chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse concerning a 13 year old female patient who on approximately 29-DEC-2009 was vaccinated with the second dose of GARDASIL. On 29-DEC-2009 the patient experienced weakness, redness on her face, swelling, pain at injection site, headache and nausea. No lot number is provided. On an unspecified date the patient recovered. No further information is available.
Fever of over 102 F, lethargy, poor appetite and fussiness sustained for over 3 days
guillian barre syndrome; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was not recovered/not resolved.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingrix.     Additional Information: GSK Receipt Date: 03-JUN-2022 Reporter's Comment: This case was reported by the patient via interactive digital media. The patient got a Shingrix vaccination and now he/she have had Guillain barre syndrome for four months. Additional Supportive Information: The follow up would not possible as no contact details were available.
Noticed low grade fever on 3/19/21 at 1400. Then on 3/20/21 reported weak, poor intake, low grade fever and vomiting. Reported to the ER 3/20/21 at 1945, admitted to observation and given IV hydration, Zofran, Tylenol and closely monitored blood sugars. Ultrasound performed to assess liver/biliary system on 3/22/21. Discharged home 3/22/21.
Both arms became "itchy" due to small subcutaneous bumps on forearms.   After the 2nd shot (6/30/20)  it became more pronounced.  Still itches and bumps are present today  -7/23/20.    Asked Dr. about it as a "side effect" or maybe some form of shingles - he said no.   The itching at times is intense.   It's not a normal rash or poison ivy.
had swelling in the neck on opposite side of where i got the vaccine. pain in my throat when i would swallow . Dr said my throat was red. Still have the lump in my neck.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended. Instead the patient contracted a persistent strain of shingles, or severe herpes zoster. On or about 10-JUN-2016, the patient was treated by a physician for the onset of a painful vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the defective ZOSTAVAX, the patient suffered and continues to suffer painful and ongoing injuries and damages, and required and continues to require extensive medical care and treatment. Further, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. The outcome of the events is unknown. Additional information has been requested.
The following is the timeline of progression: First 48 hours: Immediately following the vaccine I felt I would vomit. That lasted 2 hours. The remainder of the 48 hours I had a growing headache that turned into a migraine level. Cognitively my husband would say I was out of it, not able to focus. The area around my eyes  my eyelids and below eyelids bright red  like I had put a bright red blush on them. Three to four days later: Saturday night my symptoms started to progress over a span of a few hours very drastically. I had symptoms of Diarrhea crazy impact in my gut. Sunday I still had migraine level pain in a headache. I felt increased symptoms of nausea and diarrhea increased. Sunday I still had migraine level pain in a headache.  I felt increased symptoms of nausea and diarrhea increased. By Sunday afternoon I had full blown symptoms of stomach flu. I had chills, extreme nausea that became debilitating. We do not have a thermometer that works, as a result I do not know if I had a fever. By Sunday night I was vomiting and symptoms progressed to tightness of chest, shortness of breath, vomiting, diarrhea, chills. My gut was literally moving in sharp pain, sounds, and cramping. It was severe diarrhea. I was achy and tired, but could not fall asleep due to nausea and vomiting. I was unable to stand up without the fear of passing out. I tried to manage the nausea with medicine that I have at home. It assisted but did not ultimate make an impact. By 4:30 a.m. I was scared by the lack of breath and asked my husband to call 911. The paramedic stated that I had an increased heart rate, but good blood pressure. I went to the hospital and received fluids, two different additional doses of nausea medicine, oxygen and a gut muscle relaxer. After 30 to 40 minutes I showed improvement and was able to go home. Still had pink color tone in skin around my eyes. On that Monday (2/8/2021), I was unable to go to work and called in for Covid PTO. I slept most of the day. Five days later: Still have a headache that can be managed with Tylenol. I still have diarrhea. I no longer have nausea, the pink color around my eyes seems to be gone.The nurse team and ambulance team all stated that the second shot was awful. Three folks stated they were in fetal position for two days. I was not able to ask what that meant due to my extreme nausea and trying to not dry heave. Note: I did not have any symptoms from the first vaccine  just a dull headache.
