chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pneumovax 23 was loaded into the pyxis on 14Feb2020 at 1057 and was administered to this patient on 16Feb2020 at 0940. The vaccine was at room temperature (69F).; No additional adverse effects reported; This spontaneous report was received from a pharmacy technician, and refers to a 62 year old patient of unknown gender. Information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions or allergies was not provided.       On 14-FEB-2020, the dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # S028602 with an expiration date in 28-JUN-2021), was loaded into the system at 10: 57 and was left at room temperature of 69 degrees Fahrenheit until 16-FEB-2020 at 09:40 (72 hours), when the patient was vaccinated via intramuscular (strength, dose and frequency were not provided), for prophylaxis. As a result, it was also reported that the patient was hospitalized on an unspecified date in February 2020 (reported as "the patient was still in the hospital as it was being monitored by medical professionals"). It was also reported that there was no previous temperature excursion and that the digital data logger was not involved. No additional adverse effects were reported.  This is one of two reports received from the same reporter regarding different patients.; Sender's Comments:  US-009507513-2002USA008585:
Pt recvd vax on 2DEC91 & on 3DEC rash started aobut 3-4" below inject site; 2" wide rash that itches; rash runs down arm & branched @ elbow & continued on inner aspect of arm also; red welts on inner arm; MD stated minor allergic rxn;
Morning of 1-16-2009 noticed back pain, throughout that morning developed what felt like a mild fevers and generalized muscles aches "flu-like" feelings. Took an Aleve and felt a little better. On Sat, 1-17 noticed a rash at the injection site. Sunday 1-18 noticed rash on trunk. New rash has resolved, eyes are still bloodshot and have been since Sunday.
2 x 0.5 in diameter 4 discrete erythematous macules with scabbing.
pt recvd vax SEP95 & 14SEP95 pt exp a generalized rash; No further details were provided;
BAD REACTION; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced bad reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bad reaction was not reported. This report was non-serious.
HE WAS MOVING (TWITCHING AND HAVING MUSCLE SPASMS) EVERY 2-3 SECONDS DURING SLEEP.  HAD ONE SHORT SEIZURE AND ALSO DEVELOPED A TEMPORARY (48 HOUR) TIC.
Pt reported feeling throat tightness and difficulty swallowing, chest warmness, tachycardia and nausea with both legs elevated. Pt vomited and dry heaved. At 6:05pm, pt reported resolution of tightness. Be advised that the person involved requested to be released and denied further treatment by going to ER.  Signed written document stating despite recommending being seen at ER, she wanted to leave on her own free will.
head cold; Sinus headache; Chills; Runny nose; congestion/ nose congested; This is a spontaneous report from a sponsored program. The contactable consumer (Patient) reported for herself. A 65-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EN6198, Expiration date: unknown), via an unspecified route of administration, administered in Arm Left on 20Feb2021 16:00 (age at vaccination was 65 years) as dose 1, single for COVID-19 immunization. The patient's medical history included genital herpes from an unknown date and unknown if ongoing Verbatim: Genital herpes. Concomitant medication included ibuprofen taken for an unspecified indication, start and stop date were not reported. On Feb2021 the patient experienced chills, runny nose, congestion/ nose congested. On an unspecified date the patient experienced head cold. On 21Feb2021 the patient experienced sinus headache. Patient states that the literature was given but it doesn't list "don't take any medication" she didn't see anything like that. Caller states that she is so stressed, she had a splitting headache and took just 1 pill of 200mg Advil, then later that same day, she had the shot. Patient went to bed and had chills woke up with a head cold. It might have been on its way but she doesn't think its a side effect. The headache and clenching of teeth that caused jaw pain was prior to the first dose, she took the Advil for the headache and jaw pain at about 10-11AM same day. The Chills and head cold was on the same day starting around when she got into bed, she fell asleep woke up in the middle of the night with a runny nose, and her nose congested. The next day on 21Feb2021 she felt the sinus headache. At the moment, the ongoing symptoms are the runny nose, congestion, and the sinus in the head, but with all she was getting better. She was schedule for the second dose on 12Mar2021. Patient got genital herpes, she has had no outbreak for years, but she was having a slight outbreak because of all the stress, this recent outbreak began about 2 weeks ago. The patient underwent lab tests and procedures which included weight which showed 123lbs or 124lbs result on an unspecified date. The outcome of the events chills and head cold was unknown. The outcome of the events runny nose, congestion/ nose congested and sinus headache was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt began experiencing seizure almost immediately after receiving the vaccine. He complained of chest pain then became confused about his location and did not recognize familiar people including his wife..
WE ADMINISTERED THE BIVALENT BOOSTER AND PT SHOULD HAVE RECEIVED MONOVALENT FIRST DOSE.
