chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever of 101 F; muscle aches; This is a spontaneous report from a contactable consumer or other non-health care professional. This report was received via a Pfizer sales representative. This consumer reported similar events for 6 patients. This is 2nd of 6 reports.   A patient of unspecified age and gender received bnt162b2 (BNT162B2 Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Symptoms lasted approximately 7 hours and symptoms were relieved with one dose of Tylenol. Patient states that 5 other individuals within her department also experienced similar symptoms after receiving the second dose. On an unspecified date patient experienced fever of 101 f, muscle aches. On an unspecified date the patient underwent lab tests which included body temperature pyrexia: 101 fahrenheit. The outcome of all the events was unknown.  Information on the lot/batch number has been requested.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021157330 Same reporter/ drug/ event for different patients
This spontaneous report was received from a registered nurse refers to a patient of unknown demographics. No relevant medical history of the patient was reported. On 15-OCT-2014, the patient was inadvertently administered with an expired VARIVAX (Merck) (lot # H016577, expiration date: 05-SEP-2014) (strength, route of administration and site of administration were not reported) dose 3. There were no concomitant medications reported. There were no adverse effects reported. There was no product quality complaint (PQC) involved. The outcome was unknown. Additional information is not expected because it was reported that there were no additional information to report.
Shivers in the middle of the night, aches, slight temperature, threw up, headache most of the time (I never get headaches- haven't had a headache since I was a teenager). I slept until 3 o'clock in the afternoon.
wet and cold sensation on chest; she would have a heard time falling asleep or get no sleep at all that night; Breast discomfort/describes the breast discomfort as a contracting feeling of encapsulation; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EH9899) injection intramuscularly in right arm on 21Dec2020 around 11:00 am at a single dose of COVID-19 immunization. Vaccination facility type was at medical center. Relevant medical history included acne, migraine, and chronic neck and upper back pain; all were ongoing, and breast implant, tennis elbow in left arm and she had the flu shot in Oct but she never got any reaction. She thought a side effect of spironolactone. Concomitant medications included rizatriptan benzoate (MAXALT, strength: 5mg, tablet) at 5mg tablet as needed for migraine, naproxen sodium (ALEVE, strength: 500mg, tablet) at 500 mg tablet, one tablet as needed for pain, and spironolactone (strength: 5mg tablet) (if her skin was breaking out she will take two tablets that night and if her face was not bad she will take one tablet) from Aug2020 for acne, breaking out; all were ongoing. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was reported as none. Additional vaccines administered on same date of the Pfizer suspect was reported as none. Prior vaccinations within 4 weeks and AE(s) following prior vaccinations were reported as none. On 26Dec2020 she started feeling breast discomfort. She described the breast discomfort as a contracting feeling of encapsulation, reported it kept her up at night, she would have a heard time falling asleep or get no sleep at all that night. Her breast comfort started to lessen. The patient was breast discomfort or tenderness but she did not experience any breast discomfort till after she got the covid vaccine. She stated the breast discomfort was like a feeling that something was crawling inside, states it is like creepy crawlers. She also experienced a wet and cold sensation on her chest on 29Dec2020 and was still occurring once in a while, intermittently. At first it was just on the left breast, and the next night she felt the sensation across her chest, it felt like she spilled water and felt wet but it was not wt. She felt it while she was bed. She had breast implants. Last week she contacted her primary care doctor and she was sent to get a mammogram and ultrasound. She went to have the mammogram and ultrasound on Friday 08Jan2021 and everything was fine. She was thinking what she was experiencing was from the vaccine. The patient declined any treatment. No emergency room and no physician office required for the events. The outcome of event breast discomfort was resolving, of wet and cold sensation on chest was unknown.
In August of 2021 I received the second dose of Covid vaccine. Two weeks after vaccination I began my menstrual cycle. My cycle was unusually heavy, passing extra large clots the size of tangerines. This type of bleeding persisted for 3 months.  I was evaluated by my primary physician and a fertility specialist.  During the 3 months of heavy bleeding my hemoglobin dropped to 7.0, I had two iron infusions as well. In Nov 2021 I had surgery on my uterus to stop the bleeding. Since the surgery menstural cycles have not been normal or regular in time frame.
24 hours, post vax, the pt developed local swelling about the size of a silver dollar and a rapid increase in size over the next 24 hours requiring ED visit where pt was thought to have possible cellulitis. An office visit, 3 days post vax, showed an area of non-tender erythema (5cm X 8cm) of the thigh at the site of the DTAP or MMR.
