chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sick for more than 2 weeks.; I have flu type A; Initial information received on 02-Jan-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and gender patient who reported been sick for more than 2 weeks and i have flu type a after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (dose, strength, formulation, expiry date and lot number not reported) via unknown route in unknown administration site.  On an unknown date the patient reported been sick for more than 2 weeks (illness) and I have flu type A (influenza) (unknown latency) following the administration of influenza vaccine.  It was unknown if there were lab data/results available.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  Outcome: Unknown.
Temp above 102 X 2 days.  Started evening of 07/03/01-  Tenderness at site of injection X 1 day IMM given in R thigh
This spontaneous report as received from a 63 year old female consumer reporting on herself with breast cancer who in February 2011 was vaccinated with an unspecified of ZOSTAVAX (dose, route and lot number not provided). No other co-suspects were reported. No concomitant medications were reported. The consumer stated that on 15-DEC-2012 recently she got shingles. Acyclovir was given as a treatment for the events. A blood work done every 6 months (No results provided). The outcome of shingles was reported as not recovered/not resolved. The relatedness for shingles was unknown for ZOSTAVAX. The patient sought medical attention. Additional information has been requested.
I had a temperature of 100° F at 4 pm; soreness in my arm at the injection site; Tired; moderate body aches; sore muscles in upper back; mild joint pain; This is a spontaneous report received from a contactable consumer (patient). A 48-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3247, Expiry date: unknown), via an unspecified route of administration on 17Feb2021 as single dose for COVID-19 immunisation (Covid-19 vaccine). The patient's medical history was not reported. Patient had historical vaccine first dose of BNT162B2, Lot number: EL3247 (at 48-year-old) as single dose on 26Jan2021 for COVID-19 Immunization (Covid-19 vaccine) showed reactions fatigue, mild soreness at injection site and moderate headache. Concomitant medications included sertraline hydrochloride (ZOLOFT) from Aug20021 to ongoing, Vitamins nos (Multivitamin) from Aug2004 to ongoing, desogestrel, ethinylestradiol (VOLNEA) from 31Jan2021 to ongoing, doxycycline (DOXYCYCLINE) from Mar2019 to ongoing. Patient stated received the second dose of BNT162B2 on 17Feb2021. On the morning of 18Feb2021, I had soreness in my arm at the injection site. I was also tired, had moderate body aches, sore muscles in upper back and mild joint pain. She stated had a temperature of 100 degree F at 4pm. When she woke the next morning, 19Feb2021, she felt fine. She stated feeling fine now as of 17Apr2021. Patient reported issues (side effects, complaints, etc.) with a Pfizer product and reported issue occur after use of a Pfizer product. The outcome of event was recovered on 19Feb2021.  No follow-up attempts are needed. No further information is expected.
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 31-AUG-2020, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 ml as prophylaxis (lot # S036821 with expiration date 21-APR-2022) (strength, frequency, route of administration and anatomical location were not reported).  The improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA006106:
24 hours after vaccination - pt developed swelling that progressed to 6" wide oval area. Pt has thicker (hard) area around area of injection.
STARTED AROUND 7AM BEFORE SCHOOL AND INCREASED AFTERSCHOOL.  MOTHER WAS CONCERNED ABOUT APPEARANCE.  MEASURED ABOUT 5"X5" THIS MORNING (8:30) IT MEASURES ABOUT 18CMX18CM.  VERY WARM TO TOUCH AND TENDER.  ITCHES MORE AND IS PAINFUL. DID NOT TAKE PAIN MEDICINE TODAY. TEMP NOW 98.6 WILL ALL CLINIC AND UPDATE 1/18/10 FOR FOLLOWUP.  1/19/10 PHONE CALL FROM GUARDIAN-PROBLEM RESOLVED.
