical conditions included Blood pressure high (no medical history reported) and Type 2 diabetes mellitus. Concomitant products included AZILSARTAN MEDOXOMIL, CHLORTALIDONE (EDARBYCLOR), GLIMEPIRIDE, VITAMIN D3, ATORVASTATIN CALCIUM, NEPHRO-VITE [ASCORBIC ACID;BIOTIN;CYANOCOBALAMIN;FOLIC ACID;NICOTINAMIDE;PANTOTHENIC ACID;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE] and FAMOTIDINE for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced the first episode of PERIPHERAL SWELLING (Both my hands and feet are swollen) and the second episode of PERIPHERAL SWELLING (Both my hands and feet are swollen). On 21-Feb-2021, the patient experienced GAIT DISTURBANCE (I can't barely walk). On 22-Feb-2021, the patient experienced JOINT SWELLING (My left foot and right hand, around the ankle is swelling). On an unknown date, the patient experienced PAIN IN EXTREMITY (Excruciating pain in my feet). At the time of the report, last episode of PERIPHERAL SWELLING (Both my hands and feet are swollen), GAIT DISTURBANCE (I can't barely walk), JOINT SWELLING (My left foot and right hand, around the ankle is swelling) and PAIN IN EXTREMITY (Excruciating pain in my feet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included Epsom salt with warm water.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: follow up (TCR) was obtained on 02-JUN-2021,Reporter's email id was obtained
SUDDEN HEARING LOSS ON LEFT EAR ABOUT THREE WEEKS AFTER JOHNSON AND JOHNSON VACCINE; This spontaneous report received from a patient via company representative concerned a patient of 32 year old. The patient's height, and weight were not reported. Prior to vaccination patient had not visited doctor or other healthcare professional office/clinic visit and patient was not diagnosed with COVID-19. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) 1 total dose was administered to the left arm on 11-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included lisdexamfetamine mesilate. On 27-JUL-2021 13:00, the patient experienced sudden hearing loss on left ear about three weeks after Johnson and Johnson vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient recovered with sequelae from sudden hearing loss on left ear about three weeks after Johnson and Johnson vaccine. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210851751- Covid-19 vaccine ad26.cov2.s- Sudden hearing loss on left ear. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Death Narrative:  Patient with h/o metastatic lung CA-he was already on hospice at time of 1st and second COVID-19 vaccines.
the arm was so sore that couldn't lie down in the arm; crumpling in the legs; 99°F fever; terrible terrible head ache, is not as sore as last night, last night was terrible,; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (the arm was so sore that couldn't lie down in the arm), LIMB DISCOMFORT (crumpling in the legs), PYREXIA (99°F fever) and HEADACHE (terrible terrible head ache, is not as sore as last night, last night was terrible,) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 011120A) for COVID-19 vaccination.     No medical history  reported.  Concomitant products included ATORVASTATIN, PROBIOTICS NOS and EZETIMIBE (ZETIA) for an unknown indication, VITAMINS NOS.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (the arm was so sore that couldn't lie down in the arm), LIMB DISCOMFORT (crumpling in the legs), PYREXIA (99°F fever) and HEADACHE (terrible terrible head ache, is not as sore as last night, last night was terrible,). At the time of the report, PAIN IN EXTREMITY (the arm was so sore that couldn't lie down in the arm) and LIMB DISCOMFORT (crumpling in the legs) outcome was unknown, PYREXIA (99°F fever) had resolved and HEADACHE (terrible terrible head ache, is not as sore as last night, last night was terrible,) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99 f (High) High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information include Tylenol. Concomitant medications also include protatin and lipisture. Action taken with mRNA-1273 in response to the events was not applicable.
