chrisvoncsefalvay/vaers-outcomes huggingface dataset:
muscle pain increased after the second dose; her anxiety increased after the second dose; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program COVAX US Support. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not provided) via an unspecified route of administration on 11Mar2021 as a single dose for COVID-19 immunisation. Medical history included spinal cord disorder, anxiety, muscle pain and breast cancer (survivor for 33 years). Concomitant medications included blood pressure (unspecified),blood thinner (unspecified), pain medication and anxiety medication. Patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not provided) via an unspecified route of administration on 12Feb2021 as a single dose for COVID-19 immunization and experienced injection site swelling. On an unspecified date in 2021, patient had anxiety and muscle pain increased after the second dose. The patient wanted to know if other people experienced the same adverse reaction as she did. The outcome for the events were unknown.  No follow-up attempts are needed. No further information is expected.
Pt came back on 9/12/18 to show me her arms. Her PREVNAR shot was read and swollen about 2 inches out around the injection site. It was warm to the touch. She said that she was not able to lift her arm. I told her that typically that shot can cause the arm to be very sore the next couple of days. She said the area is slightly tender to touch. Her right arm where the flu shot was given was also swollen but not was much. It was not near as read and it was slightly warm to the touch as well. She stated that it was not as sore as the PREVNAR shot. I told patient to take ibuprofen and to place ice packs on both areas for 15 minutes. She said that she has a doctors appointment tomorrow and is going to have her MD take a look at it tomorrow as well.
20 weeks pregnant (due Aug 23) Within five minutes strong vasovagal response, blood pressure significantly dropped, dizziness, nausea,  extreme sweating, threw up, nearly passed out. Recovered enough to go thirty minutes later.  Around 12:30am that night woke with chills, body aches, which eventually turned to fever and body aches which lasted until tylenol administration.
Injection site pain; inappropriate schedule of vaccine; This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site pain and incomplete course of vaccination. On an unknown date, the outcome of the injection site pain and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per vaccine indication. The pharmacy student stated some patients at the pharmacy have missed the 2-6 month window for the second dose. The pharmacy student also mentioned that patients often report pain from the injection after getting Shingrix. Till the time of reporting patients did not received the 2nd dose, which led to incomplete course of vaccination. The pharmacy student consented to follow up. Additional details not provided at the time of this call, but pharmacy student granted permission to follow up. This case has been linked with US2019174653, reported by same reporter.
Narrative:  Pt received a covid vaccine EUA (J&J) on 6/8/2021 from medical facility patient 49 yo female. This patient has never previously been seen at medical facility for medical care. This patient has never been seen at medical facility for medical case since this date. Pt died on 09/28/2022 at unknown place and of unknown cause and unknown medical history. NO INFORMATION AVAILABLE IN MEDICAL RECORDS other than provided in this report. Likely covid vaccine is not related to this death given long length of time between date of vaccine and date of death.
Shortness of breath, fatigue, myalgia, low Vit D, slight brain fog, change to taste
Cough and wheezing noted 1/5, seen by PMD 1/15, worsened and sent to ED 1/16 - admitted resp distress and code blue that night, intubated and transferred to PICU, currently on oscillator.
Raised red rash on torso, back, buttox, legs, and arms. Went to the doctor - told it looked like an allergic reaction to the vaccine.  Given 5 day round of prednisone and told to take antihistamine.  Rash has stopped spreading and is beginning to clear. No previous reaction to any vaccination.
PATIENT WAS GIVEN PFIZER COVID VACCINE AND IS UNDER 12 YEARS OF AGE
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 44 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received paxlovid treatment from 04May2023 to 08May2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Significant swelling, redness & blister formation that drained (L) lower thigh. Resolved over few days.
I experienced itching in the left arm and became really red a week after receiving the vaccine. I went to Urgent Care the Nurse gave me a topical steroid (Cortisone) to apply to the areas where the large circular raised area on my left arm where it was painful to the touch. I had the rash for a week and then it went away.
