chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a Registered Nurse concerning a 23 year old female patient with allergic reaction to antibiotics (Biaxin), who on 13-SEP-2007 was vaccinated IM with a second dose of Gardasil vaccine, lot #657872/0515U. The nurse reported that on 14-SEP-2007 the patient called the office complaining of nausea, vomiting, flushed face and diarrhea. It was reported that the patient did not have any reaction when she received her first injection. No further information was available. The patient's outcome was unknown. Additional information has been requested.
Fatigue: intense, started 1 pm on 9/3 Injection site pain: only upon raising arm above shoulder level and touching site, pain 4/10, noticed after waking up around 7 am on 9/3 Headache: mild started around 7pm on 9/3
Information has been received from a pharmacist concerning his over 65 year old mother who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (lot number, dose and route not reported). Subsequently on an unspecified date the patient died. The cause of death was unknown. The reporter felt that the patient's death was not related to therapy with PNEUMOVAX 23. No further information is available.
Patient received 2d Moderna on 4/27/21 no lot number recorded; event occurred after 2nd vaccine; breakthrough case admission
Vaccine given to student because parent mistakenly wrote his name (instead of younger brother) on the consent form and he was called into the vaccine clinic. This student had already completed the two-dose series.  Parents were notified. He suffered no ill effects as of this afternoon.
Patient states that she feels constant pressure in her head since receiving the vaccination. She does not have HBP. The symptom is still present.
24 hrs after vaccine developed pruritic 4cm plaque/urticarial lesion.
On 5/3/99, the pt developed a rash that started on her neck and now on her abdomen and back and a fever of 103 that resolved in two days.
The patient presented with left eye peripheral visual loss, left upper and lower extremity and facial numbness sensation and weakness.  This started 1 hour after receiving COVID-19 vaccine at her place of employment.  Pt was brought to CRMC via EMS.
This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a T excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a T excursion) in a 102-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination. No Medical History information was reported. On 17-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a T excursion). On 17-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a T excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a T excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a T excursion) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. Date of temperature excursion was 10-Mar-2022. Maximum or minimum temperatures reached was 64 degrees Fahrenheit. Excursion duration was approximately 7 hours. The vaccine was stored in refrigerator at the time of the excursion. There were no changes in visual inspection. Pertinent details: At the time they were unpunctured. Vaccine was administered on 17-Mar-2022 and vials were returned to the refrigerator. Tran date was 17-Mar-2022. The patient did not experience any adverse events post injection. No treatment medications were reported.
Fever (103-104 oF) and 4"x1" red, swelling area around site of injection. Pt states she received an IV.
On 10/13/2021 My right ankle and foot was swollen, no pain, every day I would ice it, elevate it. At night it would be really big, in the morning it was fine. I knew I had not injured it.  It started to feel tight. I went to see my doctor because I was concerned it might be a blood clot.  A week later, 10/20/2021, I went to see doctor, he ordered an ultrasound to see if it was a blood clot.  Now, 10/28/2021- the foot is not as swollen as it was, but my ankle is still swollen. I have a little pain now if I put my sock on because it hit right where it's swollen. There is really no pain in that ankle unless I touch it. I don't know what is going on in that ankle. It is really weird to me.
Within 24 hours after DTAP and Prevnar given, child developed fever and seizure lasting 3-5 minutes.  Seen in office with Temperature 103.1 degrees, post-ictal but otherwise normal exam.  No treatment, given Tylenol.
Developed a rash on my stomach. Lasted for several weeks. No Topical treatments helped. Pregnant at the time, due date 7/2/19 BW 6lb. Normal birthweight based on my prior delivery.
redness; a circular bubble in the middle; swelling; itching; hot to touch; Initial information with live follow up regarding an unsolicited valid non-serious case from a physician via Agency (Reference number- 00618838) and transmitted to Sanofi on 27-May-2021.  This case is linked to cases 2021SA179435 and 2021SA179588 (same reporter).  This case involves a 03-year old male patient who had redness (vaccination site erythema), circular bubble in the middle (vaccination site mass), swelling (vaccination site swelling), itching (vaccination site pruritus) and hot to touch (vaccination site warmth), while he received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.  On 24-May-2021, the patient received 0.5 ml once dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot number: C5765BA and expiration date: 28-Aug-2022) via unknown route in unknown administration site for prophylactic vaccination.  On 25-May-2021, the patient developed a non-serious, redness (vaccination site erythema),  circular bubble in the middle (vaccination site mass), swelling (vaccination site swelling),  itching (vaccination site pruritus) and hot to touch (vaccination site warmth), 1 day following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE.  No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of the events was resolving.
