chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DIARRHEA; STOMACH PAIN; BACK PAIN; COUGH; SHORTNESS OF BREATH; RUNNY NOSE; CHILLS; FEELING TIRED/ FATIGUE; FEVER; This spontaneous report received from a patient concerned an 86 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included ulcers, blood count are always high, allergies to pain medication, and cigarette smoker, and other pre-existing medical conditions included patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 206A21A expiry: 23-JUN-2023) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced fever. On 13-APR-2021, the subject experienced back pain. On 13-APR-2021, the subject experienced cough. On 13-APR-2021, the subject experienced shortness of breath. On 13-APR-2021, the subject experienced runny nose. On 13-APR-2021, the subject experienced chills. On 13-APR-2021, the subject experienced feeling tired/ fatigue. On 15-APR-2021, the subject experienced diarrhea. On 15-APR-2021, the subject experienced stomach pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 15-APR-2021, was recovering from feeling tired/ fatigue, diarrhea, stomach pain, back pain, cough, shortness of breath, and runny nose, and the outcome of fever was not reported. This report was non-serious.
Lip swelling chest tightness.  Benadryl started along with predisone. Reaction continued with meds and ER visit was needed for iv Benadryl and decadron iv.
I gave the pt 2 meningococcal vaccines at one time. I have not been able to reach either parent or patient at this time to see if said patient has had any adverse reactions
two patients received a dose of Havrix that expired 5 weeks earlier; This case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) for prophylaxis.   On an unknown date, the patient received Havrix. On an unknown date, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional Information: GSK receipt date: 14-NOV-2022 Reporters comment: Doctor reported the patient received a dose of Havrix that expired 5 weeks earlier. The health care professional did not provide patient identifiers, lot number, or exact expiration date of product. The reporter consent to follow-up. Additional Supportive information: The patient received a dose of Havrix that expired 5 weeks earlier, which led to expired vaccine used. This case had been linked to the case US2022168145 reported by the same reporter. This case was linked to the cases US2022AMR164695, US2022163626, US2022AMR163547 and US2022AMR163515.; Sender's Comments:  US-GSK-US2022168145:Same reporter. Patient 1 of 2 US-GSK-US2022AMR164695:Same reporter US-GSK-US2022163626:Same reporter US-GSK-US2022AMR163547:Same reporter US-GSK-US2022AMR163515:Same reporter
p/ pt recv vax approx 9 days later pt devel rash @ the inject site, consisting of several vesicles. MD noted swelling described as a nodule & 2-3 crusted papules @ inject site & hardness.
RACING HEART FEELINGS; SLIGHT PAIN IN LEG; This spontaneous report received from a patient via a company representative 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced racing heart feelings, and slight pain in leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the slight pain in leg and racing heart feelings was not reported. This report was non-serious.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer on 02-Feb-2021. Past adverse reactions to the above products included No adverse event with Pfizer.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. The patient was given vaccine 6 days post expiry date. No treatment medication information was provided.   This case was linked to MOD-2021-395985 (Patient Link).
HPV4 was given pt got hot and started to sweat. Laid him down put feet up, and put a wet cool rag on neck. Pt wouldn't let nurse cont to given vaccine. After 5 minutes MCV4 was given again got hot and sweating. Applied ice behind neck gave cool H2O to drink. Wait about 5 minutes then gave Tdap. Ice applied again. Waited for 15 minutes and felt better.
pt recv vax & exp muscle spasms in the area of mid back p/vax;also during the course of tx pt became pregnant;pt miscarried at about 8wk into the term;
Patient has been experiencing shoulder pain since receiving the shots 2.5 weeks ago on 10/30/2020. Patient experiences sharp pain in upper center of deltoid muscle that radiates throughout shoulder. Patient reports having difficulty lifting her arm without being in pain and putting clothes on due to the pain.
