chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had a little bit of arm sore.; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself) from a Pfizer sponsored program. A female patient of an unspecified age received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 22Feb2021 as dose 2, single for COVID-19 immunization. Medical history included ongoing back pain for 12 years. The concomitant medications were not reported. Historical vaccine included first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route as dose 1, single for COVID-19 immunization. On an unspecified date in Feb2021, the patient had a little bit of arm sore. It was reported that patient inquired if she could take Celebrex for her ongoing back pain, she already had for 12 years and this pain. The outcome of event was unknown.  No follow-up attempts are needed; information about batch/ lot number cannot be obtained.
HEADACHE; 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 not reported, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 05:15 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021 11:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache. This report was non-serious.   .
PATIENT WASN'T FEELING WELL AFTER VACCINE (WAS A LITTLE NERVOUS) AND ASKED FOR SOME WATER. PATIENT SAT DOWN IN WAITING AREA WHILE I WENT TO GET HIM A DRINK. WHEN I CAME BACK PATIENT WAS RIGID AND LOCK JAWED AND NOT BREATHING. WHEN WE GOT PATIENT TO FLOOR HE WAS RESPONSIVE TO A STERNUM RUB AND HAD A PULSE. AT THIS TIME HE STARTED TO PRODUCE SNORE LIKE NOISES, CONVULSED FOR LESS THAN A MINUTE THEN CAME BACK TO. EMT'S CAME AND CLEARED PATIENT. PATIENT STATED HE HAS A VASOVAGAL REFLEX HOWEVER HAS NOT HAD AN INCIDENT IN MANY YEARS. IT IS UNKNOWN IF THIS IS WHAT PATIENT EXPERIENCED OR A REACTION TO THE VACCINE.
discomfort in arm;immed p/inj;large amount of blood return p.inj;described inj given 3-4in above elbow;arm very red, sore, very large, hard, warm to touch;devel hives all over chest, took DPH;c/o losing strength in arm leg, pain on side;
After receiving the shot, patient was feeling really dizzy and lightheaded. He started feeling really cold and was shaking. Paramedics were called and assessed the patient. After assessing the patient, the paramedics helped the patient to his car.
1 week after injection experiencing itching, followed 1 day later by swelling, slight redness, and discomfort.
Local reaction (redness, induration) in both right and left thigh areas that began approximately 24 hours  after immunizations were given. Treatment: warm compress, Ibuprofen, hydrocortisone cream.
Broke out with rash over back and stomach. Itchy and seems to be spreading. Not going to be seen by administering DR until around 6/10/2013.
I experienced fatigue, fever, headache and nausea. I had a temperature of 101.8 for a few days then it subsided. On day three felt fuzzy on the top of my head. My symptoms lasted for five days then subsided. Then on Dose 2 same symptoms lasted for 3 days except the fuzziness and Dose 3 same symptoms lasted for 16 hours except the fuzziness. After Dose 3 on December 2, 2021 got Covid on February 12, 2022. My Covid symptoms lasted for sixteen days, fever didn't elevate over 100, slight cough, no congestion, very weak, loss of appetite, and headache.
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 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 at 13:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in right 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto l" (unspecified if ongoing); "Epstein Bar" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing). Concomitant medication(s) included: TIROSINT, start date: 06Feb2014. Past drug history included: Compazine, reaction(s): "known allergies: Compazine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was in other medication in 2weeks, and received COVID-19 treatment with Paxlovid from 01Dec2022 to 07Dec2022.  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.
The site of the injection felt itchy for days following the injection. On February 12, I noticed an itchy bump on my right hip. The next morning, there were itchy, hard bumps on my feet and right ring finger. The bumps on my feet have become swollen and warm and seem to be growing larger, especially today on February 14. Two small bumps have also developed on my hands. I am not sure whether this is related to the vaccine, but it has become painful to walk.
