chrisvoncsefalvay/vaers-outcomes huggingface dataset:
nausea; She was just not quite herself; feeling hot and sweaty; feeling hot and sweaty; not feeling well; shaky; nervous; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9265), via an unspecified route of administration, on 02Feb2021 12:00 at a single dose on the right arm for COVID-19 immunization. Medical history included asthma, knee surgery, and bulging disc.  The patient had an MRI on an unspecified date in Jan2021 (a week and a half prior to the date of initial report) with result of bulging disc. Concomitant medications included fluticasone furoate (ARNUITY ELLIPTA) for asthma; She was supposed to take 1 puff a day. However, being in the house, she had no problems, she had maybe used it twice a week since she hasn't had any problems, she last took 1 puff on 01Feb2021). She was also taking vitamin pills concomitantly. On 04Feb2021 23:00, 2 days after the vaccine, the patient had sweats, was wringing wet, and was not feeling well. Her hair was wet, and she was sweating. She was okay on the morning of 05Feb2021 but not herself. She had a little nausea on 05Feb2021. She was just not quite herself on 05Feb2021 but doesn't have the sweats. She further reported that she had her first shot on 02Feb2021 12:00. She was fine and had no problems. However, on night of 04Feb2021, before bed, she started getting hot and sweaty, like she was wringing wet. She didn't feel good, but 2 days had gone by and she was fine. She also went to bed with something like chills (later clarified as not chills), she went to sleep on the morning of 05Feb2021 and felt okay but not that great. When queried when the chills started, she said that it was not really chills, she was just very sweaty, wringing wet. She stated that she never sweats, and in this case her whole hair was wet. Being older, she was wondering what was going. Her feeling hot and sweaty subsided during the night. She did start to feel nausea, or she thought maybe she hasn't had anything to eat and so had a half banana and then she was okay. She thought she was hungry and felt funny, she had the half banana and was okay. She also felt a little shaky and nervous on 04Feb2021; however, it all subsided after going to bed. At the date of report, 05Feb2021, she felt okay but she didn't feel completely herself. Her second dose is scheduled on 26Feb2021 at 9:15 AM. Outcome of events feeling hot and sweaty was recovered with sequel on 05Feb2021. Outcome of event not feeling well was unknown. Outcome of event nausea was recovered on 05Feb2021. Outcome of the events shaky and nervous was recovered on 04Feb2021. Outcome of she was just not quite herself was not recovered.
Client reported after Moderna vaccine administration that she had received a Tdap on 4/16/2021.
This spontaneous report was received from a physician assistant via a company representative concerning a 16 year old female patient. It was reported that on an unknown date in July 2013, the patient was inadvertently vaccinated with two doses of GARDASIL (lot number, expiry date, dose and route unspecified) on the same day due to nursing error. No concomitant therapy was reported. No adverse effects were reported. Additional information is not expected.
Patient received the vaccine and reported back to the pharmacy that she was experiencing a side effect that concerned her.  The pain went from the site of injection on the left arm to "a little bit past the collar bone".  She experienced a slight bump/nodule in the collar bone area.
Moderna COVID-19 Vaccine EUA: I developed itchy hives only on my neck (front).  Waking up the next day hives were still visible but no longer itching.  Next morning experienced marked drowsiness and muscle aches.  Tylenol helped.
Round Pink Rash on Opposite Arm and upper Legs.   Looks a bit like chicken pox or measles
HARDLY MOVE; VERY SORE OR PAIN IN THE ARM; CAN NOT SLEEP; This spontaneous report received from a consumer concerned a 53 year old male. 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 04-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced can not sleep. On 04-APR-2021, the subject experienced hardly move. On 04-APR-2021, the subject experienced very sore or pain in the arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from very sore or pain in the arm, and hardly move, and the outcome of can not sleep was not reported. This report was non-serious.
