chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a other health professional via call center representative and described the occurrence of local swelling in a 4-year-old male patient who received ENGERIX B (batch number 34PK5, expiry date 27th July 2020). Concomitant products included XYZAL. On 13th April 2018, the patient received the 1st dose of ENGERIX B .5 ml. On 14th April 2018, 1 days after receiving ENGERIX B, the patient experienced local swelling, localized feeling of warmth, walking difficulty and leg pain. On an unknown date, the outcome of the local swelling, localized feeling of warmth, walking difficulty and leg pain were not recovered/not resolved. The reporter considered the local swelling, localized feeling of warmth, walking difficulty and leg pain to be related to ENGERIX B. Additional details were provided as follows: The mother left an afterhours voicemail message for her son. The concomitant products included muiti vitamins. The patient received the vaccine at approximately 9:45 AM. The patient had a very swollen ring about 2 to 3 inches in diameter that was got to the touch and he had complained of his leg hurting badly and he could not walk. The patient had no fever. The voicemail message was left on the 14th April 2018 and the mother indicated that the symptoms were worsening in her message. The health care professional had another patient to report an adverse event for the ENGERIX vaccine but she had to disconnect the call immediately and would call us back later today. No additional  details were available.
upper upper arm is red; my arm is still sore; my arm swollen; my arm feels stiff; still get chills; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (upper upper arm is red), VACCINATION SITE PAIN (my arm is still sore), VACCINATION SITE SWELLING (my arm swollen), VACCINATION SITE INDURATION (my arm feels stiff) and CHILLS (still get chills) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced ERYTHEMA (upper upper arm is red), VACCINATION SITE PAIN (my arm is still sore), VACCINATION SITE SWELLING (my arm swollen), VACCINATION SITE INDURATION (my arm feels stiff) and CHILLS (still get chills). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of tid. At the time of the report, ERYTHEMA (upper upper arm is red), VACCINATION SITE PAIN (my arm is still sore), VACCINATION SITE SWELLING (my arm swollen), VACCINATION SITE INDURATION (my arm feels stiff) and CHILLS (still get chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported. Treatment details also include ice the area.
I developed very itchy bumps all over my body a few days after both the first and the second shot. The bumps were much worse after the second shot and continued to linger for over a month (bumps would fade and new ones would develop. Finally I took benedryl three nights in a row and that seemed to knock them back. I've done everything I can to rule out some sort of bug. The person with whom I share a bed has not been developing these bumps. They do not resemble bed bug bites. The closest resemblance is to mosquito bites, but there are no mosquitos in this area this time of year.
The patient's mother called 6/19/19 to report that the patient had a palm-sized area of redness and swelling at the injection site of her meningococcal vaccine. The patient has been taking benadryl and ibuprofen and reports some itching and firmness of the skin at the site.
Seen at the walk-In clinic on 3/9/2021 where he presented with complaints of right leg weakness, numbness, and tingling.  He was transferred to ER for further evaluation and management.    The symptoms (numbness in his hip and thigh) began around 1400 while he was working.  He went about his day. The symptoms progressively worsened while he was ambulating around the hardware store. In the ER, his sensation of his right leg was dulled as compared to the left. The numbness extended from his hip to his toes. Felt a pressure-like sensation in his thigh and calf.  Denies pain. Felt as though his right foot is floating 2 inches off the ground when standing with both feet on the ground. Reported his right leg is 1-2 inches shorter after a femur fracture many years ago. Nothing made his symptoms better or worse.  Did have an episode of feeling generally hot and then cold the evening prior to admission. Denied any trauma.     Denied any dizziness, lightheadedness, headaches, shortness of breath, cough, chest pain, palpitations, vomiting, diarrhea, constipation, blood in stools, urinary habit changes, hematuria, dysuria, pyuria, myalgias, arthralgias, recent illness, or fever.   MRI showed T2 changes on the right side of the cord down of the thoracic spine concerning for her transverse myelitis.  Patient did have Covid vaccine 7 days prior to onset of symptoms, one dose mRNA vaccine.    He is on day 3 high-dose methylprednisolone thousand milligrams IV ×3 days.  He has noticed an improvement in the pressure sensation from the knee up the thigh on the right, no longer having tingling in the right lower leg or the left foot.  He is still having numbness over the anterior right thigh.  Yesterday when he went to bear weight on the right heel, he had a sharp pain with increase in weakness.  That has since settled down.  He did have a few involuntary myoclonic movements as described yesterday.  This writer reached out on 3/22/2021 for information on his Vaccine lot number. He stated "At this point I am attending physical therapy, I am walking with the aid of crutches or a walker. There is improvement in the foot and lower leg regarding the numbness, but the upper thigh is still pretty much completely numb yet."
