chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE reported; improperly stored VARIVAX were administered to patients.; This spontaneous report was received from a registered nurse and referring to a 1 year-old female patient. The patients' medical history was not reported. Concomitant medications included measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) Hepatitis A Vaccine, Inactivated and pneumococcal vaccine conj 13v (PREVENAR 13).   On 27-FEB-2023, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot number W021740 with expiration date: 10-JUL-2024, administered subcutaneously on left thigh for prophylaxis (strength, and route of administration were not provided).   On 21-MAR-2023, it was found on the look back data logger monitoring that the defrost on the freezer has been getting too warm, out of range temp noted to be out of manufacturer storage recommendations. Temperature and time frame were unknown. There was previous temperature excursion (-9.8 degree celsius for 8 hours and 38 minutes) (product storage error). No complications, no reactions, no complaints. No adverse event.  The outcome of the event was reported as recovering.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2303USA007314:
I started having chest pain. I thought it was a heart attack but it did not feel like that kind of pain because I have had a heart attack before. I was feeling bad. I started having fever and arthritis. I had no appetite. Thursday morning I was feeling very bad and I went to the ER on 10/09/2021. From Friday to Saturday I do not remember anything. I do not remember much until Monday. They told me I had pneumonia. When I was in the hospital  I got IV antibiotics and IV steroids. I was prescribed one antibiotic and steroid for a week. I am going into my third week with pneumonia.
dry throat; itching; This is a spontaneous report from a contactable nurse. A 22-year-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced multiple spots where he was itching and reported a "dry throat or something like that." The patient's vital signs did not change and did not have any other anaphylaxis reaction. The outcome was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained.
redness around vaccine site post vaccine  itching on day 7  rash and increased itching on day 8-9  less itching and no rash on day 10  less redness on day 11
Day 7, woke up to red, swollen, bumpy rash that got progressively bigger each day. Used hydrocortisone and bendryl. Also on day 7, sore throat, chest and nasal congestion. Day 9, coughing.
Sharp nerve pain in right hip, dull pain in right thigh, sudden onset upon standing after sitting down, pain worsened over next 12 hours, became excruciating, could not sit up or walk unassisted, pain remained intense for 2 days before lessening, pain nearly gone after 5 days, still discomfort when lying on right side after 2 weeks. Treated at home with prescription pain killer for first 5 days, ibuprofen after that; used heat and elevation, bed rest. Would definitely have visited ER first night, but our local hospitals are overrun with Covid right now.
diverticulitis flare with concerns for perforation following vaccination, had COVID infection March 2021
14 hours post injection: New, sudden-onset seizure, lasting 10-15 seconds. Symptoms included convulsions, stiffness, brief loss of consciousness.   Episode was followed by chills and  intense, whole-body shivering /shaking. Fever spiked within 15 minutes, which was controlled with Ibuprophen.
turned red for a while; itches; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itches) and ERYTHEMA (turned red for a while) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itches) and ERYTHEMA (turned red for a while). At the time of the report, PRURITUS (itches) and ERYTHEMA (turned red for a while) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
No additional AE details; Inbound call from HCP stating a dose of MMR-II was inadvertently given after it's expiration date.; This spontaneous report was received from a health care professional referring to patient of unknown age and gender.  The patient's medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent.  On 13-JUN-2022, the patient was inadvertently vaccinated with measles, mumps, and rubella (WISTAR RA 27-3) virus vaccine, live rHA (M-M-R II) (valid lot #T016195, upon internal revision expiration date was: 11-JUN-2022 (but reported as 11-MAY-2022)) (Expired product administered) (strength, route of administration and anatomical location were not provided) for prophylaxis.
Pt vaccinated with meruvax II developed swollen glands, fever, rash on arms & malaise.
Pain in hands, wrists, arms. Tingling in fingers, feet. Pain in palm of left hand - for 1 week - woke in night. After 1 month. Got a little better, but now tingling in hands still a problem, pain in hands and R -  wrist still happening, feet tingling is better. All started 1 week after vaccine given.
Headache, vomiting. Then after 2 days fever, cough, chills, voice box inflammation, and lost voice for 3 days, now 3 weeks past still irritated throat and dry cough, weakness and headache. Next week will go to the doctor.