Chills, lethargy, tremor 11/15/16. 11/17/16 Broke out in a rash. She saw Dr. and they told her the worst was behind her.
Within minutes of vaccine, table was lowered, nurse turned around & pt. fell off the table straight to the floor face first and start seizing for approximately 1 full minute. The doctor said this happened because the child got up, but he never got up, he passed out & fell face first off their table. As his mother I got to him more quickly than the nurse who had turned her back to him, i got him to a soft surface to evaluate and call the nurse & doctor over before the nurse even reLized what had happened. My son is a healthy 11 yr old who is a gymnast & very active. He has never fainted in his life so to blame this seizure on a faint due to him trying to get up too quickly was absolutely uncalled for. My child bruised his face so severely we had to have xrays ordered to determine if there were any breaks to his face. Thankfully no fractures were visible in the xrays. His left arm where both injections were instilled was unusable for 5 full days due to the pain. We were at the doctor until 1 pm being evaluated by the doctor and having xrays afyer his shot was administered. There is still another week left where reactions could still occur so we are monitoring him for any additional events related to these vaccines.
1. Few minutes after the injection had paresthesia of the tongue that persists today - day 5 2. Moderate left arm pain shortly after that has decreased with medications but persistent today. Now mild 3. Lymphadenopathy of left side of neck, swelling of left axilla/left Supra and infraclavicular areas that are visible, bumps and swelling of left upper arm and elbow area 4. Low grade tactile fever
MODERNA COVID VACCINE #3 GIVEN 12/2/21, LOT #069F21A; pt brought to ED from a nursing home via EMS for SOB and had a positive COVID test; treated with dexamethasone, remdesivir, baricitinib, ABX; transferred to CCU with NRB; Dubhoff tube placed due to dysphagia; worsening respiratory status with low O2 saturations in the 80s% with maximum Airvo setting with overlying NRB mask; family decided on hospice in hospital; taken off Airvo; comfort medications given; pt passed away in the hospital
This spontaneous report as received from a pharmacist refers to a 21 year old female patient. The patient had no drug reaction/allergies. The patient's pertinent medical history included hypertension and anxiety. Past medical history was not provided. On 28-AUG-2015, the patient was vaccinated with first dose of VARIVAX (Merck) (strength, dose, lot #, vaccination site, route unspecified). Concomitant therapies included ZOLOFT, WELLBUTRIN and metoprolol. Approximately on 29-AUG-2015 (reported as one day later), the patient developed a small red bump at the injection site which was resolved on an unspecified date in 2015. On 29-SEP-2015, the patient received the second dose of VARIVAX (Merck) (lot# L004650 and expiry date: 11-FEB-2017, strength, dose, vaccination site, route unspecified). Approximately on 30-SEP-2015 (reported as one day later), the patient developed a red bump at the injection site that grew to the size of a lemon. The patient sought medical attention and visited her physician on 01-OCT-2015. The physician recommended the patient to admit in the hospital because of the adverse reaction. On 01-OCT-2015, the patient was admitted to the hospital and was diagnosed with cellulitis at the injection site while in the hospital. The pharmacist reported that, while in the hospital the patient was treated with BENADRYL, prednisone, acetaminophen, tramadol and vancomycin for unspecified reasons. Approximately in October 2015 (reported as while in hospital), the patient developed itchiness from vancomycin and was switched to doxycycline. The patient was discharged from the hospital on 03-OCT-2015. The outcome of the events cellulitis and pruritus was reported as recovering/resolving. The causality assessment was not provided. No product quality complaint was reported for VARIVAX (Merck). The event, cellulitis was considered to be serious due to hospitalization. Additional information has been requested.
After 2nd shot, my lymph node in my left arm (which I got the shot) swelled up to the size of half a baseball and the swelling went into my  left breast muscle. This was found by my acupuncturist. Pain was horrible in armpit for a week. After 5-7 days I had horrible pain in my shoulders down to my hands in both the joints and muscles. Muscle pain was sensitive to the touch. I continue with this pain and tenderness to this day. My rheumatologist had me do a steroid taper since my CK was elevated. I then did 2 more solumedrol taper's from other pain.
Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unspecified date in 2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, subsequent to inoculation, the pt was treated for shingles. The pt had and would continue suffering ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. At the time of the report, the outcome of shingles was unknown. The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
Had a very mild case of COVID in November.  Slight muscle tenderness for 1 day after first shot.  Have had same symptoms as COVID but much worse after 2nd shot.  Symptoms started Day 4 after vaccine and continue today.  Running fever for 5 days now.  Still sick.  Flu test was negative although I doubted it was anything else since I rarely get sick and when I do it only lasts a day or two.  Will have a few hours where I finally think I am getting better and then another wave hits.
