chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Entire Body became "Flushed"; Redness at  vaccination site; Loss of appetite; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of appetite), FLUSHING (Entire Body became "Flushed") and VACCINATION SITE ERYTHEMA (Redness at  vaccination site) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031620A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included NAPHAZOLINE HYDROCHLORIDE (EYE DROPS [NAPHAZOLINE HYDROCHLORIDE]) for Glaucoma, AMLODIPINE, LISINOPRIL, PRAVASTATIN and HYDROCHLOROTHIAZIDE for an unknown indication.   On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced DECREASED APPETITE (Loss of appetite) and VACCINATION SITE ERYTHEMA (Redness at  vaccination site). On 10-Feb-2021, the patient experienced FLUSHING (Entire Body became "Flushed"). At the time of the report, DECREASED APPETITE (Loss of appetite), FLUSHING (Entire Body became "Flushed") and VACCINATION SITE ERYTHEMA (Redness at  vaccination site) outcome was unknown.            Treatment medication was not provided by the reporter.  Action taken with mRNA-1273 in response to the event was not applicable.; Sender's Comments: Very limited information regarding this events has been provided at this time.  Company assessed the events to be unlikely related to company product.
Shortly following vaccine administration, 9/25 right arm at DTaP site developed swelling and redness. Child received Motrin and Benadryl on 9/26 and advised to continue PRN with cool compresses.
Patient received 2 doses of the pfizer bivalent vaccine during the same visit. Patient did not present with any signs or symptoms during the next 30 minutes after administration
Patient states left started to hurt this morning around 10:00 am and noticed arm redness, swelling, and pain. States it is pain of left arm and soreness. Left upper arm is red with small amount of swelling, slightly warm to touch. Referred patient to her private doctor. Appointment on 6-12-13 at 3:50 pm. Instructed pt to use warm compresses to area.
Covid vaccine today and rapid response called as about 5 min later, patient felt "tight breathing" and then msucle became weak. States put head back and woke up to look for help. Epi IM 0.3mL given
103 degree temperature, chills, headache. Took 1000 mg acetaminophen every 6 hours. Fever broke after initial dose of Tylenol only to come back after 3 hours.
About 10 minutes after receiving Pfizer Covid-19 vaccine, patient started feeling throat tightness. As she was being assessed by medical staff, her face began to itch. She had visible flushing, and facial/lip swelling. Epipen was used and squad called to transport to the local ED.  The hospital gave her steroids and antihistamine treatment and kept her several hours for observation. On 3/29/2021, patient reports she has been fine since release from the hospital, other than typical vaccine side effects (achiness, arm soreness).
Flu-like symptoms.  Fever of 101, severe sore throat, body aches, chills, sinus and nose congestion.  Symptoms lasted for 10 days.
I felt sick very tired and sluggish, fever of 102, nauseated, all lasted for 2 days. I had pain at the injection site. In June at an annual appointment a nodule was discovered on my thyroid. It was 3 cm, a biopsy and ultrasound was giving. The results were benign.
A report received from a healthcare professional on 05Nov02, concerning a female vaccinee in her fifties who experienced an injection site reaction the morning after receiving Fluvirin on 01Nov02. On the morning of 02Nov02 the vaccinee complained of redness, itching, and burning at the injection site. No medical intervention was required since the symptoms were self limiting. The symptoms resolved within one day and the pt has recovered. There was insufficient information to determine the reporter's causality assessment. See Ref: PJP200200682, PJP200200683, PJP200200684, PJP200200686.
Broke out in hives on left leg. Had other small area with hives throughout the body but mainly left leg.
peripheral neuropathy; This is a spontaneous report received from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 09Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient experienced peripheral neuropathy on an unspecified date with outcome of unknown. The patient received the 1st dose of the vaccine on 09Mar2021. He mentioned that he had peripheral neuropathy and had read on a website that people experienced new or worsened neuropathy after getting 2nd dose of the vaccine. He was scheduled for his 2nd dose on 30Mar2021 but was considering to not get it because of the articles he had read. He was asking for any live documentation on Neuropathy outside of the clinical trials. The case was assessed as non-serious.   No follow up attempts needed. Information about lot/batch number cannot be obtained. No further information expected.
