chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE details; TE evaluation states vaccines have been administered to multiple patients; This spontaneous report was received from Other Health Professional and refers to unspecified number of patients.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patients were vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, unk, lot #U025790, expiration date: 19-AUG-2023 or U029496 with expiration date on 21-SEP-2023, administered for prophylaxis (strength, and route of administration were not provided). The vaccines underwent temperature excursion of -14°C up to-10 degrees C for 3 hours 0 and  -10 degrees C up to 8 degrees C for 1 hour 30 minutes. No adverse event was reported.  This is one of several reports from the same reporter. This case in non-valid due to the lack of the patients' identifiers.   Follow up information has been received from the physician's office, on 24-MAY-2022, referring to a 5 year old male patient.      On 11-APR-2022, the patient was vaccinated with an improperly storage dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # U025790 expiration date: 19-AUG-2023, subcutaneous (SQ), for prophylaxis (no previous vaccine administered) product storage error.     Temperature excursion occurred on 23-MAR-2022.      No further clarify.    ; Sender's Comments:  US-009507513-2205USA003614: US-009507513-2205USA007821: US-009507513-2205USA007847:Original Case : 2204USA009330 US-009507513-2205USA007852:Original Case : 2204USA009330
swelling of site of inject & eyes, wheezing/asthma, coriza, nasal secreations; resp distress; observation 6 hrs;
Pt recvd 3 doses of Hep B vax on 14APR92 approx 24 hrs later devel pruritic rash on face, arms, & legs; pt took DPH;
BlurredVision, Headache, SkinRash, UrticariaPruritus, Diarrhea, SOB,Facial swelling, Narrative:
Patient is a 43 y.o. female who presents with complaints of tachycardia shortness of breath and feeling as though she had difficulty swallowing after receiving her second COVID-19 vaccination. Patient denies any definite swelling to her tongue lips or face she denies any rash vomiting or diarrhea. She did she does have history of anxiety as well and sometimes this can occur. Also symptoms that she has anxiety puts her into a sickle cell crisis. She currently does not have any pain at initial evaluation. She has no fevers and no difficulty breathing at this point time. Patient received Zofran for some nausea after the vaccination, and nausea is now resolved. She did not receive any Benadryl or epinephrine
Physician reported that one day post vaccine the patient developed an injection site reaction characterized by swelling, warmth and itching. The reaction extended from mid-thigh to the knee. The patient was seen by the physician and treated with diphenhydramine, cefprozil, and applications of cold compresses. The child recovered by 6/12/00.
Pt completed 3 Hep B vax series & it was determined that pt was not protected; testing resulted in a neg response;
COVID 19 Death - 7/17/2021 - Admitted to ICU from ED with symptoms of shortness of breath, productive cough, diarrhea, and chills. Started 1 week ago. COVID19 PCR positive while in ED. Diagnosed with COVID19 Pneumonia. Expired later on same day 7/17/2021.
Irregular, very heavy and long period a week after receiving my shot. I take birth control regularly and have always had consistent and normal periods,  lasting less than a week. This has been the worst one of my life and is still very heavy with bad cramps, 12 days after onset.
Severe headache started on 1/14/21 and ended on 1/22/21 with no relief from otc oral medications.  Injection site was sore, red, swollen, warm, and itchy from deltoid to mid-forearm for same duration of time.
Roof of mouth swelling, soft pallet swelling (@10 minutes),right side of upper scalp went numb (@20 mins) spreading to brow ridge -right side then spreading to left  upper lip swelling (@30 mins). tongue and throat @40mins.  Epipen given, swelling improved within a minute observed for 4 hours then released
This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 09Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The 2nd dose will be on 30Apr2021. The patient experienced body pain, her mouth, jaw and her head hurts on an unspecified date.  Outcome of events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient developed erythema, warmth, pain at the injection site the day after injection, increased 2 days after injection with development of superficial blisters.   diagnosed with early cellulitis and Augmentin 875-125 mg prescribed twice a day for 10 days.
