chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hardening of her bowel; a little stomach pain; loosening of her bowels; kidney infection; yeast infection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CONSTIPATION (hardening of her bowel), ABDOMINAL PAIN UPPER (a little stomach pain), DIARRHOEA (loosening of her bowels), KIDNEY INFECTION (kidney infection) and FUNGAL INFECTION (yeast infection) 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 medical history reported. ).    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced KIDNEY INFECTION (kidney infection) and FUNGAL INFECTION (yeast infection). On 04-Mar-2021, the patient experienced CONSTIPATION (hardening of her bowel), ABDOMINAL PAIN UPPER (a little stomach pain) and DIARRHOEA (loosening of her bowels). At the time of the report, CONSTIPATION (hardening of her bowel), ABDOMINAL PAIN UPPER (a little stomach pain), DIARRHOEA (loosening of her bowels), KIDNEY INFECTION (kidney infection) and FUNGAL INFECTION (yeast infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was unknown  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Started with headache for several weeks. Swollen lymph nodes, chronic ear infections, mono, exhaustion, sudden food allergies, still undiagnosed.
Patient had Pfizer Covid vaccine and contracted Covid-19.; Sars-Cov-2 infection; This is a spontaneous report form a contactable consumer (patient) via regulatory authority. A 20-year-old female patient received unspecified dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and Expiry date was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date patient had Pfizer covid vaccine and contracted covid-19. Event took place after use of product. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received vaccine IM at 12 noon and had seizure episode lasting at 3 minutes and starting with rolling of right eye up and moving left arm and lower extremity (2:15).
shivering; headache; fatigue; This case was reported by a consumer via call center representative and described the occurrence of shivering in an unspecified number of  patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix with an associated reaction of chills (1st dose received on an unknown date, refer linked case US2019AMR216742).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shivering, headache and fatigue. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the shivering, headache and fatigue were unknown.   It was unknown if the reporter considered the shivering, headache and fatigue to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. Several unknown patients had shivering, headache, and fatigue which was described as stronger than those experienced with 1st dose of Shingrix.  The reporter did not consent to follow-up. The reporter did not wish to participate in a safety report, she just gave a general statement about her friend's experience with Shingrix.  There were no other details.
arm is swollen; pain in her muscles; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm is swollen) and MYALGIA (pain in her muscles) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Mar-2021, the patient experienced PERIPHERAL SWELLING (arm is swollen) and MYALGIA (pain in her muscles). At the time of the report, PERIPHERAL SWELLING (arm is swollen) and MYALGIA (pain in her muscles) outcome was unknown.            After second dose vaccination the patient experienced pain in her muscles and swollen arm.No treatment information provided. Action taken with mRNA-1273 in response to the events was not applicable.
Vaccine was not administered at our hospital, but reporting since patient presented to the ED.  Presented to ED on 3/6/21 with right sided weakness.  Admitted for acute right sided weakness.  Unable to get MRI due to pacemaker.  Discharged the next day in stable condition with clopidogrel and aspirin.
Kinrix administered to a 6 months-old; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-month-old male patient who received DTPa-IPV (Kinrix) (batch number 24T2N, expiry date 7th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th February 2023, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 10th February 2023, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 Information: GSK Receipt Date: 10-FEB-2023 Reporter's Comments: The reporter consented to follow-up. Additional Supportive Information: The patient was administered Kinrix vaccine at inappropriate age, which led inappropriate age at vaccine administration.