Blurred vision even in Daytime/ Vision was blurred; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), on 13Oct2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN, Batch/ Lot number unknown), for COVID-19 Immunization. The following information was reported: VISION BLURRED (non-serious) with onset 14Oct2021, outcome "not recovered", described as "Blurred vision even in Daytime/ Vision was blurred".  Additional Information: It was reported that after taking the second Pfizer COVID-19 vaccine, the patient woke up the next morning and his vision was blurred for about 5-10 minutes. It happened every morning and even in day time, patient experienced blurred vision. The patient enquired if he will lose his vision and also enquired if these symptoms were common.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300134304 Same patient, same reporter, same product, different dose, different events;
Initial unsolicited report received from health care professional (nurse) on 14-Jul-2017. This case was linked to 2017SA107230. This case involves 60-year-old male patient who was vaccinated with a dose of TYPHIM VI (Batch number: M1572, expiration date: 24 Oct 2018, dose was not reported) via intramuscular route in left deltoid on 07 Jul 2017. The patient had a medical history of asthmatic and had restless leg syndrome. Concomitant medications included Trazadone 75 mg via oral route for restless leg syndrome and Albuterol inhaled for asthma. On 07 Jul 2017, same day following the vaccination, the patient experienced generalized weakness and malaise. On same day, the patient also had neck and back pain, dizziness, increased tiredness, had increased need of sleep, led stiff and weak. Patient had no fever, HA, SOB and localized reactions. Lab data and corrective treatment were not reported. The patient was recovering (resolving slowly) from the events. It was reported that, there was marked improvement from July 13 to July 14. List of documents held by sender: none.
The patient received a dose of Prevnar 13 on 09/19/2015 and again on 10/08/2019 when they should have received a dose of Pneumovax 23 instead.
tiredness - uncontrollable shaking, chills then would get hot, sweating, muscle pain, nausea, headache, pain at injection site.  Lasted from about 11:15PM until 8:00AM - still have a migraine very sore  - muscles are sore to touch and ache  I have been taking motrin, imitrex and phenergan for the nausea.
Patient was alert, ambulating in hallway. Patient a sudden, unexpected death in her sleep. Most likely suspect pulmonary embolis. However, patient has no pre-exisiting condition to explain this sudden death
This spontaneous report was received from a physician concerning an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 01-FEB-2017 and on 02-FEB-2017, the patients were vaccinated with an improperly stored dose of VAQTA (lot number M033611 and expiration date 02-MAR-2018, dose and route were not reported) for prophylaxis. The temperature exposure was from 8 Celsius degrees to 25 Celsius degrees for 2 hours and 23 minutes. There was not previous excursions or data logger involved. No adverse effects were reported. A product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA003523:Original Case: 1702USA001003; US-009507513-1702USA003522:Original Case: 1702USA001003; US-009507513-1702USA001003:Original Case: 1702USA001003; US-009507513-1702USA003521:Original Case: 1702USA001003.
Headache. Uncontrollable shivering.  Fatigue.  Intermittent sleep.
Onset on same day as injection of cellulitis of rt thigh surrounding injection site. Fever to 103. Hospitalized & tx w/ IV antibiotics.
Palpitations, severe headache, nausea and fatigue day following vaccination with Moderna covid vaccine #2 on 7/14/21.  She presented to ED on 7/17/21 with improving palpitations.  Headache resolved.  EKG normal.  Trop neg.  Mg 1.7.  K 4.0.  TSH sl elevated 3.799 with normal free T4 0.94.  No treatment recommended.  Observation.
Patient received the covid vaccine dose # 2 on 01/09/2021. c/o fever (temp 99.9) , body aches, diarrhea x 3, and Right axillary lymph node started 4 hours after the injection  on Right arm on 1/9/2021.   Diarrhea resolved on 1/10/2021. Still has body ache and right axillary lymph node.  Denies chills, sore throat, cough, or HA.
fever; fatigue; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), FATIGUE (fatigue) and NAUSEA (nausea) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced PYREXIA (fever), FATIGUE (fatigue) and NAUSEA (nausea). At the time of the report, PYREXIA (fever), FATIGUE (fatigue) and NAUSEA (nausea) had not resolved.            Concomitant medications were not provided. Treatment medications were not provided. Action taken with mRNA-1273 in response to the events was not applicable.
pt recv vax 19FEB97 & 29MAY97 pt devel a rash consisting of 5 lesions;
This case was received from a health care professional via another manufacturer (case ID number 2009S1013958), on 13 August 2009. A 14-year-old male patient, with no reported medical history, received TDAP (manufacturer reported as sanofi pasteur) and Amnesteem (Mylan Pharmaceuticals); lot numbers and dates of administration not reported. He subsequently experienced dyspnea and hives. No additional information was reported.
