chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Body aches; Super late period; Tired; Headache; This is a spontaneous report from a contactable consumer (patient).  A 32-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown) via an unspecified route of administration, in left arm on 29Apr2021 at 08:15 (at the age of 32-years-old) as dose 2, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: unknown) via an unspecified route of administration, on an unspecified date as dose 1, single for COVID-19 immunization. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Patient had not received any other vaccines within four weeks prior to the COVID vaccine. On 30Apr2021 at 08:00, the patient had experienced body aches, super late period, tired and headache. Therapeutic measures were not taken as a result of the events reported. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On 3/10/2021 Migraine headache started at 6:15pm Ear ringing (tinnitus) started at 7:00 pm  3/11/2021 Additional hearing muffled was was noticeable  3/16/2021: severe migraine, throwing up, nauseous  3/17/2021: facial rash prominent   **hearing loss deemed permanent, ringing continuous
This worker was able to draw up 2 doses (of 0.25ml) out of 1 vial that was labeled single dose vial. There was enough vaccine in vial to make up two doses. Gave correct dose of 0.25ml to client who was 6 years old.
I had covid nov 23 2020.  On jan 25 I had a stroke  Couldn't talk. Couldn't move my left arm or leg.  I received TPA.
Patient received Moderna COVID vaccine on 2/14/21 (lot #031L20A), 3/14/21 (lot #003A21A), 10/30/21 (lot #006D21A), and Pfizer bivalent COVID vaccine on 11/9/22. On 11/19/22, patient admitted to our inpatient facility (med/surgical unit) with pneumonia due to COVID-19 virus with acute hypoxemic respiratory failure due to COVID-pneumonia, acute encephalopathy secondary to hypoxia and pneumonia, and malignant neoplasm of lung with metastasis, with cancer associated pain. As of today (11/23/22), patient is still admitted in the med/surgical unit.
Patient received MMR, VZV, HIB, PCV and developed fever one day after; then rash; rash worsened and covered child's entire body as well as swelling of lymph nodes in neck. Child was examined by MD and dx with reaction from MMR vaccine.
Residual effects /SOB; Nausea; Vomiting; This spontaneous case was reported by an other health care professional and describes the occurrence of DYSPNOEA (Residual effects /SOB), NAUSEA (Nausea) and VOMITING (Vomiting) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 012L20A) for COVID-19 vaccination.     The patient's past medical history included Shoulder operation (Patient had right shoulder surgery over 10 years ago). Concurrent medical conditions included Contrast media allergy. Concomitant products included RALOXIFENE HYDROCHLORIDE (EVISTA) for Bone disorder NOS.   On 14-Jan-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021 at 4:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced NAUSEA (Nausea) and VOMITING (Vomiting). On an unknown date, the patient experienced DYSPNOEA (Residual effects /SOB). At the time of the report, DYSPNOEA (Residual effects /SOB) outcome was unknown and NAUSEA (Nausea) and VOMITING (Vomiting) had resolved with sequelae.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.   This case was linked to MOD-2021-027190 (Patient Link).
103 fever, severe headache lasting 48 hours, chills, severe achey pain and unwell feeling, nausea. Sudden night waking with seeming hallucinations.
This is a spontaneous report from a contactable consumer who reported for herself and from a contactable nurse. An 80-year-old female patient (height about 5 feet 6 and half inches) received PREVNAR 13 (Lot # M06899), intramuscular at 0.5 ml, single in the left deltoid on 30Oct2015 at 10:25. Medical history included ongoing blood pressure abnormal. Concomitant medication included atenolol (unknown manufacturer) at 50 mg 1x/day, amlodipine (unknown manufacturer), at 2.5 mg for blood pressure abnormal and benazepril (unknown manufacturer) at 20 mg once all started taking it a long time ago and ongoing for blood pressure abnormal. The patient experienced headache and fatigue on 10Nov2015 with outcome of not recovered, muscle weakness and decreased appetite on an unspecified date with outcome of unknown. The patient was hospitalised on 15Nov2015 for 2 days. She did not take any treatment for headaches and fatigue. The consumer mentioned that she had her last blood work done on 30Oct2015 and result was normal. the patient underwent heart catheterization with stent placement on 16Nov2015. Follow-up (15Dec2015): New information obtained from a contactable nurse includes: hospitalization, route of administration, lot # and surgical procedures.
