chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever; sore arm; Face tightening sensation on his left side; This case was reported by a consumer via call center representative and described the occurrence of fever in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (received 1st dose in June 2019, experienced fever and a sore arm, refer case US2020AMR038388).   In August 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced fever, pain in arm and skin tightness. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever and pain in arm were unknown and the outcome of the skin tightness was not recovered/not resolved.   It was unknown if the reporter considered the fever, pain in arm and skin tightness to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient experienced fever and a sore arm which lasted a fewdays after each injection and then resolved. The patient reported that about 2 weeks after dose 2, but not dose 1, the patient experienced face tightening sensation on his left side. The patient seen his dental professional which showed nothing, and his primary care physician, who referred him to his ear nose throat doctor. The reporter consented to follow up.
04/07/2022 That evening my throat was very sore and scratchy and I was very uncomfortable. The next day I still had the sore throat and a slight headache, but that was not new, I have headaches. I began losing my voice. The next day I woke up with 100.1 fever. I called into work because I felt so bad. I took ibuprofen, went back to sleep and when I woke up, I felt better, the fever was gone. My throat was still hurting. I thought it was strep, because I used to get it and that is how my throat felt. I went to a walk in clinic, told them my symptoms. They tested for strep. It was negative. I saw the health care professional. An hour after I left, I received the result back saying it was COVID-19. The doctor told me to alternate ibuprofen, Tylenol and Mucinex. I was coughing even worse, still had a headache and lethargic. I felt like I had a fever and was having chills. I did not fever. The next day I slept most of the day. I felt like I was having trouble breathing. Every time I checked my oxygen it was normal. I had to return to work. I had trouble speaking. A friend that is a nurse brought me a breathing exercise tool. The cough was keeping me up making and made it difficult to work. I was on the phone at work and had a coughing spell that lasted 5 minutes which made it difficult to breathe. I reached out to my doctor to see what else I could take for my cough. Had me do a virtual visit with the provider at the walk in clinic that did my COVID-19 test. I explained what I was going through. The doctor prescribed steroids and benzonatate gel capsules. I took steroids for 6 days and I have one more of the capsules left. I still have a lingering cough. It is not as bad. I had a new patient appointment with a new doctor. He told me to continue cough medicine, that it could take a month to get rid of the cough.
shingles; Information has been received regarding a case in litigation concerning patient of unknown age and gender. In 2010, patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not reported), as prescribed and/or administered by a healthcare provider at the medical office of a physician for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to patient's zoster vaccine live (ZOSTAVAX) inoculation, patient was treated by a healthcare provider at the medical office for shingles. As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician 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; and other losses and damages; and will continue to suffer such losses, and damages in the future. The relatedness between the adverse event and zoster vaccine live (ZOSTAVAX) was reported as related.
16 hours post vaccine, I awoke to chills/feeling of fever. I suddenly felt nauseous. I went and sat on the floor of my bathroom and went unresponsive. Per my husband. My eyes rolled back in my head, my body went limp, and I was moaning. I did not come to for 30-60 seconds despite shaking, calling my name, and sticking his finger in my throat. I came to and was alert and oriented but have no recollection of the incident. EMS was called.
Pt. came back to clinic today with fever. Fever started last night of 104 degrees.
No additional AEs reported.; vaccine administered after temperature excursions; This spontaneous report has been received from a medical assistant concerning to patient of unknown age and gender. The patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported.  On an unknown date, a temperature excursion occurred for varicella virus vaccine live (oka/merck) (VARIVAX) in which the maximum temperature reached was 10.9 degrees Fahrenheit for a time frame of 5 hours and 30 minutes. No previous temperature excursions were reported.  On 18-AUG-2022, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml, administered subcutaneous (SQ), lot W012166, expiration date 12-APR-2024, (anatomical location was not provided) as prophylaxis (product storage error). No additional events were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2209USA000437: US-009507513-2209USA000235: US-009507513-2209USA000255: US-009507513-2209USA000438: US-009507513-2209USA000177: US-009507513-2208USA011663:02236682
Moderna COVID-19 Vaccine EUA  Arm from injection point to elbow in a lot pain, horrible headache, exhaustion. It has been 27.5 hours and have taken Tylenol and all 3 still in full effect.