COVID-19 (COVID-19 infection); This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (COVID-19 (COVID-19 infection)) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Overweight. Concurrent medical conditions included Hypertension, Obstructive sleep apnea syndrome, Environmental allergy, Allergic to cats and Allergic to dogs. Concomitant products included LOSARTAN from 01-Jan-2021 to an unknown date for an unknown indication.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2022, the patient experienced COVID-19 (COVID-19 (COVID-19 infection)). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) (oral) from 12-May-2022 to 16-May-2022 for COVID-19 treatment, at a dose of 1 dosage form. At the time of the report, COVID-19 (COVID-19 (COVID-19 infection)) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: negative (Negative) Had previously antigen tested negative after paxlovid.. On 25-May-2022, SARS-CoV-2 test: positive (Positive) tested positive again..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Return of symptoms 5/24/22, tested positive again on 5/25. Had previously antigen tested negative after paxlovid. Device Date : 27May2022  Company Comment:  This spontaneous case concerns a 44-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19, that occurred approximately 6 months after receiving mRNA-1273 given as third dose in the COVID-19 vaccination series. Patient underwent a 5-day-course of Nirmatrelvir, Ritonavir (Paxlovid) COVID-19 treatment and subsequently tested negative.  Eight days later, patient presented with return of COVID-19 symptoms along with a positive SARS-CoV-2 test. No information was provided on the previous 2 doses of COVID-19 vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 44-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19, that occurred approximately 6 months after receiving mRNA-1273 given as third dose in the COVID-19 vaccination series. Patient underwent a 5-day-course of Nirmatrelvir, Ritonavir (Paxlovid) COVID-19 treatment and subsequently tested negative.  Eight days later, patient presented with return of COVID-19 symptoms along with a positive SARS-CoV-2 test. No information was provided on the previous 2 doses of COVID-19 vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Fever, chills, inc tenderness at nodes, sore gums p/ vax given;
PAINFUL BIG LUMP STICKING OUT AT THE INJECTION SITE IN LEFT ARM; This spontaneous report received from a consumer concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: psoriasis, sulfa allergy, non alcohol user, and non smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: 23-AUG-2021) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-MAR-2021, the patient experienced painful big lump sticking out at the injection site in left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from painful big lump sticking out at the injection site in left arm. This report was non-serious.
This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL dose 2, (lot number, exp.date not reported). Concomitant therapies included DEPO-PROVERA, dose 150 mg every 3 months. On an unknown date the patient experienced extreme hair loss after receiving the second shot of vaccinated with GARDASIL. The patient sought medical attention and saw the doctor. It was unknown at this time if the patient received the third shot of vaccine. The outcome of event was reported as recovering/resolving. Relatedness between therapy with GARDASIL and event was not reported. Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 56-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of chills (received 1st dose on 27th February 2018, additionally experienced night sweats and fever, for tolerance refer case US2018107293). On 1st June 2018, the patient received the 2nd dose of SHINGRIX. In June 2018, less than a month after receiving SHINGRIX, the patient experienced chills, night sweat and fever. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the chills, night sweat and fever were unknown. It was unknown if the reporter considered the chills, night sweat and fever to be related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX vaccine at around 2:00 PM. The patient experienced these events which were similar in intensity after the 1st dose of SHINGRIX. The suspect vaccine lot number and expiry date was not available. This case is one of the 5 cases, reported by the same reporter.
Initial unsolicited report received from a medical assistant on 13 January 2017. This Case Is Linked With 2017SA007206, 2017SA007210. This case involves a 4-years-old female patient who was vaccinated with dose of DAPTACEL (batch number: C5117AA, expiry date: 19 January 2019, dose and dose in series were not reported) and HEPATITIS A VACCINE (HEP A) (batch number: M032492, expiry date, dose and dose in series were not reported) via intramuscularly in the thigh site on 12 January 2017. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) and Illness at the time of vaccination was reported as none per reporter. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On 13 January 2017, one day of following the vaccination, the patient had developed a knot at the injection site. The patient required emergency room (ER) or doctor visit on an unknown date. The patient's Laboratory investigations and corrective treatment were not reported. The outcome of event was reported as unknown. List of documents held by sender: none.
