chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Additional Details: ABOUT 5 MIN AFTER THE PFIZER (GRAY CAP) WAS GIVEN, PT. COMPLAINED ABOUT NAUSEOUS AND PT. REFUSED TO OPEN HER EYES, CONTINUE TO MAKE HERSELF NERVOUS THEN HER HAND GOT COLD, SWEATING, NOT RESPONDING BUT STILL BREATHING. DAD CALLED PARAMEDICS-GOT HERE IN 10 MIN, ALL THE VITALS (BP,BS,HR) WERE NORMAL. PT. WAS TOLD IT CAN HAPPEN DUE TO ANXIOUNESS AND UNDER STRESS SITUATION. PT. AGREED THAT SHE WAS STRESSED ABOUT SCHOOL AND WAS VERY NERVOUS ABOUT GETTING A SHOT. PARAMEDICS INFORMED DAD TO TAKE HOME.
Patient experienced significant swelling of arm, back, and facial region, headache, reports kidney pain and lip and throat numbing, as well as  overall body aches. Patient took Benadryl 50mg to reduce swelling with success. Symptoms subsided completely after 4 days.
Arm soreness  Swollen lymphnodes under arms Fibromyalgoa like symptoms that wrap around my chest and back.
Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 64 year old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On unspecified date in April 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a physician for the event. The outcome of herpes zoster was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Extreme pain in arm. Could not raise above my head. On the 29th suffered widow maker heart attack. After that, arm felt normal.
Fever, chills, muscle aches, headache, nausea, vomiting, constipation, sore throat, cough, congestion
Redness, swelling and induration 3cm X 3cm on left upper thigh (we don't know whether DTAP or IPV site). At 4 days, post vax, not recovered.
Pt recv vax on 10/10/98; on 10/11/98 pt exp fever, (101F), swell/ pain at vax site; 10/12 pt exp pain in fingertips; pt imp 10/15/98
Patient was given vaccine, and in 5 minutes she walked up to the counter and stated that she felt as if her tongue was tingling.  At that time, my technician spoke to her and reported the event to me.  She was able to swallow and when I looked at her tongue and throat, there was no swelling present.  Patient was given diphenhydramine 50 mg at that time, and I sat her in a chair that had arms on it.  I proceeded to put a pulse ox on her.  Her O2 sat was 98 percent and heart rate was 73.  The pulse ox was left on throughout the entire time that I was with the patient.   Patient started saying that she was feeling tired, proceeded by nausea.  In about 3 more minutes, the patient stated that she was feeling like she was going to pass out.  I asked if she could lie down in the floor so that she would not hit her head if she passed out.  While getting the patient from the chair to the floor, patient stated that her legs were heavy.  I assisted her to the floor, and her legs were shaky and wobbly.  While assisting her to the floor, I had to physically hold the patient up.   I had ice packs on her neck, which she stated that were helping her to feel better.   She then stated that she felt as if her throat was tingling and that her lips and tongue were feeling worse.  At this time, I asked an employee to call 911, as the patient was feeling worse.  Medical personnel were here, and within minutes were assessing the patient.  The patient was taken via ambulance to Medical Center.   At around 3:30 PM, patient called and said the hospital had released her home, and she was told to continue taking diphenhydramine 25 mg TID for 24 hours.
Throat burning, lips tingly, sweaty and shaky, tunnel vision, lightheaded, super fast heart rate. All within 5 minutes of the injection.
Post vax, the pt developed tenderness in the right arm below elbow while gripping objects or turning right wrist outward. Doctor said problem was with right supination muscular tendons/tendon sheath. Pain got worse until early April when there was difficulty holding objects with arm extended. Treating with Motrin, Naproxen, and physical therapy.
lightly red, swollen and itchy immediately after injection (Day 1). Day 2-3, still itchy, bruised but swelling went down. Day 7, itching at night and scratched. woke up day 8 with large swollen and hardened mass at the injection site about 3 inches (golf ball size). still itchy and very red. also is hot to touch.   have applied cortisone cream at this time to help with itchiness (Day 8). does not "hurt" at all but still having adverse reactions
Flu like symptoms- Fever (102 degrees) started ~ 10 hours post shot lasted 48 hours, chills, body aches, headache  Rash resembling Livedo, or blood clots of the skin first notices 2 days after shot was received but may have started earlier. Condition has not worsened but livedo is still present as of 4/17/2021. Went to doctor about it and was told as long as it does not get worse not to worry.
