chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received from a health care professional on 22 December 2011. The reporter in this case is the same as case number 2011-12527. A 31-year-old female patient received an intramuscular right deltoid injection of ADACEL, sanofi pasteur Ltd. lot number C4015AA, on 16 December 2011. On 16 December 2011, the patient experienced pain at the injection site and developed a red, swollen upper arm and fever. The patient was post C-section. The patient was hospitalized (reason not specified). She was diagnosed with cellulitis. Concerns were that the fever could have been related to an endometritis. The patient's cultures were negative. The patient received treatment with intravenous (IV) antibiotics and oral antibiotics for 10 days. The outcome was reported as not recovered. Documents held by sender: None.
Pt reports she began having covid like symptoms beginning last Monday. Pt tested positive for covid-19 on 12/20. Pt reports since that time she has progressively worsening symptoms. Pt asked PCP about receiving monoclonal antibody therapy on 12/21, but never heard back and she states that is something she is still interested in. Pt was then evaluated here in the ED on 12/25 for worsening covid-19 symptoms. She received some fluids and was ultimately discharged home. Pt was then seen via telemedicine on 12/26 with questions regarding covid-19. Pt returns to the ED today with concerns of worsening covid-19 symptoms. Pt states she is having trouble breathing with SOA, productive cough with yellow sputum, and chest tightness. Pt states SOA is worse with ambulation, but just sitting at rest she feels short of breath as well. Pt also states she has been taking Tylenol around the clock for fever, but has been unable to keep her fever down with Tmax 101F. Pt complains of associated fatigue, weakness, chills, and headache. Pt endorses congestion, sore throat, rhinorrhea, and sneezing as well. Pt states she has had constipation and nausea since last Monday. She states this has lead to decreased appetite and poor PO intake. Pt denies any changes in vision, chest pain, abdominal pain, dysuria, dizziness, or syncope. Pt is ~91-94% on room air, but desats to ~84% with ambulation. Pt is tachycardic in the 100s at rest, but with ambulation pt's HR jumps into the 140s. Pt was currently hemodynamically stable at time of assessment.    Not requiring oxygen at rest but needing 2L on ambulation. She completed a course of remdesivir. While inpatient, CXR demosntrated some vascular congestion. She received Lasix 40mg IV x3d inpatient with improvement in her oxygenation and stamina.  She feels stable and ready for discharge. I agree with her and feel that she has maximized her benefit from being in the hospital. She will be discharged home with 2 more days of diuretics (bumex 1mg every day) as well as dexamethasone.   Discharge Disposition/Condition Disposition: Home Condition: Stable (s/sx potential problems absent or manageable)
fever, fatigue, swollen arm   I was told by my Primary Care Physician and Pharmacist that my vaccine was not effective because I received the 2nd dose to soon.   Please note that the pharmacist advised me to report this information because this could have happened to others.
Skin abscess (L) upper arm at site of flu vaccine. Antibiotic did not help. Had to have I+D of abscess by surgeon.
Patient had redness and warmness from injection site down to elbow. Prescriber stated it was cellulitis.
7x6 cm area of swelling and erythema over site of injection (R) upper arm beg day after vaccination. Rx KEFLEX 500 mg Q6 hr x 7 dy with warm compress.
I got the shot around 11am Thursday 4/29, worked the rest of the day (office job, at home) by evening I felt kind of run down and tired.  Relaxed and watched tv in bed a lot of the evening.  Slight headache, couldn't get to sleep but stayed in bed.  Around 3am that night I decided to get up and get some ibuprofen from the kitchen.  By the time I reached the kitchen, I felt woozy, like I had stood up too soon.  Stopped for a moment till I felt steady and then continued to walk to the cabinet, I also was going to take a xanax to help me sleep (prior to this I had not taken a xanex for probably 4-6 weeks).  I put the xanax in my mouth, grabbed the bottle of ibuprofen and felt like I should lay back down asap.  Took a few steps and passed out and hit my head on small round table shelf.  When I came to, I realized I had not even swallowed the xanex yet, it was still in my mouth. I'm guessing I wasn't out long but my husband didn't hear me fall so that is unclear.  After I woke up and got back in bed, I realized my head was bleeding some from hitting the table.  It appeared to be a small cut on the back of my head and I did not seek medical attention.  I do intend to go to dr to get checked out for what I am guessing is a mild concussion, I have an appt for tomorrow.  There seem to be 2 areas of impact on my head.  I am assuming the back of my head hit the table shelf (near the floor), which was cracked from my head hitting it, and the other impact is to the right side of my head, which I assume is from the table leg.  I think there is only a cut on the back of my head, and not the right side.
