chrisvoncsefalvay/vaers-outcomes huggingface dataset:
14 year old was administered flublok quadrivalent/no AE; Initial information received on 08-Sep-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 14 year-old-male patient who was vaccinated with INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot QFAA2006 and expiry date 22-May-2021) via unknown route at an unknown administration site on 04-Sep-2020 for prophylactic vaccination (product administered to patient of inappropriate age).  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to inappropriate age at vaccine administration  At the time of report no adverse event was reported.  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 and Module VI of the 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.
About 3-5 minutes after injection my left arm and hand felt tingly and numb then I lost my vision and my ears were ringing and I was sweaty a lot and felt cold. After sitting down for about 15 minutes and drinking water I was better.
1 hr p/vax pt broke out in hives & water blisters all over body took to clinic; dx allergy to MMR; pt devel rash;
Patient seen 2 days post vaccination for redness and swelling one extremity where vaccine was administered. Patient was referred to the local ED. Discharged same day. By day 8 post vaccination symptoms had resolved per Mom.
Acute on chronic systolic heart failure. ED visit and hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
Ran a fever and felt bad for 2 days.  Started having chest pains 5 days after vaccination and admitted to ER with check pain and numbness in Right Arm.  Later diagnosed with myocarditis as a result of the vaccination.
PATIENT RECEIVED IMMUNIZATION ON THURSDAY AFTERNOON.  SHE STATED SHE STARTED TO NOT FEEL WELL OVER WEEKEND AND LEFT ARE WAS RED. ON MONDAY MORNING SHE WOKE UP TO HER FACIAL MUSCLES DROOPING.  SHE THOUGHT SHE HAD A STROKE AND WENT TO  HOSPITAL WHERE THEY DIAGNOSED HER WITH BELL'S PALSY.
BLACK AND BLUE MARKS ON BOTTOM AND DOWN OF ARM; This spontaneous report received from a patient concerned a female 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 was not reported, administered on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On an unspecified date, the subject experienced black and blue marks on bottom and down of arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of black and blue marks on bottom and down of arm was not reported. This report was non-serious.
Backache; Chills; Fever; Headache; Overall fatigue; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Backache), CHILLS (Chills), PYREXIA (Fever), HEADACHE (Headache) and FATIGUE (Overall fatigue) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (Backache), CHILLS (Chills), PYREXIA (Fever), HEADACHE (Headache) and FATIGUE (Overall fatigue). At the time of the report, BACK PAIN (Backache), CHILLS (Chills), PYREXIA (Fever), HEADACHE (Headache) and FATIGUE (Overall fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not reported.  The treatment information was not provided.
Patient received a Modena COVID vaccine instead of Prevnar 13. Patient has already received two PFIZER COVID vaccines.
Started with general muscle soreness in the evening on 11/27/14. Pain of the top of left hand and right shoulder through the night requiring 2 ibuprofen and ultimately a Tylenol PM to be able to sleep.  Pain and swelling progressed over the next day or two with swelling of hands and feet with muscle and joint pains especially behind the knees with difficulty with motion.  Pain became so severe that I was barely able to walk on 12/3/14.  I presented to the walk-in where they told me to see my own physician the following day.  I presented to my physician's office the following day and had labs done and prescribed naproxen and a 5 day course of steroids.  The steroids did help but the condition returned.  I was told to change my thyroid from 88 to 100.  The condition worsened so I presented to the ER on 12/11/15 who suggested seeing a rheumatologist. My thyroid labs continued to deteriorate.  I returned to my physician again on 12/15/14 with no improvement.  My labs showed an increased C-reactive protein and my thyroid was off.  My thyroid was again increased to 125 and I was given and increase in my vitamin D.  More labs for thyroid antibodies were done but the condition was not improving.  I again went to the walk-in on 12/21/14 as the edema of my feet was still severe.  I was prescribed hydrochlorothiazide.  Eventually the swelling disappeared.  The joint pains lingered but did improve.  I am continuing to have thyroid issues with pain still in back, hips and shoulders.
muscles aches; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (muscles aches) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (muscles aches). At the time of the report, MYALGIA (muscles aches) outcome was unknown.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication were reported.  Patient states that she had the 1st 2 vaccines and 2 booster doses. She is getting the new vaccine and would like to know how long does the protection last for the new vaccine.
Fever, arm swelled up - fatigue, headache, chills - went to ER. Suggested by my doctor - BENADRYL & MOTRIN (should be given in 2 arms not in 1 arm).
He was a very healthy man, slight COPD.  He suddenly felt very dizzy and weak. Fell in the bathroom. Once the ambulance came and they lifted him up he turned gray and passed out completely. Wasn?t out for long, they had thought a stroke. It was not a stroke.