COVID 19 Pfizer vaccine dose#1 given 3/24/2021. COVID 19 Pfizer vaccine dose#2 given 4/16/2021. Developed puffiness and numbness on R side of face 4/29/2021. Evaluated on 5/2/2021 and diagnosed with Bell's Palsy. Will complete a four day course of steroid treatment.
Per mother report, on 4/8/06 child's left upper arm began to swell and become red and painful. Mom took him to the ER for medical treatment because of the swelling and pain. Child was given a script for an antibiotic while at the ER with instructions to begin it immediately after getting it filled.
Smelling cigarette smoke; This is a spontaneous report from a contactable consumer. A 50-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0153) via an unspecified route of administration in the arm left on 21Apr2021 at 18:00 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 in january and got fully recovered by 14 february. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included simvastatin (MANUFACTURER UNKNOWN) and lisinopril (MANUFACTURER UNKNOWN) both for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within 4 weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (COMIRNATY; Lot Number: er8732) via an unspecified route of administration on 24Mar2021 at 16:00 as a single dose for COVID-19 immunisation. On 23Apr2021 at 18:00, 48 hours after the vaccination, the patient constantly experienced smelling cigarette smoke regardless of where the patient was at. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event smelling cigarette smoke was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Bloody nose; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Bloody nose) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     The patient's past medical history included Thyroid disorder and Fibromyalgia.   On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced EPISTAXIS (Bloody nose). At the time of the report, EPISTAXIS (Bloody nose) outcome was unknown.            Concomitant medications included medications for thyroid and fibromyalgia.  No treatment details were provided.
Large local reaction (45mm x 10mm), tingling hands/feet, left ant thigh.
got explosive feeling headache suddenly /debilitating headache/ chronic headache; Migraine headache; Blood pressure still up and down; lots of pressure in head; Hypertension; This is a spontaneous report from a contactable other hcp. A 68-year-old female patient received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 05Feb2021 as DOSE 2, SINGLE for covid-19 immunization. The patient medical history was not reported. Concomitant medication(s) included estrogens conjugated (PREMARIN). Covid prior vaccination Yes. The patient previously took emycin [erythromycin] and experienced drug hypersensitivity, codeine and experienced drug hypersensitivity, None other medical history. Historical vaccine includes bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported), dose 1 for covid-19 immunization. Covid not tested post vaccination. On 28Feb2021 09:45 the patient experienced got explosive feeling headache suddenly /debilitating headache/ chronic headache since then. Seen by doctor on Fri 05Mar2021, diagnosed HTN (hypertension) she never had HNT. Seen Emergency room on Monday 3-8 due to debilitating headache. Told Migraine headache with HTN. Started Medrol Dose pack 3-9. B/P still up and down and headaches no longer debilitating but chronically top of scalp left side/ lots of pressure in head. On an unspecified date the patient underwent lab tests which included blood pressure measurement result still up and down, computerised tomogram result normal, electrocardiogram result normal, laboratory test result normal. Therapeutic measures were taken as a result of all the event's includes Lisinopril 10mg/ Medrol Dose 6 day pack. The outcome for all events was not recovered.   No follow-up attempts are possible. No further information is expected.
pt recvd vax; had fever; T inc to 104; onset of fever 8-12 hrs p/ vax; fever reduced w/ acetaminophen;
Breakthrough COVID case.  1st dose: 2/24/2021 2nd dose: 3/24/2021 COVID positive: 11/20/2021
No known adverse effects; a patient received an expired dose; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 18-SEP-2020, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, lot # S025133, expiry date 15-SEP-2020 (dose, route of administration and anatomical location were not provided) for prophylaxis. There was no known adverse event. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: S025133; expirationdate: 15-SEP-2020; deviceage and unit: 0; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Developed asymptomatic persistent atrial fibrillation and reduced ejection fraction. No health conditions prior to vaccination. Since diagnosis,  have had three cardioversions, taking antiarrhythmic dofetilide, and scheduled for cardiac ablation because medication is no longer controlling Afib.
Numbness and paresthesias  in both hands noted on 03/26/2021 spreading to her waist .Pt was admitted and seen evaluated by PMR, Neurology and Ophthalmology during the hospital course. Pt was daignosed with  Guillain- Barre syndrome(GBS)
Pt came in for vaccine appointment, needing Hep B #2 after restarting series after found to be non-immune on labs. Instead of receiving Hep B #2 an extra third dose of MenQuanfi given by nursing shift.
