chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a health professional concerning an 11 year old female student with high blood pressure, an allergy to amoxicillin (hives) and no illness at the time of vaccination who on 20-AUG-2007, was vaccinated intramuscularly with the first dose of GARDASIL (lot# 658556/1060U) into the left thigh. On 06-NOV-2007, the patient was vaccinated intramuscularly with the second dose of GARDASIL (lot# 65435/1265U) into the left thigh and with a first dose of MENACTRA (lot# U2429AA), IM into the right thigh. Concomitant therapy included VASOTEC for blood pressure. On 15-NOV-2007 it was reported that the patient developed rash over her body which started on 08-NOV-2007 (2 days after the second dose of GARDASIL and MENACTRA). A rapid Strep test was performed in the office and was negative. On 16-NOV-2009, she then had a slight growth of Staph A. She was seen again and her feet were hurting, and her left foot had slight edema. Her urine had trace protein, but no blood. She was started on KEFLEX capsules, 500 mg BID for 10 days. She was diagnosed with Streph A and Henoch Schonlein Purpura (HSP) nephritis. It was reported on 27-NOV-2007, a rash developed all over her left foot, edema, and left calf muscle. On 02-JAN-2008, the rash reoccurred. The patient was seen on 04-NOV-2008. Her urine was okay, but both her feet had red maculas, but no blisters. She was to see a dermatologist on 09-JAN-2008. Her rash cleared and no kidney tests were done. On 12-AUG-2008, she had a well exam and laboratory tests were performed. Her urine had 4+ blood, 3+ protein and "urine hemoglobin ++. Her urine protein was over 50, throat culture negative, and urine culture negative. On 14-AUG-2008, she saw a dermatologist. Her BUN was 9, creatinine was 0.5 and blood pressure was 102/52. Relevant laboratory diagnostics performed indicated HSP nephritis most likely post Strep, however, she also had the immunizations. On an unspecified date, she was seen by a kidney specialist. The patient recovered on an unspecified date. Upon internal review, Henoch Schonlein Purpura (HSP) nephritis was determined to be an other important medical event. A lot check was initialized. Additional information is not expected.   12/11/09 and 12/28/09 MR and DC summary received for DOS 03/15/09. DX:   Pt c/o hematuria, and high protein in urine, fever, myalgias and coughing. Pt had influenza at the time she was seen in ED. Pt was discharged home with a Nephrology f/u.
Coughing sensation of a mucus plug, voice change, constantly trying to clear throat. Voice dry residual day after.
Moderna COVID-19 Vaccine EUA.  Localized rash at injection site. Swelling, itching, redness, and hotness localized on right arm where injection occurred. Treated with over the counter 1% diphenhydramine hydrochloride for short term relief.
Wrong vial of covid bivalent was administered (blue cap) vs correct vial (pink cap)
Patient given expired dose of vaccine; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient given expired dose of vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient given expired dose of vaccine). On 04-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Patient given expired dose of vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Reporter stated that vial was taken out of refrigerator at 03:00 PM on 03-Aug-2021 and punctured and was remained at room temperature until injection time on 04-AUG-2021 at 10:00 AM. No Treatment medication was reported by the reporter.
Numbness at injection site, soreness, hard to walk, pain in lower back, and headaches.
This is a spontaneous report from a contactable consumer (patient). A 40-year-old (non-pregnant) female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 40, via an unspecified route of administration, left arm, on Apr 7, 2021, at 09:30, single dose, for COVID-19 immunisation. The patient has no reported medical history. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included Vitamin K2 (menaquinone), Vitamin D3 (cholecalciferol), Vitamin B12 (cyanocobalamin), magnesium and multivitamin. On Apr 7, 2021, at 10:15 (30 minutes after vaccination), patient's throat became itchy, the bottom of her tongue and back began to tingle and itch really bad. No therapeutic measures taken as a result of adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, patient has not tested for COVID-19. The clinical outcome of the events throat became itchy, the bottom of her tongue and back began to tingle and itch really bad: unknown (at the time of this report). No follow-up attempts required. Information about lot/batch number cannot be obtained. No further information expected.