FLU LIKE SYMPTOMS; MILD DIZZINESS; PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned a 37 year old male. The patient's weight was 210 pounds, and height was 69 inches. The patient's concurrent conditions included: alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no pre-existing medical history and did not receive any medication. He had no known drug or non-drug allergies and had no drug abuse or illicit use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 18-MAR-2021, the patient experienced pain at injection site. On 19-MAR-2021, the patient experienced flu like symptoms. On 19-MAR-2021, the patient experienced mild dizziness. Laboratory data included: Body temperature (NR: not provided) 100.5 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms, mild dizziness, and pain at injection site on 21-MAR-2021. This report was non-serious.
Severe pain at injection site within 2 hours. Chills, fever, lethargy and body aches within 12 hours still persistent.
We received the following literature report on 15 JUN 2009: 15 children between 6 and 59 months of age were vaccinated for the first time with an influenza vaccine (batch no. and manufacturer unknown) at the start of each influenza season (defined from 01 NOV to 30 APR) from 1999-2000 through 2006/2007. The children received a total of two doses (fully vaccinated). Vaccine effectiveness among fully vaccinated children as compared with unvaccinated children was 86% (95% confidence interval: 29-97%) for medically attended, laboratory-confirmed influenza illness. Vaccine effectiveness for the partially vaccinated group was 73% (95% confidence interval: 3-93%) as compared with the unvaccinated group. This case refers to one child (for other children, please refer to reference cases MA2009-1692, MA2009-1708 to MA2009-1710 and MA2009-1713 to MA2009-1722). Laboratory-confirmed influenza illness was reported (date?). Request was sent on 22 JUN 2009, no follow-up information received.
her arm is beginning to itch; warmth, redness, and swelling in the area where her injection was; warmth, redness, and swelling in the area where her injection was; warmth, redness, and swelling in the area where her injection was; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1686) on 06Jan2021 07:30 via intramuscular at left arm at single dose for some other people who have had COVID and she didn't want to take any chances (because of her age and knowing she works in the medical field). Medical history and concomitant medication were none. The caller states she works in healthcare, clarifies she is a medical assistant. She is calling in regard to Pfizer's COVID-19 Vaccine. She received her first dose on Wednesday and she was having no side effects until last night. Her arm started getting hot in the area where the injection was. Her arm began to get warm, red, and was swelling (07Jan2021 21:00). She took a couple of paracetamol (TYLENOL, lot number: SHA101, expiration date: Jun2024 at 500mg) and put an icepack on it. However, this morning, her arm is still the same. Caller wanted to know if she can still continue to take paracetamol and use the icepacks and just give it some time or what. She knows the redness, swelling, warmth are some side effects but she wanted to just follow-up to see if she can continue to take the paracetamol. Caller verifies she received her first vaccine on 06Jan2021. Last night, 07Jan2021, around 9 pm, she started to get the warmth, redness, and swelling. She states her arm looks the same as it did last night. However, her arm is beginning to itch (08Jan2021). It wasn't itching last night. She explains the vaccine was available to her. She took it because of her age and knowing she works in the medical field, she is around a lot of young people and patients, and also for her family and friends. She knows some other people who have had COVID and she didn't want to take any chances.  None of additional vaccines administered on same date of the Pfizer Suspect. Event was not required a visit to Emergency Room or Physician Office. Prior Vaccinations (within 4 weeks) was none. Relevant Tests was none. Patient was not recovered from the events.
Patient stated that she has bump under the skin in the spot where the vaccine was given and that her armpit area was sore--was unaware if related to Fluad vaccine that she had in September but was in that area. She said she has not been treated but I recommended to see her doctor if those symptoms do not subside.
Pt exp fever, diarrhea, joint pain, & was generally ill, which lasted all weekend;
Arm started aching shortly after vaccination, nausea. Loss of consciousness, diaphoretic. Moved to stretcher by staff- taken to medical screening for eval. Paramedic; Fire Dept. Recorded Lying B.P. 119/73   Pulse 63          SPO2=99% @15:14   B.P=107/58   HR:48 @15:17 Standing : B.P=127/72      HR=74            SPO2: 95
States when she got home she had stomach problems and felt very tired. When the stomach problems started she had diarrhea that lasted for 24 hours. Did call Dr but never received a call back.
itchiness/itching on both legs; body malaise; This is a spontaneous report from a contactable consumer (patient). A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL3242), second dose via an unspecified route of administration in right arm on 03Feb2021 as SINGLE DOSE for covid-19 immunization. The historical vaccine included First Dose of BNT162B2 which was on 02Jan2021 (Lot: EL3302) in right arm. The patients medical history included diabetes mellitus and blood pressure. Concomitant medications included LISINOPRIL taken for blood pressure and METFORMIN taken for diabetes mellitus, both on unspecified date. On 04Feb2021 the patient experienced body malaise and itchiness/itching on both legs. Outcome of the events was not recovered.
