chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received Tdap (Left Deltoid), FLUCELVAX, PNEUMOVAX (right deltoid each injection 1-2 inches apart) on 11/13/2017. On 11/15/2017 patient returned to the office with a rash on the her right deltoid. As per MD notes arm was red hot. As per MD rash was off to the side not on the injection site. Patient diagnosed with cellulitis of the right upper extremity. Given course of antibiotics KEFLEX 500 mg by mouth 3 times a day for 10 days.
COVID test Positive; COVID test Positive; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 64-year-old female patient received bnt162b2 (BNT162B2), on 23Feb2021 as dose 1, single (Lot number: EL3249), in upper left arm and on 16Mar2021 as dose 2, single (Lot number: FF8839) at the age of 63 years, in upper left arm for covid-19 immunisation. The patient's relevant medical history included: "MS", start date: Aug1996 (ongoing); "Anxiety" (ongoing). Patient's family medical history included heart disease. Concomitant medication(s) included: ZOLOFT taken for anxiety, start date: 1996 (ongoing). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2021, outcome "unknown" and all described as "COVID test Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2021) Positive.; Sender's Comments: Based on available information, a lack of efficacy (Vaccination failure and COVID-19) with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-202300319238 Same patient/Vaccine,different event,different vaccine dose;
achy; Temperature/ fever; Nausea/Extreme nausea; Shortness of breath; kind of achy with a little headache; Tired; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), PAIN (achy), FATIGUE (Tired), PYREXIA (Temperature/ fever) and NAUSEA (Nausea/Extreme nausea) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced FATIGUE (Tired) and HEADACHE (kind of achy with a little headache). On 22-Feb-2021, the patient experienced DYSPNOEA (Shortness of breath). On 23-Feb-2021, the patient experienced PAIN (achy), PYREXIA (Temperature/ fever) and NAUSEA (Nausea/Extreme nausea). At the time of the report, DYSPNOEA (Shortness of breath), PAIN (achy), FATIGUE (Tired), PYREXIA (Temperature/ fever), NAUSEA (Nausea/Extreme nausea) and HEADACHE (kind of achy with a little headache) outcome was unknown.            No concomitant products were reported. Treatment information included an inhaler, for shortness of breath. Action taken with mRNA-1273 in response to the event was not applicable.
Narrative: COVID infection following completion of COVID vaccine series 01/22/21 COVID vaccine dose #1 02/11/21 COVID vaccine dose #2 08/02/21 Pt presents to screening reporting congestion and exposure to someone with a febrile/respiratory illness within the last 14 days; COVID POSITIVE 08/03/21 Pr states being exposed at a dance event on 07/27; started to fill ill on Friday (07/30) with a headache and fever (99.9); reports loss of appetite, congestion, and cough started Sunday (08/01) and continues 08/04/21 Pt reports congestion and headache improving but continues to have fatigue; states loss of taste/smell happened 10 years ago 08/05/21 Pt reports intermittent cough, improving fatigue, and some congestion 08/08/21 Pt reports asymptomatic for 4-5 day 08/10/21 Pt remains asymptomatic; clinically resolved
"1 1/2 day of severe joint pain, felt like a huge hammer repeated[sic} hitting ankle and top of left foot - complete loss of bladder just once upon waking up"
I?m hearing a droning noise that isn?t there.  It?s not a ringing or buzzing  and definitely doesn?t seem to be coming from inside my head but it is.  The noise is constant and most noticeable when I?m sitting or trying to sleep.  Hoping it goes away but just thought I should report it
Initial information received on 30-Jan-2019 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown demographic patient who was vaccinated with both HIB (PRP/T) VACCINE [ACT-HIB] lot UI944AAb via unknown route in unknown administration site and 0.5 ml of PENTACEL (lot C54578A via intramuscular route in the right thigh) on same date of 28-Jan-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. This was an actual medication error due to extra dose administered. It was unknown that any adverse event was occurred or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Tingling all over body, pins and needles, swelling in arm. Muscle weakness and cramping.
My left shoulder after 2 months is in constant pain; Second shot in my right arm shoulder, I'm starting to get the same pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (My left shoulder after 2 months is in constant pain) and ARTHRALGIA (Second shot in my right arm shoulder, I'm starting to get the same pain) 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) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (My left shoulder after 2 months is in constant pain) and ARTHRALGIA (Second shot in my right arm shoulder, I'm starting to get the same pain). At the time of the report, ARTHRALGIA (My left shoulder after 2 months is in constant pain) and ARTHRALGIA (Second shot in my right arm shoulder, I'm starting to get the same pain) outcome was unknown.            No concomitant medications were reported. No treatment details were reported.
Patient developed itching and rash on bilateral arms, experienced flushing on arms, trunk, neck and face almost 1 hour after receiving first dose of Moderna COVID vaccine.  Patient took 25 mg of diphenhydramine orally, rash subsided and flushing decreased after about 20-30 minutes.  No other complaints.  Patient stabilized.  No issues with breathing, vital signs stable.
There was an excursion from the freezer and administered to patinet; There was an excursion from the freezer and administered to patinet; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer and administered to patinet) and EXPIRED PRODUCT ADMINISTERED (There was an excursion from the freezer and administered to patinet) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer and administered to patinet) and EXPIRED PRODUCT ADMINISTERED (There was an excursion from the freezer and administered to patinet). On 01-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer and administered to patinet) and EXPIRED PRODUCT ADMINISTERED (There was an excursion from the freezer and administered to patinet) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2021-383410 (Patient Link).