Since 2nd shot I haven't had my menstrual cycle. Pre vaccine had it every month; My platelets has increased quite a bit since my 2nd shot. I normally have high platelets but they increased a lot; Chills; achiness; This is a spontaneous report from a contactable consumer (patient). A 47-years non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN5318 and expiry date: unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 16Feb2021 11:30 as DOSE 2, SINGLE for covid-19 immunisation (at the age of 47-years). Medical history included essential thrombocythaemia. List of any other medications the patient received within 2 weeks of vaccination: Baby aspirin stopped 4 days prior to both shots. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient previously received 1 dose of bnt162b2 on 26Jan2021 (lot number: EL3302, Anatomical Location: Arm Left). 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 been tested for COVID-19. The patient experienced Since 2nd shot the patient haven't had my menstrual cycle. Pre vaccine had it every month. The patient platelets has increased quite a bit since the 2nd shot. The patient normally have high platelets but they increased a lot. 14 hrs after 2nd shot had chills and achiness for about a day. The event resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on an unknown date (Nasal Swab)(Get tested weekly (Tuesdays) as I'm a caregiver for my mom in a nursing home). Outcome of the events Since 2nd shot I haven't had my menstrual cycle. Pre vaccine had it every month and My platelets has increased quite a bit since my 2nd shot. I normally have high platelets but they increased a lot was Not recovered, Chills and achiness was Recovered.  No follow-up attempts are needed. No further information is expected.
My eyes are swollen, itchy, and dried out.; My eyes are swollen, itchy, and dried out.; My eyes are swollen, itchy, and dried out.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Nov2021 14:00 (Lot number: EW0164) at the age of 27 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0161, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 25Oct2021, when the patient was 27 years old, for Covid-19 immunization. The following information was reported: EYE SWELLING (non-serious), EYE PRURITUS (non-serious), DRY EYE (non-serious) all with onset 16Nov2021 05:30, outcome "recovering" and all described as "My eyes are swollen, itchy, and dried out.". Therapeutic measures were not taken as a result of eye swelling, eye pruritus, dry eye. No follow-up attempts are possible. No further information is expected.  Follow-up (24Nov2021): Follow-up attempts are completed. No further information is expected.  Additional information: 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.
Information has been received from a 65 year old female consumer (retired Doctor of Chiropractic Medicine) reporting about herself with drug allergy to "most pain killers" and hypothyroidism with a pertinent medical history of body weight 148 pounds and breast cancer (1999, mastectomy 2005) who in April 2011, was vaccinated with a dose of ZOSTAVAX (Merck), 0.65 ml, subcutaneously, (dose, route and Lot # unknown). Concomitant therapy included PROZAC and levothyroxine Na. In approximately April 2011 (two weeks later, after ZOSTAVAX (Merck) vaccination), the patient developed acute pancreatitis. Lipase level was 271 and amylase level was 158. The consumer reported that her blood glucose levels were increased at 150-200. In approximately May 2011 (after 5-6 weeks), consumer developed itchy, painful bumps over her left trapezius, shoulder, and down the triceps ("C7/T1/2"). The pancreatic enzyme level normalized in June-July 2011. The blood glucose level had "plateaued" at 95-105. The bumps continue to be itchy and the area was sore. The shingles was never seen by a physician (but it was also reported that consumer sought medical attention). Treatment included acyclovir, ULTRAM, hydromorphone and EXCEDRIN. Upon internal review, acute pancreatitis was determined to be an other important medical event. Additional information has been requested.
Within 15-minutes of vaccination, the patient reported a rash, hives, and pruritus at the injection site. Managed on-site.
Five days after receiving Flu vaccine, pt. experienced bilateral lower extremity weakness, gait disturbance and ataxia.  Per Dr. pt was sent to ER for eval.  Father had stroke after receiving H1N1 vaccine.
Confusion, depression, tiredness, yawning a lot (lack of oxygen). Symptoms increased over time.
Period started next day which was 2 weeks earlier than expected. Always have been on time. That period was 10 days long which was 3 days longer than my normal period. It was also a lot heavier than normal. The next month it was heavier than normal and 10 days again. This month it lasted 4 days and was very very light.
POTENTIAL ADMINISTRATION ERROR USE OF EXPIRED VACCINE; OFF LABEL USE; This spontaneous report received from a physician concerned a 71 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: 042A21A expiry: 19-SEP-2021) dose was not reported, administered on 20-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 20-SEP-2021, the patient experienced potential administration error use of expired vaccine. On 20-SEP-2021, the patient experienced off label use. The action taken with covid-19 vaccine was not applicable. The outcome of the potential administration error use of expired vaccine and off label use was not reported. This report was non-serious.
