chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 09/15/2021-   a  hepatic cyst on my liver that has been growing very slowly.  We were no longer monitoring it because it had been growing so slowly. The  pain was in my abdomen, my back and my right shoulder, started 09/15/2021.    I had a gall bladder CT  scan that revealed the hepatic cyst had grown extensively. An MRI revealed that it was bleeding into it also.   Because  of the increase growth, it has been partially excised,  drained and cleaned out. . Since the vaccine it doubled in size. I had surgery 10/25/2021, it was done in house, but I did not stay an over night stay.  I just had the surgery, 10/25/2021. I am unknown at this point if I have recovered from the AEs.
FLUMIST administered 01/24/2014. Hospitalized 02/09/2014 for ascending paralysis. Diagnosed 02/11/2014 with transverse myelitis. Received steroids. Positive pregnancy 02/16/2014. Multiple hospitalizations (4 total) and reoccurrences. Followed by high-risk pregnancy team.
Erythema, swelling, warm to touch, itching. Advice to give BENADRYL Q6-8 hours & apply cool compress return to clinic if sign & symptom get worse.
Felt lightheaded, dizziness, then leaned back passed out and was unresponsive with convulsions for 5 seconds then started responding again. Couldn't see for 15 seconds then threw up. After fluids and crackers waited for 20 minutes and then was fine.
This case was reported by a consumer via call center representative and described the occurrence of high temperature in a 85-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received and did not get any reaction). In July 2018, the patient received the 2nd dose of SHINGRIX. In July 2018, less than a day after receiving SHINGRIX, the patient experienced high temperature, axillary lymph nodes enlarged and dizziness. On an unknown date, the outcome of the high temperature and dizziness were recovered/resolved and the outcome of the axillary lymph nodes enlarged was recovering/resolving. It was unknown if the reporter considered the high temperature and dizziness to be related to SHINGRIX. The reporter considered the axillary lymph nodes enlarged to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. On the same night of vaccination, the patient experienced higher temperature and felt dizzy which lasted only a few hours. The next morning, 1 day after receiving SHINGRIX, the patient saw a swelling on the lymph node under his left arm pit. The patient saw a physician and the physician said that, it was a reaction to the shot. The patient still had this side effect, but it was softer and smaller, but still persisted.
Four days after first Covid shot woke up with extreme dizziness/vertigo at 3:30 am.  Called Hospital ambulance because I was alone.  Went into ER where they did a CAT scan and an MRI.  Showed nothing unusual, so they sent me home after 5+ hours with Meclizine.
I woke up the next day and had a headache for 10 days and I went to an urgent care center and they really just prescribed Tylenol and did a Covid test which was negative. And then on day 11 I had shingles on my face and I went to the same urgent care. They gave me Shingrex.
Hep b given shortly after birth, baby stopped breathing 4 days later was told he was fine, stopped again a week and a half later was rushed to ER, ended up having an infection in his blood stream, and a fever
Injection site reaction to left upper extremity with redness, pain, and slight induration at injection site. Redness measured approximately 4 in x 3 in.
None at time of vaccination. Pt died 3-30-13 per family report. No known connection to vaccine administration.
Significant swelling in right armpit (lymph nodes) with mild to moderate pain/ache in same area, going on 2 days now.
pt recvd vax & w/in 2 days exp cold sx w/deep cough lasting for 4 wks
This spontaneous report was received from a registered nurse and refers to a 15 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 31-JUL-2017, the patient was vaccinated with an improperly stored VARIVAX at a dose of 0.5 (units not specified) from lot # N012132 with expiry date: 17-APR-2019 (dose number, route, anatomical location and site of administration were not reported) for prophylaxis. Concomitant medications included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA004945.
Right after shot my brain felt wishy washy but went away next day.  Then on Thurs I noticed my right armpit was September and sore. It was same on Fri then gradually went down and not sore by today Sunday.  Also I had strange fatigue. I still worked by pushing through.