10 days after Moderna covid booster i developed a rash like condition when pressure or scratched on skin. It was diagnosed as dermatographia
Lost all smell for about 10 weeks; Lost all taste for about 10 weeks; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Feb-2022 and was forwarded to Moderna on 14-Feb-2022.    This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (Lost all smell for about 10 weeks) and AGEUSIA (Lost all taste for about 10 weeks) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C214A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced ANOSMIA (Lost all smell for about 10 weeks) and AGEUSIA (Lost all taste for about 10 weeks). At the time of the report, ANOSMIA (Lost all smell for about 10 weeks) and AGEUSIA (Lost all taste for about 10 weeks) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Rapid COVID test came back negative.         Concomitant information was not provided.  Patient received both his Moderna vaccines earlier in 2021 and had no problems. After he received the booster he lost all smell and taste for about 10 weeks. However, patient further stated that in the past month everything had been perfect, and his smell and taste are back.  Treatment information was not provided.  Company Comment: This spontaneous case concerns a 79 year old male with no relevant medical history reported, who experienced non-serious , unexpected, AESI event of Ageusia and anosmia which occurred on an unknown date after vaccination with the third dose of mRNA-1273 vaccine ( this patient reported he also received mRNA-1273 vaccine for the primary series vaccine with no reported adverse events ) .  The events were reported to have lasted  for 10 week  and presently has resolved. There were no reports of any medical consult and  work-up done  or if any  treatment was  given The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.; Sender's Comments: This spontaneous case concerns a 79 year old male with no relevant medical history reported, who experienced non-serious , unexpected, AESI event of Ageusia and anosmia which occurred on an unknown date after vaccination with the third dose of mRNA-1273 vaccine ( this patient reported he also received mRNA-1273 vaccine for the primary series vaccine with no reported adverse events ) .  The events were reported to have lasted  for 10 week  and presently has resolved. There were no reports of any medical consult and  work-up done  or if any  treatment was  given The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.
Systemic: Chills-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium
On Saturday 02/20  twenty four hours after receiving   the injection I felt fatigued with loss of appetite and some chills. At the same time I noticed a 2inch  red ring around the injection site. The next day I felt fine ,but had a very sore arm with the red circle and a large pink blush running down to my elbow which never disappeared. The following week the red circle disappeared but the pink blush remained. On Sunday, 02/28 I noted that the blush disappeared but I now had a 3inch red circle around the injection site. On Monday 03/1, the red circle grew and spread, and by 03/2 it was no longer in circular form but spread down my arm to 3inches by 6inches. It remains the same 0n 0/3. It is not painful or itchy. I am worried. I know this is called covid arm but my reaction does seem extreme. I do have some photos beginning on 02/28
Severe diarrhea for 20 hrs. Swelling at site of injection / severe reaction. Acute bronchitis.
8 hours after vaccine started with fever, temp 101.5, facial grimacing and tapping/flexing hands, decreased verbalization; then recovered. Hand tapping continued x5 days. No joint swelling, paratheses.
Mom states an episode of going stiff and shaking.  Looked like not breathing right, and acted confused afterward.  Dazed a few seconds.  Total episode lasted about 1 minute.  No fever temperature 97.0, and was sleepy after the episode.
