chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to a 12 year old patient of unknown gender. On 26-FEB-2015, the patient was vaccinated with improperly stored GARDASIL (lot # K007264 and expiry date: 02-MAR-2017). No adverse events were reported. No product quality complaint (PQC) was reported for GARDASIL. This is one of the several reports from the same reporter. Additional information has been requested.
Running 100.9 fever. Fever continued throughout the day. Very achy and fussy and malaise.
headache; sore armpit; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 13 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headache"; AXILLARY PAIN (non-serious), outcome "unknown", described as "sore armpit".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Heart beating fast, Nauseous. Patient left at 3:47 pm, stating that she feels much better.
The pt experienced a reddened area with a knot at injection site on right leg. Treated with Benadryl, Tylenol, Motrin, and cool compresses to the site.
Pain in left arm (injection side).  Increased difficulty with shoulder movement.   Ringing in ears. Ongoing malaise.
no adverse event happened after vaccination but there was an error in the covid -19 vaccine brand given. Pt should have received Moderna instead of Pfizer
Information has been received from a registered nurse regarding an unknown age and gender patient. On 15-OCT-2012, the patient was administered an incorrectly stored dose of ZOSTAVAX, lot # 0468AE, expiration date: 04-APR-2013 (dose and route were not reported). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
cold chills and sweats incontrollable shaking these symptoms were resolved within 48 hours of injection
This is a spontaneous report received from a contactable consumer (patient). A 60-year-old male patient received the 2nd dose of BNT162B2 (Comirnaty, bath/lot# EL3248), at the age of 60, left arm, on Mar 10, 2021, at 13:45, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Comirnaty, batch/lot# EL3247), at the age of 60, left arm, on Feb 17, 2021, at 01:45 pm, single dose, for COVID-19 immunisation. The patient had fatigue/tiredness, onset Mar 11, 2021, at  08:00, with outcome of unknown. No therapeutic measures taken as a result of fatigue/tiredness. Additional information: The patient did not have COVID-19 prior vaccination; and was not tested post vaccination. No follow-up attempts possible. No further information expected.
On 8/4/98 varicella vaccine was received. On 5/3/00, the child presents with vesicular rash-suspect varicella: (break through), mild with no complications.
sick; Initial information received on 21-Dec-2022 regarding an unsolicited valid social media non-serious case from a consumer/non-hcp.  This case involves an unknown age female patient who was sick after receiving influenza vaccine.  The patient's past medical treatment(s), vaccination(s), concomitant medication and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.     On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).  On an unknown date the patient was sick (illness) (unknown latency) following the administration of influenza vaccine. Reportedly not getting it my mom got so sick after her shots not taking chance that will happen to me as for the boosters of covid they can stick it were the sun don't shine got it after first 2 shots.  It is unknown if there were lab data/results available.  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown for the event sick.
Patient with history of allergies presented to retail pharmacy for COVID-19 vaccination. Within 3 minutes of receipt of vaccine patient reported injection site pain radiating to hand. Within 6 minutes of administration patient reported dizziness. Help called and patient brought to ED for evaluation and observation. Review of ED visit note shows no evidence of lip or tongue swelling and no respiratory distress. Upon evaluation and observation in ED, patient discharged.
June 3, 2021 1 st episide Shortness of  breath, pain in neck urgent care phone visit given  antiinflamatories, muscle relaxants July 8, 2021 2nd episode, same symptons. Hospitalized, fluid drained from pericardial sac, colchine and ibupropen perscribed. Oct 18, 2021 same symptons went to cardiologist prescribed ibuorooen and colchine
pt passed out a few minutes after receiving vaccine. he lost conscience for less than a minute and woke up on his own. called code white and emergency number. vitals were all normal
Itching of skin on arms and legs began about 15-20 minutes shot. Tenderness at site of injection developed 2-3 hours after. At about 12-15 hours after I developed chills, full body aches, and a low fever which persisted for the next 24 hours.  I felt like when I had sepsis in the past. I felt dizzy and weak into the second day past vaccination.