Information has been received from a health profesainal concerning a 4 year old Caucasina female with penicillin allergy who on 08/01/97 at 2:15 pm was vaccinated with a first dose of Varivax in the right thigh. Concomitant therapy included  then fourth dose of alum, potassium tripedia in the left thigh and a third dose of OPV. On 01/18/2001, the patient developed a rash of 5 to 6 little spots for 3 to 4 days. The patient's mother thought it may be chicken pox. The patient was scheduled to see the doctor on 01/19/2001, and was treated with Benadryl and recovered. It was also noted that the patient was exposed to chicken pox at daycare. No further information is available.
Repeated increase heart rate without chest pain/SOB. BP 120/80, HR 108, FS 257. Patient taken to ED
10/20/09 Elevated blood pressure, chest and back pain BP 185/100. Treated with medication after ER visit. Patient is taking hypertension medicine after ER visit. Was not taking meds prior to 10/19/09 or on day of vaccination. 10/27/09 BP meds. BP down to 130/100. (NORVASC 2.5mg qd Hg Lopressor 100 mg qd Hg ASA 81mg qd Hg).
pt recvd Hep B vax 1st dose & devel fever on 11SEP92 & 14NOV92 devel papular erythemtha, some macular rash on top head & neck 15SEP -> 17SEP some rash on face;
PATIENT WAS LIGHT HEADED AND FELT FAINT, ALSO HAD TINGLING SENSATION IN ARM.
After the first dose her husband tested positive of Covid 19/ came down with COVID symptoms.; This is a spontaneous report from a Pfizer-sponsored program, COVAX US support, via a contactable consumer. This consumer reported similar events for two patients (herself and her husband). This is the second of two reports.   A 49-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/lot number: EW0161, Expiry Date: 31Jul2021) via unspecified route in the left arm on 17April2021 (at the age of 49-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that after the first dose the patient tested positive of COVID-19. On 21Apr2021 he came down with COVID symptoms. On 22Apr2021 he got a positive COVID test. He was due for the second shot on 06May2021 and reporter was asking if he needed to wait some time before getting the second dose. The reporter stated they (herself and husband) both got the vaccine and they both got the virus. The clinical outcome of "after the first dose, patient tested positive of COVID-19" was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021511584 same reporter/drug, different patient
9-28-17 7:06 PM red, warm and puffy at injection site. 9-29-17 22:00 arm is worse, red, firm, warm and itchy (redness extended to mid upper arm). 9-30-17 9:14 AM arm looks much better no red, no puffy, no warm. Mom gave him BENADRYL and Ibu and ice on 9-29 and 9-30-2017.
05/18/2022 Symptoms started.    Tested positive on an At Home COVID-19 test 5/19/2022.  Symptoms were runny nose, sneezing, fatigue and a tickle in the chest that never resulted in a cough but felt like I was going to cough. for 10 days.   Sought care on 5/18/2022 as husband was symptomatic.  The doctor performed a rapid COVID-19 test and I was negative on 5/18/2022
Administration of expired dose >30 days in frigde; Product storage error; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired dose >30 days in frigde) and PRODUCT STORAGE ERROR (Product storage error) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired dose >30 days in frigde) and PRODUCT STORAGE ERROR (Product storage error). On 17-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Administration of expired dose >30 days in frigde) and PRODUCT STORAGE ERROR (Product storage error) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 02-FEB-2022, case MOD-2022-467027 became invalid as there are no identifiable patient who received the Moderna vaccine. Therefore this case will be logically deleted from the safety database.  No concomitant medication and treatment information was reported. Reporter stated that the vials were put in the refrigerator and it was only good for 30 days but it had been 60 day and were administered to patients. 30 doses were administered from 6 vials. On 29-Nov-2021 the vial was initially stored in the refrigerator. The vial did not go any temperature excursions. Date of administration of vaccine was given as: 17-DEC-2021 - 1 vial 28-DEC-2021 - 1 vial 14-JAN-2022 - 2 vial 28-JAN-2022 - 2 vial  Reporter stated that Per Moderna CMC Lot analysis, regarding dose(s) administered on 3Feb2022 at 12:45pm: Moderna cannot guarantee patients received full protection against the COVID-19 Virus.   This case was linked to MOD-2022-467053, MOD-2022-467081, MOD-2022-467090, MOD-2022-473378 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Feb-2022: Follow-up received with added reporter's information and narrative was updated. On 04-Feb-2022: Follow up received on 08-FEB-2022 which contains no new information.
