chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had a rash about a week after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of RASH (had a rash about a week after vaccination) 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 RASH (had a rash about a week after vaccination). At the time of the report, RASH (had a rash about a week after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter stated that she knew a few people (her cousin and her neighbor) who also experienced an adverse reaction after receiving the Moderna COVID19 Vaccine. She stated that both patients had a rash about a week after vaccination.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-086393 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Followup received on 21-APR-2021 and contains e-mail details.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-086393:Crosslink
Very stiff and sore neck on left back side; SEVERE stabbing/shooting pains through left shoulder and down left upper arm.  Vaccination injection was on upper left arm. 5 days later and pain continues.  Rate 10 on pain scale of 1 to 10.
1 day p/vax pt exp itching of the palms;2 days post vax pt devel a red rash on rt wrist;3 days post vax pt devel hives behind both knees & in the groin area;hives recur approx every 3 days;pt being tx w/DPH;
Approx. 2 inch whelping with another 1 inch redness around it, warm to touch. Pt does not have fever now, father denies fever or c/o pain. TYLENOL given per wt. and cold pack applied. Script given for cortisone cream & BACTRIM.
Fever, NauseaVomiting, sore arm Narrative:  Other Relevant History:
Pt recv vax on 5/21/98; on same day pt exp cont fatigue, tired, lethargic
On and off pounding in head; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (On and off pounding in head) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced HEADACHE (On and off pounding in head). On 11-Feb-2021, HEADACHE (On and off pounding in head) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided. No treatment information provided.
9 days after injection site became red and itchy. The redness has now spread from the injection site near my shoulder almost to my elbow.  It is still itchy and read  6 days after the first redness occurred. It is warm to the touch, but not painful.  It is somewhat scaley.
Patient reported increased blood pressure, palpitations, vomiting, diarrhea. Patient stated that she felt like her "brain was cooking" per patient
The patient was administered by mistake with a dose of covid vaccine outside of the 12 hours window of a punctured vial.
1/4 - 1/7/2021 ADMISSION 60 y.o. female with a PMHx HTN, HLD, hypothyroidism, T2DM, paroxysmal atrial fibrillation, COPD, and squamous cell carcinoma of the larynx (in remission)  COPD COVID PNA Acute on chronic hypoxic respiratory failure Patient discharged on 1/7 after COVID PNA.(positive 1/4) Discharged on 6L baseline 3-4L NC.  She then presented via EMS w/ concern for fever, worsening respiratory status.  CT demonstrated similar findings as prior except new RLL consolidation/collapse.  Did not appear to be new bacteria PNA and patient quickly returned to her baseline respiratory status of 3-4 L -continue PTA inhalers -continue PTA o2 goal 88%     AKI,resolved Cr 1.24, baseline 0.8. 1L IVF bolus, hold lisinopril-- resolved w/ IVF.   Hyperkalemia 5.4 but specimen was hemolyzed. Repeat 4.9   SCC of throat -takes minimal PO -dietician consult for TF   Type II diabetes mellitus - Hold PTA metformin for now; restart at discharge - Glucose check qAC/HS   Anxiety - Continue PTA buspar 10mg TID - Continue PTA zyprexa 10mg daily   Hypothyroidism TSH 4.0 in 10/2021. T4 1.14, T3 2.38.  - Continue PTA Synthroid 112mcg daily   Paroxysmal atrial fibrillation - Continue PTA Xarelto -currently rate controlled off any control agents 1/14 - 15/2021 OBSERVATION ADMISSION AND DC 1/17/2021 ED VIA EMS ADMISSION   9:50 AM - NO ADDITIONAL INFO AVAILABLE AT THIS TIME
Increasing Fever. Began at 99.7 at 9:00 on 10/1/21 Now 10/2/21 at 8:00 temp is 101.7
Pt recvd vax 26MAR92 & on 3APR had low grade fever, fine rash & continued those sx for weekend 4APR-5APR & on 5APR t104 ax pt was crying/refused food; 6APR presented to MD & again 7APR & 8APR dx ear infect;
About 10 hours after vaccine, started experiencing very severe lower back pain, and the piriformis syndrome became worst ever had.   Pain so severe, cannot walk.