My blood pressure spiked very high about 2 months after I received my second dose. This lasted for about a month.
confusion; facial swelling; elevated heart rate; entire face turned red; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (confusion), SWELLING FACE (facial swelling), HEART RATE INCREASED (elevated heart rate) and ERYTHEMA (entire face turned red) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced CONFUSIONAL STATE (confusion), SWELLING FACE (facial swelling), HEART RATE INCREASED (elevated heart rate) and ERYTHEMA (entire face turned red). The patient was treated with ACRIVASTINE (BENADRYL ALLERGY RELIEF) for Adverse event, at an unspecified dose and frequency. On 07-May-2021, CONFUSIONAL STATE (confusion), SWELLING FACE (facial swelling), HEART RATE INCREASED (elevated heart rate) and ERYTHEMA (entire face turned red) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications on use included  "HRT" and did not disclose specific name. Treatment included Benadryl.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jul-2021: Non significant follow up appended
chills-cannot seem to get warm,  pain in right arm, headache.  Arm ache started about 6 hours post injection, mild headache soon followed.   Headache intensity increased over night.  Woke me up at 3:30 am.   Took OTC meds (Acetaminophen), which has only slightly decreased the headache.  Arm ache is still the same.
Chills: lasted 6 hours, no treatment other than bundling up I didn't take Tylenol until after these had passed Body Aches: lasted 36 hours from onset. Improved with Tylenol.(1000 mg taken once at hour 8 (after getting up for work in the morning)  after symptom onset) Fever 100.8: Gone after Tylenol Mild nausea,: Lasted about 8 hours, no treatment Soreness at injection site: Worst soreness was about 4-8 hours after injection, improved by morning, possibly due to Tylenol. Much improved after 24 hours from injection.
Pain and severe soreness in right arm that radiated down arm to hand, up to right shoulder and neck. Pain NOT easily relieved with MOTRIN or TYLENOL. Started 1 hour after injection, lasted 48 hours.
bad case of shingles and he was vaccinated / Suspected vaccination failure; bad case of shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional case details were reported as follows: The reporter was patient's family member. The patient was reporter's brother in law. The age at vaccination was not reported. The patient got a really bad case of the shingles and he was vaccinated. Plus a booster (unspecified time, before event or after event). The reporter asked how safe and effective they were. This case was considered as suspected vaccination failure, as details regarding laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required..
felt muscular tension in her arms down to her hands; feels like a muscle has been used too much and sore; this morning she had a fever and for the rest of the day; a strange symptom or a heat going down her arm, and same for her legs, that went away after 12; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (felt muscular tension in her arms down to her hands), FEELING HOT (a strange symptom or a heat going down her arm, and same for her legs, that went away after 12), PYREXIA (this morning she had a fever and for the rest of the day) and MYALGIA (feels like a muscle has been used too much and sore) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     The patient's past medical history included Joint disorder NOS, Diabetic, Heart disorder and Kidney disorder.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced FEELING HOT (a strange symptom or a heat going down her arm, and same for her legs, that went away after 12). On 26-Mar-2021, the patient experienced PYREXIA (this morning she had a fever and for the rest of the day). On an unknown date, the patient experienced LIMB DISCOMFORT (felt muscular tension in her arms down to her hands) and MYALGIA (feels like a muscle has been used too much and sore). At the time of the report, LIMB DISCOMFORT (felt muscular tension in her arms down to her hands), FEELING HOT (a strange symptom or a heat going down her arm, and same for her legs, that went away after 12), PYREXIA (this morning she had a fever and for the rest of the day) and MYALGIA (feels like a muscle has been used too much and sore) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, Body temperature: 99.6 99.6 F, 98.5 98.5 F and 98.0 98.0 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication not provided.  Treatment medication was not provided.  Based on the current available information and temporal association between the use of the product and the date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the date of the events a causal relationship cannot be excluded.
