chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 62 year old previously healthy patient with sickle cell disease who on approximately 6/7/04, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # 646322/0530N). Subsequently, the patient developed a local reaction of redness, swelling and pain. A few days following vaccination, the patient returned to the office with a high grade fever of 102.4 degrees and was then hospitalized. It was noted that the patient developed pneumonia with bilateral infiltration of the lungs. At the time of the report, the patient was on antibiotics. A product quality complaint was not involved. The reporter also mentioned a second patient with sickle cell disease who had a similar experience post vaccination with pneumococcal 23v polysaccharide vaccine (lot # 646322/0530N). The reporter was concerned with the lot. The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional information is not expected. Additional information has been requested.
I felt fine for the first week and the half. All of the sudden, I felt dizzy. The room started spinning and I felt nauseous. I called my husband and we went to the urgent care near us. I couldn't even sit in the chair, because I felt like I was falling. I had to be taken away, because I began vomiting everywhere. They took me into a room and I continued to vomit. I kept my eyes closed, because the room was spinning and I was sensitive to light. They first gave me an oral anti-nausea pill. They waited about 45 minutes. The pill didn't help. I was then given an IV of stronger medications. I stayed for about 4 hours. They were able to stabilize the vomiting, but not the vertigo. I went home and never got out of bed for 2 weeks and never got out of bed except to see doctors. I could not walk on my own. I was referred to a new ENT and I took 10 days of antibiotics. They thought at first I might have an inner ear infection. The 10 days went by and there was no improvement. I was still bedridden. I still had random vertigo attacks that lasted from 1 hour to 4 hours. I was given an anti-nausea pill for vertigo and Valium (which I didn't really take). I was given a 10-day dose of prednisone, which did not help. After the prednisone did not work. I continued having continued pressure, ringing, fullness, and deafness in the left ear, which started on 4/22, and this is what caused of the vertigo. After I finished the prednisone didn't help, a second ENT suggested I undergo a direct injection of steroids in the left inner ear on 4/29. The deafness, ringing, and pressure got worse, and the vertigo became more frequent. I was then sent to a cardiologist to make sure I didn't have a virus. An EKG was done, and I went home with a wearable heart monitor. My heart is fine and has nothing to do with my symptoms. I was then sent to an ear specialist. I also saw a neurologist, because I had vestibular migraine in the inner ear, which contributed to the vertigo attacks. The neurologist put me on Inderal to try to calm the brain stem to calm the loop in my inner ear. I still have constant ringing and fullness in my ear and nearly complete deafness in the left ear, but the vertigo and vomiting are gone. I'm on a low-sodium diet and take diuretics to keep the fluid down. The neurologist did 50 Botox injections on my scalp in late April or early May, and this didn't help.
chills; headaches; tiredness; broke our on a rash on left side; rash was on eyelid; more rashes around eyebrows and corner of mouth and underneath lip; shingles; pigmentation; This is a spontaneous report from a contactable (patient) reported that. A 43-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 31Mar2021 (Batch/Lot Number: ER8737) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. Facility type vaccine: Public Health Clinic/Veterans Administration facility. After the 1st shot of vaccine patient reported - regular side effects: sore arm, nausea and feeling off. The patient reported after 24 hrs. of 2nd shot of vaccine experienced chills, headaches, tiredness, no fever within 24 hrs. on 07Apr2021 and week after 2nd shot, broke out on a rash on left side. Started on forehead then by Friday, 09Apr, rash was on eyelid. Went to Eye dry sat and urgent care on Sunday for more rashes around eyebrows and corner of mouth and underneath lip. Went to dermatologist on Tuesday, 13Apr2021 and treated as shingles. The events result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. On the mend now but it left some scars and pigmentation issue. The event outcome was recovering.
Received the booster yesterday of 0.25 mcg; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Received the booster yesterday of 0.25 mcg) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 mcg. On 19-Dec-2021, the patient experienced ACCIDENTAL UNDERDOSE (Received the booster yesterday of 0.25 mcg). On 19-Dec-2021, ACCIDENTAL UNDERDOSE (Received the booster yesterday of 0.25 mcg) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported
Redness; This case was reported by a nurse via call center representative and described the occurrence of erythema of extremities in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th August 2019 14:00, the patient received Shingrix. In August 2019, less than a week after receiving Shingrix, the patient experienced erythema of extremities. On an unknown date, the outcome of the erythema of extremities was unknown.   It was unknown if the reporter considered the erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. The nurse reported that they had large areas of redness on upper arm after having had the 2nd Shingrix shot at 2 pm. The reporter noticed that last night the redness seemed to be spreading. The reporter did not consent to follow-up. There was discrepancy in primary reporter in source document it was reported as (physician ) but in narrative it was (nurse).