Fever Migraine Chills  Vomiting Diarrhea Joint pain Tiredness
After giving vaccine, patient went to sit in his mothers lap complaining of having trouble breathing.  Mom took his mask off to see if that helped. Seemed to relieve some issues.  I gave vaccines to patients sister, mother and father.  I walked back into the pharmacy when complete. Mother knocked on the pharmacy door about 1 minute later holding the patient saying he had trouble breathing.  Patient had very labored breathing, sweating, very pale, and very lethargic.  Mom had patient lay down, I retrieved the e-kit. Got epipen ready, patient said he was getting better.  Mom and I decided on IM benadryl because pt was still having some trouble breathing and very lethargic.  I gave patient 25 mg IM bendadryl while my tech called 911. EMT's arrived within 5-10 minutes.  Took all vitals, patient was stable.  He was transported via ambulace to ER for further evaluation.  Pt was very stable upon leaving,  His father carried him to the ambulance.
On 1/12/2021 I had mitral valve repair surgery and was still recovering from that when I got my Covid 19 vaccines in April 2021. Approximately 6 weeks after my 2nd Covid vaccine dose, I had a stroke that was caused by endocarditis. The infection had attached to the repaired mitral valve. The infection damaged the valve so badly I required another surgery to have the valve completely replaced. I  underwent treatment for endocarditis with broad spectrum antibiotics given through infusion. My concern is that becasue my valve was not properly healed from surgery I became more susceptible to infection when the vaccine was introduced to my bloodstream.
Information has been received from a health professional concerning a 15- year old female who was vaccinated IM with 0.5 ml doses of GARDASIL. The patient had received all three doses. After each dose the patient developed weakness, dizziness and fainting. Unknown medical attention was sought. At an unknown date the patient recovered. No PQC involved. Additional information has been requested.
Pt vaccinated with TD after injection arm became red "quarter" size; redness increased to 5 in diameter. Redness gone next day. Apricot sized nodule until 20SEP90 then nodule quarter size.
On 6/20/2017 awoke with nausea, vomiting, diarrhea, mild headache, abdominal pain, hot and cold flashes. Symptoms persisted growing worse. On 6/21/2017 was seen at health Care urgent care mid day, then ER early evening.
Off-Label use; Interchange of vaccine products; usually has sensitive reactions to the chemicals added to the gray cap; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2 (initial pfizer dose), single for covid-19 immunisation. Relevant medical history included: "having reactions to a Pneumonia vaccine in the past" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Janssen vaccine (first she got the Janssen vaccine), for COVID-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), outcome "unknown", described as "Off-Label use"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "Interchange of vaccine products"; ALLERGY TO CHEMICALS (non-serious), outcome "unknown", described as "usually has sensitive reactions to the chemicals added to the gray cap".  Additional Information: It was reported that patient was going to get her 3rd shot of the Pfizer COVID-19 Vaccine yesterday but she usually has sensitive reactions to the chemicals added to the Gray cap, that the Purple cap did not had. She stated having reactions to a Pneumonia vaccine in the past. Caller stated to be looking for data on new shot, specifically if there were any reports on different AEs reported between the purple and gray cap. Caller mentioned that first she got the Janssen vaccine and not developing antibodies and that that's when her doctor suggested she get the Pfizer COVID-19 Vaccine. She also said that when she got the first dose she was monitored for over an hour and she did not get any side effects, but now she has worried the gray could cause her a reaction. Caller wanted to know where could she find any specific pharmacy that still had the purple cap, caller wanted to know if we were still manufacturing the purple cap. Caller wanted to know if we in Pfizer were the ones making Comirnaty. She stated being very afraid of going to the hospital for not being able to find the purple cap.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Pt received her COVID19 vaccine at 9:45AM on 1/8/2020.  -After vaccination, patient felt fine. -She was placed in observation. -10 min later, she felt as if she was having a "hot flash." She also develop a headache.  -I evaluated the patient at this time. -Pt denies rash, watery/itchy eyes, itchy throat, difficulty swallowing, difficulty breathing, chest pain, nausea, vomiting. -Vitals were stable throughout encounter (see vital section). -Patient did some deep breathing exercises with me and drank water.  -After ~10 minutes, the patient felt better. -She was discharged after close observation for 30 minutes.   -Of note, pt has a history of anxiety and panic attacks. She does not take medication for anxiety.  -Pt also has allergy to codeine (reaction - rash).
pt recvd vax; screamed the next day all day; was unconfortable before a 24 hr period was over;high pitched,none comforting screams;low grade T;could not be conforted x 8 hrs;
This spontaneous report received from a medical assistant referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored ROTATEQ (lot and expiry date: not reported). The vaccine was exposed to a temperature of 50F and a minimum temperature of 35F for an unknown time frame. No adverse effects were reported. There was no prior temperature excursions. This is one of the four reports received from the same reporter. Additional information has been requested.
Fever to 103.4 oral, headache, fatigue starting 17 hours post vaccination and lasting for about 18 hours.
