chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nurse reporting a dose of improperly stored VARIVAX; No additional adverse events reported; This spontaneous information was received from a registered nurse concerning a patient of unknown age and gender. Patient's concurrent conditions, medical history and concomitant medications were not provided.  On 31-JAN-2022, the patient received an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml for prophylaxis, lot number: U020238 with expiration date on 28-JUN-2023 (strength, frequency, route of administration and anatomical location were not provided) (incorrect product storage).  The varicella virus vaccine live (oka/merck) (VARIVAX) was stored at a temperature range of 6 degrees Fahrenheit (F) up to 14 degrees Fahrenheit (13.8F) for the time frame of 1 hour and 45 minutes and 0 seconds, and for the temperature range of 14F up to 46F (14.4F) for 0 hours 25 minutes and 0 seconds. There was no previous temperature excursion.  No additional adverse events reported.
Vaccinated at approx 1300 hrs.  I began feeling chilled 6 hours later. Chills continued for hours.   I developed a significant headache.  Also experienced some body aches.   Took my temperature via oral thermometer at 10:00 PM and it was 101.5.   Went to bed at approx 11:00 PM wearing all my clothes and under a quilt and two wool blankets.  Chills continued, but then I also began sweating profusely.   I did not rest well and was up approx every hour drinking water and urinating.  I noticed an elevated heart rate for several hours through the night.   cont'd below
Patient died after suffering a heart attack the morning after the first dose was given. Patient had history of diabetes but not heart condition.
Pt recv vax on 4/19/99; on 4/20/99 pt's breathing stopped, turned blue; on 4/21 & 4/25 pt exp low heart rate; tx=breaths & oxygen
TOOK AN UNREFRIGERATED DOSE; A spontaneous case report was received from a caregiver on 25-Feb-2019 for two consumers.  Based on the information obtained from the caregiver, two individual case safety reports PVX201902-000152 (PVX2019-513; female child) and PVX201902-000153 (PVX2019-514, male child) were created and cross-linked in the database.  This case report describes a 16-year-old female consumer who "took an unrefrigerated dose". The consumer was receiving Vivotif for an unknown indication.  It was reported that the consumer picked Vivotif on 20-Feb-2019 and left it outside of the refrigerator since then. She then took her unrefrigerated first dose on 25-Feb-2019.  The action taken with Vivotif with respect to event "took an unrefrigerated dose" was not applicable.  The clinical outcome of the event "took an unrefrigerated dose" was unknown.  Company's Comment: The causality of the event "took unrefrigerated dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took unrefrigerated dose" was considered as not applicable. US-PaxVax Berna GmbH-PVX201902-000153:
Itching, burning, and fever. She used tiger balm and BENADRYL for treatment.
Hives reaction of bilateral forearms and bilateral legs posterior/anterior noticed the following morning post vaccine continued for 3 days until sought treatment at urgent care which they prescribed methylprednisone
This spontaneous report was received from a physician assistant refers to a patient of unknown gender and age. There was no information regarding the patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapy. On 29-JUN-2016, the patient was vaccinated with first dose of GARDASIL 9 (dosing details were not provided). Physician assistant reported that at the time of this report on 14-OCT-2016, the patient visited the office to receive the second vaccine dose. It was unspecified if the patient was vaccinated with the second dose or not. No adverse effects were reported. Additional information has been requested.
Had all the damn shots one booster then got shingles/Suspected vaccination failure; I got shingles; I feel like it's screwed up my immune system.; Spent six weeks feeling like somebody hit me in the ribs; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 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 Shingles vaccine and Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, immune imbalance and rib pain. On an unknown date, the outcome of the vaccination failure, shingles, immune imbalance and rib pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, immune imbalance and rib pain to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 07-JUN-2022  Reporter's Comments: This case was received from the patient via interactive digital media. The patient reported that he/she totally agreed. The patient had all the damn Shingle shots one booster then he/she got shingles. The patient felt like it was screwed up immune system.  The patient spent six weeks feeling like somebody hit him/her in the ribs with a baseball bat, he/she would not wish it on worst enemy Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
same pain on neck and shoulder; same pain on neck and shoulder; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced same pain on neck and shoulder. The outcome of the events was unknown.    No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Pt noticed this morning the I injection site to about ~ below bandage was red, warm, hard
Got really tired at 10pm, 11 hrs after shot, but couldn't sleep until 4:30.  Was slightly nauseous. Vomiting then started around 7:30 am and continued.  Last vomit was around noon today, April 4, but am still nauseous and not sure I'm done vomiting. Been in bed since 10 pm on April 2.  Fever today is 99.0.  Also have been experiencing a lot of nasal congestion off and on.