1) Diarrhea - evening after vaccine & next day (7/20 - 7/21) 2) Fever, runny nose, cough, fatigue (7/29-8/5) - negative for COVID x2. Pediatrician (8/2) advised likely just a bad virus. OTC ibuprofen, fluids, rest. Returned to daycare on 8/2 after being symptomatic for a full week.
Ache began in neck/shoulders after chills.  This happened around lunch 1/7/21.  Took acetomenphin .  Chills and aches continued until into the night.  Took Temperature around 2:30 am 1/8/21 and it registered 99.8.  Took more acetomenphin and sweated it off.  Aches and chills continue today, 1/8/21 into lunchtime.  Taking acetomenphin approximately every 4-6 hours.
My son developed a temperature of 104. After receving his vaccinations my son was sleepy and lethargic for over four days.
blotchy red rash along entire arm from site of inj to wrist 30min post vax;
SORE NECK; 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: 1805020, and expiry: UNKNOWN) dose was not reported, administered on left arm on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, the subject experienced sore neck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore neck. This report was non-serious.
Rash on the interior of her arm and thigh; This case was reported by a other health professional via sales rep and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on an unspecified date, the patient had received the 1st dose of shingrix vaccine).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the 2nd dose of the shingrix and experienced rash on the interior of her arm and thigh. The reporter has been given the consent for the follow up.
Shoulder pain ensued upon vaccine administration as normal; however as time went by the pain became more intense and has led to a more than modest decreased mobility of the shoulder.  Of note - the vaccine was administer very high in the shoulder muscle.
I received my second Moderna booster for COVID-19 on 6/28/2022. On the night of 7/21/2022, I had an onset of sneezing, sore throat, and headache. On 7/22/2022, I then developed a fever, headaches, general malaise, and discomfort. Those symptoms remained until 7/23/2022, when I developed a cough. On 7/22/2022, I took a home test for COVID-19, and the result was positive. On 7/24/2022, I developed chest tightness. On 7/25/2022, I arranged to receive Bebtelovimab monoclonal antibodies. On the night of 7/26/2022, I experienced periods of wide complex rhythm, which were noted on Kardia. I had them at least 2 or 3 times,; the longest lasted for 10 seconds, and another lasted for about 8 seconds. After these resolved, I resumed a normal sinus rhythm with occasional premature ventricular contractions. I have had premature ventricular contractions for several years now, so this was not unusual. However, the wide complex rhythm was atypical for me, and I wonder if it could have been precipitated by the monoclonal antibodies I received. At the time of this writing, I am still not fully recovered from COVID-19, though I am making steady progress.
Redness and swelling of the L. ant. thigh with 10 x 7 cm border, started hours after the vaccine and gradually increased. Also 2 cm erythematous area at MMRV site. Not swollen.
Systemic: Allergic: Anaphylaxis-Mild, Systemic: Abdominal Pain-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Headache-Mild, Additional Details: Pt fainted 1 to 2 minutes after getting vaccinated and regained consciousness immediately. Her BP was normal - 108/80 and HR was 86. Pt's breathing was normal. She felt mild stomach pain and headache after gaining consciousness.
January 5, 2023 my husband was tested for COVID-19, and it was positive. I tested myself from January 5-6 and all test for COVID-19 were positive. On the next day in the evening, I started having chills and these symptoms were similar to a sore throat into the next day I had nasal congestion and on January 10 I started having postnasal drip and a cough.
Pt woke at 23:30 with fever of 102.1 and had 6 episodes of vomiting.