Information has been received from a registered nurse concerning a 46-month-old male with no pertinent medical history or allergies who on 16-APR-2005 was vaccinated in his left thigh with his first dose of VARIVAX (Oka/Merck) (Lot # 648305/0826P). It was unknown if there were any illnesses at the time of vaccination. On 16-APR-2005 concomitant vaccinations included a fourth dose of DTaP 9+ tetanus toxoid (Aventis) (Lot # C2184AA) administered in his left thigh and a third dose of PREVNAR (Wyeth) (Lot # A67185H) administered in his right thigh. On 18-AUG-2007 the patient developed numerous vesicles on his legs and trunk. The patient was prescribed with ZOVIRAX 400 mg three times a day for five days. The patient received from the adverse event at an unspecified date. The event was considered to be an other important medical event by the reporter. It was noted that the patient's sibling (WAES#0708USA05829) experienced an adverse event. This is one of several reports received from the same source. Further information is not expected.
pt recvd 1st dose of vax on 21NOV91; following vax pt felt tired & went home to take nap; 8 hrs later awoke w/severe shaking chills that last approx 10 mins; felt fatigued;
Immunization were given and immediately a pink smooth rash appeared 3-4 cm around each injection site. After about 30 mins. It had gotten better but not completely gone. No other symptoms noted. Received order from physician for Benadryl. Called mother the next day. She stated that only a small red spot was there. No other problems occurred.
got shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (got shingles) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced HERPES ZOSTER (got shingles). At the time of the report, HERPES ZOSTER (got shingles) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.
lethargy; Ongoing headache; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205), via an unspecified route of administration in the left arm on 10Mar2021 at 00:00 as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no known allergies to medications, food, or any other products. The patient received atorvastatin (MANUFACTURER UNKNOWN), vitamin D (MANUFACTURER UNKNOWN), atenolol (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER UNKNOWN) within 2 weeks of vaccination. The patient had not received any other vaccine within 4 weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not tested for COVID-19. On 19Mar2021, the patient experienced headache and lethargy. The events had not resulted in doctor/other health care professional office/clinic visit and emergency room/department or urgent care. No therapeutic measures were taken as a result of headache and lethargy. The clinical outcome of the events headache and lethargy was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Swelling under eyes, itching, labored breathing, crying taken to ER per parents.
sickness; Covered in hive like a lobster, face, throat; face, throat, tongue swelling; face, throat, tongue swelling; face, throat, tongue swelling; vomiting and diarrhea.....; vomiting; 104 temp; felt like she had the flu; body aches; HEADACHE; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (felt like she had the flu), ILLNESS (sickness), URTICARIA (Covered in hive like a lobster, face, throat), SWELLING FACE (face, throat, tongue swelling) and PHARYNGEAL SWELLING (face, throat, tongue swelling) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (felt like she had the flu), MYALGIA (body aches) and HEADACHE (HEADACHE). On an unknown date, the patient experienced ILLNESS (sickness), URTICARIA (Covered in hive like a lobster, face, throat), SWELLING FACE (face, throat, tongue swelling), PHARYNGEAL SWELLING (face, throat, tongue swelling), SWOLLEN TONGUE (face, throat, tongue swelling), DIARRHOEA (vomiting and diarrhea.....), VOMITING (vomiting) and PYREXIA (104 temp). On 20-Mar-2021, INFLUENZA LIKE ILLNESS (felt like she had the flu), MYALGIA (body aches) and HEADACHE (HEADACHE) had resolved. At the time of the report, ILLNESS (sickness), URTICARIA (Covered in hive like a lobster, face, throat), SWELLING FACE (face, throat, tongue swelling), PHARYNGEAL SWELLING (face, throat, tongue swelling), SWOLLEN TONGUE (face, throat, tongue swelling), DIARRHOEA (vomiting and diarrhea...), VOMITING (vomiting) and PYREXIA (104 temp) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104 (High) 104 temp.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-091854, MOD-2021-092133 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Follow up was received on 28-May-2021 included additional events were updated.
Right side of tongue tingling and slight swelling, hives on right inside of mouth, right eye slight swelling, right side of face tingling, and a dime sized hive on my right temple area.