Initially, I felt fine. Several hours later I began to feel run down, like a cold. I then began to have an ache near my right kidney that I attributed to laying weirdly. However, I also began experiencing a sort of menstrual cramping on my right side as well. This has persisted since Friday night. Today (4/12/21) at about 02:30 pm, I got my period 10 days early! This isn't normal for me. Right now it is as if I'm spotting (dark discharge to warn that full-on bleeding will happen soon). I don't usually spot. My period is rather predictable and I have been dutiful in my tracking as my cycle has shortened over the years, going from a 28 day to 25 day cycle. The malaise and aches are consistent with my PMS, but I just wasn't expecting my period right now. I really don't understand how this is happening.
barely walk; feels like 250 LBS feet,; FATIGUE IN THE LEGS; exhausted quickly; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (barely walk), PERIPHERAL SWELLING (feels like 250 LBS feet,), MUSCULAR WEAKNESS (FATIGUE IN THE LEGS) and FATIGUE (exhausted quickly) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 01-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 02-Mar-2021, the patient experienced GAIT DISTURBANCE (barely walk), PERIPHERAL SWELLING (feels like 250 LBS feet,), MUSCULAR WEAKNESS (FATIGUE IN THE LEGS) and FATIGUE (exhausted quickly). At the time of the report, GAIT DISTURBANCE (barely walk), PERIPHERAL SWELLING (feels like 250 LBS feet,), MUSCULAR WEAKNESS (FATIGUE IN THE LEGS) and FATIGUE (exhausted quickly) had not resolved.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
18oct96 woke w/ tingling in legs, weakness, worked all day. 20oct96 went to MD w/ above complaints "legs going on me" 21oct96 went to ER-admitted. 22oct96 transferred to diff hosp.  Dx: GBS
on 04/22/2021 as was getting dressed that morning I noticed I had just had all of my gold rings resized to fit me, and that morning those rings would not go to my knuckle, I did not feel or look swollen-I went to the jeweler and now my ring size went from size 9 to an 11.  As of  10/15/2021 they are now a size 10. So it slowly seems to be going down with time. I went to my annual visit on 08/30/2021 to take my annual labs and tests, I took that with me. Over the last three years we have been reducing my HSCRP, and it was lowering till this adverse event.
Pain, stiffness at injection site, 100.8 degree F temperature, nausea.
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: BD Safety glide needles 25 g x 1 inch faulty - caused blood and vaccine to immediately shoot out of patient arm when removing needle after vaccine. Pt states this happened to her once before when doing a blood draw/lab. LOT 2007149 exp 12-31-26 FAULTY
Intense flu-like malaise, body aches, headache and pain at injection site.  Treated with acetominophen.  Symptoms completely resolved by  following morning (3/3/21)
sore arm; STIFF MUSCLES; Chills; fever; HEADACHES; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), MUSCLE RIGIDITY (STIFF MUSCLES), CHILLS (Chills), PYREXIA (fever) and HEADACHE (HEADACHES) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 10-Mar-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 PAIN IN EXTREMITY (sore arm), MUSCLE RIGIDITY (STIFF MUSCLES), CHILLS (Chills), PYREXIA (fever) and HEADACHE (HEADACHES). At the time of the report, PAIN IN EXTREMITY (sore arm), MUSCLE RIGIDITY (STIFF MUSCLES), CHILLS (Chills), PYREXIA (fever) and HEADACHE (HEADACHES) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.
Information has been received from a health professional concerning a 59 year old female with asthmatic bronchitis and high cholesterol and no allergies, who on 27-Oct-2006 was vaccinated IM with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (lot#651374/0485F). Concomitant therapy included montelukast sodium, albuterol sulfate (PROVENTIL) inhaler, rosuvastatin calicum (CRESTOR) and cetirizine hydrochloride (ZYRTEC). On 27-Oct-2006 the patient experienced arm swelling, decreased blood pressure (60/35) and a decrease in breathing rate.  The patient called the office complaining of injection site right arm edema and was referred to the emergency room.  On 28-Oct-2006 early in the morning, the patient went to the emergency room and was diagnosed with anaphylactic shock in association with an allergic reaction.  That day, the patient was sent home from the emergency room with prednisone and ranitidine hydrochloride (ZANTAC).  On 17-Nov-2006, the patient recovered.  It was also reported that the patient received a dose of pneumococcal 23 polysaccharide vaccine in November 2000 and was well tolerated.  No product quality complaint was involved.  A lot check will be performed.  Anaphylactic shock was considered to be immediately life-threatening and disabling.  Additional information has been requested.