This spontaneous report was received from a pharmacist, regarding a 67 year old female patient. The patient did not have permitent concurrent conditions, medical history or drug reactions/allergies. On 25-SEP-2017, the patient was vaccinated with an unknown dose of PNEUMOVAX 23 lot # M042599 with expiration date on 17-JUN-2018, intramuscularly in the left arm for prophylaxis.  On the same date the patient was vaccinated with influenza virus vaccine (unspecified manufacturer) also given on left arm. Concomitant therapies included "pain medication", "sleep medication" and other unspecified medications. At the same day of vaccination, the patient experienced pain (pain in extremity), redness (erythema), and swelling in her left arm and hand (peripheral swelling), and "couldn't sleep" (insomnia).The patient was seen at the emergency room on an unspecified date and was treated with Clindamycin. No laboratory diagnostics or studies were performed. On an unknown date in September 2017, she also began having blisters in her mouth (oral mucosal blistering), difficulty drinking (dysphagia), and difficulty talking (aphonia). At the time of reporting, the patient had not recovered of peripheral swelling, aphonia, dysphagia, oral mucosal blistering, insomnia, pain in extremity and erythema. The pharmacist considered peripheral swelling to be serious because of disability or Incapacity. The relatedness between vaccination with PNEUMOVAX 23 and the events was not reported.
Ground glass density nodule on left upper lobe 8mm. Monitoring. Having to use Respimat daily now. Having continued difficulty breathing without inhaler. Never had problen befor vax.
sick/ill; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient. A female patient received BNT162b2 (COMIRNATY), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "Immune compromised" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Comirnaty (DOSE 1), for covid-19 immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick/ill". Additional Information: other medications Including over-the-counter medications, nutritional and herbal supplements, etc. family history, social history and other relevant information (Use this space to include any additional information that may be relevant, including any additional Events or Suspect Products.) was reported as unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous consumer report (initial receipt 14-Sep-2015) concerns a female patient. On an unspecified date, the patient received a flu vaccine (Influenza virus vaccine, manufacturer and batch number not provided). On an unspecified date following the administration of the flu shot, the patient ended up at the hospital. The outcome was unknown. Reporter's Comments: Reporter comments: The reporter stated the case was serious, as it caused hospitalisation. Sender's Comments: Company comments: Seriousness: Serious. Hospitalisation. Listedness: Unlisted. Brand of vaccine not specified. Assessment according to Assessment according to the CCSI for CSL Inactivated Influenza Virus Vaccine and the Afluria Product Information, hospitalisation due to unspecified adverse event is unlisted. Causality: Unassessable. Insufficient information such as time to onset, event description, reason for hospitalisation, investigation treatment outcome.
SHORTNESS OF BREATH; ERRATIC BLOOD PRESSURE; APPETITE LOSS; WEIGHT LOSS 5 LBS; DIZZINESS AND LIGHT HEADEDNESS; TIGHTNESS IN CHEST; MIGRANE; HARMONE FLUCTUATIONS; KIDNEY DISEASE FLARED UP; JOINT PAIN; FATIGUED; NAUSEA; INJECTION SITE PAIN; ELEVATED PLATELET COUNT; RASHES UNDER BOTH ARMS IN THE ARMPIT AREA; FEVERISH; MUSCLE ACHES/ LOTS OF ACHES AND PAIN POST VACCINATION; SLEPT FOR 36 HOURS; MEMORY WAS VERY HAZY; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: sulfa drug allergy, stage1 kidney disease, penicillin allergy, and migrane. The patient experienced drug allergy when treated with amoxicillin/clavulanate potassium, and sulfamethoxazole/trimethoprim. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 21-JUL-2021 for prophylactic vaccination. Concomitant medications included lisinopril, and propranolol. On JUL-2021, the patient experienced memory was very hazy. On 21-JUL-2021, the patient experienced slept for 36 hours. On 21-JUL-2021, the patient experienced muscle aches/ lots of aches and pain post vaccination. On 21-JUL-2021, the patient experienced feverish. Laboratory data included: Body temperature (NR: not provided) 103 F. On AUG-2021, the patient experienced rashes under both arms in the armpit area. On 03-NOV-2021, the patient experienced elevated platelet count. Laboratory data included: Blood test (NR: not provided) ELEVATED PLATELET COUNT. On an unspecified date, the patient experienced shortness of breath, erratic blood pressure, appetite loss, weight loss 5 lbs, dizziness and light headedness, kidney disease flared up, tightness in chest, migrane, harmone fluctuations, joint pain, fatigued, nausea, and injection site pain. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) ERRATIC. Treatment medications (dates unspecified) included: pramocaine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from erratic blood pressure, appetite loss, muscle aches/ lots of aches and pain post vaccination, and feverish, and memory was very hazy on JUL-2021, was recovering from weight loss 5 lbs, had not recovered from elevated platelet count, shortness of breath, rashes under both arms in the armpit area, dizziness and light headedness, nausea, fatigued, joint pain, injection site pain, and migrane, and the outcome of tightness in chest, slept for 36 hours, kidney disease flared up and harmone fluctuations was not reported. This report was non-serious.
