chrisvoncsefalvay/vaers-outcomes huggingface dataset:
come on for a Pfizer Covid 19 IMZ. I gave the IMZ at roughly 9:30 am in her right Deltoid. She was ask along with her husband to stay for 15 minutes to observer and make sure there was no reaction before leaving. In a few minutes waiting she rushed to the restroom feeling hot/cold and nauseated. She returned from the restroom and sat in one of the waiting area chairs. I immediately came out and ask her to come back into the IMZ room and lay down on the floor and I propped up her feet on a ABC plastic container and put a few sacs underneath her head. She complained about feeling hot/cold and woozy. I ask if she had any breathing difficulties and she said no and that she could breath fine. I began taking her blood pressure at around roughly 9:40. It was 123/82 and HR 63. I continued to monitor her BP and HR every few minutes. At roughly 9:50 I ask and then gave her 15ml of diphenhydramine oral solution  12.5mg\5ml to help with any allergic reaction and nausea the might have. She was sleepy but alert and talking. At 10:10 she was talking on the phone to someone while still lying down. She ask at one point if she could sit in the chair but I said for her safety for her to continue to lie on the floor until she felt very stable and she agreed. In roughly another 15 minutes I ask her if she felt like she was improving and she said not really and still felt hot/cold and woozy. I spoke to both of them and suggested calling 911 just to be on the safe side and they agreed. I called 911 and was transferred to the medical center where I gave my name, reason for calling, our address and patient's condition, IMZ received and was requesting EMS to come. While continuing to check BP and HR we waited for EMS to arrive. After 15 to 20 minutes, I believe roughly, they arrived and took over care of patient. They told her that the symptoms she was experiencing were not too unusual with the Pfizer Covid IMZ and that she might have had some anxiety that contributed to her symptoms. The assisted her into a chair at her request and again took her vitals and BS. They ask all routine questions while filling out computer visit questions. After discussing with her the options she had as to go to the hospital for observation or just monitoring herself and calling them back if needed. She decided to not go to the hospital. She signed the computer AMA about going to the hospital. She was still a little woozy and sleepy but as I had told her the EMS techs did also that the generic Benadryl might maker her feel sleepy and sluggish also. She and her husband left on there own power walking out of the clinical service room next to the pharmacy .  BP and HR readings 9:40 - 123/82 HR 63 9:50 - 120/86 HR 63 9:54 - 121-82 HR 59 9:56 - 124-86 HR 62 10:00 - 127/83 HR 60 10:07 - 126/89 HR 68 10:11 - 127/94 HR 64 10:16 - 129/92 HR 67 10:21 - 127/93 HR 67 10:28 - 126/90 HR 65
After getting the booster, I had a strong flareup of my rheumatoid arthritis, affected right thumb and fingers down to the wrist, shoulder blade, left wrist and index and middle finger, elbows. Right knee flared up too Chronic and painful inflammation, had been well-controlled before, but now it is pretty severe. Tingling in left shoulder. Pain is still persisting, but on a temporary prednisone for a few more days which has cut down the inflammation. Orencia took months to kick back in. Limited in what biologics I can take because of my reaction to embrol, my IGA dermatosis has also flared up. Had a similar reaction to the 2nd vaccine.
fever; body aches in shoulder, elbows, and ankles; This is a spontaneous report from a contactable other health care professional and consumer. A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received COVID vaccine and reported that for 24 hours on an unspecified date, she had a fever, body aches in shoulder, elbows, and ankles and then felt fine. The outcome of the events was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
8 weeks after second shot, I developed 2 superficial blood clots in my left leg.  At the time, I was taking a daily low-dose of aspirin as recommended by my doctor for people my age.  I experienced a little over a week of pain before the clots dissolved.  I have no history of blood clots.
Approximately 11 hours after 2nd shot, I began feeling weak, shakey, and nauseous at bedtime. I went to bed, but could hardly sleep. I was restless with a very sore left arm, body aches, and covered in sweat throughout the night. I took Tylenol at 1AM and was able to sleep for about 3 hours. My nausea got worse overnight and into the next day, as well as loose stools. I took Pepto Bismol for that. I had a headache and backache the next day, which I took Tylenol for. By night of day 2, I was no longer miserable, just tired. My arm barely hurt after the first night of shot #2, but hurt for 2-3 days after the 1st shot.
