chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ED to Hosp-Admission Current   9/2/2021 - present (6 days)  Essential hypertension, Hypothyroid, Hyponatremia,  COVID-19, Diarrhea  Chief Complaint Patient presents with ? Weakness - Generalized     History of Present Illness   Patient is a remarkable 86-year-old female in excellent health, past medical history significant for hypothyroidism and hypertension, active and independent in activities of daily living, works and engages in social activities. Patient has been generally unwell for 1 week's time.  Her closest dance partner had upper respiratory symptoms 1 week ago.  She is fully vaccinated against COVID-19.  She does not routinely mask in public or in dance halls.  She has had 1 week of lethargy, malaise, nausea, poor appetite, poor p.o. intake, early satiety, and diffuse watery diarrhea.  She has had no upper respiratory symptoms, has not been short of breath or coughing, no fevers.  She is generally weak and lightheaded.  She saw her primary care physician on 830, had a rapid Covid test in the office which was negative, and in her vaccination status this was thought to be accurate.  Repeat Covid is positive today.
Redness, swelling, soreness, chills, night sweats, fever. Started 9/15 in right arm, 9/16 in left arm, worsened on 9/17 in left arm and 9/18 getting better in right arm. Left arm is very badly swollen, red, hot, sore unable to lift. Lab tests done today.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. A 76-year-old male patient received BNT162b2 (BNT162B2), on 30Sep2021 as dose number unknown (booster), single (Lot number: FF2589, Expiration Date: 31Mar2021) at the age of 76 years for Covid-19 immunisation. The patient's relevant medical history included: "Cholesterol" (unspecified if ongoing); "Breathing" (unspecified if ongoing), notes: He is on Breo Ellipta inhaler for breathing. Concomitant medication(s) included: CRESTOR taken for blood cholesterol; BREO ELLIPTA taken for dyspnoea. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 30Sep2021, outcome "unknown", described as "received the first booster dose on 30Sep2021. On the label on our vaccine card the expiration date is listed as 31Mar21"; TRANSIENT ISCHAEMIC ATTACK (medically significant), outcome "unknown", described as "ministroke"; CORONARY ARTERY BYPASS (non-serious), outcome "unknown", described as "Quadruple bypass"; ILLNESS (non-serious), outcome "unknown", described as "sick"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "we were heavier when we got the shot"; GASTROOESOPHAGEAL REFLUX DISEASE (non-serious), outcome "unknown", described as "GERD". Therapeutic measures were taken as a result of transient ischaemic attack, gastrooesophageal reflux disease. Clinical course: The reporter stated that her 76-year-old husband had some serious things happen to him after he received his booster dose of the Pfizer COVID-19 vaccine on 30Sep2021. When asked about the Lot FF2589, the reporter received response that the date of manufacture is 09Jul2021 and the expiration date is 31Mar2022. The patient received booster Pfizer dose and received it at the end of Sep, and when looking at there immunization card over the weekend and realized that the sticker that they put on the card said that, that particular drug lot that they receive had expired 31Mar2021, and received it on 30Sep, six months later, so their concern was that they received expired medication. Reporter stated, her husband has been sick since this happened. He was 6' and was 188 pound. That's what they currently are, and they were heavier when got the shot. They haven't had any vaccines since the booster. He was on a heart tablet twice a day for Metoprolol Tartrate and he has GERD and he's on Nexium (Treatment). He had ministroke and he had quadruple bypass all of which he did not had before the shot. Follow-Up (12May2022): Follow-up attempts are completed. No further information is expected. Sender's Comments: Linked Report(s): US-PFIZER INC-202200687387 as same reporter/drug/event, different patient.
fatigue, low grade fever and chills began ~24 hours after the second shot. ~36 hours after second shot right armpit lymph node was visibly swollen and very tender. Swelling went down over the course of 24 hours and was unnoticeable within 48 hours of appearing.
