chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician referring to an unknown number of patients of unknown gender and age. The patients' concomitant medications, pertinent medical history, drug reactions or allergies were not reported. Since 30-MAY-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB which had the lot # reported as N00236, expiration date 24-OCT-2019, lot # N000235, expiration date 26-OCT-2019, lot # N003536, expiration date 02-NOV-2019 (dosage information and route were not informed). The doses of the vaccine experienced the lowest temperature of 32 degrees Fahrenheit and the highest of 54 degrees Fahrenheit for 49 hours. There was no previous temperature excursion. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter. Follow-up information has been received from the physician on 16-OCT-2017. Since 29-APR-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (lot # M046140, expiration date 27-SEP-2019, dosage information and route were not provided). The doses of the vaccine experienced the lowest temperature of 47 degrees Fahrenheit and the highest of 49 degrees Fahrenheit for 16 hours. This is one case from several cases received from the same reporter. Follow up information was received from the physician on 16-OCT-2017. The patient was 4 months old. On 16-MAY-2017, the patient was vaccinated with the improperly stored dose of LIQUID PEDVAXHIB (lot # M046140). The patient's and the patient's guardian's identifiers were provided.; Sender's Comments:  US-009507513-1709USA007325:
Information has been received from a certified medical assistant concerning an 18 year old patient who had been vaccinated with two doses of MMR II, but still had negative titers to measles.  It was unknown if the patient sought medical attention.  Additional information has been requested.
Large area of arm turned red and very swollen, and hot to touch. Arm went numb for 1 day and nausea after the shot.
was sick for 3 days; tired; she could taste the medicine as soon as they gave her vaccine; headache; her arm was red and sore; her arm was red and sore; This is a spontaneous report from a contactable consumer (parent) via medical information team. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient was sick for 3 days, she was mainly tired and said she could taste the medicine as soon as they gave her vaccine. She had a headache, and her arm was red and sore. The reported wanted to know if her daughter should get her second dose?. The outcome of all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information expected.
pt recv vax & exp hives & redness 2 days p/vax;rash was starting to improve @ 8OCT97
While I was doing my monthly reconciliation on 9/3/19 I noticed a Menactra with an expiration date of 08/27/2019 had been given on 08/30/2019 I contacted the CDC and was told the vaccine was not viable and the patient would have to be revaccinated. I spoke with and emailed my Field Rep with details of the incident. I spoke with the patients mother and explained the situation to her. I informed the mother that her daughter would have to be revaccinated. The mother stated she would bring her daughter in for another Menactra.
chronic hives; rash; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team.  A 39 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 03Mar2021 (Lot number: EN6205) at the age of 39 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Zyrtec, notes: zyrtec; Cimetidine; Benadryl; Prednisone; Xolair. Vaccination history included: Bnt162b2 (First dose, anatomical site: arm, Route: IM, Batch/lot no: EL9262), administration date: 10Feb2021, when the patient was 38 years old, for COVID-19 immunization. The following information was reported: URTICARIA (non-serious) with onset Mar2021, outcome "not recovered", described as "chronic hives"; RASH (non-serious) with onset Mar2021, outcome "not recovered", described as "rash". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of urticaria, rash.  Additional Information: Lab Test: Consumer stated, That was a good question, believe so, she is seeing a functional medicine specialist as well and know that she is been doing some blood work, so the last blood work that did on her was, reporter believe it was sometime in summers but she is having a lot of blood work done by another facility as well. Yeah, for the last lab work had from like July but reporter know that she is being seeing another specialist as well who have been doing quite a bit of blood work which was after that but I don't know if it was within 2 to 3 weeks. Treatment: Consumer stated, Yes, so she since the reaction she has been taking two antihistamines, she was started on Xolair, and then she is been on Prednisone and most recently Hydroxychloroquine. The patient was not hospitalized or admitted to an intensive care unit. No any organ involvement: (dermatological/mucosal). Generalized urticarial: Yes. The event required the initiation of new medication or other treatment or procedure. Patients outcome following the potential anaphylactic reaction: Not Recovered (not anaphylactic). The following laboratory tests or diagnostic studies performed in Hematology. The patient did not had a history of any previous allergies to specific products or any conditions indicative of an allergy.Patient has tried multiple medications prior to the event being reported including Zyrtec, cimetidine, Benadryl, prednisone, Xolair. The patient did not received any recent vaccines for any other conditions and for SARS-CoV-2 other than Pfizer-BioNTech COVID-19 Vaccine prior to or around the time the event being reported.  Follow-up attempts completed. No further information is expected.
