chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 35 years, in left arm 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: "Asthma" (unspecified if ongoing); "bronchitis" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "Known allergies: Shellfish" (unspecified if ongoing); "Known allergies: carrots" (unspecified if ongoing), notes: Known allergies: carrots; "Known allergies: soy" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL SULFATE]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Testing positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt received Twinrix A/B IM vaccine 12/14/2001 and state next day later in evening had liquid stool with possible blood in it.
Early evening of vaccine date got severe freezing shivers and shakes for about 3 hours then stopped.  Next morning about 7 .25 am went to bathroom and used toilet.  Stood up to exit bathroom then woke up on the floor - no warning at all.  Unable to stand.  911 called and took me to hospital.  Unfortunately ct scans showed a compression fracture on L3.
My lower extremities, from the knee down, are weak and sometimes it is hard to walk.; My lower extremities, from the knee down, are weak and sometimes it is hard to walk.; My knees also hurt; Dizziness; Skin was very pale and cold to the touch.; Profuse sweating.; Fatigue; Muscle Pain; Fainting 9 hours after administration; I had my first headache.; I had pins and needles in fingers 4 and 5 in the arm of vaccine administration; This is a spontaneous report from a contactable consumer (patient).   A 53-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 23Apr2021 11:30 (Lot Number: EW0170), at age of 53 years old, at single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient previously took asparagus for Allergy. Reported Event: Immediately after the vaccine, I had pins and needles in fingers 4 and 5 in the arm of vaccine administration. 3 hours after vaccine, I had my first headache. Severe headache, dizziness, fainting 9 hours after administration. During fainting episode, skin was very pale and cold to the touch. Profuse sweating. This was on the same day as vaccine administration. For the next 3 days, I laid in bed with fatigue, severe headache, and muscle pain. After 10 days, I still feel weak, I get tired after walking half a mile, and I have episodes of dizziness during the day. My lower extremities, from the knee down, are weak and sometimes it is hard to walk. My knees also hurt. This is still present 10 days after the vaccine. Outcome for events was unknown. Prior to vaccination, whether the patient was diagnosed with COVID-19 Was Unknown, and Since the vaccination, the patient has not been tested for COVID-19.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No follow-up attempts are needed. No further information is expected.
Fever, body aches, tiredness, headache, soreness on injection site, under the arm, up the neck and pain in the ear.
This spontaneous report was received from a Medical Assistant and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, drug reactions, allergies, concurrent conditions and concomitant therapies were not reported. On an unspecified dates, the unspecified patients were vaccinated with a dose of improperly stored PROQUAD lot number reported as: M007961; expiration date reported as: 15-AUG-2017 (dose, route of administration, anatomical location were not reported). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Received shingles vaccine on 10/26/09 to right upper outer aspect(arm). Injection site was "negative" for 3-4 days. Site became red, itchy, painful when scratched. From injection site to mid upper arm, red hot area with raised "blisters" that never developed or oozed. "Reaction" lasted 12 days. Ice applied PRN/ heat & redness. CORTISONE cream (OTC) as needed.
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 03-NOV-2012 12:49, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Day of vaccine I experienced swelling and pain at the injection site, entire arm hurt. This resolved within a few days. On 2/13/2021 I woke up and noticed my arm was itchy at the injection site. The injection site is swollen with a 2 inch red area that is hard to the touch and warm as of 11:00 pm. Entire arm hurts,  I also have pain into my armpit. Have fatigue and generally feel unwell. Will seek medical attention if not resolved within 24 hours.
Patient lost color in his face, felt sweaty, lightheaded, and warm a few minutes after first dose (10:04 AM). The warmness lasted 2-3 minutes, and then he felt cool. The lightheadedness subsided about 10:15 AM. This is when his mother called me over and told me what was going on. His BP (using automatic cuff) was 110/58 with a pulse of 55. He denied any other sx, and said he ate Special K Protein and soy milk for breakfast. We gave him a bottle of water to sip, and he continued to sit with his head near his knees. At 10:30 AM, his BP was 101/56 with pulse of 51. He said the lightheadedness returned slightly, but the sweatiness subsided. By 10:43 AM, he said he felt all better. At 10:36 AM, he took his pulse manually, and it was 66. By 10:43 AM, he felt "all better" and his BP was 135/75 at 10:54 AM, with a pulse of 57 (per automatic cuff).