Fever, fatigue, muscle cramps, aches, headache since 2am the day after getting my second dose
Vaccine injection 3:45p- woke up 9:45 pm same day-fever 102- aches all over body - had headache called doctor next day advised take 2 Tylenol and 3 hrs later, take 2 Ibprophren - alternate until fever gone - Nov 26-came down with bad case of flu .
3x6" erythematous, pruritic, non-vesicular rash around TD inj site which evolved 9 days p/vax;
This spontaneous report as received from a doctor of pharmacy refers to a patient who was vaccinated with an improperly storage dose of ZOSTAVAX (lot # 672609/1733AA, expiration date 04-FEB-2013, dose not reported) on 27-APR-2012. No other co-suspects were reported. No concomitant medications were reported. The doctor of pharmacy reported that one of the facilities that he was in charge of was recording the temperature of the storage unit of ZOSTAVAX as -5F. He reports that they recently discovered that the actual temperature of the storage unit was -5C. He did not know if the patient had experienced any adverse effects. This is one of several reports received from the same source. This report is cross referenced with the following MARRS #: 1209USA002918, 1210USA006055, 1210USA006056, 1210USA006057, 1210USA006058, 1210USA006059, 1210USA006061, 1210USA006062, 1210USA006063, 1210USA006064, 1210USA006065, 1210USA006066, 1210USA006067, 1210USA006069, 1210USA006070, 1210USA006071, 1210USA006072, 1210USA006073, 1210USA006074. Additional information is not expected.
Left arm pain/shoulder pain since SHINGRIX shot 5/2018, sore first several days; seemed to have gotten better slowly but never resolved, but then over the last couple of weeks, unable to move arm at all, worse last Thurs. night where she could not sleep due to pain. Tried ibuprofen 600 mg OTC, ICY HOT. No arm or shoulder injuries, not red or swollen, no numbness/tingling; no new activities/exercises. Hard to drive or take care of cat. No fevers. Denies neck pain. No issues with right arm/shoulder.
This is a spontaneous case, initially received from other health professional (nurse) on 07-Nov-2018, concerns a 50-year-old, adult female patient. On an unspecified date, the vaccines were stored in the refrigerator and eventually a temperature drop was noted for a moment up to plus 0.3 Celsius for less than 115 minutes, which was considered as first temperature excursion. It was reported that the vaccines were moved immediately. On 26-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: 252227 and expiry date: 31-May-2019) which underwent temperature excursion. The patient did not experience any adverse reactions after the vaccination. The reporter assessed this case as non-serious. This case (201805236) was cross-linked to case 201805327 due to same reporter. Follow-up report received from other health profession on 28-Nov-2018: The patient's age (50-year-old) was added. The route of administration (intramuscular) and anatomical location (right deltoid) of suspect vaccine were added in the product tab. The reporter confirmed that, the patient did not experience any adverse reactions. The narrative and case comment were amended accordingly.
5 PTS EXPERIENCED FEVER,CHILLS,NAUSEA AND VOMITING WITHIN 48 HRS AFTER IMMUNIZATION. ALL PTS RECEIVED IMMUN FROM SAME VIAL BETWEEN 6-1-89 AND 6-15-89.ONE PT TREATED WITH TYLENOL AND COMPAZINE
Throat swelling (but not airway), dysphasia, dysphagia, tachycardia, hypertension, fever
These case reports were previously actioned by Crucell (BERNA-2009-0209). The data was taken directly from the database repository and entered verbatim (including labeling and causality assessments) on to the safety database. Where labeling and causality assessments were absent, took the decision to assign according to company guidelines. This case was received from Novartis Vaccine, no.: 199501487BW on 28.May.2002. A 38-year old female took Typhoral-L (Batch no.: unknown) due to planned travelling to the tropics. She was tentatively diagnosed with eosinophilic myocarditis 2 months after vaccination. Further data was requested. No further data was available. Seriousness: serious (hospitalization). Causality: insufficient information. This case was found during archiving activities and has not previously been entered into the global safety database. The case was processed using procedural documents and current labelling documents. The subject was diagnosed with suspicion of eosinophilic myocarditis/heart failure, 2 months after vaccination with typhoid vaccine oral ty21a. This case was serious (hospitalization).
The pt experienced significant red blotchy rash over body especially trunk and upper extremities. Diagnosed with hives. Treated with Benadryl.
