chrisvoncsefalvay/vaers-outcomes huggingface dataset:
~ 3/10/2021 - first notice symptoms of what turns out to be Sjögren's syndrome. 3/16/2021 - mention symptoms of dry mouth & throat to PCP. 7/20/2021 - At my annual eye exam, I learn that my severely dry eyes are affecting my vision. 8/18/2021 - Receive 3rd Moderna vaccine/Booster. 9/15/2021 - Based on my symptoms, my rheumatologist, Dr. tests me for and diagnoses me with Sjögren's syndrome. It's a chronic condition. Treatment is symptom management.
Headache and rash (right wrist, right chest, left hip) began approximately 1 week after first Pfizer vaccine administered. Presented to PCP 2 weeks after symptoms began. Treated with naproxen 500mg BID and Benadryl 25mg BID x7 days. Patient returned to clinic with symptoms unimproved. Patient denied further treatment recommendations and prefers to try CBD and acupuncture.
Information has been received from a physician assistant concerning a 21 year old female patient with no drug allergies or medical history reported, who on 29-APR-2008 at approximately 16:00 was vaccinated intramuscularly into the left deltoid with the first dose of GARDASIL vaccine (year) (Lot # 659964/1978U). There was no concomitant medication. On 29-APR-2008, (previously reported as approximately 30-APR-2008), within a few days of receiving her initial dose, the patient developed a pea sized lump at the injection site. The mass has not increased or decreased in size or causes any pain or tenderness. The patient just noted mass since injection. At the time of this report the patient had not recovered. No product quality complaint was involved. Additional information has been  requested. This is in follow-up to report (s) previously submitted on 7/8/2008. Additional information has been requested.
Eye infection; This spontaneous case was reported by a consumer and describes the occurrence of EYE INFECTION (Eye infection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, 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 experienced EYE INFECTION (Eye infection). The patient was treated with DEXAMETHASONE, TOBRAMYCIN (TOBRAMYCIN + DEXAMETHASONE) for Eye infection, at an unspecified dose and frequency. At the time of the report, EYE INFECTION (Eye infection) outcome was unknown. Not Provided          No concomitant medication information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Oct-2021: Follow up received included non significant information.
About 1.5 - 2 hours after receiving the vaccination I felt very dizzy and disoriented. This was around 11:00. Around 2:00 I was still feeling disoriented, so I went to report it to my doctor. They took my blood pressure, temperature, and observed me for 30 minutes. My nurse had reported that my BP was high. After 30 minutes they took my vitals again and my BP was still high. Today on 12/18 I got my blood pressure done at 10:30 AM and my nurse had reported that my BP was still fairly high. 144/88. They then took my BP manually and it was 138/82.
Complained of headache and chills lasting about 3-5 hours until he went to bed. He states he woke in the morning feeling fine.
Local swelling & redness & pain in rt arm. Gave prescription for MOTRIN 600mg 1 po q 6hours-8 hours. Call if worse or not better by 5-9-11.
Pain in left arm; Redness in left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain in left arm) and VACCINATION SITE ERYTHEMA (Redness in left arm) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 16-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain in left arm) and VACCINATION SITE ERYTHEMA (Redness in left arm).   On 18-Jan-2021, VACCINATION SITE PAIN (Pain in left arm) and VACCINATION SITE ERYTHEMA (Redness in left arm) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to MOD-2021-020882 (Patient Link).
Client was inadvertently given a Pediatric dose of Hep B as #2 dose in his series of 3 doses.  The mistake was discovered by the clerk putting the information into the computer on August 4th, & was reported to the Administrator right away.  The administering RN was notified, the Client was informed by phone, and an appointment made for Client to get  an adult dose of Hep B according to his schedule.  Client did not have any adverse effects from the Pediatric dose of Hep B;  Client will have to have one extra shot (needle stick) of  Hep B due to this error.  Client will have a delay in completing the Hep B series.
On day 2 after immunizations pt developed induration approximately 4" x 3" in area where shots given.
This spontaneous report was received from a Registered Nurse and refers to a patient of unknown age and gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On 30-MAR-2017, the patient was vaccinated with an unspecified improperly stored dose of PEDVAXHIB for prophylaxis (lot # M032150 with an expiration date of 21-APR-2019) (dosage schedule, route and anatomical location were not reported). Other suspect and concomitant medications were not provided. No adverse effects were reported. The dose of the vaccine experienced a temperature excursion from 32 Fahrenheit (F) to 35 F for 19 minutes. The aforementioned temperature was identified due to a data logger. There were no previous temperature excursions reported. Additional information has been requested.