I had a significant spike in my Post-Herpetic Neuralgia immediately following my first shot.  I contacted my doctor who issued a prescription for Steroids that did wonders for my overall joint pain but nothing for the neuralgia. 4/4/21 at approximately 11:15 A.M.  I had my second dose of Moderna vaccine - lot number 017B21A. 4/06/21  A.M. had a worse spike of neuralgia followed by an outbreak of Shingles on 4/08/21. I immediately started taking Valacyclovir HCL 1 Gram three times daily.  I am hoping it won't interfere with the efficacy of the Covid vaccine.
Severe lethargy, brain fog, burning sensation in lungs abs breasts and stomach. Unable to walk more than a few feet. Debilitating headaches, extreme nausea.
Exactly twenty-four hours after the Shingrix injection, my face, neck, chest, arms, stomach area, and body down to my knees developed hives with a red rash and burning/itchiness.  I immediately went to the Emergency room, and within 2 1/2 hours, the rash and symptoms disappeared on their own while I was still waiting in the emergency room to be seen.  I was triaged by a nurse upon arrival, but needed to wait my turn.
sudden, severe leg pain, muscle weakness,pain on bending knees, worsened chronic  back pain , tingling i n feet
Her two most significant symptoms are fever and fatigue. It started with fatigue, and we checked for a fever at 100.7. Wednesday afternoon it was at 101.7. We gave her 5 ml of MOTRIN and went to bed at 6:15PM. The next morning, her fever was at 104 and we gave her more MOTRIN. She was very low energy and went back to sleep until about 10AM. We've been alternating MOTRIN and TYLENOL every 3 hours since yesterday morning. Yesterday afternoon about 4PM her fever was at 102.6. We stayed on the schedule with the medication, and she went back to bed at 6:30PM. This morning her fever was at 102.7. We gave her MOTRIN again. Her appetite wasn't that great but she's eating better today and had a bowel movement. She doesn't have high energy, but she is playing today and seems to be improving. She doesn't have a cough or much congestion. Her main symptoms are fever and fatigue.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with PROQUAD (merck) (lot number reported as K005648) Dose, route, and expiration date were not reported. No co-suspect and concomitant therapies were reported. The nurse reported that the patient was administered PROQUAD (merck) that was stored improperly (on an unknown date). No adverse effects reported. The outcome and causality of the event was not reported. This is one of four reports from the same source (other case # 1407USA000488 # 1406USA011997 and #1407USA005743). Additional information has been requested.
Pt received vacc. on 12/22/10. Pt called the pharmacy to report that she felt warmth in the arm and palm of hand (left) at night right after vaccination. She then noticed itch/rash on skin area below her left thumb on 12/23 & some fever w/burning sensation in her arm (left). She also developed dull headaches x 3 w/raised bump along w/blistering rash on 12/24 on her left upper scapular area & below neckline. It progressed to develop wheezing too. Also reported swollen lymph node & small patches of blistering rash on (L) forearm. Pt was seen by her PMD on 12/29 & received Valacyclovir 1 gm (TID x 7 days) & CLARITIN, Ibuprofen, VENTOLIN, CALADRYL.
No additional adverse event reported; Incorrect product storage; This spontaneous report was received from a nurse practitioner referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions or allergies were no reported.   On an unspecified date, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (Lot# U015682 and expiration date 18-MAY-2023) (exact dose and frequency were not reported) as prophylaxis. (product storage error). The vaccine underwent a temperature excursion of minus 14 degree Celsius to minus 10 degree Celsius for 0 hours 10 minutes and 0 seconds and minus 10 degree Celsius to minus 8 degree Celsius (7.4 Celsius) for 8 hours 20 minutes and 0 seconds. There was no previous temperature excursion. No additional adverse event reported, no further information provided.
CoughWheeze Body Aches, runny nose, cough and chills Narrative:
This case was reported by a other health professional 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 .5 ml. On an unknown date, immediately after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. The reporter considered the pain in arm to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. Both immunizations given at same pharmacy. Lot number was not known. Arm began to hurt immediately upon immunization of both doses. Immunized person reported never being so aware of where arm was even if the patient was not moving. With both doses, side effects lasted about 2 days. The patient thought experienced events were related to immunization. For tolerance after 2nd dose refer case US2019GSK002321. The reporter did consent to follow up.