Patient has a 25mm diameter welt of redness and swelling at injection site that is tender and warm to touch.
nausea, sharp intermittent epigastric pain, diaphoresis, dizziness
soreness in the shot area; Initial information received on 10-Dec-2020 regarding an unsolicited valid non-serious case was received from a consumer (patient) via social media.  This case involves a 76 years old patient of unknown gender who reported soreness in the shot area (vaccination site pain) was reported, while he/she received vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site, for Prophylactic vaccination.  On an unknown date, it was reported that the patient had been getting the flu shot for years, only reaction was a little soreness in the shot area (vaccination site pain), reported that it was not a big deal. (Unknown latency) following the administration of Influenza Vaccine.   No laboratory data was reported.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown.  No further information was reported.
Lips started tingling,  Left side of face felt droopy but did not look droopy to others, Sweating then extreme cold, face was red, dizzy, head pain on the left side and mottling of the hands.  When I got home my lymph node in my neck swelled up on the left side and remains swollen today.  Teeth also hurt after eating anything. Extreme tiredness and nausea.
6/8/10 10:48 -Pt. received HPV #2 and TB PPD. 11:09 -Pt. and mother were checking out. Pt. with syncopal episode in hallway, landed on R side of face/forehead. Aroused shortly after with use of ammonia inhalant. Examined by MD, MD monitored pt. Pt. will be back in office on Fri 6-11-10 to have PPD read.
01/18/22 presents to ED for "dyspnea on exertion". PMHx of "CHF, CKD, DM, HTN, HLD, RAS s/p renal stenting in 2020, CAD s/p CABG in 2016"
Patient experienced immediate side effects right after her first dose of Pfizer Covid vaccine.  The symptoms including shortness of breath, chest tightness, tremor and nausea.  The pharmacist on duty had to call for 911 due to her conditions.
Knot near the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Knot near the injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced VACCINATION SITE REACTION (Knot near the injection site). At the time of the report, VACCINATION SITE REACTION (Knot near the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no treatment drug included  Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Follow-up received TCR document and contain no new information.
Fainting spell (had it in line too, before receiving vaccine) - given juice and crackers.
Received undiluted dose of vaccine; Received undiluted dose of vaccine; headache; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team, Program ID. The reporter is the parent.  A 5-year-old female patient received BNT162b2 (BNT162B2), on 16Oct2022 at 13:00 as dose 1, 0.2 ml single (Lot number: FT1551) at the age of 5 years, in left arm for COVID-19 immunization. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HEADACHE (non-serious) with onset Oct2022, outcome "unknown"; OVERDOSE (non-serious), PRODUCT PREPARATION ERROR (non-serious) all with onset 16Oct2022 at 13:00, outcome "unknown" and all described as "Received undiluted dose of vaccine".  Additional information: The reporter stated her 5 year old daughter received a dose of the vaccine that was not diluted. Reporter tried to clarify if this was the Orange Cap vaccine that the patient received but this was unknown by the caller as the vaccine was administered by a pharmacy. Reporter was just concerned about any long term side effects for her daughter. Stated that she was taking the patient to the pediatrician on reported date (17Oct2022, at 10:45) but has not been to the physician's office at time of call. This was the first dose of the Pfizer BioNTech Covid 19 Vaccine for the patient. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations were not available) was reported as none. No additional Vaccines were administered on same date of the Pfizer Suspect. Prior vaccinations (within 4 weeks) or any other vaccinations prior to the first administration date of the suspect vaccine was reported as none. No AE(s) following prior vaccinations. Upon receipt of FU(17Oct2022), reporter updated, the patient hasn't had any reactions in terms of respiratory or anything. Patient was doing okay on the day of reporting and patient just complained of a headache.
The only affect on myself was soreness in my left arm at the injection site for several weeks following the vaccine. My son is 2 years old and still nursing a few times a day. He has sever and persistent vomiting followed by an intermittent low grade fever for several days . While having the fevers occurred his entire body was covered in a rash. The rash was tiny red bumps that didn?t seem to itch and went way almost completely during the times the fever went away.
