chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous prospective pregnancy report as received from a nurse, and refers to a female patient of unknown age. Information regarding the patient's medical history, concurrent conditions, concomitant medication and allergies was not provided. On 19-JUL-2018, the patient was vaccinated with GARDASIL 9 lot # N003703 and expiration date of 29-OCT-2019, intramuscular for prophylaxis (dose was not reported). At the time of vaccination, the patient was 32 weeks and 5 days pregnant (maternal exposure during pregnancy). There were no adverse effects reported. No additional information was provided. The patient's estimated last menstrual period (LMP) was calculated to 03-DEC-2017, and her estimated date of delivery (EDD) was calculated to be on 09-SEP-2018. No prenatal tests or results were reported. Neither the pregnancy outcome nor the fetal outcomes were known at the time of the report. The initial exposure to GARDASIL 9 was at 32 weeks, during the third trimester of pregnancy (maternal exposure during pregnancy).
Pain in arm within an hour, severe headache, dizziness, uneasiness, weakness, lethargy, nausea, stomach pain, body aches, high fever started approx 12 after vaccine was administered (101 to 102.5) very hard to control fever with medication, would continue to rise even after taking Advil. Went back to doctor next morning and they did a flu test which was negative, said that she needed rest due to vaccine side effect. Fever continued, she woke up in middle of the night crying in pain, couldn't get comfortable, everything hurt. Fever all day on Sunday January 04, 2014, called doctor's emergency number Sunday night and he said give fluids and alternate Tylenol and Advil to bring fever down. Fever continued all night until 7AM on January 05, 2015. Still feeling lethargic and 102.2 fever at 10:30 AM, took Tylenol, fever still 102 at 11:30, went to doctor and took another flu test and it was negative, strept test negative. Doctor noticed her eyes looked yellowish so they did bloodwork to test liver and to test for Mono. It's now 7:15 PM and she has 102.8 fever.
Patient stated that when she received her vaccine she experienced pain in her arm and was still experiencing this pain days later. She went to ER and doctor told her the vaccine "infected her nerve."
Patient fainted immediately upon receiving vaccine and then woke up immediately. 911 was called and paramedics came to take vital signs, etc. They determined the patient was anxious from seeing the needle and fainted. Pt has had no reaction to a vaccine in the past. Pt was allowed to go home with his father and did not need to be transported to the hospital.
Little pain at injection site; A spontaneous report was received from a Consumer concerning a 81-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced little pain at injection site/vaccination site pain.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 26 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 012M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 26 Jan 2021, the patient experienced little pain at injection site. Treatment details included paracetamol as prophylactic.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of event, little pain at injection site was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded.
CVA 2 days after 2nd COVID vaccine, with hospitalization. Pt comatose and still hospitalized.
Patient had a fever after 1 day. Submitted to ER and hospital said patient has a Staph infection due to flu shot.
per mother, patient complained of foot pain, then abdominal pain, cried, got hives on trunk and face became flushed and swollen.  no vomiting, no respiratory symptoms
Good morning, I have the patient in the hospital. We have had to give her 2 transfusion in the last 2 weeks and 2 days. The patient also had a more pronounced stroke system. We read today that people with the systems of low platelets and stoke system need to report. I have called everyone and have had no help. I believe it has to be the health department.
Upon waking on the third day after receiving the second dose of the Moderna vaccine,  I've experienced vertigo/disorientation.  This side effect has continued a second day causing me to notify my primary care provider and preparing this event report.  Other side effects experienced after the second vaccination were soreness at the injection sight, mild fatigue, and slight fever which were all anticipated. These side effects have passed.
pt recvd vax 26FEB94 & 4 to 6 hrs p/vax pt reports that felt hypersensitivity, nervous, couldn't cope, couldn't respond well or answer questions good, confused, disoriented somewhat; then went to hosp ER, t100.8;
1st dose: Itchiness all over. Mild rash on arms/chest, flushed, feels hot. Took Benadryl 50mg oral x1 and felt slightly better at 1540 BP152/101 P 85. 1600 she felt weird and looked uncomfortable and decreased energy. 1600 BP 183/105 HR 93. Hives on 2nd day. But recovered.  Followed up with PCP. PCP recommended 2nd dose with Benadryl.
muscle pain, tiredness, low fever 99.5, nausea, stomach pain, headache and of course sore injection arm.
