chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Gave her the two doses; Did not know that she had to wait three weeks; Went in to get the second dose and she got the two shots within one week after each other; She is feeling really bad/Feels awful/We won''t even know if she is running a fever because she feels so bad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "Gave her the two doses; Did not know that she had to wait three weeks; Went in to get the second dose and she got the two shots within one week after each other"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "She is feeling really bad/Feels awful/We won''t even know if she is running a fever because she feels so bad". Therapeutic measures were taken as a result of feeling abnormal.  Additional Information: This consumer reported for a female patient (reporters daughter). Reporter stated, "I am calling because my daughter received a Pfizer vaccine at a local, a drug store out there and they gave her the two doses. She registered but not showed that appointment. She made a second appointment and they gave her a Covid card and I guess she did not know that she had to wait three weeks, so she got a reminder saying that she needs to come in for the second dose and she went in to get the second dose and she got the two shots within one week after each other and she is feeling really bad not to the point, where she needs to go to the emergency room, I don't think but she just feels awful. So, what should I, should she go even though she has taken Tylenol & Motrin (later clarified as treatment). So, we won't even know if she is running a fever because she feels so bad (event captured as per verbatim since further clarification was unknown). So, that is a reason to have been really concerned or (sentence incomplete)? She got the Pfizer first and the second dose."  Follow-up (26Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Patient got up from observation to ask for a glass of water. On the way back to his seat, he fainted into the aisle and fell to the floor. Upon hitting the floor he immediately woke up and was profusively sweating. The patient was taken out by the EMT after 911 was called. Patient said he felt fine and back to normal after waking up and that he has fainted due to vaccines before.
Information has been received from a medical assistant concerning a male patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX (Lot # 661577/1161X) and had injection site reactions from PNEUMOVAX. It is unknown if the patient sought medical attention. At the time of reporting, it is unknown if the patient had recovered. This is one of several cases received from the same source. Additional information has been requested.
Information has been received from a certified medical assistant concerning a 21 year old female with asthma and no known drug allergies who on 23-Nov-2009 was vaccinated intramuscularly with her second 0.5ml dose of GARDASIL (lot number 661046/0381X). On 23-NOV-2009, after receiving the vaccine, the patient experienced tongue swelling numbness and blurred vision. Subsequently, the patient recovered from tongue swelling numbness, tongue swelling numbness and blurred vision on the same date. The patient sought medical attention by making a phone call and by contacting the emergency squad. Follow up information was received from a certified medical assistant concerning the 21 year old female. She reported that the patient received GARDASIL vaccination on the following dates: dose # 1 was given on 10-AUG-2009, lot number 661046/0381X and dose # 2 was given on 23-NOV-2009 at 1:45p.m., lot number 661046/0381X (into the left deltoid). The patient did not receive any concomitant vaccinations when the GARDASIL vaccinations were administered. The C.M.A stated that the patient had the reaction to the second dose of GARDASIL when she went back to school. The patient was complaining of tongue swelling, numbness and blurred vision. The patient was a student at the University. The patient called the physician's office and was advised to go to the nearest Emergency Room. An Ambulance was called to take the patient to the Hospital and stabilized the patient. The patient was treated for her reaction to the GARDASIL vaccination (treatment unknown to the reporter). The patient did not go to the Hospital. The patient recovered on 23-NOV-2009. The patient stated that she would not receive the third dose of GARDASIL. The C.M.A. stated that she called the patient to inquire how she was doing and the patient did not return the phone call. The patient did say she received a shot but was not sure. The reporter considered that tongue swelling, numbness and vision blurred required intervention to prevent serious criteria. Additional information has been requested.
has not received the third dose yet (more than six months / since the first dose); This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 35-year-old female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix B (received 1st dose on unknown ate) and Engerix B (received nd dose on unknown date).   On an unknown date, the patient received the 3rd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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 details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that, it was more than 6 months after the 1st dose but the patient did not receive the 3rd dose of Engerix B, which led to incomplete course of vaccination. The reporter consented to follow up.
Left thigh has red hard nodule. Indurated, non-tender area size of a nickel with 2 papular lesions 1 cm apart. Low grade temp. Reassured pt and parent.
Disoriented,  brainfog,  confusion, very sleepy,  elevated blood pressure , unable to follow directions  when instructed
third dose; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (third dose) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 017B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (third dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (third dose) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medication was reported.  Treatment information was not provided.
Patient was fine within 20 minutes of vaccination. She reported doing some other errands following her vaccine, then once home, approximately 1 hour later, she said she blacked out briefly.
His BP was very elevated-197/146/His BP remained high; This is a spontaneous report from a contactable consumer (patients parent). A 32-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration, administered in arm right on 15Mar2021 11:00 as 1st dose, single for covid-19 immunisation. Medical history included diabetes type 2, asthma and hypertension. Patient had known allergies to metformin, ritalin, adderal, eggplant and peanuts. Patient had covid prior vaccination. On 15Mar2021 11:15 AM, 10 minutes after the injection patient experienced a severe headache and dizziness. His BP was very elevated - 197/146. He was observed for almost an hour. His BP remained high and his headache continued. He was referred to the ER where he received antihypertensives and pain medication. Patient took medication for the treatment of events. He had not tested for covid post vaccination. No other vaccine received in four weeks and received antihypertensive and diabetic medication in two weeks. The outcome of the event was recovering.   No follow-up attempts are possible. Information about lot/ batch no cannot be requested. No further information is expected.