Swollen lymph nodes, pain, tx recommended was OTC pain medications, ice pack to swollen areas
The day after the vaccine, she developed a rash on her inner elbow and right shoulder pain that has continued to today.
Within seconds of last shot. Legs become red. Red splotches noted over both lower extremities, is seen by Dr. Four dime size spot on forehead. One dime size spot on mid chest. After eight minutes, rash was almost completely resolved.
Pfizer Vaccine was diluted with Sodium Chloride 0.9%, nurse was unaware that Grey Cap Pfizer Vaccine for 12 and up did not need to be diluted. Vaccine was drawn up as 0.3ml and given to the patient in the left deltoid. We are reporting this because we are unsure if patient needs to be given another dose since diluation was drawn up and injected into the vial.
After receiving vaccines (DTaP and IPV in R. thigh and MMRV in lower (L) thigh and Hep A in upper (L) thigh. Pt developed one hive in (L) lower leg (thigh) next to injection site 10 minutes after receiving injections. Dr ordered Benadryl 12.5 mg now PO Benadryl was ordered PO to take home.
Large rash on chest. Itching that began after the second week. Treated with Benadryl cream with some relief. Rash continues to remain after 7 days of starting.
2/14/05 at 12:15PM. Received phone call from mom stating with last set of immunizations child had high fever and had seizure. Took child to ER, fever was 103, no seizures after initial seizure at home. Child stayed in ER for a while then was sent home.
Information has been received from an approximately 65 year old female registered nurse with amoxicillin allergy and no pertinent medical history reporting on herself, who in approximately 2007, "5 years ago", was vaccinated with a dose of PNEUMOVAX23 (Lot # not reported) SQ. Concomitant therapy included LEVOXYL, DIOVAN and multivitamins (unspecified). The nurse reported that In approximately 2007, the same day of the vaccination, she experienced fever, headaches and redness at the site of injection after receiving a dose of PNEUMOVAX23. She had fever of 101 degrees F and large painful red area on the arm where she got the injection. The patient saw a physician and was treated with oral steroid. There were no Lab diagnosis/studies performed. The patient was fully recovered about 4 days after the vaccination. Follow up information has been from the 67 year female patient (registered nurse) (previously reported as 65) year old - at the time of the report 71 year old - with none illness ant time of vaccination and none pre-existing allergies (previously reported that the patient had allergy to amoxicillin refers to her self who in October 2008 (previously reported in 2007, was vaccinated with a first dose of PNEUMOVAX23, (dose duration and lot # not reported) (vaccination jour was reported as 11:00). In October 2008, about 4 hours after vaccination (at 14:00), the patient developed headache, redness, swollen site (reported also as cellulitis at site) and temperature of 101. No lab tests were performed. The patient was seen by PMD for adverse events (cellulitis at site, headache, and fever) and received unspecified steroid (oral) for 5 days. The patient recovered on an unknown date in 2008 (reported as 1 week later). Additional information is not expected.
Iz's given 10/6/15 - Mom called 10/15/15 sts there is a pimple at injection site. We saw patient in the afternoon of 10/15/15. Redness 30 mm x 20mm; at the site of varicella.
Information has been received from a Medical Assistant regarding a case involving VAQTA lot # M001815, expiration date 20-SEP-2017 (MARRS # 1610USA001301) who refers to multiple unknown patients of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. On an unknown date the patients were administered improperly stored doses of RECOMBIVAX HB lot # M001578, expiration date 21-NOV-2018. The vaccines were exposed to temperatures ranging from 33F to 35F for cumulative total time frame of 72 hours out of recommended storage range. There was no previous excursions reported. The data logger was reported as yes. No adverse effects were reported. There was no product quality complaint involved. No further information was provided. This is one of the several reports received from the same reporter. Additional information has been requested. This spontaneous report as received from a Medical Assistant who refers to multiple unknown patients of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. On an unknown date the patients were administered multiple unspecified vaccines of improperly stored doses of VAQTA lot # M001815, expiration date 20-SEP-2017 (dosing details were not reported), GARDASIL 9 lot # M007764, expiration date 30-JAN-2018 (dosing details were not reported) (refer to MARRS # XXXX) and RECOMBIVAX HB lot # M001578, expiration date 21-NOV-2018 (refer to MARRS # XXXX) and lot # M010212, expiration date 21-JAN-2019 (refer to MARRS # XXXX) (dosing details were not reported). The vaccines were exposed to temperatures ranging from 33F to 35F for cumulative total time frame of 72 hours out of recommended storage range. There were no previous excursions reported. The data logger was reported as yes. No adverse effects were reported. There was no product quality complaint involved. No further information was provided. This is one of the several reports received from the same reporter. Additional information has been requested.