Received vaccine 7/6/07- (R) thigh. Over subsequent 72 hr developed increasing redness, tenderness, warmth at injection site. Return of office visit 7/9/07. Site indurated, red and warm but without drainage. Impression-local tissue reaction without infection sent home on BENADRYL, cold compress. Return 7/18/07 with maculopapular rash over torso ext. vaccine site bruised, indurated.
Have a rash on my left arm at the injection site and it is about the size of a quarter; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Mar2021 (Lot number: EN6198) at the age of 61 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Premature ventricular contractions" (unspecified if ongoing); "Migraine" (unspecified if ongoing). Concomitant medication(s) included: PROPRANOLOL; TOPIRAMATE. The following information was reported: VACCINATION SITE RASH (non-serious) with onset 17Mar2021, outcome "not recovered", described as "Have a rash on my left arm at the injection site and it is about the size of a quarter". Additional information: Patient reported this event as the patient was thinking that this was an adverse event from the injection (Covid Vaccine). It was reported that that's the only place on the patient's body that the patient noticed it and patient just noticed today almost nine days after injection. The patient was querying if it was safe to get the second dose. The patient will have the second dose on 29Mar2021.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a physician refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unspecified dates, on schedules outside of the recommended schedule, the unspecified number of patients were vaccinated with an unspecified number of doses of GARDASIL 9 (lot, expiration date and dosing regimen were unknown). No adverse effects have been reported. No product quality complaint was filed. Additional information has been requested.
PATIENT WAS ADVISED AFTER RECEIVING VACCINE TO SIT FOR 15 MINUTES.  SHE THEN SAID SHE NEEDED TO GO TO THE BATHROOM.  PERSON WATCHING HER SAID THIS IS OK, BUT SHE WOULD ESCORT PATIENT.  PT THEN PASSED OUT ON THE WAY TO RESTROOM, BUT WAS CAUGHT BY PERSON WATCHING HER AND LAID TO THE GROUND.  HER FEET WERE ELEVATED AND SHE WOKE UP WITHING A FEW SECONDS.  HER MASK WAS REMOVED AND SHE WAS ALLOWED TO LAY DOWN A FEW MINUTES, THEN WAS SLOWLY BROUGHT BACK TO A SITTING POSITION, THEN EVENTUALLLY UP TO HER FEET AND TO THE BATHROOM, THEN BACK TO HER CHAIR TO SIT. SHE THEN SAT ANOTHER 25 MINUTES.
in the evening, I lost my sense of taste and smell completely. 3 weeks later and I only can smell strong smells, and taste hot and spicy foods. I did not write earlier because I was told by our epidemiologist that this was not a side effect of the vaccine
have them in mouth-had the vaccine/suspected vaccination failure; have them in mouth; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and oral herpes zoster. The patient was treated with gabapentin. On an unknown date, the outcome of the vaccination failure and oral herpes zoster were unknown.   It was unknown if the reporter considered the vaccination failure and oral herpes zoster to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 09-MAY-2022 Reporters comment: The patient self-reported the case via interactive digital media and described the occurrence of suspected vaccination failure. After receiving Shingles vaccine, the patient got shingles in mouth. The patient's doctor said it happened. The patient stated that, Gabapentin did not help. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory test confirming shingles were unknown at the time of reporting.
I still have the scratchy throat; I do have some mucus in my throat; numbness; it's really pretty bad,; runny nose with clear liquid like watery; tingling on my finger; my bones in hands hurt; shot still hurts; my muscles hurt; I'm very fatigued; headache; I had a scratchy throat; This spontaneous case was reported by a consumer and describes the occurrence of DRY THROAT (I still have the scratchy throat), CATARRH (I do have some mucus in my throat), HYPOAESTHESIA (numbness), DRY THROAT (I had a scratchy throat) and FEELING ABNORMAL (it's really pretty bad,) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced DRY THROAT (I had a scratchy throat) and HEADACHE (headache). On 28-Mar-2021, the patient experienced DRY THROAT (I still have the scratchy throat), CATARRH (I do have some mucus in my throat), HYPOAESTHESIA (numbness), FEELING ABNORMAL (it's really pretty bad,), RHINORRHOEA (runny nose with clear liquid like watery), PARAESTHESIA (tingling on my finger), PAIN IN EXTREMITY (my bones in hands hurt), VACCINATION SITE PAIN (shot still hurts), MYALGIA (my muscles hurt) and FATIGUE (I'm very fatigued). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency. At the time of the report, DRY THROAT (I still have the scratchy throat) and VACCINATION SITE PAIN (shot still hurts) had not resolved and CATARRH (I do have some mucus in my throat), HYPOAESTHESIA (numbness), DRY THROAT (I had a scratchy throat), FEELING ABNORMAL (it's really pretty bad,), RHINORRHOEA (runny nose with clear liquid like watery), PARAESTHESIA (tingling on my finger), PAIN IN EXTREMITY (my bones in hands hurt), HEADACHE (headache), MYALGIA (my muscles hurt) and FATIGUE (I'm very fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. The patient stated that she would not be definitely taking the second shot.