Mild pain to (L) upper arm with swelling and redness after vaccination 2 days ago. Patient was seen at ER yesterday. Seen at office 7/23/15 swelg of (L) upper arm redness warmth.
Left arm where site of injection with redness, hard, hot to the touch, swelling, pain and itching DUE TO THE DAPTACEL GIVEN.
Pain in left after flu shot - unable to move left arm for couple of days - Got little better - but unable to do range of motion.
At last observation check for patient so about 2:45pm, 15min after receiving her dose 2 COVID19 vaccine she complained of feeling lightheaded. The observer recommended additional monitoring and contacted their lead. At this time ARNP arrived to further evaluate. Pulse ox obtained: 99% and HR 110's trending down as patient took some sips of water and reported feeling better. Vitals @ 3:00pm: SaO2: 97%, HR 99. Vitals @ 3:02pm: Sa02:99%, HR 86. Vitals @ 3:04: SaO2: 99%, HR 86. At 3:09 while patient being observed 1:1, she began to c/o itching on her hands, she was scratching them and her chest. Noted exanthem like reaction to tops of hands and chest. Assessed this could be early signs of allergic reaction, post-observation monitor lead (ARNP) initiated internal response. Activating site supervisor, site safety officer and scribe to the scene.  Observation lead discussed clinical picture to patient and obtained consent to administer epi pen x1 @ 3:14pm. Epi 0.3mg administered IM to left thigh. At the time of administration 911 was notified. Vitals obtained: SaO2: 99%. HR: 99, BP: 138/78. Epi was tolerated well & itching improved. At 3:20pm BLS ambulance arrived. Patient was evaluated and briefed on what is anticipated when someone receives an EpiPen. Notified that medics were in route as that is the EMS protocol when Epi is administered. Upon arrival of medics patient was feeling anxious but symptoms improving. She declined EMS transport, signing their AMA paperwork. Patient accompanied by boyfriend who drove. Our immunization clinic involved many licensed providers, because we had an ER physician who was willing to pop over and evaluate her
The patient received a dose of RabAvert about a month after a dog bite; Case reference number DE-BN-2022-001171  is a spontaneous case report initially received on 01-Jun-2022 from other health care professional (reference number: USBAV22-0257) and concerns an adult male patient.  The patient's medical history and concomitant medication details were not reported.   On 10-Apr-2022, the patient was bitten by a dog who had a bat next to a food bowl.  On 07-May-2022, 27 days after a dog bite, the patient was vaccinated with the first dose of RabAvert (Rabies Virus (Inactivated, Strain Flury LEP); batch number was not provided), at a dose reported as one shot, intramuscularly in the deltoid, for a post exposure after a dog bite (explicitly coded as 'inappropriate schedule of vaccine administered').  On 10-May-2022, three days after the first dose, the patient was vaccinated with the second dose of RabAvert (Rabies Virus (Inactivated, Strain Flury LEP); batch number was not provided), at a dose reported as one shot, intramuscularly in the deltoid.  On 14-May-2022, seven days after the first dose, the patient was vaccinated with the third dose of RabAvert (Rabies Virus (Inactivated, Strain Flury LEP); batch number was not provided), at a dose reported as one shot, intramuscularly in the deltoid.  On 21-May-2022, 14 days after the first dose, the patient was vaccinated with the fourth dose of RabAvert (Rabies Virus (Inactivated, Strain Flury LEP); batch number was not provided), at a dose reported as one shot, intramuscularly in the deltoid.  It was reported that the patient didn't have any symptoms.  Additional information received on 03-Jun-2022 included local ID.; Reporter's Comments: An adult male patient was vaccinated with the first dose of RabAvert 27 days after a dog bite, which is considered as inappropriate schedule of vaccine administered. No associated adverse events were reported. Inappropriate schedule of vaccine administered is listed per company convention. The patient's medical history and concomitant medication details were not reported. Inappropriate schedule of vaccine administered is not related to RabAvert, but to a human factor. The case is non-serious.; Sender's Comments: An adult male patient was vaccinated with the first dose of RabAvert 27 days after a dog bite, which is considered as inappropriate schedule of vaccine administered. No associated adverse events were reported. Inappropriate schedule of vaccine administered is listed per company convention. The patient's medical history and concomitant medication details were not reported. Inappropriate schedule of vaccine administered is not related to RabAvert, but to a human factor. The case is non-serious.