This spontaneous report was received from a registered nurse referring to  two patients of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (strength, dose and route of administration were not reported) (lot # R017642, expiry date: 20-JUN-2020 (also reported as 02-JUL-2020)) for prophylaxis (product storage error). The vaccine was stored in between -14 °C (degrees Celsius) to -10 °C for 6 hours 15 minutes and between -9 °C to 8 °C for 1 hour 45 minutes. There was no previous temperature excursion. No adverse symptoms were reported. No product quality complaint (PQC) was involved. This is a non-valid case due to lack of patient identifiers. Follow up information was received on 06-DEC-2018 from the registered nurse referring to 3 unspecified patients of unknown age and gender. The reporter stated that the temperature excursion had taken place on 08-NOV-2018. The patients received improperly stored doses of VARIVAX on unknown date in November 2018 (reported as between 09-NOV-2018 and 13-NOV-2018). Additionally, the reporter stated that a second temperature excursion took place on 13-NOV-2018 involving the same batches of VARIVAX. Follow up information was received on 10-DEC-2018 from the registered nurse. Upon receipt of follow-up information it was determined that this case is now valid because patient information were updated. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1812USA005348: US-009507513-1812USA005347:
patient had a knot, swelling, area warm to touch as well as redness and streaks from the area, she had a doctor appointment  2 days after vaccinations and they found the area and said it was cellulitis, patient was given doxycycline to treat the cellulitis
There was no immediate reaction to the injection.  Roughly 9-10 days after receiving the injection the right arm became swollen and red.  As the redness expanded the arm also became hot to the touch which caused me to seek medical attention.  I was diagnosed with cellulitis which required treatment with antibiotics.
cough, nasal congestion, fatigue and asthma. Adding prednisone for your asthma as discussed Take with food No ibuprofen while on this Take your albuterol inhaler every 4-6 hours while you are coughing For your allergies - continue the Zyrtec and add Flonase Stay hydrated Stay home
2 shots given 3/13/12 (L) thigh. Redness noted next day on both sites. Infant started scratching the area. One site became excoriated with secondary infection. Came follow up 3/20/12.
Patient had JNJ vaccine, booster should be given at 0.25 ml. Patient was administered with 0.5 ml. Called patient, he had mild headache 12 hours post vaccine, drank water, NSAIDS, headache gone. No other side effect by the end of 11/17/21. Called patient at 1940 on 11/17/21, his wife and patient both stated he was feeling "just fine".
I had fever; headache; body aches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Mar2021 12:00 (Lot number: EP6955) at the age of 68 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (ongoing), notes: Concurrent: Hypertension; "Hypothyroidism" (ongoing), notes: Concurrent: Hypothyroidism; "Glaucoma" (ongoing), notes: Concurrent: Glaucoma; "Vitamin D3 insufficiency" (ongoing), notes: Concurrent: Vitamin D3 insufficiency; "depression" (ongoing), notes: Concurrent: Depression; "coronary calcification" (ongoing), notes: Concurrent: coronary calcification; "COVID-19", start date: 09Dec2020 (unspecified if ongoing), notes: History: COVID-19 on Approximately 09Dec2021; "frequent UTIs" (unspecified if ongoing), notes: History: frequent UTIs; "spinal fusion L4-L5" (unspecified if ongoing), notes: History: spinal fusion L4-L5; "osteoporosis" (unspecified if ongoing), notes: History: osteoporosis; "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing); "environmental allergies" (ongoing), notes: Concurrent: environmental allergies. Concomitant medication(s) included: ATORVASTATIN; METOPROLOL; BENAZEPRIL/HCTZ. Past drug history included: Erythromycin, reaction(s): "known allergies: Erythromycin"; Flagyl, reaction(s): "known allergies:Flagyl"; Ciprofloxacin, reaction(s): "known allergies:Ciprofloxacin". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6206, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 05Mar2021, when the patient was 68 years old, for Covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 30Mar2021, outcome "recovered" (Mar2021), described as "I had fever"; HEADACHE (non-serious) with onset 30Mar2021, outcome "recovered" (Mar2021), described as "headache"; PAIN (non-serious) with onset 30Mar2021, outcome "recovered" (Mar2021), described as "body aches". The patient received her booster on 18Oct2021. During the week of 08Nov2021 through 11Nov2021, the patient was caring for her sick granddaughter, and on 11Nov2021, the patient began had headaches, sinus congestion and fatigue. On 15Nov2021 and 16Nov2021, the patient additionally experienced low grade fever (99.8 degrees F). The fever resolved on 16Nov2021. On the date of this report, 18Nov2021, the headaches, sinus congestion, and fatigue were improving, but not totally resolved. The patient was seen at urgent care on 18Nov2021, had a rapid COVID-19 test, and tested positive for COVID- 19. The patient was also diagnosed with a secondary sinus infection for which the patient was prescribed doxycycline hyclate 100 mg capsules, twice daily for 10 days.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101722126 Same reporter/SD, Different dose (2nd)/AE
Patient was admitted to observation level of care on 6-29 for weakness likely due to covid. Patient tested positive for covin on 6-29. Patient has improved and stable to discharge home on this date.
