chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Seven days after Tdap patient suffered a seizure. Her arm where shot was given was red & swollen, she also stated her arm and shoulder were hurting badly and having a hard time moving it, she had another seizure as well.
Achiness over body; This spontaneous case was reported by a physician and describes the occurrence of MYALGIA (Achiness over body) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2. On an unknown date, the patient experienced MYALGIA (Achiness over body). At the time of the report, MYALGIA (Achiness over body) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter did not allow further contact
My menstrual cycle has changed since getting the COVID vaccine. I have always been very regular with 28 day cycles. I could almost pinpoint both the day and time of day my period would start. For the last 7 months my menstrual cycle has varied between 29-32 days. I have not changed my diet, my weight has not changed, I am not taking any medications or birth control, I only recently changed my exercise patterns (last 2 weeks). Additionally, I have noticed an increase of PMS symptoms with new onset of mood swings which have not been present before March of this year.
Patient's upper left arm has an area which is swollen, warm, and red with some tender/burning to touch. No fever or other symptoms noted and appears otherwise well. The symptoms started shortly after shots were given Friday and got worse yesterday. Provider discussed given MOTRIN every 6 hrs PRN pain, BENADRYL every 6-8 hrs PRN, using ice compress to area and can apply topical Cortisone cream to the area. Follow-up if symptoms persist or get worse.
Myalgia, Fever, chills, fatigue arm pain, no appetite Narrative:
patient experienced Allergic reaction; This is a spontaneous report received from contactable reporter(s) (Other HCP). Other Case identifier(s): 2022NVX-US-000002791 (Mft.).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "patient experienced Allergic reaction".  Additional information: On 29Jul2022, it was reported that a patient started treatment on an unspecified  date with Pfizer covid-19 vaccine at unspecified dose/ frequency for an unknown indication. It was reported the patient experienced Allergic reaction.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a registered nurse and refers to a 12 year old male patient with asthma. On 07-JAN-2014, the patient was vaccinated with the first dose of GARDASIL 0.5 ml, intramuscular. On 22-SEP-2014, the patient was vaccinated with the second dose of GARDASIL 0.5 ml, intramuscular. On 14-JUL-2014, the patient was vaccinated with the third dose of GARDASIL (lot number K010574, expiration date 05-APR-2017), 0.5 ml, intramuscular in the arm. Concomitant therapies included SINGULAIR and albuterol sulfate (manufacturer unknown). On an unspecified date in July 2015 the patient experienced redness and injection site swelling. On 16-JUL-2015, the patient sought medical attention (not specified). The reporter stated that the patient had full range of motion in the affected arm and that he was not experiencing any pain. At the reporting time, the outcome of erythema, injection site swelling and injection site reaction was reported as not recovered/not resolved. Additional information has been requested.
Information has been received from the father of a 22 year old female consumer who on approximately 15-MAR-2007 (about three weeks ago) was vaccinated with the second dose of Gardasil, injection. Concomitant medication was not reported. On approximately 22-MAR-2007 a week after getting the second dose of Gardasil, the patient experienced swelling in her lymph nodes and shoulder nodes. The patient sought unspecified medical attention and her cells were checked for cancer and liver tests were performed. The patient's swelling in lymph nodes and shoulder nodes persisted. Additional information has been requested.
Severe joint pain, headaches, paresthesias, severe fatigue, lethargy, difficulty concentrating
missed the second dose of Shingrix/first dose 06Jun2019; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 6th June 2019, batch number 739K3).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not received the 2nd dose of the Shingrix vaccine which led to incomplete course of vaccination. No expiration date was reported. The HCP (healthcare professional) consented to follow up via email.
She got her vaccine, was fine, came home, had supper, went to bed and around 12:00 she was freezing cold and could hardly move.  Her joints were all aching throughout her body and bones.  She did some exercises yesterday and everything is hurting today.  She got up and has moved around a bit, and her arms and joints are still aching.  Last night she took an Advil as her friend told her she was feeling bad, so she took that.
Body and Muscle pain, elevated CK.   12/4/09:  Discharge summary and hospital records received for dates of service 5/7/09 to 5/8/09.  Dx:  Allergic reaction to pertussis vaccine, rhabdomyolysis, hypothyroid, SLE.  Presented experiencing upper body aches, pain in UE's with active ROM, pain in neck, headache and chills, myalgias and trouble sleeping.
