chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 03-MAR-2016 the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot # L044055, expiration date 02-MAY-2017, dosage and route not specified). It was reported that the vaccine was stored at -13.7 degree Centigrade for 15 hours. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
feeling achy; fever; sore arm; Muscle ache; feeling Lousy; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 71-years-old female patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9266), via an unspecified route of administration, administered in Arm Left on 16Feb2021 12:30 as single dose for covid-19 immunization (71 years at the age of vaccination). Medical history included High Blood pressure, Arthritis both from an unknown date and unknown if ongoing. There were no concomitant medications. Family Medical history included heart problems (Both of her parents had heart problems).Historical vaccine included first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EK4176), via an unspecified route of administration, administered in Arm Left on 26Jan2021 as single dose for covid-19 immunization and experienced Sore arm. Patient did not receive other vaccines on the same day or in the 4-week period prior to vaccination. It was reported that mother received second dose yesterday and last night developed fever, feeling achy, took extra strength tylenol and been using ice. Patient wanted to know Is it okay to continue using Tylenol.  The patient experienced feeling achy on 16Feb2021, feeling lousy on Feb2021, fever, sore arm and  muscle ache on 16Feb2021. it was reported that patient had her last shot yesterday and so did her daughter. They both had muscle aches. patient had a fever and was achy. Her daughter had flu like symptoms. Caller stated that she herself has a sore arm and used ice on it. Both her and her daughter are feeling Lousy. Patient had her first shot and had little sore arm, but this time with the second shot both her and her daughter felt bad. her daughter has been on the couch. daughter on the couch. The patient underwent lab tests and procedures which included weight: she lost 46lbs lbs. Therapeutic measures were taken as a result of fever, feeling achy, muscle ache. Sore arm. The outcome for the events was reported as unknown at the time of this report.   Follow-up attempts completed. No further information expected.
Information has been received from a female consumer, of unknown age, concerning herself. On 05-AUG-2012, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and frequency were not reported) (Lot # and expiration date were not reported). On 08-AUG-2012, the patient arm was sore and warm to the touch at the injection site. Patient stated that she was going to have a Dr. Appointment on 10-OCT-2012, and she would bring it up then. Patient also reported that she was fine other than the symptoms that have been mentioned. At the time of the report, the patient outcome was unknown. The relatedness for her arm was sore at the injection site and her arm was warm to the touch at the injection site was unknown for ZOSTAVAX. Additional information is not expected.
Rash that looks like measles with other biopsy and nodes.  Retroauricular.
stabbing chest pain radiating up to shoulder blades for a period of several hours in 10 minute intervals with elevated heart rate, possible pericarditis
Patient said she had rapid heart beat at approximately 5 AM the next day after receiving Flu shot. She also developed rash-hot & red only on both arms. Her heart rate returned to normal by 8 AM when she work up.
Vaccine at 7:30am. Noticed swollen lip with blister at about 11:45am. Had a video appointment/evaluation about 12:15pm and was advised to take two  Benadryl  and repeat every six hours for 24 hours or until swelling subsides. Was advised to go to ER if symptoms worsened.
Patient received Varivax 10/8/08.  C/O pain at injection site throughout day.  Woke in am 10/9/08 with large area of redness/swelling which has increased throughout day.  On exam approximately 4cm circular, slightly warm area surrounding approximately 2cm film, tender area at injection site.
6 weeks after 2nd dose had huge flare up. Pain in all joints .Lasted seemed like 2weeks.since then random flare ups in hands ..wrist..varies,alot in feet and hands.Got third dose had flare up a couple days after shot.hands feet wrist....deep in joints.I dont have reg.dr. and not diagnosed officially but joints are enlarged defirmity... and since shot progressing fast
Patient requested tp receive her annual employee flu vaccination on 10/01/2019. The injection was given IM into the R deltoid muscle after was wiped clean with an alcohol prep pad. Within 5 minutes of the injection, the employee began to complain of excessive itching at the injection site. Approximately 10 minutes later, a visible light red ring appeared around the injection site  about 2" in diameter. After about another 30 minutes, the employee complained of a "hard knot" under the injection site and the ring had become a full darker red circle on her arm that was warm to the touch from inflammation. On 10/03/2019, it was observed that the "knot" and circle are still present. There are no complaints of fever or other symptoms by the employee at this time.
Pfizer-BioNTech COVID- 19 Vaccine EUA: Vaccine recipient experienced dizziness and was monitored by medic for 30 minutes. There was no treatment given.