Event: Individual received a 0.3ml dose of undiluted Pfizer Covid-19 vaccine.  Outcome: No side effects observed/reported @ 1 hour post-vaccination. One individual reported a brief period of chills/shakes @ 24 hours that quickly resolved. No side effects/adverse effects were observed/reported @ 48 hours post vaccination.
62YO was administered Pediarix; This case was reported by a nurse via sales rep and described the occurrence of inappropriate age at vaccine administration in a 62-year-old female patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concurrent medical conditions included immunocompromised.   On an unknown date, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:US2022159153   Additional Information: GSK receipt date: 01-Nov-2022 and 02-Nov-2022 Reporter's comment:  The field representative from agency reported that the patient was behind on childhood immunizations received Pediarix. There were no further details shared by field representative. The reporter consent to follow-up. .Additional supportive information: The 62 years old patient received the Pediarix, which led to inappropriate age at vaccine administration.
Pfizer Patient reported lump on the side of his neck, no pain. no fever. patient stated that it wasn't  there before vaccine. Reporter did not have lot number or location where vaccine was administered.
pharmacy  called and left messsage to patient for second dosage of shingrix and than next day patient call back saying her arm still hurts from first dosage, pharmacy asked her if she went to dr to check out and she said she did not think to go doctor and thought that pain will go away. pharmacy advised pts to go to doctor to check out and let pharmacy know.
This spontaneous report was received from a physician assistant concerning a female patient of unknown age. On 11-JUL-2012 (also reported as 22-JUL-2012), the patient was vaccinated intramuscularly with the first dose of 0.5 ml VAQTA (lot not reported). On 25-OCT-2012, the patient was vaccinated intramuscularly with the second dose of 0.5 ml VAQTA (lot not reported). No other co-suspects were reported. No concomitant medications were reported. There were no adverse effects reported. Additional information has been requested.
Infant received administration of Pediarix, hib (Sanofi), Fluzone, Prevnar, and Rotateq on 10/12/07. She had received Pediarix, Hib, Prevnar, and Rotateq previously on 6/8/07 and 8/10/07 without any adverse event.  This was her first flu vaccine dosage. That evening around 8 p.m. the infant developed high fever to 103 and had a seizure.  After the seizure, the infant appeared normal.  She had no further fever after that night. She has been growing and developmentally normal since that evening without any further seizure activity.
Sore shoulder, arm.  Swollen lymph node in same arm.  Mental fog.  Extreme tireness.
Rash  is circular around injection site, red, itchy welts, about 3 inches in diameter. Showed up 8 days after vaccine. No other symptoms. Probably a delayed harmless allergic reaction, but still thought it might be useful to report. Immediately following vaccine I only had a little pain at injection site and no rash or redness. This just popped up today out of nowhere but it?s right at the injection site and my arm has been covered all day and was not exposed to any new foods, products, etc.  After a full day and Benadryl, redness has gone down slightly
My wife and I had plans to go out of town, as a precaution we took a home COVID-19 test. She showed positive, we cancelled our plans and I started to care for her. On Friday I took another home COVID-19 test as precaution in case I needed to go out to get anything we needed. The time my test came back positive, I called my doctor to let him know I was also positive for COVID-19. I started taking the Paxlovid in the afternoon and by the end of my quarantine I was feeling better.
COVID-19; Eyes were sore; Headaches; Body aches; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19), EYE PAIN (Eyes were sore), HEADACHE (Headaches) and MYALGIA (Body aches) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced EYE PAIN (Eyes were sore), HEADACHE (Headaches) and MYALGIA (Body aches). On 02-Apr-2021, the patient experienced COVID-19 (COVID-19). On 13-Apr-2021, COVID-19 (COVID-19) had resolved. At the time of the report, EYE PAIN (Eyes were sore), HEADACHE (Headaches) and MYALGIA (Body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, SARS-CoV-2 test: positive (Positive) Positive. On 13-Apr-2021, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications was reported.  Treatment information was not provided.