THE PATIENT CALLED TO REPORT SHE FELT FATIQUED AND THAT THE INJECTION SITE WAS RED  WITH A LUMP.  DURING A FOLLOW-UP CALL THE FOLLOWING DAY,  THE PATIENT STATED SHE FELT BETTER, THE REDNESS WAS SUBSIDING BUT THE SITE WAS THE SIZE OF A COFFEE CUP
COUGH, SOB ED Discharged  3/14/2021 (2 hours)  Last attending ? Treatment team COVID-19 virus infection Clinical impression Shortness of Breath Chief complaint  Clinical Support 3/15/2021  COVID-19 virus infection Dx Medication Infusion Reason for Visit Progress Notes  (Registered Nurse) ? ? Encounter Date: 3/15/2021 ? ? Signed    arrived to the ambulatory infusion site with his wife is also receiving.. Reports dry nonproductive cough, fatigue, shortness of breath, and dizziness.    stated he discussed Bamlanivimab infusion and associates risks with his doctor prior to this infusion. Reports all question were answered to his satisfaction. Denies any concerns or needs at this time  ED Discharged  3/15/2021 (2 hours)  Last attending ? Treatment team Fatigue, unspecified type +2 more Clinical impression ED Provider Notes (Physician) ? ? Emergency Medicine Expand AllCollapse All      HPI     No chief complaint on file.     HPI 68-year-old male history of asthma, COPD, diabetes, diastolic CHF who presents ED for evaluation of right lower back pain and midline lower lumbar pain.  Diagnosed with COVID-19 yesterday.  Had a few days of cough and fever with some mild shortness of breath.  Last evening he tried to sit down, missed the chair and landed on the floor on his right side.  Has had worsening weakness due to pain in his back.  No weakness or sensory loss in his lower extremities.  No bowel or bladder dysfunction.  No urinary issues.  No abdominal pain.  He was having pain in his right ribs with coughing, seen in urgent care and this was negative.  He had monoclonal antibody fusion this morning.  He feels tired and fatigued. He did not strike his head during fall.  Chest x-ray today did not show any fracture, there is no infiltrate.
Injection administed at 11:52 am, pt has reported diaphoresis,  lightheadedness, at 11:58 with sig pain at the injection site and some blotching redness. No bronchospasms, no laryngospasms, no sob, no chest pain, no chest  tightness. Pt profusely wet and clammy and lightheaded. In clinic rapid response called by RN. Vital signs done q5 min ( see rapid response outpatient scanned record). Pt then progressed to having itching and esophageal spasms. POD called.  Pt administered 25mg IM benadryl per POD instruction with worsened lightheadedness. 911 was called and transported pt to nearest hospital at 12:40
This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient. A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Dec2020 as dose 1, single (Batch/Lot number: unknown), on 08Jan2021 as dose 2, single (Batch/Lot number: unknown) and on 27Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 36 years for Covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The patient had no known allergies. The patient was not pregnant at time of vaccination. Other medical history was reported as no. Other medication in 2 weeks was reported as no. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "not recovered", described as "COVID 19 Treatment". Therapeutic measures were taken as a result of Covid-19. Anti-viral details: Product: COVID-19 Treatment, Brand: Paxlovid, Treatment start date: 03May2022, Lot number: FY5656, Indication: Treatment of COVID-19. The device timestamp was on 05May2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162b2  cannot be excluded for the reported events . The case will be reassessed once new information is available.
Could not stand up; Felt so weak; Slight headache; This spontaneous case was reported by a consumer and describes the occurrence of DYSSTASIA (Could not stand up), ASTHENIA (Felt so weak) and HEADACHE (Slight headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-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 19-Feb-2021, the patient experienced DYSSTASIA (Could not stand up), ASTHENIA (Felt so weak) and HEADACHE (Slight headache). At the time of the report, DYSSTASIA (Could not stand up), ASTHENIA (Felt so weak) and HEADACHE (Slight headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not Applicable.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.
I previously filed a report, regarding the effects of Pfizer vaccine 1 & 2 (ID#1378159 / eReport #549200), as it relates the the lump that formed at my clavicle, after receiving the 2nd shot. Since then, from around July 2021, to present, I have been having severe hot flashes.  Prior to getting the vaccine, I was prescribed  Jintell, which controlled the hot flashes.  Since the 2nd dose of Pfizer, the Jinteli stopped working.  Had my doctor take me off the Jinteli, since it wasn't working anymore.  I had my Pfizer Booster on November 2nd, 2021, but had it in the right arm.  Since the booster, the hot flashes have gotten worse and I have an intermittent pain that runs up the right side of my neck.
Shortly after vaccine was administered, patient reported light headedness. Patient stated she was fine. She felt the dizziness was not a result of the vaccine, but a result of lack of food during the day. She remained seated and was provided orange juice. Pharmacist took patient's blood pressure (135/76). Patient reports this blood pressure was elevated in comparison to her normal blood pressure. Patient remained stationary in waiting area for approximately 10 minutes. At that point, she stated she felt fine and has made a full recovery. However, pharmacist escorted patient to the immunization room for further observation to ensure recovery. Patient remained under pharmacist observation for approximately 30 additional minutes. During the full observation, patient declined any supportive care: EMS, driver to assist in getting home, cool cloths, placing head between knees. She felt as if any supportive care was unnecessary. Patient made full recovery. Pharmacist called patient to ensure she made it home safely. Again at this point, patient indicated she was no longer symptomatic.