Patient reported that she felt as though her throat was swelling and she was having difficulty swallowing, no shortness of breath or trouble breathing, no chest pain, no actual swelling. Given 50 mg benadryl, symptoms improved within one hour.
1/2 hr p/vax pt given APAP & took pt to work;2-4 hrs later pt went limp in moms arms & eyes rolled back in head for 2sec;mom shook pt repeated this episode 2x;8 hrs later stopped breathing in car 4 times in 20 mins;eyes blank-jerked-poss sz
Noticed rash/hives on chest. SOB. Chest pain. Went to ED. Treated for anaphylaxis (epi, nebs, BENADRYL). Began to feel better on 11/18/13.
Antibody test yesterday and was non-reactive; This spontaneous case was reported by a physician and describes the occurrence of ANTIBODY TEST ABNORMAL (Antibody test yesterday and was non-reactive) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ETANERCEPT (ENBREL) for an unknown indication.   On 28-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced ANTIBODY TEST ABNORMAL (Antibody test yesterday and was non-reactive). At the time of the report, ANTIBODY TEST ABNORMAL (Antibody test yesterday and was non-reactive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Feb-2021, Antibody test: non reactive (Negative) Non reactive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Action taken with mRNA-1273 in response to the events was not Applicable.
She received 1st vaccine on 2/26/21. She tested positive for Covid on both 3/09/21 & 3/19/21 non-symtomatic and received 2nd vaccine on 3/26/21.
After administering the vaccine, the patient fainted out of her chair. She hit the ground on her right side and bumped her head off a cabinet drawer handle. She came to about 2-3 seconds after fainting and asked where she was and looked scared and pale. Her mother was with her in the room as well. We kept the patient lying down for a minute or so then she felt that she could sit up. She felt dizzy, hot (sweating), and nauseous. I got the patient a cold water bottle and she did drink some water. After about 15 minutes, patient said she felt a little better but still felt tired and did not feel herself. Patient was helped to her mother's car and I will be calling the patient's mother later this evening to see if the patient is feeling better. I will also contact the doctor's office on Monday morning to let them know what happened as well.
Received vaccines 8/19. 8/20 Mom noted redness. 8/21 Seen by MD with 5 x 7 erythema, induration LAT.
Eye lid swelling; This is a spontaneous report from a non-contactable consumer, the patient. A 16-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the left arm on 06Aug2021 at 12:45 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. 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. The patient did not receive any concomitant medications. On 08Aug2021 at 09:00, the patient experienced eye lid swelling. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event eye lid swelling was resolving at the time of this report. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD8448) via an unspecified route of administration in the left arm on 27Aug2021 at 15:30 (at the age of 16-years-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are possible. No further information is expected.
The very next day I woke up and my middle finger was tingling like I had ants in it It was driving me crazy. Then within the next few days all my fingers felt like that and my hand was swollen like a softball The pain was intense so I visited the Dr had me do multiple tests and all concurred I had RSD/CRPS Ive since had a nerve block to kill the pain and try to make the swelling go down. It looks like I will have another one in a couple of months. On August 31 I will be going for a consultation  at  a specialty medical center
Dr. called pharmacy on 10/27/2017 at after noon to report patient reaction to the vaccine. He requested information on the vaccine patient was given he said he will report the reaction.
Syncopal episode with loss of consciousness determined to be vasovagal response. Occurred within 5 mins of vaccination.