This spontaneous report as received from a physician via a Company representative referring to a 12 year old female patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On 05-JUL-2017, the patient was vaccinated with the first dose of GARDASIL 9 (lot#, dose, frequency and route of administration were unspecified) for prophylaxis. On 11-AUG-2017, the patient came into the physician's office for a routine wellness and it was found that on examination the patient had an enlarged spleen of approximately 3 cm. Then, on 18-AUG-2017, the patient returned to the office for a follow up visit and it was found that her spleen was still enlarged by about 2 cm. After that, the patient came into the physician's office for another follow up on an unspecified date in 2017, and it was found that the spleen tip seemed swollen and tender. On an unspecified date in 2017, the patient was sent for laboratory diagnostics (unspecified) and ultrasound and it was found that those came back to normal. The physician reported that the patient was recovered but still experiencing some tenderness around the spleen, therefore, it was recommended limited activity until the tenderness subsided. It was also mentioned that the patient received unspecified treatment for splenomegaly. It was reported that no intervention to prevent serious criteria was necessary, that splenomegaly was not significant disability or incapacity or life threatening, and that the patient was not hospitalized. No product quality complaint was involved. The relatedness assessment between GARDASIL 9 and splenomegaly was not provided.
Rash 5 X 5 to right arm, around injection site.  Warm to touch with slight edema.
pt recv vax 1AUG95 & 15JAN96 pt devel chicken pox which was confirmed by a MD;
Patient received vaccination at 15:22 on 7/16/20 and then went home and mowed her lawn. She woke up on 7/17/20 around 5 am feeling itching all over, and noted a few hives on her stomach and has felt some nausea and dizziness since.  She states she had mild congestion and a slight cough but cough/congestion has resolved.  She denies throat swelling, lip swelling, tongue swelling or facial swelling. She denies chest tightness, chest pain or SOB. No vomiting but does feel nauseated, she also feels dizzy and fatigued. Pt used hydrocortisone cream on her stomach and the rash has improved. Has not tried any OTCs Patient seeking treatment on 7/17/20 at 0840 am.  Pt instructed to take 1-2 Benedryl 25-50mg PO every 6-8hrs for the next 3-5days as needed for itching/hives; Zyrtec once daily for the next 3-5 days and Zantac BID for the next 3-5 days Patient called on 7/17/20 at 1500 for follow up and states she was feeling less dizzy and the itching has lessened with Benadryl.  Patient called on 7/20/20 at 0820 after the weekend. Patient had only been taking the Benadryl through the weekend and felt better. Patient did not take Benadryl today but encouraged to take an antihistamine such as zyrtec
Pt. woke at 3/30/11 2:00 AM with chills & shaking, nauseous. 4:15 AM achy, shaking, vomiting x 5. 7:30 AM temp at 100.8 deg. Pt. took TYLENOL to decrease temp. Pt. came in office & started on 0.9% Sodium Chloride IV drip. Subject received 1 liter IV fluid and discharged at 15:30. No further vomiting. Temp. decreased to 98.4 following TYLENOL & fluids. BP 108/62 at release. Pt. discharged to home. F/U this morning at 11:00 AM 3/31/11, pt. reports no more fever, vomiting, shaking and chills.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from product quality group. The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 27Sep2021 as dose 3 (booster), single (Lot number: 30130BA), in right arm and on 07Apr2022 as dose 4 (booster), single (Lot number: FM0698) at the age of 68 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Result. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The did not received any other medication in 2 weeks.  No follow-up attempts are possible. No further information is expected.
Information has been received from a Registered Nurse (R.N.) concerning a female patient who "one to two months ago" was vaccinated IM with a dose of Gardasil. The patient developed numbness in her arm right after the injection. The patient was sent home. The patient's outcome was unknown. Additional information has been requested.