chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Subsequent to receiving first and second doses of varicella virus vaccine live pt laboratory evaluation indicated varicella antibodies of 0.46. It was also reported that the pt was exposed to chickenpox and has not developed rash or virus.
Around 5PM on 4/01/2021, I started experiencing some congestion. Didn?t think anything of it. Around 4AM on 4/02/2021, I woke up with a headache that was a 8 on a scale of 1-10 which is not normal for me. I drank some water and tried to go back to sleep but was super uncomfortable. My left arm was very sore. My nose was very congested. I tried adjusting sleeping positions but that did not help. I had some chills.
Case number PHEH2013US021736 is an initial spontaneous report received from a health care professional on 16 Oct 2013. This report refers to a 16-year-old female patient. Her vaccination history included administration of MENVEO (batch number: unknown) on 23 May 2007, which was well tolerated. She was further vaccinated with MENVEO (batch number: A11082) at a dose of 0.5 ml intramuscularly in to left deltoid on 15 May 2013 at 13:45. It was reported that the patient administered the vaccine that was compromised due to refrigeration malfunction. No adverse event was reported following the medication error. Revaccination will be done at next appointment.
Patient became lightheaded; dizzy following injection. Patient was laid down on floor with legs elevated on chair. Patient was given water. Patient's mother did not disclose that patient has dizzy, syncope eoisodes with previous injections/blood draws. Patient recovered on floor [25 minutes]; then in chair for 15 minutes; then standing for 10 minutes. Patient was walked out to car with HR Support staff and mother.
Patient was sitting in chair beside this RN as she was finishing up paperwork, patient started to look pale and kind of blinked his eyes hard, this RN asked if he was ok, patient stated that he was feeling "funny" like lightheaded. This RN said lets get you in another room and lay you down. Patient went with RN and friend who was with him. Patient laid down and vitals were taken at 5 minute interval until vital were within normal range and patient stated he was feeling better. This started at 16:30 and Patient was able to leave on his own accord at 16:50.
12/29/2020 Extreme Fatigue, headache, bodyache, sore arm x 48 hr after injection, resolved after 48 hrs.  On 12/30/2020 had deep purple blue ring around injection site.   On 1/4/2021 arm became sore again, large area of deep redness.  MD visit on 1/13/2021 10x11cm redness continued.  1/14/2021 redness continues at time of report.
On 10/15/99, L/arm was very swollen, tender & warm to touch and large area of redness. "Can't lift arm high enough to open car door". Pt returned on 10/18/99, but wasn't able to wait. Messages returned from pt, states "much better".
Around 06:00 pm, which was about 9 hours after having received the J&J vaccine, I began having a slight fever and chills.  The most pain I had was in the back of my legs.  Both of my calves felt as if they had both been kicked and were badly bruised.  It was painful to walk for about 48 hours/2 days (Sunday - Monday).  That was the first time in my life that I had that kind of pain in my back calves.  Never had before from running or walking.  Then around 09:00 pm on Tuesday, a reddish dot appeared on the left side of my cheek.  I thought it was just a big zit.  But the following day, the dot got bigger, and looked like a scratch.  On Wednesday, it was definitely a scratch-like shape (2 lines, less than an inch long) and had begun to feel itchy.  That was when I had realized that it had the same pus-like dotted features of a cold sore.  But oddly, it's not right next to either side of my lips.  Instead, it is further down, towards the left side of my chin.  It is very rare for me to get cold sores.  I can't remember when my last one was, as it was years ago.  So I am wondering if this cold sore is due to having received the vaccine.  The fever, chills, and leg pain have not returned after those first 2 days.
Patient experienced redness, itch, and warm to touch around the injection site. Occurred during both injections. Also reported sleeping for 2 days, fever, and vomiting.
Fever, chills, headache, upset stomach started at 1am. Unable to sleep until 3:45am. Woke at 7am with temp of 99.2 and chills, headache. It is now 10:15am and fever is gone but headache remains.
Fever; Swollen lymph Nodes; Swollen arm; Painful Arm; Muscle aches; Weakness; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in left arm on 21Jul2021 at 09:45 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to the vaccination, it was unknown whether the patient diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medication within two weeks of vaccination. The patient had no known allergies to food, medication or other products. On 22Jul2021, the patient experienced fever, swollen lymph nodes, swollen arm, painful arm, muscle aches and weakness. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. No therapeutic measures were taken as a result of adverse events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events, fever, swollen lymph nodes, swollen arm, painful arm, muscle aches and weakness were recovering at the time of this report.
