chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt states he felt tingling in left index and middle fingers upon receiving vaccine. Symptoms corrected in middle finger but feels the same in index finger.
I WOKE UP IN THE MIDDLE OF THE NIGHT WITH PAIN, SWELLING, HARDNESS AND REDNESS ON THE INJECTION SITE OF UPPER LEFT ARM.
Couldn't sleep; Chills/Shivering; Knees were aching; Headache; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Couldn't sleep), CHILLS (Chills/Shivering), ARTHRALGIA (Knees were aching) and HEADACHE (Headache) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced INSOMNIA (Couldn't sleep), CHILLS (Chills/Shivering), ARTHRALGIA (Knees were aching) and HEADACHE (Headache). At the time of the report, INSOMNIA (Couldn't sleep), CHILLS (Chills/Shivering), ARTHRALGIA (Knees were aching) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Patient received their COVID-19 vaccine undiluted.  The patient's mother was informed of the situation and said that the patient had no adverse events besides fussiness and tiredness the following day.
Swelling, coolness and purplish discoloration of hands and feet starting about 16 hours after vaccination.
Unknown at this point if related, but approx 2 weeks after second shot, I came down with fever for one night, lost appetite for a few days. Soon after that I started experiencing heart palpitations, irregular heart beat that are still continuing. I have never experienced these symptoms in my life nor do I have a family history of them. Palpitations/irregular heart beat seems almost constant. I now have consulted a cardiologist and have worn a 2 week monitor. I will visit the cardiologist for the report next week.
The cases were received on 21 March 2014. Initial misuse report received from a healthcare professional on 18 September 2013. 06 patient's (no information was provided regarding the patient's) had received subcutaneous 0.5 ml dose of FLUZONE instead of intramuscular dose on an unspecified date and had event of site redness and swelling, i.e. vaccination site inflammation. List of documents held by sender: none.
Initial report received from a healthcare professional on 11 September 2013. A 35-year-old male patient whose medical history and concomitant medications were not reported, received a dose of IMOVAX (batch number, route and site of administration were not reported) on 24 August 2010. The patient had 3 doses of pre-exposure series of Rabies vaccine 5 years ago. The patient worked closed with bats, had lost his titer on 06 July 2013, the titer was reported as 0.2. The RABAVERT vaccine was to be administered today but till the time of this report, no vaccine had been administered. Documents held by sender: none. Additional information received on 02-Dec-2013: Patient did not have any side effects from vaccination.
Hardening, swelling and numbness in left deltoid on date of vaccine (6/18/10). Received prednisone injection by urgent care MD on 6/21/10 and started 5-day course of oral prednisone on 6/21/10.
I experienced an active herpes outbreak.  While I cannot conclusively state the vaccine caused the outbreak I can report that I have not experienced an outbreak in approximately 20 years.
Had vaccine at 3:21 pm Started itching at 4:05 pm- eye lids, scalp, bottom of foot, face felt tight- no respiratory issues. Took Benadryl with moderate relief. Area was red and sore about the size of a ping pong ball area. Area cleared on 121/2021. On 1/22/2021 area of vaccine became red, hard and itching. I took Benadryl with no change. Called provider on 1/23/2021 and was seen virtually.  Area is now between 6-7 cm . Advised to apply ice, topical steroid cream and marked the area,. Prescription for Bactrim was given incase symptoms increased. This helped some on 1/24/2021 in PM area increased , I had general malaise and a stiff neck with joint pain. I started the prescribed Bactrim-for questionable cellulitis.  provider recommended I not receive the second dose
shingles; This is a spontaneous report from a contactable consumer. This consumer reported similar event for mother in law and 3 other people.  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: unknown and Expire Date: unknown) via unspecified route of administration, on an unspecified date as dose number unknown, single for Covid-19 immunization. Patient's medical history and concomitant medications were not reported. After vaccination, the patient experienced shingles on an unspecified date. The outcome of event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 70-year-old male patient who received SHINGRIX for prophylaxis. On 22nd April 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 22nd April 2019, less than a day after receiving SHINGRIX, the patient experienced fever (serious criteria clinically significant/intervention required), chills (serious criteria clinically significant/intervention required), injection site pain (serious criteria clinically significant/intervention required), injection site swelling (serious criteria clinically significant/intervention required), myalgia (serious criteria clinically significant/intervention required) and fatigue (serious criteria clinically significant/intervention required). The patient was treated with paracetamol (Tylenol). On 23rd April 2019, the outcome of the fever and chills were recovered/resolved. On an unknown date, the outcome of the injection site pain, injection site swelling, myalgia and fatigue were not recovered/not resolved. It was unknown if the reporter considered the fever, chills, injection site pain, injection site swelling, myalgia and fatigue to be related to SHINGRIX. Additional details were provided as follows: The patient received 1st dose of SHINGRIX on left deltoid. The patient experienced fever, chills, injection site pain, injection site swelling, myalgia and fatigue after receiving 1st dose of SHINGRIX. The patient was treated with tylenol for fever and chills. This case is linked to case US2019073191, reported by same reporter.