Discharge Provider:  MD Primary Care Provider at Discharge: MD  Admission Date: 9/26/2022 Discharge Date:  09/28/2022  DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: General weakness  Generalized weakness  COVID-19    HOSPITAL COURSE: Patient is a 78 y.o. female who presents today with weakness becoming progressively worse.  Patient normally is ambulatory and able to complete her ADLs with minimal assistance.  This has become increasingly difficult this past week and she fell out of bed and get up last night.  Her husband brought her to the emergency department for evaluation she was found to have acute urinary tract infection and COVID positive.  In the face of her Parkinson's it is likely that we may be able to bring her back with some fluids and antibiotics, however, it is also possible she may require rehab in the form of home health care or subacute rehab.  We will order physical and occupational therapy evaluations and continue Rocephin therapy started in the emergency department..   9/28:  Patient had an uneventful hospital stay.  She did not show any respiratory issues related to her COVID positive test.  The fluids were hep-locked, patient was tolerating oral.  Patient was transition to Keflex to complete 3 days of therapy for urinary tract infection.  She will follow-up with her primary care provider.  Patient was seen by Physical therapy and Occupational therapy with arrangements for home therapies.  Patient otherwise has remained hemodynamically stable, afebrile, room air oxygen.  I discussed the case with the patient's husband who is wanting to take her home.  Patient is stable for discharge.  Patient was given COVID-19 discharge instructions.   Patient will continue Sinemet, and follow-up with her primary care provider, also consider neurology referral as well.
Pt fainted after his 2nd shot of Pfizer in the pharmacy sitting area. Pt is ok and homebound
Patient was not yet 18 years old. When registered this was not caught. She turned 18 eleven days later. No adverse reactions.
Swelling and itchiness of upper and lower lip, hydroxyzine 1 tab taken and repeated 6 hrs later. Swelling subsided after 1 day and a half
Pt c/o dizziness 10 minutes after receiving first dose of the vaccine. She reported that her only medical history hypothyroidism for which she takes Armour Thyroid. She reported that she only had a coconut yogurt to eat at 8am this morning. She was assessed and monitored by NP, EMT, and Paramedic. BP - 130/78, HR - 78, O2 sat 98% on RA. She was given fig bar and apple juice. She was monitored until she reported that she felt better. She was given the Vaccination information sheet and reinforced instructions on ADRs/SE she should call 911and go to the ED and also follow up with her PCP. She also instructed to avoid driving and operating any equipment today. She verbalized understanding and willingness to comply. She left site with husband who noted that he will be driving her home. She left in no acute distress, awake, alert, oriented to person, place, time and situation.
Pharmacist realized later in the afternoon, that the Pfizer pediatric vial was undiluted and patient received 0.2ml dose. Pharmacist has tried to reach the parents, but had to leave a message. No adverse events reported at the time.
Patient describes a rash over various parts of her body that is itchy. She said she treats it w/an oatmeal bath or baking soda bath and that she will follow up with her doctor.
That evening pain radiating down let arm. By the 3rd day I had pain in my clavicle, neck and arm - couldn?t sleep on left side that night or the for next week or 2.  Not sure when it started but a few days after shot I had a tingling/tickle on my left nostril and then numbness and paralysis of the left facial muscles. Right side was normal. This lasted a few days and then went away. However, the numbness lingered for a month or so.  I have NEVER had an adverse reaction to any medication to my knowledge. This was scary and a first for me.
started having the side effects at night time around 8 -9 pm on same day of vaccine. The side effects includes light headache, chill, body ache, and feeling unwell. Still has same symptoms today (8 days later).
About 2 weeks after 2nd injection - Substantial facial acne vulgaris. Symptoms still persist up to date of this report. Some history of minor acne but not to this extent and for such a prolonged period. No other changes in lifestyle, eating habits, medication, etc.  Have tried increasing cleansing, use of skin cleaner, aloe vera gel and plant rubs, epsom salt solution. No effect.