1st dose: No symptoms. 2nd dose: Body/muscle aches, dizziness, low-grade fever (flu-like symptoms).
Patient went to bed with no issues Tuesday evening. When she awoke Wednesday morning, she complained of not feeling good. Parent states she had swelling to her eyes and lips with a rash to the left side of her face and neck. She denies having any trouble breathing or swallowing. Administered Benadryl 50mg PO BID Wednesday, and 25mg PO x1 today. Swelling and rash had improved upon discussion with mom.
Pain in injection site and corresponding armpit lymph nodes; fatigue, 102 - 103 Fever for about 24 hours, chills, headache.
6/16/2020, 8:00 PM sore at injection site 6/17/2020, pre-dawn hours  sore at pelvis and knees, headache 6/17/2020, 9:00 AM chills
Site was warm to the touch, skin was blotchy, muscle was very tight and very sore even to the touch, upset stomach.
Cataract; Hard of hearing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, unknown manufacturer), for COVID-19 Immunization.  The following information was reported: CATARACT (medically significant), outcome "unknown"; HYPOACUSIS (non-serious), outcome "unknown", described as "Hard of hearing".  Clinical Course: Caller's husband had brain surgery, hematoma, and brain bleed 6 weeks after booster shot of Covid vaccine. Can he still get another booster shot. Caller confirmed details provided by transfer agent. This report was for caller. Caller and her husband got the shot after comparing shots and deciding to get Pfizer. Caller and her husband have been isolated because those who have not gotten the shot are unsafe to be around. They don't go to church or do anything that will put them in danger. At the last visit the doctor said caller could get the booster, but the doctor was not going to say to get it. No further details provided. Caller told the doctor that she would call Pfizer to get Pfizer's advice. The doctor didn't say call CDC or FDA, but to call Pfizer. There are a lot of recordings to absorb at caller's age when she called. Caller didn't know that would involve all that. It was like someone needs a lawyer to handle a phone call. She has been on the phone for 43 minutes. If he doesn't get the booster will caller have increased chances of getting the virus because he won't be protected. Caller clarified her question. How does her husband not getting the booster effects her because both should be boosted. If they get in contact unknowingly they might get virus. Caller doesn't want to stay in for 2 year for nothing. She wants to come out a pandemic survivor. Caller was hard of hearing and can't tell if a person is still talking. Her husband is vision impaired and caller is too. Caller has a cataract. They don't have a computer.    The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
601 doses were given after expiration date; Product storage error; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (601 doses were given after expiration date) and PRODUCT STORAGE ERROR (Product storage error) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (601 doses were given after expiration date) and PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (601 doses were given after expiration date) and PRODUCT STORAGE ERROR (Product storage error) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. The reporter stated that initially there were 606 doses from expired lot and they found out later that some patients that were impacted had received the Janssen COVID-19 vaccine. Date the vial placed in refrigerator was on 04-Nov-2021. There was no temperature excursion. The patient had no adverse event. No Treatment information was reported.
Approximately 6-8 hours after vaccine administration, patient began feeling "a sore throat" as per patient. This "progressively became worse" as per patient, pt reported difficulty breathing resolved with TYLENOL. Pt also reported body aches, nasal drip, denies fevers or chills, denies rash.
Rec'd DTaP and IPV at office visit on 03/02/16. (Rt) arm warm, red and swollen at site - started shortly after visit. Seen in office 03/04/16. Area 9 x 9 cm warm and indurated (Rt) upper arm noted. Afebrile tx with ibuprofen Q 6-8 hours x 48 hours; warm compresses; watch for 'streaking'.
States she had previously received 2 doses varicella, but had no record. Varicella titer result was 1.07 (positive >1.09. 09/16/11 6:00 PM - soreness & warmth @ injection site. 09/17/11 AM - awoke w/redness & swelling @ injection site. 09/17/11 11:00 AM - was seen in ED. Dx: cellulitis. Tx: ice, take Benadryl & Motrin. 09/17/11 PM - tingling from LUA to hand, increasing swelling & vomited x 3. 09/18/11 0920 AM - returned to ED. Injection site itchy, painful. MD noted 8 cm dark red area @ injection sitea LUA w/ surrounding light red are 4-6 cm; total 12-14 cm; warm to touch & swollen; tingling to entire left arm noted & pain 7-8/10. Dx: cellulitis. Rx: Vicodin 5/500 mg 1-2 PO q6hr PRN pain; Zofran 4 mg 1 PO q6-8hr PRN N&V & Doxycycline 100 mg PO q12hr x 10 days.
