chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On January 6th, 2022 I received my Moderna Covid Booster (3rd shot for me). On January 19th I woke up very itchy and when I scratched my skin it would become red, raised, hot and welt. I immediately stopped anything I thought could be causing it. On January 20th I was prescribed Prednisone 10mg and Triamcinolone Acetonide Cream. This did not help so on January 23rd I went to the clinic. They prescribed me Methylprednisolone 4mg Dospak 21s and told me if this did not help to call a dermatologist. I went to the dermatologist on February 3rd. With no improvement from anything I had tried. I was diagnosed with "dermatographism hives" and "physical urticarias". I was told to report to VAERS. I am currently taking 20 mg of loratidine and my usual morning zyrtec, this is day one of this. I was told this would suppress it but would not fix the entire problem.
This spontaneous report was received from a physical therapist (who is the mother of the patient) regarding a 14 year old male patient. The patient's medical history included seizure in 2011 for which he was treated with unspecified medication. Post this episode, the patient had not had a seizure. The patient had no drug reactions or allergies. On 23-SEP-2015, the patient was vaccinated with either GARDASIL (lot number and expiry date unknown) (dosing regimen and frequency unknown) or GARDASIL 9 (lot number and expiry date unknown) (dosing regimen and frequency unknown) (the reporter was unsure). On 27-SEP-2015 at 03:30 hours, the patient experienced a grand mal seizure (medically significant). The patient sought immediate medical attention and was sent to the emergency room (details unspecified). The patient was treated for the grand mal seizure (treatment details unspecified) and was released on the same day. After the seizure had ended, on approximately 27-SEP-2015, the patient's eyes hurt, that lasted for 2-3 hours. On 28-SEP-2015 and 29-SEP-2015, the patient had slept the entire day. On 30-SEP-2015 patient slept for about half the day and then started to return to normal. On 01-OCT-2015, the patient attempted to go back to school, but his mother was called to come and pick him up from the half way. On 02-OCT-2015, patient was cleared to go back to school. The patient was awaiting for clearance to return to sports. The reporter concluded that the patient did not seem to be fully recovered from the incident. The outcome of somnolence was reported as not recovered. An electroencephalogram (EEG) performed was normal, blood work and MRI (magnetic resonance imaging) of the brain was performed on 05-OCT-2015, with no results reported. The outcome of grand mal seizure and eye pain was reported as recovered, while the outcome of somnolence and activities of daily life impaired were not recovered. The relatedness of the events to the suspect drug was unknown. No product quality complaint was reported. Upon internal review the event grand mal seizure was considered to be medically significant. Additional information has been requested.
On the 16th in the morning I began with body aches, cough, skin hypersensitivity, more tired than usual. It was all mild. I had no fever. The next day on 17th my O2 sat dropped from 97 to 81. I went to the emergency room and they sent me home on home oxygen at 2 LPM. On the 18th the cough and body aches ended. I did start on PAXLOVID 3/17/2023 to 3/22/2023. On Friday night and the rest of the time I was on PAXLOVID I had pretty intense dizziness and had to use a walker and PHENERGAN. My O2 sats were fine so I wasn't dizzy for lack of oxygen. May have been related to PAXLOVID or may have been a coincidence. The dizziness went away after I finished the PAXLOVID. I went down to 1 LPM yesterday. Today I did a 6 minute walk test at the doctors office and have been discharged off of oxygen. I had had major abdominal surgery March 3rd which may have played a factor in all of this.
after first vaccine, numbnees in tongue and gums 4 days post injection after second vaccine, flu like sx for 4 days, bronchitis for 2 weeks, then 3 days, full body numbness and tingling that continue to persist
Episode of confusion, fever to 104, and bilateral pulmonary infiltrates consistent with ARDS. Negative infectious diseases workup.  Response to steroids. Patient was intubated due to need for supplemental FIO2 100%.
This case was reported by a physician via call center representative and described the occurrence of immunoglobulin G increased in a 55-year-old male patient who received BOOSTRIX for prophylaxis. On 31st January 2019, the patient received BOOSTRIX. In February 2019, 8 days after receiving BOOSTRIX, the patient experienced immunoglobulin G increased and total protein high. On an unknown date, the outcome of the immunoglobulin G increased and total protein high were unknown. It was unknown if the reporter considered the immunoglobulin G increased and total protein high to be related to BOOSTRIX. Additional details were provided as follows: One week and one day later, the patient had drawn laboratory test for routine physical. The laboratory tests were normal except, high immunoglobulin and high total protein. The serum protein electrophoresis test was performed and confirmed with high immunoglobulin G. The physician was not in office and did not have patient chart in front of her at the time of this call.
