chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had covid 04Jul it was just a cold symptom it was not like a first covid when she run a fever for 16-17 days.; Had covid 04Jul it was just a cold symptom it was not like a first covid when she run a fever for 16-17 days.; 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 78-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "first covid when she run a fever for 16-17 days" (unspecified if ongoing); "first covid when she run a fever for 16-17 days" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing), notes: Caller stated I use CPAP machine I have a sleep apnea; "CPAP machine" (unspecified if ongoing), notes: Caller stated I use CPAP machine I have a sleep apnea. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Had covid 04Jul it was just a cold symptom it was not like a first covid when she run a fever for 16-17 days.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: unknown results.  Clinical course: Reporter stated that (78 years old, female) has narcolepsy with cataplexy reported that she had two primary Pfizer shots, had 1st Pfizer booster shot while ago ( no exact date provided). Patient had no problems primary doses. Patient called FDA and they told her not to get a second booster told her to wait for bivalent vaccine. Had covid 04Jul it was just a cold symptom it was not like a first covid when she run a fever for 16-17 days.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sudden onset hyporesponsive, hypotonic, and pallor. Most severe lasted about 10 minutes. Took approximately 1.5 hours for patient to return to normal.
Weakness in left arm.  Very limited shoulder mobility on the Left side.  Inflamed  Teres Major/Minor.  Cannot lift even 5lbs above the shoulder level and hold.    Symptoms have persisted since 05/22/2022.  I have tried chiropractic treatment twice a week since with no improvement.  Anti-inflammatory drugs also have not helped.
heart was beating a little faster; it felt like her lymph nodes and her chest were swollen; she had trouble catching her breath.; still feel that area is burning a bit; that is still hurt a lot/ hurt on both sides after firs/ chest lymph nodes started to hurt on her left side; her chest glands or lymph nodes swelled up and it felt painful; it felt like her lymph nodes and her chest were swollen; This is a spontaneous report from a contactable consumer (patient herself). A 39-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot/batch number was not reported) via an unspecified route of administration on 27Sep2021 (age at vaccination was 39 years) as dose 1, single for covid-19 immunisation. The patient's medical history was not reported. The patient received as historical vaccine as Flu shot for immunization and experienced got bad reactions with flu shots: got bad reactions with flu shots about a year ago, with a regular Flu shot given in her doctor's office. She could not provide the brand name, NDC, Lot number or expiration date of the Flu shot. The patient's concomitant medications were not reported. Other products not provided. She had a tendency to get reactions to shots. The patient stated she received the first dose of the Comirnaty vaccine on 27Sep2021 and had some reaction. On the second day after her shot, it felt like her lymph nodes and her chest were swollen and it felt painful on 28Sep2021 and said that this had been about a week or so. She wanted to know if this was normal, for how long this would last, and this had been reported. She also mentioned her heart was beating a little faster, like had trouble catching her breath but had already went away and her main concern was the feeling of lymph nodes and chest being swollen and hurt on both sides after firs. She still felt that area was burning a bit and that was still hurt a lot. Her chest lymph nodes started to hurt on her left side, and then the next day both sides hurt. She just wanted to report this because she had no idea and it had been more than week and these things still hurt every morning when she woke up. She was concerned and nervous if she should get the second dose of her Comirnaty vaccine on the scheduled time due to her side effects and that the second dose might feel worse. She also reported that these symptoms went away. She did call a nurse who told her, if the symptoms got worse to go to the emergency room. The patient underwent lab test and procedure included heart rate: heart was beating a little faster and Sonogram: unknown result. The outcome of events her chest glands or lymph nodes swelled up and it felt painful was recovered on an unspecified date of 2021 and outcome of other events was recovered on unspecified date.  The lot number for the vaccine, [BNT162B2], was not provided and would be requested during follow up.
body aches; coughing; loss of tatse and smell; Loss of taste and smell; nauseated; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), COUGH (coughing), AGEUSIA (loss of tatse and smell), ANOSMIA (Loss of taste and smell) and NAUSEA (nauseated) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (body aches), COUGH (coughing), AGEUSIA (loss of tatse and smell), ANOSMIA (Loss of taste and smell), NAUSEA (nauseated) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and ACETYLSALICYLIC ACID, CAFFEINE, SALICYLAMIDE (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;SALICYLAMIDE]) at an unspecified dose and frequency. At the time of the report, PAIN (body aches), COUGH (coughing), AGEUSIA (loss of tatse and smell), ANOSMIA (Loss of taste and smell), NAUSEA (nauseated) and HEADACHE (Headache) 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.   Concomitant product use was not provided by the reporter.