Earache; Body aches; Nausea; Vomiting; Fatigue; fever of 100; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 09Apr2021 at 08:30 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes. The patient had history of known allergies to sulfa. Concomitant medications included metformin (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN), simvastatin (MANUFACTURER UNKNOWN) and levothyroxine (MANUFACTURER UNKNOWN); all from an unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on unknown date (at the age of 54-years-old) as a single dose for COVID-19 immunisation. She also received amoxicillin (MANUFACTURER UNKNOWN) on unknown date for an unspecified indication and experienced drug allergy. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. 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 10Apr2021 at 03:00, the patient experienced earache, nausea, vomiting, fatigue, body aches, and fever of 100. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of earache, nausea, vomiting, fatigue, body aches and fever were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Administered about Noon 4-26-07 by 6am 4-27-07 raging fever 1004.5, heart palpitations, difficulty breathing or walking. Called MD told if necessary go to ER - felt too sick to drag self to ER. Fever broke around 11PM 4-27-07 down to 101.5 F. Mild fever all day 4-28-07. Diabetes out of control still.
This spontaneous report was received from a consumer refers to her daughter of unknown age. "Yesterday" on 20-NOV-2012, the patient was vaccinated with the first dose of ROTATEQ, (lot number, expiration date and route was not reported). Concomitant medications were not reported. The consumer asked how long it would take for the side effects to go away and whether ROTATEQ, contains PCV1 and PCV2. The consumer disconnected the call before able to clarify if her daughter was experiencing side effecting and what were the specific side effects. The outcome of the event was unknown. Additional information has been requested.
The patient reported a swollen lymph node in her L armpit occuring approximately 24 hours after the vaccination.
Adverse reactions; This spontaneous case was reported by an other (subsequently medically confirmed) and describes the occurrence of ADVERSE EVENT (Adverse reactions) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced ADVERSE EVENT (Adverse reactions). At the time of the report, ADVERSE EVENT (Adverse reactions) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
This case was reported by a nurse via call center representative and described the occurrence of injection site pain in an unspecified number of patient who received BEXSERO. On an unknown date, the patients received the 1st dose of BEXSERO. On an unknown date, 3 days after receiving BEXSERO, the patients experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The reporter state that several patients returned for their second dose of BEXSERO complained of pain at injection site following their initial dose. The patients reported that the pain began about 3 to 5 days after receiving the first dose. The reporter stated that due to previous complaints of pain at injection site, patients were then given the second dose in the thigh. No further information was available or reported regarding the events.
Inability to complete simple wording phrases (knowing what things are but no being able to say the names of regular everyday objects.); Extreme forgetfulness; disorientation; administration date 27Apr2021, dose number: 1/administration date 05May2021, dose number: 2; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05May2021 12:15 (Lot number: 0542624) at the age of 42 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "chronic migraines" (unspecified if ongoing); "known allergies: seafood (shrimp specifically)" (unspecified if ongoing), notes: known allergies: seafood (shrimp specifically). Concomitant medication(s) included: PROPRANOLOL. Vaccination history included: Bnt162b2 (product=COVID 19, brand=pfizer,, lot number=0536131, lot unknown=False, administration date=27Apr2021, administration time=03:30 PM , dose number=1, Vaccine location=Left arm), administration date: 27Apr2021, for Covid 19 immunization. The following information was reported: SPEECH DISORDER (non-serious) with onset 07May2021 08:00, outcome "recovered", described as "Inability to complete simple wording phrases (knowing what things are but no being able to say the names of regular everyday objects.)"; MEMORY IMPAIRMENT (non-serious) with onset 07May2021 08:00, outcome "recovered", described as "Extreme forgetfulness"; DISORIENTATION (non-serious) with onset 07May2021 08:00, outcome "recovered", described as "disorientation"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 07May2021 08:00, outcome "recovered", described as "administration date 27Apr2021, dose number: 1/administration date 05May2021, dose number: 2". Therapeutic measures were not taken as a result of speech disorder, memory impairment, disorientation, inappropriate schedule of product administration.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Adverse event -Inability to complete simple wording phrases (knowing what things are but no being able to say the names of regular everyday objects.) -Extreme forgetfulness and disorientation This went on for about 48hrs. No treatment received.  No follow-up attempts are possible. No further information is expected.
