chrisvoncsefalvay/vaers-outcomes huggingface dataset:
flushed in the face/warm; red face; tingling sensation of lips but no swelling; mild allergic reaction; This is a spontaneous report from contactable consumers. An 88-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on 20Jan2021 11:45 at single dose (left arm) for COVID-19 immunization. Medical history included lung cancer. The patient was not pregnant. Concomitant medications were not reported. It was reported that the patient had unspecified other medication in two weeks. The reporter's mother's experienced mild allergic reaction in Jan2021 and she wants to know whether or not she should be getting her second dose. She will be asking her doctor as well as they were advised by the nurse administering the vaccine and also the doctor's nurses who observed her mother afterwards, but she was also advised to contact Pfizer. On 20Jan2021, at 12:00, within 5 minutes, the patient experienced flushed in the face/warm, red face, tingling sensation of lips but no swelling, no increased blood pressure, no hives or rash, no tongue or throat swelling, no dizziness, no nausea. It was mild but concerning. The patient was treated with oral Benadryl and Pepcid IV (also reported as IV of peptids), and extended observation for 1 hour and 30 minutes. The events resulted in doctor or other healthcare professional office/clinic visit. The patient had no Covid prior vaccination and was not Covid tested post vaccination. The consumer would like to know if her mother was safe to receive the second dose of the Covid vaccine and if the reaction to the second dose of the Covid vaccine will be more severe with a history of an allergic reaction to the first dose. Outcome of event mild allergic reaction was unknown; outcome of the rest of events was recovered in Jan2021.  Information on the lot/batch number has been requested.
fevers starting same day (12/29/2020), swelling and redness to injection site (12/30/2020) , woke up today (1/1/2021) with numbness, tingling down L arm.
Extreme Diarrhea, Fever 103 degrees, Chills, Sweating, Muscle Weakness, Fatigue, Muscle Pain, Nausea, Uncontrollable Diarrhea, Incontiness, headache, injection site welt, swelling, shoulder pain, unable to lift arm due to shoulder.  Lasted 72 hrs for most extreme symptoms: headache, ongoing fever, extreme weakness (unable to walk without help). Did not return to regular strength until 8 days after administration of vaccine.  Liquid Diet, Bedrest (4 days), Pain medication, Tylenol
pt recv vax 27OCT98  & 10NOV severe vomiting, glucose 92, felt prob viral age;25NOV seen for OM;29NOV cranky, some vomiting w/nl exam;sl weight loss;3DEC vomited againx2;dx DKA w/glucose 1310;
Patient c/o dizziness after receiving vaccine. Patient awake alert and oriented x3 Bp 131/80 P 73 T98.2 O2 100 on room air. Patient states that her BP is usually lower. Patient allowed to rest. Will continue to monitor. BP 127/72 P73 O2 100% on room air. Patient states that she feels the same.  Breathing exercises encouraged. Patient allowed to continue to rest. Will continue monitor.  Vitals assessed Bp 126/74 P 73 O2 100% on room air. Patient continues to rest. Will continue to monitor.  Bp 109/67 P 78 O2 100 on room air. Patient  states that she feels a little better. Patient allowed to rest another 15 min.  Patient went home in stable condition with husband.
Arm was really sore; Felt a little off, like she had a small cold for a few days.; Small cold for a few days; It stayed red for weeks; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was really sore), MALAISE (Felt a little off, like she had a small cold for a few days.), NASOPHARYNGITIS (Small cold for a few days) and ERYTHEMA (It stayed red for weeks) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     The patient's past medical history included Dressler's syndrome (Pericarditis, 8-9 yrs ago), COVID-19 (2 times, cannot remember when  tested positive for 1st time. Several months later, about 7 or 8 months ago, patient's Doctor thought she had the Delta strain. He treated her with antibiotics.), Hip replacement (Patient had 2 hip replacements. Left hip done 7 months ago), Surgery (About 8 or 9 yrs ago, Mini-Maze heart surgery.) and Thoracotomy (Approximately 7 yrs ago, took blood out of patient's lungs.). Concurrent medical conditions included Heart failure, Tachycardia, Bradycardia, Atrial fibrillation, Atrial flutter and COPD. Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm was really sore), MALAISE (Felt a little off, like she had a small cold for a few days.), NASOPHARYNGITIS (Small cold for a few days) and ERYTHEMA (It stayed red for weeks). The patient was treated with ALBUTEROL [SALBUTAMOL] for Adverse event, at a dose of UNK, qd and AMOXICILLIN for Adverse event, at a dose of 875 mg twice a day. At the time of the report, PAIN IN EXTREMITY (Arm was really sore) and MALAISE (Felt a little off, like she had a small cold for a few days.) outcome was unknown and NASOPHARYNGITIS (Small cold for a few days) and ERYTHEMA (It stayed red for weeks) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-404300, MOD-2021-404419 (Patient Link).