Information has been received from a health professional concerning an 11 yr old female who as an infant, was vaccinated with a 0.5ml SC dose of varicella virus vaccine live. In the summer in approx Jul 2005, the pt had classic appearing herpes zoster involving the right breast area around to the posterior back. It was not cultured. The pt was treated with oral acyclovir. It was reported that the pt recovered. No product quality complaint was involved. No other information was provided. Additional information is not expected.
Pt became dizzy, diaphoretic and felt like passing out approx 10 minutes after receiving the vaccine.  Upon arrival to med obs area, pt was alert.  BP 97/68, HR 76, O2 95%.  Pt rested on gurney and felt better shortly after having water and crackers.  recheck  BP 109/72, O2 94%.  Pt stayed in observation until 1300, with last check of BP 112/67, HR 76 and O2 97% while standing.  Pt felt comfortable being released.  She was discharged with her daughter in her own wheelchair.
pt vax in 1997 & in 1999 pt devel a severe case of chickenpox w/an excess of 200 bumps all over the body.
Jan. 6, 7, & 8 - Had chills, fever, nausea, dizziness, headache, sore throat, ear pain, & fatigue
Day after vaccination (11/13) had fever, body aches, chills which improved by 11/14. On 11/17 patient noticed an open sore and red rash on upper left side of back accompanied by burning pain. By 11/25 some improvement noted in burning sensations.
Swelling of facial nerve, some weakness, balance problems over night face & lips were distorted. 23 hours after vaccine was given prednisone 10 m.
Dose Number: 3 Batch/Lot No: Unknown./ experiencing COVID symptoms; Dose Number: 3 Batch/Lot No: Unknown./ experiencing COVID symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Oct2021 at 16:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 43 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 27Apr2022 at 09:00, outcome "unknown", SUSPECTED COVID-19 (medically significant) with onset 27Apr2022 at 09:00, outcome "not recovered" and all described as "Dose Number: 3 Batch/Lot No: Unknown./ experiencing COVID symptoms". Therapeutic measures were taken as a result of suspected covid-19.   Clinical course: Patient received Pfizer COVID-19 vaccine and had no other medications in 2 weeks. Received paxlovid as COVID-19 treatment from 22APR2022 to 26APR2022 with lot number FY4422. Patient experienced COVID symptoms again within 12 hours of taking the last dose of Paxlovid. Device Date was reported as 27Apr2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patients e-mail: This is just to let someone know about severe reaction to the pneumonia immunization on Fri. April 20. I couldn't raise my arm that I got the shot in for 48 hrs. and Flu like symptoms for a day. The shoulder pain and joint pain have almost subsided now but wanted to report symtoms.  Thank You
Pt recv vax on 10/2/98; on 10/3/98 pt exp swelling from neck area under chin to under arm of right side.
On 14Sep2021 the patient experienced COVID-19; On 14Sep2021 the patient experienced COVID-19; This is a solicited report from a contactable consumer (patient) based on information received by Pfizer (manufacturer control number: 21K-163-4088161-00).  A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular on 01Jun2021 (Batch/Lot number was not reported) as dose 1, single, then intramuscular on 21Jun2021 (Batch/Lot number was not reported) as dose 2, single for Covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) and ongoing, at citrate free for psoriatic arthropathy. Medical history included non-serious ill with fatigue on Nov2020. The patient's concomitant medications were not reported.  On 14Sep2021, the patient experienced Covid-19. It was unknown if patient was enrolled in a Covid-19 vaccine trial. The patient underwent lab tests and procedures which included Sars-cov-2 test: Covid-19 on 14Sep2021. Outcome of the event was unknown.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.; Sender's Comments: Based on the information provided in the narrative, the Company considered there was not a reasonable possibility that the reported events Drug ineffective and Covid -19 were related to the suspect vaccine BNT162B2. The event Covid -19  was more likely consistent with an intercurrent condition.