Patient received Pfizer vaccine as a first dose  Patient inadvertently receive Moderna vaccine as the second dose
This spontaneous report as received from a pharmacist refers to a 61 year old female with no reproted medical history. On 22-SEP-2013 the patient was vaccinated with ZOSTAVAX dose 1 (date, route, dose and lot number unknown). No other suspect therapy or concomitant medication was reported. On 24-SEP-2013, 3 days after onset of therapy the patient developed redness and warmth at the injection site following the administration of ZOSTAVAX. The pharmacist mentioned that the area of redness was approximately 3 inches in diameter. No treatment information was reported. The outcome of redness (area was approximately 3 inches in diameter) at the injection site and warmth at the injection site following the administration of ZOSTAVAX was reported as not recovered/not resolved. The reporters relatedness of redness (area was approximately 3 inches in diameter) at the injection site and warmth at the injection site to ZOSTAVAX is unknown. Additional information has been requested.
Within about 5-7 days after the second Moderna vaccination, I started to have sever joint pain in my knees (which resulted in an x-ray being taken). The pain then grew to my feet, fingers, wrists, and shoulders over several weeks. This pain has been consistent since it started and has not responded to a treatment of steroids. [Prednisone 10 mg Tab - 10 day dose. The joint pain declined for several days, but fully returned after the Prednisone sequence was completed.]   I have had multiple blood tests and have been referred to a rheumatologist to explore a potential autoimmune response.
1557: 15 mins after receiving COVID vaccine, pt c/o scratchy throat 1559: Benadryl 25 mg po given. BP 138/98 HR 80 RR 16 SpO2 99% 1615: No increase in scratchy throat. BP 140/90 HR 80 Sp)2 99%.  Pt released home.
Sore arm; This is a spontaneous report from a Pfizer-sponsored program, from a non-contactable consumer.  A patient of an unspecified age and gender received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) on an unknown date, at single dose, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced sore arm. Clinical outcome of the adverse event was unknown at time of this report.   No follow-up attempts are possible, information about lot number cannot be obtained.
Information has been received from a consumer concerning her son who was vaccinated with Hep-B vaccine and subsequently, the pt experienced an adverse reaction (condition unspecified). It was reported that the pt's condition was resolving. Additional information has been requested.
When I woke up on 7/22/2022 I didn't feel well but didn't associate it with COVID-19. I tested myself the next day and it was negative, but I'm not sure I did it properly. I took another test on 07/24/2022 and it was positive. My doctor wasn't available until the following Monday. I called him, although I wasn't feeling too badly. He debated whether or not to prescribe PAXLOVID but ultimately did. I actually felt a little bit worse after starting the medication. Before I began taking it, I felt almost normal, with minimal symptoms. I took my last dose that Saturday morning, and by the following Tuesday, I felt great.
Pt developed vitiligo at site of Hep B injection (3 over a 6 month period in left deltoid).
No additional AEs; syringes of GARDASIL 9 where the round portion of the plunger broke which occurred once when a nurse was giving the injection; syringes of GARDASIL 9 where the round portion of the plunger broke which occurred once when a nurse was giving the injection; This spontaneous report as received from a registered nurse referring to a patient of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided.  On 15-FEB-2021, while administering hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) prefilled syringe (dose 0.5 milliliter, intramuscularly, lot # T008152, expiration date reported as 01-JUN-2022, but upon internal validation established as 21-JUN-2022) for prophylaxis, the round portion of the plunger broke.   No additional adverse events. No further information provided. It was reported that she was unable to obtain broken syringes/plunger as they had been placed in the sharps disposal. The plunger rod (only) did not fell out of syringe barrel during use or loose and the circular part of plunger broke during use. The broken area was of one piece broken off.  This is one of two reports received from the same reporter.  This case was considered non-valid due to the lack of patient identifiers.  Follow up information has been received on 04-AUG-2021 from Merck's Manufacturing Division (MMD). The case was reopened based on new information related to a potential harm associated with broken syringe during and after injection. The device problem codes and device evaluation codes have been updated. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T008152; expirationdate: 21-JUN-2022; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Yes; productavailableforevaluation: No; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: Yes; mdcpreprationale: Refer to QCC4 record for reportability rationale; evaluationvalue - Patient / Device: N/A / 2978; N/A / 1069 evaluationvalue - Method / Result / Conclusion: 4112 / 170 / 25; 3331 / 170 / 25; 4115 / 170 / 25; 11 / 170 / 25; Sender's Comments:  US-009507513-2102USA009030:
On 6/13/2020 patient went to Urgent care complaining that left arm was still having pain since receiving vaccine on 6/2/2020.
