chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to a 73 year old female patient. No information about medical history, drug reactions and allergies was specified. On 23-SEP-2013, the patient was vaccinated with temperature excursion supported PNEUMOVAX injection (lot # K004542, expiry date: 19-AUG-2015, dose 0.5 ml, intramuscularly). No concomitant medications were reported. No adverse effects reported by patient. There was no product quality complaint. The outcome is unknown. This is one of the seven reports received from the same reporter (MARRS # 1410USA002854, 1410USA005576, 1410USA005583, 1410USA005584, 1410USA005585 and 1410USA005586). Additional information has been requested .
I received my 2nd Moderna vaccine dose on 5Feb2021 at 4pm.  I felt fine until about 10pm when I started experiencing the expected arm soreness, fever, myalgias, arthralgias, headaches, and chills.  By 1am on 6Feb2021 my fever went from 97.1 to 101.8.  My myalgias and arthralgias were extreme.  Despite ample hydration (3 L of oral rehydration formula from midnight until morning) my kidney output dropped to zero from 1am on 6Feb2021 to 2pm on 6Feb2021 (13 hours).  This started resolving around 2pm.  I did go to the ER around 3pm to have a Basic Metabolic Panel and CK checked.  These results were within normal limits.  The specific gravity on my urine analysis was obviously low due to my hydration of 3L of fluid.  By the time I was discharged from the ER my urine output was in overdrive and my vitals were stable.  My other symptoms resolved over the next 2 days except for fatigue. Was able to work the next week despite lingering low-level fatigue. A week later I went cross-country skiing using the same ski gear I have been using for the past 15 years.  My ski boots extend up to my mid-calves.  During the ski outing my lower legs became extremely sore.  Upon removing my boots at the end of the ski trip, I found that I was completely bruised on both my lower extremities.  This has NEVER happened before.  I went back to the ER for additional bloodwork.  This time a CBC, complete metabolic panel, INR, PT/PTT, CK, ESR, CRP were performed.  All results were within normal limits and I was discharged with stable vitals.  The bruising resolved over the following week.  The low-level fatigue remained. One month later I went skiing again.  This time my lower legs became very sore, but there was no bruising.  The low-level fatigue remained. I do have HSV and use valacyclovir only prn.  During the 2 months after my 2nd vaccine dose, I experienced  prodromal symptoms of an outbreak about 4 times (much more than my usual) and had to take valacyclovir for a few days each time.  These episodes were not nearly as severe as the HSV outbreak/early possible Bells Palsy I experienced after the first dose in January2021. Prior to the vaccine I would have rated my health as excellent.  I am now 2.5 months out and still do not feel 100% back to my pre-vaccine health.
About 3 days after vaccination given, I developed a rash around injection sire. It covered approximately 1/3 of out upper arm, itched intensely, and spread to about 1/2 of upper arm. Lasted about 1 week, still itches occasionally.
Fever, chills, body aches - 11/7/09, wheezing. Cough developed 11/12/09. Evaluation 11/17/09 when pt reported.
