chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About one week after receiving my injection, I started feeling a low level headache on the right side of my head and above my right eye. Gradually over time, a low level rash/small bumps started appearing above my right eye brow, becoming a little scratchy. My vision in my right eye started becoming less focused/blurry. I mentioned these symptoms to Dr., my primary care doctor, at the Medical Clinic. Dr. diagnosed this as Shingles, and referred me to the Eye Center, where I was seen by Dr., who also diagnosed this as Shingles. Dr prescribed 1000 mg of Valacyclovier, twice a day, perhaps for life. The headache and rash has resided, however my vision in my right eye remains less focused/blurry.
2/1/12 11pm seizure #1 no fever lasted approx 2 min, to medical center exam WNL, DC home. 2/2/12 5am seizure #2 temp 99.7 Ax lasted approx 2 min, to medical center exam WNL. Admitted for observation Chem 14, UA WNL. 2/8/12 seizure #3 1210pm unsure how many min, to medical center exam WNL. Referred to neurologist for evaluation.
Patient came into the pharmacy on 10/14/17 to report soreness, redness, itching & slight swelling at the site of injections. She was instructed to apply cold compress to the site for ~15minutes and may take (otc) acetaminophen or ibuprofen for pain and (otc) benadryl for itching. She was to contact the pharmacy if s/s worsen or seek medical care immediately. She informed me that the icing, benadryl, & ibuprofen did help and that soreness, itching & swelling are gone except for slight redness remained.
This spontaneous report as received from a nurse refers to a 6 month old patient of an unknown gender. On 16-FEB-2015, the patient was vaccinated with improperly stored, oral, ROTATEQ (lot # K007247 and expiry date: 17-MAR-2016 or lot# K006805 and expiry date: 24-MAR-2016). No adverse events were reported. No product quality complaint (PQC) was reported for ROTATEQ. This is one of the several reports from the same reporter. Additional information has been requested.
feeling dizzy; sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 83-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose in September 2021).   On 4th January 2022, the patient received the 2nd dose of Shingrix. On 4th January 2022, less than a day after receiving Shingrix, the patient experienced pain in arm. On 6th January 2022, the patient experienced dizziness. On an unknown date, the outcome of the pain in arm and dizziness were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and dizziness to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient experienced a sore arm and was unresolved. He also stated that 2 days after vaccination, he started feeling dizzy this morning (on the day of reporting) which was also unresolved. The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022002790:Same reporter
This spontaneous report as received from a healthcare worker (medical assistant), also reported as registered nurse (RN) refers to a patient of unknown age and gender. Medical history and drug reactions or allergies were not specified. On 26-AUG-2014, the patient was vaccinated with a dose of PROQUAD (Merck) injection, lot number K007158, expiration date 12-NOV-2015, 0.5 ml once, subcutaneously, that was stored at 42.9 (also reported as 43) degrees Fahrenheit for 744 hours (temperature excursion date reported as 25-AUG-2014). No adverse effects were reported. Concomitant medications were not specified. Additional information has been received from a healthcare worker (medical assistant), regarding a 4 year old patient. The reporter stated that PROQUAD was placed in the fridge and not in the freezer. At the time of the report the temperatures of the units in which PROQUAD (Merck) was stored were reported as 42.9 (refrigerator) and -11 (freezer). This is one of several reports received from the same source. Additional information has been requested.
Pt was given adult influenza split Fluarix instead of Fluzone. No symptoms noted at this time.
