chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The first account of the reaction that I heard came from her daughter at around 5:00 pm from her daughter.  She mentioned that about 30 minutes after receiving the vaccine her mother noticed that her lips, cheeks and knees felt prickly.  I spoke with the daughter again at 6:00 pm and she said that nothing had gotten worse.  I spoke with patient at 8:00 pm and she described the prickly feeling but she also mentioned that fer lips felt like they were slightly swollen as well as her tongue.  The swollen feeling she said happened earlier in the day, she was not sure exactly when, but after she received the vaccine.  At the time I spoke with her at 8:00 pm she said that the swollen feeling was not there.  I told her that if the swollen feeling returns that she needs to call 911. I stressed the significance of any kind of swelling in the mouth,tongue, throat and that if it got bad it could compromise breathing.  She did say that she was feeling better but if it got worse she would call 911.
ran a 106 fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (ran a 106 fever) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced PYREXIA (ran a 106 fever). At the time of the report, PYREXIA (ran a 106 fever) outcome was unknown. Possible    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, Body temperature: 106 f High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided by reporter. No treatment information was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Follow up received on 16-APR-2021 and it contains No new information.
Diagnosed  as Generalized Morphea.   Treatment included high doses of steroids & immunosuppressants. Symptoms: hard, oval-shaped patches on my skin on legs, arms, back. Time: This lasted several months with permanent skin scarring.
Tested positive for COVID-19 08/05/2021. Asymptomatic.
Information has been received from a physician concerning a patient who in June 2006, was vaccinated by mouth with the first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live.  Concomitant vaccinations included a dose of diphtheria toxoid (+) hepatitis B virus vaccine rHBsag (yeast) (+) pertussis acellular 3 component vaccine (+) poliovirus vaccine inactivated (+) tetanus toxoid. The physician reported that in June 2006, a half hour after being vaccinated, the patient began vomiting.  Unspecified medical attention was sought.  At the time of this report, the outcome was unknown.  Additional information has been requested.
swelling in my arm; I had lower back pain, it was excruciating.; Then the next morning the pain started radiating to my left leg. It was more like my left thigh; then the next morning the pain started radiating to my left leg. It was more like my left thigh; The pain was so bad I could barely walk; This is a spontaneous report from a contactable consumer or other non-HCP. A 70-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date (at the age of 70-years-old) as SINGLE for Covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient had experienced swelling in her arm. After that she had lower back pain, it was excruciating. She took some Motrin and it stopped hurting but then the next morning the pain started radiating to her left leg. It was more like her left thigh. The pain was so bad she could barely walk. It is going on 4 days now and she would like to know if this has been reported with the vaccine. Therapeutic measures were taken as a result of she had lower back pain, it was excruciating. The outcome of event the pain was so bad she could barely walk was not recovered. The outcome of other events was unknown.  Information on Lot/Batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Information has been received from a physician concerning a 17 month old female patient who on an unspecified date was vaccinated orally with the second 2 ml dose of ROTATEQ (Lot # not reported) outside of the recommended timeframe in the prescribing information. No adverse effect was reported. It was not specified if the patient sought medical attention. Additional information has been requested.
Mother called health department today, 4/14/21, to report reactions son experienced after receiving vaccine 3/4/21.  She stated that on 3/6/21 he started having headaches, weakness and leg cramps.  He went to the hospital two times with complaints.  On 3/15/21 he was unable to walk/drive because headaches were severe.  On 3/30/21 he passed out, squad was called.  He was not responsive and was put on a vent at the hospital.  A "scan" showed blood clots in brain and heart.  This individual passed away on 4/4/21.
Information has been received from a consumer concerning her daughter, a 15 year old female who in April-2008 was vaccinated with GARDASIL (unknown if this was the 1st or 2nd dose) and 01-JUN-2006, was vaccinated with the third dose of GARDASIL. The patient was the entire GARDASIL series. The mother reported that her daughter received the last dose of GARDASIL and her menstrual cramps have changed. It was about 15 days apart and a change in color; also she experienced severe cramps and pain in her legs. Her daughter cried over the severe menstrual cramps. No further information is available.