Fever: Starting 12 hours later, experienced strong chills followed by high fever of 102-103 during the night. Controllable with Advil during the day and most gone by 24 hours after the shot. Rash: By that morning, had a rash that worsened over the next day or two and lasted over a week. Was primarily on my neck, upper chest and right arm. Patches of small red bumps that were quite itchy. Took Benadryl that 2nd night, which provided some relief but not entirely. Tried Allegra 12-hour the following day, with limited relief. On Tuesday 4 days after the appointment, I went to see the doctor and she prescribed Triamcinolone Acetonide Ointment, 0.5%, which offered the best relief. Rash improved though persisted over a week.
trouble swallowing; Itchiness in throat; This is a spontaneous report from a contactable consumer (patient). This 36-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 07May2021 at 10:30 (at the age of 36-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included no chronic medicinal conditions, anxiety this year (as of 2021), and a hemorrhage after giving birth in 2018, blood transfusion that year 2018 and dilation and curettage (D&C) to address it. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included prenatal vitamins, vitamin D, and vitamin C from unknown dates for unknown indications. The patient did not have any allergies or any reaction to vaccines. The patient previously received dose 1 of BNT162B2 on 09Apr2021 at 16:30 as a single dose in the left arm for COVID-19 immunization and experienced trouble swallowing, slightly swollen glands in throat, and "slightly thump" in throat. Seven to ten minutes after the second dose on 07May2021 at 10:30 (as reported) the patient experienced the same feeling of trouble swallowing, swallowed fine with water and itchiness in throat. The patient stayed 30 minutes at the clinic. Again because she could breathe and talk she was told to take diphenhydramine (BENADRYL). The patient went home and continued drinking water. It was easier to swallow. The patient took paracetamol (TYLENOL), slept for three hours, woke up, and had slight trouble swallowing again. She took diphenhydramine and drank water. She felt better again. The outcomes of trouble swallowing and itchiness in throat was recovering. It was also reported that since the vaccination the patient had not been tested for COVID-19.
This spontaneous report as received from a medical assistant refers to a group of unspecified patients. No medical history or concurrent conditions were reported. On unknown dates the patients were vaccinated with GARDASIL. No concomitant medication was reported. The reporter stated that some unspecified patients have experienced discomfort with administration of GARDASIL on unspecified dates. The outcome of the discomfort was unknown. No further information was provided. Additional information has been requested.
Pfizer / BioNTech  Dose Number 5 / Moderna Dose Number 4; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 at 09:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 59 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09Jun2022 at 16:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure, treated" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; FAMOTIDINE; ASPRIN; LOSARTIN; BENZONATATE; CETIRIZINE; VITAMIN B12 [VITAMIN B12 NOS]; MONTELUKAST; MELATONIN. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Pfizer / BioNTech  Dose Number 5 / Moderna Dose Number 4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Vaccine Lot Unknown Reason was unable To Locate Or Read The Details. Patient had no Known allergies.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
This spontaneous report was received from a nurse referring to a patients of unknown age and gender. On an unknown date the patients were vaccinated with doses of PROQUAD (Merck) (dose and route of administration were not reported; lot # K025764 with expiration date: 08-JUN-2016 and lot# L007230 with expiration date: 03-SEP-2016), which underwent defrost cycling. No adverse effects reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Pain, swelling, and tenderness at vaccination site starting approx. 4 days after vaccination. Pain, weakness, and lack of mobility in left shoulder (front) and upper left arm (front) starting approx. 4 days after vaccination.
This is a spontaneous report from a contactable nurse received via Pfizer sales representative. A 18-year-old male patient received TRUMENBA on an unspecified date, at single dose, in arm, for immunization. Medical history and concomitant medications were not reported. On an unspecified date the patient experienced redness and swelling at injection site and could not raise arm. Events outcome was unknown. No follow-up attempts are possible, information about batch number cannot be obtained.
