chrisvoncsefalvay/vaers-outcomes huggingface dataset:
8-15-2022 after administration of vaccine client site was a little redden but not swollen. Client was advised by RN if site swells or continues to redden more to apply a cold compress on site and take either some Tylenol or Motrin and that should help. Client came in on 8-17-2022 for a different type of service and she pointed out to NP that she noticed Wednesday (8-17-2022) morning that her site was swollen and reddened. Client was asked if she had taken any Tylenol or Motrin and placed a cold compress on it and she said no. Client was advised by both RN and NP to try the cold compress and take Tylenol and Motrin interchangeably; if no improvement to please call and speak with a nurse. Client called back on 8-19-2022 and spoke with RN  and stated that the site is still swollen but is the size of pin ball, has improved from 8-17-2022 but can feel heat from site. Client advised by RN to see her primary care physician or go to an urgent center and be evaluated, to see if the doctor recommends her getting the 2nd series of the varicella, client said ok. Client has only had 1 of 2 series of the varicella vaccine.
Red circle with raised edges at site of injection. Area continues to be slightly red. No other symptoms.
Immediate flu-like syndrome night of vaccine with diffuse severe myalgia. Persistent shoulder pain. Diagnosed with subacromial bursitis.
Breakthrough case admission after 3 vaccines ; Moderna 1/19/21 lot# 037K20A;  Modern a2/16/21 lot# 037K20A;  Moderna 10/27/21 no lot#
Patient called complaining of lightheadedness and dizziness. She said she felt "funny" and was having trouble walking. Took two diphenhydramine 25 mg tabs and went to sleep. At 9am the following day she was feeling "a lot better".
Child was vaccinated on 2/25/04 in the afternoon.  Mom called the morning of 02/27/04 and said her daughter started c/o her knee hurt the evening of 02/25/04 and the next morning she noticed swelling in the right leg from the knee to the hip but not at the injection site.  She called us on 02/27/04 to find out what shot was given in that leg as the doctor was called and wanted to know.  Doctor instructed her to ice the thigh and things worsened over the weekend to go to er.  Mom notified me Monday morning 03/01/04 that the swelling was gone from thigh but child still c/o knee hurting and there is still some swellig in the knee.  She had made an appointment with pcp because an upper respiratory problem had started and she would let the doctor look at the knee also at that visit.  Mom states pcp didn't think there was a problem.  On 02/02/2004 Child no longer c/o knee pain but still is limping.
A few hours after receiving the shot I started feeling extremely feverish with hot and cold chills throughout my body. Feeling on the verge of vomiting but with no nausea just occasionally dry heaving. I passed out around midnight and woke up feeling fine
Severe vomiting, lasting overnight.  Pt is still feeling sick today 9/16/10.
Clinic did not recieved email to stop monovalent doses before this Moderna dose was given on 9/1/22  Patient was given a bivalent dose too soon (2 months not elasped from previous COVID dose) in error by MA.
This spontaneous report received from a nurse practitioner refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies and medical history provided. On unknown date (reported as the patient was 1 year old), the patient was vaccinated with the first dose of M-M-R II injection (dose, route of administration, lot # and expiry date were not reported) and with the first dose of VARIVAX injection (dose, route of administration, lot # and expiry date were not reported). On unknown date (reported as the patient was 2 years old), the patient was vaccinated with the second dose of M-M-R II injection (dose, route of administration, lot # and expiry date were not reported) and with the second dose of VARIVAX injection (dose, route of administration, lot # and expiry date were not reported). On 08-NOV-2016 (reported also as the patient was 4 years old), the patient was vaccinated with the third dose of M-M-R II injection (dose, route of administration, lot # and expiry date were not reported) and with the third dose of VARIVAX injection (dose, route of administration, lot # and expiry date were not reported). Additional information is not expected because there was no consent to contact the reporter.
Lot 026C21A with expiration of 24Oct21 was given on 25Oct21; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Lot 026C21A with expiration of 24Oct21 was given on 25Oct21) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Lot 026C21A with expiration of 24Oct21 was given on 25Oct21). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Lot 026C21A with expiration of 24Oct21 was given on 25Oct21) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications was not reported. Treatment medications was not reported.  Moderna Lot: 026C21A with expiration of 24Oct21 was given on 25Oct21 to six patients. Vials were stored in ultra cold freezer (-20 C) until they were taken out on 16Oct21 and placed in a refrigerator (4 C) where they were thawed and kept until the vial was punctured at 8 am on 25Oct21 . Doses were administered between the hours of 8am - 10am until realization of expiration and quarantine of vials. One dose was a series dose (0.5 ml) and five doses were booster doses (0.25 ml). No adverse events were witnessed for any of the patients.   Most recent FOLLOW-UP information incorporated above includes: On 27-Oct-2021: Follow received on 27Oct2021 contains additional information on route of administration and dose number and event details.