Patient developed high fever of 102-103 the next day, following administration of vaccine. Also, developed maculopapular, erythematous rash over trunk and back the third day following vaccination.
accidently gave an 18 year old patient the adult dose; accidently gave an 18 year old patient the adult dose; This case was reported by a other health professional via other manufacturer and described the occurrence of adult product administered to child in a 18-year-old patient who received HAV (Havrix 1440 adult) for prophylaxis.   On an unknown date, the patient received Havrix 1440 adult. On an unknown date, unknown after receiving Havrix 1440 adult, the patient experienced adult product administered to child and overdose. On an unknown date, the outcome of the adult product administered to child and overdose were unknown.  Additional details were provided as follows: The health care professional stated that she accidently gave an 18 year old patient the adult dose of Havrix,which led to overdose and adult product administered to child. The HCP asked for the further guidance. The HCP was advised that Merck did not manufacture Havrix product and therefore did not have the information she was requesting and suggested that the Merck Service Center could still file an AE and send it to the vaccines manufacturer. The HCP declined to provide any additional information, stating that she needed to speak to the manufacturer of the product and was not interested in filing an AE at that time and she was provided with contact information for the manufacturer of Havrix. No additional information available.
Initial and follow up information has been received from a medical assistant referring to a patient of unknown age and gender. On 01-MAY-2015, the patient was vaccinated with a dose of ROTATEQ oral, lot # K011663 (expiration date, dose and site of administrations were not reported) that was exposed to temperatures outside of the recommended range during 46 hours. No adverse effects shad been observed or reported. This is one of several reports from the same reporter. Additional information is not expected as all the follow ups requested to complete the case were received.
about a month p/2nd dose of hep b pt devel joint pain, swelling, redness, vasculitis on both legs;persistent fever between 99-100 for 3 months;dx autoimmune system disorder;
5 minutes after receiving the vaccine, the client fainted.  Attending nurse performed a sternum rub and administered an ammonia inhalant.  The client woke up pale and diaphoretic. Fire Rescue responded.  Client presented hypotension, Client's vitals recovered to normal limits.  Client was released to home at 4:45pm.  No further evaluation needed as per Fire Rescue.
Pt recv vax on 7/30/98; on 8/1/98 pt exp reddened, demarcated edges of an area measuring 15x6-8 cm.  Area swollen; itching and warmth.
This patient reported during a mass deployment screening-immunizations concerns over adverse events to the anthrax vaccination.  She began receiving the Anthrax vaccination on 15 Oct 1999 with her second and third vaccinations on 3 Nov 1999 and 17 Nov 1999.  She does not remember any unusual adverse events to these vaccinations.  Within four hours following her fourth vaccination on 6 March 2004 she noted the top of her shoulder was red with swelling and redness about the vaccination site.  Over the next few hours the redness and swelling progressed to just below the elbow, encircled her upper arm and extended onto the top of her right shoulder. She noted numbness "as if my hand/arm was asleep" to the right forearm, her hand was swollen, and she had decreased grip strength with overall weakness to the arm.  She denied lymphadenopathy, fevers, headaches, chills, discoloration (cyanosis-palor) to the arm, nausea, vomiting, or joint pain (other than above).  No other vaccinations were administered at this time.  She reported to a company HM2 and was advised she "was ok".  She thinks she was on her menstrual cycle at this time.  This discomfort resolved over the next month w/o reoccurrence. She has not received any further AVA vaccinations in 2005.  There are no reports recorded in her medical records of this reaction.
In the evening the day I had my first shot (Saturday) I had slight pain in my left jaw.  By the next morning (Sunday) the pain was in the right jaw and still slight.  By that evening the pain was severe all night and all day Monday.  I couldn't swallow, move my mouth or bite into anything without severe pain.  By late Monday night the pain had eased but returned on the following Wednesday evening.  I had swelling on the right side of my face by my ear and it was very tender to touch.  The next night I had a headache and body aches and a slight fever.  I contacted my doctor and was told to take Tylenol and Advil  every four hours, alternating the meds.    I haven't been able to eat solid foods because it is too painful to bite into anything or chew.  Today (Monday) the pain has gotten much better but not completely gone.  I am seriously concerned about getting the second shot.
pt has h/o htn and take 4 different meds. he has taken all of his meds today . pt received his covid vaccine on 03/13/2021 in the left shoulder and he woke up this morning with pain in the left shoulder radiating down his arm and it originates at the site of the vaccine.  pt denies substernal chest pain , dyspnea , doe.  he has h/o elevated blood pressures at the level seen today (180/100) when he has poor sleep and he had poor sleep last night due to pain at injection site.  no CAD hx.  pain is not changed with walking but will be worsened by moving his left arm.   PE:  a+ox3, in moderate pain left arm: injection site clean and intact.  left arm is neurovascularly intact.  no bony deformity of the shoulder lung: normal respiratory status,  cv rrr no mgr Signed on 3/14/2021 at 11:54am
Nausea and vomiting for over 12 hours. Aspirated so called EMS to go to Emergency Room. Dehydrated. Low potassium.
i got thr vaccine today first dose ,have Side Effects; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (i got thr vaccine today first dose ,have Side Effects) 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 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 VACCINATION COMPLICATION (i got thr vaccine today first dose ,have Side Effects). At the time of the report, VACCINATION COMPLICATION (i got thr vaccine today first dose ,have Side Effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Large area of redness surrounding injection site approx 2 inches in diameter, warm to touch, mildly sore & raised, no other symptoms - occurred within a day of injection.