Tiredness; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200), via an unspecified route of administration in the left arm on 18Feb2021 at 13:15 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, pre-diabetic and high cholesterol. The patient had no allergies to medications, food, or other products. Concomitant medications included losartan potassium (LOSARTIN), metformin (MANUFACTURER UNKNOWN), potassium chloride (KLOR CON) and metoprolol (MANUFACTURER UNKNOWN) and atorvastatin (LIPTOR); all for unknown indications from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Feb2021 at 18:00, the patient experienced tiredness. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the tiredness was recovered. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203), via an unspecified route of administration in the left arm on 11Mar2021 at 14:30 (at the age of 70-years-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
runny nose, sore throat, headache, fatigue, cough, achy; and nasal congestion
Vertigo/Spinning head; tinnitus; imbalance; giddiness; Benign paroxysmal positional vertigo of left ear; Acute sinusitis; Labyrinthis; Fatigue; head pressure; Sensorineural hearing loss; Puking; Flu like ilness; fever; chills; Nausea; This case was reported by a lawyer and described the occurrence of sensorineural hearing loss in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced sensorineural hearing loss (serious criteria GSK medically significant), vertigo and tinnitus. On an unknown date, the outcome of the sensorineural hearing loss, vertigo and tinnitus were unknown.   It was unknown if the reporter considered the sensorineural hearing loss, vertigo and tinnitus to be related to Shingrix.  The initial information received on 17 August 2020 via medical records (The case is medically confirmed). As per the pharmacy records on 16 September 2019, the female patient was prescribed with Shingrix 50 mcg Injection. As per record dated 11 November 2019, she reported a history of episodic vertigo and imbalance following vaccinations. Patient reports a history of MS (Multiple sclerosis). Today's results suggestive of a mild to moderately severe SNHL (Sensorineural hearing loss) bilaterally. As per records dated 12 November 2019, she had chief complaint of dizziness since getting vaccines for the flu, pneumonia, hepatitis, and shingles. She reports feeling as if she had the flu the next morning with fever, chills, and nausea. On the morning of the 18 September 2019, she felt like she was spinning when she woke up. As per the auditory complaint she had Right tinnitus since age 10, high pitch in left ear since symptoms started, decreases with steroids. On 28 December 2019, she started with head pressure, and fatigue the night before. She reports feeling over-stimulated with sensitivity to any motion. On 27 January 2020, she reported vertigo. The motion sensation described as a rotation sensation. The vertigo began 3 months ago and has since been intermittent, occurring frequently with episodes lasting 4 days. As per records dated 01 February 2020, she stated that the day after shingles vaccine on 16 September 2019, she developed dizziness and spins In October 2019, she followed with ear nose and throat specialist and was clinically diagnosed with labyrinthitis. She had two flare-ups, one started on 01 February 2020, she stated that she had past flare up but were less severe. She endorses spinning sensation with movements. She also stated she was not able to walk due to spins. She also had light headaches and poor balance and coordination.
Every day since the vaccine I have had a headache.  Also, slight sore throat, some aches and chills.  No fever.
Expired Menveo administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number amva587a, expiry date 31st August 2022) for prophylaxis.   On 6th September 2022, the patient received Menveo. On 6th September 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 06-SEP-2022 Reporter's comment: The medical assistant reported that a dose of Menveo was given to the patient and it was already expired. The reporter consented to follow up. Additional Supportive Information: The use of Menveo dose, which was already expired on 31st August 2022, which led to expired vaccine used.
injection site pain; nausea; feeling unwell; reduced appetite; loose stools with an off odor; loose stools with an off odor; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not provided), via an unspecified route of administration on 07Jan2021 (Thursday) at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. He stated that at first he had injection site pain in Jan2021 which has now gotten better but was currently experiencing nausea, feeling unwell, reduced appetite, loose stools with an off odor in Jan2021. He was asking how long these symptoms usually last. The patient wondered if he can get the second dose since he had these symptoms with the first dose. The outcome of event injection site pain was recovering, the outcome of the other events was unknown.  Information on the lot/batch number has been requested.
SWOLLEN ARM; FEVER; RASH; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (SWOLLEN ARM), PYREXIA (FEVER) and RASH (RASH) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event 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 PERIPHERAL SWELLING (SWOLLEN ARM), PYREXIA (FEVER) and RASH (RASH). At the time of the report, PERIPHERAL SWELLING (SWOLLEN ARM), PYREXIA (FEVER) and RASH (RASH) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
T/C received from mom: stating LT, red , swollen, hard to touch. Advised to apply ice and can give OTC for discomfort to return if worsens.
