chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse, who referred to an unknown number of patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant medications and drug reactions or allergies was provided. On 16-SEP-2016 and 27-FEB-2017, the patients were administered improperly stored doses of VAQTA (lot# M022924 an expiration date: 24-JAN-2018; dose, route of administration and anatomical location were not reported) as prophylaxis. The doses of vaccine were stored at 47.7 degrees Fahernheit (F) for 8 hours. All temperature excursions were detected by a data logger. No adverse effects were reported. No product quality complaint was involved. It was also reported that several improperly stored doses of VAQTA with the above mentioned lot# and expiration date were not administered to patients. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA006147: US-009507513-1706USA006148: US-009507513-1706USA006149: US-009507513-1706USA006150: US-009507513-1706USA006151: US-009507513-1706USA004143:
Breakthrough COVID case: I thought I was dealing with allergies until I started experiencing a fever. The, I went to the ER to get tested but they said they would have to admit me. They told me I could get tested at their urgent care the next morning. So, I went to the urgent care the next morning and tested positive. I took TYLENOL and ibuprofen to combat the fever and sore throat. Approximately 24 hours later, I seem to have less fever and more sinus drainage.
4" diameter swelling, redness, warm, blotchy. Flu type body aches. Fever. Rx: Benadryl.
increased blood pressure; spiked heart rate; nausea; dizziness almost to the point of fainting; dizziness almost to the point of fainting; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unknown) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the reporter wants to know if it is recommended for her to get the second dose of the bnt162b2 after she has experienced side effects from the first dose. The patient stated that she had increased blood pressure, spiked heart rate, nausea, dizziness almost to the point of fainting that the patient ended up in the emergency room. The patient also wanted to know if she has to wait some time before she gets the second dose and how long she can wait. The patient queried does she have to start over if she waits longer than the recommended period? The outcome of the events was unknown.  Information about lot/batch number has been requested.
Woke up from a nap, choking on vomit, went unconscious, turned blue, body limp, rushed to ER, unresponsive, sternum rubs, oxygen, IV, EVEN NARCAN as a precaution, fever 102.6, shallow breathing, explosive diarrhea.
Imm given at 12:00 noon 1/5/12. Child awoke 10pm very irritable, temp 102, rash to face and "red knots" at injection sites.
Employee received Tdap vaccine at approximately 1:30pm on 11-14-08.  At approximately 10am on the following day started having symptoms of joint pain/stiffness, chills with fever over 100. Symptoms lasted until the morning of 11/17/08.
significant swelling of right shoulder by 4 PM.  fever 100 degrees by Tuesday 8/9. late afternoon. right arm sore to lift.  seemed to get better Wed. on Thursday 8/11 swelling moving below elbow and redness warm.  visited clinic prescribed cephalexin and prednisone
Aching chest for a couple of hours on the afternoon of vaccination. The chest pain went away after a couple of hours followed by a headache and flu like symptoms that ended the following afternoon.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 18-MAR-2014 the patient was vaccinated with ZOSTAVAX. On 20-MAR-2014 the patient experienced injection site reaction. The pharmacist described the reaction as: red, warm with a little hardening around the injection site appearing to be about 6 inches by 4 inches in diameter. HCP adamant about not receiving and HCP stated this was an injection site reaction rather than a rash. The outcome of injection site reaction was not recovered. This is one of two reports from the same patient MARRS: 1403USA014293. Additional information has been requested.
30 seconds after receiving the Moderna Vaccine patient passed out; Fell to floor after passing out; Body was stiff when fell to floor; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (30 seconds after receiving the Moderna Vaccine patient passed out) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A221A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Cephalexin). Concomitant products included VITAMIN B COMPLEX (VITAMIN B CO) for an unknown indication.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (30 seconds after receiving the Moderna Vaccine patient passed out) (seriousness criterion medically significant). 03-Apr-2021, the patient experienced FALL (Fell to floor after passing out) and MUSCULOSKELETAL STIFFNESS (Body was stiff when fell to floor). On 03-Apr-2021, LOSS OF CONSCIOUSNESS (30 seconds after receiving the Moderna Vaccine patient passed out), FALL (Fell to floor after passing out) and MUSCULOSKELETAL STIFFNESS (Body was stiff when fell to floor) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reported mentioned that ambulance was called after the events and paramedics monitored the patient in the ambulance, patient had stable vital signs and it was offered it take him to the emergency room, but patient declined.; 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.
