chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A spontaneous report was received from a consumer concerning a 65-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events headache, aches, knee swelled up.  The patient's medical history was not provided. Concomitant medications reported were synvisc-one injection for drug use for unknown indication.  On 15 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 6 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 013L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 6 Feb 2021, the patient experienced the event(s) headache. aches. On 9 Feb 2021, the patient experienced the event(s) knee swelled up.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events were not applicable. The outcome of event(s) headache was considered resolved on 7 Feb 2021.The outcome of event(s) aches was considered resolved on 7 Feb 2021. The outcome of event(s), knee swelled up,  was unknown.
Wrong vaccine administered; No adverse effect; This spontaneous report was received from a administrator concerning to a 12 month old patient. Information regarding the patient's medical history, concurrent conditions and allergies was not reported.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # S003086 has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live expiration date reported as 29-JUL-2020 and upon internal validation established as 29-JUL-2020, in the left arm, for prophylaxis (strength, dose and route of administration were not reported). And in the right arm the patient was vaccinates with varicella virus vaccine live (oka/merck)(VARIVAX) lot # R027995 has been verified to be a valid lot number for varicella virus vaccine live (oka/merck)expiration date reported as 01-OCT-2020 and upon internal validation established as 01-OCT-2020, in the left arm, for prophylaxis (strength, dose and route of administration were not reported). Administrator reported that both vaccines were reconstituted with sterile diluent, lot #S008567, expiration date 23-SEP-2021.  It was reported that the patient should have received Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II) instead of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (wrong product administered).  No adverse effects were reported.
Patient was 17 years old and 7 months. Moderna requires patients to be 18 years old. Came to the clinic with her mother. Has had no adverse reactions from vaccine. Dad was attempted to call 3 different times, unable to reach. Have had contact with the girl.
fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jun-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 dosage form. On an unknown date, the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown.            Concomitant product use was not reported.  Treatment Information was not reported.   Reporter did not allow further contact
Pt recvd MMR/DTP/OPV on 22JUN90; On 30JUN90, pt devel fever of 101, rash on face & chest, convuls, & fatigue for 24hrs;
swell up all over her body; Allergic reactions to pneumonia vaccine; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (patient). A 60-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein), via an unspecified route of administration on an unspecified date (lot number and expiry date were not reported) as dose number unknown, single for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced swell up all over her body and allergic reactions to pneumonia vaccine on an unspecified date. It was reported that the patient had allergic reactions to pneumonia vaccine in the past, made her swell up all over her body. The outcome of all events was unknown.   Pfizer is a marketing authorization holder of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) has submitted the same report to the regulatory authorities.  No follow-up attempts are needed. Information on lot/batch number cannot be obtained. No further information is expected.
This case was reported by a nurse and described a 72 year old female patient who tested positive for hepatitis B surface antigen following the administration of hepatitis B vaccine recombinant (Engerix-B). The patient's medical history was notable for renal failure (cause not specified) requiring hemodialysis. On 03 January 2005, the patient received the second 40-mcg dose of Engerix-B (lot AHBVA068AA). The dose was administered as two separate 20-mcg injections in the right and the left deltoids. Approximately two days after receipt of Engerix-B, on 05 January 2005, the nurse reported that a "hepatitis B surface antigen titer was positive. The patient was tested again on 17 January 2005 and the hepatitis B surface antigen titer was negative. The nurse considered the event to be related to vaccination with Engerix-B.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 54-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment drugs were reported.  The vaccine was stored in the freezer and one to two vials were taken out and placed in fridge each day  as needed.