Client presented to the vaccination site on 08/05/2022 for his Moderna COVID vaccine. Today, the client consented to receive Moderna COVID booster dose #1 (0.25 ml) (Lot #: 006M21A exp: 08/19/22) by LVN. After reviewing the vaccination forms, Staff worker noted that client never receive any primary series which means he is under dose today since the client received administration of the Moderna COVID booster dose #1 instead of a first dose Moderna COVID vaccine (full dose 0.5 ml). Staff worker notified PHN supervisor. PHN supervisor submitted a medical consult via text message to the doctor, requesting for guidance on how to proceed. PHN supervisor received recommendation from the doctor with recommendation to call client to come back today (8/5/22) or tomorrow for the Moderna COVID booster dose #2 to complete the recommended first dose Moderna COVID vaccine of 0.5 ml. PHN supervisor called client to inform him of the doctor?s recommendation for him to come back for his Moderna COVID booster dose #2 to complete the recommended first dose Moderna COVID vaccine (full dose of 0.5 cc). PHN supervisor left a message for client to call back since client did not answer his phone. PHN supervisor sent a follow-up text message to the doctor informing him that client did not answer his phone and left him a message for him to call her back. PHN supervisor received a text message from the doctor that the recommendation should be for client return today or tomorrow, and if the client did not answer his phone, then nothing can be done today. PHN supervisor unable to educate client on the side effects of Moderna COVID vaccine since client left the vaccination site before the under dose of Moderna COVID vaccine given was noted and unable to obtain any information if client has any chronic conditions, current medications, or known allergies. PHN supervisor educated LVN on confirming with each client the right client, right vaccine, right dose/time frame, and any history of adverse reactions or known allergies in the future. PHN supervisor notified the PHN lead for the medical Team on 8/7/22, Sunday to call client again to inform client to return 8/7/22, Sunday to receive the Moderna COVID booster dose #2.
Site: Itching at Injection Site-Severe, Site: Redness at Injection Site-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: rash spreading to other parts of left arm-Severe
Shingles(6 weeks), Wrist pain(ongoing). Was given brace and something for pain and shingles.
Swelling of right arm on 7/26/06 6:00PM.  On 7/27/06 ran a temperature for 6 hours.  First episode of vomiting on 7/29/06 at 8:00AM.  Second episode of vomiting on 7/30/06 at 8-9:00AM.  Patient appeared sluggish and tired this AM.
At 5:00 AM on 1/29/2021 I began having chills, fatigue, earache  and was nauseated. On 1/31/2021 I began having a rash which was about 3 inches in length and 2 1/2 inches in width around the injection site.  There was a hard spot in the center of the rash.  It was extremely itchy.
I tried to sleep at 10:30pm, unable to fall asleep for many hours; at 2:10am, I felt very awake and my heart felt like it was pounding, I checked my BP which was 138/86, pulse was 97. I still had trouble sleeping afterwards, my sleep was very shallow and I was easily awakened  throughout the rest of the night
none of the patients responded to PPV23; This literature marketed report has been received from the authors of a published literature article, titled as stated below and refers to a 65 years old male patient with chronic lymphocytic leukaemia. He received 3 courses of antibiotics in the year before enrollment. There was no therapy prior to ibrutinib.  Pre-vaccination, the number of Streptococcus pneumoniae serotypes with immunoglobulin G (IgG) titers greater than 1.3 microgram/milliliter was 11. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (lot #, expiration date, dose, route, and site of administration were not reported) for prophylaxis. Concomitant therapies included ibrutinib.  Post-vaccination, the number of Streptococcus pneumoniae serotypes with IgG titers greater than 1.3 microgram/milliliter was 11. The patient did not respond to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (vaccination failure). The outcome of event was unknown. The authors considered vaccination failure to be related to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown).  A copy of the published article is attached as further documentation of the patient's experience.  This is one of ten reports derived from the same literature article (cross referenced with MARRS# US-009507513-2103USA003406).  Sender's Comments:  US-009507513-2103USA003406:
From an initial report received on 12/22/2000, it was reported that a 19 year old female was vaccinated with Menomune on 04/26/2000 at 1:40pm. Five mins later, the pt reportedly was "dizzy, throat felt tight and itchy, itching at the site of injection with no redness, no shortness of breath or dyspnea, color pink, respirations 16, BP108/68, pulse 68." The pt was given 50mg of Benadryl, orally and observed for 1.5 hours without sequelae. Pt took 50 mg of Benadryl at bedtime. The pt reportedly recovered from these experiences.