Patient came in with his wife for our 2nd shot clinic. They arrived this morning and filled out their questionnaire . We did not look to see that his appointment was on 04/29/21 and they had just got their first shots on 04/02. When we noticed later  I contacted him and he said that he heard next week and not 4 weeks away.  When he looked at his card it did say  04/29/21 for 2nd shot. They got confused and we did not notice it in the process. I contacted manufacturer and his physician. At the time I spoke with them neither was having any issues.
slightly light-headed the morning after; Very sore at injection site; tired/sluggish; tired/sluggish; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 21 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 17Mar2021 11:00 (Lot number: EP6955) at the age of 21 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergies to tree nuts" (unspecified if ongoing); "Allergies to shellfish" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 17Mar2021, outcome "recovering", described as "Very sore at injection site"; FATIGUE (non-serious), SLUGGISHNESS (non-serious) all with onset 17Mar2021, outcome "recovering" and all described as "tired/sluggish"; DIZZINESS (non-serious) with onset 18Mar2021, outcome "recovering", described as "slightly light-headed the morning after". Therapeutic measures were not taken as a result of vaccination site pain, fatigue, sluggishness, dizziness.  Additional information: The patient had not received any other vaccines within 4 weeks and had not been diagnosed with COVID-19 prior vaccination. The patient had not been tested for COVID-19 since the vaccination.  No follow-up attempts are possible. No further information is expected.
Information has been received from a RN with a history of natural varicella during childhood, who on 08/03/2000 was inadvertently splashed on the right arm when administering a does of varicella virus vaccine live. The nurse did not wipe the vaccine off right away. On 08/11/2000 the nurse developed 6-7 vesicles on her right arm. Additionally, it was reported that the nurse felt itchy that evening. It was noted that the veiscles lasted 5-7 days and resolved without complications. The nurse indicated that she did not see a physician. No further information is available.
After the third vaccine dose, 1 patient (P-53) had documented breakthrough SARS-CoV-2 infection resulting in hospitalization and recovered fully; After the third vaccine dose, 1 patient (P-53) had documented breakthrough SARS-CoV-2 infection resulting in hospitalization and recovered fully; This is a literature report for the following literature source(s):  A 65-year-old male 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: "MDS" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Seasonal influenza vaccination, for immunization. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), outcome "unknown", BREAKTHROUGH COVID-19 (hospitalization, medically significant), outcome "recovered" and all described as "After the third vaccine dose, 1 patient (P-53) had documented breakthrough SARS-CoV-2 infection resulting in hospitalization and recovered fully". The patient underwent the following laboratory tests and procedures: IPSS-R/ELN/DIPSS: 8, notes: Very high; Unknown results; Karyotype analysis: 46, XY, del(7) (q22q36); SARS-CoV-2 antibody test: Unknown results. Therapeutic measures were taken as a result of breakthrough covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162b2 in this patient cannot be completely excluded.  ,Linked Report(s) : US-PFIZER INC-202200803661 same article/product/event, different patient
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 17-AUG-2016, the patient was vaccinated with improperly stored dose of PROQUAD (lot # M007960, expiry date: 15-AUG-2017) (route: subcutaneous). The vaccine was stored at a temperature of -7.9 C for 5 hours, 31 minutes. Digital data logger was involved and the vaccine was back in range. There was no previous temperature excursions. No adverse effects reported. Additional information has been requested.
This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 63-year-old female patient who received SHINGRIX (batch number 3AF9E, expiry date 2nd February 2021) for prophylaxis. On 11th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 12th July 2018, 1 days after receiving SHINGRIX, the patient experienced injection site vesicles. In July 2018, the patient experienced injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain, injection site erythema and injection site vesicles were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site erythema and injection site vesicles to be related to SHINGRIX. Additional details were provided as follows: The reporter had a patient that received the SHINGRIX vaccine on right deltoid. Within 24 hours of vaccination, the patient reported having pain and redness at the injection site. The day after this the patient noted vesicles at the injection site. All symptoms were resolved with 48 hours of the vaccination.
On the 10th day when woke up and had only partial vision in left eye; eyes begin to water; have racing heart palpitations even while lying in bed; major headaches; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 42-year-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in left arm on 04Aug2021 16:45 (Batch/Lot Number: 3101) (vaccinated at the same age) as dose 1, single for covid-19 immunisation. Medical history included apnoea. No covid prior vaccination. There were no concomitant medications. Adverse event after receiving the first dose of vaccine: On 06Aug2021 08:00 AM, patient's eyes begin to water, later started to have racing heart palpitations even while lying in bed and major headaches. On the 10th day when woke up and had only partial vision in left eye. Then went to see an eye specialist and had eye drops pat a day Patient had numerous tests and an MRI. The heart palpitations went away after 2 weeks, vision returned after 1 month. Patient still have headaches daily. No covid tested post vaccination. Outcome of watering eye, palpitations, Partial visual loss was recovered with sequel, headache was not recovered.