1st dose on 2018, did not receive 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.       Additional Information: GSK Receipt Date: 18-APR-2022 Reporter's Comments: The pharmacist stated that the patient received first dose of the Shingrix series in 2018, but they did not receive second dose.  The patient had now come in to pharmacy requesting second dose.  The first dose was administered at a different location so the reporter did not have the exact date, lot number, or expiration date information. At the time of reporting, the second dose had not been administered. The reporter consented to follow up. Additional Supportive information: Till the time of reporting, the patient did not receive 2nd dose which led to incomplete course of vaccination. The case has been linked with the case US2022066310 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022066310:Same Reporter
I had my vaccination on 09/30/2022. In 03/2023 I started to have problems in my left eye for reading vision. I went to my optometrist and I could not see at all with my left eye. I was found to have a Branch Occlusion. I was referred to cardiologist and my tests were all shown that I am ok. The doctor gave me a injection to my left eye in 03/01/2023 and 04/05/2023. I am due for a 3rd injection on 05/05/2023.
Dizzy  Lightheaded  Brain zaps Fast heart rate/pain Increased anxiety and panic attacks
Case number PHEH2015US012027, is an initial spontaneous report received from a medical assistant on 22 Jun 2015. This report refers to a 20 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with BEXSERO (batch number: 146101A) intramuscularly at a dose of 0.5 ml on 15 Jun 2015. It was reported that the BEXSERO was administered to the patient following a temperature excursion of 49 degree F for about 4 hours on 10 Jun 2015. No adverse events reported after the maladministration.
Developed hives on shoulders and neck. Complained of severe pruritus self medicated with hazel. Did call doctor and was prescribed cortisone and "something to steep." Doctor is the client's MD.
pt recvd vax & appeared w/ transient sx 48 hrs after vax, sx incl encephalopathy & ataxic gate;
9:00 p.m. 3/14/05 patient's temp (axillary) digital thermometer 104.  Mom gave her son infant Tylenol - temp down to 102 (axillary). Infant moaning apparent pain and crying went to ER - breathing rapid. ER doctor gave infant pedialite and observed for three hours. Fever 98 when left ER 3/14/05. 3/15/05 temp okay.
PATIENT REPORTED SEVERE PAIN/SWELLING AT INJECTION SITE. UPON PHARMACIST EXAMINIATION, SITE HAD SOME SWELLING/REDNESS, BUT ELBOW ON SAME ARM AS INJECTION SITE WAS SEVERELY SWOLLEN.
suspected vaccination failure; I'm seven weeks into shingles I was told I had a bad dice of them/whole back on my chest and right arm; whole back on my chest and right arm and armpit it's extremely painful; whole back on my chest and right arm and armpit it's extremely painful; whole back on my chest and right arm and armpit it's extremely painful; whole back on my chest and right arm and armpit it's extremely painful; 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), shingles, chest pain, pain in arm, axillary pain and back pain. On an unknown date, the outcome of the vaccination failure, shingles, chest pain, pain in arm, axillary pain and back pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, chest pain, pain in arm, axillary pain and back pain to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient was seven weeks into shingles The patient had a shingles shot but could not escape them, whole back, on chest and right arm and armpit it was extremely painful. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.
pt woke from nap on the following Tuesday w/low grade fever; Wed became lethargic & started vomiting w/temp varying from 101 to 103; Thursday cont vomiting & temp inc 104.8;
This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain), NECK PAIN (neck pain), HYPERPHAGIA (she has been eating alot), WEIGHT FLUCTUATION (she went from 128lbs to 120lbs and now she is 123lbs) and DIZZINESS (she felt a little dizzy) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Herniated disc. Concurrent medical conditions included Anemia, Sickle cell trait and Thalassaemia. Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication. On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-May-2021, the patient experienced BACK PAIN (back pain), NECK PAIN (neck pain), HYPERPHAGIA (she has been eating alot), WEIGHT FLUCTUATION (she went from 128lbs to 120lbs and now she is 123lbs) and FATIGUE (felt tired). On an unknown date, the patient experienced DIZZINESS (she felt a little dizzy) and MUSCULAR WEAKNESS (muscle weakness). The patient was treated with Physical therapy for Neck pain. At the time of the report, BACK PAIN (back pain), NECK PAIN (neck pain) and FATIGUE (felt tired) had resolved and HYPERPHAGIA (she has been eating alot), WEIGHT FLUCTUATION (she went from 128lbs to 120lbs and now she is 123lbs), DIZZINESS (she felt a little dizzy) and MUSCULAR WEAKNESS (muscle weakness) outcome was unknown. No treatment information was provided. This case was linked to MOD-2021-248120 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow up Receive on 06-JUL-2021. Follow up contains the information about second dose and event of second dose On 27-Jul-2021: Additional information included medical history and event details.
