chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lost sense of taste; Lost sense of smell; Whole body is sore; Rapid test came back positive for COVID; Rapid test came back positive for COVID; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs) via a contactable consumer (patient). A 21-year-old male patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730, expiration date: 31Mar2021), via intramuscular on 29Dec2020 07:40 at 0.3 mL, single dose on his left deltoid for covid-19 immunization. Medical history included allergic to wasp stings. There were no concomitant medications. The patient had no additional vaccines administrated on the same date and no prior vaccinations were received within 4 weeks. Caller on the line calling about the COVID Vaccine he received on 29Dec2020. The day after receiving it he woke up and had a loss of sense of smell on 30Dec2020 12:00. That afternoon he went to get tested and the rapid test came back positive for COIVD on 30Dec2020. He was now waiting on the other one, clarified to be the PCR test, the lab test. The next day he also lost his sense of taste on 31Dec2020 11:00 and his whole body feels sore on 30Dec2020 around noon. Transfer agent stated the caller needs to be transferred to Medical Information as he was scheduled to get the next shot on 19Jan2021 and he was calling to ask if he should proceed with that. It was reported that the patient works in a hospital (not an HCP). No emergency room was visited and no physician office was visited. The outcome of the event "rapid test came back positive for covid" was unknown, the outcome of the other events "lost sense of smell", "lost sense of taste", "whole body is sore" were not recovered.
fever, chills, mouth swelling on my right side of my face around my ear and jaw and temple  and it is painful, with meds it was 100.7 and with out its 101.0
Sore arm at injection site for 2 days after injection.  Moderate-Severe headache for 1 day after injection.
First pregnancy, estimated due date 2/23/2022. Recieved moderna booster shot with appointment scheduled for 10:15AM 10/30/2021 at Pharmacy. Shortly after I began to "throw up" (my version of throwing up due to pyloric stenosis). I continued to repeatedly throw up throughout the day and into early morning hours. Went into emergency room in early morning hours the following day after throwing up 3-4 times in an hour and having difficulty keeping fever down. Recieved IV fluids and antinausea medications. Symptoms resolved and I went home after a couple hours. Had nausea/vomitting throughout entire pregnancy, but this was the most intense episode during entire pregnancy and required intervention. I did not have so incidents of vomitting throughout the entire pregnancy as I did within the 24 hour time frame following my booster vaccine. The most I threw up per day was 4 times outside of the period following the booster.
This case was considered medically important (OMIC). A father reported that his 19 year old daughter inadvertently received a dose of Prevnar on the morning of 8/8/03 and subsequently developed a fever, severe headache, and nausea. ON 8/8/03, at 4PM, his daughter began to get sick with a severe headache, nausea, and fever. She went to the emergency room and received 2 liters of IV fluid and a medication for nausea (not specified). She recovered on 8/10/03. No additional information was available at the time of this report.  Follow up on 09/11/2003: "Follow up information received via a telephone conversation with the physician provided confirmation of adverse event and diagnosis details.  A father reported that his 19-year-old daughter inadvertently received a dose of Prevnar on the morning of 08/08/2003.  On 08/08/2003, at 4 pm, the patient presented to the ER complaining of headache, fever to 102 degrees, vomiting and myalgias.  Treatment included infusion of 2 liters of IV fluid and a medication for nausea (not specified).  She was not admitted to the hospital.  All symptoms resolved by 08/10/2003."
No other AE; temperature excursion; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.   On 05-NOV-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # U019905, expiration date 24-JUN-2023, at a dose of 0.5 milliliter for prophylaxis (vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported). No other adverse event reported.  The vaccine was stored in a temperature of 20 degree Fahrenheit for 17 (unspecified time unit). There was no previous temperature excursion reported.
case number PHEH2014US002103 is an initial spontaneous report received from a pharmacist on 27 Jan 2014. This report refers to a 16-year-old patient of an unknown gender who was accidentally vaccinated with FLUCELVAX (batch number: not reported) intramuscularly on 23 Jan 2014. No adverse event was reported following this administration error (inappropriate age at vaccine administration). Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 27 Jan 2014: The BPI labeling of the event "Inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
This spontaneous report was received from a medical assistant concerning to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 20-NOV-2015, the patient was vaccinated with improperly stored VAQTA lot # L015460, expiration date 20-JUL-2017, (dose, dose number, route and anatomical location were unspecified). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Moderna 3/1/21, 3/31/21, 11/17/21. Positive on 2/16/22
Heart palpitations and Heaviness in chest. Lasted through the evening and for a few hours the next day.
About three hours after the injection, the back side of the left arm became very painful, from the elbow to the shoulder.  It felt like the arm was in a vise--twisted and very sore.  I could not lift the arm, and could barely move it without a great deal of pain.  I also felt slight nausea and felt chilled, with my teeth chattering.  There was also moderate swelling  at the back of the left arm, between the left elbow and the shoulder.  By the next morning, the swelling was somewhat reduced and the pain was moderate, not severe.  It was still hard to fully raise the arm, and it felt like there was a knotted muscle at the back of the arm.
