chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient contacted pharmacy around 5:30PM 8/27/18 and said her lips were swollen. I advised patient to call on call PCP Dr and to take BENADRYL 25mg. I also asked her to not be alone and call back in 1 hour and 2 hours. After the 1 hour phone call her swelling was reduced. Patient also has EPIPEN on hand for other allergies. After 2 hour call much better, checked in with patient 8/28/18 morning and swelling was gone. Asked her to follow up with her PCP and Dr.
This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced lung issue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of lung issue was not reported. This report was non-serious.
Durring monitoring period post Pfizer 2nd  COVID-19 vaccine, pt experienced "stabbing, mild left sided chest pain". Patient evaluated. Upon assessment,  patient reported that she had "left sided chest pain for 2-5 hours after 1st dose". No pain radiation, no shortness of breath noted. Patient heart rate upon palpation 82, regular. Resp rate 14, afebrile to touch. Patient takes female hormones daily, alprazolam (2/25) and ambien (2/25). Patient monitored for 30 mins without signs or symptoms of reaction. Patient ambulatory and went home.
At 1156 patient received first dose of vaccine to left deltoid. Patient was in the observation when he complained of dizziness and difficulty breathing. RN put cold pack on patients neck and summoned on-site paramedics. Patient was asked to walk to recovery area to lay on the cot. Patient fainted but was supported by multiple paramedics that assisted him to the ground. Patient was unresponsive for 20 seconds. EMS placed patient on gurney and was placed in EMS truck for observation. After 15 minutes EMS released patient in stable condition.
A consultant MD reported that a 2 month old female received her first dose of Acel-Immune on 12/29/1998. On 4/16/99, her mother reported to the pediatrician that the infant had an apneic episode 11 to 12 hours post immunization. The apneic episode lasted 15 seconds and was associated with pallor. The mother reported to the consultant that her daughter also had a small red spot at the injection site. The mother treated her daughter with acetaminophen and applications of ice to the injections site. The infant recovered. The apneic episode is considered medically important.  Additional information received from the vaccine provider on 10/17/00 indicated that the infant also received Hib-Titer and IPV vaccines.
Information has been received from a licensed practical nurse concerning a 12 month old white female patient with no known allergies who on 3/27/03 at 9:30 AM was vaccinated SC in the left thigh with a first dose of varicella virus vaccine live (lot # 644032/1059M). There was no illness at the time of vaccination. There was no concomitant medication. On 4/3/03, the patient developed a large reaction at the site of injection, also described as a local reaction. On 4/4/03, the patient developed small spots on the groin, abdomen, and back. on 4/4/03, the patient presented to the doctor's office. It was noted that this was a case of break through chicken pox. The patient was treated with diphenhydramine hydrochloride, acetaminophen, and ibuprofen. Subsequently, the patient recovered. The reporter also mentioned a second patient that developed break through chicken pox post vaccination with varicella virus vaccine live (lot # 644032/1059M). Additional information is not expected.
Vaccine administered from vial which had been punctured for more than 6 hours; A spontaneous report was received from a nurse concerning a 44-year old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) from a vial which had been punctured for more than 6 hours.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) intramuscularly in the left deltoid for COVID-19 infection prophylaxis.  On 30 Dec 2020, between 8:00-11:00 am, the patient was administered a vaccine dose from a vial that had been punctured on 29 Dec 2020 at 6:00 pm. No adverse events were reported. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The event, administered vaccine from vial which has been punctured for more than 6 hours, was considered resolved on 30 Dec 2020.; Reporter's Comments: This case concerns the 44-year old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273)  from a vial ,which had been punctured for more than 6 hours. On 30 Dec 2020, between 8:00-11:00 am, the patient was administered a vaccine dose from a vial that had been punctured on 29 Dec 2020 at 6:00 pm. No adverse events were reported. Reported event is unlisted for COVID-19 Vaccine (mRNA-1273) and causality assessment was assessed as not applicable.
