chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Normally I take a Coreg CR 20 mg @9am, and another one @9pm; blood pressure (BP) was well controlled for the last 5 years. The day of the 2nd COVID dose I started feeling malaise/weakness around 7-8pm. My BP was 188/106 (3 measurements average). Took the 9pm Coreg at 8pm; didn't feel improvement, my BP increased to 220/118. I took a Labetalol 100mg; in about 2-3 hrs my PB came down to 170/105 and I fell asleep. I woke up several times feeling sick. The next day my BP was higher than usual around 170/112 (in the morning I felt a bit better; but started to feel very sick again in the afternoon; it continued in the evening & during the night). I felt as if my heart was giving up. The only reason I did not go to Emergency was the fear I can get the COVID in the hospital.   THIS WAS A VERY SERIOUS, LIFE THREATENING EVENT; if I didn't have Labetalol in the house I believe I would be dead now.   Note: I did not panic, my pulse was around 66 the first day. The second day it was around 72.   There should be an investigation covering the side effects in people with a high BP history after the 2nd vaccine dose, to make sure their problems were not blamed on their health history. During the side effects/time frame I described, it seemed my BP medication did not have the effect it usually has on me.  I found it unacceptable that the only site reporting the spikes in BP as a COVID vaccine side effect was a hospital in another country; if there were such side effects reported by the date of my vaccine, they were not readily available for the public.   These heart problems could have been made much better if people like me knew of an increase in BP as adverse reaction to the vaccine's 2nd dose, so we could have been prepared, i.e. take the BP medication BEFORE the BP spikes up so much, so it doesn't reach critical values (especially in the conditions of malaise and general sickness given by the vaccine.)
1/8: 10:00- began to develop increased soreness and fatigue 14:00 began to develop fever, chills, headache, nausea l, muscle soreness, bone pain, fatigue onset and are consistently present.. Required to leave early secondary to symptoms. Tylenol administered 20:00  lip and facial edema noted to onset. Nausea and dry heaving onsets, feeling of malaise. Fever of 102.3. tylenol given 23:30 lip edema worsening. Pain worsening. Weakness onsets . Continued fever of 101.3. 50 mg of benadryl and pepcid administered 1/9 4:00 bone pain and chills improced. Continued fatigue, muscle aches, headache and nausea. lip edema not improved. Mild facial edema noted. Increased difficulty swallowing noted and dry heaving continues. Care sought in ED. IV decadron and benadryl administered  6:30 discharged from ED with zyrtec, prednisone taper and pepcid scripts. Countinued home monitoring 11:00 lip edema stable. Fever improved. Fatigue, soreness, headache continue to be present, but improved
Vaccine administration error occurred; patient is 21 years, vaccine is for ages 1-12 years. No adverse effects noted from error.
(Was worse, getting better) hot and swollen and very sore at injection site started swelling at home after spending 15 min. in store (pt. said she had shot 4-5 years ago, couldn't remember and had no reaction to it) told her to take BENADRYL, TYLENOL, and warm compress and go to MD if stops getting better or gets worse.
VACCINE WAS REFROZEN; REFROZEN VACCINE WAS ADMINISTERED TO PATIENT; This spontaneous report received from a health care professional concerned a 51 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, expiry date: 20-MAR-2022) dose was not reported, administered on 09-JUN-2021 for prophylactic vaccination. Age at time of vaccination 51 years old. No concomitant medications were reported.  On 09-JUN-2021, the patient experienced refrozen vaccine was administered to patient. On an unspecified date, the patient experienced vaccine was refrozen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine was refrozen and refrozen vaccine was administered to patient was not reported. This report was non-serious.
Approximately 40 minutes after injection, my tongue began to feel thick, my throat tight, and my face slightly numb.  I spoke with a nurse and was given zyrtec.   Within an hour, symptoms related to face and tongue were gone.  Even 11 hours later, my throat feels like there is a small lump in it.
was found unconscious the next day.  Had to have paramedics come and help her.  Two weeks later still sick can't get out of bed.  And suffered concussion when passed out.