This is a spontaneous report from a contactable physician received via a sales representative. This  physician reported for three patients. This is the third of three patients. A 65-year-old female patient of an unspecified ethnicity received PREVNAR 13 (lot R19477, Exp. Date Jan2018, NDC number 100009260230), via an unspecified route of administration on 11Mar2017 at 0.5 ml, single in the arm for immunisation. The patient medical history was not reported. Concomitant medication included ZOMIG. The patient experienced pink patch distal to injection site and pain on top of left shoulder on abduction on 12Mar2017 and lump noticed at site of injection on left upper arm on 13Mar2017. The outcome of the events was unknown. All the events were considered non serious and related to pneumococcal 13-val conj vac (dipht crm197 protein).
Arm swelled with head, redness, from shoulder to elbow. 10/21/16 Called back had swelling increased reaction still increasing whole arm with swelling. 10/25/16 Talked to client's Mom and she stated arm was almost back to normal.
Information has been received from a registered nurse concerning a 6 year old female patient who on 07-AUG-2006 was vaccinated with a dose of VARIVAX (Merck) (lot number not provided). In October 2010, the patient experienced an outbreak of varicella. At the time of the report the patient's outcome was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
He has had double vision that started three weeks ago. He is under the care of an Ophthalmologist. He is also having mild eye and neck pain.
pt recvd vax 11MAY93 approx 4 hrs later began crying, went limp, stopped breathing, cyanosis of face/extremities; breathing resumed p/several mins; MD visit; hospitalized-fever 102; sepsis workup neg culture; rx'd ATB/Antipyretics;
Patient received flu and pneumonia vaccine. Developed cellulitis at both sites of injection. Treated at hospital with antibiotics and steroids.
I think its arthritis and it's very painful today; She was not sure if she had twisted it or if it was arthritis; She confirms it is her knee, she thinks its arthritis, it has swelled up before but it was very painful.; She confirms it is her knee, she thinks its arthritis, it has swelled up before but it was very painful.; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3249, expiration date: 31May2021), via an unspecified route of administration on 15Jan2021 at single dose for covid-19 immunization; ibuprofen, and paracetamol (TYLENOL), both via an unspecified route of administration from an unspecified date at unknown dose for an unspecified indication. Medical history included knee pain from an unknown date. The patient clarified she had been dealing with this knee pain prior to receiving her first dose of the vaccine. The patient's concomitant medications were not reported. The patient got the vaccine on Friday (15Jan2021) and she had a knee that was giving her a fit. She was not sure if she had twisted it or if it was arthritis. She just wanted to know if there were any over the counter medications she can take such as Tylenol or Ibuprofen that she could take for knee pain that will not interfere with vaccine. She confirmed it was her knee, she thought its arthritis, it had swelled up before but it was very painful, and she was wondering if there was any medications that might be in fair with this vaccine such as Tylenol or Ibuprofen or anything like that. She said this morning it was a little better after being off it last night, it was not as painful this morning. She said previously she had been taking Tylenol or Ibuprofen and it would help it a great deal but she wanted to check since she had the first shot Friday to see if taking that would interfere with anything. The action taken in response to the events for ibuprofen and paracetamol was unknown. The outcome of the events was unknown.
Fell from seated position off exam table, was shaking on the floor. Eyes were rolling back. Speech was incoherent. Nurse gave ice pack under neck and had him lay down.