Haven't had menstrual cycle for over 9 months and had a 3 day period last week; Experienced headache for 3 weeks; Pain in arm for 2 days; Fatigue, nausea, anxiety on and off last 3 weeks.; Fatigue, nausea, anxiety on and off last 3 weeks.; Fatigue, nausea, anxiety on and off last 3 weeks.; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 31Mar2021 at 11:45 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included diltiazem (CARDIZEM), colecalciferol (VITAMIN D3), progesterone (MANUFACTURER UNKNOWN) and acetylsalicylic acid (ASPIRIN); all for unknown indication from unknown date and unknown if ongoing. The patient previously took cefalexin (KEFLEX) and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. From 31Mar2021 at 16:00, the patient experienced headache for 3 weeks, pain in arm for 2 days, fatigue, nausea, anxiety on and off from 3 weeks prior to report. The patient hadn't had menstrual cycle for over 9 months and had a 3 day period the week before reporting on an unknown date in Apr2021. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event experienced headache for 3 weeks was resolving, while that of pain in arm for 2 days was resolved on 02Apr2021. The clinical outcome of the events fatigue, nausea, anxiety on and off last 3 weeks prior to report and had a 3 day period the week before reporting was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Soreness, swelling, bruising at  injection site within two hours and continuing. Diarrhea within 7 1/2 hours; another episode at 2:45 a.m.
Later that evening probably around 07:30 after my 2nd dose I had a fever of 101 and chills so I took Tylenol and went to bed. I was achy and fatigued the next day. I did not need medical care and was fine by 03/05/2021.
About 5 hours after vaccine was administered I experienced seizure-like symptoms.. dizzy, nauseated, light-headed, hot, feverish and couldn't focus. After that subsided I had extreme pain on my left side from the top of my shoulder to my thigh. Arm is still sore and not at full strength.
The morning after the vaccine, the symptoms started with a stiff neck and headache on the left side including soreness at the injection site. As the symptoms progressed, I felt aching in my lungs on the backside, and flu-like symptoms with no fever, and spasms in my feet and stomach region. Other symptoms have been dizziness, facial puffiness and tingling, with continued aching and tingling in the left arm. The  stiff neck and headaches and general malaise has persisted throughout even until now.   As a school teacher, I have taken the appropriate precautions and received a Covid19 test: Results negative.
L arm sore and swollen,  flu-like symptoms, fever, chills, sore throat, runny nose, sinus pain. Missed 2 days of  work after vaccination.  Feeling better by 5 days after vaccination.
Information has been received from a physician concerning a 36 month old female who was vaccinated with the first 0.5ml dose of VARIVAX (Merck) when she was one year old in 2007 and experienced itchiness, fever and malaise. No lot # was provided. Follow-up information has been received from the physician indicated that the patient developed chicken pox after the first dose of VARIVAX (Merck), at the time as the fever, itchiness and malaise. The patient had sought unknown medical attention. The patient recovered on an unspecified date. No further information is available.
2 1/2 days after the shot - chills, low grade fever, muscle aches, head & chest congestion. Lasted overnight. Following day minor head & chest congestion  remained.
Incorrect product storage; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. The Information regarding the patient's concurrent conditions, medical history, concurrent conditions, drugs reactions or allergies were not provided.   On 13-AUG-2020, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (lot #S020963, expiration date: 07-JUL-2021) (dose, strength, route of administration and injection site were not reported) for prophylaxis. The vaccine was stored in temperature from 2 degrees Celsius (C) to 8 degrees Celsius (8.4 C) for a time frame of 34 hours and 41 minutes and in above 9 degrees Celsius (10.5 C) for 6 hours. The call was made due to a digital data logger. No previous temperature excursion was reported.
Patient wished to not receive the vaccine in the arm because she didn't want her arm to be sore. There was a possibility of giving the vaccine in the hip. When discussed with the nurse who looked at the site of injection, site was determined to be vastus lat (thigh). Patient had a local inflammatory reaction to the vaccination.
