chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recv vax 18MAR97 & @ 2AM the next day pt exp a prolonged (50min) sz which required anticonvulsants (valium) to stop;temp 102 upon presentation, tx w/med;
It was very red and itchy for about 4 days; I had a rash on the injection arm. It was a bout 6 inches long and 2.5 inches wide.; It was very red and itchy for about 4 days; This is a spontaneous report from a contactable consumer (patient). A 68-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 21Jun2021 at 13:00 (age at vaccination 68-years-old) as dose 1, single for covid-19 immunisation. Medical history included colectomy from 01Jun2021 to 01Jun2021, patient had colon surgery on June 1 and she was told she could get her vaccine. She waited 3 weeks. she also had a rash the day after surgery. she thinks it was what my body does. Patient had Known allergies included Penicillin and all its derivatives. Past drug history included Avelox, she was very sensitive and get rashes very often. The patient's concomitant medications were not reported.  The Patient did not receive any other vaccines within 4 weeks Prior to vaccination. The Patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. Consumer stated that, on 29Jun2021 13:00 (Day Eight after the shot), she had a rash on the injection arm. It was about 6 inches long and 2.5 inches wide. It was very red and itchy for about 4 days. she still has it slightly day 15. She sent a photo to her Primary Doctor. She read up on it and treated it with cool compresses, which helped. She heard this was rare, so she was reported it. she still planned to get 2nd shot on 12Jul2021. The adverse event resulted in a visit to Doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The outcome of the events was recovering.  Information about batch/lot number has been requested.
Rabies titer of 01/14/05 was .48. Received primary series of rabies (connaught) on 03/12/99, 03/18/99 and 04/1/99. Booster shot of Imovax was given 01/31/05. On 02/14/05, patient exhibits entire body rash. On 02/15/05, patient complained of arthralgia. Started on Benadryl on 02/14/05. 02/15/05, Benadryl discontinued and stared on Atarax.
Rash; Solid red area raised; Solid red area raised and hot; Itchy; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash), SWELLING (Solid red area raised), FEELING HOT (Solid red area raised and hot) and PRURITUS (Itchy) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     Concomitant products included PSEUDOEPHEDRINE HYDROCHLORIDE (SUDAFED 12 HOUR) for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced RASH (Rash), SWELLING (Solid red area raised), FEELING HOT (Solid red area raised and hot) and PRURITUS (Itchy). At the time of the report, RASH (Rash), SWELLING (Solid red area raised), FEELING HOT (Solid red area raised and hot) and PRURITUS (Itchy) outcome was unknown. Not Provided.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported.   Reporter did not allow further contact
patient went to doctor 5-20-21 complaining of sore right arm she states from first vaccine given on 4-19-21. patient says sharp pain and radiates to hand. patient was given 2nd shot on 5-17-21 and had no complaints of problem with  first immunization.
Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023; No adverse event; Patient had expired vaccine that was administered on March 15,2023/Dose administered after 30-day use by date or after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient had expired vaccine that was administered on March 15,2023/Dose administered after 30-day use by date or after manufacturer date of expiry), PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023) and NO ADVERSE EVENT (No adverse event) in a 19-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient had expired vaccine that was administered on March 15,2023/Dose administered after 30-day use by date or after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient had expired vaccine that was administered on March 15,2023/Dose administered after 30-day use by date or after manufacturer date of expiry), PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient had expired vaccine that was administered on March 15,2023/Dose administered after 30-day use by date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023).    Concomitant medication use information was not provided by reporter.  HCP states that expired Moderna COVID-19 monovalent vaccine was administered to approximately 75-125 people on 15MAR2023.   There was potentially a second lot number that was expired and was administered to patients on 3MAR2023, but HCP did not have any details on this event at this time.  Dose administered after 30-day use by date or after manufacturer date of expiry.  Individual vials or intact cartons was unknown.  Vial size was reported as 10 dose vial.   Date the vial was initially stored in the refrigerator was reported as 14 March 2023.  The vial did not undergo any temperature excursions.  Treatment Medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:Master case
Information was received from a certified medical assistant on 21-NOV-2014 concerning 3 female patient who between 15-OCT-2014 and 27-OCT-2014 were vaccinated with an improperly stored dose of MMR II (dose, route of administration were not reported). Lot number K005175, expiration date 10-APR-2016. No adverse effects were reported. No further information received. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Fatigue) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse reaction (No medical history reported.)On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown. No concomitant medicines were reported. No treatment information were reported.Action taken with the drug in response to events was not applicable.