Pt began having a headache and sore arm the day of the shot. The next day the patient complained of worsening headache, dizziness and "feeling like I cannot get my words out and I have to keep re-reading everything out loud  to understand". 36 hours later, Patient checked into Emergency room with obvious expressive aphasia and  complained of dizziness. Pt received CT scan and results as follows: Acute left parietal intraparenchymal hemorrhage measuring 2.8 cm, with a hematocrit effect, which can be seen in patients on anticoagulation therapy or with underlying coagulopathy. Rounded appearance raises the possibility for underlying mass. Local mass effect. No midline shift or brain herniation. Moderate associated local extra-axial hemorrhagic extension, predominantly within subarachnoid space.
I had all the side effect system, fever, chills, fatigue muscle and joint pain. The joint pain is what I would like to share my concern about. A little more than a year ago (Feb 2020) I have L4/L5 fusion surgery. The surgery was successful and for the last six month had little to no pain (no more than a 1 on the pain scale). Saturday a day after the vaccination my lower back pain was significant (5 to 6 on the pain scale). I am not sure if this was just a coincidence but thought it was worth reporting. Today, Sunday March 7th the pain is much better (about  a 2 on the pain scale and I think will completely go away as I move around more and loosen up.
Pt recvd vax & devel pain @ the inject site which lasted about 7 to 8 mins a/resolving; pt also c/o sore heaavy arm all day;
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  NEUROPATHY ACUTE NON ST ELEVATION MI
HSP dx 3 days after immunization pt had concurrent recovery from URI symptoms so might have been viral trigger vs immune trigger
This spontaneous report as received from a registered pharmacist refers to a patient of unknown age. The patient was vaccinated with a dose of ZOSTAVAX (lot # 670616/0617AA) on 04-AUG-2012 after its expiration date (26-JUL-2012). No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was unspecified if the patient had sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Dizziness Right after, fatigue, chills, racing heart, sore arm, pins and needles and numbness in limbs
A minute after receiving vaccine, became dizzy. Three minutes later stated her throat was itching and her tongue was swelling. EpiPen (own) administered at that time (10:41am) and transferred to local hospital at 11:05am.
Report 2001004896-1 describes polyarthritis in a 63 year old male who received Lyme disease vaccine (Lymerix). On unspecified dates, the vaccinee received Lymerix vaccine. As of 02/20/01, the outcome of the event was unknown. Human leukocyte antigen (HLA) typing by polymerase chain reaction PCR was negative for HLA-DR4. The adverse event of "arthritis" does not meet ICH serious criteria, but is be submitted as an expedited report by special FDA request per the 06/28/00 letter. The most recent info was received on 09/18/2001. The vaccinee was last seen by the physician on 04/20/2001. At that time, the vaccinee continued to experience polyarthritis which was treated with methotrexate. The follow-up info received on 09/18/2001 states that human leukocyte antigen typing by polymerase chain reaction was negative for HLA-DR4. The vaccinee was last seen by the physician on 04/20/2001. At that time, the vaccinee continued to experience polyarthritis which was treated with methotrexate. The follow up states the vaccinee was last seen by the physician on 1/21/02. At that time, the physician indicated a diagnosis of seronegative rheumatoid arthritis. This resovled with corticosteroid therapy and subsequent addition of methotrexate. He had been tapered off his steroids without difficulty. He also had advanced osteoarthritic changes of his knees and received hyaluronic acid (synvisc) in one knee without relief. However, the knees had gradulaly gotten better "on their own." Medications at that time included methotrexate 10mg weekly, Naprosyn 500mg twice daily, folic acid 3mg daily, and prevacid 30mg daily as needed. On physical examination, he had no palpable skin lesions. Joint examination revealed mild osteoarthritic changes of his hands. Otherwise, he had no palpable synovitis, erythema, tenderness or diminished range of motion in any peripheral joints. The physician's assessment was "seronegative rheumatoid arthritis. Doing well on current therapy with the exception of probable methotrexate-induced stomatitis." Folic acid therapy was discontinued and the physician prescribed folinic acid 5mg once a wee, 24 hrs after his methotrexate dose. The most recent info, received on 2/25/02, indicated that the seronegative rheumatoid arthritis and osteoarthritis persisted as of 1/21/02. Both had improved.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 18-DEC-2015, the patient was inadvertently vaccinated with third dose of RECOMBIVAX HB (strength and route were unknown) lot # L029631 with expiry date of 14-AUG-2015, which was less than 1 month from the 2nd dose. No adverse effects were reported. Additional information has been requested.
delayed second dose of twinrix / first dose on 11/25/2020; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 25th November 2020).   On an unknown date, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. Healthcare professional was not sure if the patient would receive delayed dose on 15th April 2021. The reporter consented to follow up.
