chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The pt reports that he received AVA#3 IM (left arm) on 3/17/10. He was in his normal state of good health at that time. On 3/18/10 the pt noted a 2cm area of redness and swelling around the vaccination site. It was also "itchy". He denied generalized rash, pruritus, SOB, difficulty swallowing, diarrhea, or abd pain. The next day the pt states that the red, swollen area had increased to about 4-5cm and that the itching at the site was worse. He was treated with MOTRIN and BENADRYL with 60% improvement on 3/21/10 and resolution of all sx on 3/22/10. On 9/29/10 the pt received AVA#4 IM (right arm) in the am. Later that evening the pt noted about 2cm of redness and swelling at the injection site again with "itchiness" at that area only. He had no other sx. On 9/30/10 he noted about 4-5cm of redness and swelling and increased itchiness. He reported to medical on 10/1/10. At that time he states that the swelling and redness extended down to his elbow and that it was "very itchy". He was treated with ATARAX and MOTRIN with marked improvement (75%) on 10/3/10 and resolution by 10/4/10. A review of the note 10/2/10: "exam shows local reaction to anthrax vaccination. Advised against anthrax immunization in the future.
It was reported in a published article, that a 10 month old pt with a history of asthma NOS was vaccinated on an unknown date with a dose of hep B virus vaccine. Secondary therapy included a dose of diphtheria toxoid+Hib conj vaccine+pertussis vaccine+tetanus toxoid and a dose of poliovirus vaccine inactivated. Two days post-vaccination, the pt developed anaphylaxis with swollen lips, rash and wheezing. The pt was treated with epinephrine, IM dexamethasone, albuterol an dhydroxyzine syrup. The pt's outcome was not reported. Upon internal review, anaphylaxis, swollen lips, rash and wheezing were determined to be other important medical events (OMIC). Additional info is not expected. It was reported that other patients also developed adverse experiences following vaccinations (WAES0310USA01792, WAES0310USA01902, WAES0310USA01903, WAES0310USA01905 and WAES0310USA01906). Follow up 3/15/05: Patient's outcome is unknown.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation.  The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested positive again 6 days after finishing Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Patient received COVID treatment: patient took the antiviral. Tested positive again 6 days after finishing Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201368703 Same patient, different product and event;
Patient had a site reaction on her arm. Arm was swollen, warm and red for greater than 3 days.
This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer reporting for him/herself. A patient of unspecified age ethnicity and gender received 1st dose of PREVNAR 13, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced pneumonia on an unspecified date 1 week after vaccination. Outcome of the event was unknown.
Started with fever, body chills, pain in left armpit, progressed to hard swelling of lymph nodes around left collarbone, severe lethargy, nausea.
Reports experiencing complete hearing loss in his right ear 2-3 weeks after his first COVID vaccine. It has not resolved.
- Received the first dose of vaccine on 5/1/21. No reactions or issues that day.  - Vertigo started the night of 5/7/21. Fell asleep and woke up 5/8/21 without vertigo, but it started up again that morning and lasted for about an hour. Have not had vertigo since.  - 5/9/21 noticed that the injection site was red and slightly elevated (possibly covid arm), but it was not itchy or sore.  - This morning (5/10/21) woke up with mild, but noticeable, tinnitus in right ear that eventually travelled to left as well.   I have not sought medical treatment, since the tinnitus just started and isn't debilitating.  I also suffer from seasonal allergies, so I am waiting to see if my immune response to the shot may be exacerbating allergy symptoms and causing tinnitus/vertigo/ear issues.
Acute hypoxemic respiratory failure; Hypokalemia; Lactic acidosis; Muscle weakness (generalized); Weakness
Subcutaneous injection formulation administered by other route; no additional adverse effect reported; Information has been received from the office manager who was also the Medical Assistant, concerning a 35-year-old female patient. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not provided.  On 21-JAN-2020 the patient was vaccinated with a properly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX), (Lot # S024369, expiration date 08-JUN-2021) reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT) (Lot # R033667, expiration date on 14-JUN-2021) (dosage not provided) administered intramuscularly instead of subcutaneously (Incorrect route of product administration).  No additional adverse effect was reported.