Patient came to clinic on 12-28-09. She was given a 2nd dose of H1N1 vaccine. 1st dose was given on 11-25-09 (32 days earlier). When clerk entered vaccine into computer, after vaccine given data indicated patient received 1st dose 32 days earlier.
patient reported swelling, hot to touch a bruise the size of a dime; she became sick with nausea and vomiting, she said she felt very hot all over and had some pain. patient stated she couldn't move .
On 2/4/23 patient stated that her shortness of breath (SOB) was worse than her normal SOB. She was unable to tolerate walking distances.
Dizziness / stomach pain during first hour. Woke up in the middle of the night with general malaise. By noon on Saturday (injection on Friday at 5:15pm), steadily rising fever. Peaked at 102.2 around 2pm. Continued in the 101 range until the following morning (Sunday).  Additional persistent symptoms: Severe headache. Light sensitivity. Muscle pain. Joint swelling. Kidney pain. Chest heaviness.
developed shingles outbreak 4 days later; This is a spontaneous report from a contactable consumer.   A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization on 22Dec2020 at single dose in the upper arm via unspecified route of administration. The patient had not medical history. Concomitant medications were not reported. On 26Dec2020 the patient developed shingles outbreak. The outcome of the event was not recovered.   Information on the lot/batch number has been requested
sore throat.; felt tired; fever was 101.9 °F; couldn't walk; chills; blood pressure going down; L side of the face started to spasm; tired; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL SPASM (L side of the face started to spasm), GAIT INABILITY (couldn't walk), OROPHARYNGEAL PAIN (sore throat.), FATIGUE (felt tired) and PYREXIA (fever was 101.9 °F) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced FACIAL SPASM (L side of the face started to spasm), FATIGUE (tired) and HYPOTENSION (blood pressure going down). On 14-Mar-2021, the patient experienced GAIT INABILITY (couldn't walk), PYREXIA (fever was 101.9 °F) and CHILLS (chills). On 01-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat.) and FATIGUE (felt tired). At the time of the report, FACIAL SPASM (L side of the face started to spasm), GAIT INABILITY (couldn't walk), OROPHARYNGEAL PAIN (sore throat.), FATIGUE (felt tired), PYREXIA (fever was 101.9 °F), FATIGUE (tired), CHILLS (chills) and HYPOTENSION (blood pressure going down) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       relevant concomitant products usage were not reported by the reporter.treatment details not included.   Most recent FOLLOW-UP information incorporated above includes: On 01-Apr-2021: Initial Additional-1
Asymptomatic breakthrough COVID-19 case. Hospitalized 8/30/2021 to 9/4/2021
Dept. of health notified by patient's employer on 4/10/17 that she would not be coming 4/11/17 for second dose. Complained of n/v, dizziness, HA, abdominal cramping on 4/4/17 at 12 noon (another report started 1730). Went to ER- given ZOFRAN. To discuss with PCP benefits vs. r/s RS continuing series. Patient to ER 4/4/17 at approximately 1900.
Information has been received from a mother concerning her son who was vaccinated with a second dose (date unspecified) of RECOMBIVAX HB (manufacturer unknown).  He developed symptoms of rheumatoid arthritis several weeks after the second dose.  No other symptoms or treatment were reported.  At the time of the report, the outcome was unknown.  This is one of two reports received from the same source.  Additional information has been requested.
Client received a Janssen vaccine 12/15/21 and a Moderna booster dose 2/16/22 at 1:55 pm.  On 2/17/22, client reported hives.
Mother reported that within 24 hours of receiving vaccine, the patient became terrified, did not seem to recognize his mother, and screamed for approximately 9 hours. He then became very irritable and remained this way for a few days. The patient had a cold 1 week prior to immunization but had recovered by the date of immunization. The patient recovered. Copies of this report have been forwarded to Merck and Aventis Pasteur, manufacturers of the concomitantly administered vaccines.
Headache, fever for 48 hrs- 101.6, shivering, aches
Employee had difficulty swalling w/numbness of the throat on the same day after receiving TTA. Symptoms began imporving, the same day and the employee is now reported to be recovered.