Severe fatigue, migraine, dizziness starting day after vaccine and continuing for at least 24 hours. Treated at home with rest, lots of sleep, hydration.
Tinnitus (ringing in ears) reported 6 hrs after injection on3-21-02 and persists. Night sweats for one might then resolved. No complaint of hearing loss.
OBSTRUCTIVE SLEEP APNEA 8/31/2022 -- RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
We checked the needle was locked to the syringe prior to administration. Upon the administration,  there was a leakage noted that patient would like a dose administered to her opposite arm in case. We got her consent on the form with her initial. After vaccination, we checked with patient and ensure she was okay with no adverse reaction during the post-vaccination observation. We told her to keep us posted if she experienced any adverse reaction from Moderna before she came back 4 weeks later for her 2nd dose
This spontaneous report was received from a 58 year old female pharmacist referring to herself. The patient's concurrent conditions included breast cancer and Crohn's disease. The patient also had unspecified "problems" with REMICADE (manufactured by Janssen) and her concomitant therapies included FEMHRT. On unknown dates, "3 or 4 years ago", the patient was vaccinated with 3 dose series of RECOMBIVAX HB (dose, route of administration, lot number and expiration date were not provided) for prophylaxis. On approximately 08-SEP-2017 (reported as "3 weeks ago), the patient experienced recurrence of unspecified symptoms of her pre-existing Crohn's disease; therefore, the patient went to her physician, where she was prescribed azathioprine and prednisone (manufacturer unknown) as treatment for these symptoms, she was additionally performed a bloodwork drawn including hepatitis B titers at this visit, which showed that she was negative for immunity to hepatitis B. At the reporting time, the patient had not recovered from the symptoms of her pre-existing Crohn's disease and the outcome of negative for immunity to hepatitis B was unknown. The causality assessment between RECOMBIVAX HB and the events was not reported. Upon internal review recurrence of unspecified symptoms of the patient's of Crohn's disease was considered to be medically significant.
The lymph node in my left armpit swelled up and hurt quite a bit for about 24 hours. Other than that mild fatigue.
Twenty minutes after patient received her first dose of the Moderna Covid-19 vaccine in her right deltoid muscle, she complained of tingling down her left arm and chest tightness.  Pt also noted experiencing the taste of the medication at this same time.   Recommendation was made for her to extend observation/monitoring time an additional 10 minutes.  EMS was on site and evaluated pt.  EMS reported normal vitals and after evaluation determined the pt was experiencing symptoms related to anxiety.   After evaluation with EMS, pt stated that she felt better and ok to leave.
Intense headaches, exhaustion, muscle pain, chills, nausea, diarrhea, fever, tightness in chest, coughing, difficulty breathing
I experienced painful enlarged lymph nodes in my neck, cervical lymph node adenopathy it was diagnosed as reactive non malignant eventually. The physicians found it was an overreaction to the Epstein Barr virus, and they have been swollen since 11/24/2021. I have had 4 ultrasounds, a CTA, 2 needle biopsies, a thyroid biopsy, and I had an open surgery biopsy 4/15/2022 which resulted in an infection and my being prescribed antibiotics after a second surgery for drainage of the infection on 04/25/2022. I still have not recovered from this adverse event; the physician stated it could take up to 2 more months for swelling to abate, and I am still experiencing the pain as well.
PATIENT CAME IN ON 4/14/21 FOR A COVID VACCINATION WITH PFIZER AFTER RECIEVING HIS FIRST DOSE OF JANSSEN ON 4/11/21 (3 DAYS PRIOR). DID NOT REPORT ANY ISSUES ON ARRIVAL OR WHEN CONTACTED 2 HOURS POST VACCINATION WITH 1ST PFIZER DOSE.
Severe headache, fatigue, nausea; Severe headache, fatigue, nausea; Severe headache, fatigue, nausea; This is a spontaneous report from a non-contactable nurse, reporting for the patient.  A 23-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: EJ1685), via intramuscular route of administration, on 30Dec2020 at 12:45 AM (at the age of 23-years-old) as a single dose for COVID-19 vaccination. The facility where COVID-19 vaccine was administered was at a hospital and anatomically located on the left arm. Medical history not reported. The patient was not pregnant at the time of vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took Penicillin (MANUFACTURER UNKNOWN) and Codeine (MANUFACTURER UNKNOWN), from unknown dates to unknown dates for unknown indications and experienced allergy. On 30Dec2020 at 07:00PM, the patient experienced severe headache, fatigue, and nausea. The patient did not receive any treatment for the events. The clinical outcome of the events severe headache, fatigue, and nausea was recovered.  It was also reported that since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.