chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received on 24-SEP-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age and his spouse. The patient's concurrent conditions, medical history and concomitant medications are unknown. On 10-NOV-2016, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a family health facility for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. Ten days after receiving the ZOSTAVAX, the patient developed an intermittent, sharp throbbing pain and blisters on the buttocks. Thereafter, the patient was diagnosed with shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment, including but not limited to, diagnoses of sciatic neuropathy, foot drop, and postherpetic neuralgia. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Two days after TDAP, pt states her arm swelled, that it was very hot, burning and red. States that she had a lot of pain and a moderate (?) fever for the 3 days that the symptoms were present. The correlation of symptoms lasted for approximately 3 days.
pt recvd vax & devel hives at inject site; felt sweaty; headache;
This case was reported by a nurse via call center representative and described the occurrence of concentration loss in a 67-year-old female patient who received FLULAVAL TETRA (batch number 972F3, expiry date 13th June 2019) for prophylaxis. Concomitant products included ZOLOFT. On 6th September 2018, the patient received FLULAVAL TETRA (intramuscular) .5 ml. On an unknown date, 1 day after receiving FLULAVAL TETRA, the patient experienced concentration loss, personality change, feeling abnormal, anxiety and irritability. On an unknown date, the outcome of the concentration loss, personality change, feeling abnormal, anxiety and irritability were not recovered/not resolved. It was unknown if the reporter considered the concentration loss, personality change, feeling abnormal, anxiety and irritability to be related to FLULAVAL TETRA. Additional details were provided as follows: The healthcare professional reported the case for herself. The patient developed lack of focus, anxiety, crankiness, out of sorts feeling, and a personality shift. The health care professional stated her adverse events are feeling a little better but they had not gone away. The health care professional was taking ZOLOFT and health care professional was concerned about potential drug interaction between ZOLOFT and the FLULAVAL. This case is linked to case US2018165445 and US2018165450 reported by the same reporter.
Pt called call center c/o feeling slight tingling in her both legs little more on right leg side and  bothering her more since last night and also feels more sitting and lying down. Started initially 2 days ago. Can able to walk without any discomfort. Pt denies numbness, redness, pain, swelling in both legs. Pt was scheduled for urgent care visit with provider
Her menstrual cramps became more intense starting in July 2021. We treated it with heating pad, rest, and TYLENOL/MOTRIN. She tested positive for COVID-19 in January 2022. She had missed her cycle in April 2022 and after 60 days we made an appointment with the pediatrician and she was prescribed birth control. She is still under doctor care and has a follow-up appointment in 6 week.
After my booster shot in Sept. 2021. I noticed a tingling sensation all over my body, as well as possible light headedness, however, I never passed out or anything. It did happen when I was driving once and that is when I began to document my symptoms. I had begun going to specialists prior to the booster shot post 2nd vaccine. I did start to see a neurologist as well as a cardiologist that have all come back inconclusive. I have just taken an Iodine MRA looking for plaque build up. I have also had an echo cardiogram as well yesterday and are waiting on the results.
spike in blood in blood sugar; This is a spontaneous report received from Pfizer sponsored program. A contactable consumer reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on an unspecified date as 1st dose, single and as 2nd dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter noticed a spike in blood in blood sugar following first dose of the patient, still manageable with insulin. Following second dose, blood sugar was not manageable with insulin. Said her insulin "acted like water, no effect." Asked to speak with medical professional to see if we have information on vaccine affecting blood sugar. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
Patient states she had swollen hands, SOA with activity, hives, increased blood pressure and heart rate. Throat tightness & back pain. Patient states she was treated with IM steroids and antihistamines.
Difficulty swallowing, tingling feeling in face, tightness in throat, odd sensation in jaw.
Temp of 99.4F, duration of 1day. Rash on left arm extending onto left breast, duration of 10 days to 2 weeks. Hives on chest, started 3 days after vaccine and lasted for duration of 3 days.
Patient received covid vaccine in clinic. He was healthy before does. Once home mild headache, that night abdominal pain and vomiting. Vomiting described as 3-4 episodes, a lot of volume, started off as food but then watery cause he was drinking a lot/started to improve, stopped at 6 am this morning. Diarrhea described as 3 episodes, very loose. No blood in diarrhea/vomit. Diarrhea getting better. Abdominal pain described as periumbilical, crampy.  Mother used medication from pharmacy with name unknown that helped vomiting. No fevers, shortness of breath, rash, tongue/lip swelling, wheezing
Patient got his 1st booster shot of moderna on 4/12/22 (Wednesday). He had no history of adverse reactions to his prior moderna vaccines. He states when he woke up this morning he had a swollen lymph node in his arm pit. He states it was bigger when he got up but has gone down a little since waking a few hours ago. He states it does not hurt but he will keep his eye on it.
