chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case, was initially received from pharmacist on 11-Dec-2017 and concerns a 59-year-old, adult, female patient. The patient's medical history included hypertension, affective psychosis and vaginitis since an unspecified date. The patient's concomitant medications included simvastatin, losartan with hydrochlorothiazide, escitalopram and TRINTELLIX for an unknown indication. On 03-Nov-2017, the patient was administered with FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 179903P and expiry date: 31-May-2018). On the same day after vaccination, the patient had severe muscle soreness in the left arm, where the vaccine was administered. It was reported that the patient had little stiffness in the shoulder, little residual soreness in left arm and unable to rotate her arm. The patient did not receive any treatment for the events. On an unspecified date, the patient had recovered from the events. The reporter assessed the case as non-serious. Follow-up received from pharmacist on 25-Jan-2018: The pharmacist confirmed that patient had recovered from the event. Narrative amended accordingly. Follow-up received from pharmacist on 14-Mar-2018: The events (shoulder stiffness and mobility decreased) were added. It was reported that, the patient still had a little stiffness in the shoulder, little residual soreness in left arm and unable to rotate her arm. The outcome of the event (injection site pain) was changed from recovered to not recovered. The reporter also confirmed that, the patient had not received any treatment for the event. Narrative amended accordingly. Follow-up information received from the pharmacist on 20-Apr-2018: It was confirmed that the patient had not been administered with any treatment medication(s). The outcome of the events was updated to recovered from not recovered/ not resolved and narrative was amended accordingly.
15cm soft warm erythematous at L thigh at injection site. sent home for observation by mom. Tx with OTC benadryl or tylenol. Return if not resolved in 2-3 days or worsens.
A few weeks after COVID19 vaccine dose 2, experienced extreme stiffness pain in knees (bilateral) and pubic symphysis, such that rolling over, getting out of bed, walking, stairs was difficult and painful.  No swelling or warmth noted.  Pain in pubic symphysis mostly resolved by August 2021, knees mostly resolved by September 2021 (although some residual pain). Bilateral stiffness pain in shoulders began in August/September 2021, and is ongoing. Again, no swelling or warmth noted.
Patient stayed at pharmacy for 20 min and felt fine. Later that night she told her daughter she wasn't feeling well. She talked with her doctor that morning. Doctor didn't think it was from vaccine. Daughter took her to ER that day. Pt was slightly dehydrated w/UTI, BP was low ER doctor told her to never get flu shot again.
My tinnitus got noticeably "louder" very soon after the vaccine.  Most recently, my left ear has been plugged for about 5 days from today, which exacerbates the tinnitus in that ear.  My ear is still plugged and ringing.  I essentially can't hear out of my left ear.  I haven't sought medical help, but plan to.
Patient states her arm has been sore & slightly dysfunctional since the administration of this vaccine.
Arm soreness; vaccine was not administered in the deltoid muscle - it was 4 or 5 inches lower on arm; A spontaneous report/solicited was received from a 53-year-old female nurse who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced vaccine was not administered in the deltoid muscle, it was 4 or 5 inches lower on arm.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 09 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 in the arm for prophylaxis of COVID-19 infection.   After receiving the vaccine, the patient reports that the vaccine was not administered in the deltoid muscle, it was 4 or 5 inches lower on arm. It was unknown if the vaccine was given intramuscularly. The patient also experienced arm soreness. No treatment was rendered for the event.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, vaccine was not administered in the deltoid muscle, it was 4 or 5 inches lower on arm, was considered resolved on 09 Jan 2021. The outcome of the event, sore arm, was unknown.; Reporter's Comments: This case concerns a 53-year old female patient who experienced an unexpected non-serious event of Pain in extremity after receiving their first of two planned doses of mRNA-1273 (Lot unknown). Additionally, the patient had Product administered at inappropriate site. Based on temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded and the event is considered possibly related to the vaccine.
Rash on right thigh on 4/28.  Vaccine given 4-25-08.  DURICEF prescribed.
Consumer reports injections site started with redness and rash approx. 4-6 hours after injection. Not reported to anyone until 11-14-08. RN visited and reported to doctor - 9 cm x 9 cm red rash surrounding injection site and site tender to touch. Doctor ordered BENADRYL and TYLENOL.
