chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It was reported that a female patient received a Fluzone SV vaccination on 11/10/2000. Within 18 hours of vaccination the patient developed Bell's Palsy to the left side of her face. The patient was treated in the ER and released. From additional correspondence received on 02/22/2001, it was reported that the patient recovered from this experience. Additional patient, vaccine administrator and responsible physician information were also provided. No further information is anticipated. This case is closed.
This spontaneous report was received from a registered pharmacist concerning a female patient who on 07-JUL-2012 was vaccinated SQ with a single 0.65 mL dose of ZOSTAVAX (lot # not provided). On 08-JUL-2012, the patient went to the pharmacy and had a hard knot at the injection site and had diarrhea. No treatment was given for the events. At the time of the report, the patient had not recovered from the events. The relatedness for the events was unknown for ZOSTAVAX. The patient did not seek medical attention. Additional information has been requested.
Patient had experienced flu-like symptoms, muscle aches, chills, fatigue, etc. about a day after receiving the vaccine. She had not experienced these symptoms with the first dose of the vaccine.
Patient reports experiencing shortness of breath that started within the week after her first dose of COVID vaccination and continues to this day. (She also reports experiencing fever and chills that started the evening after vaccination and was gone within 24 hr, which was expected.) Pt has hx of COVID (June 2020). Pt talked to Dr. about her SOB and completed a steroid and antibiotic course from prescriber. She was advised to follow up w/ her Dr. concerning her continued SOB.
doesn't feel tremendous; similar to his other disease, polymyalgia rheumatica; couldn't move; bones and muscles were aching and he couldn't move; fever; nausea; arm was just sore; A spontaneous report was received from a consumer concerning a 68-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm was just sore (vaccination site pain), similar to his other disease, polymyalgia rheumatica (polymyalgia rheumatica aggravated), bones bone pain and muscles were aching (myalgia) and he couldn't move (mobility decreased), fever and nausea and couldn't get out of bed (mobility decreased) and doesn't feel tremendous (malaise).   The patient's medical history was not provided.  No relevant concomitant medications were reported.  On 25 Feb 2021, prior to the onset of the symptoms, the patient received the first of two planned doses of mRNA-1273 (Batch number: 10A21A) intramuscularly for prophylaxis of COVID-19 infection.    On 25 Feb 2021, the patient's arm was just sore.   On 26 Feb 2021 in the middle of the night patient woke up and symptoms he experienced were similar to his other disease, polymyalgia rheumatica. The patient's bones and muscles were aching and he could not move. He had a fever and nausea and could not get out of bed. At the time of reporting, the patient did not feel tremendous, but felt a little better.   Treatment for the event included acetaminophen and ibuprofen.  Action taken with mRNA-1273 in response to the events was unknown.  The events, arm was just sore, bones and muscles were aching, he couldn't move, fever, nausea and couldn't get out of bed were considered resolved on 28 Feb 2021. The event, doesn't feel tremendous, was considered resolving. The outcome of the event, similar to his other disease, polymyalgia rheumatica, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient is pregnant and received the first dose of the vaccine; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Patient is pregnant and received the first dose of the vaccine) in a 34-year-old female patient (gravida 5) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 17-Aug-2021. On 20-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Patient is pregnant and received the first dose of the vaccine). On 20-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Patient is pregnant and received the first dose of the vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product information was not provided.  Treatment information was not provided.
This patient had tingly numbness, joint stiffness, neck pain, and joint pain. Per doc 212646, patient still has joint pain, soreness.
pt presented to Santa rosa ER approx 3 hrs p/vax assessment was febrile seizure vs febrile teething;
Soreness in her left arm; Runny nose; Tenderness in her left arm; General weakness; Flu-like Symptoms; Her head is bloated; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in her left arm), RHINORRHOEA (Runny nose), TENDERNESS (Tenderness in her left arm), ASTHENIA (General weakness) and INFLUENZA LIKE ILLNESS (Flu-like Symptoms) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced RHINORRHOEA (Runny nose), TENDERNESS (Tenderness in her left arm), ASTHENIA (General weakness), INFLUENZA LIKE ILLNESS (Flu-like Symptoms) and HEAD DISCOMFORT (Her head is bloated). On an unknown date, the patient experienced PAIN IN EXTREMITY (Soreness in her left arm). At the time of the report, PAIN IN EXTREMITY (Soreness in her left arm), RHINORRHOEA (Runny nose), TENDERNESS (Tenderness in her left arm), ASTHENIA (General weakness), INFLUENZA LIKE ILLNESS (Flu-like Symptoms) and HEAD DISCOMFORT (Her head is bloated) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.