Onset of symptoms began approximately 1.5 hours after vaccination.  Patient became weak c/o tongue swelling, nausea, difficulty breathing, numbness especially in lower extremities.  Felt she couldn't breath, numbness continued to get worse and affected her upper extremities as well, weak speech.
Patient is a 50 y.o. male with PMH of pneumoconiosis, RA chronically on steroids who presented to the hospital for worsening shortness of breath, fever, and was recently tested positive for covid-19   Constitutional: Positive for fatigue and fever. Negative for chills.  HENT: Negative for congestion.   Eyes: Negative for visual disturbance.  Respiratory: Positive for cough (Productive) and shortness of breath.    Typically wears oxygen only as needed at night though prior to admission requiring 2-3L constantly. Also prior to admission had been started on dexamethasone as outpatient on 11/9 without improvement. Treated with remdesivir x5d and continued on dexamethasone 6mg daily. Noted to have fevers this admission with significant cough productive of sputum with streaks of blood, severe myalgias, and headaches. Managed symptomatically with anti-tussives, NSAIDs, scheduled acetaminophen and oxycodone (at home takes Norco PRN).   Discharge Disposition/Condition Disposition: Home Condition: Stable (s/sx potential problems absent or manageable)
pt recv vax 12MAR99 & 15MAR99 pt returned to clinic for PPD reading & presented w/ 2 1/2in width x 3in height red & swollen on lt arm @ site of vax;began to itch, appear red & painful on 13FEB99;referred to MD;
her reaction was worse than mine and lasted several weeks; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (her reaction was worse than mine and lasted several weeks) 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.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (her reaction was worse than mine and lasted several weeks). At the time of the report, VACCINATION COMPLICATION (her reaction was worse than mine and lasted several weeks) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment details were provided.   Reporter did not allow further contact
The night after patient received her 6 month IPV and DTaP she developed a splotchy, erythematous rash on the abdomen, left arm, back and legs that turned into raised bumps some of which are now resolving 4 days after the vaccine and leaving a pale pigment change on the skin.
ALMOST DIED; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 05-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 APR-2021, the subject experienced almost died. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from almost died. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sudden sensorial hearing loss; A spontaneous report was received from a consumer who of 65-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and had sudden sensorial hearing loss/ deafness.   The patient's current conditions included high blood pressure, gastric issue- acid reflux and cholesterol unspecified. Products known to have been used by the patient, within two weeks prior to the event, included medications for high blood pressure, gastric issue- acid reflux and cholesterol unspecified.  On 11 Feb 2021, approximately 8 days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 0104M20A) in the right arm for prophylaxis of COVID-19 infection.  On 12 Feb 2021, the patient was diagnosed with an ear issue. Later on, 18 Mar 2021, a week after vaccination the patient had sudden sensorial hearing loss.  Treatment for the event included steroids for ear issues.  The seriousness criteria for the event deafness was assessed as serious.  Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Symptoms started on May 27, 2022 in the evening right after work. I had a headache that was very bothersome from the middle of my head. I felt off, my perception was off but not dizzy. On Saturday, I had a dry cough, no fever, getting was an issue, the headache was there all over my head and my perception was still off. I took a home COVID-19 test, it came back positive in two minutes. I got online and scheduled a telehealth visit, I spoke with a Nurse Practitioner who prescribed PAXLOVID that I picked up later the evening of May 28, 2022. Once I started taking the PAXLOVID, on Sunday I started experiencing a bad taste in my mouth. I tested negative on Monday June 06, 2022 although my symptoms were completely gone by June 04, 2022.