Patient already had complete shingrix series 4 years ago, but still made appointment to get another shingles vaccine. Pharmacy software was not able to flag the error. Doctor told patient to get shingrix possibly due to not being aware of their vaccination history. Patient was able to make appointment for shingrix. Patient received vaccine without incident but later questioned about the dosing schedule of shingrix. After further investigation into their vaccination history, it was discovered that the patient already had 2 shingrix vaccines 4 years ago and did not need a third dose.
Information has been received from a physician concerning a patient who was vaccinated with the first dose of RotaTeq vaccine (lot number not available). The physician reported that the patient subsequently developed diarrhea. Unspecified medical attention was sought. Subsequently, the patient recovered. It was noted that the patient did not receive the second or third dose of RotaTeq vaccine. Additional information has been requested.
Severe dizziness,nausea,vomiting,diarrhea and headache
Receive Bivalent Booster from a vial that experienced excursion for 1 minute in the refrigerator; No adverse event; Bivalent Booster from a vial that experienced excursion for 1 minute in the refrigerator and administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Bivalent Booster from a vial that experienced excursion for 1 minute in the refrigerator and administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (Receive Bivalent Booster from a vial that experienced excursion for 1 minute in the refrigerator) and NO ADVERSE EVENT (No adverse event) in a 69-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. o13B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Bivalent Booster from a vial that experienced excursion for 1 minute in the refrigerator and administered to patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Receive Bivalent Booster from a vial that experienced excursion for 1 minute in the refrigerator) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Bivalent Booster from a vial that experienced excursion for 1 minute in the refrigerator and administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (Receive Bivalent Booster from a vial that experienced excursion for 1 minute in the refrigerator) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Bivalent Booster from a vial that experienced excursion for 1 minute in the refrigerator and administered to patient) and PRODUCT TEMPERATURE EXCURSION ISSUE (Receive Bivalent Booster from a vial that experienced excursion for 1 minute in the refrigerator).    No concomitant medicine were reported. It was reported that on 14-Oct-2022, the temperature went for vial up to 8.2C for 1 minute.  There has not been a previous excursion.  The vial was moved from Freezer to the refrigerator on 13-Oct-2022. The patient received 1 Booster Dose on Monday 17-Oct-2022 and the vial was discarded within 12 hours after first puncture. No treatment medicine were reported.
?Moderna COVID-19 Vaccine EUA? The day I got the vaccine all that happened was a dead arm and then when I was driving home after the 15 minutes of waiting in the parking lot, I got a metallic taste in my mouth, but it didn't last very long. The next day my arm was sore to move, but not at the injection spot, if looking at my arm (someone else) it was down 3 inches and to the left about 1 inch. The next day that same spot was still sore but to the touch, then it went away.    What is more interesting and concerning is that on 1/6/2021 (a week after I got the shot), I noticed 3 little bumps on my arm (9:45pm), in that same location that was sore to move and touch on day 2 and 3 but they also were itchy. When I woke up the next morning (6:15 am) the area had spread to the size of my palm (3 inch by 3 inch roughly)  it was all red, hard to the touch,  stilly itchy and I had the feeling of a dead arm again. One of the nurses at my work drew a circle around the red spot so we could watch to see if it was still growing , by roughly 11:45 am it had grown an additional 2 inches.
90yr old female presents to the Ed with complaints of an infected bunion on her left foot.  Her nurse that does the dressing change was thinking that it needs lanced.  She states she's had it for a week and she has no pain.  She also has a surgical site on her left leg that Dr. removed a hematoma.  She has drainage on the bandages on her leg and bunion. 1. Cellulitis of lower extremity, unspecified laterality    2. Abscess of left foot    3. Open wounds involving multiple regions of lower extremity    4. History of MRSA infection  Patient was brought from her group home to the ED with concerns for left foot pain. Provider states that he has concerns based on the xray that the patient might be developing an osteomyelitis.   Diagnosis:     ICD-10-CM   1. Venous stasis  I87.8   2. Cellulitis of right lower extremity  L03.115   Acute Problems 1.Purulent cellulitis of left foot, with osteomyelitis 2. Non-oliguric AKI   ASSESSMENT/PLAN Left lower extremity foot wound (suspected osteomyelitis) with associated cellulitis             - Continue cefepime and vancomycin             - Podiatry would like INR of 1.5 for surgery. Discussed case this morning with Dr.  I did note that FFP is transient but can be given to reduce INR if procedure is planned for today. He noted he will check with OR but procedure maybe done tomorrow. I did note transient nature of FFP and he did request that we give FFP incase procedure done today. FFP given while he performed beside debridement today but will plan formal I&D. Given this will give Vit K 2.5mg PO x 1 so INR will hopefully be ~1.5 tomorrow             - Discussed with patient need for reversal as Podiatry would like procedure done more urgently.    Acute kidney injury -this is improved with gentle hydration and holding home lisinopril and Lasix.  Resolved.   Hypertension -continue metoprolol.  Holding lisinopril and Lasix. Chronic atrial fibrillation -warfarin held for possible procedure.  INR is 2.02.  Continue metoprolol Venous stasis dermatitis -holding Lasix due to AKI. Left groin intertrigo -continue ketoconazole cream twice daily   - DVT prophylaxis -INR is therapeutic
I broke in hives all over my body for 5 days in a row.  Very itchy welts.
