chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician via a company representative refers to a 54-year-old female patient. The patient's medical history included influenza B virus the week prior to getting the vaccination. In approximately April 2017, reported as "last week", the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported). Other suspect therapies included sterile diluent (manufacturer unknown). Concomitant therapies included diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid administered in the separate arm. In approximately April 2017, the patient experienced vomiting, injection site swelling, injection site erythema, body aches, diarrhoea, chills, pyrexia and nauseousness. The patient did not seek medical attention. Unspecified treatment was given for the adverse events. The patient's symptoms lasted for 5 days after she had received the ZOSTAVAX vaccination. The patient recovered from the events in approximately April 2017. Relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
serum sickness poss d/t vax;pt came to ER w/c/o total body rash x 3d;pt had vax & devel sore arm x 2d;pt devel pruritic rash, facial edema, sore throat & retrosternal burning;pt was eating chinese 2d p/shot;dx serum sickness;
Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were unknown. On unspecified dates, the patients were vaccinated with unspecified doses of improperly stored VARIVAX (dose, route, lot# and expiration date unknown). The vaccines were stored in temperature 6-10 Fahrenheit degree (time frame: over 18 months but exact time frame not available at the time of call). There was no previous temperature excursion. The call was due to a "data logger". No adverse effects were reported. Additional information has been requested.
Anaphylaxis, rash, hives, 15 minutes after vaccine. Given Epipen, Benadryl 50 mg IM.
Redness and mild swelling at deltoid area - at injection site. Prednisone 20 mg x 3 days 10 mg x 3 days 5 mg x 3 days.
in the last 20 years, the only time patient had the flu, was the year patient got a flu shot; Initial information received on 27-Oct-2020 regarding an unsolicited non-valid non-serious social media case received from a consumer.  This case involves a patient who had the flu, was the year patient got a flu shot (influenza), while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, in the last 20 years, the only time patient had the flu, was the year patient got a flu shot (influenza) (Unknown latency) following the administration of INFLUENZA VACCINE.  Relevant laboratory data was not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown.  There will be no information available on the batch number for this case.
Two hours after the injection I started feeling unwell and very tired, so I went to bed.  While getting up to go to the bathroom, I started to lose control of my bladder. This happened several times. I lost my appetite and didn't eat for 3 days. I started to get dehydrated, so I tried to drink, but that resulted in more losing control of my bladder. I had a fever and chills and headache. I lost all sense of time and had disturbing dreams. I fell out of my bed and it knocked the wind out of me. While on the floor, I had to call for my husband because I couldn't get up because I couldn't find my feet nor move my legs. He helped me get up and get back to bed.  I received my shot on June 26 and by Saturday, July 1 at 4:00 PM I felt all the symptoms leave, but I was extremely tired and was that way for another week. I had no reaction at all to the first shot. I never have a reaction to any vaccinations.
knuckles left hand started to hurts/pain in thigh; hand started to numb, expressed out like going to numb; joint left hand started to hurts; arm was swollen; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (knuckles left hand started to hurts/pain in thigh), HYPOAESTHESIA (hand started to numb, expressed out like going to numb), ARTHRALGIA (joint left hand started to hurts) and VACCINATION SITE SWELLING (arm was swollen) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced PAIN IN EXTREMITY (knuckles left hand started to hurts/pain in thigh), HYPOAESTHESIA (hand started to numb, expressed out like going to numb), ARTHRALGIA (joint left hand started to hurts) and VACCINATION SITE SWELLING (arm was swollen). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (knuckles left hand started to hurts/pain in thigh), HYPOAESTHESIA (hand started to numb, expressed out like going to numb), ARTHRALGIA (joint left hand started to hurts) and VACCINATION SITE SWELLING (arm was swollen) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported
Vaccine given in left deltoid. Two hours after immunization, extreme soreness, redness, and hot to touch. Redness 3 to 4 inches below injection site continues.