Arm was extremely sore to the touch and to move, energy was zapped, and curbed my appetite on the day after but by the next day I was completely fine
shingles; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 66 year-old male patient received bnt162b2 (BNT162B2), administration date 13May2021 (Lot number: EW0173) at the age of 65 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), administration date: 22Apr2021, for COVID-19 immunization. The following information was reported: HERPES ZOSTER (non-serious) with onset 24Jun2021, outcome "unknown", described as "shingles". The event "shingles" was evaluated at the physician office visit.  Additional Information: Caller wants to report to be a side effect of the Covid 19 vaccine, got the first two shots, about 2 weeks after second shot he developed shingles, recently got the booster and got shingles again. Both cases were mild. States between the second Covid vaccine and the booster Covid vaccine, he got a shingles vaccine, was supposed to protect any future occurrence. Caller was wanting to report this and curious to see if this has been reported after the vaccines.  No follow-up attempts are possible. No further information is expected.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021 at 3:41 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 13-Feb-2021 at 3:41 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 24.13.  Concomitant products were not provided.  On 13-Feb-2021, Excursion time was 9 AM, temperature was 32 respectively, total doses given for the day was 152, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 13-Jan-2021. 30 vials were sent to clinic. Vaccine BUD date was 10-Mar-2021.  On 13-Feb-2021, vials were stored in cooler 2, at following time and temperature respectively, 9 AM: 32, 10 AM: 39, 11 AM: 42, 12 AM: 41, 1PM: 40, 2 PM: 40, 3 PM: 40 and 4 PM: 41.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (had a sore left arm after receiving 1st dose on 3rd day/left arm has been hurting) and MOBILITY DECREASED (could barely lift his arm) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. No medical history was provided by the reporter. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced PAIN IN EXTREMITY (had a sore left arm after receiving 1st dose on 3rd day/left arm has ben hurting) and MOBILITY DECREASED (could barely lift his arm). At the time of the report, PAIN IN EXTREMITY (had a sore left arm after receiving 1st dose on 3rd day/left arm has ben hurting) and MOBILITY DECREASED (could barely lift his arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant products included Blood pressure medication, Anti-depressants and ANTIBIOTICS for an unknown indication. Treatment included Ice, heating pad and Muscle rub. This case was linked to MOD-2021-224267. Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: TCR was received patient address was updated.
I have experienced moderate to very severe joint inflamation and pain every single day and night since the evening of 12/24/2002.  Immediately following the 12/24/02 immunization I experienced painful feet which quickly became severe pain that lasted about 5 months (gradually got better), and inflammation of my index fingers.  Following the third immunization on 5/23/03 I have experienced inflamation and pain in numerous joints.  It has been so severe that there have been times I literally have had to fall into bed at night and roll out in the morning.  Several mornings I was so stiff and achy that I was like a zombie.  I could not click a pen, comb my hair, turn a doorknob or butter my toast.  The doctor tried numerous medications (vioxx, bextra, etc.) without results.  Started prednisone on 6/17 and plaquenil on 7/9.  I still have ongoing daily pain and/or inflamation in my left knee, left shoulder, left pinkie and left thumb ...... right wrist and right shoulder.  I have had 2 steroid shots in my wrist which has helped some.  I am also on voltaren 4 times per day. I do not know which hep b vaccine I had ...... I only have the 'ENG' number.  I also do not know the route ...... I am assuming 'intramuscular'.
few chills; sore arm-left arm at site; This is a spontaneous report from a contactable consumer (patient, self -reported). A 74-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EL8982 and expiry date was not provided), via an unspecified route of administration in arm left, on 04Feb2021, at 11:00 AM, as single dose for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 14Jan2021 and experienced both cheeks were very rosy red. It was reported that patient received second dose of vaccine on 04Feb2021 at 11:00 AM. Later that day in evening, patient had a sore arm-left arm at site. Next morning (05Feb2021), patient had a few chills, no fever. By Friday after noon (05Feb2021) arm was not sore and no chills. Patient felt good and did not really have any bad reaction. Outcome of the events was recovered on 05Feb2021.
This spontaneous report as received from a nurse refers to a patient of unknown age. The patient's relevant medical history, current conditions and concomitant medications were not reported. On 23-MAY-2016 the patient was vaccinated with expired dose of PROQUAD (Merck) (lot # K023364 expiry date 20-MAY-2016) (dosing details were not reported). No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
It was an hemorrhage with broken veins; He had his right feet hot, swelling and purple; He had his right feet hot, swelling and purple; He had his right feet hot, swelling and purple; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (It was an hemorrhage with broken veins), FEELING HOT (He had his right feet hot, swelling and purple), PERIPHERAL SWELLING (He had his right feet hot, swelling and purple) and SKIN DISCOLOURATION (He had his right feet hot, swelling and purple) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.    In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HAEMORRHAGE (It was an hemorrhage with broken veins) (seriousness criteria hospitalization and medically significant), FEELING HOT (He had his right feet hot, swelling and purple) (seriousness criterion hospitalization), PERIPHERAL SWELLING (He had his right feet hot, swelling and purple) (seriousness criterion hospitalization) and SKIN DISCOLOURATION (He had his right feet hot, swelling and purple) (seriousness criterion hospitalization). At the time of the report, HAEMORRHAGE (It was an hemorrhage with broken veins), FEELING HOT (He had his right feet hot, swelling and purple), PERIPHERAL SWELLING (He had his right feet hot, swelling and purple) and SKIN DISCOLOURATION (He had his right feet hot, swelling and purple) outcome was unknown.            Concomitant product use was not provided by the reporter.  The patient went to the hospital and was told that it was an hemorrhage due to broken veins and did not have clots.  Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.  Based on the current available information and temporal association between the use of the product and 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 events, a causal relationship cannot be excluded.