Swelling is there / a hard lump about the size of golf ball appeared under armpit; Itchy rash at injection site; Gland under arm is sore; headache; fatigue; Swollen gland under her arm since she got the shot / the size of a golf ball appeared under my armpit; had a faint  itchy rash at injection site; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of SWELLING (Swelling is there / a hard lump about the size of golf ball appeared under armpit), VACCINATION SITE PRURITUS (Itchy rash at injection site), LYMPH NODE PAIN (Gland under arm is sore), HEADACHE (headache) and FATIGUE (fatigue) in a 29-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Bee sting (Hives and illness.), Hives and Illness (due to bee sting). Concurrent medical conditions included Asthma and Hay fever. Concomitant products included ETHINYLESTRADIOL, NORGESTIMATE (TRI-SPRINTEC) from June 2020 to an unknown date for Birth control, ESCITALOPRAM from April 2012 to an unknown date for Depression and Anxiety.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 20-Mar-2021, the patient experienced SWELLING (Swelling is there / a hard lump about the size of golf ball appeared under armpit), VACCINATION SITE PRURITUS (Itchy rash at injection site), LYMPH NODE PAIN (Gland under arm is sore), HEADACHE (headache), FATIGUE (fatigue), LYMPHADENOPATHY (Swollen gland under her arm since she got the shot / the size of a golf ball appeared under my armpit) and VACCINATION SITE RASH (had a faint  itchy rash at injection site). On 21-Mar-2021, VACCINATION SITE PRURITUS (Itchy rash at injection site) and VACCINATION SITE RASH (had a faint  itchy rash at injection site) had resolved. On 02-Apr-2021, SWELLING (Swelling is there / a hard lump about the size of golf ball appeared under armpit), HEADACHE (headache), FATIGUE (fatigue) and LYMPHADENOPATHY (Swollen gland under her arm since she got the shot / the size of a golf ball appeared under my armpit) had resolved. At the time of the report, LYMPH NODE PAIN (Gland under arm is sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was reported.   This case was linked to MOD-2021-237386 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Updated Patient details, medical history, updated Rechallenge fields,concomitant medication, outcome event from Unknown to Recovered, added new events Vaccination site rash, Vaccination site pruritus
5 minutes after vaccine administration, pt reported back spasms and pain, also felt difficulty breathing. Pt went home to rest.
This is a spontaneous report from a contactable consumer. A female patient, of an unspecified age, received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, in left arm, on an unspecified date, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. On an unknown date, the reporter read an article dated Jan 12, 2021 about a woman who had "uncontrollable shaking and tongue spasms" after receiving the vaccine. It was called "some kind of conversion thing to do with the nervous system." The reporter stated she read the woman also received her injection in the same arm as she did. Reporter would like to know if tingling and muscle spasms are a side effect of the vaccine. The reporter was concerned because in her research she has not seen a breakdown of any specific adverse events occurring with specific ethnicities. The outcome of events reported unknown for all. No follow-up attempts possible. Information about batch/lot number cannot be obtained.
Patient reported hives on arms, torso, and back as well as itching. Did NOT experience shortness of breath, difficulty breathing or other allergic reaction symptoms.
Flu vaccine taken 10/26/12 at 1130 am & awoke w/ a red, raised macular rash 10/28/12 on chest. Rash spread up her neck to face & down both arms to fingers. Extremely itchy & painful. Treated w/ prednisone, topical cream, Hydroxyzine. Didn't feel good for 3 weeks, but fine now.
fever 100.4; sore arm; aches; chills; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of unspecified age received BNT162B2, via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received Covid vaccine and was good for first 12 hours, then developed sore arm, aches, fever 100.4 and chills on an unspecified date. She wanted to know if her family is susceptible because she had a fever. She was fever free today (06Feb2021). The patient recovered from fever on 06Feb2021 while the outcome of other events was unknown.  Information on the batch/lot number has been requested.
On October 5th, I had a sore throat and a runny nose. I tested negative for COVID-19. On Thursday morning, I developed a cough as well. I tested negative for COVID-19 again. Thursday night, same symptoms and tested negative for COVID-19 again. Friday morning, I had the same symptoms, but I tested positive for COVID-19. I called my doctor and was told I was not a good candidate for the antiviral due to the interactions with the medication I already take. She advised me to take over the counter cough medication and a decongestion. She asked me to call her back on Monday if my symptoms didn't improve. I took DAYQUIL and AFRIN nasal spray. Saturday, I no longer had a sore throat, but I lost my sense of taste and smell. My cough got worse. Sunday, I had all the same symptoms, and the cough was still getting worse. I called my doctor Monday morning. She prescribed codeine cough syrup. I was told to take MUCINEX instead of DAYQUIL. I was also told to continue taking AFRIN and to add CLARITIN. The symptoms persisted Tuesday and Wednesday. Wednesday afternoon, my cough started to get better. My cough continued to get better until Saturday. I stopped taking all the medications on Monday, the 17th. My cough came back in the middle of the week. On Friday, the 21st, I refilled the prescription for cough syrup and started taking AFRIN and CLARITIN again. I am taking all three currently. My cough persists.