Pressure inside ear. Felt like ear infection "hissing" sensation in ear like swimmers ear. Lastn 30 min. (10 episodes). Resolved during night. (symptoms gone by 6/9/15).
By the end of the next day, I started having shooting pains in my left arm when I moved it.  I am still having these pains. I have sharp pains when I raise my arm or move it back and forth. I am in physical therapy now.
Swelling at site, hives at site, heat at site,  Fever x 3 days, Chills, General Malaise x3days, rigors, headache, muscle pain x 3days,
Son had regression of autism symptoms, including decreased language and eye contact, increased need for sensory stimulation, decreased attention and focus, increased night wakings.
I started getting a specific very unpleasant metallic smell (and to a lesser degree taste) to pistachios, peanut butter and to a lesser degree, almond butter. I also notice the same smell in my body odor and feces (which may be related to eating the above objects). These may be related in the sense that they are all dry roasted. I am an MD and have a PhD in immunology -I have looked at vaccine smell changes, and the best I can find is that changes in smell resolve after a few days. Mine has not diminished at all.
No Additional Adverse Events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 30-DEC-2019, the patient was vaccinated with an improperly stored (product storage error) hepatitis a vaccine, inactivated (VAQTA), (Therapy type: Digital Data Logger), lot number  S023499 and expiration date 24-AUG-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007:
This case was reported by a healthcare professional and described a pt who did not respond to the Engerix-B immunization series. The healthcare professional reported that several pts did not respond to the immunization series with Engerix-B, however, pt identifiers were no provided. On an unspecified date, the pt received a series of 4 doses of Engerix-B. On an unspecified date, a hepatitis B surface antibody titer indicated that the pt "did not respond" to immunization with Engerix-B.
Was given 3 shots on the right arm and developed swelling and erythematous rash front and back of the upper right arm- treated like Cellulitis.
This case was reported by a other health professional via call center representative and described the occurrence of generalized rash in a 4-month-old male patient who received INFANRIX (batch number 2N43Z, expiry date 12th April 2020) for prophylaxis. Concomitant products included HIB VACCINE, PREVNAR 13, POLIO VACCINE and ROTAVIRUS VACCINE. On 12th June 2018, the patient received INFANRIX .5 ml. On 13th June 2018, 1 days after receiving INFANRIX, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was recovering/resolving. It was unknown if the reporter considered the generalized rash to be related to INFANRIX. Additional information was reported as follows: This case was reported by a Certified Medical Assistant. On 12th June 2018, the patient received Haemophilus influenza B vaccine, PREVNAR 13, Polio vaccine and Rotavirus vaccine. The patient received INFANRIX on the right thigh. On 14th June 2018, the patient was seen for a follow-up doctor visit. On 20th June 2018, the patient was again seen for a follow-up doctor visit, in which it was reported that, his condition was improved. The healthcare professional was however unsure of the patient's current state at the time of reporting. No further information was reported regarding the event. The reported lot number (2943Z) for INFANRIX did not exist and was updated to 2N43Z, according to sales database.
10/20/2005 6pm reports tickle in throat. 6:45 pm reports dyspnea and tightness in chest, lightheadness, used albuterol MDI w/o relief. Went to Urgent care heart rate was 145 min. Was given an injectable steroid. Left urgent care 9:30 with HR of 112 minute.
adult vaccinated with pediatric dose; adult vaccinated with pediatric dose; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 47-year-old female patient who received HBV (Engerix B) (batch number F22EZ, expiry date 3rd June 2023) for prophylaxis.   Co-suspect products included HAV (Havrix) (batch number 2JD3Y, expiry date 4th December 2022) for prophylaxis and hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 21st January 2022, the patient received Engerix B .5 ml, Havrix .5 ml and Havrix Pre-Filled Syringe Device. On 21st January 2022, unknown after receiving Engerix B, Havrix and Havrix Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were 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: Additional Information: GSK Receipt Date: 05-APR-2022 Reporter comment: The reporter consented to follow-up via email. Other supportive information: An adult patient was vaccinated with a pediatric dose of Havrix and a pediatric dose of Engerix-B, which led to underdose and adult use of a child product.