RED, SWOLLEN, AND PAINFUL UPPER RIGHT ARM WHERE THE VACCINE WAS ADMINISTERED, THE SWOLLEN AREA ALSO FELT WARM TO TOUCH.
Pt recv vax on 10/16/98; on 10/17/98 pt exp fever (99.4), malaise
have been sick eversince getting vaccination; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, 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: MALAISE (non-serious), outcome "unknown", described as "have been sick eversince getting vaccination".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
After injection, pt waited about 3-4 minutes and stood to leave - felt lightheaded - and fell to floor. LOC x < 1 minute. Following syncope noted headache x < 10 minutes (mild). Monitored x 30 more min - accompanied home by sibling.
Fever, headaches, body aches, dry mouth and insomnia.  I took tylenol at 2am and again at 645 had 99.9 fever w tylenol.
aches; mild headache; low grade fever; Chills; muscular soreness near shot site; Phantom aromas; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the right arm on 16Apr2021 at 13:00(at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included catamenial epilepsy. 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 COVID vaccine. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and multivitamin (MANUFACTURER UNKNOWN); both started on unknown date for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the right arm on 24Mar2021 at 13:45 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient previously received phenobarbital (MANUFACTURER UNKNOWN) on an unknown date and experienced drug allergy. On 16Apr2021, the patient experienced muscular soreness near shot site and 6-10 hours later experienced phantom aromas later, on 17Apr2021, 18 hours after vaccination, the patient experienced mild headache and after 24 hours experienced low grade fever, chills and aches. The patient did not receive any treatment for the events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event muscular soreness near shot site, phantom aromas, mild headache, low grade fever, chills and aches were unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
her arm is sore, painful; her arm is burning; her arm is bruised; This case was reported by a consumer via patient support programs and described the occurrence of pain in arm in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th March 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced pain in arm, burning sensation and bruising of arm. On an unknown date, the outcome of the pain in arm, burning sensation and bruising of arm were unknown.   It was unknown if the reporter considered the pain in arm, burning sensation and bruising of arm to be related to Shingrix.  Additional case details were reported as follows: The patient experienced pain in arm, burning sensation and bruising of arm after vaccination.
Information has been received from a physician concerning a 16 week old female with no pertinent medical history, drug reactions or allergies who in December 2009, was vaccinated orally with the first dose of ROTATEQ (dose and lot number not reported). Subsequently, the patient was vaccinated orally with the second dose of ROTATEQ (Lot # 664882/1522Y). Concomitant medication included all routine vaccinations. On 23-FEB-2010 the patient experienced fever and abnormal white blood cell count showed by a CBC test that was performed. The physician reported that the patient came back in the office on 24-FEB-2009 for a follow up visit and the patient had recovered. Follow up information was received from a health professional concerning a 16 week old female with pertinent medical history, no know drug allergies and no illness at the time of vaccination who on 22-FEB-2010 was vaccinated orally with second dose (previously reported as first dose) of ROTATEQ (dose not reported, lot number 664882/1522Y). It was reported that on 23-FEB-2010, the patient developed fever and elevated white blood cell count. Laboratory tests performed included CBC, UIA and urine culture (results not provided). The patient recovered from fever and elevated white blood cell count on an unspecified date. No further information is available.
would like to know if high blood pressure is "immunocompromised"/high blood pressure after vaccine; This is a spontaneous report from a contactable consumer or other non hcp via a Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date in Feb2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unknown date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. On an unspecified date in 2021, caller stated that she would like to know if high blood pressure was immunocompromised to qualify for booster vaccine. Nurse/faxed to medical for AE - high blood pressure after vaccine. The clinical outcome of the event was unknown.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 at 11:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 39 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "currently recovering from nasal surgery" (unspecified if ongoing), notes: Other medical history: currently recovering from nasal surgery; "Known allergies: Latex" (unspecified if ongoing), notes: Known allergies: Latex; "Known allergies: bell pepper" (unspecified if ongoing), notes: Known allergies: bell pepper; "Known allergies: quinoa" (unspecified if ongoing), notes: Known allergies: quinoa; "Known allergies: pineapple" (unspecified if ongoing), notes: Known allergies: pineapple; "Known allergies: cantaloupe" (unspecified if ongoing), notes: Known allergies: cantaloupe. Concomitant medication(s) included: ARMOUR THYROID, start date: Jan2010.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (Jan2023) Negative, notes: I tested negative; (Jan2023) Positive, notes: the next day tested positive again; (Jan2023) Positive, notes: I remained positive and symptomatic for another 5 days after that; (Jan2023) Positive, notes: I remained positive and symptomatic for another 5 days after that; (Jan2023) Positive, notes: I remained positive and symptomatic for another 5 days after that; (Jan2023) Positive, notes: I remained positive and symptomatic for another 5 days after that; (Jan2023) Positive, notes: I remained positive and symptomatic for another 5 days after that. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course:Paxlovid rebound. After taking my 5 day course symptoms were minimal and I tested negative. About 4 days later I became symptomatic again, with some new symptoms I hadn't had before and the next day tested positive again and remained positive and symptomatic for another 5 days after that. Patient received other medication in 2weeks. Treatment start date was 02Jan2023 and treatment Stop date was 07Jan2023.  The information on the batch/lot number for [BNT162B2, BNT162B2 OMI BA.4-5] has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162b2, BNT162b2 omi ba.4-5 cannot be excluded. The case will be reassessed once new information is available.