Baby cried immediately after vaccine but within 10 minutes he was limp and unable to arouse for 2 minutes.  911 called immediately.  Went to ER for observation and released in 1 hours.
My son's 2nd HPV shot was on 1/28/22. He complained at the time that this shot really hurt. I didn't think much of it, as he had both Covid vaccines earlier with no issues that I noticed.  3 weeks after the 2nd dose of HPV he complained for a couple of days that his chest hurt inside (Feb. 17/18, 2022). He had arm muscle fatigue that day and did not shoot well at archery practice.  On 2/22/22, he was acting "manic" during a family bowling outing. Back home, he had what seemed like a panic attack. He got really itchy all over and was scratching the top of his head and body. He gave him an antihistamine, thinking he was having some kind of allergic reaction. His nose was running and he was agitated and kept muttering about too much schoolwork. Eventually he was able to calm down and got to sleep.  3/4/22 - Patient fell on the stairs at school on his way to lunch and injured his right thumb. The school nurse called and his father and I picked him up and brought him home. He seemed subdued. This was the first time I received a call home from school during Patient's entire school career.  3/7/22 - Patient fell again after archery practice in the parking lot and was very upset. He said these falls were embarrassing. (No history of falls before this; and no falls after this time that we're aware of).  April/May 2022 - present - Patient has developed what seems like general anxiety. It's a part of his daily life now. He is very obsessed about homework deadlines, how he says his words and if he's saying them correctly, etc. We took him to a few counseling sessions in fall 2022 which he resented, but we encouraged him they would be for his benefit (his doctor encouraged this). His anxiety is "under control" for the most part and he's doing well academically, but it's so odd to me that these symptoms developed so rapidly following that 2nd dose of HPV. Prior to this time, Patient was not an anxious child.  This is the first time I have reported an adverse vaccine reaction for anyone in my family, myself included. Generally speaking I have no issues with vaccines. But due to my son's anxiety following the HPV vaccine, I do not plan to have my daughter get this one and I would like to alert other parents to potential dangers with this particular vaccine.
Pt reported on 11/09/05 that she experienced a hive on right arm, and swelling and redness from deltoid area to elbow. Pt referred to PCP on 11/11/05 TC from pt. Pt seen by PCP and prescribed Cephalexin 500mg x 3 days and withal prednisolone fm today.
Starting 06/07/2022, my whole family got sick. I knew right away it was COVID-19. I tested myself right away and it was a strong positive. I was out of work for about 5 days. I saw the doctor on video on day 4. I believe the symptoms lasted about 14 days but not 100% sure. I had very severe congestion and couldn't breathe through my nose for 4-5 days and intense headaches and body aches. Also, severe coughing.
pain & redness on lt arm near & around inj site;seen in ER & put on  IV ATB;CBC & blood cult done;arm was warm & red;pain &  redness spread to armpit & lt side of breast;to ER;T99.5;lt arm was warm to touch;hot & red around inj site;pain;
soreness in site shoulder within 30 minutes tiredness within 2 hours, lasted 24 hours chills, sweating, and nausea after 3 hours, lasted 24 hours vomiting, happened once 22 hours after shot
COVID-19 breakthrough. It started out as a head cold with sinus congestion and coughing. I also had exhaustion. I treated myself with Advil cold and sinus. I took some Mucinex to combat the cough.
Pain in joints alternatively,  Wrists, Hands and Fingers, Knees and Sholders.
Patient stated that he had severe arm pain after receiving the flu shot and could not move his arm. Patient has been to ortho doctor that diagnosed him as having bursitis in the arm that received the shot.
Pruritis, erythema, swelling, soreness in arm at injection site 3cm from area raised welt . Benedryl.
PT FAINTED AT COUNTER WHEN LEAVING CLINIC. ASSESSED BY MD. BROUGHT TO EXAM ROOM AND WATCHED FOR 30 MIN, VS TAKEN FREQ. WATER GIVEN.