Member woke during night with chills, painful skin irritation. Full body aches, light-headedness, exhaustion, lack of focus, periods of mild confusion, redness and swelling at injection site on left arm.
Vaccine card showed 1 pfizer vaccine was given on 8-2-21 and was at facility to receive 2nd dose-gave 2nd dose on  8-23-21-after reviewing database client had completed a series of Moderna vaccine dated 1-7-21 and 2-4-21.
Fever, muscle aches, fatigue, headache, burning while urinating. After 2 weeks of a fever which would have 100 degrees and peak at 102 I went to the doctor on 3/29 and was diagnosed with a kidney infection. I was prescribed cipro 2x day for 10 days.
Hypersensitivity reaction to immunization resulting in cellulitis swollen right arm for two days with itchiness and occasional pain pt. denies fever & restriction of movement.
Pt was given ADACEL and HPV while sitting, then was asked if felt nervous. Pt said yes, was noted to be holding her breathe while given the MENACTRA and Hep A vaccines in other arm. Then said she felt dizzy, so was told to lay down. As she lay down, she became pale and then stiffened for several seconds, then had jerky movements of entire body, while eyes were staring straight ahead. Some irregular breathing and paleness but no abnormal HR (ausculated after first few seconds of episode until the end). Jerking movements lasted less than 30 seconds, then patient looked around unsure where she was when asked, but responded to questions. Shortly thereafter she remembered. Was tired but awake. She tried to sit a couple minutes later but felt dizzy again so lay down again. By then EMS had arrived and patient was taken to hospital ER for further testing, I talked with ER doc about episode. Consistent with syncopal episode, probably related to HPV vaccine and nervousness of patient. Pt had been very nervous talking about vaccines earlier in visit. BP ok at onset of visit today and while EMS present. Will notify VAERS.
Bronchitis, cough, pain in chest.  MD shook in ER, said was on the verge of pneumonia.  Antibiotics Levaquin inhaler, cough medicine (cod).
Acute, extreme pain, paresthesias, profound weakness, "tightness" - shortness of breath. Complete numbness from knees to finger tips bilaterally. Unstable gait and falling - marked muscle atrophy.
Fatigue - onset approx. 17 hours after vaccine - resolved 48 hours after vaccine Muscle aches - onset approx. 20 hours after vaccine administration, resolved 36 hours after vaccine Rash around injection site (sore and hot to touch) - onset approx. 36 hours after vaccine, resolved 72 hours after vaccine Sore, swollen lymph nodes around collar bone (same side as injection site) - onset 24 hours after vaccine, still not resolved (approx. 90 hours after vaccine) Sore arm - onset approx. 3 hours after vaccine, resolved approx 48 hours after vaccine
Injection given IM instead of SC.  Child tolerated immunization well, no adverse reactions have been reported to date.
DIZZINESS; This spontaneous report received from a patient concerned a 55 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: UNKNOWN) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 11-MAY-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness. This report was non-serious.
Received vaccines on 6/9/2003.  On following day, he developed low grade temperature (99.9) with later spike to 101.  He also had swelling of extremity with marked redness and induration.  Refused to bear full weight on limb.  On 6/11/2003, had spread of redness beyond demarcation noted on 6/10/2003 with some resolution of redness in old area.  That thigh was swollen 1 inch greater than other thigh.  Pulses and capillary refill were good.  Now running on his own and bearing full weight.  No red streaking seen, and fever was resolved.  No treatment given other than cool compresses.  Also helped by time spent in swimming pool.
Mild fever for 2 days, cough and sore throat that felt like laryngitis or bronchitis for 3 weeks.