This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of INFLUENZA LIKE ILLNESS (overall feeling of coming down with the flu symptoms), IRRITABILITY (Severe irritability), VACCINATION SITE PAIN (Sore arm at the injection site) and HYPERSOMNIA (slept for 36 hours) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 011L20A) for COVID-19 vaccination. Concurrent medical conditions included Penicillin allergy, Drug allergy and Hypothyroidism (T3 and T4 are normal) since 2012. Concomitant products included LEVOTHYROXINE for Hypothyroidism, MULTIVITAMIN [VITAMINS NOS] and EVENING PRIMROSE OIL [OENOTHERA BIENNIS OIL] for an unknown indication. On 22-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (overall feeling of coming down with the flu symptoms) with PAIN (Body aches), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Severe fatigue), IRRITABILITY (Severe irritability) with ANGER (angry) and DEPRESSION (depressed), VACCINATION SITE PAIN (Sore arm at the injection site) and HYPERSOMNIA (slept for 36 hours). On 22-Jan-2021, INFLUENZA LIKE ILLNESS (overall feeling of coming down with the flu symptoms), IRRITABILITY (Severe irritability), VACCINATION SITE PAIN (Sore arm at the injection site) and HYPERSOMNIA (slept for 36 hours) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered INFLUENZA LIKE ILLNESS (overall feeling of coming down with the flu symptoms), IRRITABILITY (Severe irritability), VACCINATION SITE PAIN (Sore arm at the injection site) and HYPERSOMNIA (slept for 36 hours) to be possibly related. This case was linked to MOD-2021-024838.
Vaccine was expired for 43 days. Given inadvertently due to confusion in extended dates. Vaccine stored in refrigerator and not ultra-cold. Used ultra-cold extended date instead of 10 week expiration date.
Information has been received from a Health Care Department concerning 7 patients who over the past two months were vaccinated with a fourth dose of RECOMBIVAX HB (lot number 603895/0748V). It was unspecified if the patient's sought medical attention. Follow up information has been received from an office manager concerning an approximately 17 year old male patient who after his third dose of RECOMBIVAX HB presented with hepatitis B surface antibody test negative, "not immune". Laboratory test was less than 5. The patient was administered at least one dose of RECOMBIVAX HB, lot# 603895/0748V. On an unspecified date, the patient was vaccinated with a fourth dose of RECOMBIVAX HB (lot number unspecified). The hepatitis B surface antibody test was repeated a month after the fourth dose and the results was 301. The patient did not develop hepatitis B. No the adverse experience was reported. At the time of report the patient's outcome was unknown. It was unspecified if the patient sought medical attention. The office wanted to know if lot# 603895/0748V was associated with failed immunity. Follow up information has been received from the office manager who reported that on 19-NOV-1992 (at the age of 8 weeks) the patient was vaccinated with a dose of RECOMBIVAX HB (lot number lot# 603895/0748V) (adult dose), as an infant. The office manager could not confirm if the vaccine was stored correctly back in 1992. A lot check has been initiated. A preliminary lot check investigation was performed. To date our investigation has found that this lot conformed to quality release parameters and the manufacturing was typical of a lot of RECOMBIVAX HB. Additional information will be provided upon finalization of this manufacturing investigation. Follow up information has been received from a physician who reported that a 9 week male who on 19-NOV-1992 was vaccinated with a second dose of RECOMBIVAX HB in the left leg. On the same day the patient received the first dose of ACEL-IMUNE (lot number 3030-910) in the right leg, ORIMUNE (lot number 334-9500667E) orally and HIBTITER (lot number MOZOJE) in the left leg. On 22-APR-2010 the patient underwent a hepatitis B surface antibody which was <5 mIU/L (not have immunity to hepatitis B virus). On 28-JUN-2010, the patient's hepatitis B surface antibody which was 301 mIU/L (immunity to hepatitis B virus). This is an amended report. The code overdose was deleted since the actual dose of vaccine was not provided. This is one of several reports received from the same source. Additional information is not expected.
Redness, sickness, irritation, burning. Palm-size swelling, small red raised bumps surrounding inject site.
Muscle and joint aches all over, mild headache, lethargy, red and burning eyes, fever of 100.4, could not get warm (especially hands and feet), trouble falling asleep. Took 400mg IBU and went to bed. At ~2:00 AM on 03/17/2021, woke up sweating profusely. Got a drink of water, went back to sleep, woke up at ~6:00 AM with all symptoms resolved.
Aprox 3 days after the H1N1 vaccine the patient developed sign/symptoms of a cold.  The runny nose lasted for approx 2 weeks.  Then on 1/6/10 the patient presented to the ER with ptosis, diplopia, numbness in his hands, feet, and trunk.  Also was having trouble swallowing.  Patient also complained of fatigue and muscle weakness.  At time of admission symptoms had been present for 5 days.