Mild fever evening of vac date. 3 days later developed hives, raised welts 70% of body, (face, trunk, eyes) Benadryl x1. Next day developed swelling of feet and face. Family physician called in Prednisole bid x3 days. Smyptoms completely resolved after 2 days.
I didn't start to run a fever until 830 at night. The fever was not as intense as the other times from vaccine. I had Muscle aches and body aches. I started to be able to palpate the individual nodes but 48 hours afterwards I had a huge pocket of swelling on axillary where I got the shot. It worked up through my neck over the next few days. The muscle aches cleared up faster and it was only a few days. I still have the cold sores that started that first day in the afternoon. When that one was clearing up the second one started and hasn't cleared up yet.
Shaking so bad; Head ache over the eye and the cheek; Nauseated; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking so bad), HEADACHE (Head ache over the eye and the cheek) and NAUSEA (Nauseated) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced TREMOR (Shaking so bad), HEADACHE (Head ache over the eye and the cheek) and NAUSEA (Nauseated). The patient was treated with NAPROXEN SODIUM (ALEVE) for Headache, at an unspecified dose and frequency. At the time of the report, TREMOR (Shaking so bad), HEADACHE (Head ache over the eye and the cheek) and NAUSEA (Nauseated) was resolving.            No concomitant medications were reported.  Action taken with mRNA-1273 in response to the events was not Applicable.   This case was linked to MOD-2021-049647 (Patient Link).
3 days after vaccine (8/11/21) I had pain in my upper right abdominal in kidney area.  Due to the pain, I had to go to ER.  I was diagnosed with a blood clot in  my ureter and scheduled for surgery the next day.  I spent the night in the ER on pain medication and fluids.  8/12/21 I had surgery to remove blood clot from my kidney and identify why my kidney was bleeding.  I also had a CT scan.  Clot was removed.  Identification of why my kidney was bleeding is still a mystery.  A stent was inserted into my ureter.  Since my blood tests were showing a kidney function of 30% I was forced to stay another night in the hospital.  8/13/20 Kidney started to perform better and I was released.  8/24/20 Ureter stent was removed during office procedure.  More tests will be run to try to determine source of the problem.
Approximately 1 week after the first dose, large area of redness observed around the area of injection.  Hard and painful when touched. Fatigue and fever about 100 degrees overnight. The next day, no fever, but the area around the arm is still red and painful when touched.
swelling & redness of eyelids bilat feeling dizzy;tx ice applied to eyes, 20cc of DPH given po, 3cc of epi given SC;
Patient left to front register to buy an orange juice and fainted at front end, her father sat her on a chair in the photo lab. I wa called to the front end and saw patient twitching and then she started vomiting. I administered an epi pen 0.15 mg on her right leg. She fainted a total of 3 times. EMS checked her blood pressure and it was 91/54 mmhg and her pulse was 103. Second reading on blood pressure was 90/66mmhg and her temperature was 96.7'F. Patient had not eaten before getting her vaccine,
9/20/14 approx 1800 noticed numbness/tingling to bilat hands from wrists - circumferential. Temperature sensitive - burning sensation to hot/cold/wind. Lasted approx 2 wks. Also - numbness/tingling bilat toes. 10/14/14 noted thoracic right sided numbness/tingling on back. Size of approx 3" x 6" area.
Later on in the afternoon of the vaccine day I had chills, fevers, headaches, & a lot of sweet It was really bad flue symptoms it was worst the covid this lasted for 24hrs.
The vanishpoint syringe jammed halfway through vaccination so I had to draw up the remainder to give to the patient.
Approximately 3 hours after receiving flu injection I felt very tired & by 6:30 P.M. felt ill & went to bed with fever, chills, some diarrhea & nausea. Felt somewhat better when I got up at 6:30 A.M. but, went back to bed & slept from 10:30 AM - 11:30 P.M. Took me another day to start feeling better. Next year I plan to stay with the regular flu shot!