Event occurred after 2nd dose. Patient was diagnosed with COVID Tylenol, Zinc In-patient
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 21-year-old male. Neither medical history nor concomitant medications were reported. On 24-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.
coughing; Phlegm in the throat; Vomiting; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing), PRODUCTIVE COUGH (Phlegm in the throat), VOMITING (Vomiting) and NAUSEA (Nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Pneumonia (Previously had pneumonia and took antibiotics for it.).    On 24-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On an unknown date, the patient experienced COUGH (coughing), PRODUCTIVE COUGH (Phlegm in the throat), VOMITING (Vomiting) and NAUSEA (Nausea). At the time of the report, COUGH (coughing), PRODUCTIVE COUGH (Phlegm in the throat), VOMITING (Vomiting) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication were not provided. Treatment information were not provided.   Reporter did not allow further contact
PT WAS ONLY 17 AND RECEIVED VACCINE - MODERNA INDICATED FOR 18+
This spontaneous prospective pregnancy report was received from registered nurse, and refers to a female patient of unknown age. The patient's pertinent medical history and concomitant therapies were unspecified. On an unknown date, the patient became pregnant. The last menstrual period (LMP) and estimated delivery date (EDD) were not reported. On 08-JUN-2018, the patient was vaccinated with GARDASIL 9, intramuscular, lot # N022727, expiration date 12-JUN-2018, for prophylaxis (vaccine exposure during pregnancy). The pregnancy outcome was pending.
she felt tired; weak; joint pain; back pain; fever; This spontaneous case was reported by a nurse and describes the occurrence of FATIGUE (she felt tired), ASTHENIA (weak), ARTHRALGIA (joint pain), BACK PAIN (back pain) and PYREXIA (fever) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 immunisation.     No medical history was provided by the reporter.     On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced FATIGUE (she felt tired), ASTHENIA (weak), ARTHRALGIA (joint pain) and BACK PAIN (back pain). On an unknown date, the patient experienced PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FATIGUE (she felt tired), ASTHENIA (weak), ARTHRALGIA (joint pain), BACK PAIN (back pain) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Feb-2021, Body temperature increased: 101.6f High.     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.
I experienced an outbreak of herpes sores the day after the vaccine was administered. This also happened after my first and second dose. I did not report it the first time because I thought it was just a coincidence. I have medication (acyclovir) that I keep on hand for episodic outbreaks. I took that and the outbreak is resolving as normal. I did call the pharmacy after the first outbreak after my very first dose (June 2021) to verify that taking acyclovir would not affect the efficacy of the vaccine.
Bad headache (8 out of 10).Chills.Body aches.Fatigue
I just got really sick typical flu like symptoms and got pretty bad and also had a ear infection, went to urgent care clinic the next day on 12/31/21 and got antibiotics for the ear infection and they told me I could take Advil cold and flu for the symptoms.  My health started going down hill last year summer and now I take 2 heart medication and 1 sinus medication and a diuretic. I went from no meds to a whole bunch of meds in a year. I had to have surgery for my sinuses, they had to reduce tissue in my sinuses due to excessive tissue.  I also had to have tubes in my ears due to the swelling. I was told during my visit at the urgent care clinic my blood pressure was high and when I seen my PCP they put me on the blood pressure meds.
I was dying I felt so bad; Initial information regarding an unsolicited valid non-serious social media case received from a non-healthcare professional (patient) via social media on 23-Oct-2020.  This case involved a patient of an unknown age and gender who was dying and felt bad (Feeling abnormal), after receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by an unknown manufacturer (lot number and expiry date were not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date (unknown latency), it was reported that the patient would never get another dose. The patient was not sick but was coerced by one of co-worker to take and then immediately afterwards thought was dying and felt so bad (Feeling abnormal).  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome was unknown for the event of feeling abnormal.  There will be no information available on the batch number for this case.