No additional AE information; Customer calling to report expired vaccine administered. Vaccine did not experience any temperature excursions.; This spontaneous report was received from an unspecified customer and also a reporter from the regulatory agency referring to a 12-months-old male. It was reported that the patient had no (reported as none) illness at the time of vaccination or pre-existing physician-diagnosed allergies, birth defects or medical conditions.   On 01-APR-2022, the patient was vaccinated with dose one (1) (also reported as 1 dose) of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (recombinant human albumin) (M-M-R II) by subcutaneous route on his right vastus lateralis (dosage and vaccination scheme frequency were not reported; lot number T010650 that was verified to be a valid lot number with an expiration date reported and established as 26-MAR-2022) (expired product administered) for prophylaxis. It was stated that the vaccine did not experience any temperature excursion.  The outcome for the expired vaccine used was reported as recovered; however, defaulted to unknown per internal guideline.No additional adverse event was reported (no adverse event).
On 10/30/2019 She told me she had experienced left arm discomfort the day following injection. Her left index finger became swollen with some pain. She went yo her doctor, her left index finger was infected, she had some minor surgery  and was given some prednisone 10/7,, then and antibiotic and pain med 10/20, she feels is related to her flu shot.
Extreme fatigue to the point of passing out at the dinner table.  I had to carry her to bed. Thankfully she recovered almost entirely by the next morning. It was a sudden onset and her first injection (lot #036A21A administered on March 19, 2021)  did not cause this reaction or anything near it.
1:54 pm Post vaccination, reports feeling episode of chest tightness w/ no additional or associated symptoms; Monitor x 30 min w/ po hydration; BP 149/95 P123 RR 19 2:05pm BP 112/ 90 P90, reports "feels better and no longer anxious" ;post monitoring released from facility to home w/self
10 mins after the shot she was sitting in the chair saying that she was dizzy, nauseaous, had ringing in her right ear, had blurry vision. She was barely responsive and talking very faintly- NO difficulty breathing or any symptoms of allergic reaction. Had a staff member call 911. After a few minutes she threw up and then she was able to communicate a little more than earlier. She mentioned that she had a similar reaction to another vaccination in the past and her mother said that she (the pt) was a little scared and worried before coming in to get the shot. The paramedics arrived soon after, briefed them the sequence of events. She was doing well by then. F/u with a call to patient at around 4pm-all ok she said.
Customer is 16 yo.  Father is a physician, Mother requested MODERNA for booster. Primary doses for Moderna recommendation approved few days ago. Pharmacist on duty didn't realize the booster was not approved. Provided booster dose number one (0.25 ml) which is indicated only for 18yo & up.
Extreme Diziness and Vertigo - Onset during night - nausea, falling.  Neccisated visit to ENT specialist Dr at medical group - who prescribed Meclizine 25mg  1X3 daily - and Vestibular Physical Therapist sessions listed above.  Vestibular Physical therapist seen and adjustments made led to cessation of vertigo over next week.  The EXACT same reaction occurred after the second shot on March 27, 2021
Residual pain and reduced joint mobility of left shoulder where flu shot was administered. Ongoing as of 3 weeks after injection.
HYPERTENSION - BP 170/125, Patient admitted for 2 days, changed beta-blocker from metoprolol to carvedilol
Stomach ache, nausea, throbbing head pain that increased when going from sitting to standing orllay in to standing, fever of 100.4, lethargic- slept more then usual.
This spontaneous report was received from a physician refers to a male patient of unknown age. The patient's concurrent conditions, historical conditions, concomitant medications and drug reactions/allergies were unknown. On an unknown date, the patient was vaccinated with M-M-R II for prophylaxis. On an unknown date in November 2018, it was discovered that, the patient had titers for mumps and rubella, but not measles. On an unknown date in November 2018, the patient underwent laboratory test for measles titer and the result was negative. The patient was not treated for the event. The event did not cause significant disability to the patient. The outcome of the event measles antibody negative was unknown. The reporters causality assessment was not provided. No product quality complaint involved.
pt recvd vax; devel a tender, itchy, red area on one inch diam at inject site w/ bumps w/in the area;
Existing tinnitus (whooshing sound) in left ear exacerbated by second dose of vaccine. Had noticed the same after the first dose, although not quite as loud. After the second dose, a ringing/high pitch buzz began in left ear that was never previously present. The whooshing tinnitus I already have increased exponentially.  It has not subsided.
Arthralgia, skin rash, rash, urticaria pruritus and scratchy throat. Methylprednisolone 40 mg once, prednisone tapering pack, diphenhydramine 50 mg once.
This spontaneous report was received from a patien's mother who refers to a 15-month-old son. The patient did not have any pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies. On 17-AUG-2018, the patient was vaccinated with VARIVAX lot # N023956 with expiration date: 01-SEP-2019 (dose and route of administration were not reported) for prophylaxis. On an unknown date in August 2018, the patient experienced injection site redness, tenderness and inflammation. The patient seek medical attention and was diagnosed with an infection in the muscle. A treatment with cephalexin antibiotc was introduced. No laboratory diagnostics or studies were performed. The outcome of the events was reported as not recovered/not resolved. The relatedness between the events and VARIVAX  was not provided.