Patient developed postural tachycardia syndrome (POTS) after receiving COVID-19 vaccine. Pt has allergy to PEG-2000 which causes her to develop POTS.
Day after shot had to go to local hospital my tongue and throat swelled up had to have steroid shot.
HEART FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, race, ethnicity and sex. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1), (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination (Dose number in series 1). The patient also received covid-19 vaccine ad26.cov2.s (Dose number in series 2), (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced suspected covid-19 infection and had heart failure (Dose number in series 2). Patient's doctor said it was because of the Covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and heart failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000272571.; Sender's Comments: V0- 20230256240- Heart failure- Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
acute viral sensorineural hearing loss of left ear; acute viral sensorineural hearing loss of left ear; Information has been received regarding a case in litigation from a lawyer and referred to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 16-OCT-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route, lot# and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered sudden onset of decreased hearing in left ear with tinnitus, ear fullness, minimal dizziness and occasional pulsating-like sensation and was diagnosed with acute viral sensorineural hearing loss of left ear (deafness neurosensory, viral infection). As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using the product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacturer, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events acute viral sensorineural hearing loss of left ear was considered as not recovered. The causality assessment between the events and zoster vaccine live (ZOSTAVAX) was considered as related by the lawyer.    The lawyer considered the events acute viral sensorineural hearing loss of left ear to be disability. Upon internal review, deafness neurosensory was determined to be medically significant.
Got sick; This case was reported by a consumer via other manufacturer and described the occurrence of sickness in a female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   The patient's past medical history included chronic uti, foot fracture and clot blood (renal blood clot). Concurrent medical conditions included hypertension, endocrine disorder, renal cell carcinoma and penicillin allergy. Concomitant products included lenvatinib mesilate (Lenvima), amlodipine, levothyroxine, hydrocortisone, pembrolizumab (Keytruda), ciprofloxacin (Cipro), sulfamethoxazole + trimethoprim (Bactrim), hydrocodone bitartrate + paracetamol (Norco), paracetamol (Tylenol Es) and apixaban (Eliquis).   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Flu vaccine.     Additional Information: GSK Receipt Date: 10-NOV-2022 Reporter's Comments:  The patient received Flu vaccine and she got sick. No other information was provided. Additional Supportive information: The follow-up could not be possible as no contact details were available.
Fairly severe pain in left upper arm  + shoulder. Hard to dress or raise  arm. Severe pain 3 days - less for 4 for more days.  took Aleve for 3 days
Increased heart rate (even at rest) >100 bpm. This included one time during rest of ~170bpm. This occurred for longer than 24 hours from Thursday to Friday. It began to return to baseline around Saturday.
Arm was itching; Arm was swollen; Arm was red; Warm to touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Arm was itching), VACCINATION SITE OEDEMA (Arm was swollen), VACCINATION SITE ERYTHEMA (Arm was red) and VACCINATION SITE WARMTH (Warm to touch) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy ti PEG.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Arm was itching), VACCINATION SITE OEDEMA (Arm was swollen), VACCINATION SITE ERYTHEMA (Arm was red) and VACCINATION SITE WARMTH (Warm to touch). On 23-Jan-2021, VACCINATION SITE PRURITUS (Arm was itching), VACCINATION SITE OEDEMA (Arm was swollen), VACCINATION SITE ERYTHEMA (Arm was red) and VACCINATION SITE WARMTH (Warm to touch) had resolved.   On Sunday 24Jan2021 she took Tylenol, Benadryl, and Cortisone and the side effects went away.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  She wanted to know wheather she can take the second dose.
1. Child developed stomatitis 5 days after receiving Varivax.  2. Child dev. 1 small pustular lesion on L. leg after (7d.) Varivax.
Per guardian child had pain to site, later developed redness and swelling to site that lasted 2 weeks. Child continues to complain of pain with movement of left arm. Child was brought in today by guardian. Upon inspection of site no redness or swelling to site was noted. Child complained of having discomfort with movement of left arm and pain at night. No other problems at this time.