Site of vaccine very tender, tenderness increased to touch, swollen, red; oval shaped redness developed larger than large egg in size and shape. After several days, soreness and swelling subsided; site became itchy. Redness last to subside as became lighter in color over about two weeks. Otherwise, had fleeting nausea evening of vaccine and tired.
COVID 19 POSTIVE ON 7/21/2021 , HIGH FEVER, HEADACHES, BODY ACHES FATIGUE, LOSS OF TASTE, SMELL , COUGH, HARD TO BREATHE, THEN ON 8/2/2021 TO 8/5/21 RECEIVED INFUSIONS.   OUT OF WORK UNTIL 8/10/2021.    ONGOING ISSUES WITH EXTREME FATIGUE, BODY ACHES HEADACHES, NIGHT SWEATS, COUGH, DRY  MOUTH, DOCTORS SAY LONG HAULER./XOVID LONG.   IT IS  OCTOBER AND I AM STILL EXPERIENCING ISSUES.
DRUG EXPOSURE VIA BREAST MILK; This spontaneous report received from a parent by a Business partner (Pfizer Inc.) was received on 12-NOV-2021 and concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient's parent received covid-19 vaccine ad26.cov2.s (suspension for injection, transmammary, batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced drug exposure via breast milk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of drug exposure via breast milk was not reported. This report was non-serious. This parent/child case is linked to 20211136270.
Patient described painful arm since having the injection 19 days ago. She said the pain has progressively gotten worse over the weeks until today she was having a hard time putting clothing over it. She said the pain begins towards the shoulder bone area and radiates down the arm when she moves it. She mentioned she thought it was bursitis from doing her own online investigation and described the injection site seeming to be too high on the arm, more toward the shoulder joint instead of the center of the deltoid.
pt recvd vax;lt deltoid red,hot & swollen at inject site since vax;to er; dx:rxn to tetanus shot, poss cellulitis; no further tx given;
Pfizer-BioNTech COVID-19 Vaccine EUA, beginning on 3/17/2021 I began to feel fatigued and my legs felt tired and heavy and I had headaches and felt light-headed, then on 3/25/2021 I developed a fever of 102 degrees and had chills and my whole body ached, I contacted my doctor  who sent me to the ER for evaluation, the ER tested me for COVID-19, and Influenza type A and B and I was found negative on these tests, they sent me home and instructed me to take Tylenol, drink fluids and relax and follow up with my doctor, I spoke to my doctor the next day and he told me that I was most likely having a long term reaction to the vaccine, I began to feel some better and went back to work but on my first day back  4/5/2021  I started to feel bad again, I told my manager who sent me to the company OHS where I was told I had to do a physical which included lifting 50 pound and carrying it around many times this made me feel even worse, they sent me home for three days. I went for second dose on 4/7/2021 and was feeling some better so I went back to work on 4/12/2021 however since then I have still been experiencing symptoms such as: first, heaviness in my forehead which has now spread to my whole face and I continue to have occasional chills and light-headedness also since doing the lifting of the 50 pounds during the physical I have occasional aching in my abdomen  and I'm having cold sweats and don't feel myself.
Redness and swelling to vaccination site. (L) lower extremity, afebrile.
pt received vaccine on 1/26/23. Called hospital advice line reporting palpable half fist size of soft lump on left arm pit in this morning 1/26/23 and he feels burning sensation 7/10, pain 2/10 at this time.  Proceed the assessment with covid 19 vaccine side effect screening questions. Noted pt has no emergency s/sx at this time. Pt was advised to follow-up with ED for further evaluaiton.
This case was reported by a pharmacist via sales rep and described the occurrence of pruritus in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced pruritus. On an unknown date, the outcome of the pruritus was unknown. It was unknown if the reporter considered the pruritus to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient had severe itching. The reporter did not feel comfortable administering the 2nd dose of SHINGRIX. The reporter agreed to be follow up.