Arm & hand numb during night after injection; lymphadenopathy in left armpit (injection given in left arm); This is a spontaneous report from a Non-contactable Nurse (Patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL9261), via an unspecified route of administration, administered in left arm on 02Feb2021 (at the age of 60-years-old) as 2nd dose, single for COVID-19 immunisation. Medical history included allergic to penicillin and Imipramine, and hypertension. Concomitant medication(s) included Elderberry Syrup, Zicam, HCTZ, lisinopril; all for unknown indications from unknown dates and unknown if ongoing. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 12Jan2021 as 1st dose, single for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Feb2021, patient experienced arm and hand numb during night after injection, lymphadenopathy in left armpit. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Headache; Back pain/Severe back  pain; Nausea; Excruciating and debilitating pain; 2 Sleepless night; Unable to perform basic tasks/could not move her arm/can't tie her shoes or throw a blanket over herself, unable to take her clothes off at night; Lost appetite; Vertigo; Brain fog; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo), FEELING ABNORMAL (Brain fog), PAIN (Excruciating and debilitating pain), INSOMNIA (2 Sleepless night) and MOBILITY DECREASED (Unable to perform basic tasks/could not move her arm/can't tie her shoes or throw a blanket over herself, unable to take her clothes off at night) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN (Excruciating and debilitating pain), INSOMNIA (2 Sleepless night), MOBILITY DECREASED (Unable to perform basic tasks/could not move her arm/can't tie her shoes or throw a blanket over herself, unable to take her clothes off at night), DECREASED APPETITE (Lost appetite) and NAUSEA (Nausea). On 06-Mar-2021, the patient experienced BACK PAIN (Back pain/Severe back  pain). On 07-Mar-2021, the patient experienced HEADACHE (Headache). In March 2021, the patient experienced VERTIGO (Vertigo) and FEELING ABNORMAL (Brain fog). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. On 06-Mar-2021, INSOMNIA (2 Sleepless night) had resolved. At the time of the report, VERTIGO (Vertigo), FEELING ABNORMAL (Brain fog), MOBILITY DECREASED (Unable to perform basic tasks/could not move her arm/can't tie her shoes or throw a blanket over herself, unable to take her clothes off at night), DECREASED APPETITE (Lost appetite), BACK PAIN (Back pain/Severe back  pain), NAUSEA (Nausea) and HEADACHE (Headache) outcome was unknown and PAIN (Excruciating and debilitating pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 11-Mar-2021: Follow-up information received on 11 Mar 2021 contains Additional details regarding the events - cannot move arm and severe back pain. On 18-Mar-2021: Follow-up information received on 18 Mar 2021 contains no new information. On 03-May-2021: Follow-up information received on 03 May 2021 included non significant information. On 21-Jul-2021: Follow-up information received contains added events - brain for and vertigo
Then symptoms came back again 2 weeks later; Then symptoms came back again 2 weeks later; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Then symptoms came back again 2 weeks later". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: tested negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Follow-up attempts are completed. No further information is expected.
Menquadfi timing - given to soon - menactra was given on 6/15/21-(should've been 4 years between doses.} Bexsero - given to soon - age 13 yrs 8 months - and first dose due at age 16.
Localized reaction-- urticarial plaque measuring 14 cm x 12 cm, intermittent and ongoing 14 days post injection. No other associated symptoms or concerns. Tx supportively- cool compresses, NSAIDs, OTC hydrocortisone cream or ointment.
received vaccine on 5/27/22, then a second on 6/3/22; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 3rd June 2022, the patient received the 2nd dose of Shingrix. On 3rd June 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 7-JUN-2022 Reporter's Comment: The patient received 1st dose of Shingrix vaccine on 27th May 2022 and 2nd dose on 3rd June 2022 from the pharmacy. The reporter asked what should they advise the patient to do. The reporter also asked should he still get another dose. Additional supportive information: The patient received 2nd dose of Shingrix vaccine earlier than the recommended interval, which led to shortening of vaccination schedule. The reporter consented to follow-up.