chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore throat; sore ears; little cough at night when laying down; feeling down; it was going in her chest; feeling unwell; This is a spontaneous report from a contactable consumer reported for herself received via medical information team.  A 67-year-old female patient received bnt162b2 (BNT162B2, formulation: Solution for injection, Batch/Lot Number: EL3247), dose 1 via an unspecified route of administration, injected in her left arm on 05Feb2021 (at the age of 67-year-old) as single for covid-19 vaccination. Medical history included diabetes mellitus from an unknown date and unknown if ongoing, Caller said was diagnosed about 5 years ago. The patient stated that Height: Caller said she was 5 feet 2 inches tall and shrinking, which she clarified was before vaccine. The patient said concomitant medications, they have not had any other recent vaccinations or started any new medications. On 21Feb2021, the patient experienced sore throat, sore ears, little cough at night when laying down and feeling down. On an unspecified date in Feb2021, the patient experienced it was going in her chest and feeling unwell. Consumer called about the Pfizer COVID-19 vaccine who said she had her first COVID-19 vaccine dose back on 05Feb2021 and then was supposed to have her second one, she was not sure if that was supposed to be today or Friday of this week. She said since Sunday she has been feeling down, she has a sore throat and ears, and a little cough at night when she was laying down. She said she doesn't know if she caught something or if it was just allergies or something. She said she was unsure if she should take second dose or not right now, and she also doesn't know when they will have it again at the hospital. Caller said, not provided on handwritten vaccine card. She said that the first dose was given to her around 12:15-12:30 PM. Caller said that her sore throat and ears and cough have stayed about the same. She says it started with just the sore throat, now it was going in her chest. Caller wanted to know if it would be okay to get the second dose of the covid vaccine this week because she's had a sore throat, sore ears and a little cough at night. Can she receive second vaccine, no fever but feeling unwell as described. If she have to put off the vaccine was that okay, What about past 6 weeks, does she have to restart the vaccine series. Outcome of the events sore throat, sore ears and little cough at night when laying down were not recovered and unknown for other events.  No follow-up attempts are possible. No further information is expected.
it was rpt p/vax pt exp a local react of redness, swelling and erythema
red rashes on left foot, left pan and finger joints; itching; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number- ER8727 ), via an unspecified route of administration, in left arm on 20Mar2021 at 12:30 (at the age of 43-years-old) at a single dose for COVID-19 immunization. The patient's medical history was reported as none. The patient's concomitant medications were not reported. The patient had no known allergies to medications, food or other products. No other vaccine was given in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. The patient experienced red rashes on left foot, left pan and finger joints and itching from 27Mar2021 at 04:15 PM. It was unknown if treatment was given for the events. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Patient was given Prevnar 13 IM in left arm on 5/30/16. Patient reported to pharmacy a red itchy rash around left arm injection site on 6/3/16. Patient was seen by physician later in the day on 6/3/16 who provided treatment.  Patient was given Zostavax SQ in right arm on 5/30/16. Patient reported to pharmacy a warm ring around right arm injection site on 6/3/16. Patient was seen by physician later in the day on 6/3/16 who provided treatment.
Called 11-15-07 Stated: "I got TDAP on 11-13-07 and today I have Flu type symptoms, temp 101, and some swelling at injection site." Instructed she could use a cold compress to site prn, and Tylenlol or Ibuprofen if not allergic to either. Also explained that there are a lot of virus' going around right now and she could have been exposed to one of them or it could possibly be a reaction tot he TdAP, as everyone reacts differently to medications. Instructed if symptoms are no better or if she sees a Dr to let us know, will F/U. in the AM tomorrow.