6:30 pm - headache, progressively worse, no temp, but elevated heart rate (90) 8:30 pm - chills, overall aches, no temperature, elevated heart rate 9:00 pm - used heating pad for comfort - the next part was bizarre - my husband massaged my shoulders and it caused an intense, positive physical reaction (orgasm). Heart rate remained elevated. 11:30 pm - took 600 mg ibuprofen 2:00 am - heart rate still elevated, but chills gone and felt like a fever had broken 6:00 am - heart rate finally went down to normal 58-61
For 2 days, pt experience moderate intense muscle tightness and aching and a sense of limps feeling limp.  This interfered with her ability to play sports.
Had vaccines on 5/20, cough fussy in the evening. Low grade temp and wheezing on 5/21.
pt recvd vax & devel high pitched crying x 1-2 hrs p/vax; mom described cry as unusual never heard before, hasn't heard since
Progressive severe right shoulder and upper arm pain followed by nausea and vomiting. Treated symptomatically with IV fluids, antiemetics and pain meds.
L upper arm 3x5 cm erythema and 3 x 2.5 cm erythema with none scar bruise. R arm upper 7 x 10 cm erythema and swelling no bruising
SHINGLES INFECTION (FEVER, CHILLS, BODY ACHES AND INTERNAL PAIN, FEEL UNCOMFORTABLE AROUND THE BREAST AREA  AND ON BACK LIKE AN IRRITATION); This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included some breast issues, and other pre-existing medical conditions included patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 18:30 for prophylactic vaccination. No concomitant medications were reported.  On 12-MAR-2021, the subject experienced shingles infection (fever, chills, body aches and internal pain, feel uncomfortable around the breast area and on back like an irritation). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of shingles infection (fever, chills, body aches and internal pain, feel uncomfortable around the breast area and on back like an irritation) was not reported. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.
Dizziness, Headache, Myalgia, Arthralgia, Sore left arm Narrative:
vaccination +24 hrs: High fever (to 103.8 F), treated with OTC anti-pyretics (alternating doses of Advil and Tylenol), brought under control within hours; vaccination + 36 hrs: redness, sensitivity to touch, swelling on arm; affected area from 2" below armpit to 4" below elbow, including site of Pneumovax23 injection (rt. triceps); treated with OTC anti-inflammatory (Advil); mostly resolved by today (only a small patch around the injection site is still a little swollen)
Headache, high fever, fast heartbeat, fatigue, muscle soreness in legs and elbows, dizziness, inability to sleep
This spontaneous report concerning a male patient of unknown age, was received from the patient's mother who is a medical assistant. The patient's concurrent conditions and pertinent medical history were not reported. On 12-APR-2016, the patient was vaccinated with M-M-R II and VARIVAX (Merck), (lot #, expiration date, strength, and dose were  not provided for both of them), both were administered via the intramuscular route rather than the subcutaneous route (incorrect route of drug administered). Additionally, it was also reported that the vaccines were administered in the back of the child's thigh rather than the side (drug administered at inappropriate site). There was no concomitant therapy reported. No adverse effects were reported. Additional information has been requested.
numbness throughout body 4/10 and 4/11 which  then was resolved by morning of Monday 4/12.
Stiff neck & L arms with 1st vaccine, and stiff neck, swelling of R index finger, L wrist, & R knee with 2nd injection given 1 month later.