Swollen lymph node in right armpit started about a week after the vaccination. It?s been a week and has not subsided.
JOINT PAIN; HEADACHE; MUSCLE PAIN; FEELING LIKE COMING DOWN WITH  THE COLD-BUT NEVER CAME DOWN  WITH ANYTHING; SORE ARM; This spontaneous report received from a patient concerned a female of unspecified age. 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: 1805022 expiry: UNKNOWN) dose was not reported, administered on 05-MAR-2021  on left arm for prophylactic vaccination. No concomitant medications were reported. On 05-MAR-2021, the subject experienced feeling like coming down with the cold-but never came down with anything. On 05-MAR-2021, the subject experienced sore arm. On 06-MAR-2021, the subject experienced joint pain. On 06-MAR-2021, the subject experienced headache. On 06-MAR-2021, the subject experienced muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on 05-MAR-2021, and had not recovered from feeling like coming down with the cold-but never came down with anything, joint pain, headache, and muscle pain. This report was non-serious.
Muscle aches, joint pain, chills, fever (100.8) in order of onset; starting ~6:30 pm progressing to severe chills at 9:00 pm followed by fever (100.8) at 9:30 pm. Fever resolved by 1 am.  Fatigue, mild headaches throughout the course of symptoms.  (All events resolved 12 hours after onset of events.)
I had congestive, coughing, dry throat, sneezing, and slight headache. These lasted for about 4 days. I went to an urgent care. On Feb 7th, I tested positive for COVID-19.
Developed moderate to severe Tinnitus. Had no prior history of Tinnitus. Attempting treatment with Prednisone for 7 days.
no adverse effects; the patient was inadvertently administered an expired dose Varivax on 22-AUG-2014; This spontaneous report as received from a nurse referring  to a 9-year-old patient, gender was not reported. No information regarding patient's concurrent conditions, medical history, drug allergies or reactions were provided.    On 22-AUG-2014, the patient was inadvertently vaccinated with an expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # H015560, expiration date 16-AUG-2014,  for prophylaxis (strength, dose, frequency, anatomical site of administration and route were not reported) (expired product administered). A sterile diluent used was mention, no adverse effects were reported. The events outcome was unknown.
BODY ACHE, STIFFNESS, CHILLS, FEVER, FATIGUE
Patients received incomplete dose; Part of the liquid came out patient's arm.; liquid came out patient's arm; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 75-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number G2MG3, expiry date 24-FEB-2025) for prophylaxis.   On 09-OCT-2023, the patient received Arexvy. On 09-OCT-2023, an unknown time after receiving Arexvy, the patient experienced accidental underdose (Verbatim: Patients received incomplete dose), inadvertent exposure to vaccine (Verbatim: Part of the liquid came out patient's arm.) and exposure via skin contact (Verbatim: liquid came out patient's arm). The outcome of the accidental underdose, inadvertent exposure to vaccine and exposure via skin contact were unknown.   Additional Information: GSK Receipt Date: 09-OCT-2023 The reporter reported that during administering Arexvy vaccine part of the liquid came out patient's arm, which led to accidental underdose, inadvertent exposure to vaccine and exposure via skin contact The reporter stated that the patient received incomplete dose.  Patient was not immunocompromised. The reporter consented to follow up via postal.
