chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approx. 5 minutes after administration of Gardasil vaccine, patient left doctors office with her mom, she suddently said I feel everywhere is white then she felt that she is not hearing anything, she said I feel dizzy and then she fainted for about 5 seconds. Her mom held her and avoided her collapse.
Unable to function; Cellulities; Felt Awful; Dehydrated; Swelling; Numbness; Fatigue; Muscle Aches; Trigger finger; Intermittent pain in the lower right arm; Scabbiness; Initial Telephone Call, 14 Jun 2021 Pt. reported that was administered TDVAX (MassBiologics lot #A125A) in her left arm on 11 Apr 2021 for wound management after cutting her left ring finger on a can. On the same day, pt. was prescribed the antibiotic, amoxicillin, by her doctor for wound management. Pt. stated that the vaccine site was not appropriately cleaned prior to the injection and that she was unsure if the TDVAX was administered via an intramuscular injection. On 12 Apr 2021, she felt "awful", dehydrated and fatigued. She also reported muscle aches in her lower back, and noticed that cellulitis had started to develop at the injection site.   Pt. stated that over the couple of weeks post-vaccination she developed swelling in her feet and left hand.  Due to this, she could not exercise and felt tired all the time. Pt. stated that she has Epstin-Barr Virus and that could have played a role in her reaction to the vaccine.  During this call, she also mentioned that she still feels numbness in the left hand and pain at the wound site. In addition, she could feel little lump on the injection site which was painful if she applies pressure. She added that overall, her adverse reactions were getting better as of 6/14/2021 though she was not completely recovered.  Follow-up Telephone Call, 25 Jun 2021 During this call, pt. provided more information on the diagnosis of her cellulitis - A week after vaccination, her infectious disease doctor confirmed that she had cellulitis in her left arm and mentioned that the antibiotic which she is taking for the wound management would take care of the cellulitis as well. Therefore, Dr did not prescrib treatment to address the cellulitis.  However, Dr. prescribed Meloxicam to treat her inflammation and pain.  Pt. mentioned that she was feeling better; however, the AEs she reported were not fully recovered. She also mentioned that she had some numbness in her left hand and was feeling achy.  Further, pt. reported that she had recently developed a trigger finger (her right thumb) within the past week.  Follow-up Telephone Call, 15 Jul 2021 Pt. mentioned that the cellulitis in her left arm was no longer present but that numbness in her left hand, which she believes was the result of nerve damage, was worsening. She was planning to visit the neurologist for the numbness.  Further Follow-up After this call, MassBiologics attempted to reach out to pt. several times to check the status of the numbness of her left arm and to learn about her overall health but pt. did not answer calls on 10 Aug 2021, 18 Aug 2021, email on 31 Aug 2021. Thus, MassBiologics closed this case.; Sender's Comments: The adverse event reported in this case was assessed as follow: 1) Cellulitis, Generalised muscle aches, and Swelling was assesed as Non-serious and Labeled. 2) Rest of the AEs were assessed as Non-serious and Unexpected.