Mom reported that patient woke up and started to have seizure like activity. EMS recorded a temp of 102.4 at the scene and patient was taken to Hospital, where she had 2 more episode of seizures on the day of admission. Patient was given Ativan for seizure. Did well until day 3 when she experienced another clonic tonic seizure.
Vaccine 10-3-12. To ER 10-12-12 with (L) arm pain. Seen 10-13-12 & transferred to cardiologist at hospital she declined there, was diagnosed with Guillain-Barre, transferred to where she expired.
suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, he/she knew someone who got Shingles vaccine and also got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Narrative: 93 yo M with a history of pancreatic cancer, T2DM, HTN, OA of the knee, and BPH. Patient received covid vaccinations on 1/19/21 and 2/22/21. Patient died under hospice care on 6/30/21 due to complications of the patients pancreatic cancer. Death seems to be unrelated to covid vaccinations.
Full body itchiness/hives. Missing periods, very irregular periods, spotting in between periods.
24 hours later.  Pain that radiated from injection site in left breast and into back and entire arm.  A red 2 inch circle about an inch over injection site.  Swelling in left arm pit and itching in arm put for 5 days. Fever of 103 degrees Ferenhite.  Body chills. Back of head during fever would shake as if about to have a seizure.  Woke up next morning in a sweats but flu like synptoms gone.  Very scary with the feeling of almost have seizures.
Swollen Left arm/ Swollen  Left hand; could not raise or move her left arm; Throat redness; Throat swelling; Throat burning; Hair loss; Hearing loss Left ear; This case was reported by a consumer via call center representative and described the occurrence of hearing loss unilateral in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number 7742Z, expiry date 25th March 2023) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2021-2022 season) for prophylaxis.   The patient's past medical history included shingles and covid-19. Previously administered products included Zostavax. Concurrent medical conditions included hospice care and penicillin allergy.   On 19th October 2021, the patient received the 1st dose of Shingrix and Influenza vaccine Quadrivalent 2021-2022 season. In October 2021, less than 2 weeks after receiving Shingrix and Influenza vaccine Quadrivalent 2021-2022 season, the patient experienced hearing loss unilateral (serious criteria GSK medically significant), mobility decreased, red throat, throat swelling, burning in throat and hair loss. On 20th October 2021, the patient experienced swelling arm. On an unknown date, the outcome of the hearing loss unilateral and mobility decreased were unknown and the outcome of the swelling arm, red throat, throat swelling, burning in throat and hair loss were not recovered/not resolved.   It was unknown if the reporter considered the hearing loss unilateral, swelling arm, mobility decreased, red throat, throat swelling, burning in throat and hair loss to be related to Shingrix and Influenza vaccine Quadrivalent 2021-2022 season.  Additional details were provided as follows: The patient self-reported this case. The patient received Shingrix vaccine in left arm and flu vaccine in right vaccine at same time. The patient experienced hearing loss in her left ear, swollen left hand swollen left arm, throat redness, throat burning, throat swelling, and hair loss. The patient stated that she could not raise or move her left arm (she stated that she could not pick up a cup of coffee). The patient admitted that she was still having problems using her left arm but was better than it was on 20th October 2021. The patient enquired the efficacy of first dose and does not want to get second dose. The reporter did not consent to follow up.
Half dollar sized area of redness over (L) lateral thigh with mild warmth to touch, now tender, no fluctuance noted.
Feb 8th 2nd vaccination. Next day lost consciousness, fell no injuries. Following day Feb 10th weak and could not stand, BP low, Dr sent him via ambulance. EMS identified him having a heart attack that started Feb 9th. He had no cardiac history He was hospitalized for a sudden blockage, had a vtach episode, did not lose consciousness, one stent placement, had a 2nd vtach episode and did lose consciousness. Placed on blood thinner, within a few days had uncontrolled urinary bleeding, catheter to irrigate, changed blood thinners and did not stop. Continued weakness and decline. Then developed pneumonia the following week. Placed on antibiotics, oxygen 2-7 L/nc. Went to rehab, back and forth to hospital. Came home twice, once Feb 14th for 24 hours, then 2nd time March 9 (his birthday) for his final 2 weeks  t home where I cared for him until he passed March 21st. On 4L/NC, did not have catheter, bleeding had stopped.