01/02/22 presents to ED for "fatigue" "polyuria and polydipsia" "no significant PMH"
Pt had chest pain and shortness of breath approximately 10 days after vaccine administration.  Pt was evaluated at an ER and diagnosed with pericarditis.  Pt was treated symptomatically and symptoms resolved without sequelae.  Follow up exam unremarkable.  In addition, pt had questionable satellite lesions which resolved spontaneously.
pt recvd flu vax & w/in 48 hrs the pt devel baseball-sized induration;
This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug allergies and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 injection (dose was not reported) (lot number: M041212; expiration date: 21-JUN-2019) administered intramuscularly, for prophylaxis. According to the reporter, when she was administering the dose using a pre-filled syringe, most of GARDASIL 9 dose leaked out from the base of the needle, where it attached to the lower portion of the pre-filled syringe. The reporter believed that the patient received very little amount of GARDASIL 9 (accidental underdose). No adverse effects were reported. A product quality complaint was involved. Additional information has been requested.
Patient received Meningitis B from Pfizer TRUMENBA on 10-12-16 in the PM. Patient returned to office on 10-13-16 due to pain on the left arm, headaches, changes in skin texture, feeling weak and sensitivity on the left arm. Discomfort began in the AM on 10-13-16. Physician examined: hypersensitivity on entire (L) upper limb, local skin induration, no moderate deficit, normal skin color, no axillary adenopathy.
I am a breastfeeding mother and I went from pumping 8oz per session to 1-2oz per session starting the first time I pumped following the vaccine. I had to feed my baby every hour for over a week (including through the night) and take supplements to increase my supply. Baby screamed crying for 3 days following the vaccine. She has dairy sensitivity.
pt recvd vax & c/o aching in the arm, sl tingling in the fingers & arm;  seen by MD 15OCT93 & was treated w/Cortisone inject;
Patient reported rash in armpit of left arm, that has spread to her breast and private areas on 11/4/22
Per History and physical on 1/10/22: "patient is a 72 y.o. female with a history of Sick Sinus syndrome s/p pacemaker placement, diastolic CHF, hypertension, Diabetes Mellitus, hyperlipidemia, hypercalcemia (follows nephrology), and anxiety who presents to ED with complaint of generalized weakness, malaise, and worsening confusion. Was recently admitted on 12/20/21-1/05/22 for altered mental status and hypercalcemia. Scheduled to see Nephrology next month. Covid-19 positive on admission today."  Patient later had possible TIA.
Pt reports mouth twitching evening of receiving vaccine. States as of 3/1/2021 is a bit better, but continues to have the twitching  on the left side of her mouth.    Pt states she feels fine otherwise.  States she asked her chiropractor about it and according to patient   he told her it was up to her about getting the second dose.
Headache 4 hrs after the shot & runny nose a day after the shot . Symptoms are less now
Shivers, dripping red eyes, sore throat, felt like something was stuck in throat, runny nose, cough, high fever 101.
sore left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left injection site arm) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore left injection site arm). At the time of the report, VACCINATION SITE PAIN (sore left injection site arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication were reported.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-546519 (Patient Link).
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a female patient who received FLULAVAL QUADRIVALENT 2018-2019 season (batch number PP732, expiry date 30th June 2019) for prophylaxis. On 1st October 2018, the patient received FLULAVAL QUADRIVALENT 2018-2019 season. In October 2018, 1 day after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced injection site erythema, injection site pain, injection site warmth and injection site swelling. On an unknown date, the outcome of the injection site erythema, injection site pain, injection site warmth and injection site swelling were recovering/resolving. It was unknown if the reporter considered the injection site erythema, injection site pain, injection site warmth and injection site swelling to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional details were reported as follows: The age at vaccination was not reported. The day after vaccination, the patient experienced bull's eye redness, swelling, pain and heat all around the injection site. This case has been linked with case US2018180225 and US2018180228, reported by the same reporter.