Large red swelling at injection site.  Was hot and sore to the touch.  Swelling and discoloration lasted approximately 14 days.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 20-FEB-2016 the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot # L044055, expiration date 02-MAY-2017, dosage and route not specified). It was reported that the vaccine was stored at -13.7 degree centigrade for 15 hours. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous case was reported by a pharmacist and describes the occurrence of NEOPLASM MALIGNANT (Diagnosed with Cancer after receiving primary series and booster dose) in a male 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NEOPLASM MALIGNANT (Diagnosed with Cancer after receiving primary series and booster dose) (seriousness criterion medically significant). At the time of the report, NEOPLASM MALIGNANT (Diagnosed with Cancer after receiving primary series and booster dose) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. The Patient was instructed to receive a third full dose of the Moderna COVID-19 vaccine. Treatment information was not provided. COMPANY COMMENT: This is an Spontaneous case concerning an unknown-years-old male patient with clinical history of COVID-19 immunisation with two doses and booster Moderna mRNA-1273 vaccine who experienced the unexpected event of NEOPLASM MALIGNANT (Diagnosed with Cancer after receiving primary series and booster dose) unknown days after a booster dose of RNA-1273. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: COMPANY COMMENT: This is a Spontaneous case concerning an unknown-years-old male patient with clinical history of COVID-19 immunisation with two doses and booster Moderna mRNA-1273 vaccine who experienced the unexpected event of NEOPLASM MALIGNANT (Diagnosed with Cancer after receiving primary series and booster dose) unknown days after a booster dose of RNA-1273. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
This case was reported by a pharmacist via call center representative and described the occurrence of fainting in a 9-year-old male patient who received FLUARIX TETRA (batch number BF7CA, expiry date 30th June 2018). On 18th November 2017, the patient received the 1st dose of FLUARIX TETRA (intramuscular) .5 ml. On 18th November 2017, less than a hour after receiving FLUARIX TETRA, the patient experienced fainting and confusion. On an unknown date, the outcome of the fainting and confusion were recovered/resolved. It was unknown if the reporter considered the fainting and confusion to be related to FLUARIX TETRA. Additional details were provided as follows: Intern reports that a male patient received a flu vaccine at a clinic off site. The age at vaccination was not reported. Within a minute or two, after receiving FLUARIX TETRA, the patient experienced fainting. Less than a day, after receiving FLUARIX TETRA, the patient awake confused per the Intern. The issues resolved and the patient departed the facility with his mother. The reported did not have information on the clinic site where the vaccination took place.
Patient reports burning and warm sensation at the injection site 8 days after administration. She also states she has a big red circle around the injection site.
Pt recvd vax & became stiff on lt side of neck & shoulder which lasted for 2 days;then lt shoulder & arm joint became very painful & difficult to move full range;arm became numb @ times, w/tingling feeling;dx inflammation of muscle lt arm
"the upper arm still is very sensitive at injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE DYSAESTHESIA ("the upper arm still is very sensitive at injection site) 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 VACCINATION SITE DYSAESTHESIA ("the upper arm still is very sensitive at injection site). At the time of the report, VACCINATION SITE DYSAESTHESIA ("the upper arm still is very sensitive at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       for mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. treatment product included steroid cream no concomitant product was reported
tingling and swelling of tongue; tingling and swelling of tongue; lightheadedness; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program Pfizer First Connect. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration in the left arm on an unspecified date, dose 1, single for COVID-19 immunisation. Medical history included severe allergic reaction to contrast dye that used for a CAT scan to check her lungs. The patient's concomitant medications were not reported. The patient asked about the ingredients before she gets the COVID vaccine on 02Feb2021. The patient was scheduled to get the vaccine on 02Feb2021. The patient had a severe allergic reaction to contrast dye that was used for a CAT scan to check her lungs and she wanted to make sure the ingredients in the vaccine were not similar to ingredients in contrast dye. The patient asked if it was okay to take the vaccine. The patient did not know what the ingredients were in the contrast dye. The patient's doctor said it should be fine to get the vaccine. On 02Feb2021, the patient experienced tingling and swelling of tongue, lightheadedness. The patient was not admitted to the hospital for the event. No treatment was received for the events. The patient was fine from the events as of this report. The outcome of the events was recovered in Feb2021.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Patients skin is puckered/indented at site of injection. Patient states no pain or itching or discoloration, she just noticed it about 1 month after being vaccinated.
Left deltoid area. warmness around the sit of injection. BENADRYL 12.5/5ml, 2 tsp by mouth 96 degrees as needed, warm compress.
p/ pt recv vax approx 3 yr later devel breakthrough case of chickenpox w/over 100 lesions generalized vesicles all over body. also fever 104f & sore throat.
More sensitive skin: Had mild localized reaction to adhesive (redness, itching/burning, small bumps) that resolved in about 10 minutes after removing adhesive. Skin on legs formed large welts after scratching. Small spots of blood noted. This has never been an issue before vaccine. Showering/ shaving caused no issues.