Developed throat swelling with difficulty swallowing.  She went home and took a Benadryl 25 mg at 5:30.  She continued to feel itchy and throat tightness but no wheezing.  She began to have pain of her hand and feet.  She went to bed and awakened at 3 AM and  took 50 mg Benadryl and went back to sleep for 4 hours. She awakened at 7 AM and felt extremity pain, pruritis, and burning of her throat but could swallow. No respiratory symptoms. She took a Benadryl capsule, she thinks 25 mg. Now she has pain of her hands and feet joints with burning of the joints. Plan: Prednisone 20 mg bid x 3 days then 20 mg qd x 3 days. OTC ibuprofen or naproxen for pain (no history of ASA allergy).
13AUG91 pt devel fever; given APAP; AM frequently restless; 4AM rhythmic jolting movements & sudden screaming; t105.7, called MD; Advised APAP; t105 & convuls, taken to ER no cause found; red like welts; bridge of nose swollen;
pt recvd vax; 12oct @ 5pm;awake at 1am 13oct w/ severe SOB, wheezing;unable to work or have any exertion w/o worsening sxs; to MD & tx w/ inhaler;cont to exp tightness & wheezing;to see PMD for assessment;
Patient has been experiencing irregular menses since receiving her first vaccine dose. Prior to vaccination, patient has a 19-year history of regular menses occurring every 26-28 days for 5-6 days with no history of hormonal birth control.   Since receiving first dose, patient has experienced: 1. An irregularly heavy menses immediately following the first dose 2. An early (25 days) and irregularly light but long (9 days) menses approximately one month later 3. A late (35 days) menses, still ongoing
Shoulder pain, limited ROM, tenderness, burning, burning from shoulder to wrist immediately post injection, constant ache, stiffness, Physical Therapy.
pt recv vax 3FEB97 & 8JUL97 dx w/chickenpox;pt blisters were diverse all over the body;
Patient is a resident at local LTC (long term care). He was given bivalent vaccine on 12/8/22 from the local County Health Dept. Local County Health Dept. returned to site on 2/7/23. Resident was inadvertently given the same vaccine a second time.
Information and follow up information has been received from a registered nurse concerning a 10 week old male patient with no pertinent medical history and no drug reactions/allergies who on 02-DEC-2009 was vaccinated orally with the first 2 ml dose of ROTATEQ (Lot #). Concomitant therapies included ENGERIX-B (Lot#AHBVB769AA), PENTACEL (Lot#C3545AA) and PREVNAR (Lot#D87186). On 04-DEC-2009 the patient was diagnosed with rotavirus infection after receiving the first dose of ROTATEQ. The patient had been vomiting and had diarrhea and was diagnosed with rotavirus infection. On 09-DEC-2009 the patient was seen by the physician. On 09-DEC-2009 the patient was admitted to hospital. The patient's stool culture was positive for rotavirus. On 12-DEC-2009 the patient was discharged from the hospital. The patient had recovered. The patient had recovered. The reporter considered the dehydration to be life-threatening. Additional information is not expected.
pt experienced syncope after vaccine administration. Monitored for 20 mins and pt seemed fine. No other reactions/ symptoms
Arm started to swell and was very sore.  4 days later arm still hurts. Swelling is down but arm is red and hot to the touch.
Headache, Fever (100.4°F), light-headedness, tired.  After two days, resolved.
Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about medical history and concurrent condition was not reported. On 02-FEB-2015 the patient was vaccinated with improperly stored RECOMBIVAX HB lot # K006682 with expiration date of 17-DEC-2015; dosage and route unspecified. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Feeling minor fatigue after her first Pfizer covid 19 vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Feeling minor fatigue after her first Pfizer covid 19 vaccine". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
about 4 days after I received the first shot of vaccine the red spots returnedover my body; the spots and skin lesions re-appeared; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (about 4 days after I received the first shot of vaccine the red spots returnedover my body) and SKIN LESION (the spots and skin lesions re-appeared) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Psoriasis (Had about 10years ago; The spots and lesions disappeared for the past 6 years; ).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH MACULAR (about 4 days after I received the first shot of vaccine the red spots returnedover my body) and SKIN LESION (the spots and skin lesions re-appeared). At the time of the report, RASH MACULAR (about 4 days after I received the first shot of vaccine the red spots returnedover my body) and SKIN LESION (the spots and skin lesions re-appeared) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   Treatment information  was not reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Added Medical History - Psoriasis; Added Dose number-- 1; Added Event - Skin lesion;
Information has been received from a Nurse Practitioner for the Pregnancy Registry for GARDASIL concerning an 18 year old female patient with no drugs reactions or allergies who on 11-APR-2008 was vaccinated with a first dose of GARDASIL (Lot# not reported). On 18-JUN-2008 she received third dose of GARDASIL (Lot# not reported). On 01-APR-2009 she received third dose of GARDASIL (Lot# not reported). There was no concomitant medication. When the patient received first and second dose of vaccine she became pregnant. The patient experienced pre-eclampsia and the physician had to induce delivery and used magnesium sulfate during labor. The patient was hospitalized. Delivery was at 36 weeks and 4 days. The patient had a healthy baby boy on 27-JAN-2009. In July - 2008 Cervical smear was performed and showed normal results. The patient sought medical attention was at office. The Nurse practitioner considered pre-eclampsia and premature to be other important medical events and life threatening. Additional information has been requested.
Right sided facial numbness: stiff and tight neck, right sided facial numbing. Treat with prednisone.
Early am on 9/5/19 High fever up to 101.9 throughout the day and night , severe  soreness and redness on left arm only , Early am on 9/6/19 lips swelled up and as well as left side of face. Temperature dropped 99.9 (taking Tylenol) Red raised rash on upper left arm from the injection  site to the underside of left arm
Patient passed out post injection. Patient was seated in chair and regained consciousness  in a few seconds. He sat for a few minutes and drank cold water. The pharmacy intern took him outside for fresh air with his mother where they remained for about 30 minutes to make sure he felt better. Upon follow up around 4pm the mother stated he was resting and felt fine.
No adverse effects; the patient was administered PROQUAD that may have been improperly stored. The PROQUAD was reconstituted with Merck STERILE DILUENT that may have been improperly stored; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's current condition, concomitant medications, medical history and historical drugs were unknown. On 21-AUG-2019, the patient was administered with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) of lot number S003169, expiry date 30-JUL-2020, therapy type rHA (dose, strength, frequency, route of administration were unknown) for prophylaxis and it was reconstituted with improperly stored merck sterile diluent (product storage error) of lot number R022412, expiry date 14-NOV-2019 (dose, strength, frequency, route of administration, indication were unknown). There were no adverse effects reported (no adverse event). There was no Product Quality Complaint (PQC) identified.
One day after vaccination, mother reports itching and bumpy rash at vaccine site. Advised benadryl and to f/u with PCP. ER precautions provided for worsening allergic response such as difficulty breathing or spreading of rash.
Noticed rash on 2/18/2000, on ear, stomach, legs and toes the size of mosquito bites. Saw family MD. No dx assigned to rash. On 2/22/2000, appears to be fading.
Pfizer-BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 2/3/2021 and 2/24/2021. Presented to ED on 8/5/2021 with shortness of breath. Medications administered: acetylcysteine, baricitinib, dexamethasone, methylprednisolone, prednisone, ceftriaxone, azithromycin, remdesivir, piperacillin/tazobactan, zinc, and vancomycin. During hospitalization, patient aspirated and had small bowel ileus subsequently requiring vasopressor support. Patient eventually went to cardiac arrest and expired on 9/01/2021.
after about 12 hours of first dose, the arm that had the injection became very sore.  was hard to move without pain.  Pain dissipated completely at about 46 hour mark after the injection.  Also, felt fatigued and as if I had a mild flu. Those symptoms dissipated a bit sooner, and were gone after about 41 hours.