Client did not experience any immediate adverse events following vaccination. Client died on 6/8/2021, approximately 8 weeks after vaccination with Janssen product. Cause of death is unknown to this reporter.
This spontaneous report was received from a nurse and refers to multiple patients of unknown demographics. There was no information about the patients concurrent conditions, concomitant therapies or medical histories provided. On an unknown date, the patients were vaccinated with improperly stored doses of PROQUAD albumin status RHA, lot# N010866, expiration date 01-OCT-2018 (dose and route of administration were not reported) for prophylaxis. Concomitant therapies included properly stored sterile diluent (MERCK STERILE DILUENT). No adverse events were reported. Administered doses of vaccines experienced the temperature excursion from 6 degrees Fahrenheit to 14 degrees Fahrenheit (also reported as 6.8 degrees Fahrenheit) for 72 hours. Data logger was involved. There were no previous excursions reported. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1709USA002037:
pt recv vax;exp HA,gen aches & indigestion similar to sx w/ 1st vax;
Moderna was given as First Dose on 12/23/2020 Pfizer was given as Second Dose on 01/15/2021
pt noticed an abscess on his left chest about 3 days after vaccine. a day or two later another abscess on his right upper eyelid.
HCP calling to report AE for VAXELIS PFS and ROTATEQ. Vaccines administered experienced a temperature excursion.; No side effects reported; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 19-JUN-2023, the patient was vaccinated with diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (VAXELIS) (V419) (lot number U7374BA has been verified to be a valid lot number, expiration date reported and validated as 06-MAY-2025) and Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) ) (lot number W026137 has been verified to be a valid lot number, expiration date reported and validated as 05-FEB-2024) after a temperature excursion (product storage error) at 8.74 centigrade degrees (C) with a timeframe of 35 minutes. Both vaccines were administered as prophylaxis (strength, dose, if a digital data logger was involved, vaccination scheme, route of administration and anatomical location were not provided). Additionally, there was no previous temperature excursion, and no effects were reported.
Patient presents with a potential reaction to the COVID19 vaccine. The patient reports a single potential hive on the L forearm, they had the same reaction after the first injection, which responded to Zyrtec. They request repeat dosing. 10mg of oral Zyrtec given for a local skin reaction with good results, as with the previous injection. Returned home at baseline.
Pt recvd 3 doses of Hep B vax 4FEB91, 11APR91, & 13AUG91 & 17DEC91 it was determined that the titer was neg; booster dose was given 2JAN92 outcome of booster dose is pending as of 3JAN92;
Mild discomforted; Achy; This spontaneous case was reported by a patient and describes the occurrence of DISCOMFORT (Mild discomforted) and PAIN (Achy) in a 55-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. A57145B) for COVID-19 prophylaxis.     The patient's past medical history included Sleep apnea. Concurrent medical conditions included Hypothyroidism, Hypertension, Allergy to intravenous contrast media (IV Dye Allergy) and Iodine allergy. Concomitant products included NAPROXEN from 11-Apr-2023 to 12-Apr-2023 for an unknown indication.    On 14-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 16-Sep-2022, the patient experienced DISCOMFORT (Mild discomforted) and PAIN (Achy). On 17-Sep-2022, DISCOMFORT (Mild discomforted) and PAIN (Achy) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Patient had previous doses of Moderna covid-19 vaccine on 25 Mar 2021, 27 Apr 2021, 01 Nov 2021 and 04 Apr 2022. Patient had Paxlovid on 10-APR-2023 till 15 Apr 2013 for COVID-19 treatment. The patient was taking other medications or products within 2 weeks of starting COVID-19 treatment. Device date was reported as 22 Apr 2023. No treatment information was provided.
MORE RINGING IN EARS THAN NORMAL (MORE IN LEFT EAR); HEADACHE; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's past medical history included: migraine, and concurrent conditions included: non alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no known drug allergies. The patient was otherwise healthy and not on any medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: 19-SEP-2021) dose was not reported, administered on 07-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-SEP-2021, the patient experienced headache. On an unspecified date, the patient experienced more ringing in ears than normal (more in left ear). Treatment medications (dates unspecified) included: acetylsalicylic acid/caffeine/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 20-SEP-2021, and the outcome of more ringing in ears than normal (more in left ear) was not reported. This report was non-serious.