Pt developed rash appeared on forarms & torso. Rash was raised rough, raised "like sand paper" lasted 72 hrs. Rash would reappear & itch /p showers. Rash resolved
Pt was contacted to schedule second dose of Shingrix and reported immediate pain in left shoulder after 1st dose. Had been a long time since getting a shot and though it was typical arm pain.  A week later she was still in pain and saw an orthopedist, who diagnosed it as frozen shoulder. Pt reported that Dr said the needed went through the muscle and out the other side. Had to get cortisone injection in that shoulder. Rph apoligized and investigated what happened.  Pt still wants to get second dose but would prefer in alternative site, not arm because arthritis in Right shoulder.  RPh following up with Dr.
she still has enough pain in her arm to keep her up at night; This is a spontaneous report from a contactable consumer (the patient).  A female patient of an unspecified age received pneumococcal 13-val conjugate vaccine (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced pain in her arm on an unspecified date. She reported that she still has enough pain in her arm to keep her up at night after two weeks from vaccination. The event is non-serious with outcome of not recovered.  Therapeutic measures taken as a result of the event includes treatment with ALEVE.  The information on the batch/lot number has been requested.
Redness underneath my armpits; Rash on my elbow area; rash on both arms; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received second dose of BNT162B2 (BNT162B2 Lot number EL9269, expiry date not reported) via an unspecified route of administration on 06Feb2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced redness underneath my armpits and rash on my elbow area; rash on both arms on 06Feb2021. Consumer stated, "I just had a quick question about the side effects. I had the shot yesterday, the second one, Pfizer and then last night I noticed that I had redness underneath my armpits and also like a rash on my elbow area but not on the elbow. On the other side you know. A rash on both arms. One forced from the other. But nothing around the actual shot area. So, I do want to know is that normal thing or what?" The outcome of the events was unknown.
Pt states rash over stomach/(L) shoulder about 1 wk after Zostavax vaccine. Rash "like little pimples" that itch/burn. Seen at clinic, given oral steroids. Seen at dermatologist x 2, given steroid creams. Pt states biopsy = + zoster.
Information has been received on 26-JAN-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 02-JUL-2015, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) subcutaneous, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 14-JAN-2017, the patient was treated by a physician for the onset of a severe vesicular eruption accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient has been prescribed valacyclovir for management of her painful symptoms. 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. Additional information has been requested.
This spontaneous report was received from a physician, concerning a male patient of an unknown age. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On 19-APR-2017, at a pharmacy, the patient was vaccinated with a dose of ZOSTAVAX vial (dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. On 21-APR-2017, he went to the physician's office with a 9 cm by 9 cm injection site swelling, redness, tenderness and painful area. He did not have rash, itching, shortness of breath or fever. On an unspecified date in April 2017, the patient received BENADRYL as treatment and it was unknown whether or not this treatment provided relief to him. At the time of the report, the outcome of the adverse events was unknown. The causality between the adverse events and ZOSTAVAX was unknown. Additional information has been requested.
This case was reported by a physician via call representative and described the occurrence of pale skin in a 11-year-old female patient who CERVARIX (batch number BF7A2, expiry date 28th May 2016). Concomitant products included MENVEO. On 7th August 2015, the patient received CERVARIX .5 ml. On 7th August 2015, 5 min after receiving CERVARIX, the patient experienced pale skin and dizziness. On an unknown date, the outcome of the pale skin and dizziness were unknown. It was unknown if the reporter considered the pale skin and dizziness to be related to CERVARIX. Additional details were provided as follows: The patient had unremarkable medical history and was not on concomitant medication. On 7th August 2015, 5 to 7 minutes after receiving CERVARIX, the patient experienced pale in skin Colour and dizziness. The reporter was wondering about any clinical studies regarding adverse events after CERVARIX, so the caller was escalated to MIS scientist. The reported batch number B1782 for CERVARIX, which does not exist as per sales data sheet and updated as BF7A2.
symptom on set 10/27/2021, COVID test completed 10/28/21 and was +. Symptoms included productive cough, increase weakness, fatigue, and shortness of breath, room air SpO2 84%
Developed a rash around injection site on L arm. Mom says she had the bandage on until this AM. Not itchy. He currently has a headache. 8 yo male w/ urticarial rash surrounding flu vaccine site.
Fever at night 101.7 1/28/15 103.0 2/3/15.