1/15 through 1/19 Pt was hospitalized for COVID symptoms and diagnosed COVID +. received remdesivir and plasma on 1/15. 1/19 discharged home and doing well until 2/12 2/11 received pfizer vaccine 2/12 readmitted to hospital after being found unresponsive at home, sats 35%, rales, temp 103.8, CXR infiltrates, placed on PR mask then BIPAP- diagnosed with cytokine storm possibly from vaccine. 2/13 sats 78% on BIPAP, sweating, rapid response called and stabilized 2/16 pt found with left sided weakness, droop and left arm flaccid. CT scan revealed ischemic stroke 2/17 6L salter lab remain weak on left side 2/19 increased to 10L salter lab 2/20 possible aspiration - worsening sats 2/21 continues to have decreased sats PR mask at 15L. then back on BIPAP 2/22 discussion with family about poor prognosis. DNR comfort. 2/23 Pt passed away
Sensitive skin Cold chills Moderate headache 101 fever  Weezing dry cough Tired   Most conditions gone by Friday morning  Cough lasted until Friday night  Headache still lingering as of Saturday
Chest tightness, increased heartbeat , no energy , no energy , trouble breathing, Nausea
Syncopal episode, unconscious approx 4 mins,,pale diaphoretic, dizzy, nausea and vomiting, black sugar 80, BP 166/109 , HR 100,Resp 24.  Alert and oriented x4,   vitals before transit. P 86, pulse ox 95% ,  BP  Tx: Hosp161/95.
Developed extreme pain in injection site several hours after injection. Became worse the next day with a hot, red circle around it.  The red circle became even larger today (More than 48 hours later. It is hot to the touch and hard.
Received shot in left arm--it seemed high as per patient. Patient indicated that it was pulled immediately and hard and she felt pain right away and she did bleed (soaked a cotton ball)--the arm was very sore that evening--raised swollen and hard area. Next morning patient felt chills, shakes, body aches, headache, and a fever (100.9--taken 1.5 hours after taking Acetaminophen 500 mg--1 tablet). Came home after work, still feeling terrible. Called Urgent Care and she was seen. Now are is bruised. She was diagnosed with cellulitis--cephalexin 500 mg TID X 7 D.
This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age and gender who on an unknown dates were vaccinated with improperly stored doses of RECOMBIVAX HB 2.5 MCG/0.5, (dose, route, lot # and expiration date were not provided). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
"Moderna COVID-19 Vaccine EUA"  Severe chills, fever 100, nausea started at 2:00 AM. Threw up 3 times, fever and chills ended about 4:30 after hubby gave me Tylenol. Next day stayed in bed with weakness and achy body.  2nd day still weak but did move around with naps in-between.  Sunday stayed up and feeling much better.
Intractable H/A for 5 weeks. Severe, intense, no ability to concentrate, aura, light sensitivity, pounding, etc.  Treatment with Imitrex (oral), Trazodone (then temporarily replaced with cyclobenzaprine, and subsequently tizanidine); OTC: Tylenol. Peaking throughout the first 3.5 weeks, then waning.  Then, got 2nd dose of vax and H/A began to peak again 3 days later. Took injectable imitrex once, resolved to very low grade H/A within 45 min. Then was nearly completely gone by 3/8/21.   2/5/21 H/A began. Increased in intensity to the most intense, severe, mentally distracting/unable to focus or function normally H/A I ever experience. Intractable H/A. Cannot take Advil and Tylenol was barely helping at all. The intensity kept increasing over the course of a week, where I finally realized it's not going away and I need to seek care.  2/8/21 & 2/12/21 Telehealth visit with my PCP. DX: R51.9; RX: Trazodone (25mg/night), Sumatriptan 50 mg tablet (total of 9 tablets). 2/26/21: In person Urgent Care visit per PCP advice, as her schedule wasn't open. Dx: G43.011. RX: Sumatriptan 6 mg/0.5 mL injection pen kit (used 1 pen dose 3/4/21), Reglan (did not take raglan). 3/4/21: Spike in H/A that was reducing intensity the week prior. Began with an aura, began peaking, realized what this was, took the Sumatriptan injection, within 45 min stopped the peaking of the H/A. 3/8/21: E- Consult Peer to Peer: Neuro to PCP; By this time, the headache had waned to nearly gone, no meds needed.  4/7/21: Telehealth Neuro Consult - concluded this was vax rxn, as I have no prior hx of anything remotely similar.