Two weeks after being vaccinated I noticed that there was a loss of smell and taste. On January 13,2022 seen by EMT and he did smell test and they recommended smell therapy and that does not work at all. Since being vaccinated smell and taste buds are completely gone. Can't taste any flavors.
Severe pain, flu symptoms for 48 hours commencing approximately 10 hours after injection.   Emergence of shingles in multiple body locations (right leg, left arm, scalp) began 2 days after injection and has not abated.
Suspected vaccination failure; she got shingles about a week ago mostly on her leg; Said it burns like crazy; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 6 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and burning sensation. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and burning sensation were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and burning sensation to be related to Shingles vaccine.  Additional details were provided as follows The patient was the reporter's wife. The age at vaccination was not reported. The reporter and the patient both received Shingles vaccine about 6 months ago from the date of reporting. About a week ago from the date of reporting, the patient got shingles, mostly on her leg. The patient stated that, it burnt like crazy. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization and laboratory confirmation of shingles were not provided.
Headache, flushing, swelling and increasing redness around the injection site and area hot to the touch
Around 06/03/2021 it was increase shortness of breath and fatigue. It felt like my heart was swollen. I had more episodes with rapid heartbeat.
Information has been received from a consumer concerning her 12 month old son with no pertinent medical history and no drug reactions who on 05-OCT-2009 was vaccinated with a dose of VARIVAX (Merck) (lot#, route and site of administration not reported). There was no concomitant medication. On 05-OCT-2009 the patient developed a low grade fever and varicella like pumps on his back, torso, neck and skull after vaccination. The patient did not seek medical attention and there were no laboratory diagnostics studies performed. At the time of this report, the patient had not recovered. No further information is available.
Headache which started on 5th day after 2-shot vaccination.  Typical side effects - fatigue, fever of 99-100, pain at injection site from 7 to  38 hrs post injection.
Right arm from elbow to shoulder became extremely swollen, hard, red, and tender to touch.  Patient was uable to move the arm without pain. As of 11/10/15, the arm is still swollen and painful but decreasing.
Information has been received from a physician concerning a patient (age and gender not reported) who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently the patient experienced an injection site reaction. The patient's status was reported as "improved after a couple of days". There was no product quality complaint involved. Attempts are being made to obtain additional identifying information to distinguish the individual patient mentioned in this report. Additional information will be provided if available. This is one of several reports received from the same source. Additional information has been requested.
Case number PHEH2014US017769 is an initial spontaneous report received from a pharmacist on 04 Sep 2014. This report refers to a 66 year old male patient. His medical history and concomitant medication were not reported. On 04 Sep 2014, he was erroneously vaccinated with the liquid component of MENVEO (batch number: X14022) intramuscularly instead of the pneumonia vaccine (other manufacturer) which he was supposed to get. He was only due to receive the pneumonia vaccine and there was no plan to administer MENVEO to him. Men CYW-135 was mistaken for the pneumonia vaccine. Reporter as not aware of any adverse event at the time of reporting. No adverse event was reported following this administration error (wrong vaccine administered).
itchy rashes that go and appear somewhere else; This spontaneous case was reported by a patient family member or friend and describes the occurrence of RASH PRURITIC (itchy rashes that go and appear somewhere else) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Blood pressure abnormal (has been ongoing for 15-20 years) and Blood cholesterol abnormal (has been ongoing for 15-20 years).    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced RASH PRURITIC (itchy rashes that go and appear somewhere else). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency; RANITIDINE HYDROCHLORIDE (ZANTAC) at an unspecified dose and frequency and ALUMINIUM HYDROXIDE, MAGNESIUM TRISILICATE, SODIUM ALGINATE (PEPCID [ALUMINIUM HYDROXIDE;MAGNESIUM TRISILICATE;SODIUM ALGINATE]) at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (itchy rashes that go and appear somewhere else) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication included patient was taking medication for blood pressure and cholesterol. Dosage text was reported as unknown dose and shot on her hand was unknown. Reporter seriousness for Allegra-Stated that it was not working for the rash: Unspecified. Patient was told to take some allergy medication and stated that it was not working for the rash. Reporter stated that patient had the rash a week after the vaccine. Therapy dates and if the dose was changed in response to the event not provided.