This case was reported by a other health professional via call center representative and described the occurrence of burning in eyes in a adult female patient who received KINRIX (batch number 3N7Y7, expiry date 27th May 2017). On an unknown date, the patient received KINRIX. On an unknown date, immediately after receiving KINRIX, the patient experienced burning in eyes, stinging and inadvertent exposure to vaccine. On an unknown date, the outcome of the burning in eyes, ocular stinging and inadvertent exposure to vaccine were unknown. It was unknown if the reporter considered the burning in eyes and ocular stinging to be related to KINRIX. Additional details were provided as follows: The reporter stated that while, the patient (physician) was administering KINRIX to a vaccine, it splashed into her eyes and the vaccinee's mother's eyes. The patient reported burning and stinging in her eyes. The patient rinsed her eyes out immediately and she did not have any visual difficulties. No other information was reported. This case has been linked to case US2015GSK119587 (vaccinee's mother's case), reported by the same reporter.
might have received the Menveo / reconstituted with sterile water.; might have received the Menveo / reconstituted with sterile water.; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA548A, expiry date 28th February 2022) for prophylaxis.   On 21st July 2021, the patient received Menveo. On 21st July 2021, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that the patient might had received the Menveo vaccine reconstituted with sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter stated might, because she was not sure if it was this patient or another that received the improperly reconstituted vaccine. No further events were reported at the time of reporting. The reporter consented to follow up. This case has been linked with the case US2021163838 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021163838:same reporter
Flu vaccine given in right arm. Patient came back stating felt "flushed and light headed". Patient was advised to sit and nurse checked pulse-bounding, regular rhythm. Few minutes later patient reported feeling better, but shortly afterwards patient stated he felt another rush come and his wife came bck to the area and they took him to blood pressure machine, 176/110 and pulse 76, patient asked to call 911.  EMT tested sugar @ 97.
2nd dose was due but was out of town and still has not receive the 2nd Moderna vaccine; arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (2nd dose was due on but was out of town and still has not receive the 2nd Moderna) and MYALGIA (arm was sore) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     Concurrent medical conditions included Contrast media allergy (Contrast Dye).    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYALGIA (arm was sore). On 11-May-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (2nd dose was due on but was out of town and still has not receive the 2nd Moderna). On 10-Mar-2021, MYALGIA (arm was sore) had resolved. At the time of the report, INTENTIONAL PRODUCT USE ISSUE (2nd dose was due on but was out of town and still has not receive the 2nd Moderna) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not provided by the reporter. Patient did not use any treatment medications.
severe leg muscle pain/achiness, feeling bad (like flu coming on), fatigue and fever up to 101.5 degrees for 48 hours after vaccine
w/in 1st 2hr of receiving vax pt was fussy;mom states pt never did have a fever but APAP given;930PM that noc MD called pt had been licking lips & fussy;pt coughing d/t exposure to whooping cough, & on med;pt tired;
red rash on chest,arms, and back face flushed afebrile pt. administered Benadryl 50mg by mouth rash resolved with medication
Within 20 mins after receiving flu mist had a severe nose bleed in automobile on way to walmart.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, for routine adult health maintenance and the intended purpose for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended. The patient subsequently contracted a persistent strain of herpes zoster. On or about 21-JUL-2015, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as herpes zoster with unspecified nervous complication. The patient was prescribed acyclovir and hydrocodone for management of her painful symptoms and chronic pain. On or about 12-AUG-2015, the patient sought subsequent treatment for a vesicular outbreak, which was diagnosed as herpes zoster with unspecified nervous complication and postherpetic neuralgia, a chronic condition of pain and nerve damage secondary to herpes zoster infections. The patient was prescribed gabapentin for management of her painful symptoms and excruciating pain. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
March 15th right upper thigh pain, sore to the touch. Around April 1st had to buy a cane to help with walking
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's relevant medical history and concomitant medication were not reported. In 2015 (reported for all vaccines as since 14-MAY-2015, which was the date the excursion occurred), the patient was vaccinated with a dose of VARIVAX (Merck) (dose, route af administration, lot# and expiration date were not reported0, which underwent supported temperature excursions. No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Case number PHEH2014US003974 is an initial spontaneous report received from a pharmacist on 24 FEB 2014. This report refers to a 15-years old male patient. His medical history and concomitant medications were not reported. It was reported that this patients under 18 years of age was vaccinated with an intramuscular dose of FLUCELVAX (batch number: not reported) on an unknown date in JAN 2014. No adverse events were reported following the maladministration.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 24 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
pt recv vax 19NOV97 & 25DEC97 pt exp cerebellar ataxia, encephalitis & was seen by MD;it was reported that no LP was done as recommended by neurologist;f/u in JAN98 indicated than MRI came out negative;
- Mild localized pressure and tightness in injection site muscle (not as strong as with first dose of Pfizer Vaccine). Lasted about 24 hours. - Mild fever and moderate fatigue (just treated with rest). Lasted about 48 hours.