When standing at the front desk after the appointment was over she fainted and fell to the floor.  Patient was sweaty and pale on examination and her one hand did shake for a few seconds. The episode did not last long and patient was able to walk out of the clinic with her father after laying down for a while with cold rags and water. Patient was assessed by the nurse and provider during this episode. We are unsure if this was truly from the vaccinations or if there was some anxiousness.
Headache, Myalgia & Diarrhea dose 2-day1-2-sorearm/ pain; day 1-3-insomnia; bodyache; diarrhea; ha; fatigue
Site: Pain at Injection Site-Mild, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: pteint complianed of radiating pain around neck area to back and blurry vision-Medium, Systemic: Weakness-Medium
I was with my 16 year old daughter for her booster COVID-19 vaccine #3 at Pharmacy [Fax unknown].  ~5 minutes post shot she developed  marked swelling/hives of palm  of left hand under second digit and on thumb and then on right palm/thumb.  No respiratory distress and no GI distress.  I took her to PCP Dr. at 4:15pm for evaluation of worsening generalized hives/itching .  I gave her 25 mg Benadryl immediately in store when reaction began which I had in my purse.  Her PCP recommended Zyrtec 10mg  BID and to use Benadryl for breakthrough hives.  She was very pale on 1/1/2022 but afebrile and only hives.  As of 1/5/2022 today she continues with intermittent waves of generalized hives on abdomen, neck, thighs, face which wax and wane and are worse at night.  She seems like she is getting better slowly.
Patient fainted briefly about 12 hours after receiving the vaccine. Patient had muscle spasms in her hands before fainting. Patient also experienced nausea, fever, headache, and chills.
Severe headache; Blurred vision; Elevated blood pressure; Nausea; Injection site severe swelling; Fever; Body aches; Tiredness; Underarm/breast lymph nodes swelling; Nose bleed only from left nostril; This is a spontaneous report from a contactable healthcare professional, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the left arm on 13Sep2021 at 15:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as not applicable. The patient had unspecified allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medication was not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Sep2021 at 15:00 (reported as Day 01), the patient experienced injection site severe swelling, fever 100.5 (unspecified units), body aches, severe headache, blurred vision, elevated blood pressure, nausea, and tiredness. On an unknown date in Sep2021 (reported as Day 02-04), the patient experienced underarm/breast lymph nodes swelling, severe headache, nausea and tiredness. On an unknown date in Sep2021 the patient experienced nose bleed only from left nostril and continued severe headaches from 15Sep2021 (reported as Day 03) to present (at the time of this report). Therapeutic measures were taken as a result of the events nausea, headache, lymph node swelling and nose bleed. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department visit or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events injection site severe swelling, fever 100.5, body aches, blurred vision, elevated blood pressure, nausea, tiredness, underarm/breast lymph nodes swelling and nose bleed only from left nostril was recovering while the outcome of severe headaches was not recovered at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Within one week pt developed 3 rashes that were shingles-like without erythema but dermatomal on right thigh, R chest and R arm.
Mom states developed fever of 104.8F, 7 days after administration of vaccines. Taken to ER and transferred to another ER. States skin was mottled. Developed rash, 10 days after vaccine, over entire body.
rash left arm after injection with body aches and chills several hours after which lasted for several days.  no neck swelling, dysphagia or wheezing.
Vaccine was administered to patient.  Within 10 minutes of administration, the patient had an episode of syncope and fell out of his chair.  I immediately went out to help the patient and a technician called for EMS.  The patient woke up within 2 minutes and reported feeling dizzy, tired, and numb. While waiting for EMS to arrive, the patient was situated in a sitting position and I continued talking to him to keep him awake. EMS assessed him and took him out to the ambulance to wait for a relative to come.  It is unknown if the patient went to the emergency room or not.
Patient came in today and stated that he had a rash and itching that developed starting 5/3 and gradually got worse until 5/7.  Starting 5/8, it started getting better.  He still has occasional itching.
