chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ARMPIT PAIN; INJECTION SITE PAIN; TIREDNESS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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, the batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers, expiry date: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced injection site pain. On APR-2021, the subject experienced armpit pain. On APR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the injection site pain, armpit pain and tiredness was not reported. This report was non-serious.
31 weeks + 3 pregnant. estimated due date 4/12/21. Low grade fever of 100 degrees F, body aches, chills, headache. Lasted until 2/12/21 at 8:00am.
Elevated temp. Left arm swollen and red from shoudler to elbow. Warm to touch with a large  knot. Mom instruction to follow-ujp with family physician. Instruction to use ice on area until seen by Dr. Mom called Dr - Dr stated to come in if swelling not gone in seven days - Swelling gone 10-1-14.
treatment of COVID-19; treatment of COVID-19; This is a spontaneous report received from a contactable reporter (consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 04Mar2021 as dose 1, single (batch/lot number: unknown), in left arm, on 25Mar2021 as dose 2, single (batch/lot number: unknown), in right arm and on 19Nov2021 as dose 3 (booster), single (batch/lot number: unknown) at the age of 64 years, in right arm for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "treatment of COVID-19". The patient underwent the following laboratory tests and procedures: RAT: (unspecified date) unknown results; (22May2022) negative; (25May2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a registered nurse refers to a 12 month old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 17-OCT-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M020102, expiry date: 08-MAR-2019, for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706.
Left  chest pain 24 hours after injection, sent to emergency room 48 hours later and held for overnight observation as blood test revealed elevated level of troponin. released the following day after tests reveled overall sound heart health. Symptoms developed into pins and needles throughout extremities and shortly after Joint pain consistent with early rheumatoid arthritis.
felt sick; itchy nose; ping sensation in legs; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt sick), NASAL PRURITUS (itchy nose) and PARAESTHESIA (ping sensation in legs) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Singulair on 30-Sep-2021 and Zyrtec on 30-Sep-2021. Past adverse reactions to the above products included No adverse event with Singulair and Zyrtec. Concurrent medical conditions included Allergic to cats, Allergic to dogs and Seasonal allergy.    On 02-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Oct-2021, the patient experienced MALAISE (felt sick), NASAL PRURITUS (itchy nose) and PARAESTHESIA (ping sensation in legs). At the time of the report, MALAISE (felt sick), NASAL PRURITUS (itchy nose) and PARAESTHESIA (ping sensation in legs) was resolving.            Concomitant medications was not provided by the reporter. Patient experienced her side effects was still ongoing but its not major happening every 2 weeks. Patient visited her primary care doctor to get consultation for booster shot. Reporter initially said that felt fine, however next day felt sick, The patient felt ok so didn't take medications anymore.   This case was linked to MOD-2021-046577 (Patient Link).
Patient received vaccine and was sitting for her 15 minute observation. She reported after about 10 minutes feeling flushed, throat feeling dry and she started coughing. EMS triaged patient. BP 198/105, P 65. She reported taking all of her medication this morning and reported while the cuff was being pumped up a "twinge of chest pain, nothing bad though." She was able to drink water and reported swallowing with no problems. BP 187/110, then 176/90. Patient reported feeling better. She was instructed she will be observed another 15 minutes, she verbalized understanding. Patient was checked out without any other adverse reactions.
This case was reported by a pharmacist via call center representative and described the occurrence of swollen tongue in a 78-year-old female patient who received SHINGRIX (batch number B9739, expiry date 22nd November 2020) for prophylaxis. On 12th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 13th June 2018, 1 days after receiving SHINGRIX, the patient experienced swollen tongue, sleepiness, injection site erythema, lip swelling and dry mouth. On an unknown date, the outcome of the swollen tongue, lip swelling and dry mouth were recovering/resolving and the outcome of the sleepiness was unknown and the outcome of the injection site erythema was not recovered/not resolved. It was unknown if the reporter considered the swollen tongue, sleepiness, injection site erythema, lip swelling and dry mouth to be related to SHINGRIX. Additional details were provided as follows: At 18:30 hours, the patient received SHINGRIX in left arm. The patient had not reported the events to her physician but questioned if she should receive the 2nd dose. The pharmacist was encouraged to have the consumer report the events to her physician and discuss.