The morning after the injection, she woke up and was unable to lift her arm over her head and a throbbing pain which is improving. Tx - heat, ice, decrease activity.
felt fatigue; body aches; This is a spontaneous report from a contactable consumer (patient).   An adult patient of an unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiry date were not provided) via an unspecified route of administration on an unknown date as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received previously first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date for COVID-19 immunization. The patient did not have medical allergies, no other medical conditions. On an unknown date, the patient felt fatigue and body aches for 24 hours after second dose of Covid vaccination. The outcome of the events was recovered on an unknown date.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Immediately: site soreness, erythema at injection, lethargy 14 days post vaccine: diaphoresis, severe epigastric pain, nausea, vomiting, diarrhea,  severe lethargy, severe weakness, unable to tolerate PO x 6 days until clear fluids but chronic inability to tolerate solid PO until medical intervention, near syncope with loss of vision and visual disturbances, bounding pulse and increased pulse rate, hypertension with diaphoresis and night sweats x 5 months with interventions from PCP and referral to cardiologist for rule out cardiac origin. Medical disabled from work. Cardiologist ruled out cardiac origin. Medications started and helping but overall s/s not resolved, new referral to neurologist.
Little headache; Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Little headache) and VACCINATION SITE PAIN (Arm pain) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     Concurrent medical conditions included Vertigo. Concomitant products included MECLIZINE [MECLOZINE] for an unknown indication.   On 07-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 07-May-2021, the patient experienced HEADACHE (Little headache) and VACCINATION SITE PAIN (Arm pain). On 08-May-2021, HEADACHE (Little headache) had resolved. At the time of the report, VACCINATION SITE PAIN (Arm pain) had resolved.            Treatment for the events was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-080005 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Additional information received on 09-Jun-2021 contains no new information. On 09-Jun-2021: Additional information received on 09-Jun-2021 as correct email was provided. On 09-Jun-2021: Additional information received on 09-Jun-2021 as non significant follow up.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Aspirin" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Starting yesterday 12/12/2022 really bad cough and runny nose; awaked out of sleep with coughing spells.
Headache, Myalgia, Diarrhea, chills, tiredness, "weird taste in mouth" immediately after vaccine Narrative:
No adverse effects reported; Multiple patients were vaccinated with improperly stored VAQTA; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 06-JUN-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided), lot # R018935, expiration date 05-SEP-2019, for prophylaxis (dose, route, anatomical site and frequency were not reported). The reporter stated that the vaccine had a temperature excursion of 34.2 F for 4 hours and 54 minutes, which was detected by a data logger. The vaccine had no previous temperature excursion and there were no adverse effects reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-1907USA001174: US-009507513-1907USA004852: US-009507513-1907USA004853: US-009507513-1907USA004854: US-009507513-1907USA004855: US-009507513-1907USA004856: US-009507513-1907USA004857: US-009507513-1907USA004858: US-009507513-1907USA004859: US-009507513-1907USA004860: US-009507513-1907USA004861: US-009507513-1907USA004862: US-009507513-1907USA004864: US-009507513-1907USA004865: US-009507513-1907USA004866: US-009507513-1907USA004867: US-009507513-1907USA004868: US-009507513-1907USA004869: US-009507513-1907USA004870: US-009507513-1907USA004871: US-009507513-1907USA004872: US-009507513-1907USA004873: US-009507513-1907USA004874: US-009507513-1907USA004875: US-009507513-1907USA004876: US-009507513-1907USA004877: US-009507513-1907USA004878: US-009507513-1907USA004879: US-009507513-1907USA004880: US-009507513-1907USA004881: US-009507513-1907USA004882: US-009507513-1907USA004883: US-009507513-1907USA004884: US-009507513-1907USA004885: US-009507513-1907USA004886: US-009507513-1907USA004887: US-009507513-1907USA004888: US-009507513-1907USA004889: US-009507513-1907USA004890:
Patient was given the flu shot with her mom and little sister present.  The patient was a little nervous about getting the vaccine.  After vaccine was given, mom and children walked around the store a little but and then proceeded to walk to car to leave.  As patient got into the car, mom says she fainted.  Mom then brought her back into the store and laid her on the floor at the front of the store entrance.  By the time I got to the scene EMS had already been called and the child was laying on the floor and talking.  I asked her if she knew her name and age and she did.  There was another bystander who took her pulse and felt it was slow.  The child also looked pale.  While waiting for EMS to arrive the child was talking more and then able to sit up.  Her pulse was taken again and was getting better.  She was also given a bottle of water.  No complaints at this point of dizziness or feeling sick.  EMS arrived and checked her vitals and determined she was ok but also gave mom the choice to be taken to the hospital to be looked at.  Mom refused as she lived close to the hospital if she needed to be taken.  It was also determined that maybe the child needed to eat a snack/was hungry so she was given a bag of Doritos while EMS was still there and was able to eat.  We followed up with mother the next day and she reported that the child felt really good and went to school that day.  The mom thinks she is having a growth spurt and was probably hungry at the time of the vaccine visit and also nervous which may have contributed to the fainting.