10/16 patient falls from sob and low 02 level.  Patient sent to ER and passed away 10/17/21.
mild nummular eczema has evolved into diffuse psoriatic type rash w bx pos for psoriaform rash
This spontaneous report was received from a physician referring to 19 month old patient of unknown gender. Pertinent medical history or concurrent conditions were not reported. On 08-AUG-2017, the patient was vaccinated with improperly stored doses of VAQTA which had the lot # N005274, expiration date 03-APR-2018) (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32°F and the higher was 54°F for 70 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one of several cases from the same reporter. Sender's Comments: US-009507513-1709USA007325: US-009507513-1709USA012768.
inflamed lips and rush all over my body; inflamed lips and rush all over my body; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206), via an unspecified route of administration in the left arm on 12Mar2021 at 02:00PM (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included shrimps and cat's allergy. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient did not receive other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19. On an unknown date, the patient had undergone COVID-19 virus test (nasal swab) and was tested negative. On 15Mar2021 at 12:00 AM (as reported), the patient experienced inflamed lips and rush all over the body. Therapeutic measures were not taken for the events (inflamed lips and rush all over my body). The clinical outcome of the events (inflamed lips and rush all over my body) was not recovered. No follow-up attempts are needed. No further information is expected.
I was diagnosed with  Accute IPT -  platelet count dropped to 10,000 and was hospitalized for 2 days.  Also, noted petechial rash in bilateral lower extremities.   I received Platelet infusions.  I quite smoking in 2003 - over 18 years ago.
Mild Headache; Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Mild Headache) and VACCINATION SITE PAIN (Sore Arm) 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.    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, the patient experienced HEADACHE (Mild Headache) and VACCINATION SITE PAIN (Sore Arm). At the time of the report, HEADACHE (Mild Headache) and VACCINATION SITE PAIN (Sore Arm) outcome was unknown.            Products known to have been used by the patient, within two weeks prior to the event were  not provided.  No laboratory investigations were provided. The Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.
This spontaneous report was received from a Medical Assistant, referring to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not provided. On 02-MAY-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L042265; expiration date: 26-OCT-2017, (administration route was not provided). No concomitant therapies were reported. No adverse effects were reported. The vaccine underwent a temperature excursion (10F) for a time frame of 3 hours and 16 minutes. No previous temperature excursions were reported. This is one of several reports from the same reporter. Additional information has been requested.
At about 4:15 pm which is 3.5 hours after receiving vaccine, I experienced tightness, swelling in my throat, tingling, numbness of my face in around my mouth, red flushing of the skin in my upper chest and throat.  I took 2 Benedryl tablets and experienced symptoms for the next hour. They subsided by 5:30 pm . I was able to breathe and swallow during the whole episode. I had very similar reactions several times in June when I was for unknown reasons experiencing hives and had same response when prescribed Bactrim, and then Keflex because of a UTI. I had no further incidents with the chest, throat, mouth reaction since mid June until yesterday.  I had no adverse reaction to the vaccine until 3.5 hrs after receiving it. I feel this is because my body has some sensitivity, not that anything was done incorrectly in administration of the vaccine. All personnel were very attentive and careful that I observed.
Patient reports heart pounding and legs feeling funny as well as difficulty catching breath. Patient was given juice and observed. Condition improved and patient was released home.
EXTREMELY HIGH BLOOD PRESSURE; INCREASED HEART RATE; SHORTNESS OF BREATH; INCREASED GAS AND INTESTINAL PROBLEM; CHEST PAIN; SHAKINESS; CAN'T DISTINGUISH HOT FROM COLD; UNCONTROLLED MUSCLE PAIN; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included auto-immune disease, thyroiditis, high blood pressure, non alcohol, non smoker, latex allergy, sulfa allergy, and erythromycin allergy, and other pre-existing medical conditions included the patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and  expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 15-APR-2021, the subject experienced extremely high blood pressure. On 15-APR-2021, the subject experienced increased heart rate. On 15-APR-2021, the subject experienced shortness of breath. On 15-APR-2021, the subject experienced increased gas and intestinal problem. On 15-APR-2021, the subject experienced chest pain. On 15-APR-2021, the subject experienced shakiness. On 15-APR-2021, the subject experienced can't distinguish hot from cold. On 15-APR-2021, the subject experienced uncontrolled muscle pain. Laboratory data included: Lab test (NR: not provided) UNKNOWN. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from extremely high blood pressure, increased heart rate, chest pain, and increased gas and intestinal problem, had not recovered from shakiness, and can't distinguish hot from cold, and the outcome of uncontrolled muscle pain and shortness of breath was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Shortly after the vaccine I returned home to work. I started having stomach cramps like my cycle was starting. The cramps became worse and I started spotting. I took two ibuprofen but they provided no relief. I became nauseas and had a headache as well. I felt better the next day except my arm aches and mild stomach cramps. The cramps have continued still.
pt recv vax 12NOV98 & devel fever 13NOV98 to ER & d/c w/febrile illness ? secondary to DTP home on antipyretics 13NOV98 late in day inc fever w/APAP began to vomit, diarrhea, dec feeding;URI & lt otitis;
Tennis elbow pain. Shoulder joint pain. Effects daily ability to move and do things. Moderate to severe.