PRESENTED TO THE ED WITH COLD SYMPTOMS AND GENERALIZED WEAKNESS. Patient started with cough, sneezing, nasal congestion, body aches for a few days before admission to ED (8/27). Also increased confusing over the last few days. Admitted with COVID pneumonia and pulmonary embolism. Will receive dexamethasone x 10 days and remdesivir x 5 days. Was up to 10L oxygen, down to 6L.
Sore arm for 2 days; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 8-May-2022 Reporter's comments: This case was reported by a consumer via interactive digital media. After receiving Shingles vaccine, the patient had sore arm for 2 days.
Temp to 103, headache, stomach ache and nausea-onset 4 hrs. after H1N1 nasal mist.
sore throat; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (reporting for herself) An unspecified age female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration single dose on 18Jan2021 for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced sore throat  on an unspecified date. The outcome was unknown.    Information on the lot/batch number has been requested
Bell's Palsy; Neck pain and rigidity; Neck pain and rigidity; Pain in the ear; Epiphora; Could not blink; Shoulder soreness; Chills; Fever; A spontaneous report was received from a Consumer and a healthcare professional concerning a  35 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced facial paralysis, arthralgia, chills, fever, neck pain, nuchal rigidity, ear pain, lacrimation increased and lagophthalmos.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 12-Feb-2021, prior to the onset of the events, the patient received their second planned dose of mRNA-1273 (lot/batch: 030M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On the same day, the patient experienced shoulder soreness, pain in the ear, chills, fever, neck pain and rigidity, epiphora, couldn't blink and face paralysis.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the events was unknown.; Reporter's Comments: Based on the information provided which includes a strong temporal association, a causal association between the reported events and the administration of the mRNA-1273 vaccine cannot be excluded. The events of arthralgia, chills and fever are consistent with the known safety profile of the vaccine.
Administered outside of approved age. Patient is 17 y/o, MODERNA approved for 18 y/o and older
Staff member was waiting 15 min post her last vaccination shot when she began to have dizziness and become light headed. B/P taken and was abnormally high. Staff squaded out to hospital for further evaluation.
Patient presented 12-10-16 with a red, swollen, hot to touch lower upper left arm. Received PNEUMOVAX 23 and BOOSTRIX 12-7-16 in left arm. Patient has been taking ZYRTEC and ibuprofen with no relief. Recommended patient go to urgent care.
started w/fever a prolonged fever; had less movements; eye contact not slower sometimes no contact; brain damage; motionless; place on meds;
patient called several hours after vaccine stating he has pain and weakness in leg. He was not sure if it was from covid shot or if he hurt it somehow
(07/20/2021) sharp pain in right heel, usually walks 5 miles/day without pain. Experienced sharp pain (10), during walking. After icing the foot, got it down to a 5 on the pain scale.
20 hours after Pfizer immunization C/O left hand pain with dime size hard lump located on palm of hand.
Red rash near injection site with bruise-like pain and mild itching. Patch Roughly 3in. x 2in.
At 4:00 am on Thursday morning (12 hours after vaccination),  I got up to use the bathroom and when I was finished, I fainted.  My mom heard the loud noise and found me on the bathroom floor and could not arouse me.  She called 911 and I came to when she was on the phone with them.  She helped me up and I felt weak and flush.  She gave me some cold towels and I felt better soon after.  She then took me to ER because I had a gash on my chin and my jaw was very sore.  I asked the ER doctor if my fainting could have something to do with the vaccine and he didn't think so.  He did a CT scan to check my jaw and an EKG and they were both normal.  I told him that I have been very busy at work the last week or so and I know that I haven't been eating or hydrating properly.
Peridcarditis.Discomfort  of mid sternum - onset 2 hours after booster injection. EKG completed. Signs and symptoms remain but appear to be improving as of 11/10/21.
Patient stated he had a body rash, burning and itching 30 hours after administration of immunization.  Patient also stated increased heart rate and bp for 7 days after.
Nauseous body aches chills headache itching(not by injection site) rash (not by injection site) they all started 6/7/2021 @7p
Redness, swelling and warmth  to injection site.  DX with cellulitis.  She saw inhouse physicain. Three medications started Keflex 500mg BID for 7 days, Prednisone 20 mg daily x 5 days, hydrocortisone 2.5% to lue bid x 7 days.  no fever.