NAUSEA; FEVER; SLIGHT ARM PAIN; This spontaneous report received from a patient concerned a 63 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 180890 expiry: UNKNOWN) dose was not reported, administered on 02-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, Laboratory data included: Body temperature (NR: not provided) 99.8. On 02-MAY-2021, the subject experienced slight arm pain. On 04-MAY-2021, the subject experienced nausea. On 04-MAY-2021, the subject experienced fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 97. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slight arm pain on 02-MAY-2021, and had not recovered from nausea, and fever. This report was non-serious.
Localized tissue edema to left deltoid at the site of pneumococcal vaccine about 4 hours ago.
Local: swelling, redness, warmth Systemic: myalgias, arthralgias
pt broke out w/itchy erythema vesicular rash on trunk & abd;no tx prescribed other than symptomatic;
black and blue mark that was red and  left; black and blue mark that was red and  left; was tired   after the Booster of Moderna; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (black and blue mark that was red and  left), ERYTHEMA (black and blue mark that was red and  left) and FATIGUE (was tired   after the Booster of Moderna) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN DISCOLOURATION (black and blue mark that was red and  left), ERYTHEMA (black and blue mark that was red and  left) and FATIGUE (was tired   after the Booster of Moderna). At the time of the report, SKIN DISCOLOURATION (black and blue mark that was red and  left), ERYTHEMA (black and blue mark that was red and  left) and FATIGUE (was tired   after the Booster of Moderna) outcome was unknown.            No concomitant medications were reported.  Treatment information was not provided.
Per patients' mom and dad they noticed that patient was limping with is (R) leg while running on 3/22/15 at about 4pm. Patient just had his vaccines as listed below at 2pm at our office. Patient with normal neurological evaluation today 3/24/16.
Rt leg 2-2 1/2" in diameter-red, swollen area at injection site x 2 days.
Described as red blotchy rash which occurred 1-2 days after vaccine (mother stated it looked like hives over abdomen and lower extremities) No other symptoms.
I had a fever; Pain on my arm; Fatigue; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (patient's mom got it and it was horrible).   On 17th June 2022, the patient received the 2nd dose of Shingles vaccine. On 17th June 2022, less than a day after receiving Shingles vaccine, the patient experienced fever, pain in arm and fatigue. On an unknown date, the outcome of the fever, pain in arm and fatigue were unknown.   It was unknown if the reporter considered the fever, pain in arm and fatigue to be related to Shingles vaccine.     Additional Information: GSK receipt date: 17-June-2022 Reporter's comment: The patient self-reported the case via interactive digital media. The patient got the shot and had a fever, pain on arm and fatigue.  The patient stated that he/she would rather have this than shingles. Additional Supportive Information: Consent to follow up was not possible as no contact details were available.
COVID-19 Treatment; COVID-19 Treatment; Dose 1 and 2: Moderna, Dose 3: Pfizer; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Jan2022 as dose 3 (booster), single (Lot number: FJ8762) at the age of 39 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 26Mar2021 as dose 1, single (Lot number: 046A21A), in left arm and on 22Apr2021 as dose 2, single (Lot number: 038B21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: High blood pressure. There were no concomitant medications.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 06Jan2022, outcome "unknown", described as "Dose 1 and 2: Moderna, Dose 3: Pfizer"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "not recovered" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 includes Paxlovid from 06Sep2022 to 11Sep2022.  No follow-up attempts are possible. No further information is expected.
10 minutes after an immunization patient came saying he is not well. He was pale, sweating, had elevated breathing. He stated he feels very dizzy and feels like passing out. I sat down patient, called 911. as were waiting he was feeling better, breathing came to normal pace. He did not go to ER. Stayed longer in the lobby and later left.