HIB was not mixed with diluent.  Patient only received diluent.  Immunizations were prepared by MA and I assisted her in giving immunizations.  Will notify parents to bring child back for immunization.
Patient received vaccine on 12/11/13. Pt came back to pharmacy on 12/13/13 w/ redness on arm and arm stiffness. Advised patient to see physician.
Pfizer vaccine malfunctioned and started discharging medication just prior and just after patient injected.  Spoke with Pharmacy, explained how much medication poured out of vaccine in open air instead of in patient deltoid, advised to give second vaccination.  Second vaccination given with no issues.
Had Moderna #1 on 2/27/21, Developed Shingles 3/22/21
Developed chicken pox 6/19/04 15 days after vaccine- had been in isolation since 6/9 for MRSA pneumonia.
Heavy menstrual cycle started 4/20/2021. Passed a few blood clots. Definitely not normal cycle for me
Pt was vaccinated at 1630 and then proceeded to the monitoring area for her 30 minutes due to allergy hx. At 1700 pt started to c/o to monitoring RN that she felt tingling in her both her arms and legs. RN provided pt wit diphenhydramine 25mg PO with water. Pt continued to be monitored. No additional s/s of an allergic rxn were noted. Tingling improved and pt was discharged home with son at 1720.
In the early afternoon hours of 11/9/2018, my physician injected a "seasonal flu shot" into my right arm. On the night of 11/10/2018, my body started having a mild hive reaction. The mild hive reaction appeared throughout my arm, stomach and legs. On the night of 11/11/2018, my body started to become itchy and eventually I start seeing symptoms of hives. I examined my body and saw a more severe case of hives than the prior night. Immediately, my family took me to hospital and the doctor there examine my vital signs and symptoms. The results showed that my heart rate is normal and I had no signs of a fever. The register nurse, provide three forms of medications: diphenhydramine (BENADRYL) @ 11:23PM, famotidine (PEPCID) @ 11:23 PM, and prednisone (DELTASONE) @ 11:22PM. The hives eventually subsided overnight but my body start showing symptoms of hives approximately @ 2:00PM.
pt recvd vax & immed exp localized swelling & redness to site;no other c/o was noted or voiced by pt;VS BP 120/84 sitting;P80 & temp 98.4
I started to experience extreme leg and back pain the day after the vaccine. I have since been experiencing muscle spasms throughout the entire headache. I am still experiencing back pain. My legs and hands feel very weak and I feel sharp shoot pains, numbness, and tingling through all extremities. I also experience stomach spasms.
I recieved my shot at 12:15 p.m.  Sore arm within hours.   Chills began within 9-10 hours.   Fever that went as high as 102.1 degrees after appoximately 24 hours (so, midday on the following day).  Fever lasted approximately 12 hours and was gone when I woke up on the 3rd day following the shot. It should be noted I had taken Tylenol and it responded to that by going down, but it came back up and required a 2nd dose of Tylenol.  By then, I was just tired from the previous day, but was fine and felt completely betterby the 4th day.  I also experienced significant swelling of the glands to the right of my right breast; in the armpit area.  This came on during the second day, when I had the fever.  The skin of both armpits also had reddish/purplish splotches.    I performed slow, gentle lymphatic drainage massage to the area periodically for a couple of days and it resolved almost completely by the 3rd day of onset of those particular symptoms.  At present, if I press my right arm closely against my body, I can tell that the glands have not 100% returned to normal, but they do not bother me.
This isn't an ADR, it's an administration timing error.  The patient came in at the 21-day mark, as recorded on vaccine card, which states Pfizer vaccine given for first dose.  Patient insists that she received Moderna.  Looking at card, lot number corresponds to Moderna.  Second dose was given as Moderna, but then it was realized that the dose was given 7 days too early.  Therefore, this is a timing error, where second dose of Moderna vaccine was given at 21 day interval instead of 28 days.
Health Department informed us of a excursion with our refrigerator and that our vaccine was nonviable.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. In 2009, the patient was inoculated with ZOSTAVAX (dose, route of administration, site of administration and lot # were not provided) at a medical center/healthcare facility, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2015, the patient was treated by the medical center/healthcare facility (by unspecified healthcare professional) for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. 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 direct and proximate result of these malfunctions, 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. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Developed shingles-type rash on back of left leg, radiating to front of knee.  Blistering rash became itchy within a few days of onset.