Member had a syncope episode/ vasovagal immediately following the vaccine administration while sitting in the chair. He immediately recovered after the episode and was AAOx3 when transferred to urgent care.
When I first got the vaccine I was fine but as the day went on I felt soreness in my left arm with some stiffness in my neck. Later on in the afternoon, I started getting a headache, neck was getting stiffer and my back started to hurt. When I got home around 5 I fixed some dinner, within 30 minutes or less it felt like my stomach exploded, I was throwing up continuously, it was so intense, I tried sips of water to throwing it up as well. I could feel my esophagus burning up to my throat, and starting to feel like it was closing up. All during this time my eyes hurting and light really bothered me.  I was to afraid to lay down, I  got myself to calm down, and doing deep breathing. That seemed to help me. I was scared. I stayed home through the  night and woke up the next day feeling better.  I still have headaches to this day.
Patient stated had difficulty hearing, tingling of lower lip, dizziness. Code white called (get members of management to area) as well as 911. Spoke with patient and she felt hot and dizzy. Patient felt OK sitting down and did not want to move. Father left to get a short sleeve shirt as she was wearing a sweatshirt. Kept patient talking while waiting for EMS to arrive. Patient was coherent and answered questions accurately. Was asked by management if she was thirsty but I would not let her get water in the event she passed out. EMS arrived and spoke to patient and father and she declined to go to the hospital and within 5 minutes of them arriving they left and patient left with father to go home. Spoke to  office @ 1:06pm and reported adverse reaction.
Information has been received from a physician concerning a 33 year old female patient who on 18-MAY-2011 was vaccinated intramuscularly in the left arm with a dose of PNEUMOVAX 23 (lot # 668008/1157Z), expiration date 08-MAR-2012. The physician reported that on 18-MAY-2011 and within a few hours the patient developed an injection site reaction. The injection site reaction was described as a swollen, warm and painful (sensitive to touch) area from the top of the arm to the elbow. It was unclear at the time of the call if the patient had received a previous vaccination with PNEUMOVAX 23. The physician also mentioned during the call that he had past patients (unspecified names, number and dates) that had not developed pneumococcal immunity after receiving PREVNAR. Treatment given for the adverse events included prednisone and arm soaks. Laboratory diagnostics studies were not performed. at the time of the report, the patient had not recovered. It was reported that the patient sought medical attention by office visit. This is one of two reports from the same source. Additional information has been requested.
Immediately after second dose, my upper left shoulder started to hurt. By 2 hours after, I felt a huge knot in my muscle. By the end of the day, I could not move my left arm due to the excruciating pain in my shoulder and upper arm. The pain was so severe I couldn?t sleep that night from the pain. Next morning I went to the doctor as I couldn?t stand the pain and was concerned something was extremely wrong.  There was fluid built up in my shoulder and my left arm was retaining water even down to my wrist and fingers. Doctor gave me NORCO for the pain. The NORCO didn?t help the pain so I stopped taking after one day. By day 3 I could start to move my arm about 15 degrees from my body without excruciating pain. Each day after day 3 has slowly gotten a little better but my pain has yet to go away.
Patient received Pfizer COVID vaccine on 1/29/21 (lot # EL3302), 2/19/21 (lot # EI3302), and 12/21/21 (lot # FD7218). Patient tested positive for COVID on 5/21/22 and was admitted to our inpatient facility on 5/22/22 with severe sepsis due to COVID-19 pneumonia +/- secondary bacterial pneumonia/aspiration and acute respiratory failure due to COVID-19 and likely secondary bacterial pneumonia/aspiration. Patient was admitted in our med/surg unit and discharged back to her AFH on 5/26/22.
NECK PAIN; OCCASIONAL BACK PAIN; PAIN AROUND LEFT EYE; PAIN IN MUSCLE FROM NECK TO SHOULDER WHILE TURNING HEAD TO LEFT AND RIGHT (MORE TO THE RIGHT); This spontaneous report received from a patient concerned a 73 year old male. 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: 1808609 expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced neck pain. On APR-2021, the subject experienced occasional back pain. On APR-2021, the subject experienced pain around left eye. On APR-2021, the subject experienced pain in muscle from neck to shoulder while turning head to left and right (more to the right). Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the neck pain, occasional back pain, pain around left eye and pain in muscle from neck to shoulder while turning head to left and right (more to the right) was not reported. This report was non-serious.