This spontaneous report as received from a pharmacy student refers to a unspecified number of patients of unknown age. On an unknown date the patients were vaccinated with PNEUMOVAX23 dose, route and lot # not specified. On an unknown date after the use of PNEUMOVAX23 the patients experienced cellulitis. The outcome of cellulitis was unknown. The relatedness between PENUMOVAX23 and adverse events was unknown. Additional information has been requested.
face turned puffy; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided) solution for injection, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter was asking if the second dose of the vaccine should be taken if you experienced a reaction after the first dose. It was reported that the patient's face turned puffy on an unspecified date. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
She got her vaccines (Shingrix and 2nd booster).  That evening she got dryness in her mouth, now has burning pain, throat is burning, tongue is burning and her eyes are burning, foggy and is getting much worse.  She does not know what to do.  She told her doctor about it who does not know what to do.  She was tested for Sjogren's, and her dentist told her to try Biotine.  She takes a little ice and nothing helps.  It is very difficult for her.   She cannot live like this she said.  It has progressively gotten worse and the past 2 months have been the worst.   She wakes up catching her breath from it.  She did not have any of these symptoms prior to the vaccine.   She has never had dryness in her mouth before.  She had to stop taking the sprays for her COPD and her asthma as it makes the symptoms worse.  She cannot eat anything citrus oriented as it makes it worse.  She has to limit a lot of foods due to the reaction she gets from them and hardly eats anything and is loosing weight.   She has lost her taste as well.  Her lips are cracked, she has sores all over her mouth.  She went to an ENT and they could not do anything for her.  She is very thirsty all the time, but due to her kidney disease she cannot take in a lot of fluids.
12/4/21- patient fainted after his 2nd Pfizer Pediatric dose. I turned around to throw away the band aid wrapper and alcohol swab and he fainted at that time.  Dad stated he thought patient was just bending down and he ended up falling off the chair.  I am unsure if he hit his head(but dad thinks he did).  Patient quickly came to and sat on dads lap breathing fast at first and then started to slow his breaths and started to feel better.  After feeling better, patient stated he felt light headed right after I gave him his vaccine.  Dad and patient stayed in the counseling room with me for an additional 15- 20 minutes and then went out in to the waiting area for an additional 15 minutes to make sure he was okay. Dad did say that patient was worried about trying to get home for getting on to play game at a certain time and it was already past that time.  I did inform his Dad to make sure he informs anyone giving patient a vaccine in the future that he has had an episode of fainting before.  I called later that night on 12/4 at 6:26pm  to check in on patient, but I had to leave a message.  I remembered that patient has a wrestling tournament tomorrow and probably wouldn't be able to reach him the next day.  On 12/5/21, mom and dad came in with patient and stated that he was fine the rest of the evening and was doing well today also.
Moderna vaccine is not approved for under the age of 18. Patient does not turn 18 until 7/17/2021.
Pt experienced a papular rash on right upper extremities and back, 1 day post Anthrax vaccine. Resolved with oral Benadryl, no sequelae.
AEs lasting <48 hours: moderate headache, moderate nausea, severe fatigue, severe diarrhea, mild fever, insomnia, moderate flushing, moderate joint aches, severe muscle aches, mild facial tingling, severe arm pain at injection site, severe shoulder joint pain on right (injection) side, severe pain in the armpit with and without use of the arm, moderate cough, moderate dizziness, mild hot flashes, moderate chills, severe brain fog. AEs lasting <2 weeks: mild headache, mild fatigue, moderate diarrhea, mild joint aches, moderate arm pain at injection site, moderate, shoulder joint pain on right (injection) side, moderate pain in the armpit with and without use of the arm, mild dizziness, moderate brain fog. AEs that have not yet resolved:  recurring diarrhea, mild joint aches, mild arm pain at injection site, mild shoulder joint pain on right (injection) side, moderate pain in the armpit with and without use of the arm, mild dizziness, mild brain fog.
24 hours after - Swelling in neck, lump in throat, tightness in chest, shortness of breath 6 days after - Left chest pain, tightness in chest, shortness of breath.
This spontaneous report was received from a licensed practical nurse and refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, concomitant medication and medical history were not provided. On unknown dates, the patients were vaccinated with unspecified number of improperly stored doses of VARIVAX, lot # reported as M105731, expiration date 30-MAR-2018 and lot # M009766, expiration date 23-FEB-2018 (dose, route and site of administration were not reported) for prophylaxis. No adverse effects were reported. Product quality complaint was not involved. The administered doses of VARIVAX were stored in the temperature of 10 degrees Fahrenheit for 3 hours and in the temperature of 14 degrees Fahrenheit for 17 minutes. Data logger was involved. At the time of reporting, no further information was available. Lot number M105731 is an invalid lot number for VARIVAX. Follow-up information has been received from the licensed practical nurse on 12-DEC-2016. It was reported that since 03-NOV-2016, there had been no adverse effects reported. Additional information has been requested. Narrative had been updated. Sender's Comments: MERCK 1611USA001989:Mfr number.
got Shingrix shot #1 on 20-Jan-2020 / has not yet received shot #2; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose on 20th January 2020 intramuscularly in an unspecified arm).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter was the patient.  Till the time of reporting, patient did not received 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter stated that,the patient had passed the 6 months window. The reporter did not want to share MD contact information. The reporter did not consent to follow up.