First noticed red splotch on arm with a radius of 1.5" around the shot location. Two days later Splotch turned dark red with bumps.  Pain in arm and numbness made me go to immediate care and a physician on 10/21.
suspected vaccination failure; I still get them; I have taken three shots; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and extra dose administered. On an unknown date, the outcome of the vaccination failure, shingles and extra dose administered were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.  Additional details were provided as follows The patient had reported for him/herself. The age at vaccination was not reported. The patient received three shots of Shingles vaccine which led to extra dose administered. After receiving Shingles vaccine, the patient still got shingles. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation were not provided.
Affected my arm; My elbow and around elbow too, it seems like when I grip my fist together, it hurts there and if I lift something, grips my fist and pull up, it hurts; It seems like my joint or like straight out to it, it hurts; This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Batch/Lot Number: EWO185), via an unspecified route of administration, administered on 30Jun2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: unknown), via unspecified route of administration, administered on unspecified date as dose 1, single for COVID-19 immunisation and experienced ache. It was reported that on an unspecified date in Jul2021, the patient had a vaccine shot, the second one, patient affected arm, elbow and around elbow too, it seems like when patient grip fist together, it hurts there and if lift something, grips patient fist and pull up, it hurts and it has been three weeks that is why (sentence incomplete). Patient looked online and it says it is for couple of days, it is not couple of days, it is three weeks. Patient just wanted to know what (sentence incomplete). On an unspecified date in 2021, it seems like joint or like straight out to it, it hurts, it's a kind of (sentence incomplete), it was not worse, but it was not better, it was just the same amount." Patient stated as, "I have got EWO185, I don't know if it is O or 0, let me read it again, it is EW and then I think it is 0185 or it is O, I am not sure if it is O or 0." and just wanted to know about the side effect why it was not going away. The outcome of event was not recovered.
Rash on trunk spreading to arms and upper thighs occurred on 3/30/21 in the early evening.  Redness and itchiness persisted for about 4 hours.  Long bath with taken to soak, Benadryl tablets taken, aloe lotion applied.  Rash diminished and disappeared completely after about 6 hours.
Patient came for nurse only visit for influenza vaccine. Nurse collected wrong dose 0.5 ml versus 0.25 ml.
The patient claims that the next day after being given the vaccine, they started to get a red itchy rash all over their body. The worst was the upper torso and arms. They did not start any new medications or go outside or do anything that could really result in this reaction. They saw the doctor a week later and the doctor gave the patient a MEDROL dose pack and ATARAX to help with the rash and itching. This helped and the patient is doing better, but they still have some of the rash even 2 weeks later.
Vaccine administered at 9:30am. At 9:36am patient reported lightheadedness, dizziness, and feeling clammy. HR 50, RR 17, BP 100/70, O2 100%. Phone call to regional medical director, instructed to give patient food and water and monitor for 30 minutes. At 10:05am patient stated she was feeling well. HR 88, RR 15, BP 110/80, O2 98% at 10:05am. Patient left via personal vehicle with spouse driving.
pt recvd vax & 24 hrs p/vax exp painful fever blister on the lower lip that lasted 2 wks; 24 hrs p/2nd dose of vax exp a chronic painful fever blister on upper & lower lip that appears to start fading away, but a/it totally clears up erupts
Edema, redness & pain to right upper extremity, Injection site & surrounding area.
Within 45 minutes of vaccine, my left leg went numb. 2 days after my left cheek went numb. I had vaccine on 8/2/07 and I am still experiencing worsening symptoms on 8/9/07. I now have tingling "electric" feeling in leg and arm.
Provider did not realize patient received multivaccine KINRIX previously and thought she had not received IPV and ordered dose today. Patient received 2 doses IPV. Discussed with CDC to monitor for adverse reaction, none known according to CDC.
Sudden onset of tinnitus 2 weeks post shot #2. As of today, 9 weeks post-onset, still constant with no improvement.