Dizziness, HYPOtension & Syncope Narrative:  Other Relevant History:
Heart rate got higher like it's skipping and she got lower blood pressure; Heart rate got higher like it's skipping and she got lower blood pressure; This is a spontaneous report from the patient. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not provided), via an unspecified route of administration, on 20Jul2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not provided), on 18Jun2021 as a single dose, for COVID-19 immunization. The patient reported that, after an hour of administration, on 20Jul2021, her heart rate got higher like it was skipping and got lower blood pressure. The outcome of the events was unknown at the time of report.  Information on Lot/Batch information has been requested.
Extreme fatigue , joint pain in knees hips shoulders ankles fever 101.7 -102.5, constipation, pain at site and under arm and to shoulder, lasted 1/23 10pm. Some of the fatigue and inability to wall freely were cleared up some and i was able to move around more through the house  1/23 9 am fever lasted last check 100.7 at 10pm 1/23
Arm soreness at injection site Temp 102 F for 48 hrs Severe shaking chills, rigors for 48 hrs Headache 72 hrs Severe myalgias for 72 hrs Joint pain 72 hrs Sweats, particularly at night for 72 hrs Fatigue for 96 hrs Took multiple doses of Tylenol 1000mg over course of 72 hrs.
Report received from a nurse on 18-OCt-2010 (received via Merck WAES: 1010USA02163). A 69 year old male patient received 0.5ml of AFLURIA, (batch: 11149121A, expiry: 30-JUN-2011) on 05-OCT-2010 for preventative immunization. The patient's concurrent medical conditions included hypertension and hypercholesterolaemia. The patient had no drug allergies. Concomitant medications included amlodipine, atorvastatin, olmesartan and terazosin. On 09-OCT-2010, approximately 4 days post administration with the suspect drug, the patient experienced a grand mal seizure. The patient was transported by ambulance. The patient was admitted to the hospital on a Friday and remained there over the weekend and was discharged on Monday. Tests included a CT (computed tomography) and MRI (magnetic resonance imaging) of the brain and blood tests of which all were normal. The patient said that he had the same experience last year, one month after receiving his flu shot (brand unknown). The event outcome was updated to recovered. The case was reported as serious due to life threatening events, hospitalisation and medical significance. The company considered events possible in relation to the suspect drug. Information derived from this AE report does not change the current safety profile of the product. Follow up 1 (29 Oct 2010): Confirmation from physician, patient date of birth, medical conditions, concomitant medications, vaccination and adverse event date, batch number, tests at hospital, details of previous adverse event to flu shot and patient outcome.
Narrative:  3/172022 ED visit: Pt presented to agency ED with c/o general weakness since yesterday. Pt said he got COVID vaccine yesterday. Denies SOB. Has some cough, body aches at home. He states he woke up with 104 temp today. 3/24/22 - Pt states he is doing okay but says last Wednesday (3/16) he had his COVID booster and the next day he woke up and "felt paralyzed" as he says he could not move. He went to a community ED but after being sent home, he decided to come to the facility. He says a few hours later he felt better and was allowed to be discharged. He says he was having fever and could not walk so he tried crawling but skinned his legs in the process. He is much better today and has no complaints.
Only the adjuvant was given; Only the adjuvant was given; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 56-year-old male patient who received Herpes zoster (Shingrix) (batch number 7C4B3, expiry date 14th November 2022) for prophylaxis.   On 20th August 2021, the patient received Shingrix. On 20th August 2021, unknown after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered and inappropriate preparation of medication. On an unknown date, the outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.  Additional details were provided as follows: The reporter stated that, the patient received only the adjuvant portion of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. This case was linked with cases US2021182201, US2021182199, reported by same reporter for differnt patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021182199:Same reporter US-GLAXOSMITHKLINE-US2021182201:Same reporter
Consumer reports that two of children exp respiratory distress following 2nd immun; pt 2 was immunized 1990;
Per pt she has panic attacks. She felt like she was dizzy, lightheaded, could not breath, heart pounding, and nausea. Pt wanted to step outside, RN had pt sit and take deep breaths. Vitals were WNL. Pt monitored for 30 minutes until stable. pt left w/ husband and advised to f/u w/ MD if s/s worsen.
Haven't had a period for 3 years and then almost 3 weeks after first dose, I had a full period. And now 29 days later, I am having another period.
Pt started w/an uncomfortable feeling in right arm on 01/27/06. On 01/28/06 pt started experiencing a hard, painful, red and very warm area in upper right deltoid. The redness started radiating down right deltoid to the elbow and was continuing at her 01/31/06 office visit. Using Benadryl and cold packs to lesser the Sxs.