administered expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 58-year-old female patient who received HAV (Havrix) (batch number unknown, expiry date 24th May 2022) for prophylaxis.   On 10th June 2022, the patient received Havrix. On 10th June 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 21-JUN-2022 Reporter's comment:  The patient was administered expired doses of Havrix. The reporter was consented to follow up Additional Supportive Information: The patient was administered Havrix which was already expired in 24th May 2022, which led expired vaccine used. This was 1 of 3 linked cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022095706:Same reporter US-GLAXOSMITHKLINE-US2022095754:Same reporter
This spontaneous report was received from a consumer referring to himself, a male patient of 46 years old.  The patient's concurrent, historical medical conditions and concomitant medications, previous drug reactions and allergies were not provided. On unknown date, the reporter indicated that he received GARDASIL 9 (lot number, expiration date, route of administration, were not reported), while he was 46 year old on unspecified date. No adverse effects were reported. The action taken, outcome and causality were not reported.
soreness at site of injection (1 to 48 hours), mild chills (24 to 48 hours), mild fever (from 24 to 48 hours), mild fatigue (from 24 to 48 hours), mild pain in shoulder joints (24 to 48 hours), heavy headedness (36 to 48 hours). No treatments taken. All resolved completely within 48 hours after injection.
fever chills  excruciating headache pain in arm injected pain in shoulders neck jaw ears hands  and feet next day nausea diarrhea    fever and other symptoms gone by wednesday sep 30 other than shakiness and weakness  loss of energy
Patient reported a increased heart rate and could not sleep that night. He mentioned that the increase in heart rate may have contributed to the lack of sleep.
Horrible body aches, left arm weakness (could not hold even a coffee cup in my left hand all day) also stomach discomfort and headache. Tylenol did help but nothing else helped.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. No information concerning the patients' concomitant medications, pertinent medical history, drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with improperly stored PNEUMOVAX 23 (dose, route of administration were not reported; lot # M038359, expiration date 13-MAY-2018), for prophylaxis. The vaccine underwent a temperature excursion of 31 degrees Fahrenheit or colder (25.2 degrees Fahrenheit) for 16 hours and 48 minutes, for two cycles. No previous temperature excursions were reported. Digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA013861: US-009507513-1705USA011701:
Uncontrollable sneezing and difficulty breathing. Engaged Doctor at 9:00am, who recommended X Ray.  Went to hospital for X Ray and when breathing condition worsened, patient went to ER.  Subsequently, patient was admitted to hospital for breathing problems and overall weakness until her release on 01/10/2010.
Urticaria devel w/in 24 hrs of vax administration; no distress of any sort;
Redness and swelling at injection site.  Extreme trouble falling asleep and staying asleep.  Typical wake up time 1-2 hours later, unable to fall asleep for morning nap.  Took afternoon nap.  Awoke at 2 am on Sunday morning and unable to fall back asleep until 4:30 am, re-awoke at 7 am.  Awoke at 2:30 am Monday morning and unable to fall back asleep except for 30 minutes from 4:20-4:50 am and 5 minutes during car ride to daycare.  She is not teething and nothing else seems to be outside of normal except for the vaccination from Friday.
case had symptoms of cough, shortness of breath and wheezing. admitted to hospital on 3/28 and was diagnosed with covid and upper respiratory infection
currently at 8 weeks of daily headaches. I have taken antibody tests for the covid virus and results are NEGATIVE. Brain fog began to calm at about 5 weeks. I now have strong tingling and numbness in my feet and calves. Sometimes my legs feel weak. In the last 2 weeks, my knee joints are swollen and I cannot fully bend. In addition to swollen joints, I have increasing joint pain in knees and hips and aches in my back and legs. Continued tightness in the back of my neck.