I experienced weakness on my right side along with numbness/dizziness and a headache and went to see my doctor who informed me that I was having a stroke while I was at the clinic from work. I was immediately transported to the hospital by the fire department (feeling in my right side started to return while being transported to the hospital). I was admitted to the hospital and a series of tests were administered to find out the cause of my stroke. I was administered medication to reduce my blood pressure and cholesterol along with aspirin 81mg and Atorvastatin during my 3-day stay. I received a prescription for the medication upon being released from the hospital.
Onset of shingles within 5 days of 2nd Moderna COVID-19 vaccination. No prior hx of shingles. Received 1st dose of Shingrix vaccine in November 2020.
Patient reported (today - 10/6/16) that after receiving the vaccine on 9/30/16 she had flushing, swelling at the injection site (pretty large). Rash, itchiness, and headache. She self medicated with Benadryl and Hydrocortisone topically (OTC). She asked that we report the reaction.
Lightheadedness for several days, then increased dizziness/vertigo and fatigue for 3 weeks
pt recv vax & 1-2 days later devel a huge area of redness & swelling @ inj site;
Localized erythematous rash to area of vaccination on l upper arm. Also a preexisting mosquito bite on the same arm of vaccination.
Patient received vaccination and reports redness and swelling 3-4 inches below shot the next day. The red, swollen area is approximately 2 inches x 3-4 inches and warm to touch.
Redness of the skin below the injection site about a size of a credit card after 2 days of receiving vaccination. Patient felt achy for a couple of days but feels fine. No achiness or rash.
The patient began having pain in the left underarm area about 24 hours after the shot. Forty hours after the shot patient's left axillary lymph node swelled and has stayed swollen for 4 days. Swelling has spread to neck lymph nodes as well but not as severe. Swelling in the underarm is roughly the size of grapefruit.
Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # was reported as M002218, expiration date 03-SEP-2017; dose and route were unknown). No adverse effects was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Fever at night. Chills for 2 days. Lethargy and Swollen painful burning injection site.
Paresthesias started 9/21/2022 in arms and legs. NCV/EMG and Skin biopsy on 12/08/2022 Diagnosis of small fiber neuropathy.
Information has been received from a health professional concerning an adolescent male pt who on 06/06/95 was vaccinated with a dose of varicella virus vaccine live (Lot # 608580/0408B).  There was no concomitant medication. "Over the past week", on approximately 02/13/04, the pt developed chickenpox. He developed about 300 lesions with nausea and a low grade fever. He was treated with Benadryl over the counter orally and topically. Unspecified medical attention was sought. No product quality complaint was involved. The pt's sister (WAES # 0402USA01853) had a similar experience after vaccination with varicella virus vaccine live (Lot # 608580/0408B). Additional information has been requested. Follow up information indicated that approximately 9 years after given varicella virus vaccine live, on Jan 30 2004, the child developed chickenpox. It was reported at 9:00 am that he had over 300 lesions. The patient recovered on Feb 4 2004. There were no lab or diagnostic test done. It was also reported that the mother was concerned that he developed chicken pox after receiving the vaccine. Additional information is not expected.
Sicker than I have been in a long time; Having a sore was the least of my problems; Was tired; This case was reported by a consumer and described the occurrence of sickness in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingles vaccine with an associated reaction of no adverse event (received the original shingles vaccine several years ago from reporting day with no adverse reaction) and shingrix with an associated reaction of pain in extremity (1st dose received on unknown date and  experienced sore arm refer case US2021AMR000324).   On 28th December 2020, the patient received the 2nd dose of Shingrix. On 28th December 2020, less than a day after receiving Shingrix, the patient experienced sickness, pain and tiredness. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the sickness and pain were unknown and the outcome of the tiredness was recovered/resolved.   It was unknown if the reporter considered the sickness, pain and tiredness to be related to Shingrix.  Additional details were reported as follows: The patient was in reasonably good health. The patient got so sick within 8 hours of receiving her 2nd Shingrix vaccine. The patient had every side effect listed except fever. The patient was approximately 7-8 hours was sicker than she had  been in a long time. The patient was sore and was tired for 2 days after vaccination with no other side effects, fine at the time of reporting. The patient was extremely worried that she had Covid but she had none of the other Covid symptoms. The patient was received the original shingles vaccine several years ago with no adverse reaction. The patient was retired GSK employee. GSK was paying  pension and most of medical to patient hence she wanted to keep GSK up to date.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR000324:Same reporter
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 13-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). On 13-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was also not provided.  Treatment activities for event was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Follow up received as no new information.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this unspecified age female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
C/O violent shaking, crushing chest pain and left sided paralysis the evening of 9/1/06. Episode lasted approx 2 hours. The following day had severe head ache. All symptoms resolved within 36 hours.