No side effects reported; GARDASIL 9 was administered after it experienced a temperature excursion; This spontaneous report was received from a medical assistant referring to a 13 years old male patient. The patient's medical history and concurrent conditions were not provided. Concomitant therapies were not reported.  On 27-JUL-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, at a dose of 0.5 milliliters (lot #W028573 and expiration date on 06-JAN-2025), administered for prophylaxis (strength, and route of administration were not provided) after it experienced a temperature excursion (product storage error).  No side effects were reported.   The dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was exposed to a temperature excursion of 50 degrees Fahrenheit (°F) during a time frame of 1 hour, 40 minutes, 0 seconds. There was no prior temperature excursion.        ?
arm swelled, became hot to the touch, extreme pain to move or touch arm for 10 days.  High temperture of 100.2 for 4 days.  Then temperture started to drop.  Around injection site was red and very painful.  After 3 days the redness started to spread like a rash across arm, shoulder to elbow.  I took benedryl and rash lessened but took another 3 days to disappear.  Once rash was gone pain lessened, but arm was painful for about 10 days, with the first 5 days being extermely painful requiring pain medication (800 mg Ibprofen q 6 hrs) to control pain.  When I called the Dr. they were unconcerned because I didn't have any trouble breathing, so I didn't come back in to see the dr.
fever, respiratory distress & circulatory collapse < 48 hrs p/1st vax given;
onset of dizziness 1 hour after injection- persisting but lessening 5 days after vaccine at time of this report headache onset within 2 hours of injection, persisted for 2-3 days site soreness onset 3 days after vaccination back pain, hip pain days 2-3 post vaccination
Information has been received from a registered nurse concerning an 11 year old white female patient who on 12/15/98 was vaccinated SC in the left arm with a 0.5ml first dose of varicella virus vaccine live (lot # 627875/1245H). On 6/30/04, the patient developed chicken pox and the mother called the medical office to report the outbreak of chicken pox. Unspecified medical attention was sought, but the medical office did not see the patient in person to confirm anything. It was noted that therapy with varicella virus vaccine live was discontinued. The patient's sibling had chicken pox the week before this report. A product quality complaint was not involved. Follow up information from the nurse indicated that on 6/30/04, chicken pox disease was suspected post exposure to her sister (WAES0409USA00474) who had chicken pox. No complications were noted for the patient. The patient was not seen in the office for a diagnosis. Subsequently, the patient recovered. No further information is expected.
Flu like symptoms the day after; Very sore arm; Joint aches; Uncontrollable shaking for a couplehours; Fever; Chills; This is a spontaneous report from a non-contactable consumer, the patient. A 29-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the right arm on 23Apr2021 at 09:00 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included unspecified over the counter allergy medicine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 02Apr2021 at 08:30 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. On 23Apr2021 at 20:00, the patient experienced very sore arm, joint aches, uncontrollable shaking for a couple of hours, fever and chills. On 24Apr2021 (reported as the day after), the patient experienced flu like symptoms. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events very sore arm, joint aches, uncontrollable shaking for a couple of hours, fever, chills and flu like symptoms was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
headache, nausea, muscle pain - neck & upper back, joint pain - left shoulder and both hips, feel unwell, brain fog
8 days later - woke up with significant rash on left arm, arm had been very itchy.  It is now 10 days after vaccine,, rash still present but less severe, less itchy.   Still have sore arm. Day after vaccine, woke up with headache, felt as though I had run a marathon the previous day (I am a runner), sore arm.