I woke up this morning with a very severe right dry eye. It was not responding to water or eye drops which is the first time that has ever happened to me. After several eye drops, I was able to drive to work where I was fine except for the eye pain until 10am. Then I started getting body aches, light-headedness and weakness. On the drive home (40 minutes), I developed a fever and the body aches worsened. If I do not consume liquid continuously, I get very light-headed and weak.
Pt seen in ER hrs after receiving immunizations with temp 103 at home. 101.2 in ER. Treatment: TYLENOL infant drops 80 mg/0.8 cc 1 dropper q 4 hour PRN.
light headache; low fever; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th November 2020, the patient received the 2nd dose of Shingrix. On 25th November 2020, less than a day after receiving Shingrix, the patient experienced headache and fever. On an unknown date, the outcome of the headache and fever were unknown.   It was unknown if the reporter considered the headache and fever to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as an adult as per the vaccine indication. The patient did not have these reactions after the first shot. The patient received Shingrix shot yesterday morning from the day of reporting. By evening, the patient had a light headache, and later a low fever.  The reporter wanted to know do have to worry about having Covid, or are these side effects common after shot two.
7/25/12 mom reported sudden onset complete loss hearing. To have cochlear implant.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. On 19-AUG-2014, the patients were vaccinated with doses of VARIVAX (Merck) (lot # J012377 exp date 03-OCT-2015 also reported as 08-NOV-2014) (dose not reported) subcutaneously that were improperly exposed to 7 degrees C from 13-MAY-2014 to 19-AUG-2014. No known adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected. All follow ups requested to complete the case were received.
This non-valid spontaneous report as received from a nurse and refers to multiple patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. On unknown dates, the patient were vaccinated with improperly stored doses of VAQTA (lot # N028743, expiration date: 23-NOV-2018, dose and route of administration were not reported) or M-M-R II (lot# N013867, expiration date: 04-MAY-2019, dose and route of administration were not reported) both for prophylaxis. Both vaccines were reconstituted with improperly stored sterile diluent (MRK) (lot#, expiration date, dose and route of administration were not reported). Reporter stated that the vaccines were stored between 32° degrees Fahrenheit  to 35° degrees Fahrenheit (also reported as 32.9 Fahrenheit) for 23 hours prior to administration. There was previous temperature excursions reported as between 47° degrees Fahrenheit to 77° degrees Fahrenheit (also reported as 53.5 Fahrenheit) for 1 hour. The digital data logger was used. The patients did not experienced any adverse events. Product quality complaint was not involved.
Loss of control of bladder; Patient got her second dose after 35 days of first dose; fever; Convulsions; terrible contractions of muscles; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of SEIZURE (Convulsions) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced SEIZURE (Convulsions) (seriousness criterion medically significant), MUSCLE CONTRACTIONS INVOLUNTARY (terrible contractions of muscles), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient got her second dose after 35 days of first dose) and PYREXIA (fever). On 09-Apr-2021, the patient experienced URINARY INCONTINENCE (Loss of control of bladder). On 08-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient got her second dose after 35 days of first dose) had resolved. At the time of the report, SEIZURE (Convulsions), MUSCLE CONTRACTIONS INVOLUNTARY (terrible contractions of muscles), URINARY INCONTINENCE (Loss of control of bladder) and PYREXIA (fever) had resolved.            No relevant concomitant medications were provided. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Shooting pains in right breast (opposite from the arm where the injection was received).; Uterine cramping; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Apr2021 at 11:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included a known allergy to latex. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified birth control medications (MANUFACTURER UNKNOWN) from an unknown date for birth control and an unknown if ongoing. The patient previously received ampicillin (MANUFACTURER UNKNOWN) and experienced a drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 07Apr2021 at 11:45, the patient reported that during the 30 minutes waiting time, she experienced uterine cramping. On 08Apr2021, the next morning after the patient received the vaccine, she experienced shooting pain in the right breast (opposite from the arm where the patient received the injection). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event shooting pain in the right breast (opposite from the arm where the patient received the injection) was resolved on an unknown date in Apr2021.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
PENTACEL vaccine was not reconstituted. The patient only received the DTaP-IPV component of the vaccine. Pt will return for vaccine for Hib.