Body aches that have persisted for 3 weeks.  Significant flare up of osteoarthritis and fibromyalgia. Significant fatigue that has persisted for 3 weeks.
MOBILITY ISSUES; CAN NOT SLEEP; CAN NOT MOVE SHOULDER (HER BLOUSE HURTS ON HER SKIN, CAN NOT GET SEATBELT ON)/CAN NOT LIFT BAG; SHOULDER INFLAMMATION; CAN NOT DO MUCH OF WHAT SHE USED TO DO; SEVERE PAIN IN ENTIRE SHOULDER AREA (SUPERFICIAL PAIN AND DEEPER PAIN INSIDE THE SHOULDER, AMPLIFIED PAIN RESPONSE THAT BOTH GROSS AND MORE MINUTE); FELT SICK; INTENSE INJECTION SITE PAIN; FEVER; This spontaneous report received from a consumer concerned a 71 year old female. The patient's height, and weight were not reported. The patient's past medical history included: car accident, and shoulder was hurt. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the patient experienced severe pain in entire shoulder area (superficial pain and deeper pain inside the shoulder, amplified pain response that both gross and more minute). On 13-MAR-2021, the patient experienced felt sick. On 13-MAR-2021, the patient experienced intense injection site pain. On 13-MAR-2021, the patient experienced fever. On an unspecified date, the patient experienced mobility issues, can not sleep, can not move shoulder (her blouse hurts on her skin, can not get seatbelt on) /can not lift bag, shoulder inflammation, and can not do much of what she used to do. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt sick, and fever on 23-MAR-2021, and had not recovered from intense injection site pain, severe pain in entire shoulder area (superficial pain and deeper pain inside the shoulder, amplified pain response that both gross and more minute), can not move shoulder (her blouse hurts on her skin, can not get seatbelt on)/can not lift bag, shoulder inflammation, mobility issues, can not sleep, and can not do much of what she used to do. This report was non-serious. This case, from the same reporter is linked to 20211047262.
This case was reported by a other health professional via call center representative and described the occurrence of vomiting in a 4-month-old male patient who received KINRIX (batch number 3N7Y7, expiry date 27th MAY 2017). On 18th JANUARY 2016, the patient received KINRIX .5 ml. On 18th January 2016, less than a day after receiving KINRIX, the patient experienced vomiting and inappropriate age at vaccine administration. On 19th JANUARY 2016, the outcome of the vomiting was recovered/resolved. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. It was unknown if the reporter considered the vomiting to be related to KINRIX. Additional details provided were as follows: On 18th JANUARY 2016, the patient received a dose of KINRIX vaccine at the age of 4 months, which led to inappropriate age at vaccination. On 18th JANUARY 2016, less than a day after vaccination, the patient experienced vomiting, this resolved in the end of the 19th JANUARY 2016. The reporter wanted safety recommendations.
Pt had second Pfizer covid 19 mono valent vaccine given on 01/26/2023 In office yesterday received Pfizer Covid 19 BIVALENT was supposed to be 2 months from the second doses therefore given too soon parent aware returning in 2 months for Covid 19 Bivalent booster
This case was reported by a consumer via call center representative and described the occurrence of erythema in a 74-year-old female patient who received SHINGRIX for prophylaxis. On 12th October 2018, the patient received the 1st dose of SHINGRIX. On 14th October 2018, 2 days after receiving SHINGRIX, the patient experienced erythema, pain and swelling. The patient was treated with BENADRYL. On an unknown date, the outcome of the erythema, pain and swelling were recovering/resolving. It was unknown if the reporter considered the erythema, pain and swelling to be related to SHINGRIX. Additional details were reported as follows: The patient did not intend to get 2nd dose of SHINGRIX vaccine. The patient took BENADRYL to help with the pain and redness.  The patient had denied permission to contact their physician.
Redness and swelling at injection site. Soreness like a bruise. Redness started about the side of a nickel and progressed over the next 6-8 days to the size of a baseball. Localized swelling of that area was noticeable but not alarming. At two weeks the redness had completely resolved leaving just a nickel sized bruise. As of today 1/6/2021, everything has resolved.  - Sought out no medical treatment for condition, just monitored at home.
