chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pericarditis with effusion to heart and lungs.  Severe chest and back pain started 1 week after receiving vaccine.  Also had shortness of breath/difficulty breathing, high blood pressure, elevated heart rate, arrhythmia, nausea, fever, dizziness/light headedness, numbness/tingling in legs.    Ultimately led to inpatient hospitalization after emergency room visit.  After leaving hospital was  given colchicine for 6 weeks, ibuprofen, pantoprozol, and augmenten.  The severity of the pain and fatigue led to needing to take short term disability and a leave of absence from work.  5 weeks after hospitalization, back pain is still significant (as of 12/27).
approximately 2 weeks after each vaccination she developed a localized burning rash of the bilateral buttocks, and patchy areas of the extremities, seen by urgent care than primary doctor then referred to my clinic in Dermatology.  She was treated with topical steroids and prednisone, when the rash occurred after the 2nd vaccination I did perform a punch biopsy, and this showed a dermal hypersensitivity reaction, both the biopsy findings and the timing of this rash occurring in same distribution after the each vaccination approximately 14 days I do think this is a vaccine triggered hypersensitivity phenomenon with a localized clinical appearance looking like dermal hypersensitivity.
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On unknown dates the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (lot # L007230, expiry date: 03-SEP-2016) (route, dose# and site of administration not reported). Concomitant medication was not mentioned by the nurse. The vaccine was stored at -2.0 degree Centigrade for a time frame of 12 hours and 10 minutes (incorrect product storage). There was no previous temperature excursion. The call was a result of a "data logger". No adverse effects were reported. No additional information was provided. Product quality complaint was not filed. Additional information is not expected as the reporter did not wish further contact. This is one of the three reports received from the same reporter.
This case was reported by a consumer via call center representative and described the occurrence of headache in a 75-year-old male patient who received SHINGRIX for prophylaxis. On 3rd February 2018, the patient received the 1st dose of SHINGRIX. In February 2018, 2 days after receiving SHINGRIX, the patient experienced headache, general body pain and chills. In February 2018, the outcome of the headache, general body pain and chills were recovered/resolved. It was unknown if the reporter considered the headache, general body pain and chills to be related to SHINGRIX. Additional details were provided as follows: The reporter was the patient. All his symptoms lasted for about a week. He did not know the specific dose given. The patient reported the contact details of the physician. For tolerance to next dose, refer case US2018115927. This case has also been linked with US2018115928 (patient's sister-in-law), reported by the same reporter.
Pt stated that she had severe flu like symptoms for 3 to 4 days after injection. Was very fatigued.
Moderna Vaccine Reaction: 12/30/2020 vaccinated Moderna vaccine at 2:15pm  no issues 12/31/2020 experienced chest tightness at 8am resolved with albuterol 1/1/2021 awakened from a nap at 3 pm with hot itching rash across front of chest & back of neck.  Eyelids slightly reddened and swollen.  Allergic to IV Benadryl (total body rash after given IV push Benadryl to get MRI claustrophobic).  No benadryl.  Routinely take Zyrtec daily that had been taken.  Took extra strength Tylenol and pushed fluids.  Through the day slowly improved. 1/2/2021 Rash almost gone no longer itching.  Eyelids only slightly red. 1/3/2021 Used antihistamine eyedrops once.  Later no longer red.
Information has been received from an office registered nurse concerning a 16 year old female patient who on an unspecified date was vaccinated with the first dose of GARDASIL. After receiving the vaccine the patient had a seizure. The patient sought unknown medical attention. The nurse reported that the patient was not receiving anymore doses of GARDASIL and was now on anti-convulsant medication (name and manufacturer unspecified) for the seizures. Additional information has been received from the registered nurse who indicated that the patient's mother had come to the clinic for a DEPO-PROVERA injection. The patient's mother stated that her daughter had received the first dose of GARDASIL at another physician's office (physician's name and contact information was not reported). The patient began to have seizures after she had received GARDASIL vaccination. The GARDASIL vaccinations were discontinued because it was not known if the GARDASIL vaccination had caused the seizures. The reporter stated that she did not know the patient's name or contact information and was not able to give any additional information. At the time of report the patient's status was unknown. Upon internal review, seizure was considered to be an other important medical event. Additional information is not expected.