Patient's brother contacted the Dept. of Health at 10/22/21 @ 0641. He left a message stating that his sister, 'was feeling very sick, with many symptoms'. I contacted the brother, as the parents do not speak the language as their first language, he stated that the patient was at the Dept. of Health on 10/20/21 and recieved vaccinations. On  10/21/21, she began to feel warm (temperature was not taken) and intermittent periods of shortness of breath. Prior to him going to work, she was feeling a little better as their mother had given her some medications, but he did not know what their mother had given her. I contacted the patient, she stated the same, that she was feeling warm (temperature not taken) and having periods of shortness of breath. She further stated that her arms were sore. I told her that her arms could be sore from the injections that she recieved, however the temperature (?) and the shortness of breath could be COVID symptoms. I advised her to go to the emergency room as soon as possible for testing and treatment. She verbalized understanding.   I called her brother back, who was at work. I told him that I spoke to his sister and that the symptoms that she was complaining of (temperature? Shortness of breath) could possibly be Covid symptoms and that because she was experiencing shortness of breath, it was advised that she goes to the emergency room as soon as possible for testing and treatment. He verbalized understanding. Unknown if patient went to the emergency room as advised or not.
severe headache; fever of 100.8; chills; joint aches; swollen lymph nodes on left side neck; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EK5730), via an unspecified route of administration, administered in Left arm on 24Mar2021 11:15 (at the age of 58 year) as dose 2, single for COVID-19 immunisation.  Medical history included, allergies to sulpha drugs. Concomitant medications included carvedilol, losartan, and levothyroxine, all for an unspecified indication. The patient was not pregnant at the time of vaccination. Prior vaccination, patient did not receive any other vaccines within four weeks and had not diagnosed COVID-19. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number EJ1685, via an unspecified route of administration in left arm, on 04Mar2021 11:00 (at the age of 58 year), as single dose for COVID-19 immunization. On 25Mar2021, patient had severe headache, fever of 100.8, chills, joint aches, and her lymph nodes on left side neck swollen. Since vaccination, patient had not been tested COVID-19. No treatment was given in response to the events. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Patient is complaining of pain in the injection site.  Has not seen a physician; has been applying a heat pack to the site.
sore arm; This is a spontaneous report received from contactable other healthcare professional for a Pfizer sponsored program (60820).  A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 19Feb2021 (Batch/Lot number: unknown) at the age of 48 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "breast cancer" (unspecified if ongoing). Concomitant medication included: IBRANCE taken for breast cancer, start date: Sep2016, stop date: 19Feb2021. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "sore arm".  Additional information: The patient has stopped taking IBRANCE since receiving the first dose of BNT162B2. The patient would get the second on 12Mar2021 and she was to call physician after second one and see when she is to restart IBRANCE.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
lymphoma; wasn't feeling well; anaphylaxis; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000004047.  A male patient received BNT162b2 (BNT162B2), in Jan2021 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: ANAPHYLACTIC REACTION (medically significant) with onset 2021, outcome "unknown", described as "anaphylaxis"; LYMPHOMA (death, medically significant), outcome "fatal"; MALAISE (non-serious), outcome "unknown", described as "wasn't feeling well". The patient date of death was unknown. Reported cause of death: "The individual contracted lymphoma and died". It was unknown if an autopsy was performed. Clinical course: On 31Oct2022, it was reported that a patient started treatment on an unspecified date in Jan2021 with Pfizer BioNTech COVID-19 Vaccine at an unspecified dose for COVID-19 immunisation. It was reported the patient got anaphylaxis. "He had a terrible reaction, hard to give any more information because it was back in 2021 and he stopped getting anything after that." The individual contracted lymphoma and died (date of death not queried). The reporter stated that the patient took Pfizer and had a violent reaction. He stayed at the place where he had his shot for about half an hour and was going to drive to a friend's house but wasn't feeling well so ended up going home. The reporter repeated that the patient had a "violent reaction to Pfizer, looking backwards, people thought it was related to PEG. I say anaphylaxis but I should just say violent reaction. It was not medically diagnosed."  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: The individual contracted lymphoma and died
Shooting pain from neck to feet, fever 101, dizzy, headache, sore muscles, no energy, times 2 days.
Patient has redness and swelling of her left arm. Warmth, tenderness. Treatment: Cephalexin 500mg three times daily for 7 days.