Night sweats; chills; Tired; This is a spontaneous report from a contactable consumer (Patient). A 46-year-old male patient received  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Brand: Pfizer), dose 1 via an unspecified route of administration, administered in Left Arm on 03Mar2021 12:45 PM (Batch/Lot Number: EN6205, Lot unknown: False) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included High blood pressure, High heart beat rate. Facility type vaccine: Other, Facility type vaccine other: Vaccination Center. Known allergies: No, Other medical history: High blood pressure, high heart beat rate. There were no concomitant medications. If other vaccine in four weeks: No. The patient experienced night sweats (non-serious) on 05Mar2021 02:00 am, chills (non-serious) on 05Mar2021 02:00 am, tired (non-serious) on 05Mar2021 02:00 am. Adverse event: Night sweats and chills 36 hours after taking the vaccine. Tired up to 48 hours after taking the vaccine. Adverse event country: US. If patient recovered: Recovered. If treatment ae: No. If covid prior vaccination: No. If covid tested post vaccination: No. Explicit consent: Yes. For all events, outcome was recovered on an unspecified date in 2021.    No follow-up attempts are possible. No further information is expected.
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns a 51 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 16-Sep-2016 the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Intramuscular. Batch number: WT54306. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 16-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. On 04-Oct-2016, the remaining 42 doses of lot number WT54306 were discarded. The patients will be contacted for revaccination.
Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Shakiness-Mild, Additional Details: ambulance was called. pt felt better eventually, per paramedics: pt went home with friend, did not want to go to hospital.
Subconjunctival hemorrhage right eye  onset 10/13 / 23 and becoming severe  11/14~15 I have had prior similar events probably due to blood thinner and an familiar with the condition. This event however was unique in its severity?if the prior worst events were rated a 6, this event would be rated a 10
At the injection site (upper left arm) I woke up with the spot feeling tender and sore.  The reaction was extremely strange as when I initially received the vaccine my arm was sore for a few days.  Well when I checked my arm later that morning I had a bruise that was black, blue and a tiny bit yellow.  The arm was sore and is still a bit sore as I type this.  The bruise is slowly going away.  The only other reaction is that spot is slightly itchy on occasion- but a bit of cortisone helps.
Information has been received from a nurse concerning some babies (number unspecified) who were vaccinated orally with 2 ml doses of ROTATEQ. Subsequently the patients got a light blue color on their lips, a goofy look and "seemed like" they could not breath for a second. The patients outcomes were unknown. They sought medical attention at the office. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Additional information has been received from a nurse indicating that she could not pinpoint the patient's names but that the incidents happened to 4-6 patients over several appointments during the winter to spring months of 2008. She witnessed "like a perioral cyanosis" after giving p.o. ROTATEQ to several infants anywhere from 2 and 4 months old. She did not think it was an adverse event until it happened several times to different infants, then she began to wonder. Also, the infant would briefly have a staring look or eyes would roll back for a split second with cyanosis periorbital. After waiting 15-40 seconds, it went away and the patient looked normal. There were no illnesses at time of vaccination and no diagnostic test performed. Additional information is not expected.