Pt recv vax on 11/1/97; on same day pt exp burning, redness & soreness of vax site; tx=Motrin & ice.
I've been experiencing extreme fatigue and malaise. I have been in bed for 6 days now. Finally today on 11/18/2014 I forced myself to take a shower because I felt disgusting. But just taking a shower was exhausting. I'm very concerned about how I am feeling. I already suffered with fatigue, but the severity of the malaise and fatigue since my flu shot have me very concerned. I've also experienced nausea and a worsening of numbness and tingling in my hands and legs. I hope it goes away very soon.
Flu like symptoms; Low grade fever; body aches; chills; fatigue; This is a spontaneous report from a non-contactable consumer (patient). A 48-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration, administered in the right arm on 15Feb2021 at 09:15 (lot number was not reported) as dose 2, single for COVID-19 immunization. Medical history included allergy to shellfish on an unknown date. The patient did not have COVID prior to vaccination. The patient's concomitant medications were not reported. The patient did not received other vaccines in 4 weeks. The patient previously received the first dose of BNT162B2 (lot number: unknown) at 48-years-old on 18Jan2021 at 09:15 on the right arm for COVID-19 immunization. The patient was not tested for COVID post vaccination. The patient experienced flu like symptoms, low grade fever, body aches, chills and fatigue on 16Feb2021 at 01:30. The patient did not receive treatment for the events. The outcome of the events was recovered on an unknown date in Feb2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) PFIZER INC-2021233912 similar report from same reporter
rash caused itching.; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (rash caused itching.) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hyperthyroidism.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced RASH PRURITIC (rash caused itching.). The patient was treated with PREDNISONE for Rash all over, at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (rash caused itching.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: negative (Negative) negative. On an unknown date, Skin test: negative (Negative) negative.         The reporter stated after the second dose she got the worse rash in her life. She stated she had going to see a dermatologist ever since. She reported the bad, severe rash was all over her body. The caller stated the rash caused itching. She stated the rash would come and go on her ankles and heals, but always remained on her back. She had prescribed steroids, prednisone, and a big jar of cream. She reported that she spent over 400 dollars worth on treatment medications. She mentioned that she had no drug or food allergies. She reported she takes a medication to treat hyperthyroidism. The caller stated she would be not going to get the booster dose.  This case concerns a 89-year-old, female patient, with no relevant medical history, who experienced the non-serious, unexpected event of pruritus and non-serious expected event of rash. The events occurred on unknown date after second dose of mRNA 1273 vaccine. The patient had itchy rash all over her body, especially her back, ankles and heels. She has visited a dermatologist and taking a steroid for the rashes. The rechallenge is not applicable as patient had treatment for the events. The events were considered related to the product per the reporter's assessment. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 24-Nov-2021: Follow Up Received contain Non-Significant information.; Sender's Comments: This case concerns a 89-year-old, female patient, with no relevant medical history, who experienced non-serious, unexpected event of Rash pruritic. The event occurred on unknown date after second dose of mRNA 1273 vaccine. The patient had itchy rash all over her body, especially her back, ankles and heels. She visited a dermatologist and she had prescribed steroids. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
This spontaneous report was received from a medical assistant and refers to a patient of unknown gender and age. The patient's pertinent medical history, concomitant medications, drug reactions or allergies were not reported. On 03-JAN-2019, the patient was vaccinated with RECOMBIVAX HB (dose, frequency, anatomical location, lot number and expiration date were not provided) intramuscularly as prophylaxis. On the same day, the patient was vaccinated with PEDIARIX (dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided) as prophylaxis as well (overdose). No adverse effects were known.