No other AE for this patient; The caller said a patient received PROQUAD after a temperature excursion; This spontaneous report has been received from a Health Care Professional concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.  On 18-AUG-2022, the patient was vaccinated with an improperly storage dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) administered as prophylaxis, lot number U022729 with expiration date of 16-JAN-2023 (dosage regimen and route of administration were not provided). The mentioned vaccine underwent a temperature excursion of 11.5 degrees Fahrenheit (F) for 53 minutes, with no previous temperature excursion. No additional adverse event was reported for this patient (No adverse event).; Sender's Comments:  US-009507513-2208USA008698:02230187 US-009507513-2208USA008719:02230189
Pregnancy due on July 27th no previous miscarriage, adverse effects are: fever, body ache, headache, nausea, starting at 9 am the following day and lasting all day. Took a Tylenol at 9pm the first night for sore arm, one at 4am the next morning for extremely sore arm and body aches, two the following morning at 11am for sore arm, body aches, headache, and nausea, then one at 7pm for headache and body aches. One more at 11pm to sleep then fine when waking up at 9am. Took multiple naps totaling 4-5 hrs Sat.
This case was reported by a consumer via call center representative and described the occurrence of shingles in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles in past and also had 2 other times in his lifetime).   On 22nd October 2021, the patient received the 1st dose of Shingrix. On 1st November 2021, 10 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient himself. The patient had shingles in the past.  The patient received his first dose of Shingrix and advised that he got Shingles. It lasted about 2 and a half weeks and was now resolved.  Provided info per content that the clinical trials for Shingrix excluded patients with a history of shingles therefore there was little information.  The reporter consented to follow up.
Lt thigh-area of skin depression -> atrophy w/ hyperpigmentation - 0 bony tender.
patient received a flu-zone quad that was out of range due to  delayed shipment/no AE; patient received a flu-zone quad that was out of range due to  delayed shipment/no AE; Initial information received on 05-Nov-2019 regarding an unsolicited valid non-serious case received from a non-health professional.  This case is linked to cases 2019SA311020, 2019SA311021, 2019SA311022, 2019SA311023, 2019SA311024 and 2019SA311025 (same reporter)  This case involves a 56 years old female patient who received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (Prefilled Syringe Lot UT6713KA, Exp. Date: 30Jun2020, Box: Lot UT6713KA, Exp. Date: 30Jun2020) on 04-Nov-2019 after product received late due to delayed shipment.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to Incorrect product storage and Product shipment delay.  It was not confirmed whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Injection site arm pain for 5 days, followed by pain in left neck and left collarbone lymph node approximately 1 week after injection. 10 days after injection pain in collarbone increased, area tender and discomfort when bending forward and shrugging.
This spontaneous report was received from a 60 year old female patient, who was a nurse, reporting on herself. The patient did not have any pertinent medical history. In approximately October 2014 (reported as about 18 months ago), the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date and exact dose were not reported), subcutaneously. Concomitant therapies included unspecified calcium, vitamin D and folic acid. In approximately October 2014 (reported as 1 day after the ZOSTAVAX injection), she developed a flat, round, red area (size was unspecified) at the site of injection. About 1.5 days after the appearance of the red area, she recovered. In November 2015, the patient started therapy with IMURAN (strength, formulation, dose, frequency, route of administration and indication were not reported). On an unspecified date, she developed shaking, chills, high fever and malaise. Therapy with IMURAN was discontinued on an unspecified date. Subsequently, the patient recovered from shaking, chills, high fever and malaise on an unknown date. The patient did not seek any medical attention and no treatment was given for the events. No lab diagnostic studies were performed. The relatedness between the events and the suspect therapies was not reported. Additional information has been requested.