EUA at this date was for 12 years and older.    This pt was 11 years and 4 months old.    No reported adverse reactions occurred.   Reporting to VAERS due to EUA use & pt's age.
inflamation, fever x 30 hrs; unable to bend leg x 30 hrs; sl swelling @ site ambulating w/o difficulty;
pain in the arms, when they raise their arm perpendicular to their body it hurts; pain in the neck; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Feb-2021 and was forwarded to Moderna on 02-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in the arms, when they raise their arm perpendicular to their body it hurts) and NECK PAIN (pain in the neck) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Cholesterol.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced PAIN IN EXTREMITY (pain in the arms, when they raise their arm perpendicular to their body it hurts) and NECK PAIN (pain in the neck). At the time of the report, PAIN IN EXTREMITY (pain in the arms, when they raise their arm perpendicular to their body it hurts) and NECK PAIN (pain in the neck) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Treatment for the events included Tylenol, Advill and muscle relaxers. Concomitate medication was not provided.
Droopiness of the right eyelid - possibly myasthenia gravis ocular type
On 04-12-2021, I experienced itchiness at the injection site and both of my arms had rashes and large bumps that lasted two weeks. I had these same symptoms four times in the two weeks span. I spoke with a doctor through a telehealth consult and was prescribed Loratadina medicine.  I can say today I have recovered from the rashes and large bumps on my arms and do not have any symptoms today.
mom states pt afeb when she left for work 2PM;pt awake from nap w/high fever,hands/feet blue, started shaking-paramedics called;pt had febrile sz taken to ER;given bath & meds fever subsided;seen by MD dx w/ear infect;
severe bilateral Achilles tendinitis; could barely walk down the steps; pain in arm; tired; felt flu-ish; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (felt flu-ish), TENDONITIS (severe bilateral Achilles tendinitis), GAIT DISTURBANCE (could barely walk down the steps), VACCINATION SITE PAIN (pain in arm) and FATIGUE (tired) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (felt flu-ish), VACCINATION SITE PAIN (pain in arm) and FATIGUE (tired). On 20-Apr-2021, the patient experienced TENDONITIS (severe bilateral Achilles tendinitis) and GAIT DISTURBANCE (could barely walk down the steps). On 10-Apr-2021, INFLUENZA LIKE ILLNESS (felt flu-ish), VACCINATION SITE PAIN (pain in arm) and FATIGUE (tired) had resolved. At the time of the report, TENDONITIS (severe bilateral Achilles tendinitis) and GAIT DISTURBANCE (could barely walk down the steps) outcome was unknown.            Concomitant medication included Birth control pills. No treatment medications were provided.  Patient reported on 20-May-2021 she received first dose of Moderna vaccine on 8-Apr-2021 in left arm from a local county health department, patient did not know the name. Patient reported she had for approximately 2 nights, pain in arm, tired and felt flu-ish. Patient stated on 20-Apr-2021, she had severe bilateral Achilles tendinitis, she states she could barely walk down the steps. Patient states she did receive the second dose. Patient stated her tendinitis has improved, but has not been completely resolved. Patient has treated symptoms with Ibuprofen. Patient consent to Safety follow via email.
pt recv vax & 3months post vax pt exp elevated liver enzymes;no tx was given
Pt vax w/ booster & approx 12-14 days p/ vax,pt devel measles & fever.
Pt recvd HIB NOV90, JAN91, MAR91 & on 1AUG was dx w/periorbital cellulitis, had fever of 102.8, blood culture was positive for H. Flu & Beta Lactamase; Hospitalized on 1AUG91 for five days & treated w/Mefoxin IV;
Syncope shortly after taking the vaccine. Blood pressure dropped to a very low rate and almost fainted.
Information has been received from a Registered Nurse concerning a patient who was vaccinated with VARIVAX (Merck) (Lot # not reported) instead of ZOSTAVAX (Merck). Registered Nurse reported this was not a product confusion and that it was an office error. No further information is available.