No adverse event; HCP states that they administered 16 shots to patients after their expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 048L21A) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was unknown if patient had any relevant medical history conditions, allergy, concomitant diseases and risk factor.     In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date).    No concomitant medication was reported.  Suspect product dosage text was reported as unknown. The intact cartons of 0.5 ml of were initially stored in the refrigerator and the thaw dates were the same as administration dates as 01-Sep-2022 ,25-Aug-2022, 04-Aug-2022, 26-Jul-2022 and 19-Jul-2022. The vial did not undergo any temperature excursions. No treatment medication was reported. This case is reported for patient 9 out of 16 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-739796 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-739796:master case
Adverse reaction to the COVID vaccine.  Pt. complained of aches all over, wanting to vomit, feeling shaky, heart beating fast, and seeing colors. Pt. was presented at ER for observation.
pt reported 2 days past inject redness & swelling lt arm region. Area of induration approx 4cm
Moderate Pain at injection site, Chills, Sleep issues, Nausea, Arm very swollen.
Symptoms began in A.M. of 6/11/08 with redness, swelling, warm to touch and mild bruising in Left arm where Dtap was given on 6/9/08.   Mom  will take him to see health care provider 6/11/08.
asthma has been "real bad"; can't go to work or walk 10 feet with an asthma attack; can't go to work or walk 10 feet with an asthma attack; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 17Sep2021 as dose 2, single (Lot number: FW01F0) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (ongoing), notes: Comments: Asthma history of asthma. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: FC3183), administration date: 25Aug2021, when the patient was 60-year-old, for COVID-19 Immunization. The following information was reported: ASTHMA (non-serious) with onset Oct2021, outcome "not recovered", described as "asthma has been "real bad""; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), GAIT DISTURBANCE (non-serious) all with onset Oct2021, outcome "not recovered" and all described as "can't go to work or walk 10 feet with an asthma attack". Therapeutic measures were taken as a result of asthma.  Additional information: The reporter stated the patient had a history of asthma and the patient was fine for about a month after receiving the vaccines but after receiving the vaccines his asthma has been "real bad", so much so that he can't go to work or walk 10 feet with an asthma attack. The patient "never had a problem of  asthma".  It was reported that the patient was using Prednisone, Trilogy and nebulizer before the Pfizer Covid-19 vaccines and had been taking them for a long time and had taken them after the vaccines.
Event occured after 2nd dose of Covid  vaccine.  12/16/21: Day of the admission when the patient fell from the toilet and she may had a seizure patient also was more confused and disoriented.Patient came to the emergency evaluated at the emergency the oxygen saturation was 83% patient to be on 3 L of oxygen to keep her saturation over 90%. And the patient had a Covid test came back positive
This is a spontaneous report from a contactable pharmacist received from a Pfizer sales representative. A 67-year-old female patient received PREVNAR 13 (NDC number: 00005197102, lot R49357, exp.date 31May2018) at 0.5 ml single dose via intramuscular route in her left arm, on 09Aug2017 18:30. On unknown date the patient also received the first dose of FLUAD (lot 178502, exp.date 01Apr2018) via intramuscular route in the right arm. Relevant medical history was Diabetes. On 09Aug2017 the patient experienced a bump on her arm, painful bump in her arm, her arm was really hurts and her arm is hard to move. The outcome of the events was not recovered.
Sneezing; Runny nose; Dry cough; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Mar-2021 and was forwarded to Moderna on 01-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (Sneezing), RHINORRHOEA (Runny nose) and COUGH (Dry cough) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-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 SNEEZING (Sneezing), RHINORRHOEA (Runny nose) and COUGH (Dry cough). At the time of the report, SNEEZING (Sneezing), RHINORRHOEA (Runny nose) and COUGH (Dry cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-029896 (E2B Linked Report).; Sender's Comments:  MOD-2021-029896:
Patient woke the following day complaining of cough, body aches, and congestion that lasted for 2 weeks.
Information has been received from a medical assistant concerning a 66 year old female with a penicillin allergy, who on 18-JAN-2005 at approximately 16:00, was vaccinated IM into the right arm with a dose of Pneumovax 23 (lot # 647657/0947N). There was no illness at the time of vaccination. At approximately 18:00 "dinner time", the pt complained of increased itching and swelling on her right arm. Four hours after vaccination, she experienced SOB. The pt was noted to have a local reaction to the injection. It was reported that her doctor told her to take Benadryl which improved her symptoms. On approximately 19-JAN-2005, the pt recovered. It was also reported that this was not her first dose of Pneumovax 23. No product quality complaint was involved.