Upper right arm has itchines; Burning sensation on upper right arm; Upper right arm has redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Upper right arm has redness), VACCINATION SITE PRURITUS (Upper right arm has itchines) and VACCINATION SITE PAIN (Burning sensation on upper right arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00A42A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Upper right arm has redness) and VACCINATION SITE PAIN (Burning sensation on upper right arm). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Upper right arm has itchines). At the time of the report, VACCINATION SITE ERYTHEMA (Upper right arm has redness), VACCINATION SITE PRURITUS (Upper right arm has itchines) and VACCINATION SITE PAIN (Burning sensation on upper right arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Moderate injection site pain, mild loss of appetite, mild headache, mild fatigue and mild nausea.  No treatment.
This spontaneous report as received from a healthcare worker refers to a 17 year old female patient. There were reported no pertinent medical history, drug reactions or allergies. On 26-JUN-2013 the patient was vaccinated with the second GARDASIL 120 Y (lot # J003727, exp date 07-NOV-2015), 0.5 ml, intramuscular for immunization, at a routine vaccination visit. It was reported that the patient started therapy with GARDASIL (dose 1) on an unspecified date in 2010. Concomitant therapies included MENACTRA and HAVRIX. Healthcare worker stated that on 26-JUN-2013, 5 min after injections of GARDASIL, MENACTRA and HAVRIX, the patient felt dizzy and fainted. The patient lay down for 30 minutes af the office and then was able to walk without fainting. The outcome of patient felt dizzy fainted was reported as recovered/resolved on 26-JUN-2013. No treatment was given for the adverse event. No lab diagnostics studies were performed. The relationship between GARDASIL and the events was not reported. Additional information has been requested.
6MAY93 rash spreading over body worsening by 7MAY93 to be generalized w/itching; 5MAY93 temp elevated to about 100 relieved by APAP orally; 7MAY93 seen by MD dx erythema multiforme;
Flu like symptoms; Arm hurts going up into shoulders; Headache; weak; Dizzy.
Pt developed localized, warm, red lump at injection site. Was told to put ice on it and watch it and to come in if it got worse.
Severe body aches, nausea, headache; 24 hour duration; Patient fully recovered
Moderna COVID-19 Vaccine EUA 5  hours after getting my first vaccine I had a breathing crisis with my oxygen dropping into the low 60s. I have COPD and use home oxygen as well as portable on the rare occasion that I leave the house since COVID 19.  I've also had a thoracotomy and thoracentesis in 2019. But my oxygen never drops that low. We turned up my oxygen, I used my rescue inhaler, and we started a breathing treatment. None of it was helping and I felt like I was suffocating. My husband called emergency services. The EMTs got me on oxygen with a face mask and gave me IV Magnesium in the ambulance. I was breathing better by the time we got to the ER. They gave me additional medications and oxygen there. They took a chest X-ray too, but said it looked clear.
Elevated heart rate. Started about 12 hours after second dose of vaccine. Heart rate is in 120s resting and 140s or higher when moving. No history of elevated heart rate before second dose.
Per ER diagnosis:  Cellulitis in right deltoid area two days post vaccination.  Injection site was purple; red wheal, 2-inches in diameter formed around the purple area.  Warm to touch.  Increased pain (touch and movement).  Elevated temperature=101 degrees Farenheit.  Treatment:  Erythromycin 333 mg. t.i.d. X 10 days; Vicodin PRN.
Extremely nauseated/though she was going to throw up; She had a rash all over; This spontaneous case was reported by a patient and describes the occurrence of RASH (She had a rash all over) and NAUSEA (Extremely nauseated/though she was going to throw up) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059a22a, 048c21a, 036a21a and 031m20a) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2022, the patient experienced RASH (She had a rash all over). On 25-Jul-2022, the patient experienced NAUSEA (Extremely nauseated/though she was going to throw up). At the time of the report, RASH (She had a rash all over) and NAUSEA (Extremely nauseated/though she was going to throw up) had resolved.            Patient had no allergies to medications, food and other products. Concomitant medication included Statins. Patient used  a pill that you put under your tongue and a spray to treat nausea.   This case was linked to MOD-2022-614661 (Patient Link).