I felt sick to my stomach for 2 days after the shot. Had the shot on Wed. Sept 25, 02 and noticed I was broke out with a rash on Friday Sept. 27, 02.
Varicella type rash with low-grade fever, 1 week, post vax.
Fatigue (12-18 hrs) chills, general body aches and headache (5-6 hrs), fever(100.5, unknown 2-3 hrs).
I have had ongoing neurological problems, gastrointestinal, cognitive issues, paraseizures vision disturbances, tachycardia all diagnoses by doctors.
Information has been received from a 19 year old female with attention deficit disorder (ADD) who on 13-MAY-2008 was vaccinated with the first dose of GARDASIL (LOT # was not provided). Concomitant therapy included ADDERALL TABLETS. The results of blood work were unknown. The patient received her second dose in October 2008 and her third dose in February 2009. The patient experienced rapid weight gain (40 pounds) ever since she had her first dose of GARDASIL. The patient also mentioned they skipped a dose and started the process all over again. The outcome of the event was unknown. The patient sought unspecified medical attention. Additional information has been requested.
covid home test which came up positive/COVID 19 Treatment; covid home test which came up positive/COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 24Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 18Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Skin cancer" (unspecified if ongoing); "Allergy to bee stings" (unspecified if ongoing), notes: Known allergies: none known other than bee stings. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid home test which came up positive/COVID 19 Treatment". Having finished the full treatment, the patient began to feel unwell about 26Jun2022. Sneezing, runny nose. Today (on 28Jun2022) symptoms worsened with aches, low grade fever, headache. Took covid home test which came up positive. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Jun2022) Positive, notes: covid home test. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 12Jun2022 to 17Jun2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
p/vax pt devel five varicella-like lesions on lt shoulder & abd & a h/a;the lesions were describe as being pruritic;
Couldn't sleep; Stomach popping; Stomach cramping and painful; Sharp pain for 8 hours in the stomach; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Couldn't sleep), GASTROINTESTINAL SOUNDS ABNORMAL (Stomach popping), ABDOMINAL PAIN UPPER (Stomach cramping and painful) and ABDOMINAL PAIN UPPER (Sharp pain for 8 hours in the stomach) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 INSOMNIA (Couldn't sleep), GASTROINTESTINAL SOUNDS ABNORMAL (Stomach popping), ABDOMINAL PAIN UPPER (Stomach cramping and painful) and ABDOMINAL PAIN UPPER (Sharp pain for 8 hours in the stomach). At the time of the report, INSOMNIA (Couldn't sleep), GASTROINTESTINAL SOUNDS ABNORMAL (Stomach popping) and ABDOMINAL PAIN UPPER (Stomach cramping and painful) outcome was unknown and ABDOMINAL PAIN UPPER (Sharp pain for 8 hours in the stomach) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products were reported. No treatment information was provided.
reconstituting Menveo with saline water; reconstituting Menveo with saline water; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number amva5218, expiry date 30th April 2022) for prophylaxis.   On 19th August 2021, the patient received Menveo. On 19th August 2021, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were reported as follows: This case was reported by a nurse. The nurse reported that sterile water was used to reconstitute Menveo,which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consent to follow up.
On 4/18/01 a phone call with Mom stated the left upper arm swollen, reddened. Motrin and Tylenol for pain and discomfort, cold compresses. Decreased swelling, to observe in 24 hours. Follow up with concerns. On 4/19/01 in office, redness and edema, sore to touch, a 10x10cm red area, a 5x5cm indurated area around upper vaccine puncture.