COVID Arm -- Painful rash that was symmetrical around the injection site in left arm. This lasted for 3-4 days and then faded. It measured around 5" diameter on average and was more or less a circle on my shoulder moving down my arm.
7 days p/vax pt exp abd pain, devel henoch Schonlein purpura, easily bleeding/bruising, internal bleeding from blood vessels, lesions, arthritis, & kidney problems;ER visit required;to bathroom 4-5x in 20min & just dribble;
Extreme body pain and lymph node swelling. Unable to move.  Left armpit (vaccine administered on left arm) so swollen as to be bruised. Body aches and muscle weakness due to pain extreme.
Information has been received from a consumer concerning a friend who on an unspecified date was vaccinated with a dose of Zostavax (Oka/Merck). Subsequently the patient developed a case of shingles. It was unspecified if medical attention was sought. The patient's outcome was not reported. There was no product quality complaint involved. No further information is available.
redness/rash inches below injection site on lower portion of arm occurring about 5-6 days after vaccination. no treatment given yet. patient has no other signs/symptoms. she has been told to contact her doctor if redness doesn't go away soon.
Patient said he felt warm and lightheaded. He was pale. I observed the patient and directed him to remain seating while monitoring him. I gave him some cool water and instructed him to remove his sweater. It was warm in the store so I placed a fan so he could cool off.  He waited about an additional 15 minutes in our consultation room after which time he said he was feeling better and was able to leave the store under his own volition. I tried calling about an hour later but received no response.
episode of crying for 2 1/2 hrs p/receiving DTP vax; occured 3-4 hrs p/inject; resolved w/o treatment;
Red, raised, painful area 2'x2" at site of injection (L) upper arm with 6x2 cm area Zylol med on injection site with 10.5 x 12 cm pus area around it. 2x32 purple bruise below rahs on arm.
Pt called 1 pm, Nov 4, 2015 - no injection site rxn - said felt like had flu during night, throat tightened - fine at time of call.
h/a next day fine 3rd dose of vax 30SEP95 w/h/a w/in 1/2hr of vax;7OCT95 had 4th dose of vax w/h/a, fever 101, malaise, arthralgia, myalgia;apple sized lump @ site w/tingling;next dose due 26OCT95;
21 x 20 area, 16 x 12 area both arm, red, raised, itching.
pt recv vax & 2 wk later pt exp a stiff neck & h/a; No further details were provided;
Arm began to hurt in injection site over 2 weeks after 1st dose.; Cannot move my arm.; Left side frozen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Apr2021 08:30 (Lot number: EW0170) as dose 1, single for covid-19 immunisation. Relevant medical history included: "known_allergies penicillin" (unspecified if ongoing), notes: known_allergies penicillin. The patient's concomitant medications were not reported. The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious) with onset 12May2021, outcome "unknown", described as "Left side frozen"; VACCINATION SITE PAIN (non-serious) with onset 16May2021 06:00, outcome "not recovered", described as "Arm began to hurt in injection site over 2 weeks after 1st dose."; LIMB DISCOMFORT (non-serious) with onset 16May2021 06:00, outcome "not recovered", described as "Cannot move my arm.". Therapeutic measures were not taken as a result of musculoskeletal stiffness.  Additional information: Prior to the COVID vaccine, the patient did not receive any other vaccines within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment drug received for the adverse events.  No follow-up attempts are possible. No further information is expected.
01/19/21 @ 4:30 pm Body aches, chills, headache and runny nose for tow days. Verbalize feeling well and recovered.
Weeping rash and surrounding cellulitis developed the day after vaccine administration. Treatment with cephalexin and mupirocin.
Pt presented back to us at 17:40 with 5" X 4" red, hot, itchy, swollen and indurated area of R deltoid. The rash induration, etc was also on L cheek, under chin, L arm and R thigh of variable sizes. No involvement in mouth, throat, tongue. At 17:43, 5mg Benadryl IM L arm was administered. Approx. 5 minutes later, redness was beginning to subside; alter 30 minutes much improvement was seen. No breathing difficulty. Adjusted Benadryl 4-6 hrs prn and if breathing, throat, or tongue swelling occurs call 911.