itchy dry skin; Skin is sensitive to cloth, sheets; drive me nuts; This non-serious case was reported by a consumer via call center representative and described the occurrence of dry skin in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Flu shot (on an unknown date patient received flu shot), covid 19 (on an unknown date patient received covid 19 shot) and Shingrix with an associated reaction of pruritus (received shingrix dose-1 on 29-Oct-2022, refere linked case US2023AMR035201). Concurrent medical conditions included pruritus. Concomitant products included COVID-19 VACCINE (COVID-19 BOOSTER).   On 10-JAN-2023, the patient received the 2nd dose of Shingrix (intramuscular, right arm) 50 ug. On 10-JAN-2023, the dose was 50 ounce. On an unknown date, an unknown time after receiving Shingrix, the patient experienced dry skin (Verbatim: itchy dry skin), sensitive skin (Verbatim: Skin is sensitive to cloth, sheets) and feeling irritated (Verbatim: drive me nuts).  The outcome of the dry skin, sensitive skin and feeling irritated were not recovered/not resolved.   It was unknown if the reporter considered the dry skin, sensitive skin and feeling irritated to be related to Shingrix.     It was unknown if the company considered the dry skin, sensitive skin and feeling irritated to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR035201   Additional Information: GSK Receipt date- 03-MAR-2023 The reporter was the patient.  The patient did not have email.  The reporter reported that he received his first Shingrix shot on and ever since the first shot his chest, back, and arms itch all the time. There was no redness. There was no breakout. But his skin was now sensitive to cloth and sheets.  One thing he had tried which helps a bit was when he showers he uses body wash which was recommended for itchy dry skin because it contains no alcohol.  This event had not resolved and he said that it was driving me nuts. Patient reported that after receiving his second Shingrix shot which was also the same day he received his final Covid-19 booster shot. The patient was unable to find the lot number for the Shingrix vaccines but he did provide the pharmacy contact information which should have the lot numbers on file. The reported was consented to follow up. The reporter did not currently have a primary care physician. Patient was willing to share his new MD contact information with GSK in the future if he receives a letter requesting it.; Sender's Comments:  US-GSK-US2023AMR035201:Same reporter
Onset tremor, cold sweat and dizziness at 1645 after receiving injection at 1215.   Ate breakfast and had a bagel w cream cheese and sweet drink at 12:45, so unlikely to be intake related, no history of DM or hypoglycemia.....   Tried eating snack but dizziness persisted such that I have to lie down and couldn?t drive to pick up my kids
erythema, pruritus, boggy edema, induration surrounding site of inj;
Severe pain at site of injection. Large red area formed and is now purple.  Eye sight seems to have gotten worse. Feels like glue is on my eyes.
pt stated that she was extra tired that night and the next day she had upset stomach and then diarrhea that lasted 2 days.  Pt states she is still feeling like she has a gastro infection.  She has not contacted her PCP at this time.
Severe lower abdominal intestinal cramping initially lasting for 2 hours and continuing sporadically for 13 days
Case number PHEH2044US019693, is an initial spontaneous report from a medical assistant received on 29 SEP 2014. This report refers to a 32-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 141001, 141301) intramuscularly at a dose of 0.5 ml on unspecified date between 19 SEP 2014 and 23 SEP 2014. IT was reported that the patient received FLUVIRIN that was stored at a temperature of -1.7 to 11.8 degree C for 191 hours. No adverse event reported after the maladministration (incorrect storage of drug).
Administered Tdap that has a reduced dose and is for age 7 and up. Should have administered Dtap. No adverse reaction was observed while in the clinic post vaccination.
This is cluster of two cases and linked with AER # 2012-6409 (Adverse event occurred following ADACEL vaccination lot number U4329AA). Initial report received from a consumer on 22 June 2012. A female patient; whose medical history and concomitant medication were not reported; had received 1st dose of intramuscularly ADACEL vaccine (lot number U4329AA) in left arm on 18 June 2012. On 18 June 2012; i.e. same date the patient presented with left arm very sore at the injection site and the upper arm. The lab details and corrective treatment were not reported. The outcome was not recovered. List of documents held by sender:none. Follow-up information was received from healthcare professional on 26 September 2012. The patient had no known allergies and denies any past medical history (PMH). Patient's other medications included: birth control pills (unspecified). The patient ongoing illness included none. The patient did not receive any other vaccines. The relevant laboratory investigations included none. The patient's outcome was recovered on 24 June 2012.
localized redness at injection site. Stomach ache. Headache. Redness spreads to right of back. Low grade fever (99)
a week and a half after the injection i woke up to redness, approximately 3 inches, around the injection sight that narrowed down my arm (right arm) It is warm to the touch. I'm not running a fever, and it is not raised.
Red rash and very itchy skin .  area from bra line to below pubic bone  was also swollen, hot to touch.   Red rash and itchyness spread to entire body,  felt  itchy inside body not just skin    Periodic hot flashes. Prednisone taper 40 mg, 30 mg, 20 mg and 10 mg took about a week for symptoms to go away
Patient developed fever 101-102 F erythematous skin rash and swelling of the face, the hands and the legs.
Patient received KINRIX vaccine afternoon of 11/15/16. Parent noticed last night pt had 4" x 2" swelling and redness at injection site. No fever.