This spontaneous report as received from a medical assistant refers to a 16 years old patient. The patient was vaccinated with a dose of GARDASIL (lot # H012973; exp date 05-MAR-2015) on 06-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. The medical assistant reported that GARDASIL was exposed to 72 degrees Fahrenheit for 120 hours and the vaccine was administered to the patient after the temperature excursion. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
pt was hosp JUN-mom called & reported info of inc LFT in assoc w/hep B vax;19JUN97 mom reported gall bladder-?-MD ordered diet & rest;
p/vax pt started breaking out on abd & back c/itching; rash has spread to all parts of body; rash has pus in the center; T95
It started out normal, my hand started hurting. About 6 hours later I had a fever of 102.7, This lasted for about 48 hours. My fever then dropped to 101. I got a bullseye rash around the injection site. I went to sleep and the next morning I woke up and it had spread across my shoulder, my scalp, my elbows. The doctor told me to take antihistamine and cold compress. I took Benadryl which stopped it from progressing. Due to my fever, the doctor did not want me into the office. He told me to go to the emergency room if things got worse or I had trouble breathing. It fully resolved in a few days. I still have a slight itch but the rash is no longer visible.
At 4:00pm on 4/28/2021, I woke up paralyzed on one side (left side of body). Stayed in bed and wore off after 1 hour. After 1 hour, my left arm considerably stayed in pain. I took Tylenol  for the pain to subside. Arm was swollen. Swelling went down.  I went to the doctor and there is no swelling. Pain is present at site of injection, limit of mobility. Lifting a box with a certain amount of weight, pain comes on strong the next day at the injection site.
absolutely the most debilitating and severe upper arm/shoulder pain I have ever had. EXCRUCIATING!!!! Woke me up out of a sound sleep and it was nearly a month before I could use that arm. I STILL get twinges in that arm about once a week. I believe it may have been a type of bursitis?? I can not stress how painful this was. On a scale of 1-10, it was a 10.
The client reported sweating and feeling thirsty to EMT. RNs responded. Vitals obtained at 11:25 AM were as follows: BP 116/66, HR 92, O2 99%. The client reported feeling more saliva in his mouth, denied any swelling of his throat or tongue, or shortness of breath. RN offered the client a cool pack and they declined. Repeat vitals obtained at 11:30 AM were as follows: BP 110/74, HR 96, O2 98%. The client started drinking water and stated that it felt normal. The client denied any sweating and stated his mouth felt normal. The client's mother reported a history of rhinitis related to exposure to a guinea pig. Repeat vitals obtained at 11:41 AM were as follows BP 108/82, HR 100, O2 98%. The client stated that he felt normal. The client stated that he ate breakfast this morning. Repeat vitals obtained at 11:46 AM were as follows BP 104/68, HR 99, O2 98%. The client stated he felt his "heart in my eyes" after obtaining the client's blood pressure. The client described this feeling "like a headache." The client described the headache as a 4-5 on a 10 point scale. The client stated the headache was "going all the way back" in his head. The client was alert and oriented to person, place, time, and situation. At 11:51 AM the client reported the headache at a 4 on a 10 point scale. RN provided education to the client and his mother regarding s/s of anaphylaxis and when to seek EMS. The client and his mother voiced understanding of this education. At 11:55AM the client stated that he felt normal. The client ambulated unassisted with a steady gait out of the vaccination site at 11:55 AM.
I received my second dose on 10/13/2021. I had a positive pregnancy test on 10/30/2021 and at this time my last menstrual cycle started on 10/7/2021. This would make my conception week the same week as my second dose. I sarted to miscarry on 11/7/2021. My estimated delivery date would have been 7/14/2022.
Severe acute necrotizing pancreatitis occurred, patient developed multi organ failure and he is currently on life support 9 weeks later.  All causes of pancreatitis have been ruled out.
I had Covid-19 back in November so I had a strong reaction to the first dose for 24 hours. I had joint pain in my knees which was very painful. It lasted for eight weeks and my doctor was unsure whether to get the second shot and decided not to.  I had some joint pain in my elbows and ankle on some days. The joint pain in my knees was different in severity as the eight weeks went on. It ebbed and flowed on different days. I used Biofreeze and it helped a little but I am usually in good shape and exercise 7-10 hours a week. I had to modify my activities to avoid pressure on my knees. It is better now after twelve weeks.
The patient experienced a 4 minute generalized tonic-clonic seizure. She was hospitalized overnight for close observation. No additional seizure activity occurred.