Hospitalized with the following. Fever, chills, nausea, shaking, vomiting
Fever, malaise, body aches, diarrhea, leg cramps, severe pain at site of injection, superficial ulceration at site of injection, itching on left arm, redness. Treatment: Tylenol for pain, wound care with bacitracin/bandaid, Benadryl for itching, comfort care such as rest, fluids and position of comfort for the arm.
This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm and mobility decreased. On an unknown date, the outcome of the pain in arm was unknown and the outcome of the mobility decreased was recovered/resolved. It was unknown if the reporter considered the pain in arm and mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The date of birth of the patient was unknown. The age at vaccination was not reported. The pain was so bad that the patient could not raise her arm for 4 days. It hurt more than any other vaccine which the patient had received. The reporter agreed to be contacted for follow up.
Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patient's concomitant medication, medical history and drug reactions/allergies were not reported. On unspecified dates, the patients were administered improperly stored doses of GARDASIL 9 (lot # L024993 with expiration date 17-OCT-2017; dose and route were not reported). The vaccines were exposed to 1 degree Celsius (C) for 60 hours and 90 minutes. A data logger was used to log temperatures, and there were no prior excursions. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient pre-screened and given 1st dose of Pfizer vaccine then transferred to the post vaccine waiting area.  After 15 minutes patient was on his way to the car and accompanied by mother and sister.  At exit threshold patient reported "feeling woozy" and fell forward onto his face possibly chipping 2 teeth.  Patient's mother rolled him to a supine position and called for help.  Upon arrival this RN instructed mother to lower head.  2nd RN,  arrived and elevated feet.  Pt responding to verbal stimuli, unable to recall syncopal episode but otherwise oriented to person, place, time, and all events leading up to episode.  During assessment patient stated he works outside and has been participating in football conditioning/practice outside and not drinking enough fluids or replacing electrolytes.    Mother confirmed.  Vital signs taken and as follows: HR 74, Bp 86/70, SpO2 100%,   Pulse strong and regular, breath sounds clear on auscultation.   No generalized redness, rash, or hives.  Patient denies shortness of breath.  Snack and juice provided.  After 10 minutes patient reports improvement and was assisted to an upright position.  No dizziness or lightheadedness reported.  Patient assisted to a standing position prior to  being seated in a wheelchair.   Patient wheeled to and assisted to personal vehicle driven by mother who took the patient to  Emergency Room across the street.  Assisting RN,, called report to receiving ER.
5 years old male came for vaccination. DTaP-IPV, HEP B Varicella. No previous medical history, no known allergies. Vaccines given. Few minutes later baby developed severe urticaria with swelling of face/lips. Heart rate 140-160. Immediate epinephrine given x 1 reaction observed . Vital signs became stable. Was sent to ER for further observation.
This spontaneous report as received from a pharmacy technician refers to a 4-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported. On 08-FEB-2018 the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry date: 23-AUG-2019) (dose, frequency and route were not reported) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1802USA001558.
Information has been received from a bachelor of science in nursing concerning a 15 year old female patient who on 23-JUN-2010, was vaccinated with the first dose of GARDASIL (Lot# 663551/1498Y) and on 29-SEP-2010, the patient was vaccinated with the second dose of GARDASIL (Lot# 663551/1498Y) with no concomitant vaccination administered at that time. It was reported that on an unspecified date, the patient experienced anaphylactic reaction and difficulty breathing after her second dose of GARDASIL. The patient's parent called the physician's office and stated that on 30-SEP-2010, the patient had developed a severe rash and hives at the injection site and all over her body. The patient went to the Emergency room. The patient had a topical reaction and was advised not to get another GARDASIL vaccination. The treatment that was given to the patient was unknown. On an unspecified date, the patient went to her primary care physician who stated that the patient had an allergic reaction to GARDASIL. The bachelor of science in nursing stated that the patient's chart was flagged indicating that the patient had an allergic reaction to GARDASIL. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
redness; rash under breast; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash under breast) and ERYTHEMA (redness) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. MRN0300183274) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (rash under breast) and ERYTHEMA (redness). At the time of the report, RASH (rash under breast) and ERYTHEMA (redness) outcome was unknown. On 12JAN2021, the patient's husband phoned the call center to report events, "wife received the Moderna vaccine as the first shot yesterday 11/JAN/2021 in the left arm at 1:pm as the first dose and developed a rash under breast and redness."      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Follow up; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
2.5 in x 2 in area of redness and swelling at site, (+) tender, seen at 48 hrs post vx, gradually began resolving at 72 hrs post vx.