Excruciating neck pain beginning at ~5:00am on 2/3. Turned into debilitating nerve pain down my left arm and eventually my right as well. Pain went down the back/side of both arms and into my hands (chilled hands, electric shock feeling, tingling and pain). Now on gabapentin 2x/day, nerve pain is still there (one month later) but much better than it was.
pt recv vax & devel peeling of face & scalp & facial flushing;to MD given cortisone;now states has generalized weakness & sore throat;
Within 15-minutes of vaccination, the patient reported pruritic, erythematous hives on his face and chest. EMS evaluated the patient on-site. EMS administered 50mg IM Benadryl and placed patient on O2lpm via nasal cannula. Patient was hypertensive (161/84) with a FSBG of 134mg/dl. EMS transported the patient to Emergency Department for further evaluation. In the ED, the patient reported that after receiving the IV Benadryl, their facial flushing, redness, and hives have disappeared. The patient did continue to have some generalized itching. The patient remained hypertensive (163/83).  Physician administered 20mg IV Pepcid and 125mg IV SoluMedrol. Patient reported improvement and was discharged with a diagnosis of allergic reaction - improved. Physician prescribed Benadryl 25mg PO QID, Pepcid 20mg PO BID, and Prednisone 40mg PO QD for 4-days.
The patient experienced no symptoms; there was no diluent available for use; the patient was unable to receive the dose of M-M-R II; Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 17-MAR-2020, the patient came into the pharmacy for administration of a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (M-M-R II) (strength, dose detail and route were not reported) (lot # S009753, expiration date 31-MAR-2021) and sterile diluent (STERILE DILUENT) for prophylaxis.  The patient was unable to receive the dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) on 17-MAR-2020 because the sterile diluent (STERILE DILUENT) used for administration of the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) dose had expired and there was no sterile diluent (STERILE DILUENT) available for use at that time (circumstance or information capable of leading to medication error and product availability issue). The patient experienced no symptoms.
This case was reported by a physician via call center representative and described the occurrence of injected limb mobility decreased in a 20-year-old female patient who received BEXSERO (batch number 160601A, expiry date July 2018). On 6th November 2017, the patient received BEXSERO .5 ml. On an unknown date, 1 day after receiving BEXSERO, the patient experienced injected limb mobility decreased, injection site pain and injection site lump. On an unknown date, the outcome of the injected limb mobility decreased and injection site lump were unknown and the outcome of the injection site pain was recovering/resolving. It was unknown if the reporter considered the injected limb mobility decreased, injection site pain and injection site lump to be related to BEXSERO. Additional details were provided as follows: The patient received BEXSERO on unknown arm. The patient experienced soreness at injection site and was barely able to move arm. The patient was seen back at the facility for a follow-up visit, at that time, no further treatment was administered. After 8 days post vaccination, the patient reported that the pain was resolving, however the lump remain unchanged. No further information provided regarding the events.
Patient came into the clinic to receive the Moderna Bivalent but was inadertently given the Moderna pediatric 0.5 mL dose. Department of Health and Environment, CDC and Moderna Helpline were notified this same day for guidance. Patient was notified same day of the  error.
Redness; Hives; Itching; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of   in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No relevant medical history reported.). Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), VERAPAMIL and MEMANTINE HYDROCHLORIDE (NAMENDA).    On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided No treatment information provided
Reaction began about 1.5 hours after vaccination.  Bright red & itchiness of both hands (palms and top), forearms red, about #10 hives.  Patient took Benadryl and says it seems to have calmed down.
The pt was making verbal sounds and then stopped at the age of 15 months, developed PDD. Symptoms at the age of 2 years. Now he is 3 years old, is still not speaking and continues with PDD symptoms.
Information has been received from a licensed practical nurse concerning a 57-year-old female who on 06-May-1999 was vaccinated with second dose of PNUEMOVAX 23. On 04-May-1999, following vaccination, the patient experienced injection site redness and swelling. It was noted that the patient received first dose of PNEUMOVAX 23 approximately five years ago. Additional information has been requested.
Knot on right collar bone, tender, sore, swollen right armpit (as previous 2 times reported to PCP). This time made my neck & shoulder flare up. Arm still swollen and sore at injection site. Symptoms occurred not even 24hrs later
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. On an unknown dates in 2014 (reported as "between 06-SEP-2014 and 18-DEC-2014), unspecified number of patients were vaccinated with a dose of RECOMBIVAX HB (lot number, Expiry Date, dose, frequency, route were not reported) for prophylaxis that underwent multiple temperature excursions. It was unknown if any of those doses were supported. No adverse experiences were reported.