After patient received shot, she jumped up and cried. She then was alternating between crying and laughing and "felt weird" for an hour. Blood pressure and pulse stable. No LOC, always conversant. But felt she could not walk (though took a few steps to the stretcher). Mom did not feel safe taking her home because she was afraid something would happen. Ambulance called and went to ER. When she arrived at ER she felt fine and walked in. EKG and exam were s WNL and she was discharged home.
Headache; Bodyaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and MYALGIA (Bodyaches) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache) and MYALGIA (Bodyaches). At the time of the report, HEADACHE (Headache) and MYALGIA (Bodyaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter.   No treatment medications were reported.
Event - 22 week stillbirth Pregnancy history - G2P1001, EDD 6/13/2021, h/o twin gestation with 1st trimester vanishing twin.  Otherwise uncomplicated.
Day after vaccination, upper arm red, fever that night, swollen and itchy from shoulder to elbow by afternoon. Redness and swelling the size of baseball around injection site, not an inner aspect of arm. Temp 99.1.
we have a weird circle on our arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.This report is for 1st of 2 patients.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SKIN DISORDER (non-serious), outcome "unknown", described as "we have a weird circle on our arm".  Additional information: Patient reported that he and his wife got the Pfizer shot couple of months ago and now we have a weird circle on our arm.   The lot number for [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) :PFIZER INC-202101512081 same product and event, different patients
The hospital pharmacy dispensed a Pfizer monovalent vial instead of the Pfizer Bivalent vial to vaccination staff. Staff administered the Pfizer monovalent vaccine instead of the Pfizer bivalent vaccine as ordered. No adverse effects noted. Patient remains asymptomatic and continues on monitoring.
12/8/05 Started having chills and joint aching. 12/16/05 Developed swelling of ankles and feet; also itching of feet and ankles. 12/18/05 Went to emergency room - blood work done and was told ok. Sent home with Lasix 20mg one po q.i.d. to follow up with family MD.
Excema- topical steroids stop itching. Then sebhorrhea- medicated shampoos daily. comes back most days
Feverish; Chills; Extremely exhausted; definitely had some tiredness in my eyes; Started to feel nausea before I went to sleep; woke up in the middle of the night feeling very sick/The following day I was pretty sick; Ended up throwing up a good bit; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 20Apr2021 at 12:00 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy and COVID-19 on unknown date. Concomitant medications were not reported. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 20Apr2021 at 16:00, the day the patient got vaccine, the patient felt mostly fine, definitely had some tiredness in eyes. The patient started to feel nausea before he went to sleep, woke up in the middle of the night feeling very sick. The patient ended up throwing up a good bit. On 21Apr2021, the following day, the patient was pretty sick, feverish, chills and extremely exhausted. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events tiredness in eyes, nausea, feeling sick, throwing up a good bit, feverish, chills and extremely exhausted was resolved on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a nurse refers to a female patient of unknown age. The nurse reported that a patient who received a dose of PNEUMOVAX 23, 0.5 ml, intramuscular on 29-JAN-2014, received a second dose of PNEUMOVAX 23, 0.5 ml, intramuscular on 01-NOV-2014. No adverse effect reported. No other information is available at this time. Additional information has been requested.
Severe allergic reaction after receiving immunizations. Presented with swelling of lips. Hives on face, arms and chest. Administered 50 mg BENADRYL, 0.3 mg epipen. 911 called pt transported for observation to hospital.
She complained of a headache--she explained that she started feeling "sluggish" about 3:00 PM and by 5:00 PM, she had a headache.  Later that evening, it developed into a "full-blown" migraine.
Within 24 hours after receiving vaccine, I had extreme vertigo, nausea, headache, body aches.  Most symptoms lasted no more than 24-48 hours, but vertigo persisted for four days.   But, I?d take it again tomorrow!
Status epilepticus, whole body tonic-clonic activity requiring several anti-epileptic medications and intubation.
Hospitalization with severe vertigo. Diagnosed as Labrynthitus from swelling of the inner ear.