Information has been received from a licensed practical nurse concerning a 13 year old female with no medical history and no drug allergies, who on 20-AUG-2007 was vaccinated intramuscularly with a 1 vial first dose of Gardasil vaccine (Lot#655205/1426F). There was no concomitant medication. On 20-aug-2007 the patient experienced dizziness and neck spasm immediately after the vaccination. The patient recovered quickly. The patient was experiencing headaches, nausea, and dizziness for 15 days following the vaccination. The patient also lost 5 pounds. The patient was seen by the doctor. No laboratory diagnostics were performed. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.  01/07/2008 This is in follow-up to report(s) previously submitted on 11/14/2007. Initial and follow-up information has been received from a licensed practical nurse concerning a 13 year old female student with no medical history and no drug allergies, who on 20-AUG-2007 at 16:45 was vaccinated intramuscularly in the left deltoid with a 1 vial first dose of GARDASIL (Lot# 655205/1426F). There was no concomitant medication. On 20-AUG-2007 at 16:45 the patient experienced dizziness, lightheadedness, then syncope with neck spasm, twitching/jerking, and loss of consciousness that lasted a few seconds. The patient regained consciousness and improved quickly/appropriately over a time period of 3 to 5 minutes. The patient was experiencing headaches, nausea, and dizziness for 15 days following the vaccination. The patient also lost 5 pounds. The patient was seen by the doctor. No laboratory diagnostics were performed. The patient recovered 15 days later on an unspecified date. It was noted that the patient has a fraternal twin with controlled asthma. No product quality complaint was involved. Additional information is not expected.
Metallic taste and dry mouth inmediately after injection that stopped on its own and lasted for less than a minute.  Severe headache migraneous type that started an hour after injection, treated with OTC Acetaminophen at home but did not resolved until 6 hrs later.  Moderate Myalgia and general malaise without fever or chills that started 20 hours after injection and was treated with Ibuprofen and bed rest at home. Lasted 12 hrs aprox.
Few hours after vaccination he started getting allergies (little bumps or rash) in his left arm and I called the doctor she said to let him take Allegra. The next day the rash expanded all over his body and I called the doctor and was advised to take him to the ER. He was prescribed with Siladryl, Prednisone, Benadryl and Hydrocortisone cream.  As of today it the rash disappeared on some part of his body but there are still remaining on his other side and his body temperature has been really warm for the past few days since he got his first dose.
3JUN94 started to become tired, loss of energy,  since 5JUN94 nausea, frequent stools, h/a, chills, hot flashes, loss of appetite, dizziness, weakness, muscle, joint aches; 14JUN-17JUN94 hospitalized for arthralgia & dehydration
Hives on trunk and extremities. Treated with Benadryl Elixir
The patient fainted (syncope) minutes after receiving the vaccine while waiting in the post-vaccine waiting area.  He regained consciousness almost instantly.  911 was called and paramedics checked him out.  He previously stated he had no history of syncope, but after the event he admitted he sometimes passes out from getting his blood drawn.
Random orgasms; This spontaneous case was reported by a consumer and describes the occurrence of ORGASM ABNORMAL (Random orgasms) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Sep-2021, the patient experienced ORGASM ABNORMAL (Random orgasms). At the time of the report, ORGASM ABNORMAL (Random orgasms) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Unsure of exact dates, felt sick after the vaccine, didn't continue series.  Numerous ER visits for years after vaccine for reasons listed below. Facial paralysis, debilitating headaches, right side palsy. Shaking, tremors, numbness right side of body, difficulty walking and coordinating, Hashimotos thyroiditis, excessive swelling.  Current symptoms: Frequent Urination (becomes thick and smelly at the end); Fullness/Pressure in head; Sporadic headache behind ear/eyeball; Stiff/Heavy Neck; Hear noise in head, leaks down throat, odd taste; Tremors; Seizures; Difficulty breathing, becomes heavy for a few minutes; High heart rate; Right Side Paralysis with Drooling; No feeling in right eye, right cheek, and wrists; Numbness of Face, Arms and Legs; Swollen Face, Arms, and Legs.; Difficulty Speaking, swallowing, walking; Poor coordination. Lost feeling to the right side of my body on April 14, 2014.
COVID SYMPTOMS; CHILLS; NAUSEA; TASTE SENSATION; LIGHTHEADEDNESS; This spontaneous report received from a patient concerned a 56 year old female. 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: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, Laboratory data included: PCR (NR: not provided) Negative (unit unspecified).  On 11-APR-2021, the subject experienced taste sensation. On 11-APR-2021, the subject experienced lightheadedness. On 11-APR-2021, the subject experienced chills. On 11-APR-2021, the subject experienced nausea. On 19-APR-2021, the subject experienced covid symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from taste sensation, and chills, was recovering from lightheadedness, and covid symptoms, and had not recovered from nausea. This report was non-serious.
Patient stated that about a week and a half after she got the vaccine, her arm became swollen, warm, red, and puffy. It went away the next day.