Severe (L) shoulder pain, arm & chest pain. Also having stiffness. Fainted twice when she was in the shower.
Patient fainted, loss of consciousness for about 2 minutes.  Checked for pulse and breathing, patient had a strong pulse and steady breath.  Patient regained consciousness and was warm and sweaty and disoriented.  He was responsive and wanted to call 911.  Paramedics came and checked vitals and was taken to hospital for follow up.
I had a sore arm for about two days. I tested negative for COVID-19 via home test on 06/20/22 but tested positive on 06/21/22 via PCR test at clinic. I had symptoms of a head cold. I was given the prescription of Paxlovid and it helped with the symptoms. It left a terrible metallic taste in my mouth.
patient received pneumovax23 vaccination 10/13/2020 and presented in office on 10/14/2020 with a rash. The rash has taken up the upper part of her right arm. It is hard and warm to the touch. Patient also reported pain, swelling, and neck stiffness. Declined: SOB, wheezing, swelling of lips, tongue or throat. No recation was reported previously to the Prevnar13 vaccination.  Prescribed 50mg Benadryl q 6 hours and Medrol dose pack. Discussed signs of advancing recations and advised to go straight to ER if occurs.
After infant was given MMR, noted 1 1/2 cm wheal at the site. No other symptoms. Lungs clear, no generalized swelling. Given Benadryl. Wheal resolved in 1 hour. Child had history of eating eggs without problems.
This spontaneous report was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 19-FEB-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds 0.5 ml Vls 10 SDV (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had an excursion of 27 degrees Fahrenheit (-2.77 degrees Celsius) (lowest recorded temperature) for 1212 hours (sum of hours in excursion). The vaccine status was reported as "in excursion". The vaccine storage criteria and type reported as "refrigerator (R)". No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
I had pain at injection site, mild night sweats, and increased tinnitus (I have had tinnitus for many years) the night of / after the first and second shots (03/26/21 and 04/16/21)  After the second shot, I had less pain at the injection site, mild body aches, and increased tinnitus the night of the second injection.  However, the real reason I am reporting this is because after the second dose, the increased tinnitus continued intermittent, usually in the evenings. The tinnitus became especially pronounced on day 2 or 3, 4,  5 and day 8 - the ringing became so loud on the evening of day 2 that it seemed I was having trouble hearing the television. And on the evening of day 8 after the second dose, the tinnitus again became quite loud, with the additional symptom that external noises were annoying / irritated me.  I have had constant tinnitus for at least 20 years, and it almost never bothers me (or is even noticeable.) However, the tinnitus symptoms after the second Pfizer shot were pronounced enough that I thought I would report it. Of course, I can't be sure the tinnitus symptoms - especially those at days 4, 5 and 8 - are indeed side effects of the second dose of the Pfizer vaccine, but since I had increased tinnitus symptoms the night after both the first and second Pfizer doses, it would seem to me to probably not be a coincidence.
Sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in an adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  Previously administered products included Shingles vaccine with an associated reaction of pain in extremity (1st dose received on an unknown date and experienced sore arm, refer case US2021AMR104393).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follow: The case was reported by the patient. The age at vaccination was not reported. The age group was not reported but captured as an adult as per vaccine indication. The patient received 2 shots and experienced sore arm, which was way better than shingles.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR104393:
Patient was given meningitis A & Tdap (Boostrix) instead of the regular 4 year old vaccines (Kinrix & MMRV)
Inpatient treatment for facial included solumedrol/ranitidine/loratadine; ECF treatment for angioedma included IM solumedrol 125 mg, Benadryl 25 mg IM;  patient was already on mechanical ventilation
This spontaneous report was received from a physician via a sales representative concerning his 1 year old daughter who on an unknown date about 4 or 5 year ago received the first dose of VARIVAX (Merck) (route, lot number and expiration date were not provided). The physician reported that his daughter developed shingles on her shoulder. The patient received the second dose as schedule with no problems. At the time of the report, the patient recovered from the event. Additional information is not expected.
Mother of patient requested COVID-19 vaccination with Pfizer manufacturer. Pharmacy technician asked screening questions and thought mother requested flu vaccination. Flu vaccination was entered by technician and pharmacist verified data and administered flu vaccination. After administration, mother asked about second dose and error was recognized that requested vaccination was not administered. No immediate adverse effects seen in patient.