Hospitalized 01/23/2022; COVID-19 positive 01/23/2022; fully vaccinated plus booster  Discharge Provider:  Primary Care Provider:   Admission Date: 1/23/2022 Admitting Diagnoses: COVID PRESENTING PROBLEM: COVID   HOSPITAL COURSE: The patient is a 65 year old male with past medical history significant for dementia with behavioral disturbance. He presented to the ED for AMS and generalized weakness. And additionally found to be COVID positive although otherwise asymptomatic. The patient remained on room air during his hospitalization and did not require further medications in regards to COVID infection. The patient is now past the five days of isolation required by the CDC with his positive test 1/23. They patient should have a mask for the remainder of the follow five days. The patient has residual generalized weakness and was evaluated by PT/OT who recommended return with increased assistance and wheelchair.     The patient required haldol in ED and then was lethargic following administration. After talking with sister it was determined that is a typical reaction after receiving that medication. The patient became more interactive once the medication worse off and no longer required a posey bed as of 1/26. The patients home aricept, zyprexa, depakote and zoloft were continued at discharge. The patient was hemodynamically stable at time of discharge.
PATIENT CALLED ON 12/01/2020 STATING  SHE GOT THE SHINGLES FROM THE VACCINE. SAID SHE HAD SHINGLE LIKE BUMPS COME UP ON HER ANKLES AND ELBOW. SHE HAS NOT CONTACTED HER PHYSICIAN.
15 minutes after receiving her vaccination, she experienced lightheadedness. She was taken to a private section of the arena and monitored.
Pt recvd DTP/OPV & that evening, approx 6 hrs following immun had temp 105.5 despite taking APAP; No office visit; Pt is fine;
Very lethargic x4 days, flu-like symptoms (nausea and vomiting, diarrhea, body aches, fever) x3 days. Also, since vaccine, have had trouble concentrating and remembering simple things.
Right after I had tingling in arm and roof of mouth, but my face became very flushed and hot, I could breath fine so didn?t report..had window down and air conditioning on to try and cool off lasted about 25 minutes, after I had neck pain and headache for a week then a week later had high blood pressure and pulse. After 8 days I finally started feeling better
This is a spontaneous report from a contactable pharmacist. A 79-year-old female patient received PREVNAR 13 (Lot# J20343, Exp date May2016) intramuscular, on 12Feb2015, at 0.5 ml single. Relevant medical history and concomitant medications were not reported. The pharmacist mentioned that no anti-pyretic drugs were used around the vaccination time. On 13Feb2015 in the morning the patient experienced severe fatigue and decreased appetite. In Feb2015 at 03:00 PM the patient didn't want to get out of her bed. The pharmacist mentioned that the patient had not taken any treatment for fatigue and decrease in appetite and did not undergo any laboratory test. Outcome of fatigue was not recovered, outcome of the other events was unknown. The pharmacist mentioned she was not sure that severe fatigue and decreased appetite were because of PREVNAR 13.
They thought it was the heart at first, but they think it's a thinning vessel. It can create all kinds of stuff and cause issues and problems; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, 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: CARDIAC DISORDER (non-serious), outcome "unknown", described as "They thought it was the heart at first, but they think it's a thinning vessel. It can create all kinds of stuff and cause issues and problems". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller wanted to discuss what she found out she has that she never had before the Covid vaccine. She declined to provide any further information. Caller clarified that she was a very healthy person. Yearly check-ups and blood work. Now, since she had the first and second vaccine and first booster, she has concerns that have gotten worse after she got the first vaccine. The doctor sent her, to all kinds of places to be checked out. They have found stuff that I have researched online that other people have had as well. They got never had issues after getting the vaccine that they before. They have found something that is totally similar to everyone else issue when they took the vaccine, which is very scary. What or how can be done. They though it was the heart at first, but they think it's a thinning vessel. It can create all kinds of stuff and cause issues and problems. She has had symptoms for about 2 years already. What can she do; if I can say it came from the vaccine, I want to know what Pfizer can do about it if I get sick or end up in the hospital. If it came from the vaccine, they may have to take care of my bill, was asking. She said that the booster was worse. She sais she will never take the second booster. She states she has spoken to someone at Pfizer already but has not gotten an answer. She states she has spoken to her attorney. She states she has spoken to someone at Pfizer already but hasn't gotten an answer. She says she will never take the second booster.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date).    This case contains information of the 20th patient out of 20 patients.  No concomitant and treatment medications were reported.