Headache; Muscle aches; Fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 32-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 07Apr2021 at 13:45 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included paracetamol (TYLENOL) and loratadine (MANUFACTURER UNKNOWN). 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 left arm on 17Mar2021 at 14:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in Apr2021, after second jab the patient experienced headache, muscle aches, and fatigue, which were cleared up after 24 hours. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events headache, muscle aches, and fatigue were resolved on an unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected.
D68.9 COAGULATION DEFECT, UNSPECIFIED TYPE, IN PREGNANCY, UNSPECIFIED TRIMESTER 1/11/2023 ACQUIRED INEQUALITY OF LEG LENGTH G62.9 NEUROPATHY 10/14/2022 ACQUIRED INEQUALITY OF LEG LENGTH
Mild nausea on 9/5/18. Left arm swelling, redness, warmth on 9/5/18 and 9/6/18. Recommended ice and Ibuprofen for inflammation.
Pt c/o tingling over entire body within 1 day after Flu shot administered. Also noting increased feeling of "heat" over upper back & arms. Symptoms always present but increase in intensity. No improvement since symptoms started.
This case was reported by a consumer via call center representative and described the occurrence of chills in a patient who received FLUARIX. On an unknown date, the patient received FLUARIX at an unknown dose. On an unknown date, an unknown time after receiving FLUARIX, the patient experienced chills, headache, fever, general body pain, nasal stuffiness and sore throat. On an unknown date, the outcome of the chills, headache, fever, general body pain, nasal stuffiness and sore throat were unknown. It was unknown if the reporter considered the chills, headache, fever, general body pain, nasal stuffiness and sore throat to be related to FLUARIX. Additional details provided were as follows: The patient received an Influenza vaccine (unspecified season). The patient experienced chills which throw up shakes, headache, fever, body aches (body pain) stuffy head (nasal stuffiness) and sore throat.
vaccinated with expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received Men B NVS (Bexsero) (batch number unknown, expiry date January 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th February 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 9th February 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made 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 reported. The patient was vaccinated with an expired dose of Bexsero, which led to expired vaccine used. No patient's details were provided. The reporter did not consent to follow-up.
PATIENT RECEIVED H1N1 AND SEASONAL FLU VACCINES AT THE SAME TIME.  COMPLAINS OF BODY ACHES, JOINT PAIN, FEVER ONSET 2 DAYS AFTER VACCINATIONS.
After vaccine 5/6 - 2 days later felt pre-syncopal w/chills & muscle aches & sx resolved in 2 days. Site was without redness, swelling or increased warmth - did not take temp.
1/7/2021   3pm Immediately at injection a tingling feeling from vaccination injection site down to middle finger on left arm.   4pm Slightly swollen tongue feeling   minor tenderness at injection site, no treatment 1/8/2021    10:45 am start intense heavy pain in left arm, difficulty lifting arm, could not sleep on that side (left arm) that night.  took advil slight reduction in pain 1/9/2021  3am full body ache, extremely tired, diarrhea.  Slept, advil and pepto, ginger ale
POTENTIAL ADMINISTRATION ERROR; VACCINE VIALS WERE TRANSPORTED IN A STYROFOAM BOX WITH ICE WITH NO TEMPERATURE READINGS FOR 30MIN; This spontaneous report received from a health care professional concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced vaccine vials were transported in a styrofoam box with ice with no temperature readings for 30min. On 20-MAY-2021, the subject experienced potential administration error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the potential administration error and vaccine vials were transported in a styrofoam box with ice with no temperature readings for 30min was not reported. This report was non-serious.
I had flu-like symptoms for about 3 days and then had stomach discomfort/nausea for four weeks (did not have an appetite, felt motion-sickness-type nausea). I also experienced an impact on my breathing, which persisted for at least 2 months and is still not completely resolved. The sensation is as if my lungs have smaller capacity so can't take in as much air at one time (and so I get out of breath quicker while walking, etc.).
This non-serious spontaneous case, initially received from other health professional (nurse) on 19-Oct-2018, concerns a 46-year-old, adult, female patient. The patient had no relevant medical history and concomitant medications. On 09-Oct-2018, the patient was administered FLUCELVAX QIVc [dose: 1.5 ml, anatomical location: left deltoid, batch number: 252235, expiry date: 30-Jun-2019, route of administration: intramuscular]. At the time of this report, no adverse events were reported. This case 201804664 was cross-linked to the source case 201804657 due to the same reporter. The reporter assessed the case as non-serious.
4/29/04: temp 99F. 5-8 erythematous macules on arms, trunk, face and base of penis. Developed on morning of visit. 1 Vesicle.