This spontaneous report as received from a Registered nurse refers to a 16 year old patient of unknown gender. On 23-SEp-2013 the patient was vaccinated with a first dose of PROQUAD (route, lot number and expiration date not reported) for vaccination and then received a second dose of PROQUAD (Merck) (route, lot number and expiration date not reported) for vaccination. There was no concomitant medication reported. It was reported that there was not product confusion, just a medication error. No Adverse event reported. Additional information is not expected.
eye problem before, did get worse after 1st shot; eye problem before, did get worse after 1st shot; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer (patient) reported that male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration unspecified), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included eye problem, and cataract surgery. The patient's concomitant medications were not reported. It was reported that on 01Feb2021, a small eye surgery was scheduled to remove an eye film, from a post cataract surgery result. Patient had first vaccine. It was reported that the patient had eye problem before, and it did get worse after the first shot on an unspecified date, and so surgery scheduled. The second dose of vaccine was scheduled prior to surgery. The clinic wants to have him get Covid test prior to surgery and wants to know if Covid test will provide a positive result just because of the vaccine. The patient does not think the eye problem was result of vaccine but will fax as possible worsening of condition after shot. Outcome of event was unknown.  Information on the batch/lot number has been requested.
My dad took vaccine 4/1 5pm, he had arm pain 4/2 morning, felt like fever in the afternoon. After 5pm, he compliant with joint pain. He was found on the floor dead 4/3 at 1am at home.
Given IPV/Comvax in R thigh. DTaP L thigh. Developed immediate erythematous papules on R leg with a few on L leg. Started to fade after about 20 minutes. No other sx . Had vaccines at 2months with no reacton.
Pt reports pain at site, immediately after immunization/injection into R deltoid. Pain persistent for 7 days. No local care or pain medicine. Reports ability to raise arm beyond 90%. No /// or weakness.
Swelling, pain in joints of left hand, Muscle swelling, redness/pimple-like lump at injection site and 3 days later is still in pain/still has redness and swelling.
staff member noticed that it looked slightly frozen with no reported adverse event; Initial information was received on 14-Oct-2021 regarding an unsolicited valid non-serious case received via a nurse via Agency, Inquiry Number: 00812622).  This case was considered as valid case due to patient involvement.  This case involves an unknown age female patient who experienced was administered slightly frozen INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] with no reported adverse event (product storage error).  The patient's medical history, past medical treatments, concomitant medications, vaccinations and family history were not provided.   On an unknown date, the patient received a 0.7ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number: UJ768AC and expiry date: 30-Jun-2022 via intramuscular route in the deltoid for prophylactic vaccination.   It was reported "Nurse states that one of their staff members took home FLUZONE HIGH DOSE to administer to their mother, states the FLUZONE HIGH DOSE was placed directly on an ice pack in a Styrofoam cooler, states she is unable to report an exact temperature for temperature excursion because there was no temperature tag in the cooler; states it was there for 15-20 minutes. Nurse states when staff member took out the FLUZONE HIGH DOSE to administer, staff member noticed that it looked slightly frozen. Staff member thawed product by placing it against her skin then administered the product to her mother. Nurse states she thinks it was given 07OCT2021. Nurse does not know if it was the right or left deltoid Nurse asks if the product that was administered was still viable for use since it had appeared frozen, asks if the staff member's mother should be re-vaccinated. Agent provided nurse with stability data per Stability and Storage document, informed nurse we are unable to provide accurate suitability without a worst-case scenario temperature, agent informed nurse, per Stability and Storage document, vaccine should be discarded if it has been frozen. nurse states patient did not receive any treatment after receiving FLUZONE HIGH DOSE.nurse states patient was not pregnant at time of FLUZONE HIGH DOSE administration."  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.