Itching all over; Itching increased to a burning; Minor chest burning; Tongue/throat itching; Tongue/throat itching; A metallic taste in the mouth; This is a spontaneous report from a non-contactable consumer (patient) reported for herself. A 32-year-old non pregnant female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection Batch/Lot Number: ER8727) via an unspecified route of administration in arm Left on 22Mar2021 09:30 as dose 1, single at the age of 32 year for COVID-19 immunisation. Medical history included migraines, allergies to pineapples, nickel, from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22Mar2021, 09:45 AM 15 minutes after injection, patient experienced itching all over and a metallic taste in the mouth. Received a steroid shot that same day because itching increased to a burning and tongue/throat itching. As of today, five days after injection, I am still experiencing the same symptoms itching all over, occasional tongue, throat itching, minor chest burning. Treatment received was asteroid shot/steroid prescription/referral. Prescription of steroids and Benadryl stopped working. Adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event was not resolved.  No follow-up attempts are possible. No further information is expected.
Vaccine was administered after the FDA announcement that all monovalent Pfizer vaccines are no longer used.  I did not have guidance from the local dept. of health to only administer bivalent Pfizer vaccines on this day.
Patient received 2nd dose of Pfizer Pediatric dose on 10/07/2022 Lot FL2757. Product removal update on 10/25/2022 for Lot FL2757
This is a spontaneous report from a contactable consumer, reporting for himself/herself, via a sales representative. This patient of unspecified age, race, ethnicity and gender received a single dose of PREVNAR 13 via an unspecified route of administration in the arm on an unspecified date for immunization.  The patient medical history and concomitant medications were not reported. On an unspecified date, a week after the vaccination, the patient experienced redness on arm around injection site. Outcome was unknown. No follow-up attempts are possible. No further information is expected.
12 days after immunizations were given, baby had apneic episode. Seen 1 day before apneic event with cough, low grade fever. PE - Ok. Treated with albuterol MDI.
2 weeks from the date of injection I began to experience moderate to severe pain at the injection site.  I am still experiencing this issue as of today, 4/14/21.
9/18/09 8am  client called and returned to clinic to have RN check "vaccine reaction".  Left anterior deltoid visibly red, with swelling around injection site.  60mm X60mm raised area.  Client denies fever or other S & S.  Recalls similar reaction approximately 4 years ago. Has had flu vaccine last 3 years with no reaction
This spontaneous report was received from a physician via an unspecified reporter referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 04-FEB-2016, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 PK 0.5mL SD-PFS LLokwTip 10PK" and lot number L014876 with expiration date of 13-JAN-2017 (route of administration and anatomical location were not reported), which was stored at a lowest recorded temperature of 27F (-2.7 Celsius) for 1764 hours. The vaccine states was reported as excursion and the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Received vaccine past its 30-days expiry date vaccines went into 2-8 degree C thaw state on or about 24-Dec-2021; Patient received vaccine past its 30 days expiry date; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30 days expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days expiry date vaccines went into 2-8 degree C thaw state on or about 24-Dec-2021) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2022 at 2:53 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 12-Feb-2022 at 2:53 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30 days expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days expiry date vaccines went into 2-8 degree C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30 days expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days expiry date vaccines went into 2-8 degree C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient ethnicity was reported.  Concomitant medication of the patient was not reported.  Vaccine administration time was given as 12-Feb-2022 at 14:53:45  No treatment information was provided by the reporter.   This case was linked to MOD-2022-542869 (Patient Link).
Hardening swollen area ranging from behind ear to neck and jaw line; Hardening swollen area ranging from behind ear to neck and jaw line; Hardening swollen area ranging from behind ear to neck and jaw line; This spontaneous case was reported by a consumer and describes the occurrence of EAR SWELLING (Hardening swollen area ranging from behind ear to neck and jaw line), SWELLING (Hardening swollen area ranging from behind ear to neck and jaw line) and SWELLING FACE (Hardening swollen area ranging from behind ear to neck and jaw line) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 008B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced EAR SWELLING (Hardening swollen area ranging from behind ear to neck and jaw line), SWELLING (Hardening swollen area ranging from behind ear to neck and jaw line) and SWELLING FACE (Hardening swollen area ranging from behind ear to neck and jaw line). At the time of the report, EAR SWELLING (Hardening swollen area ranging from behind ear to neck and jaw line), SWELLING (Hardening swollen area ranging from behind ear to neck and jaw line) and SWELLING FACE (Hardening swollen area ranging from behind ear to neck and jaw line) outcome was unknown. Not Provided          No concomitant and treatment details were provided. Action taken in response to mRNA-1273 was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Follow-up received on 27-MAY-2021. TCR document was attached. No new information was reported.
Right upper arm with well circumscribed area of induration, mild erythema and warmth, tense, tender to palpation.
Pt. developed erythematous, raised, pruritic, generalized rash on 9/22/09.  No change in diet, soap, meds can explain this.