This spontaneous report was received from a male pharmacist of an unknown age who was referring to himself. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 13-OCT-2017, while preparing to administer a ZOSTAVAX (lot# was reported as N02117 and expiration date: 27-OCT-2018) reported as vaccine, a small hole in the bottom of the vial caused an unknown amount of liquid to leak out on the patient's hand. The patient washed the affected area with soap and water and sterilized the area with rubbing alcohol. No adverse effects have been noted after the exposure. The patient's was recovered at the time of this report. The relatedness between the events and inadvertent exposure to ZOSTAVAX was not reported. Lot number N02117 has been verified to be a non valid lot number for ZOSTAVAX.
Death   Less than Two weeks after vaccine Pfizer booster. Autopsy report stated cardiomyopathy with CHF  . Died suddenly  was previously healthy.
Nickel taste, throat itching, mild anaphylaxis, chest tightening, upper right back tightening
patient was administered ROTATEQ and regurgitated some of the ROTATEQ; patient was administered ROTATEQ and regurgitated some of the ROTATEQ; This spontaneous report was received from a medical assistant, referring to a 9-week-old female patient. The patient had none pertinent medical history, concomitant medications, drug reactions, or allergies.  On 20-MAY-2020, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (vaccination scheme was not reported; lot number 1660951, which has been verified to be valid, expiration date reported and validated as 11-NOV-2020), administered orally as prophylaxis, and regurgitated some of the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (regurgitation and underdose).  It was reported that the patient did not seek medical attention, treatment was not given, and none laboratory diagnostics/studies were performed.  The patient recovered from regurgitation the same day of vaccination. The causal relationship between therapy with vaccine, live, oral, pentavalent (ROTATEQ) and regurgitation was not provided.
Left arm where vaccine given turned red and edematous mother took to physician, who advised against continuing series. Mother reported to HD 5-20-15 when checking for immunizations that were due.
PATIENT REPORTED UNABLE TO STOP SHAKING. PT ALSO GOT A RASH. PATIENT WENT TO THE HOSPITAL.
Received flu shot 10/16/10. Late November 2010 sudden onset of numbness and tingling to point where she could not walk. Admitted to hospital. Still has numbness in her finger tips b/l and left forearm and left leg.
Had vaccine 10/23/07 @ 10:30 a.m Started feeling poorly during night. Believed had fever. Body ache-"throbbing H/A". Ran fever up to 102 deg F Spoke to on 10/26-Feeling much better
the left side of my face and my left arm started twitching a lot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Aug2021 11:30 (Lot number: FC3182) at the age of 22 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known Allergies: Shellfish" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Aspirin, reaction(s): "Known allergies_Aspirin"; Zithromax, reaction(s): "Known allergies_Zithromax". The following information was reported: MUSCLE TWITCHING (non-serious) with onset 17Aug2021 14:00, outcome "recovered" (2021), described as "the left side of my face and my left arm started twitching a lot". Therapeutic measures were not taken as a result of muscle twitching.  Additional information: It was reported that roughly 2.5 hours after the injection, the left side of face and left arm started twitching a lot when patient attempted to drink water. It wasn't too terrible. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The medication patient received within 2 weeks of vaccination was Women's daily multivitamin.   No follow-up attempts are possible. No further information is expected.
(R) thigh redness, slight swelling, hot to touch. Tx: oral BENADRYL as needed for itchy skin.
Injection site is warm to the touch; Injection site is swollen and is two and half inches in diameter size; This spontaneous case was reported by a consumer and describes the occurrence of   in a 70-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 11-Feb-2021, 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.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.    This case was linked to MOD21-035149 (Patient Link).