1st dose: sore arm, couldn?t even lift it 2nd dose: vomiting, chills, fever, body aches, mildly sore arm, extreme body weakness, back ache
Information has been received from a registered nurse (RN) concerning a 33-week-old female with no medical history who on 29-MAR-2007, 31-MAY-2007 and 20-SEP-2007 was vaccinated PO with the first, second and third (lot #656707/0410U) 2.0 mL doses, respectively, of Rotateq.  It was unknown if medical attention was sought.  No symptoms were reported.  Additional information has been requested.
Times are based on amount of time having passed since vaccination   - [ ] 5-10 mins - Itchiness randomly all over body on and off - [ ] 30-40 mins - throat itchiness, felt light headedness, took 2x Zyrtec - [ ] 1 hr - upper back aches - [ ] 2 hrs - left side and left side of chest/lung felt achey - [ ] 2-3 hrs - back and feet feel achey - [ ] 5 hrs - itchy throat returns  - [ ] 6 hrs - sneezing  - [ ] 7 hrs - headache
Vaccine administered after temperature excursion; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: Vaccine administered after temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 02-MAY-2023 The reporter was a pharmacist. The reporter reported that a dose of Shingrix vaccine was exposed to colder than recommended storage temperature and it was administered to the patient. The reporter was unable to provide any additional vaccine details at the time of reporting, because event was happened in a different pharmacy. There was no information provided to which temperature the vaccine was exposed only it was reported the below recommended temperature.  The reporter did consent to follow-up via email. The Shingrix vaccine was exposed to colder than recommended storage temperature, which led to incorrect storage of drug
Bad headache; Chills; Fever 101F (never went over 101)/Light fever; Nausea; Vomiting; This is a spontaneous report from a contactable consumer (patient herself). A 63-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EP7534; Expiry Date: 31Jul2021), via an unspecified route of administration in arm right on 17Mar2021 18:15 as dose 1, single (at the age of 63-years-old) and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0162; Expiry Date: 31Jul2021), via an unspecified route of administration in arm right on 07Apr2021 18:15 as dose 2, single for COVID-19 immunisation. She did not receive any other vaccines prior to 4 weeks. The patient's medical history included diabetes mellitus, she was a juvenile diabetic, so she has had diabetes for like 40 years. The patient's concomitant medications included Levemir 8 units a day, she has taken it for a few years for diabetes mellitus. On 18Mar2021 03:00, the patient experienced bad headache, chills, fever 101 Fahrenheit (never went over 101) and light fever, nausea and vomiting. It was reported that the side effects were to be perfectly expected had then after both vaccines, seemed to be coming back intermittently. These side effects started after both vaccines about 8 hours after the injection. After the first dose, the side effects went away after about 2.5 days. After the second dose the side effects came back after 7 to 10 days and then came back again that week, Thursday, at 3 o'clock in the morning. The same thing lasted 18 hours. The events were over first 8 hours about 6 times with a total of 3 times with each re-occurrence. It was reported that the bad headache lasted about a day and a half. The vomiting only lasted about 8 hours. It was reported that after the second dose, she woke up next day on 08Apr2021 at 04:00 and her headache woke her up. It was pretty much the same progression as everything after the first dose. This was more like 24 hours after the second short, it lasted a little longer. It was 24 hours before her side effects were gone. That was on 09Apr2021 that all of her symptoms went away. It was reported that she woke up on 10Apr2021 and was feeling 100% better. She gets bloodwork done every 3 months and she has had it done since she had the vaccine. The patient underwent lab tests and procedures which included blood test: unknown, body temperature increased: 101 Fahrenheit. It was not required for patient to visit the emergency room or physician office. Therapeutic measures were taken as a result of fever 101f (never went over 101) and light fever (pyrexia) included Tylenol (It was for about 18 hours). The outcome of the events was recovered on 09Apr2021.    No Follow-up attempts are needed. No further information expected.
Several hours after the shot on 4/28, I started to feel nauseated and fatigued (not bad enough to impair functioning, so I ignored it). Nausea and fatigue improved on 4/29 so I forgot about it. On the morning of 4/30, fatigue and nausea were back much worse, and I noticed a rash on my lower back: a small red patch that hurt to touch, mildly itchy. On this patch, there were several blisters that stung. I have had shingles before and I'm pretty sure I recognize it, and this rash in the exact same place that I've had the shingles rash before. Today, 5/1, the rash isn't any worse, but the nausea is quite bad (enough to keep me home).