Patient presented to  ED with fever, chills, and one episode of vomiting the day following her booster COVID19 vaccine. The patient was noted to have a drop in sodium and was given a dose of steess-dose steroids given her adrenal insufficiency. She also was given Ciprofloxacin empirically for a UTI, given positive leukocyte esterases in the urinary analysis, and discharged home.
patient presented to emergency department on 9/20/21 with vomiting, cough and myalgias patient  was found to be covid-19 on 9/15/21 and started on azithromycin on 9/14/21. patient ws started on prednisone 10mg 9 day taper on 9/16/21 patient was admitted to hospital on 9/20/21 for covid-19 and treated with dexamethasone patient was discharged to home on 10/6/21
Pt recv vax on 3/4/99; on 3/8/99 pt exp vax site rash to one side of body to knee & wrist
brain foggy; exhausted; weird arm pain in left arm.; on and off headache; Chills; shakes; fever; bruise where the vaccine was given; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 26Mar2021 at 11:00 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety, post-traumatic stress disorder, pollen allergy, house dust allergy, high cholesterol and blood pressure high when anxious. The patient had no allergies to medications, food, or other products and even the patient had a test at the allergist's prior to getting the vaccine to make sure that she wouldn't be allergic to any of the additives. Concomitant medications included buspirone hydrochloride (BUSPAR), hydrochlorothiazide (MANUFACTURER UNKNOWN) and Vit + Supplements (MANUFACTURER UNKNOWN). 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 vaccines within four weeks prior to the COVID vaccine. On 26Mar2021, the patient experienced bruise and on same day at 23:00, the patient experienced shakes, fever and chills. On 27Mar2021 (Saturday), the patient experienced on and off headache. On 27Mar2021, the patient underwent test for body temperature and the result was 101.5 degrees Fahrenheit. The patient took Advil and drank plenty of fluids due to headache and fever. On 28Mar2021 (Sunday), the patient was exhausted and experienced weird arm pain in left arm. On 28Mar2021, the patient underwent test for body temperature and the result was 100.4 degrees Fahrenheit and she continued with the Advil and fluids. On29Mar2021 (Monday), the patient had foggy brain (confusion). The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the events bruise, chills, shaking, fever, headache, exhaustion, brain foggy and pain in arm was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Injection site is red warm and swollen. Patient was advised to ice area and take analgesics if needed.
It started out with sneezing, running nose, headache, sinus pressure, and fatigue. I tested positive for COVID-19 at home. I went to an urgent care and prescribed me Paxlovid. Then I tested negative after 2 weeks then I rebounded. I had a running nose and fatigue.
Previously I had one outbreak a year. In three weeks after dose I had 4-5; In the weeks after my second dose I have had almost continuous outbreak of hsv1.; This is a spontaneous report received from a contactable consumer (Patient). A 58-years-non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Er2613) via unspecified route of administration in arm left on 25Mar2021 10:00 (at the age of 58-years-old) as single dose for COVID-19 immunization. Medical history included asthma and covid-19 all from an unknown date and unknown if ongoing. Patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Enen6200) via unspecified route of administration in arm left on 04Mar2021 11:30 (at the age of 58-years-old) as single dose for COVID-19 immunization. Patient has known allergies: sulfa. Concomitant medication included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, liothyronine (LIOTHYRONINE) taken for an unspecified indication, progesterone (PROGESTERONE) taken for an unspecified indication all within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. Within weeks after second dose patient had almost continuous outbreak of hsv1. Previously had one outbreak a year but in 3 weeks (29Mar2021) after dose patient had 4-5. On 22April sought treatment and have been on medication to suppress the virus. It has been successful but required higher dose of valacyclovir to stop outbreaks. Patient realized vaccine didn't give me this but something in vaccine or body activated hsv1 in big way. Patient reported the adverse event to Doctor or other healthcare professional office/clinic visit. Patient received treatment for the adverse event (Medicine). Outcome of the event is recovering.   Device Date: 29May2021.  Follow-Up (29Jun2021): Follow-up attempts are completed. No further information is expected.
BIVALENT BOOSTER WAS GIVEN BEYOND EXPIRATION DATE AFTER BEING DRAWN.
cold sore after first shot; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (cold sore after first shot) in a female patient of an unknown age 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 ORAL HERPES (cold sore after first shot). At the time of the report, ORAL HERPES (cold sore after first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drug was reported.  No treatment drugs were reported.  The patient got an antiviral, valacyclovir, and was not t sure if it would affect the vaccine. She stated she never took the medication because she didn't want it to affect the vaccine.