Began with red spot just below injection site. (Raised & hot). Then stuffy nose & head. Dry cough. Patient treated symptoms w/OTC medications.
mom reported that pt was unconsolabe for 3 hrs; mom did not call the office;
5-10 minutes after administering the vaccine, patient started to gets swelling, hives on right shoulder around the site of the injection. No breathing problems. No other site on the body had hives or swelling. The attending Physician was alerted, by the medical assist. Dr. and the patient's mother discussed options on how to address the reaction. The patient's mother elected to have the patient take liquid diphenhydramine and to put ice on the shoulder as well. Patient was given 12.5 ml of liquid diphenhydramine orally and ice in a bag was applied to the site with ease. After 25-30 minutes the swelling and hives went down. Advised to call the clinic if hives or swelling returned OR to go to the Emergency Room if after clinic hours. Patient and mother voiced understanding. Questions were encouraged and answered. Patient and mother left office. N
The team was their for the Father's first dose but he was busy and the mother asked if her children could get vaccinated while they waited. The mother stated that this was everyone's first dose so they were all inputted as a walk-in for their first dose. When the RN was filling out their vaccination card for their first dose, the mother then stated that she already had a vaccination card  and that it was actually his second dose today. The mother first stated that they received their first dose on June 17th but actually it was July 17th.
Feeling warm; Sore injection site arm; Chills; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Feeling warm), INJECTION SITE PAIN (Sore injection site arm), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) in a 69-year-old female patient 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 FEELING HOT (Feeling warm), INJECTION SITE PAIN (Sore injection site arm), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, FEELING HOT (Feeling warm), INJECTION SITE PAIN (Sore injection site arm), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown.            Concomitant medications were not reported. Treatment details not provided. Action taken with mRNA-1273 in response to the events was not applicable.    This case was linked to MOD-2021-325855 (Patient Link).
This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 73-year-old female patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020). On 8th March 2018 16:35, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 8th March 2018, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms, insomnia and generalized pruritus. On an unknown date, the outcome of the influenza-like symptoms was unknown and the outcome of the insomnia and generalized pruritus were unchanged. The reporter considered the influenza-like symptoms, insomnia and generalized pruritus to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. In the evening on the same day, the patient experienced flu-like symptoms, insomnia and tremendous itching all over her body. The reporter was unable to provide additional details.
A non-serious spontaneous report of patient inadvertently given expired FLUMIST was received from a health professional concerning a 29-year-old male. Neither medical history nor concomitant medication was reported for this patient. The product expired on 29-Nov-2010. On 22-Dec-2010, the patient received expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information received on 10-Mar-2011 and incorporated into case: no late occurring adverse events.
patient started with soreness that escelated to red round raised area with swelling then progressed to a yellow purple color with red splotches about a 1.5" diameter looked more like jaundice color than a bruise. After turning yellow patient complained of itching.
Pt recv vax in 3/93; in 1993 pt exp limpness x 2dy, fever (104F), lethargy, regression; 4/96 pt exp decreased language skills; tx=physical therapy & special education
Dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Apr2021 13:00 (Lot number: EW0170) at the age of 42 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 24Apr2021, outcome "recovered" (01May2021), described as "Dizziness". Therapeutic measures were not taken as a result of dizziness.  The additional information: The second dose was received on 14May2021 at 14:00 intramuscular in  left arm Batch/Lot number: EW0168. Dizziness started 5 days after vaccination. The event dizziness lasted for 7 days.  No follow-up attempts are possible. No further information is expected.
The pt experienced hives 6 hours after injection over trunk, face, and extremities. 20 hours later with left thigh swelling with multiple hard 3 cm painful nodules over both legs. Left thigh girth 2cm greater than right thigh. Treated with Benadryl.
Approximately 4 hours following the injection I began to experience abdominal pain. After 12 hours, in addition to abdominal pain, I was experiencing low grade fever, chills, dizziness, and body aches. After 24 hours, I was experiencing the previously stated effects with the addition of vomiting that lasted until 34 hours after the injection.  Effects began to ease at approximately 48 hours  flowing the injection. At 60 hours following the injection, all adverse effects were gone.
Pt complaint of sore neck, blinding headache, upset stomach. Pain at back of neck. Symptoms onset 2 days after injection. Advice from doctor -> TYLENOL or ibuprofen. Warm compresses to neck. Cool compress to forehead.