pt recv vax 4PM 1MAY95 in lt deltoid; @ 8AM 2MAY95 pt sent home by school nurse w/red papular hives on arms, legs, face, trunk; No SOB-but itching; pt given Tavist & westcort cream;
LOW-GRADE FEVER; This spontaneous report received from a patient concerned a female of unspecified age. 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 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced low-grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from low-grade fever on 2021. This report was non-serious. This case, from the same reporter is linked to 20210604983.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 49 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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: "Depression" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) negative, notes: testing negative for the past 5 days; (08Mar2023) positive, notes: Testing positive 4 days after paxlovid treatment ended. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: no Other medication in 2 weeks and no known allergies. The patient was treated with Paxlovid from 27Feb2023 to 03Mar2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300102035 same reporter/patient, different product/event;
Night sweats; Achiness; Slight fever; Headache; This spontaneous case was reported by a patient and describes the occurrence of NIGHT SWEATS (Night sweats), PAIN (Achiness), PYREXIA (Slight fever) and HEADACHE (Headache) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939903, 032L20A and 025L20A) for COVID-19 prophylaxis.     The patient's past medical history included Flu vaccination. Concurrent medical conditions included Drug allergy (Codeine and derivates), High cholesterol (Start Date : 35 or 40 years ago), Esophageal reflux (Start Date : 25 or 30 years ago) and Asthma (Start Date : 25 or 30 years ago). Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for Asthma, SIMVASTATIN for High cholesterol, FLUOXETINE HYDROCHLORIDE (PROZAC), PRIMIDONE, CALCIUM and VITAMINS NOS for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, the patient experienced NIGHT SWEATS (Night sweats), PAIN (Achiness), PYREXIA (Slight fever) and HEADACHE (Headache). On 30-Oct-2021, NIGHT SWEATS (Night sweats), PAIN (Achiness), PYREXIA (Slight fever) and HEADACHE (Headache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient had received flu shot before 1st booster.  Other concomitant medications includes Nexium .  After the first dose, On 30-Dec-2020, the patient experienced Night sweats, Achiness, Slight fever and Headache. On 31-Dec-2020 events had resolved. After the second dose, On 25-Jan-2021, the patient experienced Night sweats, Achiness, Slight fever and Headache. On 26-Jan-2021 events had resolved.  No treatment information was provided.   This case was linked to MOD-2022-607741 (Patient Link).
Patient was administered a Pfizer Covid-19 vaccine that was exposed to a temperature excursion. (Vaccine was between 8-14.5 degrees C for 7hrs and 48 minutes). Pfizer was contacted and advised the clinic to consider the dose as invalid and to revaccinate. Patient was revaccinated n 03/19/21 and has since received dose 2 on 04/09/21.
Area of erythema, swelling, and warm to touch; 70 x 55 mm diameter on left thigh.
Diarrhea (11/21: 2:25 am, 5:00 am; 11/23: 7 am; 9 am) Mild fever 100 degrees F, aches, chills, headache (11/21 11am - 6pm) cough (11/19-ongoing).
Normal resting heart rate of 58-61.  At 10 PM, heart rate increased to 137 while watching TV, heart rate continues to average at 102 bpm for 120 minutes + and counting.  Body feels warmer than usual
Case number PHEH2015US016313, is an initial spontaneous report from a physician assistant received on 17 August 2015. This report refers to a 21-year-old female patient. Medical history included meningitis (about 6 years ago). No other health problems were reported to the patient. Concomitant medications included BCPs. The patient was vaccinated with MENVEO (batch number: M15018, expiration date: 01 May 2016) on 10 Aug 2015. In Aug 2015, after vaccination the patient experienced intermittent headaches. The headaches come and go and the patient went to the doctor's office to see her HCP about the headaches. Final outcome, seriousness and causality were not reported.
Vomiting 3 times in the span of 3 hours; Low grade fever; inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO161) via an unspecified route of administration in the right arm on 14Apr2021 at 09:30(at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included progressive neurodegenerative disorder, primary progressive aphasia. The patient had no known allergies to food, medication or other products. The patient did not receive any other medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the right arm on 29Mar2021 at 12:15 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 14Apr2021 at 17:00, the patient experienced vomiting 3 times in the span of 3 hours and low-grade fever. The clinical outcome of the event low grade fever and vomiting was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Pt reported to Rx on 10/18/2017 (next day) with reddened erythematous area approx 4"x6" warm to touch enveloping skin tissue for R distal deltoid and all of biceps. Complaint of progressive stiffness and intermittent chill. No raised areas, striations, or encapsulated areas (knots) noted. Placed patient on 25mg diphenhydramine po bid-tid, IBU 400mg q4-6h prn, and cold compresses to site at this time with directions to see MD for steriod if not improved by morning 10/19/2017.
This case was reported by a healthcare professional (nurse) and described the occurrence of hives in a 30-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 1 October 2012 the subject received a dose of FLULAVAL (.5 ml, unknown route, left deltoid). On 1 October 2012, approximately 2 hours after vaccination with FLULAVAL, the subject experienced hives. The subject was treated with CLARITIN. "The next day her symptoms recurred probably when the CLARITIN wore off." On 2 October 2012, the event was resolved. The nurse reported two cases of adverse experiences with FLULAVAL. See case A0998207A for details.