A mother reported that her 2 month old son received his 1st doses of Hib-Titer and Acel-Imune vaccines on 1/10/00 and inquired about the thimerosal content of said vaccines. The next day, he experienced many petit mal seizures and was hospitalized for 48 hours. Exams, including spinal were within normal limits. The mother decided that her child would not receive further immunizations. At 13 months of age, he cut his finger and required a tetanus vaccine. After this vaccine, she noticed that her son's language skills decreased significantly. A dx of autism was made. See related HQ2288713MAY2002. Additional information received from the pediatrician on 01 Jul 2002 provided concomitant vaccine and follow up to the seizure episode. A mother reported on 09May2002 that her 2 month old son received his first doses of Hib-Titer and Acel- Immune vaccines on 10 Jan 2000 and inquired about the thimerosal content of said vaccines. The pediatrician indicated that the child was admitted to the hospital for seizure activity on 11 Jan 2000, and was discharged the following day. He was seen by neurologist on 17 Feb 2000. Neurological exam and EEg were normal, but it was recommened that the child not receive pertussis in the future.
pt recvd vax 6MAR96 & mom stated no problems;fed pt @ 5AM on 7MAR96;checked pt @ 7AM & found dead
Increases in RR, PCO2, ESR and CRP, SqO2 dropped, retracting, tachypnic tachycardia oxygen increased to 1/2 liter per nasal cannula, then placed on NPCPAP.
Initial and follow-up information has been received from a medical assistant concerning a 15 year old female who on 22-June-2007, was vaccinated in the right deltoid with a first dose of Gardasil (Lot #0211U), concomitantly with BOOSTRIX.  On 22-JUN-2007 the patient fainted.  It was reported that the patient came out of the room and stated "grandma" and went down on the floor.  The patient was treated with something to eat and drink for 1/2 hour.  It was reported that the patient had nothing to eat or drink since the night before.  On 22-JUN-2007 the patient recovered.  Medical attention was sought.  Additional information is not expected.
I felt extremely agitated and unsettled for several days after this shot. Increased anxiety and agitation. Not normal! Eventually that subsided but I have had cognitive lapses/forgetfulness and brainfog to a greater extent since my vaccination. I also contracted Omicron  January 2 of 2022.
This spontaneous prospective pregnancy report as received from a nurse practitioner for GARDASIL, a Pregnancy Registry product, refers to a 23 year old female patient with history of headaches, no drug reactions/allergies. On 24-SEP-2013, a urine pregnancy test was negative. On 30-SEP-2013, the patient was vaccinated with GARDASIL injection, 0.5 ml, intramuscular, lot # H021346, expiration date: 01-OCT-2015. No concomitant medications. On 14-OCT-2013, a urine pregnancy was positive. The patient was determined to be pregnant with LMP of 01-SEP-2013 and EDD of 08-JUN-2014. Initial exposure to GARDASIL was at 4 week(s). No problems reported. No treatment was given for adverse event. The patient sought medical attention, visited office. The pregnancy outcome was pending. Additional information has been requested.
Pain around back (still experiencing sympstoms/ sought physical therapy); This case was reported by a other health professional via sales rep and described the occurrence of back pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix .5 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced back pain. The patient was treated with non-drug therapy (Physical Therapy). On an unknown date, the outcome of the back pain was not recovered/not resolved.   It was unknown if the reporter considered the back pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 12-Sep-2022 Reporter's Comment: Patient reported that had pain for 2 months following administration of Shingrix on right arm, had physical therapy and pain around back.  The patient still experiencing pain. The reporter agrees to follow up from GlaxoSmithKline.
This spontaneous report as received from a nurse via Poison and Drug Centre refers to an unknown number of patients of unknown age and gender. Patients' medical history, concurrent conditions and concomitant medication were not reported. On unknown dates in 2017, multiple unspecified patients were vaccinated with GARDASIL. Dosing details, route of administration, lot number and expiry date were unknown. On an unknown date, in the beginning of 2017, the vaccine was reported to have been out of range. It was reported that "the other employees who record the temperature never reset the button". On 03-JAN-2017, for example, the "min/max" temperature was "33/47" (units unspecified) and "she didn't reset the button". The temperature was observed to be 43 (units unspecified) when she arrived at the office and when she left, it was 47 (units unspecified). It was never observed to be out of that range. It was also reported that "on the 3rd, 4th, 5th, and 7th, everything was in the same range and was 43, 38, 35, 45, 43, or 45" (units unspecified). As of 06-MAY-2017, it was not known if the patients were still administered the GARDASIL. This report is one of three reports that are linked via same reporter link. Additional information has been requested. Sender's Comments: US-009507513-1705USA007740: US-009507513-1705USA007741.
Received the second vaccine on 2/10/21 and just yesterday (3/3/21- 3 weeks after my second dose) started having pain/soreness at the injection site like I had immediately after the first and second doses. Unsure why the pain came back. My skin looks fine- no redness or raised from what I can tell.