06/23/2006 7:30 am infant found lying face down unresponsive on crib, to Dr at 7:45am with right side flaccid, transferred to hospital dismissed to home 6/25/06. 7/27/06 Received ER records from 1st hospital which reveal patient seen with acute right sided hemiparesis on day following vax.  No hx of trauma.  Exam revealed head deviated to left, moving right side only occasionally & would not turn eyes to right. Transferred to 2nd hospital.  8/21/06 Received medical records from 2nd hospital.  D/C summary reveals principal dx of new onset seizures & secondary dx of Todds paralysis.  Exam in PICU reveled less movement on right side with right hand drop.  DTRs were normal bilaterally.  No further seizure activity noted & d/c to home in good condition/ss
sick for 8 months/walk all tore up; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received the 1st dose of Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Flu vaccine 3 years ago and was sick for 8 months had to walk daughter for her wedding all tore up the shot never again.
pain in neck; sore arm/ Pain in arm; pain in shoulder; This spontaneous case was reported by a nurse and describes the occurrence of NECK PAIN (pain in neck), PAIN IN EXTREMITY (sore arm/ Pain in arm) and ARTHRALGIA (pain in shoulder) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 060A22A, 077C21B, 007M20A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2022, the patient experienced NECK PAIN (pain in neck), PAIN IN EXTREMITY (sore arm/ Pain in arm) and ARTHRALGIA (pain in shoulder). In June 2022, NECK PAIN (pain in neck), PAIN IN EXTREMITY (sore arm/ Pain in arm) and ARTHRALGIA (pain in shoulder) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Reported that after taking his last booster on 10-Jun-2022, he had a sore arm, pain in arm, shoulder and neck and each time pain lasted 1 day.  No treatment medications were reported.   This case was linked to MOD-2022-588957, MOD-2022-588873, MOD-2022-589013, MOD-2022-589031, MOD-2022-589045 (Patient Link).
Patient's wife called complaining that husband had fallen ill four days after receiving the vaccine. States that patient developed nasal and chest congestion, which developed into self-reported laryngitis which has left him unable to speak
I had a fever up to 100 degrees for a whole day, and I recovered without treatment after 1 day.
Ischemic stroke, right side of the brain - collapsed at approximately 8:30am on 19-Jan-2023.  Blood clot identified and removed by Dr at a HCF at approximately 11:30am
Patient had right deltoid IM injection of PNEUMOVAX and since then had local reaction, large, of pain, edema, a erythema slowly improving.
Five minutes after I received the shingles vaccine Zoster, I had a headache which lasted for the next 10 days. Two days (48 hours) after I received this vaccine, I had redness, soreness, swelling, and itching at the site of the injection and I vomited on 8/22/2012 because of the intense headache.
Site: Pain at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium
When receiving shot client felt burning at site of injection. By evening, left arm was painful to move in all directions. Disrupted sleep due to pain.
No adverse outcomes. Patient arrived to our site 7/19/21 to receive his planned second dose of Moderna. After verifying his vaccination information, our greeter noted he had previously received 2 dose of Pfizer earlier (12/29/20 and 1/19/21). It's unclear why this was missed for his first dose, as it is our practice to verify all patients before they are vaccinated. In discussing with the patient, he stated he didn't remember getting the Pfizer shots earlier in the year. He reported he worked at a long-term care agency at the time. We explained he had already been fully vaccinated, so we couldn't give him his 2nd Moderna shot. If he is concerned the initial Pfizer doses were reported in error, he needs to contact DOH to update his records so we can provide him his second Moderna shot.