No adverse effect from vaccine Nasal congestion, slight fever, fatigue Tested positive for COVID two weeks after second booster Tested negative six days later for certificate of recovery so I could return home from another country.
Tingling, numbness of lips, inside cheek and tongue for approx. an hour.  Given oral 50mg benadryl at 1025, nothing progressed or got worst.
Patient stated that she got the pneumonia shot on 09-15 and she couldn't move her arm and it was very painful where it limited her ability to change clothes. She stated she had fever too. She stated that she had that feeling for about 5 days. Patient called today on 09-25 to tell me. Patient eventually her arm got better.
Hives on her back and stomach; Ringing in the ears.; Headache; Pyrexia; chills; Headache; Fever 102.2 F; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (Hives on her back and stomach), TINNITUS (Ringing in the ears.), the second episode of HEADACHE (Headache), PYREXIA (Pyrexia) and CHILLS (chills) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced the first episode of HEADACHE (Headache) and PYREXIA (Fever 102.2 F). On 01-May-2021, the patient experienced URTICARIA (Hives on her back and stomach), TINNITUS (Ringing in the ears.), the second episode of HEADACHE (Headache), PYREXIA (Pyrexia) and CHILLS (chills). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form and CORTISONE at a dose of 1 dosage form. On 25-Mar-2021, PYREXIA (Fever 102.2 F) had resolved. At the time of the report, URTICARIA (Hives on her back and stomach), PYREXIA (Pyrexia) and CHILLS (chills) outcome was unknown and TINNITUS (Ringing in the ears.) and the last episode of HEADACHE (Headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, Body temperature: 102.2 102.2F.         No concomitant medication were reported.    Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Follow up information received on 09-jul-2021 contains significant information. Updated events Headache, Fever and chills. Event ringing in ears added.
Localized redness, warm, swelling 4 1/2" right deltoid. By 6/23 swelling, redness and warm. Travel down to right elbow, with increased pain. By 6/26 deltoid area still red. Swelling decreased right elbow and pain decreased.
This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 66-year-old female patient who received SHINGRIX. The patient's past medical history included shingles. Concurrent medical conditions included atrial fibrillation (Diagnosed prior to taking SHINGRIX) and immunodeficiency (Diagnosed prior to taking SHINGRIX). Concomitant products included Warfarin and Metoprolol. On 20th January 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In January 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema, injection site induration, injected limb mobility decreased and fever. On 20th January 2018, the patient experienced extensive swelling of vaccinated limb. On an unknown date, the patient experienced shingles. On an unknown date, the outcome of the extensive swelling of vaccinated limb, shingles, injected limb mobility decreased and fever were recovered/resolved and the outcome of the injection site erythema and injection site induration were unknown. The reporter considered the extensive swelling of vaccinated limb, shingles, injected limb mobility decreased and fever to be almost certainly related to SHINGRIX. It was unknown if the reporter considered the injection site erythema and injection site induration to be related to SHINGRIX. Additional details were provided as follows: The patient started to have swelling at the injection site about an hour after receiving the vaccine, and by the time she got home, she could not lift her arm. By that night the swelling was about the size of a grapefruit (7 inches, 7 diameter) and was red and hard. She stated that she also felt feverish. She stated that it took about 2 weeks for the swelling to go away completely. Before she received the vaccine she would have shingles outbreaks often as she had an immunodeficiency. She stated that she also had a shingles recurrence since receiving the vaccine, but it was not nearly as painful and could tell a huge difference since taking the vaccine.
I developed tinnitus two weeks after second Pfizer shot. Shot was in my lef arm and tinnitus was only in my lef ear.
patient received a bexsero dose exposed at 28 degree F; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 18-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced incorrect storage of drug (Verbatim: patient received a bexsero dose exposed at 28°F). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 19-JUL-2023 A nurse reported that a patient received a Bexsero dose exposed at 28 degree F which led to incorrect storage of drug. The reporter consented to follow up.