chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a 74 years old female patient with no drug reactions/allergies. The patient was vaccinated into right arm with a dose of ZOSTAVAX (lot # 0171AE, exp date: 20-MAR-2013) on 25-JUL-2012. No other co-suspects were reported. There was no concomitant medication. The pharmacist reported that on 25-JUL-2012 the patient developed a dry cracked lip, bright red face, a spot on the hand and a red blotch on the inner right thigh following vaccination with ZOSTAVAX. The dry cracked lip and bright red face occurred a few hours after receiving ZOSTAVAX. The bright red face was described as starting on the right side by the eye and traveling down the face to the chin and then back up the other side (left side) to the left eye. The red face was described as burning like sunburn and itchy. It was unclear just when the spot on the hand and red blotch on the inner right thigh developed. The patient went to her family physician (name unspecified) and also went to an emergency room (name unspecified). The patient reported that the symptoms were decreasing starting 30-JUL-2012. Treatment including CORICIDIN, BENADRYL and MEDROL dose pak was given for the events. Additional information has been requested.
Swelling, erythema?, warmth at injection site 2 days after shot. Treated symptomatically.
Instead of regular Fluzone Quadrivalent, patient was administered Fluzone high dose quadrivalent dose 0.7mL. Patient is currently pregnant. Did feel light-headed after administration but patient reported she usually feels that way with vaccines. Manager was called to report medication error and educated patient that because received higher dose, would have more potential symptoms from receiving the high dose vaccine such as muscle aches, fatigue, soreness at site. Also educated patient would call Sanofi to determine if there was any other safety concerns.
Woke up on May15th realizing he could not hear as well in the left ear, May 16th it got worse. Went to work that Monday, May 17th and realized could not hear anything in left ear while wearing headphones so he called the doctor. Patient did state symptoms started with feeling like he had a cold. Also complains of dizziness and vomiting at time of reaction.
crying w/high pitch noise for approx 3 hrs; called MD says reaction to DTP; next immun to get ped DT; pt had temp night of immun;
Pain all over from head to toe, now lasting 6 days without any relief. Reported to my PCP, who prescribed Oxycodone for the pain. I have only taken it at night since 01/19/2021. Received Tramadol injection 01/20/21, did not help the pain at all. I have been trying to report my symptoms to V-safe & the website is not working. I need to know if this is happening to anyone else, if so how long will sever  this pain last for.
She was given covid vaccines at her dr office.  She came here to get a b12 shot.  She was asked by 2 different people if she was getting the covid vaccine and she told them yes.  After she was given the shot she went and sat down then came back up and said she wanted a b12 shot not covid, because she had already had her shots at her dr office, so she got a 3rd covid shot from us.
Delayed rash on arm; Itchy rash; Bump in rash; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Bump in rash), RASH (Delayed rash on arm) and RASH PRURITIC (Itchy rash) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 immunisation.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced SWELLING (Bump in rash). On 02-Apr-2021, the patient experienced RASH (Delayed rash on arm) and RASH PRURITIC (Itchy rash). At the time of the report, SWELLING (Bump in rash), RASH (Delayed rash on arm) and RASH PRURITIC (Itchy rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant product usage were not reported by the reporter. No treatment details were added.
Severe dizziness and pain left arm - started on 4/1/03 and lasted 3 days.
3 1/2" area on upper thigh that was red, swollen & hot to touch;
morning after had HEP A shot had bilat hand swelling and palms looked red, had been fussy during night. swelling was gone by end of day, feet were nl, no swelling noted by mother at site of shot.
Patient describes very sore arm. Also, arm is red and swollen and warm. Began day after vaccine and worsened 2 days after vaccinne.
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 PAIN IN EXTREMITY (Pain in arm). At the time of the report, PAIN IN EXTREMITY (Pain in arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.    No relevant concomitant medications were reported. No treatment information was provided.