No adverse event; Patient was potentially impacted with a compromised dose of the Moderna COVID-19 monovalent vaccine.; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient was potentially impacted with a compromised dose of the Moderna COVID-19 monovalent vaccine.) and NO ADVERSE EVENT (No adverse event) in a 5-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1417B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Apr-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (Patient was potentially impacted with a compromised dose of the Moderna COVID-19 monovalent vaccine.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient was potentially impacted with a compromised dose of the Moderna COVID-19 monovalent vaccine.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient was potentially impacted with a compromised dose of the Moderna COVID-19 monovalent vaccine.).    No concomitant medication was reported.  The patient had not reported any adverse reactions. No treatment medication was reported. This case is reported for patient 1 out of 2 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-737601 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-737601:Patient 2
Client received 2 doses of Sinovac COVID vaccine in country and requested a booster dose of Moderna vaccine. Administered dose of Moderna COVID vaccine. After client left realized that a full 0.5 ml dose of Moderna was administered instead of 0.25 ml booster dose.
After taking the 2nd dose, I experienced severe cramping in my legs and my left leg muscle tightened substantially. I felt a lot of pain in both legs & calf and the pain was unbearable. My lower back tightened as well.  I had a hard time walking or getting up.  I took pain medication and it didn't help. I was given steroids by my doctor, but the steroids helped temporarily. I am currently getting physical therapy for my legs to help relieve strain on my muscles and to walk better again. I've also reduced the amount of drugs I've taken as well so it doesn't conflict with the vaccine I took.
pt MD suspected an allerg rxn to the mercury in vax;adverse rxn included local swelling, fever, h/a, dizziness, pain locally as well as back pain, nausea, HTN, swelling of entire arm;tx inc BP meds temp/rest;
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 17-FEB-2018, the patient was vaccinated with improperly stored dose of PROQUAD recombinant human albumin (rHA) (lot # M048201, Expiry date : 05-JUN-2018 ) for prophylaxis reconstituted with properly stored sterile diluent (Manufacturer Unknown). It was reported that the vaccine experienced a temperature excursion of 6 degrees Fahrenheit up to 14 degrees Fahrenheit (6.9 degrees Fahrenheit) for 1 hour (incorrect product storage). There was previous temperature excursion reported, temperature was reported as 6 degrees Fahrenheit up to 14 degrees Fahrenheit for 10 hours 30 minutes. There were no adverse effects reported. There was no product quality complaint reported. It was reported that this case was reported due to a digital data logger.
Tingling in left hand shortly hour after vaccine off and on. Has since stopped. Pain in lower left neck area off and on hour after vaccine. Has since stopped. Day after  vaccine at 1200 fever, chills, headache, severe fatigue.  Day 3 after vaccine only symptom is fatigue and congestion and some hot flashes
Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Additional Details: pt experienced itching of through, coughing, increased need to clear throat. no swelling
Miscalculated interval between second dose and booster. Booster given one month to soon.
Swollen, red, warm posterior left arm, improving by the time she was seen in office (three days after injection), but still red, warm, measuring 18x16cm. Already on fexofenadine, hydroxyzine added.
On Friday, March 12th, 2021 approximately 10:35 am, 60-year-old female received her first dose of Moderna Vaccine (Lot Number: 003A21A) in her left deltoid at the facility.  Patient received the Moderna Vaccine. After which she sat in the designated medical observation area for her allotted 15 minutes. Approximately nine minutes post-injection around 10:44 am, she felt a bit ?wobbly? when standing up. A medical assistant called Emergency Medical Services (EMS) immediately and the Physicians Assistant went over to assess patient's symptoms.   During the wait time for EMS?s arrival, the physicians assistant performed an assessment. Patient states to have experienced lightheaded-ness, mouth/tongue tingling, shortness of breath and palpitations. She denied throat constriction, denied itching, redness or pain at the site of injection. She said the tingling she did experience resolved around 20 mins post-injection.   During the assessment, the physicians assistant noted clear breath sounds, irregular health rhythm, increased heart rate, extra-ocular movements intact with no nystagmus, no redness or swelling on the injection site and good grip strength.   Upon EMS arrival at approximately 10:48 pm, the firefighters triaged as per their assessment. She expressed that she is taking ?Lexapro? and allergic to sulfa-drugs. She claims to be ?borderline diabetic? and that the lightheaded-ness has ?never happened before?  The EMS took her to a separate room in the building and assessed her further. After approximately 20 minutes she left and did not leave in an ambulance against medical advice.  She left with her husband and went home. She was made aware that she should go to the hospital immediately if she felt her health was compromised.