The patient developed a headache, nausea, vomiting, chills, tenderness and redness at site of injection over an 18x10 cm area, and orthostasis. Doctor will treat with Keflex and Prednisone. Will also check cbc.
This spontaneous report was received from a pharmacist concerning a 80 year old patient of unknown gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 20-MAR-2018, the patient was vaccinated with PREVNAR 13 for an unknown indication (dose, frequency, route of administration, lot number and expiration date were not reported). On 22-MAR-2018, the patient was vaccinated with PNEUMOVAX 23 for prophylaxis (dose, route of administration, lot number and expiration date were not reported). No adverse effects were reported.
I HAD A NORMAL REACTION TO DOSE 2 INCLUDING A LOW FEVER AND CHILLS. ONE WEEK LATER, TINNITUS STARTED OUT OF NOWHERE. I AM WORKING REMOTELY, NO LOUD EVENTS, NOTHING TO PRECIPITATE SUDDEN ONSET OF EAR RINGING
pt died during the noc p/the hepatitis vax was given;@ this point the coroner believes it is d/t SIDS;
Myocarditis 4 days after initial vaccination ; first 48 hours with body ache, chills, malaise
Patient registered to receive a COVID updated booster.  Patient received 3 prior vaccines.  Patient received a bivalent Pfizer booster instead of monovalent Pfizer (due to her age).  Patient was observed for 15 minutes after the vaccine was administered.  Patient did not exhibit any abnormal reaction.   Spoke with both the Mom and Dad on 10/30/2022 via phone.  They stated that she did not have any reaction to this vaccine.  She only felt soreness at the injection site for the first 24 hrs.  Otherwise had 'normal' activity as stated by her Mom.
Came into office with head cold and was behind in immunizations, so MD's office brought him up-to-date with shots. Pt died on 7/20/02, 5 days, post vax.
Patient presents with a potential reaction to the COVID19 vaccine. The patient presented with a true vasovagal syncopal episode after vaccination. He did have a LOC for about 2-3 seconds and spontaneously returned to the aroused state. Close monitoring, aggressive hydration, and supine positioning were put in place.  He returned to baseline with close monitoring and hydration. He returned home with his wife as the driver.
pt. received in clinic Td and Pneumovax injection.  Pt states that evening she was ambulanced to ER with severe body aches, chills, and diaphoresis.  Pt states she was informed it was an allergic reaction to the vaccinations she was given.
12/14/22 presents to EC ED for "shortness of breath". PMHx of "Crohn's with ostomy"
Date of booster 11/28/21 not 9/11/21 (correction)  Increased heart rate and sob within hours of booster, still present but less frequently over a yr later-getting less and less frequent and shorter duration than previously-occurs randomly Resting heart rate 104-112 (normal 74-85) Occurs sporadically now and last few hours rather than days like before Increased heart rate not present after first and second vaccine but was present for 6 months after having covid 3/2020 and echo was normal
His arm was quite painful; Aches of the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (His arm was quite painful) and PAIN (Aches of the arm) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced PAIN IN EXTREMITY (His arm was quite painful) and PAIN (Aches of the arm). The patient was treated with IBUPROFEN on 30-Jan-2021 for Pain in arm, at a dose of Took 2 tablets. At the time of the report, PAIN IN EXTREMITY (His arm was quite painful) and PAIN (Aches of the arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Event outcome received, patient has recovered and does not wish to be followed up
Patient up to date on COVID vaccinations who admitted with encephalopathy.  Provider discharge note below:  "Patient is a 86 YO male who was admitted for acute encephalopathy, found to have hypotension in the setting of cardiomyopathy EF 25-30%. He also had AKI likely cardiorenal vs pre renal form decreased intake, chronic a fib. Also tested for covid 19 but asymptomatic and on room air, refusing breathing treatment. Patient's situation was discussed with daughter who did not want any aggressive measures and to keep him comfort measures only. Hospice was consulted, and paper work was signed. Patient was discharged to his facility with hospice."