This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 82-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included high blood pressure (Diagnosed prior to receiving the vaccine) and high cholesterol (Diagnosed prior to receiving the vaccine). Concomitant products included lisinopril and lovastatin. On 11th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced erythema of extremities, local swelling, itching, stomach ache, pain in arm and swelling arm. The action taken with SHINGRIX was unknown. On an unknown date, the outcome of the erythema of extremities, local swelling, itching, pain in arm and swelling arm were not recovered/not resolved and the outcome of the stomach ache was recovered/resolved. The reporter considered the erythema of extremities, local swelling, itching, pain in arm and swelling arm to be almost certainly related to SHINGRIX. The reporter considered the stomach ache to be unlikely related to SHINGRIX. Additional details were reported as follows: The patient's concomitant medication included Vitamins. The patient's arm was red, sore, had swelling, itches and feels kind of funny (like she can feel something in there, maybe a lump). She stated that she also had a stomach ache but thought it was from something else. The reporter provided her with the appropriate adverse event information from the PI and suggested that she call her physician about her symptoms and for recommendations. Obtain permission to contact MD.
Information has been received from a physician concerning a 14 year old female patient who on 13-FEB-2008 at 12:45 was vaccinated into the left arm with the first dose of GARDASIL (Lot # 659655/1486U). On 13-FEB-2008, immediately after the shot was administered, the patient developed pain in the left arm. She cried for about seven minutes and began to complain of heaviness in her arm and stinging and aching. She then became dizzy and had to lie supine for fifteen minutes. She left the office in stable condition. Within one to two hours she developed swelling and discoloration of all fingers of the left hand. This lasted twenty-four hours and resolved spontaneously. Additional information has been requested.
Patient experienced swelling of lips and itching.  Reports low grade fever, less than 100 F.  Patient took Benadryl and started to feel better.
Shooting pain from wrist to inside of elbow. Inside and outside of forearm have spots that feel numb.
It was determined there was a preparation error on 1/19/23. Between 4-5 individuals received Moderna 6 month to 5 years monovalent formulation. Preppers unintentionally prepared 1 vial of the 6 months to 5-year monovalent formulation (with volume of 0.5 ml per dose) and labeled it as a Moderna 12+ years bivalent formulation. There was a total of 14 patients scheduled to receive the Moderna 12+ years bivalent on 1/19/23. Clinic is unable to determine if patient received the correct bivalent dose versus the Moderna 6 month-5 years monovalent formulation.   Information about other Moderna formulation: Moderna 6 months to 5 years monovalent dose, Lot AS1414B, manuf. exp 2/13/23.  Patient has been notified of vaccine error that may have potentially impacted her. No reported signs/symptoms of adverse reaction.
nausea, dizziness and chest compression with in 15 minutes of shot.  oxygen and laid supine flat.  Itchiness within 60 minutes. Benadryl 25 mg.  Resolution post shot 3 hours, released home.  At 3 PM I experienced chest compression again and used my rescue inhaler with resolution of sx, also took another benadryl Note: I was premedicated with zyrtec and 50 mg of diphenhydramine at the time of the second shot
My arm was very tender for three  days following the shot, so much so that I would wake up from the pain while turning in bed at night. One week after the shot, I noticed that the pain at the injection returned, and  I gently rubbed the area of the injection site, which did not feel as soft as the surrounding muscle.. On the eighth morning following my first injection, the area is still tender, and there is a red blotch approximately 4.5" long and 3.5" wide around the injection sight. It burns slightly and is tender to the touch.
Arm hurts a lot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurts a lot) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-May-2021, the patient experienced PAIN IN EXTREMITY (Arm hurts a lot). The patient was treated with IBUPROFEN for Pain, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm hurts a lot) outcome was unknown.            Concomitant medication included medications for diabetes.
The son came on 05/06 to receive the 2nd dose of Pfizer vaccine and informed us that his mother passed away on 04/18 after 3 days of post vaccination.  A home hospice patient with Stage 5 Chronic kidney disease and Stage 4 COPD (Oxygen dependent) came in on 04/15 around 4:30 pm to receive a first dose of Pfizer. After 15 mandatory waiting in the pharmacy, she went home. Around 5:00 pm, patient told her son that she is feeling nauseated. Hospice nurse was contacted. On 4/16, patient experienced hallucination. She told her son that her fingers were disappeared. Hospice nurse was contacted. Please note that vaccine adverse event is not clearly related to vaccine, since patient was on hospice, stage 5 CKD and stage 4 COPD.