HEAVY FEELING IN CHEST; FLU-LIKE SYMPTOMS(FELT FEVERISH, HACKING COUGH, SUDDEN TIREDNESS, HEADACHES, MUSCLE ACHES); This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 27-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 27-JUL-2021, the patient experienced heavy feeling in chest. On 27-JUL-2021, the patient experienced flu-like symptoms (felt feverish, hacking cough, sudden tiredness, headaches, muscle aches). Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heavy feeling in chest, and flu-like symptoms (felt feverish, hacking cough, sudden tiredness, headaches, muscle aches). This report was non-serious.
sore arm; muscle aches; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), MYALGIA (muscle aches) and FATIGUE (fatigue) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), MYALGIA (muscle aches) and FATIGUE (fatigue). On 02-Apr-2021, PAIN IN EXTREMITY (sore arm), MYALGIA (muscle aches) and FATIGUE (fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment information were provided.   This case was linked to MOD-2021-091831 (Patient Link).
Nausea; vomiting; fever temperature of 102F; A spontaneous report was received from a nurse concerning a, female patient who experienced [EVENT nausea, vomiting and fever.   The patient's medical history was not provided.    Concomitant product use was not provided by the reporter.   Consumer got the first shot of moderna vaccine on 21Jan2021 and developed nausea and vomiting, and fever temperature of 102F.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the events was not reported.
The patient developed a severe itchy rash that has lasted over 2 months - he has erythematous macules and plaques on his legs, back, belly, arms.  First biopsy showed "ID reaction" and a repeat biopsy has shown a "lichenoid vaccine reaction" and it has been responsive to steroids.  No trigger for this allergic rash besides the covid vaccine has been idenified.
pt recvd vax & 3 days p/vax exp swelling on lt side of face & cheek & throat;also exp edema in lt shoulder & lt arm;tx DPH;
METALLIC TASTE IN MOUTH; FACE WAS RED; FLUSHING ON FACE; RIGHT LEG PAIN DESCRIBED AS DULL ACHE; This spontaneous report received from a patient concerned a 44 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included gout. The patient could not take statins because they cause muscle pain but not an allergic reaction.  The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 205A21A) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-MAY-2021, the subject experienced metallic taste in mouth. On 10-MAY-2021, the subject experienced face was red. On 10-MAY-2021, the subject experienced flushing on face. On 10-MAY-2021, the subject experienced right leg pain described as dull ache. The action taken with covid-19 vaccine  was not applicable. The patient recovered from face was red, and flushing on face on 10-MAY-2021, and was recovering from metallic taste in mouth, and right leg pain described as dull ache. This report was non-serious.
Vaccine administered on 10/10/05. On 5/17/06, pt dx'd with influenza via in office flu test. Antibody titer levels drawn on 5/19 show inf type A; Ab <8; inf type B; AB <8, vaccine failed.
Pt received Pfizer COVID vaccine on 12/22/20 and 1/11/21. 7/1 pt tested positive for COVID requiring home quarantine.
11MAR98 3:30 temp 100-slumped over, rolled back fixed, nonresponsive ridged stiff, hands & lips blue, assist resp pulse present, gagged, vomited;breathing on own w/in 1min per mom;
pt received menactra and gardasil. Within 30-60 seconds she was pale around the mough and then limp in her chair. Assisted her to the floor and fanned her. Recovery began within the next 1-2 minutes. Allowed her to lay, then sit on floor, then to chair before leaving at approx 15 mins. Denied any reoccuring feelings, and insisted she felt ok at that time.