Ketorolac (Toradol), SON-US DOPP UPPER EXTR, VEINS LEFT(deep vein thrombosis) and RAD-ARM (humerus) left during ER VISIT and 2pills 500mg TYLENOL for the next 3 days
Left arm red, swollen numbness, cant make a fist, hard to move fingers. Motrin and ice.
3-4 hours post shot=chills, shivering uncontrollable dizziness mild nausea-went to bed. No appetite only H2O. Now: OK relieved.
C/O very sore left arm, progressively worse from date of inj.  Soreness  radiated from l/deltoid to l/elbow.  Very sore and stiff and painful elbow today, no redness noted.
I started out with a stuffy nose and then soon it became a full on cold with runny nose, sneezing, coughing, and tightness in chest.
Patient experienced a very itchy rash on body that turned painful after repeated scratching. Event occurred gradually, but intensified 2 days before her birthday. Patient went to her dermatologist and after a skin test on her back it was determined that the reaction was caused by the booster. The emergency room and her allergy doctor gave her medications to treat the symptoms. These include: claritin, an unknown steroid cream,  unknown steroid pills, methylprednisolone 4mg, and hydroxyzine 25mg. Patient is still recovering from rash. It seems to be getting better but still has symptoms. She has a follow up visit on Thursday with her allergy doctor to assess her progress.
have a bad headache.; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (have a bad headache.) 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 (have a bad headache.). At the time of the report, HEADACHE (have a bad headache.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment medications provided.
Left knee inflamed and swollen; Entire left side of body, to bottom of foot arch, was achy and inflamed; Entire left side of body, to bottom of foot arch, was achy and inflamed; Wrong vaccine administered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Mar2023 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history included: "Known allergies: sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 28Mar2023 at 12:00, outcome "unknown", described as "Wrong vaccine administered"; PAIN (medically significant), INFLAMMATION (medically significant) all with onset 29Mar2023, outcome "recovered" (2023) and all described as "Entire left side of body, to bottom of foot arch, was achy and inflamed"; ARTHRITIS (medically significant) with onset 29Mar2023, outcome "recovering", described as "Left knee inflamed and swollen". The events "left knee inflamed and swollen" and "entire left side of body, to bottom of foot arch, was achy and inflamed" required physician office visit. Therapeutic measures were taken as a result of arthritis, pain, inflammation. Clinical course: Entire left side of body, to bottom of foot arch, was achy and inflamed. After a few days it dissipated but left knee continued to be inflamed and swollen. Had to go to orthopedist to get cortisone shot. Patient had no other vaccine in four weeks. Vaccine was obtained at Pharmacy or Drug Store. Event resulted in Doctor or other healthcare professional office/clinic visit.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
T101, redness of leg about size of grapefruit w/soreness; small amt heat @ site;
Information has been received from a registered nurse concerning a 15 month old white male child with no allergies, who on 8/22/02 was vaccinated SC with a first 0.5ml dose of MMR (second generation) (lot # 642695/0490M). Concomitant vaccination on 8/22/02 included an IM 0.5ml dose of aluminum, potassium (+) diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid (TRIPEDIA) (lot C0813AA). The patient was well at the time of vaccination, and although he had no previous exposure to this or a related drug, he had previously tolerated all other immunizations without any adverse experiences. On 8/31/02 the patient developed a fever. On 9/2/02, the patient's mother called the physician's office to report that the child had a fever of 105.7F with a rash that consisted of pink bumps that blanched and itched located on his neck, back, and chest. On 9/3/02, the child was seen in the physician's office and diagnosed with a red papular rash on his neck, chest, arms, back, and legs. At this time, the physician also diagnosed left otitis media and fluid in the right ear. This was considered to be an incidental finding. The child was given ibuprofen for his fever and the physician also prescribed amoxicillin trihydrate (+) clavulanate potassium and hydroxine HCL for the itching. The child was referred to an ENT for the otitis media. It was also reported that the patient's sibling had fever, which started 9/2/02, and symptoms of Coxsackie virus on 9/3/02. on 9/24/02, the nurse reported that the patient had since recovered with his fever lasting 48 hours and the rash lasting gone week. The patient's fever was considered to be an other important medical event. No further information is expected.