p/vax pt seen by MD & dx w/varicella;pt had vesicles on torso & lower abd;
Patient states he requested to receive Moderna booster upon arrival  to clinic but was directed to Pfizer table.  1st vaccine was J&J on 3/25/2021, Pfizer 0.3ml booster to patient.  Patient states he had normal side effects related to vaccine. Denies any adverse reaction.  Patient did not know he received Pfizer until he down loaded docket.  He assumed it was a docket error. States he contacted docket who informed him to contact the DOH.  Notified patient that he received Pfizer and not Moderna. Patient expressed understanding.  I will send new card with proper vaccine information.
I experienced dizziness, slight electrical feeling in my entire body, disoriented. It was so strange. I am a very healthy person and run marathons. It felt like it was going to get worse, but didn't. My body was tingly for some time. It happened about 3 or 4 different times over the next 2- 3 months. No recurrence since then. I also felt a sharp pain in my left shoulder. About 4-5 times that lasted for 5 minutes. It was not muscular. It felt deep in the bones, no relief for this pain.
Initial health authority report received on 05 Jan 2010: This patient with medical history of hemodialysis was vaccinated with  Influenza A H1N1 vaccine (manufacturer and batch number unknown) on 04 Dec 2009. The patient experienced presented with pyrexia, Influenza and abscess on 04 Dec 2009 after vaccination. No outcome was reported for the events.
Headache began at 2 pm on 10/9/12. Was unrelieved with rest and aspirin. Headache became progressively worse, so pt went to the ER. Was given DILAUDID injection which relieved the HA.
This spontaneous report as received from a nurse refers to a 16 years old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) GARDASIL injection, lot # K005881, exp. date: 14-JAN-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Lymphadenopathy of R axillary nodes causing significant swelling, mottled rash and pain in the R axilla. Improving slightly with ibuprofen on day 4.
First two weeks- muscle weakness and soreness in limbs (arms and legs) and throat inflammation.   December 2021- neuropathy in face/neck involuntary spasms in face. Tongue swelling. No sensation in hands and feet.  Brain is constantly telling muscles to contract which further confirms it?s a neurological issue caused by this vaccine. Had no  issues with movement nor any central nervous system problems prior to this vaccine.
Can dizziness happen 1 week after vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of dizziness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 week after receiving Shingles vaccine, the patient experienced dizziness. On an unknown date, the outcome of the dizziness was unknown.   It was unknown if the reporter considered the dizziness to be related to Shingles vaccine.     Additional Information: GSK receipt date: 29-OCT-2022 Reporters comment: This case was reported by a consumer via interactive digital media. The reporter asked could dizziness happen 1 week after vaccine. Additional Supportive Information: The follow up would not possible as no contact details were available.
Fever of 100.2 starting morning after vaccination.  Body aches, chills, fatigue.
This spontaneous report as received from a registered nurse refers to a patient of unknown demography. Patient's concurrent conditions and relevant medical history was not reported. On 30-JAN-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) (dose, frequency and route unspecified) (lot number: K011314 with expiry date of 14-FEB-2016). Concomitant medications were not reported. The reporter stated that, between 07-JAN-2015 through 19-FEB-2015, the VARIVAX (Merck) was exposed to 34.4 Fahrenheit temperature which was outside the recommended condition. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with VARIVAX (Merck) was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Developed left supraclavicular and left axillary adenopathy, painful, supraclavicular area erythematous. Left ant deltoid warm and partly erythema (not near injection site). Myalgias, afebrile, Keflex 500 7 TID.
Patient received abdominal pain, spine pain, stiffness, and weakness shortly after getting influenza vaccine. Patient requested a nitroglycerin tablet so pharmacy administered one to patient. Patient states she felt better after that but was still having weakness so was evaluated at the Hospital. Patient got cleared. Is feeling better today with no concerns.
Rec'd Imms on 1/9/12. Presented to office with sore (R) arm with red, swollen areas, on deltoid & on lower arm that started 1/10/12. Red areas warm to touch. Pt was taking BENADRYL. Dr. ordered KEFLEX 250 mg qid x 5 days for mild cellulitis.