This spontaneous report was received from a certified medical assistant referring to multiple unspecified patients (age and gender unknown). No information regarding the patients' concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. The reporter stated that, on unspecified dates, the patients were vaccinated with improperly stored doses (incorrect product storage) of VARIVAX (lot# L045956 with expiration date 17-NOV-2017; lot# L046888 with expiration date 23-NOV-2017; lot# M004662 with expiration date 27-JAN-2018; lot# M025867 with expiration date 24-MAY-2018; lot# M037008 with expiration date 25-AUG-2018; lot# M039318 with expiration date 20-SEP-2018; and lot number reported as L035141 with expiration date 03-AUG-2018) (strength, dose, frequency, route of administration and anatomical location were not reported) for prophylaxis. The vaccine doses were exposed to a temperature excursion between 15 and 46 Fahrenheit degrees for 7 hours (also reported as "23.9 F"); and between 6 and 14 Fahrenheit degrees for 8 hours and 30 minutes; digital data logger was involved. No adverse effects were reported. Additionally, it was reported that the sterile diluent (unspecified) used to reconstitute the administered vaccine did not undergo a temperature excursion (Lot # M015992 with expiration date 26-NOV-2018; Lot # L037795 with expiration date 04-MAY-2018; Lot # L019306 with expiration date 04-MAR-2018; Lot # L006552 with expiration date 12-NOV-2017; Lot # M001834 with expiration date 08-MAR-2018; Lot # M022946 with expiration date 17-DEC-2018; Lot # M024781 with expiration date 21-FEB-2019. There was not product quality complain (PQC) reported. This is one of three reports received from the same reporter. Additional information has been requested; Sender's Comments: US-009507513-1703USA010175: US-009507513-1704USA001190:
Side effects are pain, redness, swelling at my injection site, on the left arm my limitation of arm movement in injunction site, muscle pain, decreased appetite, chills.
Breakthrough case after three vaccines Pfizer 4/22/21 Lot# Ew0164;  Pfizer 5/13/21 Lot# Ew0183;  Moderna 8/15/22 Lot# 011B22A
Patient was inadvertently given 1 ml of influenza vaccine instead of correct dose (0.5 ml).  Patient reported that her arm was sore x 1 wk but has resolved.
employee received the vaccine without incident; about a half hour to an hour later, ambulatory services where she was getting blood drawn contacted us to notify of the employee having a seizure in the facility while preparing to get blood drawn; the employee reported that she fainted
2nd dose given too early; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 28-JUN-2022 Reporter's Comment: The case was submitted via online. The reporter asked should a patient receive another Shingrix shot if their 2nd one was given too early or was the series completed at that point. The patient received 1st dose Shingrix on 9th June and 2nd dose received on 28th June. No further details provided. The reporter consented to follow up. Additional supportive information: The patient received the 2nd dose of Shingrix earlier than the recommended interval, which led to shortening of vaccination schedule. The year of occurrence of the event was not provided as per source document.
Pt complained red bump and itchy at site of injection. After 7 days of injection.
Had a 4cm round, reddened area on rigth upper arm--flu shot site. Area slightly warm and puffy. Pt. denies any other symptoms.
Clinic visit 3-16-10. 37 yr old female is here for c/o upper left arm pain "since tdap" was given in that area in 03/10/10. Aching L arm 6 days. Most severe last Thurs. Treatment - ice, ADVIL. Limit movement. No fever.  She notes that injection was given higher in L arm very near the shoulder joint. The actual injection was painful when she inserted the needle, possible too deep. Site of injection very high in arm near insertion of deltoid. Not in middle area of muscle. No abscess, no swelling of muscle. Mild tenderness. Range of motion of shoulder mild pain with abduction and ext rotation. No edema. L arm pain. Likely related not to a reaction from immunization but rather from how/where this was injected. To high in muscle where thin, tendonous insertion. Try heat to disperse/improve circulation.
Fluzone Quadrivalent and Adacel vaccines which were stored at 27 C were given to 8 patients/ NO AE; Initial information received on 18-Sep-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves 8 patients (unknown demographics) who received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number: C5661AA and expiry date: 08-Aug-2021) and INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (0.5, pre-filled, lot number: UT7006NA and expiry date: 30-Jun-2021)  which was stored at 25 Celsius and those were unsuitable for use since 01-09-2020 for prophylactic vaccination (product storage error).   The patient's medical history, concomitant medication, past medical treatment, vaccination and family history were not provided.  It was an actual medication error case due to incorrect product storage.  At the time of reporting, no adverse event was reported.  Reporter does not have the patient information or AE details with her and asked if patients should be revaccinated.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On 14-OCT-2015, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB, lot number L016427, expiration date 13-APR-2017, (dose, route and anatomical location were not reported). No adverse effect was reported. There was no concomitant medication reported. This is one of several reports from the same source. Additional information has been requested.