58-year-old diabetic male with history of hypertension, stage IV CKD, CHF and diastolic heart failure referred to the emergency department by for further evaluation of abdominal pain and dyspnea.  Patient is COVID-19 vaccinated. He received Moderna booster 1 week ago, 8/10.  Since COVID-19 booster, patient reports gradual onset of diffuse aching abdominal pain x5 days, which has remained persistent and gradually worsening. Abdominal pain is mild (8 out of 10), exacerbated after food, non-radiating. He also felt after the vaccination some myalgia and malaise, which has persisted mildly. Patient states he has been unable to take daily medication, including Lasix, secondary to nausea.  He presented to urgent care for evaluation of above symptoms. He was found to be COVID-19-positive on PCR and hypoxic. He was placed on nasal cannula oxygen. During evaluation, patient's room air O2 saturation is 91%.  He says he has in the past been on home oxygen but has not required it over the last year or so. He has a history of COVID-19 infection 7/18/2020 denies post COVID-19 supplemental oxygen. He reports he was on supplemental oxygen one year ago secondary to heart failure exacerbation.
Day of shot- neck reddened and itched/ extremely weak and tired Day 1- extreme weakness/ couldn?t get out if bed/slept all day/ no appetite/ neck still completely  red and itchy/chills and fever Day2-pain and soreness developed in back of my neck and lower back/ bad headache/ ear ache  Day 3 - got out of bed for the first time, Arm still swollen and red
experienced boils on skin groin area, ankle, and face/head; itchy bumps on legs and long recovery from bruising; itchy bumps on legs and long recovery from bruising; This is a spontaneous report from a non-contactable consumer (patient). A 46-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 30Mar2021 (age at vaccination 45-years-old) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had no Known allergies. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date (age at vaccination 45-years-old) as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive other medications in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not tested COVID-19 post vaccination. On 01Jun2021, the patient experienced boils on skin groin area, ankle, and face/head. Also, itchy bumps on legs and long recovery from bruising. The patient did not receive any treatment for the events. The outcome of the events was not recovered.  No follow-up attempts are possible, Information about Lot/Batch number cannot be obtained.
Patient complained of arm pain from shoulder to elbow. She was instructed to seek medical attention. She was diagnosed with an infection and is currently on medication to treat.
She took the test twice and the results are positive.; She took the test twice and the results are positive.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-healthcare professional), Program ID: (159558). The reporter is the patient. A female patient received BNT162b2 (BNT162B2), 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 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 "She took the test twice and the results are positive.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: She took the test twice and the results are positive.   Clinical course: Patient got the first and second dose of the Pfizer COVID-19 vaccine and also the first and second booster shot, and out of curiosity she took the test twice and the results are positive. Caller was asking if we ever heard of this situation.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
A report has been received from a Health Professional concerning a 9 year old, Male subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT started on an unknown date. It was reported that the patient had administration of expired product which started on 30-Dec-2013. The outcome of the event of administration of expired product is unknown. The report was considered to be non-serious.
diffuse redness at injection site, warmth, pain and swelling . neck and right shoulder pain
pt recvd vax & started to itch  & had nausea, was lightheaded & dizzy; pt was given DPH; pt recovered;
This is a spontaneous report from a contactable consumer. A male patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on 19May2017 as a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced a reaction that started about two weeks ago in Jun2017 and it was in the arm he received the injection. The arm had been getting more and more sensitive. If he went through the day moving it, it seemed to loosen up, but at night it tightens up and was quite painful and very difficult to move. He can't even reach around his body to the other arm in the early morning. Outcome of the events was not reported.
Fever, Headaches, nausea, bodyache. Became very weak, fainted and fell on the floor. lost all her memory about the incident.
rt leg swollen, rash, hard area @ inj site on 24APR97 in PM on 25APR97 AM;mom stated leg rt 2x's nl size swollen from buttocks to knee;pt to MD;seen again by MD 26APR97;devel vomiting;bruising;
Fever of 101F, body aches, joint pain, headache.  Symptoms persisting beyond 48 hours post vaccination.
she had a very sore arm; she had fatigue; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 68-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 30-OCT-2023, the patient received Arexvy (left arm). On 30-OCT-2023, less than a day after receiving Arexvy, the patient experienced pain in arm (Verbatim: she had a very sore arm) and fatigue (Verbatim: she had fatigue). The outcome of the pain in arm and fatigue were unknown.   It was unknown if the reporter considered the pain in arm and fatigue to be related to Arexvy.     It was unknown if the company considered the pain in arm and fatigue to be related to Arexvy.   Additional Information: GSK receipt date: 01-NOV-2023 The patient self-reported this case. The patient stated that she had the Arexvy vaccination and later that day the consumer reported she had a very sore arm and fatigue. No further information was known. The reporter did not consent to follow-up.