nasal congestion; weakness; cough; dizziness; chills; fever; fatigue; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Apr-2021 and was forwarded to Moderna on 12-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (nasal congestion), ASTHENIA (weakness), COUGH (cough), DIZZINESS (dizziness) and CHILLS (chills) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced NASAL CONGESTION (nasal congestion), ASTHENIA (weakness), COUGH (cough), DIZZINESS (dizziness), CHILLS (chills), PYREXIA (fever) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) for Chills, Fever, Weakness, Fatigue, Dizziness, Cough and Nasal congestion, at a dose of unk,unk and DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) for Chills, Fever, Weakness, Fatigue, Dizziness, Cough and Nasal congestion, at an unspecified dose and frequency. At the time of the report, NASAL CONGESTION (nasal congestion), ASTHENIA (weakness), COUGH (cough), DIZZINESS (dizziness), CHILLS (chills), PYREXIA (fever) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient's second dose is scheduled on 06-MAY-2021. Consent to follow up with Safety given for SELF.
Started 11APR92 fever 103; c/o h/a, didn't eat well; 12APR92 fever 103 to 100; c/o feeling bad; ate better than on Sat; Sunday afternoon mom noted rash over entire body aobut 6PM; pt became more playful & feeling better around lunch time;
sore arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced VACCINATION SITE PAIN (sore arm at the injection site). At the time of the report, VACCINATION SITE PAIN (sore arm at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported . treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-138859 (E2B Linked Report); Sender's Comments:  MODERNATX, INC.-MOD-2021-138859:
Major all over body aches, headache, chills, dizziness, light-headed, nauseated.
Acute onset chest pain, increased work of breathing and hypoxia requiring BiPAP. CT scan with bilateral ground glass opacities  of unclear etiology
Patient is 17 years old and this Vaccine only for 18 years old and above called the mother on the 17th but no one answer the mother called the pharmacy on the 18th. she Mentioned that her Daughter is doing fine now. She states that we ( the parents ) want her to take JNJ vaccine
Missed the second dose; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed the second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed the second dose) outcome was unknown.        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.
Redness and swelling where to infection was given with soreness to left arm. Edema extending down the entire injection site. Tylenol given by parent.
Information has been received from a nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 28-NOV-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot # M013636, expiration date 15-FEB-2018 (strength, dose, administration route and anatomical location were not provided) for prophylaxis. No adverse effects were reported. The vaccine had two temperature excursions one of 29.9 Fahrenheit (F) for 2 hours 30 minutes and the other of 47.7 (F) for 30 minutes; with a data logger involved. Also it was reported no previously temperature excursions. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected because the reporter do not want to be contacted; Sender's Comments: US-009507513-1611USA013515: US-009507513-1612USA000347: US-009507513-1612USA000348: US-009507513-1612USA000349: US-009507513-1612USA000350: US-009507513-1612USA000351.
No AE reported; temperature excursion / temperature 30.6 F; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information regarding their medical history, concurrent conditions nor concomitant therapies provided.  On 17-AUG-2021, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 ml, lot # T009743, expiration date 27-JAN-2022 (route of administration and anatomical location were not provided) for prophylaxis. The administered vaccine was stored in a temperature of 30.6 degrees Fahrenheit (F) for 26 hours and 14 minutes. Previous temperature excursions were reported: 34.9 F for 1 hour 54 minutes and 48.6 F for 21 hours. No adverse event (AE) was reported.  This is one of three reports from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp devicelotnumber: T009743; expirationdate: 27-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2108USA006442:01995286 US-009507513-2108USA006422:
pain in toes of the right foot as well as redness and swelling.  Feeling of nerve pain to touch and with pressure
A half dollar coin sized rash under the injection site. Chills that lasted about 30 min during the night
Throat swelling and difficulty breathing within minutes of the injection. Benadryl 75mg po x1 taken followed by Benadryl every 4-6 hours for 48 hours post vaccine due to continued symptoms.
From the middle of my back up my neck I broke out in a rash. The big bone between the shoulder blades was a blood red coloring, it's just now turning into a brown color and finally fading some.  It was on my scalp also, it didn't go onto my front. I called the CDC phone number and they took down a lot of information. From what I understand my antibodies are in hyper drive and is a normal reaction my doctors tell me.  I'm exhausted all the time now and my muscles feel like I've done a crazy workout everyday. I had a phone appointment with my doctor and she said this is kind of an expected thing for some people and to give it a few weeks to go away.  My mom gave me a medication called Clobetasol propionate topical solution 0.5% and it seems to help.