Information has been received from a registered nurse concerning a 4 year old female with a history of dyspnea, lethargy and pyrexia following vaccination with MMR II/Varicella on 9/24/03 (WAES0609USA01195), who on 9/1/06 was vaccinated SC with a 0.5ml dose of MMR II/Varicella (upgrade process) ( lot 653834/0521F). There were no concomitant vaccinations. It was reported that when the mother took the child out to their car to go home the child became unresponsive. Medical attention was sought and the child was taken back to the physicians office. It was reported that the child was pale in color and her heart rate was about 50 bpm. She was started on oxygen and IV fluids and was stabilized within 30 minutes. She was sent to the local ER for evaluation. At the time of the report she was reported to be recovering. The reporter considered the pts pallor, decreased heart rate and unresponsiveness to be other important medical events (OMIC). Additional information has been requested.
2/16 at midnight started with fever 103 and body ache. Progressively worsened, was unable to walk by Monday that family took to ER. Has also had vomiting and poor appetite since onset. Mother reported ER stated child had URI or less likely vaccine reaction. Fever ceased Wed 2/20/08.
Fainted the next morning after doing yoga. Was dizzy and nauseous.  Woke up laying  on floor. Passed  out
Patient received a 4th dose of Moderna. 1st dose on 1/25/21, 2nd dose on 2/22/21, 3rd dose on 5/12/21, 4th dose on 6/9/21.
UrticariaPruritus ITCHY AT INJECTION SITE, ANXIETY Narrative:  Reported inching at insertion site immediately after entering observation room and thought she was more anxious than anything.. Received diphenhydramine 50mg oral. Say 15 minutes and then felt fine. Patient believed it was anxiety
Severe back pain, barely able to walk, sore right eye(strabismus surgery June 2022). Back pain has resolved
Patient awoke complaining of numerous muscle aches and pains. About 10 minutes later felt dizzy and flushed. Sat down, perspiring profusely and experienced full syncope. Placed patient in reclined position with feet up. Pulse faint but regular. Patient awoke in about 2 minutes complaining of feeling hot. Temperature was 97.1 F. Blood pressure could not be read during syncope, - instrument error on 2 readings. Blood pressure on waking was 110 over 50 mm Hg. Patient requested TYLENOL for aches. Recovery was uneventful.