Patient had rashes all over her back, rash was not raised, no pain, and not itchy
This spontaneous report as received from a other health professional refers to a 11 years old female patient with no illness at time of vaccination, no adverse events following prior vaccination and no preexisting allergies, birth defects or medical conditions. The patient was vaccinated with lot # (668051/1262AA) dose 2 GARDASIL, IM, right deltoid on 28-DEC-2011 at 03:07 PM. No other co-suspects were reported. No concomitant medications were reported. It was reported that the patient was administered an immunization that was stored at invalid temperatures, the immunization was stored at a temperature of 32 degrees F or less. No adverse reaction occurred. There was no labs diagnostic performed. This is one of several reports from the same source. Additional information is not expected.
Upper respiratory congestion like head cold started 6-1-22. Progressed to pronounced non productive  cough, achey,  lack of energy by 6-2-22. Started on Paxlovid around  6PM on 6-2-22. Cough and congestion resolved between 24-36 hours. Still on isolation at home. Per my employer, planned retest 6-8-22.
Information has been received from a female patient of unknown age and reporting on herself. Information about concurrent conditions, medical history and concomitant medication was not provided. The patient received a PNEUMOVAX 23 injection on 17-DEC-2014 (dose, route and lot# unknown). The patient states that her primary care provider gave her a booster injection of PNEUMOVAX 23 in December 2015. No adverse effects were reported. Additional information is not expected since there was no contact details provided.
Shakes; A lot of fatigue; Nauseas; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shakes), FATIGUE (A lot of fatigue) and NAUSEA (Nauseas) 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 13-Mar-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. On an unknown date, the patient experienced TREMOR (Shakes), FATIGUE (A lot of fatigue) and NAUSEA (Nauseas). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 13 milligram. At the time of the report, TREMOR (Shakes), FATIGUE (A lot of fatigue) and NAUSEA (Nauseas) outcome was unknown.            Concomitant medication list was not provided. Action taken with mRNA-1273 in response to the event was not applicable.     Reporter did not allow further contact
Information has been received from a health professional concerning a male with no past medical history and no allergies who in March 2006 was vaccinated with a dose of Varivax. Concomitant therapy included acyclovir. Subsequently, on 05-AUG-2006, the patient developed varicella zoster. A PCR for wild vs vaccine type was obtained from the patient's left buttock on 05-AUG-2006. Follow up information indicated that the specimen showed wild type virus. Follow up information indicated that on 05-AUG-2006 the patient developed a rash with lesions on the left perineal S2-S3. He was diagnosed with varicella zoster. A specimen (a vesicle type lesion) was obtained on 05-AUG-2006 from the patient's left buttock. VZV DNA was amplified. The interpretation showed adequate specimen, wild type strain. The outcome was reported as recovered. There was no recent exposure to chickenpox or shingles. Additional information has been requested.
Severe pain in arm.  It got to where I could not even lift my arm.  As of 12/28/2014 the pain is still there.
Not an adverse effect, but wrong vaccine administered. Patient got Pfizer COVID original vaccine instead of bivalent booster.
Within 30 minutes had large red hives o face, neck and inside throat.  Paramedics came ?  I said Benadryl should help and did not want to go to hospital.  It helped  Next day had sore throat ,body aches and extreme tiredness.
Extremely sore arm. Pulsing pain  Breathing more labored. Brain fog   Nausea   Extreme  Fatigue.   For two days
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 20Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 03Apr2021 as dose 2, single (Batch/Lot number: unknown), in right arm, on 05Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 18Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in right arm for covid-19 immunisation. The patient's relevant medical history included high cholesterol addressed with vitamins, diet and lifestyle. There were no concomitant medications. The patient experienced Covid 19 on an unspecified date. The patient received PAXLOVID for Covid 19 treatment from 23May2022 to 18Jun2022. The patient tested negative for Covid 19 after finishing his PAXLOVID treatment. The outcome of Covid 19 was recovered on an unspecified date in 2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Developed red rash at injection site 9 days after vaccination. Also had red rash on cheeks same day.