I started with extreme fatigue that turned into flu like symptoms. While many of my colleagues symptoms lasted for a few day my symptoms persisted for 9 days and I still have a sore throat.  My most significant symptoms were fatigue  and swelling and pain in my hands, and sore throat. I was unable to make a fist for almost 6 days post vaccination.  I am getting better but I am not back to my normal routine yet.
Patient received vaccine, appeared to be fine, I went back into pharmacy and about 1-2 minutes later, patient fainted and fell onto the floor out of his chair.   We called 911 immediately and they were here within 5 minutes.  Patient continued going in and out of consciousness and they brought him to the hospital via Ambulance where he was later released that day.
An 18 month old child was brought to clinic by parents to state child appears to have rash & itching all over body. Observation was made on child & there was rash & itching all over the body, parents informed to take him to the hospital. As per father child received a Hep B vaccine & reacted the same way, yet no mention before administrating vaccine not documented on questionnaire form.
pt recvd vax about 1PM about 7PM pt listless, quiet, pale, lips were purple in color;skin clammy; sleep between 1/2 to 1hr when awoke color was good & seemed fine;given APAP;18MAY95 DPT not given
Rash at injection site, bronchospasms that required nebulizations and steroids.
Pain in upper arm and shoulder and inability to lift arm to dress or to lift and extend left arm above waist height.
hives; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team. The reporter is the parent.  A 2-year-old female patient received BNT162b2 (BNT162B2), on 28Jun2022 as dose 1, 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: URTICARIA (non-serious) with onset 13Jul2022, outcome "recovered" (17Jul2022), described as "hives".  Additional information: It was reported that caller was a pharmacist called on behalf of his daughter (2y/o female) who had a reaction to her first dose of the Pfizer Covid19 vaccine. He reports, "she got her first Pfizer dose like 28Jun2022 and then the hives started on 13Jul2022" noting the hives were "over her whole body" and "got worse for a couple of days", and by yesterday they were "completely cleared". He states that "the allergist said it could be from the vaccine". He's looking for information about a delayed reaction to the vaccine. Also, from PI "Adverse Reactions in Post Authorization Experience: Severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions (e.g., rash, pruritus, urticaria, angioedema), diarrhea, vomiting, pain in extremity (arm), and syncope have been reported following administration of the Pfizer-BioNTech COVID-19 Vaccine." [LAB; Revised: 17Jun2022]. No information for incidence/onset of hives after vaccine administration. Typically, adverse events reported closer to time of administration. No info for delayed allergic reactions.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
nurse called reported that tenivac was given to 2 patients but the tenivac was expired on 24sep2023 with no reported adverse event; Initial information received on 29-Sep-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2023SA301831.  This case involves a 8 years old male patient and nurse called reported that Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] was given to 2 patients but the tenivac was expired on 24sep2023 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Prophylactic vaccination; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Prophylactic vaccination; INFLUENZA VACCINE (INFLUENZA VACCINE) for Prophylactic vaccination; and POLIO VACCINE (POLIO VACCINE) for Prophylactic vaccination.  On 29-Sep-2023, the patient received 0.5 ml total (1x) dose of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult Suspension for injection (lot number: U7183AA; Expiry date: 24-Sep-2023) (Strength: Standard, Frequency: once) via intramuscular route in the left deltoid for prophylactic vaccination (Immunisation).  On 29-Sep-2023, the nurse called reported that Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] was given to 2 patients but the tenivac was expired on 24sep2023 with no reported adverse event (expired product administered) (latency: same day).  It was reported, A nurse called reported that TENIVAC was given to 2 patients on 29Sep2023 but the TENIVAC was expired on 24Sep2023. Caller asked if it is a valid dose. This situation is reported as a medication error due to expired vaccine administered.   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 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.
Redness and swelling in arm at injection site. The following day the swelling had doubled to about 3x5 inches and redness and warmth present.   By the  evening on the 12th, it increased a small amount and was still warm.   The area then began itching but remained warm.  By the 13th it had stopped not increased in size  and was less warm.  Applied Benadryl gel for itching.  Today it is less red and not as warm and no increase in size.  Had headaches on evenings of 3/11 and 3/12.  Took acetaminophen with relief both times.