Swelling, redness, pain, heat from shoulder to elbow, near bicep muscle, no fever
like chest pain on the first day chest pains; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHEST PAIN (non-serious), outcome "unknown", described as "like chest pain on the first day chest pains".  Additional information: it was reported that her chest pains the first day severe chest pains lasted about three minutes slight chest pain on the first day really bad chest pains that lasted about three to four minutes chest pains  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received vaccination and was in the room as other family members were getting coats on and talking with the vaccinator. Patient had vasovagal syncope episode. Regained consciousness within 15-30 seconds.
pt admitted to hospital with SOB, generalized weakness, chills; found to be positive for COVID; hypoxic with O2 saturations in the 70s; given O2 supplement; dexamethasone, Tocalizumab; respiratory status worsened; transferred to ICU; placed on sedation; BiPAP and Vapotherm; became BiPAP dependent; poor oral intake; DNR; transitioned to comfort measures and passed away in the hospital
arm is slightly sore; This is a spontaneous report from a contactable consumer, the patient. A 15-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO183) via an unspecified route of administration in the right arm on 13May2021 at 09:30 (at the age of 15-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications was not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13May2021 at 09:45 the patient experienced slightly sore arm, but that was it. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event slightly sore arm was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Fever/chills and severe muscle aches/soreness for about 18 hours post vaccination - then resolved
Warmness at the injection site; Itchiness at the injection site; Redness at the injection site; Soreness at the injection site; swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warmness at the injection site), VACCINATION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE PAIN (Soreness at the injection site), VACCINATION SITE SWELLING (swelling at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site). On 07-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Warmness at the injection site), VACCINATION SITE PRURITUS (Itchiness at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site). At the time of the report, VACCINATION SITE WARMTH (Warmness at the injection site), VACCINATION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE PAIN (Soreness at the injection site), VACCINATION SITE SWELLING (swelling at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
Arm became red at the injection site/Redness in streaks near injection site; Arm became itchy at the injection site; A spontaneous report was received from a consumer concerning a 89 year old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm became red at injection site, redness in streaks near injection site/vaccination site erythema, arm became itchy at the injection site/vaccination site pruritus.  The patient's medical history, was not provided by the reporter. Concomitant medications reported included atenolol, multivitamins and vitamin D 1000.  On 28 Jan 2021, prior to the onset of the events, the patient received their dose of mRNA-1273 (Batch number: 007M20A) intramuscularly in left arm for prophylaxis of COVID-19 infection.   About nine to ten days later, the patient's arm became itchy and red at the injection site. The redness occurred in streaks near the injection site  Treatment for the event included loratadine which help to treat the side effects.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event arm became itchy and red at the injection site and the redness occurred in streaks near the injection site were unknown.
Patient came to the pharmacy for a scheduled Bivalent booster. Technician entering vaccine failed to verify stock on Bivalent - the pharmacy had been out since the 26th due to the hub store being out of stock. We had a patient earlier in the day that had gotten their second dose of the monovalent and had a vial in a tote in the cooler. The administering technician pulled the vial without verifying and the traveling pharmacist on duty did not verify or ask to verify the vaccine before the technician gave the shot. I returned to the pharmacy and the technician let me know they had pulled the last vial of bivalent. Knowing that we did not have any I informed the technician of the error. Patient had been given a third dose of monovalent instead of bivalent.
Dizziness, pallor. BP 100/59 (pulse 79). Given crackers.
This spontaneous report as received from a nurse refers to unspecified patient of unknown age and gender. No medical history and current conditions were reported. The nurse reported that on an unknown date unknown number of patients were vaccinated with that does of ROTATEQ (unspecified dose and route) lot 1000425 expiry date 21-JUN-2016. On an unspecified date the vaccine had been improperly stored.The outcome of event was unknown. No adverse effects reported. Product quality complaint (PQC) was not reported. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. Information about the patient's relevant medical history or concomitant medications was not reported. Since May 2015 (for both vaccines reported as since 08-MAY-2015), the patients were vaccinated with improperly stored doses of ROTATEQ (route default as oral, dose, lot# and expiration date were not reported). No adverse effect was reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
On 8/25/21, (Pharmacist) did a PFIZER COVID-19 vaccine for patient.  She did NOT dilute the vaccine and gave the patient 6 doses of the un-diluted vaccine to the patient.  The patient did not report any side effects from the vaccine. Pharmacist called the CDC and spoke with a co-worker who advised her to have patient monitor for any adverse events.  We will follow up with patient later today and tomorrow to check on him.