Began experiencing sore throat and stuffiness on July19, 2022.  Used home test and tested positive for COVID on July 21, 2022.
sores in mouth; chapped lips; fever; chills; body ache; headache; This spontaneous case was reported by a consumer and describes the occurrence of STOMATITIS (sores in mouth), CHAPPED LIPS (chapped lips), PYREXIA (fever), CHILLS (chills) and MYALGIA (body ache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced STOMATITIS (sores in mouth), CHAPPED LIPS (chapped lips), PYREXIA (fever), CHILLS (chills), MYALGIA (body ache) and HEADACHE (headache). At the time of the report, STOMATITIS (sores in mouth), CHAPPED LIPS (chapped lips), PYREXIA (fever), CHILLS (chills), MYALGIA (body ache) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported. No treatment medications were reported.   Reporter did not allow further contact
103 degree fever, chills, slight cough.  At noon he was feeling better to eat a bowl of soup.  However, he now says he won't get the second shot.  I think this is a bad idea!!
The patient called in to the pharmacy the day after receiving her second dose of the COVID vaccine saying that she was experiencing what she believed was an irregular heartbeat starting around noon. She is a nurse and said she believed them to be "PVCs," but did not report any other issues. She was instructed to seek medical attention ASAP.
Fever  Chills Lethargic  Limbs felt heavy Headache Body aches
MEDICATION ERROR; This spontaneous report received from a patient concerned a 68 year old female. The patient's weight was 68.95 kilograms, and height was 166 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry were not reported) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced medication error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of medication error was not reported. This report was non-serious.
About 2 months after the 2nd shot she started to have tremors and seizures.; About 2 months after the 2nd shot she started to have tremors and seizures.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the parent.  A 17-year-old female patient received BNT162b2 (COMIRNATY), in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE (both the Pfizer shot last year)), administration date: 2021, for Covid-19 immunization. The following information was reported: SEIZURE (medically significant), TREMOR (non-serious), outcome "unknown" and all described as "About 2 months after the 2nd shot she started to have tremors and seizures.". Clinical course: it was reported that, about 2 2 months after the 2nd shot she started to have tremors and seizures, where before the shots none of these happened.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient was administered a fourth dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (Patient was administered a fourth dose of the Moderna COVID-19 vaccine) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0311H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 100 mcg. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 100 mcg. On 22-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 100 mcg. On 07-Dec-2021, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 50 mcg. On 07-Dec-2021, the patient experienced EXTRA DOSE ADMINISTERED (Patient was administered a fourth dose of the Moderna COVID-19 vaccine). On 07-Dec-2021, EXTRA DOSE ADMINISTERED (Patient was administered a fourth dose of the Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment information was not reported.  The first three doses were of full doses. The patient reports experiencing no symptoms as of yet.
Other complications following immunization, not elsewhere classified, initial encounter on 2022-04-14.
client reports with 1st pfizer dose had dizzy spells that begun 2hrs after vaccination and lasted 2 days. Per client only took tylenol for arm pain. Per client did not follow up with provider.
This spontaneous prospective pregnancy report as received from a 42 year old female patient refers to herself. Information about concurrent conditions, concomitant medication and medical history was not provided. On 09-DEC-2014 the patient was inadvertently given GARDASIL (injection, 1 single shot, lot#, expiry date and route were not provided) instead of an unspecified "whooping cough" vaccine. The single shot of GARDASIL was administered by an unspecified nurse. The patient was 35 weeks pregnant at the time of the vaccination. The last menstrual period (LMP) date was approximately 08-APR-2014 and estimated delivery date (EDD) was approximately 13-JAN-2015. The pregnancy outcome was outcome pending. The patient said that she had an anxiety attack on 09-DEC-2014 when she was told of this by a physician at the practice. No other side effects were indicated. The outcome of "anxiety attack" was not provided. Additional information is not expected because no contact information was provided.