Rash in his shoulder; Fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 55-year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunization. The following information was reported: RASH (non-serious), outcome "recovered", described as "Rash in his shoulder"; PYREXIA (non-serious), outcome "recovered", described as "Fever". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient stated that he lost his card of vaccination which he needs because he was travelling next Sunday and need to prove that he got the vaccination at the airport. He was requested to visit the vaccination centre for the concern. When probed for side effects from the vaccine, consumer stated, " The second one, yes had rash in shoulder and got fever for one day and that's it." Other medications were reported as Prasugal. Lab tests was confirmed as yes, and details was stated as nothing. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Frequent urination/going to the bathroom every hour/decrease in frequency of urination; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of POLLAKIURIA (Frequent urination/going to the bathroom every hour/decrease in frequency of urination), CHILLS (Chills) and FATIGUE (Fatigue) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043b21a, 007m20a and 010a21a) for COVID-19 vaccination.     Concomitant products included NIFEDIPINE (PROCARDIA [NIFEDIPINE]), PREDNISONE, HYDROCHLOROTHIAZIDE, TRIAMTERENE (DYAZIDE) and ARACHIS HYPOGAEA OIL, METHYL SALICYLATE (FORTEX) for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Sep-2021, the patient experienced POLLAKIURIA (Frequent urination/going to the bathroom every hour/decrease in frequency of urination), CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, POLLAKIURIA (Frequent urination/going to the bathroom every hour/decrease in frequency of urination), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was mentioned.
Patient was sitting in the observation area after receiving his 1st vaccine. Patient stated he wasn't feeling well. Skin pale, cold and clammy. Patient Diaphoretic. Patient c/o chest pain B/P 130/78 SPO2 85%.  911 called. Patient felt like he was going to vomit and pass out. Non rebreather mask applied at 15 LPM.  SPO2 99% HR 77. 10:29AM  Patient feeling much better, 911 arrived and transported patient to the hospital
Extreme sight pain. Muscle pain. Unable to move arm up or down. Even the slightest touch hurts.
extreme swelling and redness at site, rash, fever, drowsiness, gastrointestinal problems
About 8 minutes after vaccine was given, nurse went in to see how she was feeling and asked her if she had any itching or anything and patient stated she had some itching and patient was told she could stay an extra 5 minutes. Next time nurse went in patient complained of chest tightness. Listen to heart and it was normal, vital signs were taken at around 3:30; BP 98/68 pulse 84. at this point patient was told that 911 needed to be called and she said no its ok. Went back in room to check on patient and she said that she had a pain in her neck that went up her head and was told again that 911 needed to be called and she said no she just wanted to stay a  longer.
One week ago pt received flu vax (R) arm, PCV 13 (L) arm. Next day felt onset of chills, headache and noted (L) arm swelling, pain, itchy. Taken to hospital ED. Referred back to PCP. Swelling has improved, but remains tender, itchy, swollen. Denies cough, SOB, wheezing.
pain is moving into the patient's neck; patient cannot move arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A 50 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose no : 2, Batch/lot number : NA), for Covid-19 immunisation; Bnt162b2 (Dose no : 1, Batch/lot number : NA), for COVID-19 immunisation. The following information was reported: NECK PAIN (non-serious), outcome "unknown", described as "pain is moving into the patient's neck"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "patient cannot move arm".  Additional information: Caller did not provide any contact information, Agent states the caller was calling on behalf of a friend, states the patient got the booster, and patient cannot move arm and pain was moving into the patient's neck. Caller states they are talking about a fourth booster, confirms of the Pfizer Covid vaccine, states her friend, the patient, got it several months ago, the first booster, and states now they are authorizing a second booster, states her friend got over the bad effect of the booster shot, states there were several days she couldn't move arm or neck, it went away after several days, states it was the same arm that had the injection, the left arm she doesnt know for sure, caller states the patient was over 50 years old and states she was concerned about getting the second booster, the fourth shot. Caller states cannot do the report, just needs to know the answers. Specifically wants to know if there was a list online of side effects or if she should get the fourth dose, the second booster. Caller declines to provide any further information. Patient sex is documented as female because the caller referred to the patient as she/her.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Iron-deficiency (low hemoglobin) could have been a contributing factor.; weight loss/I lost 10 lbs. (down to 127 lbs measured in Aug 2021)./ I continue to lose more weight (another 10 lbs.) until now. I also experienced a known side effect of fatigue during the same period; Iron-deficiency (low hemoglobin) could have been a contributing factor. This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 (Lot number: OCHD) 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: IRON DEFICIENCY (non-serious), HAEMOGLOBIN DECREASED (non-serious) all with onset 03Apr2021, outcome "recovering" and all described as "Iron-deficiency (low hemoglobin) could have been a contributing factor."; WEIGHT DECREASED (non-serious) with onset 03Apr2021, outcome "recovering", described as "weight loss/I lost 10 lbs. (down to 127 lbs measured in Aug 2021)./ I continue to lose more weight (another 10 lbs.) until now."; FATIGUE (non-serious) with onset 03Apr2021, outcome "recovering", described as "I also experienced a known side effect of fatigue during the same period". The event "iron-deficiency (low hemoglobin) could have been a contributing factor." was evaluated at the emergency room visit. The events "weight loss/i lost 10 lbs. (down to 127 lbs measured in aug 2021)./ i continue to lose more weight (another 10 lbs.) until now.", "i also experienced a known side effect of fatigue during the same period" and "iron-deficiency (low hemoglobin) could have been a contributing factor." were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of iron deficiency, weight decreased, fatigue, haemoglobin decreased.  Additional information: No other vaccine received in four weeks. The most serious 'potential' side effect may be the unintentional weight loss, which started early Apr2021 (after 1st, before 2nd dose). Patient lost 10 lbs. (down to 127 lbs measured in Aug2021). Patient continued to lose more weight (another 10 lbs.) until now. Patient also experienced a known side effect of fatigue during the same period. Iron-deficiency (low hemoglobin) could have been a contributing factor. Iron supplement seems to help w/this issue.  No follow-up attempts are possible. No further information is expected.