After buying the vaccine, I kept it in freezer for a few days, with no reported adverse event; Initial information received on 23-Jul-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves an unknown age male patient who reported after buying the vaccine, i kept it in freezer for a few days, with no reported adverse event while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date the patient after buying the vaccine, kept it in freezer for a few days, with no reported adverse event (product storage error) (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Action taken: Not applicable.  Outcome was Unknown for the event after buying the vaccine, i kept it in freezer for a few days, with no reported adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient signed up for a COVID vaccine on our online scheduler and it was accidentally run through as a flu vaccine. When patient arrived at the pharmacy, the technician verified that she was here for her flu vaccine at this point she replied yes. Once she got home, she looked at her leaflet and saw that she received the flu vaccine instead of the COVID vaccine. She did not experience an adverse event from the flu vaccine (patient received each year prior), but she was given the wrong vaccine. She had not received a flu vaccine yet this year, so it was not a duplicate but patient was pretty upset because she wanted the first COVID vaccine, which she did end up receiving as well later that day.
itching; This is a spontaneous report from a contactable nurse. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced itching without the presence of rash for 13 to 14 days on an unspecified date. The patient was asking if she should get the second dose of the vaccine if she had itching without the presence of rash for 13 to 14 days after receiving the vaccine. Clinical outcome of the event was unknown.  Information on the lot/batch number has been requested.
Pt. received pneumonia PPSV23 vaccine on 9/19/13 app. 11AM. Presented to H.D. on 9/20 8:30AM with c/o pain in (L) arm and shoulder, fever of 101 and generalized achiness. No redness or sign of local reaction to (L) deltoid area.
This spontaneous report was received from a physician via a field representative regarding a currently 32 year old female patient. The patient's medical history included melanoma. Her concurrent conditions and concomitant therapies were not reported. On unknown dates in 2009, the patient received a 3 dose series of GARDASIL (lot #, expiration date, dose, anatomical location and route of administration were not reported) for prevention of HPV. On an unspecified date, after receiving the 3 dose series of the vaccine, the patient was diagnosed with cervical intraepithelial neoplasia III (CIN 3 carcinoma) by an obstetric and gynecology physician. It was unknown if any treatment was given for the event. On an unspecified date in December 2017, a colposcopy was performed to the patient, and on an unspecified date in April 2018, a cone biopsy was done, both results were not provided. The outcome of the cervical intraepithelial neoplasia III was unknown as well as the causality assessment. Upon internal review, the cervical intraepithelial neoplasia III (cervix carcinoma in situ) was considered to be medically significant.
Breakthrough case admission after three vaccines Moderna 3/17/21 Lot# 038A21A;  Moderna 4/14/21 Lot# 037B21A;  Modern 1/5/22 Lot# 028K21A
Pt received the Gardasil series of shots on July 20, 2007, Sept. 26, 2007 and Feb. 20, 2008. In Jan. 2009, she told me (her mother) about a large lump on her neck.  It had clearly been there for sometime based on it's size (4cm x 3cm) and consistency. The pediatrician thought this was a benign swollen lymph node, but subsequently, this was biopsied by a surgeon and patient was diagnosed with Hodgkin's Lymphoma, nodular sclerosis type. While we understand that there is not live virus in the vaccine, we believe that there is an association between the generated immune reaction to the HPV recombinant protein and Hodgkin's Lymphoma. My daughter is now undergoing chemotherapy for her cancer. I sincerely hope the CDC will collect data on Gardasil and the onset of Hodgkin's lymphoma in young girls.  9/1/09 PCP medical records received DOS 7/15/08 to 1/19/09. Patient presents with anxiety, migraines, sinusitis.  9/1/09 PCP medical records received 2/17/09 to 7/17/09. Assessment: Lymphadenopathy. Patient presents with headache frontal, associated with nausea and vomiting. Three migraines last two weeks, throbbing, photophobia. Sore throat, unable to swallow. Cervical lymph nodes bilateral. Rash on abdomen. Swollen cervical  lymph nodes 2 months left side.  9/21/09 Received ENT & Heme/Onc consults. FINAL DX: Hodgkins lymphoma, nodular sclerosing, stage IIA. Records reveal patient was pale & had firm left clavicular lymph node.  Excisional biopsy done 7/23/09 revealed diagnosis.  Tx w/chemotherapy & possibly radiation tx when chemo completed.