On 5/10/01, had fever to 102F-103F, lasting 3 days. On 5/13/01, macular rash on trunk, face and all extremities and frequent, watery diarrhea with poor appetite. On 5/14/01, exam showed no Koplik's spots; exam not consistent with measles. Looks well.
On day 8 after first dose of Moderna, injection arm started itching . It was under the arm of the injection site. On day 9 injection site also became itchy, red and swollen and bigger than the day before. It feels hot and slightly painful. Day 10 the warmth went down but still itchy, red and feel a hard lump on injection site.  Today is day 11 and still red and itchy but feels slightly better.
20 mins post receiving vaccination, pt began inconsolable screaming and temperature to 100 degrees.
Swollen, Sore, and Warm extremity where both immunizations were given.  PNEUMOVAX and Influenza. Soreness continue migrating distally, along with angioedema.
tested positive for covid; tested positive for covid; 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 male patient received bnt162b2 (BNT162B2), administration date 21Dec2021 (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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. The patient reported he was due for his second dose on 13Jan2022 and stated he recently tested positive for COVID. The patient wanted to know if he tested negative before or by the date of the second vaccine could he get the second dose or should he wait longer.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Immediately after vaccination itching started at injection site, it progressively got worse with burning and bruising started at injection site and then spread. Also nose running, clear water. Did not take anything. All the symptoms continue through today. A week after injection, at flu clinic in facility, spoke to nurse at site and he mentioned that it could be normal but if it persist call us. Sent email to doctor on 10/22 and explained the situation and staff encouraged pt to make doctor appointment. Took BENADRYL on 10/22 did not help with any of the symptoms. Tried topical cortisone cream and it did not work. Bruising, improves and then reappears in different spot in the same area. Area extremely tender to the touch and it feels like it burns from inside.
Dizziness; This is a spontaneous report from a contactable nurse (patient). A 59-years-old female patient received second dose of bnt162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL0142; expiration: not reported), via an unspecified route of administration, administered in arm left on 27Jan2021 as single dose for covid-19 immunisation (at the age of 59 years and the patient was not pregnant at the time of vaccination) at hospital. Medical history included iron deficiency from an unknown date and unknown if ongoing, migraine from an unknown date and unknown if ongoing, sulfa allergy from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included zolpidem tartrate (AMBIEN) taken for an unspecified indication, start and stop date were not reported; cetirizine hydrochloride (ZYRTEC) taken for an unspecified indication, start and stop date were not reported; bupropion hydrochloride (WELLBUTRIN SR) taken for an unspecified indication, start and stop date were not reported; HCTZ (HCTZ) taken for an unspecified indication, start and stop date were not reported; pregabalin (LYRICA) taken for an unspecified indication, start and stop date were not reported and hormone replacement therapy (HRT) (all medication within 2 weeks of vaccination). Previously, patient received BNT162B2, via an unspecified route of administration, administered in arm left on 06Jan2021 (Batch/Lot Number: EJ1685; expiration: not reported) as first dose, single for covid-19 immunisation (at the age of 59years). On 29Jan2021 04:30, 2nd day after 2nd dose the patient woke up extremely dizzy. Dizziness had lessened in intensity over last 6 hours but has not resolved. No treatment received for the adverse event. Outcome for event was not recovered.  Follow-up (15Apr2021): Follow-up attempts are completed. No further information is expected.