Extreme soreness and tenderness at site of injection, immediately, and continuing on to next day. Chills/shivering, evening of vaccine, and throughout the entire night and into next morning.  Body aches, next day. Severe headache through the night, severe enough to wake me from sleep, which continued into mid morning. (took ADVIL for this) This vaccine caused flu-like symptoms. With regard to Item 20 below, I am still having symptoms, but much more mild now.
At 9:00pm I began having  uncontrollable muscle spasms, almost like a seizure. This was 11.5 hours after having received my booster at the Clinic (the information on the previous pages is for the physician and facility where I was treated. Clinic did not see me for the reaction.) My entire body, inside and out hurt severely. I felt like I was developing sepsis which I had 18 months previously.  The injection site and the shoulder area were hot to the touch.  We were still traveling home from the clinic with approximately 3 hours left. I couldn?t tolerate the pain and we decided to stop at the ER.  At the ER my temp was initially 102.4 gegrees and topped out at 104.5. It was slightly over 100 degrees at discharge.  I was given solumedrol., Tylenol, Benadryl and versed along with fluids all by IV.  Labs were drawn.
I was diagnosed with otitis media 2 days after having received the shot. I also have bruising at the injection site.
fatigue Narrative:  Fatigue interrupted daily activities - Patient slept most of the day days 1-3 after recieing the vaccine
Fullness and decreased hearing in right ear starting 5 days after vaccination. Got hearing test on 2/15/21 which showed decreed hearing in right ear secondary to nerve conduction problem.  Within a few hours hearing got better, and hearing was retested the next day and found to be essentially back to normal.  I had taken Naprosyn on 2/15. MD had originally prescribed Prednisone bur I did not take since I was getting better without it. By 2/16/21 in the AM my hearing in the right ear seemed fine and there was no sense of fullness.
Localized adverse reaction at site of immunization. No difficulty breathing. Area of reaction is hot, with erythema, indurated 9.0 cm x 9.5 cm on (R) deltoid. Area is sore and itchy. Feels sleepy. Ice applied. Verbalized relief.
Doses administered after 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided. On 17-Dec-2021, the vial was initially stored in the refrigerator. Vial didn't underwent temperature excursions. BUD (beyond use date) was on 16-Jan-2022. No treatment information were given.
Tingling and numbess between upper lip and note, followed by tingling and numbness in chin and lips, hands, and feet.
Information has been received from a physician concerning a 64 year old male who on 06-MAR-2007 was vaccinated intramuscularly with a 0.5 ml dose of Gardasil instead of Zostavax. It was reported that there was no product confusion and that is was a medication error. Additional information has been requested.
This spontaneous report was received from a medical assistant professional, referring to multiple unspecified patients of unknown age and gender. Information about patient's medical history, concurrent conditions and concomitant medication were not reported. On unspecified dates, the patients were administered doses of improperly stored PNEUMOVAX 23 (lot # L013428, expiration date 03-FEB-2017) that were exposed to temperature of 49F and 48F each one, during an hour. This excursion was detected with a digital data logger. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
no symptomatic adverse events; GARDASIL-9 that was expired.; This spontaneous report was received from other health professional (medical assistant) and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 14-AUG-2023, the patient was vaccinated with the first expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, once (lot #1780867, expiration date: 08-AUG-2023) for prophylaxis (strength, and route of administration were not provided) (expired product administered). It was confirmed no symptomatic adverse events were reported (no adverse event). It was confirmed product did not have any temperature excursions.
postherpetic neuralgia.; shingles; Information has been received from a lawyer regarding a case in litigation, regarding a female patient of unknown age (the patient's concurrent conditions, pertinent medical history, drug reactions/allergies and concomitant medications were not provided). On unknown date, in 2014 patient received a dose of Zoster Vaccine Live (ZOSTAVAX) (dosage, route, anatomical location, lot # and expiration date were not provided) for the long-term prevention of shingles and/or zoster-related conditions. Subsequently, after receiving the vaccine, on unknown date, the patient was treated by a healthcare provider for shingles and post herpetic neuralgia. As a direct and proximate result of patient's use of Zoster Vaccine Live (ZOSTAVAX) vaccine, the patient have and will continue suffering ongoing injuries, including but not limited to significant medical and related expenses as result of these injuries, losses and costs included care for hospitalization, physical care, monitoring, treatment, medications, and supplies, diminished capacity for the enjoyment of life, diminished quality of life, increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions. At the time of the report, the patient had not recovered from the events. The reporter considered the events to be related to Zoster Vaccine Live (ZOSTAVAX).