erythema was seen around site of vaccination.; swelling; pruritus; bruising; erythema; This is a spontaneous report from a contactable physician. A adult female patient of unknown age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 26Feb2021 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was unknown if the patient was pregnant. On 28Feb2021, the patient experienced erythema, swelling, pruritus. The patient was presented 45-60 days later to clinic with persistent pruritus in upper extremities and around the knee and inner thigh. Erythema was seen around site of vaccination. Bruising and erythema were in other locations as well. The physician was unsure if it was from the vaccine or resultant scratching due to pruritus. Therapeutic measures were taken as a result of erythema, swelling, pruritus and bruising and included treatment with loratidine (MANUFACTURER UNKNOWN) and topical steroids (MANUFACTURER UNKNOWN). The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcomes of the events erythema, swelling, pruritus, erythema was seen around site of vaccination and bruising in other locations as well was unknown at the time of reporting.  The lot number for the vaccine, [BNT162b2], was not provided and will be requested during follow up  Follow up (16Sep2021): No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Covid breakthrough case. All I had was a sore arm for a day or two following the vaccine. May 4th, I flew overseas and arrived on the 5th of May I continued to feel fine until the morning of the 8th. I had a scratchy throat, so I took a home test and it was negative. I felt fine the rest of the day the next day I felt bad like a cold but not horrible. I had no fever, but I did have poor appetite and a scratchy throat still. May 9, I rested and felt better, and I went out on the town, and we stopped to have tea and I fainted. I came back I was only out for 20 seconds according to my sister. I felt okay after that, but I still felt that I needed to go to the hospital, so I did. ER, They did the standard Covid test to create a safe zone for NONCOVID patient's and that was a lateral flow test which came back positive. They did and entire work up, blood pressure, EKG, chest X-ray, standard blood work for patient that have fainted. I was at the hospital for a total of four hours. After getting discharged I felt much better and because we were out of town, we had to walk to find a bus and then a train. I tested positive on May 15th which would've been the standard 24 hour test prior to my flight but still positive. I was scheduled to leave May 16 but I couldn't, so I stayed and rested. I also had to get a letter stating that I was recovering from COVID so I flew back home May 20th. As strange as it may seem my sister which was traveling with me only received two boosters one Moderna which she didn't like the way it made her feel so her next booster was Pfizer. My sister shared a room with me, and we were together the entire time and she tested negative.
Pt seen by school nurse @ 11AM 16OCT91, w/temp of 99.4; sx reported by pts mom; rash, fever, itching, nausea, vomiting, h/a, aching all over; lt arm soreness & swelling, diarrhea; pt seen by MD for muscle aches & pains;
SORE ARM; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 at 10:00 am for prophylactic vaccination.  The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious.
It was discovered on 04/14/2022, the Patient mistakenly received Pfizer COVID vaccine for age 12 and older at age 11yrs 9months on 01/20/2022. This was the first dose in the series. Patient was watched for standard 15 minutes after receiving Pfizer COVID vaccine and Influenza vaccine without any signs adverse reaction.  Mother of patient was notified on 04/14/2022, and informed us the Patient only experienced soreness the next day after receiving vaccines.
told me to get the 2nd one in two weeks so I did; feeling bad/ dont feel well; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concomitant products included SHINGLES VACCINE (NOS) (SHINGLES VACCINE).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On 24th May 2022, unknown after receiving Shingles vaccine and an unknown time after receiving SHINGLES VACCINE, the patient experienced feeling unwell. On an unknown date, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the feeling unwell and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 24-May-2022 Reporter's Comments: The patient self-reported this case. The patient went to two different pharmacist and the pharmacist told him/her to get the 2nd dose of Shingles vaccine in two weeks and the patient did. On the day of reporting the patient did not feel well and was reading information that one should not get the 2nd dose until 2 to 4 months. Since the patient received the 2nd shingles shot in two weeks which was too quick, the patient wanted to know if he/she was in any physical danger other than feeling bad. Additional Supportive Information: The patient received 2nd dose of Shingles vaccine within 2 weeks after the 1st dose, which led to shortening of vaccination schedule. The follow-up would not be possible as no contact details were available.
This spontaneous report was received from a state vaccine official concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, allergies and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL 9 for prophylaxis (lot # M023169) (dose, frequency, route of administration, expiration date, and batch # were not reported). There were no adverse effects reported. The dose of the vaccine was exposed to a temperature of -4 degree Celsius (C) (below 32 degrees Fahrenheit/0 degree C) for a time frame of 78 hours. There were no previous temperature excursions. A digital data logger was involved. Furthermore, No product quality complaint (PQC) was involved. Additional information has been requested.