TOOK SECOND DOSE A DAY LATE; This spontaneous case (PVX2019-2309) was received from a consumer on 09-Sep-2019. It described a female consumer who "took second dose a day late" (PT: Inappropriate schedule of product administration), while being on oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer did not take the Vivotif doses according to the schedule. The first two doses were taken on 05-Sep-2019 and 08-Sep-2019, respectively.  Action taken with Vivotif was not applicable.   The clinical outcome for the reported event was unknown.  Company's Comment: The causality of the event "took second dose a day late" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took second dose a day late" was considered as not applicable.
Redness in the Left thigh, Hot to touch, Rash, Hives, Welts from hives. Started 24 hours after shot.
Affecting menstrual cycle. Cycle appeared 9 days sooner than expected, heavier flow, extreme cramping, nothing like a normal cycle.
I wake up in the morning and I woke up with two lymph nodes between my neck and shoulder
SWELLING OF LEGS; SWELLING OF FEET; This spontaneous report received from a patient concerned a 51 year old female. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 02-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced swelling of right leg, and swelling of right feet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling of legs, and swelling of feet. This report was non-serious.
pt recvd vax & c/o joint pain-knee pain that felt like Hep B vax caused it; pt was ask to see MD;
he fell in the bathroom and passed out; he fell in the bathroom and passed out; tested positive for Covid; This is a spontaneous report from a contactable consumer (patient's son). This consumer reported similar event for two patients (father and mother). This is the first (father) of the two reports.  A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Dose 1) via an unspecified route of administration, administered in the left arm on 26Mar2021 (batch/lot number: ER8727) at 79 years old as SINGLE DOSE for COVID-19 immunization. Medical history included ongoing AFib (atrial fibrillation) diagnosed between 1 and 2 years ago. Patient also has a pacemaker from an unknown date. Patient was exposed to COVID-19 prior to vaccination. Concomitant medication included apixaban (ELIQUIS) oral from an unspecified start date and ongoing at 5 mg twice a day taken for AFib (atrial fibrillation). On 07Apr2021, the patient was admitted to the hospital due to a fall; he fell in the bathroom and passed out. The patient is on Eliquis, so they were worried about bleeding. He tested positive for COVID on 07Apr2021, this was the same day he was admitted to the hospital. He was discharged on 10Apr2021 and was improving. It was reported that the reporter (patient's son) tested positive for COVID on 27Mar2021, so it was likely his parents were exposed or infected prior to their first dose of the vaccine. The reporter confirmed he has not been vaccinated. The patient was due to get the second shot today, but the reporter cancelled the appointment since his dad was still in quarantine. The reporter heard different things about when to get the second dose, everyone says to wait 90 days, they're getting mixed information, then he has heard 3 weeks is long enough to wait. The reporter wanted to know when his dad can get the second dose of the vaccine after having the COVID-19 infection. The patient is recovering from "he fell in the bathroom and passed out." Outcome of the event "tested positive for Covid" was unknown.   This case involves a Product Complaint: Consumer reported that his father and mother tested positive for Covid infection on 07Apr2021 after receiving the first dose of the Pfizer COVID vaccine on 26Mar2021. It was not provided if a sample of the product was available to be returned, if requested and if packaging was sealed and intact.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021443810 same reporter, same drug, same event, different patient
Patient received a FLUZONE HIGH DOSE flu shot on 9-28-17. She came into the pharmacy on 10-6-17 to pick up a prescription and while talking to her she mentioned that a few days after her flu shot she developed a rash on her neck. She did go into her doctor to look at and he said it might be a reaction to the shot. She did not think she had received the high dose shot the year before but when I informed her that she had she mentioned that she did not feel right after receiving the shot  in 2016. The doctor wants her to try the regular flu shot next year and if she has a reaction to it then to stop the seasonal flu vaccines.
Initial information received on 05-Dec-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case involves an unknown demographic patient who was vaccinated with only half dose of vaccine PENTACEL (lot number, Exp. Date, route and site of administration not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. It was an actual medication error case due to vaccine underdose. It was not reported whether the patient experienced any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
the patient tested positive for COVID 19 after receiving dose #1 of the COVID 19 Pfizer vaccine.