DROWSY/SLEEPY; HEADACHE; VOMITING; UPSET STOMACH; UPPER STOMACH HARDNESS; SHOOTING PAIN ON LOWER BACK; SHOOTING PAIN ON LEFT LEG/RIGHT LEG; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021, the subject experienced vomiting. On 08-APR-2021, the subject experienced upset stomach. On 08-APR-2021, the subject experienced upper stomach hardness. On 08-APR-2021, the subject experienced shooting pain on lower back. On 08-APR-2021, the subject experienced shooting pain on left leg/right leg. On 09-APR-2021, the subject experienced drowsy/sleepy. On 09-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from upper stomach hardness on APR-2021, had not recovered from shooting pain on left leg/right leg, headache, shooting pain on lower back, vomiting, and drowsy/sleepy, and the outcome of upset stomach was not reported. This report was non-serious.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A male patient received bnt162b2 (BNT162B2), intramuscular, administration date 14Oct2021 10:00 (Lot number: FE3590, Expiration Date: 05Nov2021) as dose 3 (booster), single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), administration date: 2021, for COVID-19 immunization; Bnt162b2 (Dose: 2, Consumer also informed that the second dose got him very sick, with flu like symptoms, no more information provided), administration date: 2021, for COVID-19 immunization, reaction(s): "very sick", "flu like symptoms". The following information was reported: BALANCE DISORDER (non-serious) with onset 16Oct2021, outcome "unknown", described as "Equilibrium is off, my balance is, I feel like I am going to fall over". Additional information: I was just calling on, I had my Pfizer booster on Thursday and it has been 6 months before I had have my other two shots. What is going on right now is, I went to work this morning and my equilibrium is off, my balance is, I feel like I am going to fall over. Now, is that a side effect from that booster?". I am going to wait until tomorrow and if I am still feeling this way, I might go to an emergency. You cannot answer that? You haven't had anyone with this reaction. Consumer also informed that the second dose got him very sick, with flu like symptoms, no more information provided. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. No follow-up attempts are possible. No further information is expected.
she feels much worse than when she had covid; really sore arm/really intense muscle pain; chills; headache; throwing up; all muscles in the body were having spasms; upset stomach; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (all muscles in the body were having spasms), ABDOMINAL DISCOMFORT (upset stomach), CONDITION AGGRAVATED (she feels much worse than when she had covid), MYALGIA (really sore arm/really intense muscle pain) and CHILLS (chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced MUSCLE SPASMS (all muscles in the body were having spasms), ABDOMINAL DISCOMFORT (upset stomach), MYALGIA (really sore arm/really intense muscle pain), CHILLS (chills), HEADACHE (headache) and VOMITING (throwing up). On an unknown date, the patient experienced CONDITION AGGRAVATED (she feels much worse than when she had covid). At the time of the report, MUSCLE SPASMS (all muscles in the body were having spasms), ABDOMINAL DISCOMFORT (upset stomach), CONDITION AGGRAVATED (she feels much worse than when she had covid), MYALGIA (really sore arm/really intense muscle pain), CHILLS (chills), HEADACHE (headache) and VOMITING (throwing up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitants were not provided. Patient used heating pad for muscle pain.   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Non-Significant Follow Up Appended- Contact Information updated
Constrictive pericarditis. Began after first dose and got better with treatment. Reoccurred after booster shot. Diagnosed with 2 MRIS. Chest pain.
Pt recv vax on 11/17/98; 3-4 hr post vax pt exp red/swollen/ painful vax site; dx=sterile abscess; tx=purulent exudate drainage
Caught covid late May-June. It was a mild case. Was given Plaxlovid.  Chronic pain completely disappeared for 3 weeks. Came back during week 3.