Patient has had flu shot in past.  Hot, sweating, shaking, dizzy.  BP 120/79, pulse 99.  10 min later recheck 125/79, pulse 89.  Cold compress, orange juice, crackers given.
This is a spontaneous report from a contactable Reporter who reported for a consumer. A female patient of an unspecified age and ethnicity started to receive TRUMENBA via an unspecified route of administration at unknown dose from an unspecified ate to an unspecified date for an unspecified indication. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced hives on her face and on her legs on an unspecified date with outcome of unknown. Follow-up (22JUL2015): Follow-up attempts completed. No further information expected.
Information has been received from a registered nurse concerning a 17 year old female patient who on 29-MAY-2009 was vaccinated with the first 0.5 mL dose of GARDASIL (lot # 662300/0100Y). It was reported that on an unspecified date the patient experienced headache, nausea, stomach ache, lost of interest for social activities, dizziness, lots of dreams and she always wants to sleep. The GARDASIL was discontinued. At the time of the report. her outcome was unknown. The patient sought medical attention with a nurse. Additional information has been requested.
At 7:35 AM on 9/28/2012, patient started to become sweaty, with flushed face, nausea, and red spots around injection site. Patient was given Benadryl and Pepcid by mouth, which resolved symptoms. At 9:00 PM, patient noted redness coming back around injection site on left arm, she took another Bendaryl and symptoms resolved again. On 9/27/12 at 6:30 AM, patient noted red blotchy areas on face and left arm. She took another Bendaryl and symptoms resolved. She didn't have any more signs and symptoms after 09/27/12 at 6:30 AM.
Varicella shot given on 9/10/09 at 2:30p woke up on 9/4/09 10 am broke out with spot on L upper arm 30x40 mins.  Given BENADRYL, TYLENOL, Cool pack to site.
The patient called us and told us a week after her vaccine she developed a knot at the injection site and her arm was red and itchy. She did not mention any treatment, but said 3 days later it was resolved.
08/28-2:00Am woke up with sore arm, fever of 100 and chills.10:00am still feverish off and on, weak feeling, dizzy, brain fog, tired with radiating prickly pain in arm around the injection site.  08/29- 09/18, Still having some days feeling very tired with brain fog, 2-days I slept all day and 3 days I've had chills, feeling very cold. Still having having the prickly pain in the left arm that travels down and up the arm over to the upper chest area making arm feel weak. This usually only last a few seconds off and on throughout the days. 08/31, my heart started feeling like it is skipping beats making me feel light headed, this is intermittent.
came back for TB test to be read; nurse noticed lt arm swollen fr shoulder to elbow & hot to touch & red; nurse called MD & told them thought it could be cellulitis; dx by MD later that day cellulitis; Lorabid BID x 7 days
Painful, visible gland swelling in armpit proximal to injection site onset approximately 24 hours following injection and lasting at least 60 hours.
System was down; unable access record. According to Yellow shot card patient provided. #1 HPV given 12-21-2011. No other doses shown. Administered #2 03-09-2012. Later in day when clerk entered information which was now up it showed that she had #1 on 07-09-2009, so the 12-20-2011 dose was actually #2, which would make #3 due 03-21-2012. This made on 03-12-2012 twelve days early. We need to repeat #3.
Tingling sensation in shin down to feet; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and PARAESTHESIA (Tingling sensation in shin down to feet) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B2A) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis. Concomitant products included GABAPENTIN, FLUOXETINE, BACLOFEN, MELOXICAM, OXYBUTYNIN, MULTIVITAMINS [VITAMINS NOS] and ZINC for an unknown indication.    On 30-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) and PARAESTHESIA (Tingling sensation in shin down to feet). At the time of the report, PAIN IN EXTREMITY (Sore arm) and PARAESTHESIA (Tingling sensation in shin down to feet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Lump on opposite arm on inside of forearm near elbow. First noticed two days after vaccination, still present six days later. Somewhat firm and tender, no redness.
Severe nerve pain lowerleft back. Left leg gives out when walking. Left front of leg numb below knee to ankle. Ongoing  Discussed over the phone with on call MD. Asked for consult with nerologist. Pending appoinmet/s
Pt States  "Feels funny".  Nausea.  No SOB; Pulse strong and regular.  Oriented x 3 Color normal.   @ 1615 states feels better.  Instructed to f/u with PCP if needed.