Rash; Rash is warm to the touch; Rash is a red circle; Lump under the rash; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2022-2023 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th October 2022, the patient received Fluarix Tetra 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device. In October 2022, less than a week after receiving Fluarix Tetra 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced rash, skin warm, red rash and mass. On an unknown date, the outcome of the rash, skin warm, red rash and mass were not recovered/not resolved.   It was unknown if the reporter considered the rash, skin warm, red rash and mass to be related to Fluarix Tetra 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device.This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-OCT-2022  Reporter's Comment: The reporter reported that, patient received Fluarix Quadrivalent on Sunday, between 1:15 and 1:30pm.  The reporter stated that, patient reported becoming aware of rash at the time of reporting.  The reporter reported that, patient might have had rash yesterday, but only became aware of it at the time of reporting because it began bothering them.  The reporter reported that, patient stated rash was warm to the touch and had the appearance of a red circle, but did not elaborate on size of circle.  The reporter reported that, patient stated there was also a lump under the rash. The reporter reported that, patient reported no allergy to eggs or latex.  The reporter consented to follow up with HCP.
My Menstrual cycle has been lasting 15 to 25 days each month since February 2022 to present day after my third dose of Moderna in November 2021. I believe it could be related to the vaccine. My cycle was always regular until this point
Bell's palsy; Low grade fever; Felt tired; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Bell's palsy), PYREXIA (Low grade fever), FATIGUE (Felt tired) and NAUSEA (Nauseous) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced PYREXIA (Low grade fever), FATIGUE (Felt tired) and NAUSEA (Nauseous). On 14-May-2021, the patient experienced BELL'S PALSY (Bell's palsy). The patient was treated with PREDNISONE for Bell's palsy, at an unspecified dose and frequency. On 06-Feb-2021, PYREXIA (Low grade fever), FATIGUE (Felt tired) and NAUSEA (Nauseous) had resolved. At the time of the report, BELL'S PALSY (Bell's palsy) was resolving.            No relevant concomitant medications were reported. Patient had Bell's palsy and was brought to ER and stayed for less than 24 hours. As per doctors, the event Bell's palsy wasn't related to the vaccine. Treatment for the events included anti-viral medication and eye drops.  Company comment: This case concerns a 75 year old female patient, with no relevant medical history, who experienced the expected event of Bell's palsy. The event occurred approximately 4 months after the second dose of Spikevax. The benefit-risk relation of Spikevax is not affected by this report. Event of Bell's Palsy was automatically upgraded as a Serious event. However, based on information available and as per medical criteria was classified as Non-serious.   Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2021: Follow up received contains no new information.; Sender's Comments: This case concerns a 75 year old female patient, with no relevant medical history, who experienced the expected event of Bell's palsy. The event occurred approximately 4 months after the second dose of Spikevax. The benefit-risk relation of Spikevax is not affected by this report. Event of Bell's Palsy was automatically upgraded as a Serious event. However, based on information available and as per medical criteria was classified as Non-serious.
After a couple of hours stream pain in the left arm and headache. Next day fullness in the stomach and nausea. Body felt like flue symptoms.
Pt with 8x6cm of erythema, 5x5cm of induration.  NOT ALL INFORMATION IS AVAILABLE.
Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Allergic: Rash Generalized-Mild
she got the vaccine herself a while ago and didn't feel like myself for a month after; This is a spontaneous report received from a contactable consumer (patient herself). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number and Expiration date was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the caller stated that, she got the vaccine herself a while ago and didn't feel like myself for a month after. The outcome of the event was unknown.
Narrative: 74yo in MICU unit inpatient with the following diagnoses: Hx of CVA, poa, Hypophosphatemia, not poa, AAA, with mesenteric atherosclerosis, poa, CVD, poa, HLD, poa, Bladder Cancer, poa, BPH, poa, BPH, poa, COPD, poa, History of AVR, 9/2011 for severe AS s/p mechanical valve, poa, HFrEF (EF: 35%), UTI, not poa, Troponemia, not poa, & Leukocytosis, not poa presented to agency ER on 8/19/2021 for age related debility requiring long term placement. Pt was admitted to a medicine team. Pt had declined on 9/4/2021 and was transferred to MICU. On 9/5/2021 pt died. Per Md death note - Death was caused by: Acute Hypoxic Respiratory Failure Pt had received covid vaccines on 3/9/2021 & 4/7/2021. Pt's death is not related to covid vaccines
An MA reported that a child received an injection of Acel-Imune and subsequently, developed an unspecified reaction. This is 1 of 5 pts from this facility who experienced an adverse event following receipt of Acel-Imune, lot 467009. The reporter indicated that 5 pts experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided.