ANCA vasculitis; dose received 3; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 75 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 13Nov2021 (Lot number: FF8841) at the age of 75 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: sulfa" (unspecified if ongoing), notes: known allergies: sulfa, morphine; "Pneumonia" (unspecified if ongoing), notes: other medications in two weeks: IV antibiotics for pneumonia during, hospital stay. The patient took concomitant medications. Past drug history included: Morphine, reaction(s): "Known allergies morphine". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6203), administration date: 02Mar2021, when the patient was 74 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6201), administration date: 09Feb2021, when the patient was 74 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (hospitalization) with onset 13Nov2021, outcome "unknown", described as "dose received 3"; VASCULITIS (hospitalization) with onset 06Dec2021, outcome "recovering", described as "ANCA vasculitis". The event "anca vasculitis" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (06Dec2021) negative. Therapeutic measures were taken as a result of vasculitis and included treatment with IV steriod, riuximab.  No follow-up attempts are possible. No further information is expected.
FLU LIKE SYMPTOMS; This spontaneous report received from a patient via a company representative 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced flu like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms. This report was non-serious.
HEADACHE; BEING TIRED; 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: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced headache, and being tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and being tired was not reported. This report was non-serious.
Fatigue lasted from 1:00 PM until the morning of the following day around 5:00 AM. Slight headache from 1:00 PM until 8:00 AM.
Moderna COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccine on 2/01/21, 03/05/21 and 08/26/21. Presented to ED 04/16/22 c/o diarrhea, dyspnea, generalized weakness, poor appetite, and confusion x7 days, Covid +. Recently tx'd for acute sinusitis with omnicef in early April. Pt stated she was dx'd with COVID19 03/18/22 after attending a family member's wedding. Initial labs:  Glucose 106, Na +132, K +3.3, calcium 7.8, lactic acid 2.7, procalcitonin 0.9, INR 1.4, WBCs 17.8.  UA positive for glucose and ketones. Imaging showed multi lobar PNA. Hospital course c/b NSVT and afib RVR. Admitted for sepsis w/o acute organ dysfx c/b acute resp failure w/hypoxia 2/2 Covid-19.
inc lethargic /sleepy w/no po intake x 8-10hrs p/vax;
PT received Varivax on 08/05/05 developed acute cerebellar ataxia on 09/01/2005 seen in ER a follow up by Pedia. neurologist on  09/01/2005 developed acute generalized Varicella like rash all over.
The night of vaccination patient had a metal taste in mouth and lost all sense of taste. 12/19/2020 she developed a fever, body aches, and chills. 12/20/20 Continued to be febrile, then was told to follow up with PCP.
I received the rubella vaccine after the birth of my fourth child.  About 8 months later there was a rapid onset of arthritis.  It was in both hips.  Couldn't walk, bend, stoop, lean, or run without severe pain.  After numerous tests, exrays, my physician referred me to a surgeon.  Prior to this, I was very  healthy, jogged 1 mile everyday.  I gave myself 30 days before I would see surgeon I added several glasses of fresh vegetable juice and plenty of water.  Eventually the pain left.  My hips will still crack and pop as a reminder of the pain from those five or six months.
Woke up feeling thirsty, walked to the kitchen to get water, felt nausea, then passed out, hitting head on the cabinet toward the floor.  Upon waking, drenched in sweat and sitting again for maybe 25 seconds, started heaving as if to vomit, eyes rolled back and passed out again.  Never lost consciousness for more than 3-5 seconds.  Blood sugar was measured by dexcom and separate tester at around 99. Temperature was taken and it was about 98.4.  He never fevered  before or after this incident.  Paramedics were called and measured high blood pressure first, 170 over something, and then after time and more rest returned to normal 120 over 78.  We rejected transport to ER for evaluation.  Follow up with Doctor's office later with labs (CBC, CMP, TSH) revealed nothing abnormal.  We suspect low blood pressure caused fainting.
Day 1 - 3 = tenderness, swelling, slight fever. Day 8 - 13 = large, red hot spot Narrative:
No side effect noted; administration of Gardasil 9 to a 5 years old patient; This spontaneous report has been received from a nurse regarding to a 5-year-old male patient. The patient's concurrent conditions, medical history, concomitant therapies, drug allergies and reactions were not reported.    On 08-FEB-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 0.5 mL, lot # 1775808, expiration date reported as 20-AUG-2023, intramuscular in his left arm for prophylaxis with no side effect at the reporting time.
headache,fever,chills. BIB by EMS w/ c/o HA/Vomiting/Chills/Fevers x 6 hours, reports taking 650mg Tylenol around midnight with no relief; reports getting COVID vaccine 9Feb around 1130am; 2 episodes vomiting, denies any blood.
Patient was inadvertently given a PEDIARIX vaccine instead of HAV. No adverse reaction per mother. Reported to CDC.