MOTHER STATES THE CHILD HAD HER PREVNAR VACCINE WEDNESDAY 9/10/08 AND AREA BECAME RED HOT AND SWOLLEN. AREA APPROXIMATELY 6.5 BY 5CM. TX WAS COLD PACK TO THE AREA
Started feeling pain in right side (opposite side of shot) about 2 am on 2/9/21. Got worse during day and no sleep at all 2/9/21. Called Dr. 2/10/21 for appt next day. Severe pain on right side under armpit, shoulder and neck. Very painful to lay down (would get spasms), could not lift right arm at all and extremely painful to bend over. At 2/11/21 appt, was prescribed 10 mg Zyrtec twice daily, Aleve every 10 hours and Hydrocodone 5-325 mg at bedtime. Was able to get a little sleep 2/11/21 but pain back with a vengeance 2/12/21. On the morning of 2/13/21, the pain was less on right side but now also on left side in same areas.
Developed  right facial droop in the hospital, lead to a  new diagnosis of Bell's Palsy  (MRI no evidence for stroke,  CT no acute abnormality)  She has Johnson and Johnson Vaccine and she is currently hospitalized after a fall at home
Approx 9 days post MMR immun developed painful swollen lymph glands in her neck & throat area. 6MAR she developed a red rash on her chest & abd. fatigue was also present along w/aching joints.
Cramping in arm and hand - noticeable swelling (3rd Hep B) day after. Cramping started day vaccine was given 8-14-13. Still cramping today 8-16-13 but better - still small amount of swelling as well. No other vaccine given that day only TB test done in same arm. Sore to touch.
I took the vaccine at 4:25pm on April 7. On April 8 at 4am, I started feeling sick, chills, feet was cold, a lot of pain on my body, headache, couldnt sleep. I took Ibuprofen 800 and 1 hour later I was feeling a little better. I was able to sleep. When I woke up I was fine. Around 11am on April 8 I started feeling very sick again. I had diarrhea all day.   Evacuated about 10 times during the day. I felt dizzy, nauseas, no fever, pain on my arm, heavy shoulders, back pain, head was lightweight. I took ibuprofen at 12pm and then 8pm. I was able to sleep from April 8 to April 9 and woke up without severe symptoms, only arm pain.
Case number PHEH2013US022291, is an initial spontaneous report received from the health care professional on 22 Oct 2013. This report refers to an 11-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: A12119) intramuscularly on 24 Sep 2013. It was reported that before administration, the vaccine was stored at 31.2 F for 12 hours. No adverse event was experienced following this mal-administration.
patient received pnuemovax and fluzone quad in same arm on 08/14 and returned 08/16 with red band of swelling below the injection sites. patient reported pain/soreness with it. Visually inspected for rash or blisters and found none. Red area was warmer than non. Patient reported it looked better than day 1 of noticing the redness. Instructed patient to take TYLENOL/Ibuprofen for heat/swelling/pain and she stated she was already had been. Also advised to take BENADRYL if it began to itch and contact the doctor in 48 hours if there was no improvement.
Fever of 105F; decreased slightly with Tylenol (given X1). By 08:00 AM, father concerned that son had a seizure. MD visit and admitted to the hospital for observation. Pt had slight diarrhea. Parent states client had a headache the morning of 4/4/01 but was well at the time of shots. No seizure noted in the hospital. Parent states client was aphasic for a short time. Discharged without dx of symptoms and clear tests.