got very sick after both doses; This spontaneous case was reported by a physician and describes the occurrence of ILLNESS (got very sick after both doses) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     none vaccines given within 1 month prior to Moderna COVID-19 vaccine.  The patient's past medical history included COVID-19 (had all the symptoms, but COVID tests were not available at that time) on 16-Feb-2020, Eczema in 1975, Arthralgia (extremely bad) and Vertigo (had vertigo during COVID in 2020 and vertigo went away after the infection cleared) in 2020. Concurrent medical conditions included Allergy to vaccine (flu vaccine), Latex allergy, Allergy to animal (cat allergy), Penicillin allergy, Sulfonamide allergy, Allergy to plants (aloe allergy), Allergy to plants (citrus), Allergy to lanolin, Pollen allergy, Dust allergy, Allergy to molds, Allergy to chemicals (nitrile), Hypothyroidism since 2009, Asthma (Start Date maybe 1985) since 1985 and Allergy (sunlight, progressively worse) since 2002.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (got very sick after both doses). At the time of the report, ILLNESS (got very sick after both doses) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, SARS-CoV-2 test: (Negative) later and it was negative.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The physician was reporting on behalf of herself. Patient had allergy's to many many more. No concomitant drug was reported. The patient believed that patient had COVID in Feb-2020. Patient had all the symptoms, but did not test until four weeks later it was negative. Patient was recapitulating when patient had COVID the first year. Patient reported having extremely bad arthralgias. The patient thinks that during her initial COVID infection, the virus went to her ear on the left side because patient also had vertigo. patient thinks it's an autoimmune effect that was triggered by the vaccine.  No treatment drug was reported.   This case was linked to MOD-2022-635848 (Patient Link).
Expired Rotarix (lyo) was administered to patients; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a female patient who received Rota (Rotarix lyophilized formulation) (batch number G973H, expiry date 01-JUL-2023) for prophylaxis.   On 17-JUL-2023, the patient received Rotarix lyophilized formulation. On 17-JUL-2023, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced expired vaccine used (Verbatim: Expired Rotarix (lyo) was administered to patients). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 18-Jul-2023 The reporter consented to follow-up. The patient received an expired dose of Rotarix lyophilized formulation, which led to expired vaccine used.
Sweats, facial rash, difficulty breathing.  Patent took Benadryl and was given Depo Medrol 80mg IM in the office.
Patient had swelling/redness/heat on arm after receiving vaccine. She reported to us 10/20/23. Reaction spanned about 2 inch radius from injection site. She also reported ongoing headache since getting the vaccine. We followed-up today 10/23/23 after patient has been taking benadryl and tylenol. She reports that her only symptom now is ongoing headache and still some redness. She is following-up with her PCP.