Vaccine administered 5/27/03 - child ran a fever and broke out in a vesicular rash on 6/23/03.
I had my first dose of vaccine on 1/8/2021. So far I had no reaction whatsoever. But since yesterday that is Sunday 1/17/2021, I saw redness and a knot around my arm where I had received a shot. Rash is much lighter today. The knot is almost gone. It's not hurting. I don't have fever, no other symptoms. This may not be related to Vaccine as it came after so many days. I think of vaccine related is site of rash and knot. The reason I wanted to let you know is, this is a new vaccine, and I know you are collecting data. I am ready for a second dose scheduled for 2/6/2021.
redness, swollen area approx 4"x7". area warm to touch, lump near area of injection, painful when bending arm (right arm).
Patient and husband arrived to received covid-19 vaccine together, 12:30 pm and 12:45 pm appointments. I informed patients that if they wanted to, they can both enter room together. Both patients were counseled on side effects/ what to expect. Patient was administered the Moderna COVID-19 Vaccine first in left arm. Upon vaccination, patient's arm began to bleed from injection site. I informed patient I would clean her arm, and attempted to hold gauze in place myself. Patient stated she would hold the gauze instead. After applying bandaid and cleaning area, I began process to vaccinate her husband. While vaccinating husband, patient stated she felt dizzy/faint. Patient sat in chair. Husband stated she is prone to fainting spells. I offered EMS services.Husband refused. I elevated patient's legs with other chair. Patient started to become non-responsive.  I stated I would use an epi-pen. Patient's husband refused epipen. Informed technician, to contact 911. Informed technician to contact front end manager. Patient continued to be non-responsive. Asked husband if I should get patient juice. Ran to get patient orange juice and straw. Husband wet patient with water. Patient started drinking orange juice through straw. Felt better. Started becoming responsive. PAtient and husband waited for EMS. Refused EMS services.
some leaked out/some of the vaccine leaked out of the patient's arm; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (some leaked out/some of the vaccine leaked out of the patient's arm) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Dec-2021, the patient experienced UNDERDOSE (some leaked out/some of the vaccine leaked out of the patient's arm). On 02-Dec-2021, UNDERDOSE (some leaked out/some of the vaccine leaked out of the patient's arm) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient reported that she has not experienced any symptoms. No additional doses have been administered at this time to her. She has not taken any medications or treatments No concomitant medications reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Dec-2021: Follow-up received Updated Non-Significant Information
Numbness on the left side of the upper and lower lips. lasted for approximately 1-2 hours.
Redness, swelling, pain at site  Ice pack to area; alternate Tylenol an ibuprofen
Patient contracted COVID-19 after initial Comirnaty vaccine series; Patient contracted COVID-19 after initial Comirnaty vaccine series; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP. The reporter is the patient.  A female patient received BNT162b2 (COMIRNATY), as dose 1, single (Batch/Lot number: unknown) and as dose 2,  single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "recovered" and all described as "Patient contracted COVID-19 after initial Comirnaty vaccine series".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
T 105.5 starting late in evening of 5/15/06 with vomiting and headache that night actually 2:30AM only. 5/16/06. High fever lasted until 5/16/06 at 6PM. OK since.
SORE THROAT, BODY PAIN, NASAL CONGESTION, COUGH, WITH EXPECTORATION, BODY PAIN, MYALGIA, HEADACHE.
8-12 days after the first injection I broke out with fever sores on the left upper lip.  The same occurred after the 2nd injection and this time it was on the lower lip, right side
The vaccine was administered too low (as confirmed by several health care professionals). It was not administered in the deltoid but rather half way between by shoulder and elbow (below armpit level).  Due to wanting to minimize the risk of exposure, pictures were sent to the healthcare professionals rather than a clinic visit. Of note, the vaccine was administered by the national guard.  Side effects were pain, redness (3 inch diameter), and swelling at the injection site. Today is day 8 since the injection and there is still some swelling and redness as well as itchiness.
Fever of 101 F. Chills, Blood shot eyes, extremely sore arm.
Slight chills then feel hot-no fever  2 days so far, nausea , brain fog, slight sore throat, slight runny nose, irritable.