Following vax pt felt hot, no temp measured; rash other than @ inject site, generalized adenopathy, hives, pain in joints, tenderness in joints, paresthesis continues as of 20MAY91;
No noted adverse reaction. Patient received Dtap vaccine instead of the recommended Tdap vaccine. Patient received adequate protection with Dtap. No need to further immunize. Watch for increased local reaction and/or increased joint, muscle aches per Sanofi medical information services.
Headache; General body pain; Palpitations; Menstruation increased; Menstrual flooding; Menstruation normal; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION NORMAL (Menstruation normal), HEADACHE (Headache), PAIN (General body pain), PALPITATIONS (Palpitations) and HEAVY MENSTRUAL BLEEDING (Menstruation increased) in a 46-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.     Concomitant products included QUETIAPINE FUMARATE (SEROQUEL) and SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.   On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced MENSTRUATION NORMAL (Menstruation normal), HEAVY MENSTRUAL BLEEDING (Menstruation increased) and HEAVY MENSTRUAL BLEEDING (Menstrual flooding). On 13-Apr-2021, the patient experienced HEADACHE (Headache), PAIN (General body pain) and PALPITATIONS (Palpitations). On 14-Apr-2021, HEADACHE (Headache), PAIN (General body pain) and PALPITATIONS (Palpitations) had resolved. At the time of the report, MENSTRUATION NORMAL (Menstruation normal), HEAVY MENSTRUAL BLEEDING (Menstruation increased) and HEAVY MENSTRUAL BLEEDING (Menstrual flooding) outcome was unknown. Not Provided          Treatment information included Tylenol. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-083459 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-083459:cross linked to Dose 1
Received vaccination and for subsequent 2 days had ongoing tachycardia and dizziness.  Temp to 103.  She went to ER and received IVF (as per ER notes)
Pt recvd vax & devel hives p/vax; resolved 4-5 days, sx recurrent;
Patient received her second dose of pfizer vaccine and 10 to 15 minutes into the vaccine, she started seeing flashing lights with circle shapes but no other symptoms. Patient was awake, alert and oriented.  The flashing lights does not seem to go away so advised patient to lie down on the couch to allow blood flow to the head. Patient started feeling a little better, still alert, oriented and engaged in conversation. She is still seeing flashing lights that are like shooting stars. followed by headache. At this point, we elevated her leg up by putting pillows under the leg to allow more blood flow to the brain. Patient said she hydrated herself the day before and the morning of the vaccination and ate about an hour ago.  She said she is feeling better but feels cold, little nausea, headache and still seeing flashing lights. Patient took some tylenol at this point for the headache. Patient was observed for about 50 minutes total post vaccination, patient did not have any anaphylaxis type of reaction. She started feeling better and just wanted to rest on the couch so pharmacy team left patients home. Pharmacy  called about 20 minutes later to follow up and patient says no more headache but now she has diarrhea. Patient advised to make sure to keep herself hydrated and eat bland food- banana, rice etc. Patient also advised to call 911 or their PCP if symptoms gets worse and does not go away within the rest of the day.
Developed throat tightness and hoarse voice and anxiety approx. 45 minutes following receiving the seasonal flu vaccine. Went to ER and eval. by MD. Received BENADRYL x 1 50 mg PO and symptoms resolved within 15 minutes.
her uncle received an unknown shingles vaccination about a year ago and developed shingles; This spontaneous report was received from a consumer referring to a 92-year-old male patient. The patient's pertinent medical history, concomitant drugs and drug allergies were reported unknown. His historical vaccine included unspecified skin condition shingles vaccine in 2016.   In 2020, the patient was vaccinated with the first dose of zoster vaccine live (ZOSTAVAX) (dose, strength, frequency, route, lot number and expiration date were not reported) for prophylaxis.   In 2020, he got shingles after the first shot of zoster vaccine live (ZOSTAVAX). The action taken with zoster vaccine live (ZOSTAVAX) was not applicable. It was unknown if the patient sought medical attention and if he received any treatments. The outcome of shingles was not provided.   The causality assessment between shingles and zoster vaccine live (ZOSTAVAX) was not provided.