Fully vaccinated with Janssen, and boosted.   COVID infection breakthrough and inpatient ICU stay
I got sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (I got sick) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (I got sick). At the time of the report, ILLNESS (I got sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.
A non-serious spontaneous report of received expired FLUMIST was received from a health professional concerning a 14-year-old female. Neither medical history nor concomitant medication was reported for this patient. The product expired on 08-Dec-2010. On 13-Dec-2010, the patient received expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information was received on 03-Mar-2011 and incorporated into case: there were no late occurring adverse events following administration of the expired FLUMIST.
Site: Pain at Injection Site-Mild, Additional Details: Patient claims arm pit hurts when arm is in motion.
MODERNA COVID-19 VACCINE EUA  Severe headache, body aches and chills that began 20 hours later. Lasted throughout entire next day. Low Grade Fever (sub 100.0 F) for initial 8 hours after onset of symptoms, even with recommended dosage of Acetaminophen (per label). Fever was gone at 1200hrs 24FEB21 after 6 hours of initial dose of Acetaminophen, then all symptoms returned as severe as they were at onset, minus the low grade fever.
Localized induration, erythema, edema and excorration 3cmx3cm painful.
Muscle swelling and tenderness, itching, reduced to a lump and disappearing after 4 days. 1 reactin after 1st Hep B vaccine (8/21/03) (next day) on right leg. 3 reactions (on right arm) after 2nd Hep B shot (9/19/03).
Headache, muscle ache which lasted all night starting in earnest around 10 PM, shoulder ache began at around 8PM, spreading to the whole body at the aforementioned time, nausea started around 12AM. 2 Ibuprofen 200mg were taken for pain with little to no effect. The next morning I awoke with no symptoms.
Rash Narrative:  Pt received booster dose Moderna, about 30 min later began having rash in lower leg. Benadryl given, no improvement, pt went to ED....No dyspnea. pain, AMS or other issues on presentation..Pt admitted for IV antibiotics, DCd with PICC line and home oxycillin
Had minor reactions to each of those shots; Diagnosed with alpha-gal allergy in July 2022; This spontaneous case was reported by a patient and describes the occurrence of FOOD ALLERGY (Diagnosed with alpha-gal allergy in July 2022) and IMMUNISATION REACTION (Had minor reactions to each of those shots) in a 64-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received fourth dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. In July 2022, the patient experienced FOOD ALLERGY (Diagnosed with alpha-gal allergy in July 2022). On an unknown date, the patient experienced IMMUNISATION REACTION (Had minor reactions to each of those shots). At the time of the report, FOOD ALLERGY (Diagnosed with alpha-gal allergy in July 2022) and IMMUNISATION REACTION (Had minor reactions to each of those shots) outcome was unknown.            It was reported that patient could not eat red meat because of this condition. Patient wanted to know if the vaccine contained materials of animal origin.  Patient stated that she was planning to get her Pfizer COVID-19 Bivalent booster dose for Omicron on Thursday 27-Oct-2022. Patient had Alpha Gal allergy but never had anaphylaxis. Patient talked about how rare the disorder was and out of the small percentage of the population with this allergy a smaller percentage react negatively to the bone char. Patient was aware that the product does contain sucrose and wanted to verify if the sucrose has been filtered with the Bone Char. Patient stated that she was previously vaccinated but with Moderna and had minor reactions to each of those shots, however this was prior to her being diagnosed with Alpha Gal as well.  Patient did note that it was scary enough already that animal derived products were used in production, although noted to not be in the final end product. The patient did request to have further specified in regards with the Bone Char.  No concomitant medications were reported. No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-Oct-2022: Follow-up document received on 26-Oct-2022 from Pfizer with Event added and I-narrative supplement updated.
No adverse event, vaccine was given to a person 17 years old and vaccine is not approved for this age.
Redness around injection site started the day after injection. Patient developed severe myalgia that radiated from neck to shoulder and small pustules on 4/18/18. Describes pain as burning and tingling. Has office visit with PCP. PCP did not treat as the symptoms were receding.
Erythematous hive rash over palms of hands, viral ulcerative lesion (R) pharynx.