Swelling of arm from shoulder to right above elbow, heated and very painful for approximately 4 days of right arm.
Lathargic, swelling across chess and under arm on right side, extreme burning in both forearms(veins), stiffness in neck, sinus burning, numbness in hands and feet, joint pain.
Tachycardia, facial flushing, dizziness, and back/neck pain within five minutes of vaccine injection. Because I?ve had anaphylaxis several times in the past, I know these are warning signs that my reaction is heading toward anaphylaxis. Rite Aid called 911 and EMT came ten minutes later. I took Benadryl and Advil immediately after my tachycardia started. My heart rate went back to normal by the time the EMT arrived because my Benadryl had started working. I was still flushed and dizzy with pain in my back and neck. I did not go the hospital or use epinephrine. For the next 12 hours at home, I took Benadryl and Advil every time my heart started racing.  12 hours after my allergic reaction started, all symptoms had stopped. I will not be getting a second dose of ANY Covid-19 vaccine.
chills; Tiredness; generalized body aches; fever 101.4; This is a spontaneous report from a contactable Nurse (patient). A 30-year-old non-pregnant patient female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EJ1686),intramuscular at Right arm on 06Jan2021 08:15 at single dose for COVID-19 immunization. Facility type vaccine was Hospital. Medical history included covid-19 prior vaccination. Concomitant medication included levothyroxine and multivitamin. The patient experienced tiredness, generalized body aches, chills, fever 101.4 on 06Jan2021 20:00. No treatment received.  Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
potential Bell's palsy; A spontaneous report was received from a 84-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was diagnosed with Bell's palsy.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 07-FEB-2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection. Approximately around 25-FEB-2021, the patient's face started to droop. She was unable to close her eyes. The patient went to the emergency room. The patient was diagnosed with potential Bell's palsy and was prescribed prednisone. The patient was asked to follow-up with the physician.  On 07-MAR-2021, the patient received their second of two planned doses of mRNA-1273 (lot number: unknown) intramuscular for prophylaxis of COVID-19 infection. The patient had an appointment with her physician on 15-MAR-2021.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of event potential bell's palsy was unknown.  The reporter did not provide the assessment for the event, Bell's palsy.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Moderna 3/20/21, 4/17/21, 1/25/22. Positive on 10/17/22
I had serve body ache, chill, and fever. Within 3 days, my left armpit lymph nodes swelled up. It got bigger as well. My lymph nodes are still swollen since my second dose in January. I was advised by my doctor not to get any booster shot.
Approx 1 week after vaccine, at 1230 a.m. was woken from sleep with severe leg cramps.  Cramps in both top of thighs at the same time.  Severity was off the chart and lasted for approx 30 minutes, could not stand or straighten legs to reduce pain.  Eventually wife applied heat pads and cramps reduced.  Cramps were so severe, caused profuse sweating and light head. Never have had cramps before and have not had since this episode.
Information has been received from a nurse practitioner concerning a 16 year old female patient who on 03-JUN-2008 was vaccinated with a dose of GARDASIL. Concomitant therapy included MENACTRA. On 14-SEP-2008 the patient delivered at 29 weeks pregnant. The status of the baby is unknown. Additional information has been requested.
15 min s/p varicella, DTaP - cough, wheezing. Given 0.01 mg/kg epi SC x 1 - resolved cough, wheeze (within 5 min). Vitals stable.
Multiple vesicles scattered over body, fever up to 103 F.  Diagnosis-Varicella.  Treatment-Acyclovir
Info has been received from a physician concerning a female pt who in approx Sept 2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. In approx Sept 2002 the pt developed cellulitis at the injection site. The pt was treated with antibiotics. It was also reported that one male pt developed cellulitis at the injection site (WAES #0212USA00380), one female pt developed cellulitis at the injection site in the left arm for 2 days (WAES #0302USA00556) and one female pt developed cellulitis at the injection site (WAES #0306USA02587). The symptoms of 2 of the pts cleared up without event. Two pts were seen over the weekend within "a day or two of injection" and at the time of this report follow up had not occurred. Additional info has been requested.
Vaccine administered into subacromial/subdeltoid space causing significant pain and limited range of motion of the left shoulder joint. This has persisted for several weeks with worsening pain over time.