Per Mom: C/O (L) thigh swollen and red and hot from immunization on 8-5-10. Still red but decreasing in size. PE - (L) thigh inferior to inj. site has 8-9 cm red, cool skin, tender to touch.
Information has been received from a physician concerning a 16 year old female patient who on 23-FEB-2011 was vaccinated with the first dose of GARDASIL (Lot # and expiration date not reported) and who after vaccination had "super clavicular lymph node enlargement with tenderness". The patient discontinued the series of GARDASIL. It was unknown if patient sought medical attention and the patient's outcome. Information has been received from licensed practical nurse concerning a 16 year old female patient with no pre-existing allergies, birth defects or medical conditions who on 23-FEB-2011 at 4:30 pm was vaccinated in the left arm with the first dose of GARDASIL (Lot# 666987/1016Z, expiration not reported). On 23-FEB-2011 the patient experienced supraclavicular (LT) lymphadenopathy and tenderness. At the time of reporting the patient had recovered. No further information is available.
received the Menveo vaccine / in her thigh; This case was reported by a other health professional via call center representative and described the occurrence of vaccine administered at inappropriate site in a 15-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA466A, expiry date 21st October 2022) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced vaccine administered at inappropriate site. On an unknown date, the outcome of the vaccine administered at inappropriate site was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the Menveo vaccine in thigh,which led to vaccine administered at inappropriate site. No further events were reported at the time of the call. The reporter consented to follow up. The HCP consented to follow-up by email.
I received my vaccine shot at 9:40 on Friday.  Suddenly around 4:00pm, I experienced EXTREME chills.  The shaking was uncontrollable for hours.  Could not get warm.  I know I was running a fever but was unable to take my temperature.  Some nausea and some diarrhea.  The shaking finally lessened around 2:00am.  The next two days (Saturday and Sunday) I was very light-headed and dizzy.  Saturday I laid flat all day, went to bed early,  Experienced some chills but not as bad as the night before.  Sunday was a bit better, I could sit up in a chair for some periods of time.   Today (Monday) I would describe as what others have said was their reaction - sore arm, some achiness.
PATIENT WAS VACCINATED ON 01/21/2022. PATIENT WITH A SECOND DOSE ADMINISTERED ON 09/03/2021 AND THE REINFORCEMENT WAS ADMINISTERED BEFORE 5 MONTHS. A FAMILY MEMBER WAS CALLED TO VERIFY THE MINOR'S HEALTH STATUS.
"achy feeling like I had had a shot - I expected it for awhile, but it still hurts today on 10/5/09 when I move my arm....I put some ice on my arm a couple of times"
Feeling hot around ears, tongue heavy with tightness back of throat, lightheadedness. Tx: In ER, received SOLUMEDROL and PEPCID.