1 day after varicella, arm got warm, itchy and swollen at injection site. Had temp 100.3 10/18/2005.
syncope, lightheadedness, dizziness, clammy skin followed by unresponsive, shallow breathing and shallow pulse.  Appeared to be in shock
MOTHER STATES CHILD "NOT ACTING THE SAME" AS USUAL, WHEN ASKED TO CLARIFY, MOM STATED SHE IS "NOT ACTING RIGHT." cHILD SLEPT AFTER IMMUNIZATIONS UNTIL 9:OO P.M., AND CHILD'S TEMPERTATURE WAS 101 DEGREES. CHILD IS RECEIVING TYLENOL EVERY 4 HRS. PER MOTHER, STARTED TYLENOL AFTER RECEIVING SHOTS. MOTHER ALSO COMPLAINED CHILD HAD "KNOTS" UNDER BOTH EYES, WHEN ASKED TO CLARIFY, DESCRIBED AREAS AS SWOLLEN, NO DRAINAGE NOTED. AREAS WERE DESCRIBED AS "A LITTLE RED."
had vax early in the afternoon; awoke 3AM generalized grand-mal sz, t104 @ time taken;
Itching all over, welts on back, chest, neck; Seen by MD 10OCT91; rx w/Hydroxyzine; relief from itching; rash fading 11OCT91;
Complaints of paint to right arm 2-3 days after flu shot. Also complaints of pain to right shoulder, under arm, and side of neck. Tx with Medrol dose pack with no improvement. Referred to neurologist. Tx with physical therapy for pain syndrome. Thinks shot was given too high.
After leaving vaccination room with mother, heading towards the lobby for minimum of 15 minutes post-vaccination observation, patient collapsed/ fainted and fell to floor. Mother was able to catch and support patient's head as patient slowly fell to floor. After only seconds, patient alert again and speaking and answering questions correctly. Patient attempted and was able come to a complete unassisted standing position, but was immediately encouraged to stay lying down until EMT has arrived.  EMT arrived, assessed patient vitals, and encouraged patient and mother to go with them to hospital if they were concerned, but mother declined and signed affidavit.  Patient and mother left to go get late lunch, as it was revealed patient had not eaten breakfast or lunch yet and was nervous about getting the shot.
About a day after getting my second Pfizer COVID vaccine, I started hearing a ringing in my ears -- high in pitch.  It is fairly constant during my waking hours and slightly louder or more dominant in my right ear.  There is no external sound making this noise.  Moreover, I do not have hearing loss.
Felt lightheaded and warm.  Started to lose hearing.  BP dropped 90/50's, HR 40's.  Recovered in 20 mins
Member reported to reserve center medical department representative in the morning, was advised to report to medical center ER. Member reported hives and rash on body.
Very sore at injection site and had a small round red spot.  4-5 days later it started itching , very tender, very red & very hot to touch.  2 days later the spot was getting bigger.  As of this  minute it is not as red, but hot and has a bit of a streak down from the injection site.  It is about 2 1/2" tall &  2 1/4" wide.
about 2 hours after vaccine vomiting occurred, then patient was sick and everything hurt and couldn't lift her head off of the pillow. She felt like she couldn't move for two days.  this self resolved after 2 days.
Pt. reported hive type rash/reaction about 2 days after getting her vaccines. She reports the reaction being specific to where she got her flu shot (lower in her left upper arm muscle). She used Benadryl 50mg PO q4h PRN as recommended. She called her PCP and pharmacy for this recommendation and was also told to follow up with urgent care if the reaction gets worse or does not get better. Pt states as of 9/15/17 about 11am that the rash is better/going away and the Benadryl is helping.
1st dose in 10/13/19 / 2nd dose 3/30/21; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 13th October 2019).   On 30th March 2021, the patient received the 2nd dose of Shingrix. On 30th March 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were reported as follows:  The patient received the 2nd dose later than the recommended interval, which led to lengthening of vaccination schedule. The reporter consented to follow up
She developed some redness in the midupper aspect of her left. Has progressed in size is tenderness. Injection site inspection: the area around this is completely clear and unremarkable.  Several cm below it, she has a double palm sized area of well demarcated erythema, mild induration and tenderness.  There is some edema along the anteromedial aspect, but no true bolus transformation and no circumferential involvement.  Distal neurovascular status is intact.   Arm cellulitis-doxycycline 100 mg b.i.d. for 14 days    4/23 Has responded very nicely and quickly to the Doxycycline. The area of involvement has not extended and the erythema is virtually resolved.  No fever, other systemic signs.