Coughing, chest tightness, tachycardia within 3-5 min. of injection. Rec'd 25 mg Benadryl + 125mg solu Medrol with resolution of symptoms
RECEIVED HALF DOSE FOR BOOSTER; This spontaneous report received from a health care professional concerned multiple patients of unspecified age, race and ethnic origin. The patient's weight and height were not reported. No past medical history or concurrent conditions were reported. The patient was previously vaccinated with covid-19 vaccine ad26. cov2. S (series 1 - manufacturer unknown) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 01 total, start therapy date were not reported, for prophylactic vaccination. No adverse event were reported associated with previous with (series 1) covid-19 vaccine ad26. cov2. S. The patient received booster dose with covid-19 vaccine ad26.cov2.s (series 2) (suspension for injection, route of admin, and batch number were not reported) 0.25 ml dose, 01 total, start therapy date were not reported, for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient  received half the dose for booster. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received half dose for booster was not reported. This report was non-serious. This case, from the same reporter is linked to 20211202250, 20211202199, 20211202193 and 20211202469. This report was associated with a product quality complaint: 90000204554.  The suspected product quality complaint has been confirmed to be voided (There is no product quality issue reported. Approval to void due to no identified.) based on the evaluation/investigation performed.
Awoke 2 days post injection on morning of 3/29 with red spot approximate size of a "quarter" and located approximately 2" below injection site: warm and very sore to touch, slightly raised, and itchy (appearing "hive" like). 24 hours later size of spot had more than doubled.  s 1 and 2 following vaccination I experienced  fever as high as 100.7, the sense of a headache trying to manifest itself however never really occurring and extreme fatigue - all what I would have expected based on information available for 2nd injection. NOTE: 1st injection produced a sore shoulder area at injection site but absolutely no rash or other symptoms.
The day after immunization began having localized erythema, swelling, and pain at the injection site. No other systemic symptoms. Swelling and pain persisted for 2 days until it started decreasing. I saw the patient 8 days after vaccination. There remained a localized circumscribed area of erythema and bruising on the right deltoid about 5 cm diameter with a very subtle underlying induration (no fluctuance). No other abnormalities.
No additional adverse event; the patient was inadvertently administered a dose of ROTATEQ on 2/25/2020 that bad been improperly stored; This spontaneous report was received from a medical assistant and refers to a female patient of unknown age. No information regarding patient's medical history, concurrent conditions, concomitant medications, drug allergies and reactions was provided.  On 25-FEB-2020, the patient was inadvertently vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, lot # S006050 has been verified to be a valid lot number, expiration date 12-DEC-2020 (exact dose and dose number were not provided) for prophylaxis.   Administered dose of vaccine was exposed to the temperature excursion above 47 degrees Fahrenheit (50.9 degrees Fahrenheit) for 30 minutes on 08-FEB-2020 and above 47 degrees Fahrenheit (52.7 degrees Fahrenheit) for 15 minutes on 25-FEB-2020. It was also reported that administered dose of vaccine was exposed to the temperature excursion above 47 degrees Fahrenheit (50.7 degrees Fahrenheit) for 25 minutes on 03-MAR-2020 (after vaccine administration). Data logger was involved. There was no previous temperature excursions.  No additional adverse events were reported.
The same day I got a fever, and I was exhausted and had no energy at all, and it felt like flu like my arm was hurting and I had a headache. I took Tylenol and went to sleep. I had it for two weeks and my arm is still swollen and itchy. I also tried NyQuil. The third my arm was not just swollen it felt like it was on fire.
involuntary muscle twitching on the arm right after the 1st dose taken on 23Jan2021; This is a spontaneous report received from a contactable consumer (patient). A male patient with age reported as 39 (unit unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), via unspecified route of administration in right arm on 23Jan2021 as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient mentioned that he received both doses of the Pfizer COVID vaccine. He experienced muscle twitching on the arm right after the 1st dose taken on 23Jan2021. He was asking if that was reported as a common side effect. He was also asking if Amyotrophic Lateral Sclerosis (ALS) was a contraindication to vaccination or if it was reported to be a comorbidity in the clinical trials. The outcome of the event was unknown.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
24 1/2 hours after the Shingrix shot I experienced pain from my shoulders to my ankles, sweets, chills, nausa, diareah & stomach pains. This lasted 48 hours - 2 days later started to cough & I'm still coughing. I did go to the ER because of the cough. All of this within 5 days