Left face nubness lasting for two days. Ongoing rinining in both ears. Pain at the injection site for three days. Arm pain . Eye pain.
Pt given DTAP on 7/3/01 and on 7/4/01, pt had significant swelling and redness of arm with water-filled lesions.
Sore arm for approximately 1 month following immunization, couldn't sleep on that side or apply pressure, also couldn't raise arm.
feeling faint/ feeling like she's going to faint; dizzy; Third dose: has pain throughout her body; She states it is hard to stand up; throwing up; headache; diarrhea; high fever/ temperature before she called was 103.5; She got the booster yesterday and she has been quite ill/ really sick right now; Third dose: she's so weak right now; This is a spontaneous report from a contactable consumer (patient). A 72-years-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration, administered in left arm on 14Oct2021 11:30 (Lot Number: FF2590) (at the age of 72-years-old) as dose 3 (booster), single for covid-19 immunisation. The patient no medical history. The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 (COMIRNATY), via an unspecified route of administration, administered in left arm on 03Feb2021 (Lot Number: E51666) (at the age of 71-years-old) as dose 1, single for covid-19 immunisation; and bnt162b2 (COMIRNATY), via an unspecified route of administration, administered in left arm on 26Feb2021 (Lot Number: EN6206) (at the age of 71-years-old) as dose 2, single for covid-19 immunisation and experienced high fever, dizzy, was throwing up, headache, felt like needles and couldn't stand up after dose 2. Patient took vaccine because she works in healthcare, not as a clinician, but leads a national group. Patient got the booster a day before reporting and she has been quite ill with that one. After the third dose on 14Oct2021, she had those symptoms (high fever, dizzy, throwing up), as well as feeling faint, diarrhea, and a headache. She stated it was hard to stand up on 14Oct2021, and she had thought she was in pretty good shape for her age. She also mentioned that this was only the second time in her life she's had a headache; the first was after the second dose. Her fever was 103-104 F for 2.5 days in 2021. Now it was closer to 102-103 F. Her maximum temperature was 103.5 F on the morning of day of reporting. Patient stated that she was experiencing the same symptoms, but a little worse, now she can't stand up without feeling like she's going to faint, her temperature before she called was 103.5 F. She got the shot at 14Oct2021 11:30, and the symptoms started around and they got really bad at night on 14Oct2021, they are all ongoing and worsened. She stated she has a very high temperature, very dizzy, she had pain throughout her body, she never had headaches, but she has one. The patient stated that she doesn't take anything, she did take an ibuprofen last night 14Oct2021, she usually never takes anything, but she had gotten it just in case and she took one and that was it. The events did not require visit to emergency room and physician office. She stated just put that just she's really sick right now, she was so weak right now in Oct2021. The outcome of all events was not recovered.  No follow-up attempts are possible. No further information is expected.
The site of the injection has been swollen, red and itchy for over 6 days. The symptoms improve and then get bad again.
Tested positive for COVID-19; Tested positive for COVID-19; congestion; headache; cough; Patient has asthma; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old male patient received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) at the age of 30 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Pfizer-biontech (Dose Number: 2, Prev dose product: COVID 19,, Prev dose brand: Pfizer-BioNTech,, Prev dose brand unknown: False,, Prev dose lot unknown: True, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: Mar2021, when the patient was 29 years old, for COVID-19 immunization; Pfizer-biontech (Dose Number: 1, Prev dose product: COVID 19,, Prev dose brand: Pfizer-BioNTech,, Prev dose brand unknown: False,, Prev dose lot unknown: True, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: Mar2021, for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Jan2022, outcome "recovering" and all described as "Tested positive for COVID-19"; NASAL CONGESTION (non-serious) with onset 25Jan2022, outcome "recovering", described as "congestion"; HEADACHE (non-serious) with onset 25Jan2022, outcome "recovering", described as "headache"; COUGH (non-serious) with onset 25Jan2022, outcome "recovered" (25Jan2022), described as "cough"; ASTHMA (non-serious) with onset 25Jan2022, outcome "recovering", described as "Patient has asthma". The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: (25Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19, nasal congestion, headache. Therapeutic measures were taken as a result of cough, asthma. Clinical course: Tested positive for COVID-19 on 25Jan2022 using a home rapid test, following receipt of the primary series in Mar2021 and a booster in Oct2021. Patient reports congestion, headache and cough. Patient has asthma and required rescue inhaler medication, that resolved cough.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt. felt flu-like symptoms, fever a couple hrs after shot that lasted for about 36 hours.