On 10/9, patient described she had soreness in her arm and arm was red.  Site of injection was not raised.  Patient also had some redness on her neck.  She said she was going to her primary care.  I called her the next day and left her a message.
she had some "arm pain"; pain in the injection site; period pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 20 year-old female patient received bnt162b2 (BNT162B2), administration date 08Apr2021 (Batch/Lot number: unknown) at the age of 20 years 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: PAIN IN EXTREMITY (non-serious) with onset 08Apr2021, outcome "not recovered", described as "she had some "arm pain""; VACCINATION SITE PAIN (non-serious) with onset 08Apr2021, outcome "unknown", described as "pain in the injection site"; DYSMENORRHOEA (non-serious) with onset Apr2021, outcome "unknown", described as "period pain".  Additional information: She stated she had some "arm pain" However, she's on her period now. Can she take acetaminophen or ibuprofen acetaminophen or ibuprofen for her period for her period. The reporter is a consumer who received her first dose Pfizer Covid Vaccine yesterday, 08APR2021 and is wondering if she is allowed to take Ibuprofen or Acetaminophen. The reporter states she currently is on her period and wonders if she can use Acetaminophen or Ibuprofen for pain. The reporter clarifies the pain she is experiencing is from her period. The reporter reported she feels arm pain, but nothing drastic. States this arm pain occurred the same day she received the Pfizer Covid Vaccine first dose 08APR2021. The arm. pain began a couple hours after is still ongoing now. The reporter clarifies the pain she is experiencing is from her period. The reporter felt arm pain but nothing drastic. States this arm pain occurred the same day she received the Pfizer Covid Vaccine first dose 08APR2021. The arm pain began a couple hours after is still ongoing now. The reporter reports the arm pain is persisting. Clarifies, the arm pain is the same as yesterday. The reporter reports her period pain is really bad. The reporter received Pfizer Covid-19 vaccine first dose on 08Apr2021 and experienced pain in the injection site. 2nd dose will be on 29Apr2021. Wanted to know if she can take Ibuprofen or Acetaminophen.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Flu vaccine was ordered, but we did not double check patient's chart to verify if he had it placed already.
Chills, fever, body aches, muscle pain, soreness at sight of injection,  joint pain.
Patient complained of swollen and tender arm. Client came in today to receive her second dose of vaccine and a visible mark is still present. Resembles a bruise. Client did not report the reaction after the vaccination was given.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021 at 3:05 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Nov-2021 at 3:05 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Reporter stated that on an unknown date the facility had a temperature excursion for the Moderna COVID-19 vaccine and the excursion duration was 1 month. And also, the vaccine was stored in an ultra cold freezer at -82 degrees Fahrenheit. On 19-Nov-2021 the Moderna COVID-19 vials went from the super cold freezer to the refrigerator. 70 vials were in the ultra cold freezer, 8 vials were in the refrigerator. The vaccine was never refrozen. Number of vials impacted were 78 and none of the vials were punctured and there were no previous temperature excursions.   This case was linked to MOD-2021-402935 (Patient Link).
This spontaneous report as received from a physician via a company representative refers to a 11 year old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 07-JUN-2016, the patient was vaccinated with GARDASIL 9, intramuscularly, lot # M003659 (strength, dose, site of administration and expiry date were not reported). On 07-JUN-2016, the patient experienced vertigo, headaches, dizziness and not wanting to eat. There was no treatment given for the events. The outcome of the events was unknown. The relatedness between the events and GARDASIL 9 was not provided. Additional information has been requested.
Severe arthritis pain in hands and back for about 2 weeks,  Severe sinus paid over left eye that started day after shot and lost 6-7 days Tightness is chest that started say after shot and lasted 5 days Tinnitus that started on approx 5 days after shot and still exists as of today (May 9th)
Started having chills; Upset stomach; Slight nausea; Headache; Feeling unwell; Mild symptoms; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 22Feb2021 at 14:00 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome (IBS), thyroid disease and lactose intolerant. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), famotidine (PEPCID), escitalopram oxalate (LEXAPRO) and linum usitatissimum seed oil (FLAX OIL); all for unknown indications from unknown dates and unknown if ongoing. It was reported that the patient had mild symptoms with 48 hours and those were subsided. On 01Mar2021 (Monday) at 17:00, about one week after the shot, the patient started having chills, upset stomach, slight nausea, headache and feeling unwell. On the same day, the patient underwent blood test (reported as blood taken) for routine tests ordered by one of her doctors and the result was unknown. The patient was still having these symptoms and she was wondering if this was a latent reaction to the Pfizer vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events headache and upset stomach and included treatment with paracetamol (TYLENOL) for headache and simethicone (MANUFACTURER UNKNOWN) for stomach. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event mild symptoms was recovered on an unknown date in Feb2021. The clinical outcome of the events started having chills, upset stomach, slight nausea, headache and feeling unwell was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Injection at noon 1/27/21. woke up in the middle of night dizzy and nauseated. took nausea medication and went back to bed. Next day felt headache, fatigue, body aches the whole day. Went to bed early, slept 10 hours. Felt fine the following day.
VACCINE HIT LIKE A TON OF BRICKS; EVERY MUSCLE ACHED; SEVERE FATIGUE; MILD FEVER; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) 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 subject experienced vaccine hit like a ton of bricks, every muscle ached, severe fatigue, and mild fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine hit like a ton of bricks, every muscle ached, severe fatigue and mild fever was not reported. This report was non-serious.
14 days post immunization papules/vesicles. Fever 99.2 degrees Fahrenheit.