8 hours after the vaccination, I experienced fairly severe body aches, chills, muscle aches, fever of 102, and severe headache. After 4 days, I feel much better, but still do not feel 100% normal.
Patient was given Dtap #5 and IPV #4 in left arm on 5/30/07. Next day child's upper arm was red, swollen and warm to touch from shoulder to elbow. Family was in Missouri, stopped by ER. Ice applied. Today has slight redness but most of edema is gone.
headache, muscle and joint pain, nausea vomiting, diaraha, very hard chills shaking, bp 138/113 pulse 122- I took a water pill -around 5 am I had vilant vomiting at 8:15 am bp 130/76 pulse 107 I went to sleep and on 2/18 at 9:24 am bp 117/73 pulse 82 --my friend called and she call the pharmacy for me to see if I could take anything and said for me to take benyadryl  after going back to sleep I felt much better
Lethargy, vomiting, (dec grade fever day a/vax) t97.6 day of inject; dusky upon arrival in ER; no resp distress; pt flaccid, pale, & lethargic;
Indigestion that produces slight regurgitation Tight upper abdominal muscles  Slight muscle spasms in different areas on my back
After second dose of Pfizer COVID-19 vaccine, patient felt nauseous. She did not vomit. She stated she has 2 bowel movements, denies diarrhea. She felt very tired. Both her hands felt tingly. BP 117/75 - 85bpm - 98% RA. She was not pale or diaphoretic. No medication given. She slept for ~90 minutes in the vaccination room on the gurney. She felt well upon awaking. Drank water and ate crackers. She left in stable condition.
Adverse event; night sweats; he couldn't even walk 100 meters; very very ill; fatigue/absolute sapping fatigue; joint pian; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Adverse event), NIGHT SWEATS (night sweats), GAIT INABILITY (he couldn't even walk 100 meters), ILLNESS (very very ill) and FATIGUE (fatigue/absolute sapping fatigue) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Adverse event), NIGHT SWEATS (night sweats), GAIT INABILITY (he couldn't even walk 100 meters), ILLNESS (very very ill), FATIGUE (fatigue/absolute sapping fatigue) and ARTHRALGIA (joint pian). At the time of the report, ADVERSE EVENT (Adverse event) outcome was unknown and NIGHT SWEATS (night sweats), GAIT INABILITY (he couldn't even walk 100 meters), ILLNESS (very very ill), FATIGUE (fatigue/absolute sapping fatigue) and ARTHRALGIA (joint pian) had resolved. Not Provided          No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-114923 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Added E-mail address. Added Event information- Night sweats, gait inability, illness, fatigue, arthralgia.
Pyrexia around 38.5 degree C; Chill; Headache; Malaise; This is a spontaneous report from a non-contactable consumer (patient). A 42-years-old male patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at the age of 42-year-old) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications was not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date not reported), via an unspecified route of administration in an unspecified anatomical location on an unspecified date as  dose 1, single for COVID-19 immunization and experience muscle pain. On an unspecified date the patient experienced pyrexia around 38.5 degree c, chill, headache and malaise. The patient underwent lab tests and procedures which included pyrexia: 38.5 centigrade. The events outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021565024 same reporter/patient different vaccine dose/AE
MA reports administration of Boostrix stored at 31.7F x 14 hours.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 46-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 13-OCT-2023, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: MA reports administration of Boostrix stored at 31.7F x 14 hours.). The outcome of the incorrect storage of drug 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: 13-OCT-2023 Medical Assistant (MA) reported administration of Boostrix stored at 31.7 Fahrenheit for 14 hours, which led to incorrect storage of drug. The reporter consented to follow up.