Within 15-30 minutes after leaving the pharmacy, I began to have burning pain in the left side of my neck above my injection site.  A day later, it was radiating down my left shoulder. Within days I began having numbness and tingling down my left arm and hand.  In June, my neck became so painful, I could hardly move, get in and out of bed and if anyone bumped me, there was terrible pain.  I treated it with CBD pain cream, increased dosages of Ibuprofen, hot and cold packs, but with little to no relief.  This same event happened again in August and September. I finally consulted my doctor on 9/20/21.  She ordered Gabapentin 300 mg bid.  That has lowered the pain and stiffness, but not completely.    I was treated for these same symptoms back in 2007-2008. I received physical therapy and two epidural injections during that time.  However, the symptoms had completely resolved and I have not received any treatment for this problem since...UNTIL NOW.  It feels like the medication went directly to an area of previous weakness and aggravated it and potentially, made it worse.
swollen that the thumb is unable to move; severe pain was felt around the thumb join/ arthraligia; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (severe pain was felt around the thumb join/ arthraligia) and SWELLING (swollen that the thumb is unable to move) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     The patient's past medical history included No adverse event (No medical history provided.).    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced ARTHRALGIA (severe pain was felt around the thumb join/ arthraligia). On 02-Feb-2021, the patient experienced SWELLING (swollen that the thumb is unable to move). At the time of the report, ARTHRALGIA (severe pain was felt around the thumb join/ arthraligia) and SWELLING (swollen that the thumb is unable to move) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant medications were not provided. Treatment information was not provided.
Patient reported dizziness five min after getting shot. She turned white and lost conscience for a couple seconds. Response team was called and patient was taken to the ER
Post vax on 12/12/2000 the patient developed shingles on his upper right thigh, corresponding with the injection site, which was described by the physician as a rash. The rash became "bumpy" which spread and blistered. The rash did not itch and was not painful. The patient was seen by a pediatrician and a dermatologist and was diagnosed with herpes zoster. The patient was treated with acyclovir for 10 days and subsequently recovered. Additional information is not expected. Per F/U 6/17/02: There was no illness at the time of vaccination. On 12/12/00 (previously reported as 12/12/99), the pt developed shingles on his upper right thigh which was described by the physician as a rash. The physician reported that the pt's sister (WAES 01032315) had a similar experience. Additional info is not expected.
Information has been received from a pharmacist referring to a female patient who was a healthcare worker of unknown age. Concurrent condition and historical condition were reported as none. On unknown dates the patient was vaccinated separately with three doses of RECOMBIVAX HB (dose, route, lot number and expiration date unknown). Concomitant therapy was reported as none. On an unknown date after the third dose, the patient had titers drawn and it showed "a lack of protection". No treatment was given. The outcome of event was unknown. The causality was not provided. Additional information is not expected as no reporter's contact details were provided.
Acute Saddle Pulmonary embolism, Hospital for 8 days, put on blood thinners ( Xarelto) I had severe chest pain and shortness of breath.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021 at 3:40 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 4:40 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 37.22.  Concomitant products were not provided. On 28-Mar-2021, Excursion time was 10 AM with temperature as 35. Total doses given for the day was 150. Condition of vaccine prior to administration was not frozen. Vaccine was moved to fridge on 23-Mar-2021. Vial was moved to clinic on 27-Mar-2021. 15 vials were sent to clinic. Vaccine BUD date was 22-Apr-2021. On 28-FEB-2021, Excursion time was 09 AM and 1PM. temperature was 27 and 26 respectively. total doses given for the day was 152, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24-FEB-2021, vial was moved to clinic on 27-FEB-2021. 20 vials were sent to clinic. Vaccine BUD date was 26-MAR-2021.  On 28-Mar-2021, no hourly temperature recordings available. On 28-FEB-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 27, 10 AM: 40, 11 AM: 44, 12 AM: 46, 1PM: 26, 2 PM: 37, 3 PM: 43 and 4 PM: 45   The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
My arm was very sore. I could not lift my arm without intense pain. Saturday, I had a low grade fever. Intensity of pain in my arm was severe. Sunday, I started wheezing, coughing, and developed a rash. I took Benadryl and Aleve. Monday, rash had doubled in size, still coughing, wheezing.