This case was reported by a nurse and described the occurrence of chest pain with radiation to the left arm in a 23 year old female patient who received hepatitis B vaccine recombinant (Engerix B). The patient's medical history included foreign travel in June 2004 and a blow to the head with a baseball (date not provided). On 9/23/03, the patient received the first dose of Engerix B in the left arm (lot ENG5447B6). On 11/4/03, the patient received the second dose of Engerix B in the right arm (lot ENG5338B6). Approximately nine months after the second dose, on 8/4/04, the patient received the third dose of Engerix B in the left arm (lot ENG5595B6). [The recommended interval between the second and third doses of Engerix B is five months.] Approximately three days after the administration of the third dose of Engerix B, on 8/7/04, the patient experienced numbness and tingling of herleft arm and left leg, numbness in her face, chest pain which radiated down her left arm and back, difficulty swallowing, chills, severe fatigue, and headache. The patient was seen by her physician. Examination by the physician on 8/7/04 revealed a decreased pulse from 80 beats per minute on 8/4/04 to 60 beats per minute on 8/7/04, and a decreased blood pressure from 120/80 on 8/4/04 to 100/60 on 8/7/04. On unspecified dates in either August or September 2004, the patient tested negative for unspecified tests for West Nile virus and Lyme disease. In addition, unspecified X-rays, a spinal tap, and MRI of brain, neck, and spine were reportedly inconclusive. The events were ongoing at the time of initial reporting. Comment: Chest pain with radiation to the left arm was assessed as medically serious (OMIC).
Information has been received from a registered nurse concerning an 85 year old male patient with a history of cataract surgery 3 weeks ago (approximately 11-FEB-2011), who on an unspecified date was vaccinated SQ with a dose of 0.65 ml of ZOSTAVAX (Merck) (lot number not provided). On an unknown date, the patient who received ZOSTAVAX (Merck) developed shingles in the same eye that he had cataract surgery 3 weeks ago. The patient sought unspecified medical attention. At the time of the report the patient had not recovered. Additional information has been requested.
Patient came in ER one day after receiving her second dose of HPV vaccine complaining of sore throat, swelling of hands and feet. Patient showed no signs of distress and was discharged home.
Patient was given a pediatric dose of Hepatitis A instead of an adult dose.  Patient had no reactions and  was told what had happened by phone within 30 minutes of noticing the error and was given an appointment to come back for the correct vaccine.
Information has been received from a physician's client concerning a friend's child who was vaccinated with MMRII and developed autism. This physician indicated that this was a case of hearsay only. Upon internal review, autism was determined to be an "Other Important Medical Event". No further information is available.
WHOLE BODY WAS IN PAIN; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: UNKNOWN) dose, start therapy date were not reported 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 whole body was in pain, and fever. Treatment medications (dates unspecified) included: paracetamol, and ascorbic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from whole body was in pain, and fever. This report was non-serious.
Woke at 5AM and felt like I had been hit with a ton of bricks. Headache/dizzy/tired/unable to process thoughts logically. Arm somewhat sore, but not horrible.  This lasted until I went to bed Friday night at 11:00 PM
Hives and swelling. h1 and h2 blockers given within the hour.
Patient came back to office within 30 mins of vaccine administration with tongue swelling and throat swelling. She was flushed in her cheeks and face. Speech became slurred due to tongue swelling. Patient was treated with 50 mg Benadryl. Patient waited in our office for an additional 30 mins after administration.
Exhausted with GI symptoms; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Exhausted with GI symptoms) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On 14-May-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 ABDOMINAL DISCOMFORT (Exhausted with GI symptoms). At the time of the report, ABDOMINAL DISCOMFORT (Exhausted with GI symptoms) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Medication was provided. No treatment  was provided.  Patient had  first Moderna shot on 05-14 and the next day was exhausted with GI symptoms   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: No new information was reported.
On 11/04/2022, I started feeling very fatigued. On 11/05/2022, I woke up with a sore throat and a headache. I tested myself for Covid-19 and the test was positive. I went to urgent care and tested negative on there rapid test. I tested at home on 11/06/2022, at home, and the test was positive again. I was not prescribed anything from urgent care. I called the Nurse Practitioner, and she called in antibiotics for me. I had a cold since before Christmas, and I tested on 01/01/2023, but it was negative. I tested again on 01/06/2023 and this test came up positive. I had already been on AUGMENTIN because I was still sick, so I was not prescribed PAXLOVID.