1wk p/vax pt exp paralysis in fingers & feet along w/slurred speech;pt was hosp & dx w/GBS;
PATIENT DEVELOPED FEVER THE NEXT DAY. HAD A ONGOING SET OF FEVERS FOR A WHOLE MONTH AFTER GETTING VACCINATED. REPORTED TO THE EMERGENCY ROOM ON 10/21/2014. FOLLOWED UP WITH THE DOCTOR ON 10/23/2014. MEDICATION WAS WRITTEN & DOCTOR REFERRED PATIENT TO SPECIALIST.
The vaccine was given past the beyond use date. Moderna was notified and per Moderna that vaccine maintained the necessary activity to protect against COVID-19. No additional intervention required.
16 hours after administration, my child experienced sudden onset of menstrual bleeding; 7 days before her normal predicted cycle start day. Now 6 months later she has not had a normal menstrual cycle. Her cycles are coming as soon as every two weeks  now. She also had rough skin patches appear all over her body within days of the vaccine
14 yo female here for evaluation of syncopal episode today. Patient started with headache at 9:15 am, pain was fairly severe. Pain radiated to the arms and legs about 1.5 hours afterwards. By 11:30 am pain was so severe that patient felt that she needed to go home. Patient was at her locker around 11:30 am and she started to feel dizzy and she started to fall, was caught by a friend. No head trauma or trauma in general. Patient continues to have leg and head pain and arm pain. Patient feels more sleepy than usual. No fever. Patient was here for physical exam yesterday and given the Menactra and flu vaccines, was well up until this morning. No new activities yesterday. Patient has dizziness. No changes in vision. Patient reports weakness. Denies sexual activity. Denies Drug use.
Shaking chills, much sneezing, runny nose. Much like common cold. Sore arm, malaise. No fever or cough.
Dizzy, nauseous after 25 mins of receiving. This got worse during the night into a Friday January 15.    Felt very tired.  By 11am I felt like I had a bad flu.  Fever, nauseous, very bad body aches, chills.   Later that day, I developed a headache on top of that.  I had taken Advil few times. Helped with fever but nothing else. During the night I felt worse and had cramp in left calf and left arm,  extremely painful cramp. I felt this way all day .   Tried Aleve.   Didn?t help.   Still had bad body aches , weak , headache.  This continued till Sunday January 17.   By afternoon I felt completely fine.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: ems called out of caution  patient fainted   patient declined further treatment
Within an hour a bruise appeared at injection site and grew to 1 1/2" circle. Over the weeks pain grew at the site and swelling appeared beneath the site. Still have pain in upper arm.
My baby experienced lethargy, fever up to 101 and stomach cramping. She was just comforted at home, no meds were given. Her fever broke sometime in the early morning but she still experienced stomach pains through the next day; January 26th.
Per safety officer to this writer: Pt DOB 10/2/1972. Pt had first dose of Pfizer vaccine, began feeling dizzy and lightheaded immediately after. Pt stated "its hard to speak". Pt given juice and water. AID called to evaluate Pt. Pt requested interpreter. Pt states she had not been feeling well the last several days, has low grade fever and allergies to ibuprofen (itchy and trouble breathing). 10:19: Pt was evaluated by EMTs, released from EMT care. Pt rested on cot in observation area. RN assisted in calling Pt ride to pick Pt up. Pt reports hx of migraines. 10:46: a friend/relative arrived to pick Pt up and drive her home.  11:14: Pt walked out with significant other to car.   VS 1010  BP 120/80 HR 110 RR 24 Temp 99.6F temporal O2 sat 100% on RA  VS 1023 HR 85 RR 20 Temp 99.9F temporal O2 sat 100% on RA  VS 1033 Temp 98.5F temporal
Vaccine that had been more than 30 days in the refrigerator was given to 16 patients/vaccinate past its expiration date of 10/1/21; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that had been more than 30 days in the refrigerator was given to 16 patients/vaccinate past its expiration date of 10/1/21) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that had been more than 30 days in the refrigerator was given to 16 patients/vaccinate past its expiration date of 10/1/21). On 07-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine that had been more than 30 days in the refrigerator was given to 16 patients/vaccinate past its expiration date of 10/1/21) had resolved.        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.   No concomitant medication was reported. No treatment medication was reported