protocol is for pregnant women at their facility to receive flu vaccines, Covid vaccines and TDAP with no reported adverse event; Initial information received on 12-Dec-2022 regarding an unsolicited valid  non-serious case received  from a other health professional.  This case involves an unknown age female patient who was exposed to vaccines DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE, COVID-19 VACCINE and INFLUENZA VACCINE in context of protocol is for pregnant women at their facility to receive flu vaccines, covid vaccines and tdap with no reported adverse event.   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.  The date of last menstrual period was not reported.  The estimated due date was not reported.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a suspect Influenza vaccine for Immunization,covid-19 vaccine, Diphtheria, tetanus and acellular pertussis vaccine produced by unknown manufacturer (strength, dose, formulation, frequency, lot number, route, administration site and expiry date: not reported) for prophylactic vaccination    On an unknown date the patient developed a non-serious event protocol is for pregnant women at their facility to receive flu vaccines, covid vaccines and tdap with no reported adverse event (exposure during pregnancy) (Latency- Same day) following the administration of influenza vaccine,covid-19 vaccine, diphtheria and tetanus and acellular pertussis vaccine.  Action taken : Not applicable.  At time of reporting, the outcome was Unknown for the event   Additionally, at time of reporting, the outcome of the pregnancy was unknown.
PATIENT RECEIVED DOSE #2 OF MODERNA VACCINE ON 5/28/21 (SECOND DOSE WAS SCHEDULED FOR 6/3/21).  PATIENT RECEIVED SECOND DOSE 22 DAYS AFTER FIRST DOSE (APPROPRIATE WINDOW IS 24 TO 28 DAYS AFTER FIRST DOSE), PATIENT BEGAN HAVING SYMPTOMS DAY FOLLOWING VACCINE, LOW FEVER, ONGOING HEADACHE, EXTREME VERTIGO, UNABLE TO STAND ON HER FEET FOR LONG PERIODS, UNLIKE HERSELF, OUT OF IT. PATIENT WENT TO PCP ON 6/8/21 AND TRANSMITTED VIA SQUAD TO HOSPITAL WHERE SHE IS STILL CURRENTLY INPATIENT.  ALL TESTS/LABWORK/SCANS HAVE COME BACK NEGATIVE FOR PROBABLE CAUSES. MEDICAL TEAM CANNOT DETERMINE IF THIS IS FROM THE VACCINE OR FROM THE TIMING OF THE VACCINE, BUT CANNOT RULE IT OUT EITHER.
in bed for a couple of days; felt fatigued after the first dose and stayed in bed for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (in bed for a couple of days) and FATIGUE in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced ASTHENIA (in bed for a couple of days) and FATIGUE. At the time of the report, ASTHENIA (in bed for a couple of days) and FATIGUE outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.       No concomitant medication reported. no treatment medication reported.   This case was linked to MOD-2021-097731.
I noticed last year around Oct/Nov that I had a lump on the right side of my head, like sinus pressure.  It moved over the few months so I though it was sinus.  Now both ears, especially the right feel like they are cloudy and full of water.  The pain comes and goes when I rub on it. I have not gone to the doctor; however, pressure helps to relieve it.
arms was very sore; lump in my arm started getting bigger and turning red; turning red; This spontaneous case was reported by a consumer and describes the occurrence of LIMB MASS (lump in my arm started getting bigger and turning red), ERYTHEMA (turning red) and MYALGIA (arms was very sore) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jun-2021, the patient experienced LIMB MASS (lump in my arm started getting bigger and turning red) and ERYTHEMA (turning red). On an unknown date, the patient experienced MYALGIA (arms was very sore). At the time of the report, LIMB MASS (lump in my arm started getting bigger and turning red), ERYTHEMA (turning red) and MYALGIA (arms was very sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. Treatment information was not provided.
site discomfort first day Day 2 woke with a severe headache, more discomfort at injection site, muscle soreness difficultly lifting arm, fatigue Day 3 same as above not as severe, new symptom joint pain in right shoulder
Pt was given "adult" dose of Pfizer (for 12+). Pt should have received pediatric dose due to age (11).
Paralysis in the right side of my face.  Can't close my eye.  This has been going on for 1 week so far.
itching; redness; swelling; Site reaction; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching), ERYTHEMA (redness), SWELLING (swelling) and VACCINATION SITE REACTION (Site reaction) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.    On 04-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 PRURITUS (itching), ERYTHEMA (redness), SWELLING (swelling) and VACCINATION SITE REACTION (Site reaction). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (itching), ERYTHEMA (redness), SWELLING (swelling) and VACCINATION SITE REACTION (Site reaction) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.