I was vaccinated with my second vaccine on 1/26/21. This morning, 1/28/21 I started experiencing gross hematuria.
Chills started at 9:30 pm. Then progressed to a fever, fatigue, muscle aches. Vomiting started at about 8:30 am. At 12:30 pm symptoma started to disappear and by 3:30 pm all symptoms were gone except fatigue.
1 dose YF given IM inadvertently thinking it was another vaccine, 1 dose given SQ.  2 days later in checking on him - the company MD reported 101 degrees & very achy.  Follow up call made x3 & at 1wk he was symptom free.
Mild soreness at first. Next day, stomach started grumbling. Couldn't keep his eyes open, sweating,, weakness, abdominal pain, muscles aches, and vomiting this morning.  no fever.
Bottom  lip is numb. Feels like when you get that anesthetic on your gum at the dentist; This is a spontaneous report from a contactable other hcp (patient). A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0186), dose 1 via an unspecified route of administration, administered in arm left on 08Jun2021 as dose 1, singe for covid-19 immunisation. Medical history included blood pressure measurement (BP). Concomitant medication included metoprolol. The patient previously received flu shots and experienced allergies. The patient stated, "Bottom lip is numb. Feels like when you get that anesthetic on your gum at the dentist (on 08Jun2021 11:45)." The patient received treatment for AE included Benadryl. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was resolving.; Sender's Comments: Based on the close temporal relationship, the association between the event "bottom lip is numb" with BNT162b2 can not be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
8 DAYS AFTER THE VACCINATION SWELLING  REDNESS  SORENESS ITCHING
Systemic: numbness and tingling in the arm-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe
8 days after the first Moderna vaccination on February 17, 2021 I experienced what has been described as covid arm for approximately 24 hours. That was my only reaction to the first vaccine.  Two weeks after my second Moderna vaccine on March 17, 2021, I again experienced "covid arm". That time it lasted about 36 hours. I had another attack of it starting on April 6, 2021 and still continuing on April 9, 2021. It starts with soreness in my left arm around the injection site and shoulder. The area becomes hot and swollen. About 24 hours later it moved down my arm into my left hand which became swollen and sore as well.  Although the pain in my shoulder has subsided some it has not completely gone away. The swelling in my hand and ache there is just starting to subside now.
2/03/2021: Patient stated shortness of breath and generalized weakness on admission. Patient started on Azithromycin 500 mg every 24 hours for 2 days, Ceftriaxone 2g every 24 hours for 2 days, and Acetaminophen 1000 mg once followed by acetaminophen 650 mg for 2 days.  2/04/2021: Patient diagnosed with pneumonia attributed to aerobic bacteria although no cultures were obtained. COVID and Influenza PCR negative. 2/05/2021: Patient discharged with no new prescriptions.
Patient received vaccines and later in visit admitted she was sexually acive and had a positive pregnancy test.  No treatment given
possible stroke; small clot that went through and resolved on its own; Loss use of left leg/couldn't use her leg; tingling in left arm; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (possible stroke), THROMBOSIS (small clot that went through and resolved on its own), MONOPLEGIA (Loss use of left leg/couldn't use her leg) and PARAESTHESIA (tingling in left arm) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included Familial hypercholesterolemia, Peripheral arterial disease and Stent placement (has stents in her iliac ery). Concomitant products included ATORVASTATIN CALCIUM (ATORVASTATIN [ATORVASTATIN CALCIUM]), ACETYLSALICYLIC ACID (BABY ASPIRIN) and SERTRALINE for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (possible stroke) (seriousness criterion hospitalization), THROMBOSIS (small clot that went through and resolved on its own) (seriousness criterion hospitalization), MONOPLEGIA (Loss use of left leg/couldn't use her leg) (seriousness criterion hospitalization) and PARAESTHESIA (tingling in left arm) (seriousness criterion hospitalization). The patient was hospitalized from 27-Mar-2021 to 28-Mar-2021 due to CEREBROVASCULAR ACCIDENT, MONOPLEGIA, PARAESTHESIA and THROMBOSIS. At the time of the report, CEREBROVASCULAR ACCIDENT (possible stroke), THROMBOSIS (small clot that went through and resolved on its own), MONOPLEGIA (Loss use of left leg/couldn't use her leg) and PARAESTHESIA (tingling in left arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Computerised tomogram: Inconclusive. In March 2021, Magnetic resonance imaging: Inconclusive.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  No treatment information was provided.   Patient reports an MRI and CT scan was done, and she was informed that they suspected she had a small cot that went through and resolved on its own.  Company Comment: Based on the temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However patient's hx of familial hypercholesterolemia, peripheral arterial disease and stent placement are confounding factors that may play a possible contributory role.