anaphylactic reaction; blood pressure went up; dizzy; could not breathe; heart raced; Initial information received on 14-Sep-2020 regarding an unsolicited valid serious case received from a (patient) consumer/non-healthcare professional.  This case involves a 80 years old female patient whose blood pressure went up (blood pressure increased) was dizzy (dizziness) and she could not breathe (dyspnoea) and her heart raced (palpitations), and it was resulted into anaphylactic reaction, while she received INFLUENZA VACCINE.  The patient's medical history, past medical treatment, past vaccination and family history were not provided. Concomitant medication were not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via an unknown route and administration site for prophylactic vaccination.  On an unknown date, the patient's blood pressure went up (blood pressure increased) was dizzy (dizziness) and she could not breathe (dyspnoea) and her heart raced (palpitations), and it was resulted into anaphylactic reaction (unknown latency) following the administration of INFLUENZA VACCINE.   These events were assessed as medically significant.   Relevant laboratory test results included: On an unknown date, the blood pressure was increased.  The patient cannot take ibuprofen, lidocaine and cortisone.  The event outcome was reported as unknown for anaphylactic reaction.  Information on the batch number was requested; Sender's Comments: This case concerns a 80 years old female patient who experienced anaphylactic reaction (unknown latency) following the administration of INFLUENZA VACCINE  produced by unknown manufacturer.  Medical history concomitant medication, lab data ruling out alternative etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine could not be assessed.
sore lump on her right arm and it hurts when it is touched; sore lump on her right arm and it hurts when it is touched; This is a spontaneous report from a contactable consumer. An 83-years-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration in right arm on 16Mar2021 at single dose for COVID-19 immunization. The patient medical history included hip problem, back burn injury and hypertensive (a patch for high blood pressure). Concomitant medications included certain medications. She gets epidural shots for three months now. The patient experienced sore lump on her right arm and it hurts when it is touched on an unspecified date in 2021. The outcome of the event was unknown. She is scheduled to get her second dose on 06Apr2021.  No follow-up attempts are needed. No further information is expected.
On same day of injection, recipient developed a headache, swollen lymph nodes under arm, red and warm swollen injection site area
Approximately 5 minutes after immuns given, nurse called to waiting room because receptionist thought she heard pt "crying". Pt in chair unresponsive, LE extended, arms and hands clenched into body, back arched over side of chair, mouth clenched, sl. circumoral cyanosis. Pt started to arouse as soon as attempt was made to reposition pt. Dazed but knew she was in the Dr's office. Also noticed pt had been incontinent of urine. By 1630-1635 < pt alert, responsive, oriented, lying down with feet up.  DC'ed home with father about 1715.
within 10 minutes of vqccine patient felt throat tightness and tongue swelling up; given epi pen with some relief
Right foot gout flair; Pain was "pretty intense"; Couldn't walk for 3 to 4 days; Osteoarthritis; This spontaneous case was reported by a patient and describes the occurrence of OSTEOARTHRITIS (Osteoarthritis), GOUT (Right foot gout flair), PAIN (Pain was "pretty intense") and GAIT DISTURBANCE (Couldn't walk for 3 to 4 days) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (1st primary series dose) on 13-Apr-2021 and Pfizer (2nd primary series dose) on 04-May-2021; for Drug use for unknown indication: Codeine. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer; and Rash with Codeine. Concurrent medical conditions included Drug allergy (Codeine (rash)), Asthma (30 years ago, No recent change in status such as improvement or worsening.) since 1992, Blood pressure high (Start Date: More than 10 years ago, No recent change in status such as improvement or worsening.), Atrial fibrillation (Start Date: More than 10 years ago, No recent change in status such as improvement or worsening.) and Hashimoto's thyroiditis (Start Date: More than 10 years ago, No recent change in status such as improvement or worsening.).    On 12-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. In June 2022, the patient experienced OSTEOARTHRITIS (Osteoarthritis). On 17-Jun-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced GOUT (Right foot gout flair), PAIN (Pain was "pretty intense") and GAIT DISTURBANCE (Couldn't walk for 3 to 4 days). The patient was treated with CELECOXIB (CELEBREX) at an unspecified dose and frequency and DICLOFENAC at an unspecified dose and frequency. At the time of the report, OSTEOARTHRITIS (Osteoarthritis) had not resolved and GOUT (Right foot gout flair), PAIN (Pain was "pretty intense") and GAIT DISTURBANCE (Couldn't walk for 3 to 4 days) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: results not provided Results not provided.         Concomitant medications included unknown "high blood pressure" medication, unknown "thyroid" medication. The patient experienced a right foot gout flair on 17Jun2022 that lasted for 3 to 4 days. Patient stated the pain was "pretty intense" and she couldn't walk for 3 to 4 days. The patient went to see her primary care physician and had an X-Ray performed. Patient stated her doctor believed it may be gout and also osteoarthritis. Additional tests in the future are to be performed to diagnose gout definitively. Patient was prescribed Celebrex and diclofenac for treatment. Patient reported on 29Jun2022 her right foot was "pretty normal". Patient stated all symptoms have improved.