About three weeks after receiving the fourth dose of Pfizer, I started to experience some chest pain on the left side. This pain and aching lasted for several days. I was experiencing indigestion also. I sleep on my left side so I was thinking it could have been from that. Around August, it started to ease up and get better, but then it would come back. When I cough, sneeze or take a really deep breath it hurts. I put myself on the back burner for a while since my mother was sick. I had a doctor's appointment with my PCP in November. I was explaining about my chest pains and how I had it for a while and she was very concerned. She told me to contact a cardiologist. I had an EKG scheduled and the results were normal. I also had an ECHO performed and the results were normal on that as well. I have been prescribed medication, but I haven't taken it yet because my insurance won't cover it. My doctor prescribed a new medication, but the pharmacy is currently out of stock. I have a follow up appointment with the cardiologist in two weeks.
Pt states injection site increased in soreness, itching and became warm and red within 24 hours of injection. Worsened  X another 24 hours. Peaked symptoms at 48 hours and getting better at 72 hours after injection. Presents today with noticeable warmth, reddened area and some swelling.  Getting better.
Two days after Hep A injection was given to patient and twin brother, both developed a rash that appeared similar to Gianotti Crosti syndrome.
5 inch by 3 inch pink/red area of slightly swollen skin surrounding the injection site of VARIVAX he received 48 hours ago; there is a central area of induration approx 1.5 inches in diameter that is extremely painful.
Pt recvd high pitched shrill cry & was pale, unconsolable for 90 minutes; This episode occcured 2 1/2 hrs p/immun; mom called family MD & told it was a purtussis react;
Patient reports that within 2-3 minutes (10:06 AM) after receiving the vaccine that he felt dizzy and light headed with blurry vision. PT pulse was 50 with BP 90/60. EMS called and evaluated patient. BP was 88/52 when EMS arrived and pulse was 60. Before EMS left BP was 100/74. Patient reported feeling better prior to EMS arriving but was still evaluated by EMS.
She was tested positive for Covid on the next day after first dose of vaccine; This is a spontaneous report from a contactable consumer (patient's son) via Pfizer sponsored Program. A 72-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot Number and expiration date was unknown) via an unspecified route of administration on 22Feb2021 (at the age of 72-years-old) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 23Feb2021, the next day of vaccination, patient tested positive to Covid-19 virus. Patient was fully recovered to Covid-19 virus, 4-5 days now without a fever she just back up and running around. Reporter inquired if patient could go ahead and take the 2nd dose to the assigned schedule appointment to her at 15Mar2021. The outcome of the event was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
ACUTE RESPIRATORY FAILURE 7/1/2022 DM 2 W CKD STAGE 3A (GFR 45-59) W HTN
Rash on left upper arm surrounding arm, has increased in size since 11/28/2017. On 11/29/2017, patient went to MD office for Abx on 11/30/17.
Heavy and prolonged bruising associated with minimal bodily contact. Severe bruising when contact is more substantial. This bruising is very abnormal for me and extremely long lasting after a bruise forms/ is visible.
PATIENT REPORTED PAIN IMMEDIATELY AFTER INJECTION. I (PHARMACIST) INFORMED PATIENT THAT IS NORMAL TO HAVE INJECTION-SITE PAIN AFTER A SHINGRIX VACCINATION. PATIENT CALLED BACK TO STORE MANAGEMENT AND STATED HER PAIN HAS PERSISTED FOR A MONTH.
She states that she felt lightheaded and that her vision  "went black" for about 10 seconds, during which time she was standing and holding  on to her husband, and then quickly recovered spontaneously and subsequently felt  fine. Has had a previous history of this adverse event with previous injections. Namely the allergy shots she gets from her allergist.
The pt was given a Pfizer adult dose and formulation instead of the pediatric dose and formulation
first noticed inc soreness @ site w/in 6hr p/vax;that evening 2 staff hit rt deltoid for a joke while @ work;next day inc redness & warmth noted @ site 3in x 3in area;denies any SOB, wheezing or resp diff;
Large area of patients arm became red, swollen and warm - right arm. More than a normal reaction. MD put on antibiotics.
Tiredness; Mild headache; Sore arm; This is a spontaneous report from a contactable consumer (patient). A 72-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm right on 17Feb2021 at 14:30 (age at vaccination was 72-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. No medical history was reported. No known allergies. The concomitant medications were not reported. On 17Feb2021 at 16:30 , the patient experienced tiredness, mild headache and sore arm. No treatment was received. No covid prior vaccination and no covid tested post vaccination. The outcome of the events was recovered on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
Patient reports experiencing hypotension with blood pressure of 55/39. The onset was 12 hours after receiving the booster. Patient reports the symptoms lasted 12 hours.