05/11/2022 I had a slight sore throat. I called the doctor because I knew I had been exposed to COVID. She told me to wait until tomorrow and do a home test. I had allergy symptoms, nothing out of the ordinary for allergies, except the sore throat. The next day my COVID test was positive. I had a tele visit with the doctor the next day. He prescribed Paxlovid. I took it for 5 days. I have finished it now. My throat is still a little scratchy and I feel fine. I do not feel sick in slightest.
Left arm swollen, with purple area approximately 10 cm long and 10 cm wide on bicep/deltoid area, with purple bruise in center, erythema surrounding, warm to touch. Fever up to 101.3 same day as vaccine. No fever currently.
Patient has severe anxiety towards needles. After her vaccination she was pale, felt lightheaded, and was slightly nauseous. Knowing she would feel faint, the patient brought and drank most of a Slim Fast protein shake. Shortly after consuming the shake the patient's nausea worsened considerably and she vomited twice. The patient was monitored for another 45 minutes, after which she and her husband stated she felt better (color was back in face and she was much more alert) and the husband drove the patient home.  I called to check on patient a few hours later but only got voicemail  and asked her to call if she she still felt unwell.
Expired vaccine used; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021 at 11:25 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 04-Nov-2021 at 11:25 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 04-Nov-2021 at 11:25 AM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that upon delivery of each vaccine order the vaccines were placed into the freezer the same day they were delivered. They only removed a vial from the freezer and put it in the refrigerator the day before it was used. Thus, vaccines were not in the fridge for more than a day unless patients did not appear for their vaccine. They did not have a vial stay in the refrigerator for more than a week, since all unused vials were utilized for the following patients. No concomitant medications were mentioned. No treatment details were reported.
temperature excursion due to a refrigerator malfunction, dose post temperature excursion outside acceptable guidelines for excursion standards with no reported adverse event; Initial information regarding an unsolicited valid non-serious case received via health professional received on 19-Apr-2022.  This case concerns a 43-year-old female patient who experienced administering dose post temperature excursion outside acceptable guidelines per stability standard with no reported adverse event while receiving vaccine Diphtheria-2/Tetanus/5 AC Pertussis Vaccine (Adacel).  The patient's past medical history, concomitant medication, medical treatment(s), vaccination(s) and family history were not provided.  On 24-Mar-2022, the patient received a dose of suspect Adacel vaccine at a dose of 0.5 ml once with lot C5963AA expiry date 18-Jan-2024 via intramuscular route in the right deltoid for Immunization.  On 18-Mar-2022 the patient developed administering dose post temperature excursion outside acceptable guidelines per stability standard with no reported adverse event (product storage error) following the administration of Adacel vaccine. Reportedly negative 2.1 C from 07-Mar2022 until 31-Mar-2022 Did it occur due to a human error: No. Does extended stability data cover the excursion: No and in case of negative advice was the product used by/ administered to the patient: Yes-14   Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
Tingling & numbness in face, congusion & h/a are reported in pt who recvd flu vax; the day p/the vax, pt had tingling & numbness in face which lasted 24 hrs & confusion lasting 3 hrs; There were no apparent sequelae;
This spontaneous report as received from a pharmacist refers to a patient of unknown demographics. The patient's current conditions or medical history were not reported. On 07-JAN-2015, the patient was administered an expired dose of ZOSTAVAX vial lot number J011826,  expiration date 26-DEC-2014 (dose number, route of administration and anatomical location were not reported). No adverse effects were reported. Additional information is not expected as the reporter did not wish follow up contact.
feeling sick; laying down right now; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 58 year-old male patient received bnt162b2 (BNT162B2, Solution for injection), administration date 28Sep2021 (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE: 1), for COVID-19 Immunization; Bnt162b2 (DOSE: 2), for COVID-19 Immunization. The following information was reported: MALAISE (non-serious) with onset 2021, outcome "recovered" (2021), described as "feeling sick"; FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "laying down right now". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (28Sep2021) 126/88; body temperature: (28Sep2021) 98.9; heart rate: (28Sep2021) 99.  Additional Information: Consumer reported her 58-year-old son with special needs received the booster dose of the Pfizer-BioNTech Covid-19 Vaccine yesterday, 28SEP2021. Consumer wanted to know if the pulse rate was still normal. She also said that her son was still feeling sick and was laying down right now. She wanted to know if that was normal. Consumer provided mailing address and stated patient was doing fine.   Follow-up attempts completed. No further information is expected.
Chest tightness at first Hard to breathe  Feeling light headed  Feeling faint
Vaccine expired on 9-6-2021, was administered on 9-7-2021