This spontaneous report was received from a physician via a company representative referring to a female patient "in her 20's". The patient's historical condition, concomitant medications and drug reactions or allergies were not reported. On an unknown date in 2018, reported as "a couple months ago", the patient was vaccinated with PNEUMOVAX 23, for prophylaxis (dosage schedule, anatomical location, lot number and expiration date were not reported). On an unknown date in 2018, after administration, the patient had "an injection site reaction" that was described as "swelling down to the elbow" (injection site joint swelling). The patient sought medical attention and received unspecified treatment for the event. At the time of the report, the patient had recovered from injection site joint swelling. The causality between injection site joint swelling and PNEUMOVAX 23 was unknown.
Pain at injection site plus severe body aches from head to toe, shivering, headache, nausea, and fatigue started in the afternoon and worsened in the evening. Could not move without pain and difficulty. Normal activities extremely limited. Took 3 extra strength TYLENOL at 9 pm. Slept 10 pm-5 am and woke up feeling much better, but still some body aches. Took 2 extra strength TYLENOL at 6 am. Pain at injection site and some redness continues. After 24 hours from injection, most symptoms are better. I'm reporting this incident just to add to the statistics about the number of patients experiencing problems that limit normal activities.
pt recv vax 6SEP96 & 10JUN97 pt devel a moderate varicella type rash consisting of less than 50 lesions;
18 hrs post vaccine, had been very fatigued since the beginning, but started to get uncontrollable shaking, nausea, body pain and racing heart. Checked heart rate and it was up to 170, then plunged to 80, then back up to 170 - it went like this for a while. Called nurse and then advised to call 911. EMS hooked me to EKG and confirmed the same heart rate findings bouncing around between 70s and 150s. Hospital ER diagnosed tachycardia, as a post-vaccine symptom.   Potential unknown underlying issues: POTS (Postural tachycardia syndrome)
Presented to emergency department on 7/27/2021 with fever and altered mental status. She was exposed to COVID-19 by her daughter who lives with her. She was found to be positive for COVID-19 and admitted for further management. She was treated with remdesivir, dexamethasone, and supplemental oxygen during admission. She was discharged from hospital on 7/31/2021 with home hospice services.
a four months old female patient accidently received a 0.25 ml dose of Fluzone Quadrivalent/No AE; Initial information received on 18-Mar-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a four months old female patient who accidently received a first dose of 0.25 ml dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] lot U6653BD, expiry date: 30-Jun-2020 via intramuscular route in the left thigh on 18-Mar-2020 for prophylactic vaccination.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to inappropriate age at vaccine administration.  At the time of reporting no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient had extremely sore arms within an hour after the vaccines.  Within 24 hours she began feeling flu like symptoms with light headed feelings and general bad body aches.  Thirsty.
Patient arrived to COVID vaccine clinic around 9 am on 9/27. She was very nervous to get her shot and verbalized this to other patients while waiting in line. About 15 minutes into her 30-minute observation (allergic to Penicillin and bee venom) a staff member was grabbing an emesis bag for the patient, so I went to assess her. As I approached, the patient slumped over onto the desk and became unresponsive. Patient began shaking all over. I lowered her to the ground and held her head for the duration of the seizure for safety. Another patient came over stating she is a nurse and checked the patient?s pulse, stating it was very fast and weak. Patient was unresponsive and shaking for 1-2 minutes. When the shaking ended, she opened her eyes and was able to ask where she was. After another minute or so, we assisted patient onto the gurney and patient was able to help by using her legs to push up from the floor.  We took patient to the ED for evaluation. Patient remained lethargic but was responsive to voice while en route to the ED
Patient: Arun Walcott- DOB 2/24/2006; CC: Red, painful eyes with blurred vision, right >>L; HPI: patient is a 15 year old AA male with no prior PMH except Allergic rhinitis who was in his USOH until; 8/25- onset of OD erythema, mild eye pain, photosensitivity, ? mildly pruritic, minimally blurred vision, watery but never purulent discharge. No other symptoms at that time. No intercurrent illness. He was treated with Artificial tears and erythromycin with a presumptive dx of atypical viral conjunctivitis. His sxs seemed to slowly self-resolve and by 8/31 most symptoms had resolved except minimal residual erythema. 9/4 Awoke with marked right > left eye pain, erythema, photosensitivity, headache, blurred vision again without purulent discharge. This time associated symptoms - sneezing, congestion, swollen glands under right arm/ right side of neck and fatigue. He complained of a 30 second, chest pain more right-sided which was reproducible on palpation. No tachycardia, no dizziness, no palpitation, No fever, no SOB, no cough, no persistent chest pain. Restarted erythromycin ointment, started  Tylenol 500 mg po q 6hrs, cool compresses; changed to Ibuprofen 400 mg po bid by 9/5; Changed to Vigamox 1 gtt tid on 9/6 until could contact family ophthalmologist on 9/7. Mother became very suspicious for uveitis on 9/5. Seen on 9/8 by local Ophthalmologist who confirmed diagnosis of anterior uveitis with mild vision loss in OD.  Started on Prednisolone gtt on 9/9 ( needed to be ordered by the pharmacy so unavailable for application until 9/9). Patient was reassessed on 9/10 by ophthalmologist but the visual acuity in the right eye was slightly worsened although the erythema and eye pain was marked improved. Photosensitivity and blurred vision are the current symptoms. Current plan is to see a Uveitis specialist on 9/17. Pfizer Covid- 19 vaccination #1 received on 8/20. Pfizer Covid- 19 vaccination # 2received on 9/3. No FH of known autoimmune disorders but Aunt has a high nl ANA of 1:80 as well. Mom had a history of erythema nodosum after Hepatitis B vaccination as an adult. Patient has tolerated all his prior vaccinations without difficulty.