Part of his girlfriends tooth came off; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH FRACTURE (Part of his girlfriends tooth came off) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced TOOTH FRACTURE (Part of his girlfriends tooth came off). At the time of the report, TOOTH FRACTURE (Part of his girlfriends tooth came off) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported.
headacke. stomick acke  day2. headacke, seveie stomick acke where it double me over day 3,4,5 feel like i have flu,headacke, body acke and tiredness
Patient received Johnson and Johnson COVID-19 vaccination on 4/8/21 on left arm. On 4/16/21, patient had an aura prior to on and off headache (across the forehead). She also had on and off headache the following day. On 4/18/21, the headache worsened in terms of pain to the point of nausea. Had one episode of vomiting (non-bloody). Patient took ibuprofen as needed for the headaches. No issues since then.
felt like Bell's palsy like a paralysis in my face; Swelling in face; This is a spontaneous report from a contactable consumer (the patient). A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0168) via an unspecified route of administration, administered in Arm Right on 11May2021 10:00 at age of 63-year-old at single dose for COVID-19 immunisation. Medical history included Bell's palsy (reported as "I had in my life I had Bell's palsy"). No other medical history. There were no concomitant medications. On 11May2021, the patient had like some swelling in her face and she was still having it. She had in her life she had Bell's palsy and that was what it felt like, it felt like paralysis in her face (also reported as "felt like bell's palsy like a paralysis in my face") and she wondered if she had to go to the emergency room. No treatment received for the events. No investigation assessment. The outcome of event "swelling in face" was not recovered, the outcome of event "felt like bell's palsy like a paralysis in my face" was unknown.
Information was received from a medical assistant regarding a patient, demographics not provided. The patient was administered the first dose of GARDASIL series on 25-SEP-2013, the second dose on 08-JAN-2014, and the third dose on 26-MAR-2014 (dosages and routes of administration not provided). No adverse effect reported. Additional information is not expected.
NKDA. Possible Guillain-Barre Syndrome. Patient developed bilateral lower extremity weakness, no longer able to ambulate. Patient has received vaccines in past annually with no problem. On IVIG 0.4 grams/kg 5 days. Admitted to hospital.
This spontaneous report as received from a physician refers to a 18 year old female patient. On 06-JUN-2013, the patient was vaccinated with the first dose of GARDASIL (lot # H021346; exp. date: 01-OCT-2015) (dose not provided). On 08-AUG-2013, she received her second dose of GARDASIL (lot # H021346; exp. date: 01-OCT-2015) (dose not provided). There were no concomitant medications. On 31-DEC-2013, when the patient was in the physician's office preparing to receive her third dose of GARDASIL, she told the physician that after her second dose on 08-AUG-2013, she experienced dizziness. The patient reported that she was "seeing stars and her vision was getting darker" for about one to 2 hours after receiving the dose. There was not given any treatment for the events. The patient recovered the same day on 08-AUG-2013 and she had not residual effects. Additional information has been requested.
12 dasy p/2nd vax had stiffness & swelling of the feet, toes & ankles; (dx as Rheumatoid arthritis) slowly progressed to hands, ankles & fingers (MAY94), moving to knees DEC94; on Pred & Ansaid as of this date;
her leg muscles hurt (both legs in calves and at top of legs); very weak; fatigued; has lost 30 pounds because she can't eat due to nausea; has lost 30 pounds because she can't eat due to nausea; This is a spontaneous report from a contactable consumer or other non hcp (patient) via Medical information team. A 75-year-old female patient received second dose of BNT162B2 (COMIRNATY, Formulation: solution for injection, Lot number was not reported), via an unspecified route of administration on 28Jan2021 DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient historical vaccine includes first dose of COVID vaccine (COMIRNATY, solution for injection) as DOSE 1, SINGLE for covid-19 immunisation. Patient received her second Pfizer Covid vaccine dose on 28Jan2021 and has been experiencing side effects ever since. She has seen her MD and reports her bloodwork was normal. Patient states she was very weak, fatigued, has lost 30 pounds because she cannot eat due to nausea, and her leg muscles hurt (both legs in calves and at top of legs) on an unspecified date in 2021. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Immunizations given at 11:30- by 21:00 that evening (10/15/15) pt. was "flushed". Woke up and had redness on neck. Came home from school that afternoon and had generalized redness with wheezing/SOB. In ED pt - given steroids. *DC home.
After the vaccine where administered 2 min later 2 small hives noted on the upper and inner left thigh near the injection site of DTaP #2 and MMR #1. Informed MD, Benadryl PO STAT ordered and given by RN. Pt observe for 20 min. No further hives noted on the body and no s/s of respiratory distress.
Pt recv vax on unspecified date; subsequently pt exp injection site rx of swelling &redness.