Death NOS; This case was reported in a literature article and described the occurrence of unknown cause of death in a 12-year-old female subject who received HPV vaccine unknown for prophylaxis.   On an unknown date, several hours after receiving HPV vaccine unknown, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death.   It was unknown if the investigator considered the unknown cause of death to be related to HPV vaccine unknown.  Additional information was provided.  This case was reported in a literature article and described the death NOS in a 12-year-old female who was vaccinated with unspecified human papillomavirus (HPV) vaccine (manufacturer unknown) case for prophylaxis.  The patient was a part of the study that employed the Twitter data to understand content characteristics and the patterns of content flow of the conversations about the HPV vaccine debate. [In this study, Twitter activity related to HPV vaccination was collected in one-week period datasets, started from 20th September 2016 for ten weeks]. No information on patient's medical or family history or concurrent condition or concomitant medication was provided.  On an unspecified date, the patient received the injection of unspecified HPV vaccine (administration site and route unspecified; dosages unknown; batch number not provided).  On an unspecified, hours after vaccination, the patient died. The cause of death was not reported. It was unknown if an autopsy was performed.  The authors did not comment on the relationship between the event of death NOS' and unspecified HPV vaccine.  The authors stated, "Our findings show that positive emotion is positively correlated with cluster density, an indicator of strong ties and rapid information flow. In the case of negative emotion, we found that anger is a significant negative predictor for graph density. We also found a correlation between certainty and tentativeness; both at cluster as well as at tweet level, suggesting that clusters bring together people who are sure about the HPV vaccine and people who are exploring for answers."  The article corresponding to this case is not available for regulatory submission due to copyright restriction.  This is 1 of the 3 valid cases reported in the same literature article.; Reported Cause(s) of Death: Unknown cause of death
Itching; Rash which is increasing in size; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), RASH (Rash which is increasing in size) and FATIGUE (Fatigue) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced FATIGUE (Fatigue). On 11-Mar-2021, the patient experienced PRURITUS (Itching) and RASH (Rash which is increasing in size). At the time of the report, PRURITUS (Itching) and RASH (Rash which is increasing in size) outcome was unknown and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication list include synthetic thyroid medication. Treatment information was not provided.
This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 57-year-old female patient who received DTPa (Reduced antigen) (dTpa vaccine) for prophylaxis. On 9th July 2018 10:00, the patient received dTpa vaccine. On 9th July 2018, several hours after receiving dTpa vaccine, the patient experienced diarrhea, injection site pain and tiredness. On an unknown date, the outcome of the diarrhea, injection site pain and tiredness were unknown.  It was unknown if the reporter considered the diarrhea, injection site pain and tiredness to be related to dTpa vaccine. Additional details were provided as follows: The patient was not sure what brand vaccine she received on the reporting day. The patient only knew it was a Tdap for Pertussis. The patient received the vaccine on the right arm. The patient reported pain at the injection site immediately upon vaccination and her arm had been sore all day. The patient ate lunch late in the day around 4:00 and experienced the diarrhea shortly after that. The patient felt tired all day following the vaccination.
According to mom pretty immediately baby started getting bloody diarrhea. On 8/14 went to APR Hospital. Testing was completed; positive stool test, no X-rays, CBC shows some anemia. Patient was released; clinically looked good all the time. Follow-up the next day attributed incident to diaper rash.  Mother reports patient was also fussy and vomiting but not sure if related to reflux. Mother reports 2 days of bloody stools. Regular doctor visit on 10/25 but no vax were administered due to the reported incident. Patient recovered completely.