I got a raised, itchy and red rash at the site of the injection. It started about 6 days after the shit and lasted for about 5 days. I also got small rashes all over my body. Although the raised rash around the injection site went away after 5 days, I'm still dealing with small rashes.
Date removed from freezer 8/9/22 . Thaw expiration date 9/8/22 @1100. Dose administered 9/16/22. Doses administered after 30 day thaw expiration. Moderna was contacted for assessment of vaccine activity for both doses. Based on the assessment vaccine maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration per Moderna.   Patient seen in office with complaints of fever, dry cough and rhinorrhea on 9/27/22
Slightly below the injection site, circling about 2 inches in diameter, my upper right arm became very itchy, welted and warm to touch.
I have a swollen lymph node under my right under arm pit the size of an orange.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 01Apr2021 (Lot number: ER8737, Expiration Date: 02Jul2021) at the age of 60 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ATORVASTATIN CALCIUM. Vaccination history included: Bnt162b2 (Lot number: EN6206, Administration time: 10:00 AM, Vaccine location:  Right arm, Dose number: 1), administration date: 11Mar2021, when the patient was 60 years old, for COVID-19 immunisation. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 02Apr2021 22:00, outcome "not recovered", described as "I have a swollen lymph node under my right under arm pit the size of an orange.". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: It was reported that the patient did not had any other vaccine in four weeks. The patient did not taken any prior COVID vaccination and the patient did not had COVID tested post vaccination. The patient did not had any known allergies.  No follow-up attempts are possible. No further information is expected.
Persistent and constant headaches since day after receiving Johnson and Johnson vaccine. At first she rated her headache on a pain scale of 3-4. She said it would come and go and wake up with headaches. Sometimes they would get worse.
Employee reported dizziness that lasted for several hours and a sore throat. Also reported drowsiness.
Case reference number 1999015692-1, is a spontaneous report from a physician/patient. Allergies, medical history and concomitant medications are not specified. The pt received his first and second dose of Havrix on 01/01/99, and 06/01/99, respectively.  Following dose two of Havrix, during next few days and weeks, the pt complained of GI distress, RUQ pain and transient nausea. Liver function test, including bilirubin were elevated slightly ( less than 1.5x normal) Ultrasound was normal. The most recent information received on 06/11/99 reports the condition of the pt is ongoing.
Low fever (about 101) that begun about 16 hours after the injection and lasted for about four hours. Associated minor chills, body aches, fatigue.
12/22/07 pt. seen in office with bruise on (R) thigh where flu shot given - red - hard - raised. Dx with cellulitis, given Omnicef. 12/27/07 Recheck, fever started - had bloody discharge, sent for cultures. After opened wound by doctor, started on Bactrim. 12/29/07 Seen again to check wound. 12/31/07 Opened and drained again.
Developed episodes of shaking, twitching of arms throughout the night after receiving vaccines. Resolved by the next morning. No treatment given. No other change in behavior. Somewhat more fussy.
6x 7 cm induration surrounding injection site in left thigh with swelling of the anterior aspect of entire left thigh. No erythema.
She got her vaccines, her arm became sore with the Shingrix vaccine.  She got it in the evening and felt bad and went to bed, she had nauseated, chills, fever, loss of appetite and weak, and felt so bad that she stayed in bed most of the next day except to feed her cat.  On 6/8/22 she felt better, weak and shaky, diarrhea and had lost some weight.  She had to take the cat to the vet so she got up and did that.  She then noticed  4" x 3" hives on her arm, and had taken a picture but they had gone down in size, so probably had them the initial day.  She did not go to the doctor, and just relaxed and did not take anything for it.  The reaction finally went away, 2 days after the swelling was not as bad.  The symptoms finally went away.  The following week she had loose stools for a few days and lost more weight 3#.  She is never sick and does not know what this is all about.    She is not back to full speed.  She is never getting 2 vaccines at the same time again.  She feels that she was forced to get the vaccine.    She read an article that the efficacy was not as good if she got it with another vaccine and wonders in about 5 months if she needs to get another Shingrix.  She would like to be contacted if she got a bad lot#, and if it is a wise idea for her to get another Shingrix in about 6 months since she waited 8 months.