Administered her covid vaccine and then noted it expired and had a short expiration of 09/30/2022 at 8:50am. We received the vaccine from the Public Health 08/31/2022. The vaccine was still kept in the fridge at appropriate temp the whole time.
Red lump at injection site; baseball sized blisters (red, raised) the size of a pencil eraser. Treated with Benadryl.
A 15 year old patient was administered with PROQUAD; Information has been received from a registered nurse concerning to a 15 year old patient (gender not reported). No medical history nor concurrent conditions were reported. Concomitant therapies included sterile diluent (manufacturer unknown). On 20-DEC-2019, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (Lot No. S017244, expiration date not reported but upon internal validation determined to be 01-DEC-2020), rHA (strength and route of administration not reported) for prophylaxis (product administered to patient of inappropriate age).
5 MINS AFTER RECEIVING VACCINE, SUDDENLY HOT, DIZZY, HEART RACING/POUNDING. RELIEVED AFTER BEING BROUGHT BACK TO OBS VIA W.C. AND LAYING DOWN ON STRETCHER AT 1005. VSS THROUGHOUT OBSERVATION. ESCORTED TO EXIT WITH NO ISSUES AT 1040. 1005 INITIAL BP 147/79 HR 63 SATS 100% RA 1018 BP 129/85 HR 71 SATS 100% RA 1030 STANDING BP 133/95 HR 69 SATS 100% RA
no adverse  effects reported.   vial used was opened 1/30/23 and not disposed of.
Moderna COVID-19 Vaccine EUA Two raised sores appeared at the injection sites a couple weeks after my second shot.  Both have redness surrounding them and are itchy.  They have gotten worse even though I avoid scratching them.  Both sores are about a half inch in diameter with the redness.  I've had them about 3 weeks now.
This is a 95y.o. female admitted through the emergency room with complaint of generalized fatigue, body aches and mild dry cough.  She was seen by her primary care physician, yesterday and tested positive for COVID-19.  History of 2 shot COVID vaccination without booster vaccine.  Compliant with home medication program. Feeling much better this morning.  No fever, chills.  No shortness of breath or cough.  Stable oxygenation status. Laboratory studies reviewed. COVID19 LABS   Lab Results Component Value Date   COVID19 Positive 01/12/2022   COVID19 Sofia2 01/12/2022   FLRA Negative 01/12/2022   FLRB Negative 01/12/2022   FLRR Not Detected 11/03/2021
Initial information received on 09-Oct-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a 4 years old female patient who experienced local reaction, while she received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MMR for Immunisation. On 15-Jun-2015, the patient received (fourth dose in series) a 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via subcutaneous route in the thigh (expiry date not reported). On an unknown date, patient developed a non-serious local reaction following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. It was also case of actual medication error due to Inappropriate route of vaccination. Dose was accidentally given subcutaneously instead of intramuscular to a four-year-old child. Relevant tests were not reported. Final diagnosis was local reaction. It was not reported if the patient received a corrective treatment. On an unknown date, patient was recovered from local reaction. 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 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. Additional information was received from physician on 09-Oct-2018. Patient demographic, Concomitant medication and dose of suspect added. Documents held by sender: none.
This spontaneous report as received from a pharmacy technician refers to a 1-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported. On 05-MAR-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry date: 23-AUG-2019) (dose, frequency and route were not reported) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1802USA001558.
I have been having my menstrual cycle every 30 days from the day I know my self. But after the first doze of vaccination, I had 5 days earlier and very heavy.; I have been having my menstrual cycle every 30 days from the day I know my self. But after the first doze of vaccination, I had 5 days earlier and very heavy.; This is a spontaneous report from a contactable consumer (patient). A 38-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. Patient medical history was not reported. The patient had no covid prior vaccination. There were no concomitant medications. The patient did not receive any other other vaccine in four weeks and did not receive any other medications in two weeks. The patient has been having menstrual cycle every 30 days from the day she knew herself. But after the first doze of vaccination, she had 5 days earlier and very heavy. The patient did not receive any treatment for the event. Patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 15Jun2021 12:00 AM. The patient had not tested covid post vaccination. Outcome of the events was recovered.  Information about the Lot/batch number has been requested.