Severe pain at injection site, neck and down left arm, bruising, swollen lymph notes in L neck.
A crown of very watery blisters appeared at the top of my head. A rash developed across my forehead a few days later that still persists. The area between my eyebrows swelled to give a "lioness" appearance to my eye area. A few weeks after a blurring developed in my right eye that I had check out and it was said to be an "odd" type of cataract. The blurring persists.
Patient developed redness, warmth, swelling and pain on injection site on 10/5/2019. She applied ice pack over her arm and the swelling slowly went down over the last few days.
AFTER ADMINISTRATION PATIENT FELT PASSING OUT.  ANXIOUS,  TURNED EXTREME PALE, SWEATING, SHAKING,  NOT ALERT,  SHOWED SIGNS OF FAINTING, CALLED 911. OBSRVED ALL TIME . PATIENT STARTED FEELING BETTER AFTER 10 MINUTES .  ALL VITAL WERE NORMAL EXCEPT BP WAS LO W.  PATIENT DID NOT REMBEER WHOLE EPISODE WHEN GOT BACK TO NORMAL.
Systemic: Fainting / Unresponsive-Mild, Additional Details: PT fainted shortly after receiving COVID vaccine. PT and mom reported after fainting that patient has a fear of needles and has a history of fainting after having blood drawn. Patient was observed for an additional 15 minutes before leaving and both PT and mom reported she felt fine and declined emergency medical attention.
- Muscle/body aches  fever, started on Monday, missed work on Tuesday due to sx - better by Thursday & Friday.
Initial and follow up information has been received from a registered nurse for the Pregnancy Registry for GARDASIL concerning an 18 year old female who on 06-AUG-2007 was vaccinated intramuscularly in the deltoid with the first dose of GARDASIL (lot # 657622/0388U). It was reported that at the time of vaccination the patient was not pregnant. It was reported that the patient's last menstrual period was on 01-AUG-2007 and not on 01-AUG-2006 as it was previously reported. Four weeks after vaccination the patient was involved in a motor vehicle accident. After the motor vehicle accident the patient found out that she was pregnant. The pregnancy was confirmed (method unknown). At the time of the report it was unknown how far along the patient was in her pregnancy. On 12-JUN-2008 a telephone call was made to the doctor's office to obtain pregnancy outcome information and a message was left. On 13-JUN-2008 the nurse called back and reported that the patient "had a miscarriage early on in her pregnancy." She had no further information. Upon internal review patient having a miscarriage in her early pregnancy was determined to be an other important medical event. Additional information has been requested.
1035AM immed p/vax pt appeared faint became pale; became ridged w/elbows, wrists, hands & fingers flexed to chest; never cynotic; 911 was called; BP 90;/40, P28 & R36; remained unconscious approx 30-45seconds; c/o h/a, nausea & dizziness;
Error occurred when administering a dose of Pfizer Bivalent vaccine. Clinic staff did not dilute vaccine vial prior to administration and so patient received concentrated vaccine. Estimated dose administered ~28 mcg rather than intended 10 mcg.  Patient/caregiver did not report any adverse event.
Red rash below injection site, size of a quarter, warm to touch, itchy, no pain,  started 7 days after injection was received, grew in size daily. Resolved after 1 week.
This spontaneous report was received from a Medical Assistant referring to a 4 year old female patient. The patient's concurrent conditions and medical history were not reported. There was no concomitant medication reported. The Medical Assistant reported that on 06-JUL-2018, the patient was vaccinated with a dose of MENACTRA (dose, route and anatomical location were not reported, lot number U5984AB, expiration date 14-AUG-2019) instead of intended M-M-R II (lot number and expiration date not reporte) both for prophylaxis. No adverse effects were reported.
This spontaneous report was received from a certified medical assistant concerning a child patient (reported as pediatric) of an unknown age and gender. Medical history and concurrent conditions were not reported. On 08-JAN-2015, the patient was vaccinated with a dose of MMR II (dose, dose number, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. The certified medical assistant reported that on 28-JAN-2015, the patient developed a rash. At the time of the report, the outcome of the rash was unknown. Additional information has been requested.
pt is stating that her arm is still sore 1 month after vaccine, and not full range of motion. She came in today 2-3-2021. I suggested that she put heat on area and try aleve/ or ibuprofen for a few days and see how i is. I will follow up with her in a few days