Upon receiving the vaccine, the patient was lightheaded and when sitting in the chair started to feel numb & "like insides were shaking". Patient reported only having eaten cereal & jello all day and had taken hydralazine & carvedilol about an hour before coming for immunization. EMS was contacted and upon evaluation patient was transported to local hospital.
No adverse reactions noted, Pt given pediatric doses  of Hep A at 9 month of age vaccine not valid until 12 mo of age.
Couldn?t move head/neck  without moderate to severe pain, lymph nodes on affected side where injection was give were hard and extremely painful to palpate. Neck and jaw pain day three extremely bad migraine causing me to miss work
Patient reported got vaccine on 8/27/2020, the symptoms start within 24 hours included skin rash on the portion of his right forehead (rash seems red, swelling and itchy), needle like pain in the head, eye watery, eye blurry if concentrate for approximate 5 minutes. Left arm felt heavy, and had hard time to lift, but it got better after 2 days. On 9/1/2020, Patient noticed there were a spot of bleeding nose once, and then it went away. Patient described on Tuesday 9/1/2020, the symptoms were worse, and today 9/3/2020 he came in to the pharmacy and he stated it gets better. The rashes on forehead is still swelling and red.
Pt developed chickenpox the subsequent to receiving the varicella virus vaccine live. Reportedly the pts sibling had a similar experience.
11:47 AM.  Patient complained of feeling dizzy, light,  headed, no energy, needing to lay down. Provided water, instructed to take deep breaths.  BP 135/88, Pulse 87bpm, O2 99%, Resp: 18bpm, Temp: 97.4. 12:15 AM.  BP:  132/84, Pulse 76, O2:  99%, Resp:  16bpm, Temp: 98.2
Pt came in on 8/2/13 with c/o (R) thigh redness and swelling. Provider ordered BENADRYL 25 mg/10 ml. 5 ml PO a x 1 now. Rx prednisone 15 mg/5 ml 1 tsp PO once daily x 5 days.
On 5/16/11 went to med center with vomiting & diarrhea transferred to children hospital with laparoscopic reduction.
Wednesday after my shot, I was tired and achey and I woke up next day I felt better. Then Friday I noticed on my right  arm I noticed arm had blisters all of it, I had a really bad head and I had really bad congestion if I bent over I would get super light headed. I finally went to urgent care on May 6, they told me blisters on my arm were shingles, my oxygen was between 86-88 and they did a chest xray. I had pneumonia. They tested me for covid. My covid test was negative. On may 18th I still wasn't feeling well went to my primary care I had rash under bra and had a yeast infection on my skin and on June 21st they did a repeat xray still had pneumonia. My doctor did blood test. On July 12th I went back to my doctor and last chest xray had revealed my heart was enlarged and they ordered an EMG, They ordered d dimer, they checked for DVT, my d dimer was slightly elevated.  on July 19 my doctor put me on a Zpac.  I do have an appointment with a pulmonary speacialist on Aug 17
2 years and month baby was administrated by error Kinrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 5th April 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 5th April 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The 2 years patient received Kinrix, which led to inappropriate age at vaccine administration. No adverse event was reported. The reporter consented to follow up.
First genital HSV1 outbreak in more than 10 years.  32 weeks pregnant at time of second dose, EDD 3/28/21.
no adverse affects; first dose was given on 8/5/2019, and second was given on 9/18/2019; This spontaneous report was received from a nurse prescriber via company representative and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported.  On 05-AUG-2019, the patient received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, route of administration, anatomical location, lot# and expiration date were not reported) for prophylaxis. On 18-SEP-2019, the patient received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, route of administration, anatomical location, lot# and expiration date were not reported) for prophylaxis. The nurse prescriber reported that the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was given sooner than it should be. No adverse effects reported.
A BIT RUN DOWN BUT DID NOT LAST LONG; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced a bit run down but did not last long. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from a bit run down but did not last long. This report was non-serious. This case, from the same reporter is linked to 20210801289.
This spontaneous report was received from a pharmacist via Pfizer referring to a patient of unknown age and gender. No concurrent or historical conditions were reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (lot number and expiration date were not provided) dose, route and anatomical location were not provided. No concomitant medications were reported. On an unknown date, the patient experienced a severe reaction to PNEUMOVAX 23; a severe injection site reaction and syncope and fainting. At the time of the report, the outcome of injection site reaction, syncope and fainting was unknown. The reporter considered injection site reaction and syncope and fainting were related to PNEUMOVAX 23. Additional information is not expected because there are no request letters.