Information has been received from a licensed practical nurse concerning a 8 weeks old patient of unknown gender who on 07-OCT-2014 was vaccinated with ROTATEQ (lot # J014868, expiration date 13-OCT-2015), oral (dose not reported). The vaccine was reported to have temperature excursions from 10-SEP-2014 to 12-SEP-2014. No adverse reports. This is one of several reports from the same source. Additional information is not expected because all follow ups requested to complete the case were received.
Sx-  redness, swelling .  Was treated supportively w/ ice packs.   Pt. had same reaction with last year's Flu vaccine administration.
LIMITED USE OF ARM; CANT SLEEP ON THAT SIDE; BAD SORE ON ARM AT INJECTION SITE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced limited use of arm, cant sleep on that side, and bad sore on arm at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bad sore on arm at injection site, cant sleep on that side and limited use of arm was not reported. This report was non-serious.
Flu like symptoms; her daughter experienced covid arm rash / Had a rash from her shoulder to her elbow; had a high fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE RASH (her daughter experienced covid arm rash / Had a rash from her shoulder to her elbow) and PYREXIA (had a high fever) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Down's syndrome (was diagnosed with Down's syndrome at birth. It was genetic before the vaccine).   In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE RASH (her daughter experienced covid arm rash / Had a rash from her shoulder to her elbow) and PYREXIA (had a high fever). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE RASH (her daughter experienced covid arm rash / Had a rash from her shoulder to her elbow) and PYREXIA (had a high fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: ran a 101 fever which is high for her.         Concomitant medications were not reported.  No treatment information was provided by the reporter. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-626226 (Patient Link).
Information has been received from a physician concerning a 15 year old female with no pertinent medical history who was vaccinated with a second dose of Gardasil. There was no concomitant medication. Subsequently the patient experienced dizziness for three days. Unspecified medical attention was sought. There were no laboratory or diagnostic tests performed. Subsequently, the patient recovered. Additional information has been requested.
12 days after vaccine #1 Moderna: intense hives on both upper arms, chest, both sides of face. lasted 2 days . Hives went away after day 14 but now have red itchy rash over body. Hives and burning itchiness persist day 23 after vaccine. My dr. referred me to dermatologist who examined me on 2/23/21, viewed pictures of my hives, and examined my back rash. She advised me to start double dosing on Zyrtec and to proceed with Moderna booster but to report to this site. Zyrtec does not seem to relieve my ongoing itchy rash symptoms. After 2nd vaccine, I having burning, irritated skin however no hives anymore. Rash pigmentation is secondary to the prickly burning skin when it touches anything, this includes clothing. Physician has recommended to me to use Gabapentin, however I did have an allergic reaction to Prednisone which I had to visit urgent care for. Currently Gabapentin does not seem to be giving any benefits to my symptoms. I am concerned about receiving the third vaccine due to possible reaction worsening and this is holding me back from receiving the booster in the future.
phone call from a 71 YR OLD FEMALE who is calling to report on her ADVERSE REACTION to MODERNA VACCINE that she received on 1/25/2021. Caller reports that on 1/26/2021 pt began having shortness of breath, which progressed to n/v, headache, muscle weakness, and fever. Caller reports fever is no longer present but pt still has shortness of breath. Advised with severity and duration of sx would refer to HCF for further eval. Caller reports she will not be going to HCF today but is amenable to callback. Advised SNT35 and that PIC is available prn. PVH
Large red spot formed around the injection sight.  Hot to the touch and has spread in the last 8 hours.  First noticed the "reaction" the morning after the injection.
Approximately 10 mins. after receiving Hep A/B #2 stated he was "lightheaded, scared, seems like I'm choking" Continuously conversant without difficulty; B/P increased from 158/100 to 178/128; Transported per ambulance  to local ER @ his request. Benadryl 50 mgm given prior to transport