Pt was at the pharmacy when she reported she can't open her eyes and feels pressure to her head and left arm numbness. Pt reports had covid vaccine 20 minutes ago. Ambulance was called. Pt was given EpiPen at 11:58 am and was then brought to the walk in clinic to wait for ambulance. Ambulance arrived and pt taken to ED for evaluation.
Slight shortness of breath; I sleep for 7-8 hours and wake up with a feeling as if I had not slept at all; Extreme fatigue\ I Feel exhausted, physically weak; Joint pain; Second dose of Moderna COVID-19 vaccine administered more than 35 days after first dose.; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Slight shortness of breath), INSOMNIA (I sleep for 7-8 hours and wake up with a feeling as if I had not slept at all), FATIGUE (Extreme fatigue\ I Feel exhausted, physically weak) and ARTHRALGIA (Joint pain) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Jun-2021, the patient experienced DYSPNOEA (Slight shortness of breath) (seriousness criterion medically significant), INSOMNIA (I sleep for 7-8 hours and wake up with a feeling as if I had not slept at all) (seriousness criterion medically significant), FATIGUE (Extreme fatigue\ I Feel exhausted, physically weak) (seriousness criterion medically significant), ARTHRALGIA (Joint pain) (seriousness criterion medically significant) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of Moderna COVID-19 vaccine administered more than 35 days after first dose.). On 09-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of Moderna COVID-19 vaccine administered more than 35 days after first dose.) had resolved. At the time of the report, DYSPNOEA (Slight shortness of breath), INSOMNIA (I sleep for 7-8 hours and wake up with a feeling as if I had not slept at all), FATIGUE (Extreme fatigue\ I Feel exhausted, physically weak) and ARTHRALGIA (Joint pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood test: normal (normal) not find anything out of the ordinary and thus discharged the patient. In 2021, X-ray: normal (normal) not find anything out of the ordinary and thus discharged the patient.         Over-the-counter "stimulants" and "energy drinks" were provided as treatment drug information. 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. Further information has been requested.; 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. Further information has been requested.
Fever to 102.  Inconsolable crying started about 24 hours after immunizations and then continued intermittently for 4 days.
got the vaccine around 10:45 am on 9/16    most of the day just had a sore arm at injection site went to bed and around 11:30 pm started feeling extremely cold- cold continued to worsen and my teeth began chattering really hard my whole body was shaking with cold- covered up with lots of blankets and a heating pad and took two advil cold and shaking went on for 20 minutes and finally subsided
9/3/13 loss muscle tone jaw, slurred speech onset, progressive neuro muscular weakness, diagnosed by L/P 9/14/13 w/Guillain Barre Syndrome.
Lazy, limp, screaming, inconsolable, couldn't hold himself up on his legs, hung his head and could hold it up for a few seconds like he could before, wouldn't eat much, tried but cried instead.
First started with nausea, slept because was very tired, this is now 10 hrs after vaccine. Went outside after nap for short walk with husband, started sweating, came in house was getting sick to stomach. Started vomiting, dry heaving then passed out hit chin and fell hit head on tile floor. continued with dry heaves, got chills. We called for ambulance EMT to check vitals. Decided not to go to hospital, to wait it out. Vials were ok just blood pressure was up.
Bad stomach pain; Achy upper shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Bad stomach pain) and ARTHRALGIA (Achy upper shoulder) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Breast cancer (Patient stated that recently in march beat breast cancer.And did 27 radiation treatments a month an a half ago. Still fatigued from that.).    On 18-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Bad stomach pain) and ARTHRALGIA (Achy upper shoulder). At the time of the report, ABDOMINAL PAIN UPPER (Bad stomach pain) and ARTHRALGIA (Achy upper shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Didn't feel "right", felt like her throat was closing, couldn't swallow, shortness of breathe, breathing got worse, called 911, 1 Epipen given, she started to cough and talk to us,  then couldn't breathe again, couldn't talk, paramedics arrived.
red pin dot rash noted on face, neck, trunk-about 20min p/vax;phone conversation w/family MD;