I woke up in the middle of the night the day after receiving the vaccine with chills. I checked my pulse and it was extremely high and didn't come down until the following morning. I called my doctor and informed him that I was having extreme heart rate. I spoke to a nurse practitioner that I work with at the office who informed me I suffered from tachycardia. After that day, everything was fine; I've only had one similar episode since then approximately 7 months later this past summer. That lasted about 7-8 hours and subsided.
pt recvd vax & w/in 12hrs exp lightheadedness;lightheadedness resolved 29DEC94
got sick; This case was reported by a consumer via call center representative and described the occurrence of sickness in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included autoimmune disorder and cancer.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 76 or 77 years. The patient got sick from the first shot of Shingrix.   The reporter mentioned that her friend had both shots of the Shingrix. The reporter consented to follow up. The case has been linked to the case US2019143866, reported by same reporter.
11:30 SHOT GIVEN, BY 11:40 FELT TINGLING IN LIPS AND THROAT AND HEART RATE 125 (MY RESTING HEARTRATE IS 68),  BY 11:45 TIGHTNESS IN CHEST AND NECK, HEARTRATE STILL 125 RANGE,  NOON: BP 154/75 (MY NORMAL IS 96/58) AND HIVES 12:10 BENADRYL (25MG) GIVEN  12:25: BP 163/78 AND ALL OTHER SYMPTOMS STILL PRESENT 1:00 SECOND BENADRYL (25MG) GIVEN 1:11: BP 158/78 1:45 HEARING TURNED MUFFLED MOVED DOWNSTAIRS TO ER SECTION AT HOSPITAL GIVEN STEROIDS, PEPCID AND WATCHED FOR ADDITIONAL TIME ON 1/9/21: STILL ON BENADRYL AND STEROIDS: WOKE UP AT 8:00 AM SORE ARM AND SLIGHT HEADACHE, 9:00 RED SPLOTCHES ON FACE, NECK AND CHEST,  11:30AM ON 1/9/21: TIGHTNESS IN CHEST AND NECK CONTINUING STEROIDS AND BENADRYL
MODERNA COVID-19 Vaccine EUA. Patient came for scheduled Moderna dose. Dose administered approximately 12:45 in Right Arm. Patient came back to pharmacy at 5:50 describing pain in arm, severe headache, mood changes - specifically crying, and jittery/trembling. The headache started shortly after leaving. Pt checked out at 1:09. Arm pain started 2:30, crying and jittery feeling started approx. 5:30.  Pt had not taken anything to relieve pain. Pts temperature was 98.2 upon returning to the pharmacy. No signs of anaphylaxis.
pale, dizzy & weak approx 1 min p/inject; had pt lie on floor x 10mins;
Developed elbow and knee burning joint pain. One month after vaccination had Parvovirus infection. Pain continues, no other rheumatologic disease.
Started developing itchiness, blotchiness, hives a few minutes after receiving the vaccine. Has had previous vaccine without issues. Took 50mg of BENADRYL. Symptoms resolved within 30-40 minutes.
started with problems with extremely sore muscles, then issues with gait on day 3.5 then continued with gait getting worse and having to pull myself up the stairs ...by two days later could not walk at all for four hours. Subsided after bath needed a walker or cane for two days later. Gait is still slowed but not needing any item to lean on
Mother of client reports rash appeared late PM (6/29/06) reports rash resembled hives. Ct began temp of 102 which lasted 4 days. Increased fussiness and crying, seen in ER 7/2/06. Told reaction to immunization. Ct's mother reported giving Ct Motrin and Tylenol temp continued at 102.
Two hours after administration of 0.5 ml FLUZONE HD patient reports shaking all over, powerful headache and copious amounts of blood in his urine.
This spontaneous report was received from a physician assistant, via a sales representative, regarding a 4 year old female child. The patient's pertinent medical history and drug reactions/allergies were not provided. On an unspecified date, the 4 year old female child received a dose of GARDASIL, (dose, route, lot number and expiration date were not provided). Co-suspect therapy and concomitant medications were not provided. No adverse event was reported. Additional information has been requested.
Healthy, normal developing normal, no problems , illnesses or allergies until last series of immunizations. After last immunizations Vomiting , fever, severe rash all over the body that lasted about 4 months. Developed skin problems, developed eggs allergies, milk sensitivity. It caused developmental delays. Diagnosed with autism on May, 2017.