This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age. On unspecified dates, the patients were vaccinated with (Oka/Merck) VARIVAX which was exposed to unknown temperatures out of the recommended range for an unknown period of time (dose, route, lot# and expiration date unknown). No adverse effect had been reported. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a Registered Nurse concerning a female adult patient who on an unspecified date, was vaccinated with the first dose of VARIVAX (Merck) (lot# not reported). Subsequently the patient developed a small breakthrough case of chickenpox after vaccination. Vaccination with VARIVAX (Merck) was discontinued. At the time of reporting, the outcome of the event was not reported. It was unspecified if the patient sought medical attention. No further information is available.
Onset of pain and significant swelling, redness in right upper arm on 05/01/04.  Parent contacted physician instructed to use ice to area, Benadryl and pain reliever.  Much improved in 36-48 hours. Rechecked 05/03/2004.
Low grade fever 99.7 (02/12/21 & 02/13/21 36+hrs) Severe body aches (02/12/21 24 hours) Nausea/ upset stomach  (02/12/21, 02/13/21, 02/14/21 48hrs)
1-APR95 r/a had red area over inj site w/edema painful to touch, inflamed; 3APR95 edema dec no inflammation; cont to be painful to touch;
Case number PHEH2015US003146 is an initial spontaneous report from a nurse received on 10 Feb 2015. This report refers to a 11 year old patient of unknown gender. The patient was vaccinated with MENVEO (batch number: M14071, expiry date: Nov 2015) intramuscularly on 14 Jan 2015. It was reported that the vaccine was frozen with excursion at 0.4 Celsius for 1 hour 16 minutes before vaccination to the patient. No adverse event reported following this medication error (incorrect storage of drug).
Pt recv vax on 10/19/98; on 10/28/98 pt exp flu sxs of achy, chills, sweaty, stomach ache, weak body x 3dy
Post vax, this pt experienced a rash, eruptions on legs, buttocks, and scalp and flu-like symptoms. She was treated with acyclovir. She was seen again 1 week post rash and status post treatment. The rash noted as crusted or healed. Specimen taken for VZV analysis and is pending.
Mother states when child woke this AM she felt very hot.  Digital thermometer used with temperature 101.5 AX. Gave Tylenol. Temperature @ 1:00p.m. 99.9 Ax.  Temp @ 3:00p.m. 99 Ax.  Denies baby crying, states child is alert and smiling.
4-5hr delayed rxn-severe swelling, pain, itching @ site of inj;4-5 in diam, raise area approx 1/2-3/4in_ swelling remained thru 2nd day & very sore;ice was applied & took antihistamines;
Unexplained abdominal bruises on several occasions. I have previously had a history of abdominal pain; I don't know if the abdominal pain I now have is related in any way to the vaccine. First unexplained bruises appeared on about May 24th or 25th. Additional bruises since then, with the most recent one being on about July 22nd. I do not know if the bruising is a reaction to the vaccine. I am reporting in case my information is helpful to research. And of course, I would like to know if the bruises are related and if there is any action I should take.
3/3/22 Rapid Heart rate, shaking, weakness, tightening of the chest, swollen lymph node.  Gave him 500mg acetaminophen per Dr.'s direction at 6pm the day of the vaccine 3/2/22 (since this happened also with shot #2).  He woke at 3:35am with this heart beating very rapidly and hard. Gave more acetaminophen 500mg. Resting heartrate while on acetaminophen was 130bpms all day.  Stayed in bed and weak all day 3/3 and 3/4 was having a bit more energy.  Highest temperature reached was 99.6  With shot #2 his resting bpm was 180 in June 2021. On 3/5/22 lymph node is still slightly swollen, arm pain and general weakness.
a raspy voice/voice changing; congestion; This is a spontaneous report received from a contactable consumer (patient). This female patient of unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number unknown) on an unknown date for COVID-19 immunisation. The patient initially called to obtain information about vaccination for her brother; during the call she reported she had received both doses of BNT162B2 and was having a raspy voice and congestion; further stating she didn't know why her voice was changing. The clinical outcomes of raspy voice/voice changing, and congestion were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.