I woke up and my shoulder was very itchy. I looked under my sleeve and there was a rash. The itchiness and rash are new today, however a lump has been present since injection. The rash is directly above the lump. It may be unrelated, but I've also been unusually drowsy (noticed before taking the benedryl).  I took benedryl and applied lotion to the rash. My pregnancy began July 4th and I was 28 weeks pregnant at the time of the vaccine. My estimated due date is March 25th, 2021. At the time of the adverse reaction, I am 29 weeks pregnant.
patient received Adacel 12/22/06 the was given an additional Adacel on 12/21/07
Started with severe myalgias day of evening, the next day grew to include low grade fever Tmax 100.5, severe chills, inability to stand without feeling dizzy. Most sx resolved by this morning (2 days out from shot).
No adverse effect reported; one patient received an improperly stored VARIVAX; This spontaneous report as received from a registered nurse and refers to a 4 year old patient (gender not reported). The patient's concurrent and historical conditions, as well as drug reactions or allergies,  were not reported.  On 05-SEP-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R006221 with expiration date 29-FEB-2020 R029517 with expiration date reported as 14-2020, but upon internal validation established as 14-OCT-2020). The route and dose was not reported, and the patient was vaccinated for prophylaxis. The varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with properly stored Sterile diluent (unspecified).  It was reported that the temperature time frame was -14°C to -10°C (-11.91 °C, multiple), for 8 hours. There were no previous temperature excursions and the call was because of a data logger.
I woke that evening with shortness of breathe, fatigue, and muscle aches. I spot at the injection site that is swollen and red the size of a baseball.
"Covid arm", arm had round, slightly raised, red, area approximately 5 inches in diameter on bicep area approximately 2-3 inches from injection site. The area has almost completely healed at this point.
Pfizer COVID vaccine incorrectly diluted with 0.9% normal saline in multi-dose vial with preservative. Correct diluent should be 0.9% normal saline in single-dose vial without preservative. When Pfizer was called at store level, they were not able to give any information on anything other than the single-use vials that were studied. Client called the morning of 8/3/21 and spoke to Representative on the medical team who gave the same information. Representative  was able to say that the reason Pfizer wants medical providers to use the single-use vials is so that there is no cross contamination from puncturing the vial multiple times to dilute multiple vaccine vials. The multi-dose vials that were used were only punctured once so no risk of contamination. Considering this a valid dose still since the vaccine was still diluted and administered with normal saline.
Child refusing to walk, irritability, cranky behavior the same evening. Fever (?) same night. Woke up several times at night from possible pain.
This spontaneous report as received from a licensed practical nurse refers to a multiple unspecified patients of unknown age and gender. There was no information about patients' concomitant medications and pertinent medical history reported. On an unknown date, unspecified patients were vaccinated with doses of improperly stored GARDASIL 9 Lot# L007560, expiry date 15-JUN-2017 or Lot # L027282, expiry date 21-SEP-2017 (route and sites of administration, doses were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
PATIENT CALLED IN  STAYING SHE FELT CHEST PAINS AND SHORTNESS OF BREATH FOR  4 TO 5 DAYS  AND IT RESOLVED BY ITSELF.
Sore arm; Body aches; Nausea; Patient receieved 1 mL instead of the recommended 0.5 mL; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Sore arm), MYALGIA (Body aches), NAUSEA (Nausea) and ACCIDENTAL OVERDOSE (Patient receieved 1 mL instead of the recommended 0.5 mL) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (morphine), Hypertension, Pain, Anxiety, ADD and Vitamin D deficiency. Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for ADD, DIAZEPAM (VALIUM) for Anxiety, LOSARTAN for Hypertension, HYDROCODONE and MORPHINE for Pain, ERGOCALCIFEROL for Vitamin D deficiency.    On 28-Jul-2021 at 3:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 milliliter. On 28-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL OVERDOSE (Patient receieved 1 mL instead of the recommended 0.5 mL). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), MYALGIA (Body aches) and NAUSEA (Nausea). On 28-Jul-2021, ACCIDENTAL OVERDOSE (Patient receieved 1 mL instead of the recommended 0.5 mL) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm), MYALGIA (Body aches) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Relevant medical history updated, vaccine facility details updated, doctor/HCP details updated, concomitant medications updated, new events added.
Fever of 103, bilateral muscle weakness, overall flu-like muscle aches, overall sense of feeling unwell, decreased mental acuity, confusion, decreased balance, electrolyte imbalance, shaking, and loss of appetite.
Reported hives- both arms, facial flushing, mild chest, discomfort. Took BENADRYL- Resolved.