Severe allergic reaction; Heart was racing/heart rate was 180 bpm; Throat felt like it was closing; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Severe allergic reaction), HEART RATE INCREASED (Heart was racing/heart rate was 180 bpm) and OROPHARYNGEAL DISCOMFORT (Throat felt like it was closing) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced HYPERSENSITIVITY (Severe allergic reaction), HEART RATE INCREASED (Heart was racing/heart rate was 180 bpm) and OROPHARYNGEAL DISCOMFORT (Throat felt like it was closing). At the time of the report, HYPERSENSITIVITY (Severe allergic reaction), HEART RATE INCREASED (Heart was racing/heart rate was 180 bpm) and OROPHARYNGEAL DISCOMFORT (Throat felt like it was closing) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, Blood pressure measurement: 204/100 (High) High and 130/80 (normal) After 1 hour. On 19-Mar-2021, Heart rate: 180 (High) 180bpm.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment provided was IV in the ambulance.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow up received on 06-Aug-2021 and included Outcome of all the events were updated to recovered and reporter details (e-mail ID) was added.
Redness and itching at site (right upper arm) of injection; ice and hydrocortisone at needed.
HEADACHES, PAIN TURNING HEAD, STIFF NECK, MOST SYMPTOMS IN RIGHT EAR AND EAR LOBE.  NURSE PRACTIONER SAID IT COULD BE NEURALGIA FROM SHINGLES. THAT WAS TWO WEEKS AGO AND NO VESCICLES, AND PAIN WAS ON LEFT SIDE TOO.  PLEASE NOTE ONE WEEK AFTER RECEIVING SECOND VACCINE MY LEFT UPPER EYELID TWITCHED FOR SEVERAL WEEKS.  MY ARMS DEVELOPED PUNCUATE RED SPOTS. ALL ARE NOW RESOLVED. PAIN MEDICATION GOT ME THROUGH THE HORRIBLE HEADACHES
Chest pain. Per progress notes:   1/18/22: 18-year-old male brought back from the vertical process to T1 for concerning EKG suggestive of STEMI in the setting of recent receiving the January vaccine.  Patient describes chest pain with shortness of breath starting today - the chest pain is ongoing but the shortness of breath has significantly resolved.    STEMI code was called prior to my assessment of the patient and the interventions arrives shortly after I I did.  Further history and exam was truncated by STEMI protocol to not delay catheterization   Patient denies known cardiac history, lower extremity swelling or pain, past PE or DVT.  Denies history of uncontrolled hypertension or pain radiating through to the back  1/19/22: This morning's CPK shows that the patient has myocarditis in addition to pericarditis so he has myopericarditis presumably post a vaccination.  Have us discussed the case with Medical College this morning.  They recommend that is nonsteroidal be stopped in that he have a cardiac MRI to assess the burden of inflammation that he be started on high doses of steroid that is Solu-Medrol 500 mg IV 3 times a day his colchicine be continued.  We need to be mindful of LV function checking an echo in a couple of days.  We need to limit activity he is going to need to take it easy we have to keep a close eye on him to make sure he does not developed LV dysfunction.  I would think that at the earlier sign of LV dysfunction we would need to discuss transfer.  1/19/22: Acute myopericarditis presumably secondary to the coronavirus vaccine.  EF is preserved.  MRI confirms that the patient is myocarditis confirms that his EF is preserved shows relatively small amount of ventricular inflammation and does show a very small hemodynamically insignificant pericardial effusion.  I discussed the case as noted earlier with the heart advanced heart failure team.  We both agreed that nonsteroidals are not say for a good idea with myocarditis the colchicine makes sense for the pericarditis and they recommended very high dose steroid and that we keep an eye on his EF checking an echo in a couple of days.  Post discharge she will have to modulate his activity.  We will have to decide long-term how we will use steroids.  I will reach out to our new associate to lay out a long-term plan
tested positive for covid after the second vaccine; tested positive for covid after the second vaccine; This is a spontaneous report from a Pfizer sponsored Program. This consumer (patient) reported similar events for 2 patients. This is 1st of two reports. A 24-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, age at vaccination: 24-year-old), via an unspecified route of administration, in Arm Left (left deltoid) on 12Jan2021 (Batch/Lot Number: EL1284) as single dose, and dose 1 via an unspecified route of administration on 22Dec2020 (Batch/Lot Number: EJ1685, age at the time of vaccination: 24-year-old) as single dose for COVID-19 immunisation. The patient had no medical history and concomitant medications. On 19Jul2021, the patient underwent COVID-19 PCR test and tested positive for COVID after second vaccine dose. The patient feels dumb because the patient thought this vaccine was supposed to work, as the patient works in a hospital and believes science. The outcome of events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100919321 same reporter/product/event, different patient