Right arm was extremely itchy, swollen, red and warm around the injection site.; Right arm was extremely itchy, swollen, red and warm around the injection site.; Right arm was extremely itchy, swollen, red and warm around the injection site.; Right arm was extremely itchy, swollen, red and warm around the injection site.; This is a spontaneous report from a non-contactable consumer, the patient. A 91-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the arm right on 05Mar2021 at 13:15 (at the age of 91-year-old) as a single dose for COVID-19 immunisation. Medical history included congestive heart failure and parkinson's disease. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not have any concomitant medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9810) via an unspecified route of administration in the arm left on 07Feb2021 at 12:00 (at the age of 91-year-old) as a single dose for COVID-19 immunisation. On 05Mar2021 at 15:00, the patient's right arm was extremely itchy, swollen, red and warm around the injection site. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events right arm was extremely itchy, swollen, red and warm around the injection site was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
the total volume of the dose was not administered to the patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number 34EC5, expiry date 02-JUL-2024) for prophylaxis.   On 20-MAR-2023, the patient received the 1st dose of Shingrix. On 20-MAR-2023, an unknown time after receiving Shingrix, the patient experienced incomplete dose administered (Verbatim: the total volume of the dose was not administered to the patient). The outcome of the incomplete dose administered was unknown.   Additional Information: GSK Receipt Date: 14-JUN-2023 The reporter asked if this dose is considered as valid. The reporter consented to follow up. The reporter reported that during administration of the Shingrix to a patient, the total volume of the dose was not administered to the patient, which led to incomplete dose administered.
This spontaneous report was received from a nurse manager refers to a 13 year old female patient. Patient's pertinent medical history and drug reactions were not reported. On an unknown date the patient was vaccinated with a dose of GARDASIL (dose, frequency, lot#, expiration date unspecified). Concomitant medications were not reported. On an unknown date after vaccination the patient experienced dizziness and numbness of the hands and feet (medically significant by the reporter). The patient sought medical attention. Patient went to the emergency room (ER) two days later, due to continuing symptoms, and then had a second trip back to the ER. Outcome of the events were not reported. No product quality complaint (PQC) was reported. Causality assessment was not provided. Additional information is not expected.
After 2 weeks, my arm has swelled and turned red.  About the size of a grapefruit circle.  Itches as well.  Seems to be getting worse.
Within 2 minutes of receiving vaccines, patient went into restroom, turned pale and vomited. Patient returned to room rested 15-20 min, drank water BP 120/66. Ambulated out of office under care of her mother, color improved and feeling fine.
fatigue; headache; nausea; stiff neck; light sensitivity; This case was reported by a nurse via call center representative and described the occurrence of fatigue in a 22-year-old female patient who received Rabies NVS (RabAvert) for prophylaxis.   On an unknown date, the patient received the 1st dose of RabAvert. On an unknown date, unknown after receiving RabAvert, the patient experienced fatigue, headache, nausea, stiff neck and photophobia. On an unknown date, the outcome of the fatigue, headache, nausea, stiff neck and photophobia were unknown.   It was unknown if the reporter considered the fatigue, headache, nausea, stiff neck and photophobia to be related to RabAvert.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that the patient received RabAvert for pre exposure prophylaxis and developed fatigue, nausea, a stiff neck, light sensitivity and a headache. The caller works in the facility which wrote the RX for the patient, but the patient was going to college in where she got the first dose.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020109772:same reporter
I received the COVID Vaccine yesterday (1/24/21) around 12:10pm. I experienced no effects while waiting the allotted 30 minutes. The next morning, January 25th 2021, I started to experience arm soreness and blurry vision. The blurry vision is worse in my left eye. My vision has not improved after waking up, taking a shower and putting saline drops in both eyes. The best way to describe the sensation is hazy, blurry and sometimes double vision.
Had ProQuad on 9/12, within 24 hrs developed redness at the site. 9/14/06 developed limp 4 1/2 by 4 inch area of pinkness, warm to touch with central area, 1 x 1 1/2 inch marked redness and warmth, mild to moderate tenderness over interior aspect of lesion, no Fluctuance.
nausea, headache, diarrhea, gas, low-grade fever, dry mouth/trought
Shortness of breath, fever of 100.1, metallic taste in mouth, elevated HR, chest heaviness, joint pains.
I had the common side effects that lasted a day.  Approximately, two weeks later, I developed muscle pain and aches that lasted for a few months.  Then I developed carotid artery inflammation that lasted for approximately 2 months, and now, I have developed an issue with frequent urination for the past 3 weeks.
Swelling/inflammation and redness at injection site. BENADRYL and KEFLEX.
I did not have an adverse reaction to the vaccine. I tested positive for COVID-19 in 01/2023 and in 08/2022. In both cases, it was a very mild sickness with a sore throat. I did have congestion and fatigue along with a sore throat. I got a prescription for Paxlovid in both cases. As of today, I do not have any lingering symptoms of COVID-19.
Patient experience wheezing, throat tightning and red eyes that night. Next day she had a swollen pink eye, headache. Second day she noticed some swelling her arm and streaks along ehr sholder and under arm. Patient reported of having a fever. Patient states she started taking benadryl on the first day.