Arm pain started approx 10 hours  after second shot. Aching/throbbing from shoulder to wrist and underarm/breast area on side of shot. Lasted approximately 40 hours. Tylenol managed pain. Extreme tiredness during same timeframe.  No reaction to first shot.
This 19-year-old male received his first dose of the Covid-19 vaccine mRNA Moderna on March 11, 2022. On April 1st, 2022, the patient was administered his second dose of the Covid-19 vaccine moderna which is 21 days earlier than his scheduled dose. Patient experienced no adverse effects from this vaccine. On April 4th, 2022, I spoke with prescriber who states that patient is doing okay and experienced no adverse effects from the early vaccine administration.
11/22 Report taken from mom. Mom stated patient had a grand mal seizure on 11-12-06. Was taken by ambulance to ER and was seen by Dr. a neurologist on 11/13. Per mom, MRI was done and within normal limits and EEG was abnormal. Patient was put on Lamictal and has not had another seizure. Mom has currently called patients doctor to discuss the seizure episode.
I have had two extra long periods since the last covid vaccination that lasted over 14 days and were very heavy.
Husband interpreted for patient throughout the entire incident.   Received vaccine at 15:23- LOC at 15:28, likely vagal. Patient was not able to answer questions but could follow commands. Blood sugar was 99, Blood pressure 52/27 initially. EMS started 20 G IV of NS and called for transport. Patient was able to get out of vehicle and transfer to ambulance stretcher with medical assistance. Blood pressure in ambulance was 91/53  RN Charge nurse was notified
Patient with history of dementia, CVA's, and a fib received an influenza vaccination at this private MD's office in the morning. That night he came to ER with mental status changes and low grade fever. Spouse stated that patient didn't seem his baseline that morning prior to receiving influenza vaccine. Patient admitted for observation 11/1/03. Discharged 11/3/03, family states patient is back to normal baseline. Medical record states dehydrated. msv
On 31JAN2017 patient was 4 months old and was given a KINRIX (DTaP/IPV). KINRIX is only indicated/licensed for use in ages 4 years-6 years.
tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for COVID-19) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Aug-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for COVID-19). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Aug-2021, COVID-19: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant medications  were not reported. treatment medications were not reported.
Following day - entire body became hot and totally turned red with severe itching (entire body) - throat felt tight, left deltoid felt very heavy & sore. Administered BENADRYL with ASAP with some relief - in A.M. slightly reddened - no itching at that time.
Dry, itchy, painful rash appeared on hands approximately 6 months later. During exacerbations pustules appear on the back of hands and fingers. Eczema like lesions on hands, refractory to treatment. Treated with Lamisil for a possible fungal infection. His symptoms improved slightly but never resolved. He returned to sick call for evaluation and was told it was not a fungal infection. He was referred to internal medicine and given Cidex that had minimal impact on his symptoms. In October 2001, a doctor evaluated him and he diagnosed him with dyshydrotic eczema and prescribed Temovate 0.05% cream. He also recommended patch testing and allergy testing to determine if there is an allergic component involved. Currently he is using the Temovate cream twice a day as directed. He still experiences exacerbations that do not seem to be related to increased hand washing, foods, gloves, stress, water intake, etc. The lesions (when flaring) often wake the pt from sleep.
arm hurt like hell; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In July 2022, the patient received the 1st dose of Shingles vaccine. In July 2022, less than 2 weeks after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 23-JUL-2022 Reporter's Comments: The patient self-reported the case via interactive digital media. The patient got first dose last week from date of reporting. The patient's arm hurt like hell, but as per patient shingles hurt much more. The patient would get 2nd dose in mid of the September. Additional Supportive Information: The follow up would not be possible as contact details were not provided.