Mild fever; muscle and joint pain; muscle and joint pain; malaise; This is a spontaneous report from a contactable consumer reported that a 77-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; age at the vaccination 77-year), via an unspecified route of administration, in right arm on 02Feb2021 12:15 as single dose for covid-19 immunisation. Medical history included covid-19 (prior vaccination). The patient's concomitant medications were not reported. Patient had allergies to penicillin. The patient not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient been not tested for COVID-19. On 03Feb2021, patient had Mild fever, muscle and joint pain, malaise. The reported seriousness was non serious. Patient not received treatment for the adverse events. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Tender, red macule, approximately 24 hours after Varicella vaccine administration.  Temperature 99.4.  Macule = 6 cm consistant with cellulitis.  Patient will be treated with Augmentin, 4 mg PO BID.
pt recv vax 27SEP96 & the day p/vax pt cried easily, was tired, slept a lot, exp a loss of appetite;
4/14/03 - 4/15/03 Began to experience URI symptoms. 4/16/03 Chest tightness and congestion started in addition to other symptoms. 4/17/03 Went to physician and was admitted based on abnormal EKG which showed PVCs and bigeminy. No known etiology. 4/19/03 Discharged from hospital. Following 24 hr course of beta-blockers problems resolved.
Information has been received from a registered nurse concerning a 36 week old patient who was vaccinated PO with dose three of ROTATEQ. No symptoms were noted. There was no product quality complaint. Additional informtion has been requested.
Temperature, terrible muscle. aches / spasms - from hip to foot., sore on top of foot - left side only
PATIENT STATED HE WAS FEELING DIZZY ABOUT 5 MINUTES AFTER RECEIVING THE VACCINE. I INFORMED HIM TO STAY SEATED IN THE CHAIR AND GOT HIM A BOTTLE OF WATER. I ASKED HIM IF HE WAS FEELING ANY BETTER AND HE SAID HE WAS GETTING HOT AND WANTED TO TAKE HIS JACKET OFF. HE SAID HE STARTED GETTING HEART PALPITATIONS AND HE SAID HE CONTRACTED HIS WIFE AND SHE WAS EN ROUTE.  HE TOOK HIS JACKET OFF AND SAT BACK DOWN. HE THEN STARTED TO LOSE CONSCIOUSNESS SO I RUSHED OUT AND TOLD MY TECHNICIAN TO CALL 911. SHE CALLED AND I STAYED OUT THERE WITH HIM TRYING TO WAKE HIM AFTER HE WAS UNCONSCIOUS. HE WAS UNCONSCIOUS FOR ABOUT 20 SECONDS AND I WAS CHECKING HIS PULSE AND HE STILL HAD A PULSE. HE THEN WOKE UP AND AND SAID HE WAS STILL NOT FEELING RIGHT. I INFORMED HIM HE PASSED OUT FOR ABOUT 20 SECONDS AND WE CALLED 911 AND THEY WERE ON THEIR WAY.   THE AMBULANCE ARRIVED AND TOOK OVER AND GOT HIS VITALS AND SAID THEY WERE GOOD.  PATIENT STATED HE DIDN'T WANT TO GO WITH THE PARAMEDICS.
Appro 25 min after rec'ing H1N1 vacc pt stated felt very hot, sat down looked pale. Pt passed out, eyes twitching, legs/arms felt felt heavy. Regained color, sat up, vitals ok. Felt syncopalagairc and passed out. Ambulance called. Spoke to pt - advised by ER = possible reaction to vacc.
AMBULANCE RIDE TO HOSPITAL COULD NOT BREATH HARD CHEST PAINS; FAINT; DIZZY; NAUSEA   STARTED ABOUT 2PM HOSPITAL ADMINISTERED SEVERAL TREATMENTS  HEART RATE WAS OVER 200 STAYED AT 134 TILL ABOUT 1:40  AM SUNDAY MORNING
Extreme fatigue--slept for over 24 hours after receiving vaccine Shortness of breath Dizziness Irritable diarrhea the first day Had to leave work the next day as dizzy and unsteady and diarrhea