22APR92 t102 @ 7PM APAP; 103 @ 4AM gave tepid bath; took feeding alert; cranky some sl t101.4 @ 10AM playful, alert, swelling;
Approx 20 mins post vaccination pt felt dizzy,  hot, not diaphoretic, skin w&d, AxO. No LOC.  Was given protein bar, water and ice pack applied to back of neck. pt rested in chair.  Vitals, 3:50pm BP 180/90 P 120. 4:15pm BP 158/76 P 76 4:20pm pt feeling better, vss, Left for home with ride from co worker.
10/13/16 Flu shot left deltoid; customary discomfort. Pain did not subside; worsened to included shoulder, radiating down left arm under breast. Saw doctor; prescribed Ibuprofen. Referred to PT heat tx massage, exercises (11-23-16-). Orthopedist: Assessment-X-ray-MRI-consult recommended cortisone.
Felt like pins and needles all over my hands and body going through, went away; Dark bruise larger than the size of a quarter in her left arm, the arm where she received the vaccine; Sore everywhere, her body is sore, and when she presses on her arm it is sore; when she presses on her arm it is sore; allergic reaction; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 06Oct2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PARAESTHESIA (non-serious) with onset Oct2021, outcome "unknown", described as "Felt like pins and needles all over my hands and body going through, went away"; VACCINATION SITE BRUISING (non-serious) with onset Oct2021, outcome "unknown", described as "Dark bruise larger than the size of a quarter in her left arm, the arm where she received the vaccine"; PAIN (non-serious) with onset Oct2021, outcome "unknown", described as "Sore everywhere, her body is sore, and when she presses on her arm it is sore"; VACCINATION SITE PAIN (non-serious) with onset Oct2021, outcome "unknown", described as "when she presses on her arm it is sore"; HYPERSENSITIVITY (non-serious) with onset Oct2021, outcome "unknown", described as "allergic reaction". Additional information: the patient received her first dose of the Pfizer BioNtech covid 19 vaccine on 06Oct2021. She stated that in the beginning it felt like pins and needles all over her hands and body going through, went away. She didn't look at her arm for a while and then now she noticed a few days ago she had a dark bruise larger than the size of a quarter in her left arm, the arm where she received the vaccine. She also reported that she was sore everywhere, her body is sore, and when she presses on her arm it was sore. She was most concerned about the dark bruise and was told by her pharmacist who administered the vaccine to call Pfizer, pharmacist also told her that it could have been an allergic reaction. The patient asked if she should get the second dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
30 minutes after receiving immunizations patient developed severe hives, puffy eyes, itching. Patient returned to clinic received BENADRYL, ORAPRED, monitoring of HR, BP and pulse ox. No respiratory involvement. ARNP also consulted & allergist. Patient monitored in clinic for 2 hours.
Feb. 14 -17 woke up with Laryngitis. No sore throat but no voice. Lasted 3.5 days. At the same time my left arm started feeling ?deeply achy.? Up to that point I had relatively no vaccine site pain. I had forgotten about it. Then the ache started. After a couple more days, my left arm felt like someone had hit me with a baseball bat. I couldn?t lift anything. No swelling. I take Advil to help with pain. I have no elevated temperature. Ache still persistent. Very distracting but just think it?s a delayed muscle reaction.
Local reaction with redness, induration around site, Gradually getting bigger, 8 cm by 6 cm right thigh, Motrin and Benadryl given by mother
was noted to be pallid,sweaty @ 440PM,15mins p/vax was placed on exam table w/feet elevated assessed;BP et pulse remained WNL over next 45mins w/color;dizziness;pt recv DPH & Pred;
bilateral synovitis of the hands bilaterally, starting 4 days after the 2nd dose of the Shingrix.  Gradually worsening at 6 weeks post dose
Woke up in middle of the night, shivering, terrible headache, nauseous, whole body ached... all my muscles and joints ached and hurt. Running a fever.