Moderna Arm; red blotches; itchy blotches; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION COMPLICATION (Moderna Arm), RASH MACULAR (red blotches) and RASH PRURITIC (itchy blotches) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Moderna Arm), RASH MACULAR (red blotches) and RASH PRURITIC (itchy blotches). At the time of the report, VACCINATION COMPLICATION (Moderna Arm), RASH MACULAR (red blotches) and RASH PRURITIC (itchy blotches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Symptoms: It was reported that the patient stated the events experienced by 16 patients after taking Moderna COVID-19 vaccine, out of which 13 were women, onset of event was 2-12 days post vaccination and median duration was 5 days till 21 days.  No concomitant medications were reported No treatment medications were reported
Information has been received from a physician concerning a female who was vaccinated with the first dose of Gardasil.  Subsequently the patient experienced dry heaves, vomiting, nausea, and flu-like symptoms, which lasted for three weeks.  Subsequently, the patient recovered.  On 05-Feb-2008 the patient was vaccinated with her second dose of Gardasil.  At the time of this report, no symptoms were noted.  Additional information has been requested. Information has been received from a physician concerning a female who on 12-Dec-2007 was vaccinated with the first dose of HPV vaccine (lot # 655154/1210U). Subsequently the patient experienced dry heaves, vomiting, nausea, and flu-like symptoms, which lasted for three weeks. Subsequently, the patient recovered. On 05-Feb-2008 the patient was vaccinated with her second dose of HPV vaccine. At the time of this report, no symptoms were noted. Additional information has been requested. 02/12/2010 Subsequently after second dose of GARDASIL the patient experienced severe stomach pain that induced dry heaves, and nausea. Symptoms continued for approximately 5  days. Additional information has been requested.
received a dose of Pentacel after it was exposed to a temperature excursion of 22.7°F with no AE; Initial information regarding this unsolicited valid non-serious case was received from Other Healthcare Professional via Medical Information (Reference number- 00418447) and transmitted to Sanofi on 06-Jan-2021.  This case is linked with 2021SA005526, 2021SA006645 (same reporter).  This case involved a 2 months old male patient who received a 0.5 ml first dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot: UJ382AA, expiration date: 01-Oct-2021) once via unknown route at left vastus lateral for prophylactic vaccination on an unknown date which was exposed to a temperature excursion of 22.7 degree Fahrenheit (product storage error).  The patient's medical history, medical treatments, vaccinations and family history were not provided. Concomitant therapies were not asked.  It was an actual medication error due to product storage error temperature too low.  The reporter stated that the facility initially reported temperature excursion of 32.5 degree Fahrenheit and were cleared to immunize based on that temperature. However, on further review, it was discovered facility made a mistake and the actual temperature the vaccines were exposed to was 22.7 degree Fahrenheit. During that time period, three patients received vaccines that were actually unsuitable for use. The reason documented in that case for the temperature excursion was a technical malfunction of the refrigerator. The reporter wanted to know how they should proceed and if they should revaccinate the patient. Doctor/emergency room visit on 05-Jan-2021.  No adverse event reported to the patient at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Expired pentacel was administered with no reported adverse event; Initial information received on 20-May-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a patient of an unknown age and gender and it was reported expired pentacel was administered with no reported adverse event , while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 20-May-2022, the patient received an unknown  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE, ( lot : UJ433AA; expiry date: 17-May-2022)  in unknown administration site for prophylactic vaccination.  It was reported that  expired pentacel was administered on 20-May-2022 and it expired 3 days prior (expired product administered) (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Action taken : not applicable.  Outcome: unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pt. relates no energy level, very tired, with dizziness, lightheadedness since yesterday afternoon (3/31/04). Relates no fever. Signs continuing today, but has gone to work anyway. Weak grip. 4/2 pt. still weak. Did not see doctor. Felt better with taking Ibuprofen.
Dizziness, Myalgia, Fever, NauseaVomiting, CHILLS, ARM PAIN Narrative:
This child was swollen, inflammed, tissue (warm to touch), at the site of the DTaP and MMR vaccination (left deltoid). Rx: Augmentin.
Administration of an expired dose of MMR II [Lot: T018893, Exp: 06/2/2022 to a patient on 7/21/2022. Caller confirmed vaccine was stored at recommended storage range until date of administration.; No additional AE reported; This spontaneous report was received from a medical assistant concerning a 25-year-old male patient. His medical history, historical medications, known allergies, concurrent conditions, and concomitant therapies were not reported.  On 21-JUL-2022, the patient was vaccinated with an expired single dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin (rHA)) (M-M-R II) with the verified lot number T018893 (expiration date: 02-JUN-2022) administered for prophylaxis (strength, volume of injection, and route of administration were not provided) (Expired vaccine used). Moreover, the reporter stated that the suspect vaccine had been stored at the recommended storage range until the date of administration. No additional information or adverse events were provided.
Information has been received from a health professional concerning a 2 yr old male who on 09Feb04 was vaccinated in the left arm with a first dose of varicella virus vaccine live (lot647520/1106N). On 06Jun05 the pt developed chickenpox lesions. Additional information is not expected.