Hospitalized 1/5 transferred to larger hospital on 1/15 hypoxic respiratory failure due to covid pneumonia with refractory ARDS Intubated, mechanically ventilated, sedated and paralyzed, AKI on CKD, prone/supine cycles.
Suspected vaccination failure; Shingles; Pain; This serious case was reported by a consumer and described the occurrence of vaccination failure in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15-MAR-2023, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and pain (Verbatim: Pain). The patient was treated with paracetamol (Tylenol). The outcome of the vaccination failure was unknown and the outcome of the shingles was resolved and the outcome of the pain was not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingrix.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingrix.   Additional Information: GSK receipt date: 8-JUL-2023 The patient received a dose of Shingrix and had shingles. The patient was diagnosed in emergency room and given prescription for percoset. The seriousness for shingles was reported as intervention required. The reporter consented to follow-up. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Patient was given inj f/m PNEUMOVAX last Friday.  Pt came in today with c/o high fever (103.8) severe pain in rt arm & nausea 30Jan09
Approximately one hour after vaccination my face, neck and back flushed red. Appeared to be a mid grade sunburn. Was gone the next morning. Then on April 23 rd appx  1:00 on my lunch break I took my Rx dose of bacterium for the kidney infection. I had been taking that Rx since the 16th, twice a day. Immediately within 30 minutes my head, Wrist,  knees and ankles  Started to itch. I kept having small places to start itch For the next few hours. However, as the day progressed about seven or 8 PM I started to notice raise welts with white bull?s-eye in the middle. It progressively got very bad overnight. My forearms, my thighs and stomach were covered in hives. The back of my head near my neck was also covered in hives. Are used it?s relief cream and took a Benadryl. On the morning of the 24th I knew it was going to require medical attention. I went to the local walk-in emergency clinic. There I was given a steroid shot to stop the reaction. I was prescribed prednisone for five days to begin taken orally the following morning. I was also instructed to take another antibiotic besides the Bactrim for the kidney infection if needed. As of 6:40 PM on the day of the urgent care visit I have improved greatly. All of the lesions on my forearms are almost completely gone. Little evidence of them remain.However, the tops of my legs have not improved as much as my arms. I am now getting new hives on the inside of my thighs. They are not nearly as bad or intense as the original hives that started on Friday afternoon.
I gave patient the injection and right after he stated he felt faint. I layed him back on the wxam table and waited 5-7 mins. He tried to sit up and felt faint. I noticed that he was pale and diaphoretic. I layed him back down for another 5-7 mins. Sat him up and gave him some water. After sitting for 5 min. he tried to walk out with his dad. He got to the wiating room and sat sown again. He was pale and diaphoretic again. I called Dr from the PICU and explained the situation. She and two other nurses came to the clinic. I took patient's BP and it was 58/24. We placed him in the wheelchair and took him to the ER. Report given to the ER nurses and DR.
Chest pain, palpitation, shortness of breath on exertion, abnormal ECG 2/19/21 . Ignored my symptoms. Stopped working out  and having  caffeine  Symptoms resolved  in 1-2 weeks. Cardiologist exam with 2 D ECHO 3/20/21  was normal .  Changes on ECG were explained as a possible  viral infection.
This spontaneous report received from a nurse referred to a unspecified patients. The patient's medical history, concurrent conditions and concomitant medications were not reported. The nurse reported that an unspecified number of improperly stored doses of GARDASIL 9 (lot number: M030380; expiry date: 01-FEB-2019, lot number: M024261; expiry date: 30-JUL-2018, lot number: M023169; expiry date: 13-JUN-2018, lot number: M018810; expiry date: 28-MAY-2018) was administered to an unspecified number of unspecified patients. The vaccines were stored at 32 F for 13 cumulative hours. No adverse effects reported. This is one of the two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA006253: US-009507513-1612USA006253.
Left leg with Baseball sized knot warm at touch and with redness x 1 month after vaccine was administered.
evening p/vax-inj site began to swell x 2 or 3 days extremely painful-10 days swelling went down bruise devel x 3wk then severe pain devel & cont upper lt arm;