Pt vaccinated with DTP developed find papular rash (pin head to slightly larger in size). Skin colored no redness or swelling. confined to anterior lateral aspect of lt thigh. Non-pruritic appeared on day following immunization.
first shot over a year ago; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st shingrix shot received over a year ago).   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 details were reported as follows: This case was reported by the patient for himself. The age at vaccination was not reported. The patient asked about the timing of the second shingrix shot and what to do if outside the 6 month window. The patient stated that he got his shingrix shot 1 year ago, which led to incomplete course of vaccination. The patient did not consented to follow-up.
has not been feeling well since receiving the pfizer covid vaccine; has an ongoing, non stop headache/her head really hurts; stuffy and runny nose; stuffy and runny nose; very tired and not herself; dizzy; seems like sinus issues going on; This is a spontaneous report from a contactable consumer (patient's mother) via Pfizer Medical Information department.    A 12-years-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: FA6780) via an unspecified route of administration on 24Jul2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications was not reported. On Jul2021 the patient experienced not been feeling well since receiving the pfizer covid vaccine, had an ongoing, non stop headache/her head really hurts, stuffy and runny nose, stuffy and runny nose, very tired and not herself, dizzy, seems like sinus issues going on. Therapeutic measures were taken as a result of has an ongoing, non stop headache/her head really hurts. The patient had an ongoing, non stop headache and was given Motrin. The patient also experienced stuffy and runny nose. The patient was very tired and not herself. The clinical outcome of the event seemed like sinus issues going on. Patient did not recover at the time of this report while other events outcome was Unknown.  QR Comment: Reporter type was not available over the call as the reporter denied answering further questions, hence reporter type captured as consumer or non-healthcare professional by default.   Follow-Up (05Aug2021): Follow-up attempts are completed. No further information is expected.
Fever, as high as 102.  Chills.  Headache.  Neck ache.  Fatigue.
I received the vaccine at around 11:50 in the morning and by 11 pm at night I was in immense pain. It came on really fast and felt like my joints and bones were on fire. I was in immense pain for about 6 hours before finally passing out from exhaustion from being so miserably in pain.  I felt feverish, had horrible muscle and joint pain, migraines, and tiredness that was beyond something I've ever experienced before.  That was just after receiving the vaccine, For the last 4 and a half weeks I have continued to have immense joint and muscle pain, and a feeling of exhaustion that isn't explainable,  I can't sleep and literally no medication is helping me be able to get sleep. I can't lift or open a jar of tomato sauce because my muscles are so weak.  I am not able to do the things I was before getting the vaccine. It has really hurt and weakened my immune system to the point that I am barely functioning. I am continuing to get intense migraines as well.  I've been dealing with these symptoms for the last month and have been miserable. I have two jobs and I can barely sleep and its only now, a month later I started to pinpoint when I started to feel crummy, which was after receiving the vaccine.
Patient reports feeling very thirsty, dry mouth. Had reflux and flushing. Felt her heart was beating fast.
PT RECEIVED PNEMOVAX 23 IMZ IN RIGHT DELTOID AND A FLUCELVAX IMZ IN LEFT DELTOID ON 9/13/23. SHE STOPPED BY PHARMACY ON 9/14/23 WITH HER SISTER. SHE STOPPED BY PHARMACY ON 9/18/23 AND SHOWED ME A LARGE BRUISE ON HER RIGHT ARM. THE BRUISE WAS FROM HER RIGHT SHOULD TO THE ELBOW. THE BRUISE WENT AROUND THE WIDTH OF HER ARM. SHE STATES THERE WAS REDNESS, PAIN, AND A LUMP WHERE SHE RECEIVED THE IMMUNIZATION ON THE RIGHT DELTOID ON 9/14/2023. SHE STATES SHE PUT ICE ON THAT AREA ON 9/14/23. SHE STATES THE PAIN IS GONE TODAY. SHE STOPPED BY THE PHARMACY TO SHOW ME THE BRUISE.
pt had hives all over body 1-2 days after the vaccine. pt reports she often has a red area around injection site, but this time it is hives on arms, middle and many places
pt recv vax 8APR96 & that same day pt exp a sore throat, cough, upper resp malady & disturbed sleep;no further details were provided
Sporadic pain in left arm behind muscle. Tingling/Numbness from point of injection to fingertips. Pin in front and rear should joint.
Within 30 minutes after receiving Influenza vaccine, developed throat tightness, oral swelling, vocal change. See in E.D., received x 3 I.M. doses Epinephrine, then an Epinephrine infusion. Admitted to ICU. Discharged 10-16-15.