Presented w/ SOB, fever, cough, wheezing. Recent outside Covid+ test. Tx / dexamethasone, Redesivir, zinc
Rash all over body only after 2nd shot as raised pink bumps, also hot flashes and night sweats. Patient also reports having an autoimmune disease.
Reported by the patient on the next day: Within 20-30 minutes of vaccination patient had congestion, headache, redness and swelling of the face and felt dizzy. During next 28 hours he felt dehydrated and suffered from hot flushes and "foggy brain" that completely resolved in the afternoon of the next day. Pt used ORS only
REQUIRING NAPS ALMOST DAILY; WOOZY FEELING/BROWN OUT; DEPRESSION; DOES NOT FEEL LIKE HERSELF; LACK OF ENERGY; HEADACHE; LETHARGY; HARD TO TAKE A DEEP BREATH; WEIGHT GAIN; METALLIC/NUMB TASTE IN MOUTH; SWELLING; LOWER BACK PAIN; STOMACH CRAMPING; BODY SORENESS; ALMOST PASSING OUT; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included menopause. The patient experienced anaphylaxis when treated with acetylsalicylic acid for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 005A21A expiry: UNKNOWN) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAY-2021, the subject experienced lethargy. On 15-MAY-2021, the subject experienced hard to take a deep breath. On 15-MAY-2021, the subject experienced weight gain. On 15-MAY-2021, the subject experienced metallic/numb taste in mouth. On 15-MAY-2021, the subject experienced swelling. On 15-MAY-2021, the subject experienced lower back pain. On 15-MAY-2021, the subject experienced stomach cramping. On 15-MAY-2021, the subject experienced body soreness. On 15-MAY-2021, the subject experienced almost passing out. On 15-MAY-2021, the subject experienced woozy feeling/brown out. On 15-MAY-2021, the subject experienced depression. On 15-MAY-2021, the subject experienced does not feel like herself. On 15-MAY-2021, the subject experienced lack of energy. On 15-MAY-2021, the subject experienced headache. On an unspecified date, the subject experienced requiring naps almost daily. Laboratory data (dates unspecified) included: Weight (NR: not provided) 16 pounds gained. Treatment medications (dates unspecified) included: caffeine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from woozy feeling/brown out, headache, lower back pain, stomach cramping, body soreness, depression, and hard to take a deep breath, had not recovered from lethargy, weight gain, metallic/numb taste in mouth, swelling, lack of energy, does not feel like herself, and requiring naps almost daily, and the outcome of almost passing out was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious
This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (the patient) reported that she was a 73-year-old female patient of an unspecified ethnicity that received PREVNAR 13, via an unspecified route of administration on Jan2017 at single dose for immunisation. The vaccine was administered by her primary care physician (PCP). Medical history included she a tumor in her lung removed in 2006. The patient's concomitant medications were not reported. On an unspecified date one week later vaccination, she experienced coughing, shortness of breath, allergy symptoms but much worse, very sick feeling and weakness. She visited PCP who gave her an inhalation therapy and was given several nebulizer treatments. Symptoms continued and went back to the lung specialist. The outcome for all the events was not recovered. No follow-up attempts are possible. No further information is expected.
Adverse menstrual issues: - First period after vaccine EXTREMELY painful.  Pain NOT like period cramps, instead was similar to pain I have experienced after previous uterine surgeries (ie. feeling severely inflamed). Period was heavier + lasted 2 days longer than usual.  - Second + third periods after vaccine painful again. Much less so than the prior month, but still much more pain than I usually feel. Pain seems to radiate from lower back + lower abdomen. Period slightly heavier still.  - Third period after vaccine I passed a large stringy blood clot. I have never done this before.  - Experiencing increase in endometriosis pain. Usually pain is quite sporadic + only occurs 10 times a year . Now experiencing pain weekly or biweekly.   NB. I have Asherman?s Syndrome. Due to this I haven?t experienced any period pain for 6yrs + my periods have been extremely light. This has been well documented with my Obgyn + Reproductive Endocrinologist. Therefore I can conclusively identify the vaccine as signaling these changes to my menstrual cycle.
The patient was in her normal state of good health prior to the vaccination.  Almost immediately after receiving the vaccination, she began having a headache, then got an urticarial rash.  She then felt a "lump in [her] throat."  She was coughing uncontrollably.  She was brought immediately to the Emergency Department where I assessed her with my resident.  She had signs of a Type I Hypersensitivity Reaction including a hoarse voice, globus feeling and diffuse urticaria.  She was treated at the vaccination site in the hospital with Benadryl 50 mg PO prior to ED evaluation and she self-administered Ibuprofen 400 mg.  She did not have stridor or airway swelling.  She was able to speak in full sentences.  She was NOT treated with epinephrine, as she was in stable respiratory condition and improved with Benadryl (as previously administered at the vaccination clinic, Pepcid IV and Solumedrol IV.  My concern over this reaction is that the patient has NO PRIOR HISTORY OF ANY ALLERGIES AT ALL.  I have read and seen in the media reports of anaphylaxis with a history of allergies, however, this is the first case I have heard of regarding an anaphylactoid reaction in a patient with no prior history.
Minimum soreness at injection site; however, sometime during that night I awoke with pain down my left side, particularly in the hip, thigh, and calf -- painful enough to take ibuprofen for relief. The pain came back for several subsequent nights before gradually occurring about once a week at this point. Also, two or three days after the vaccination, my left eye developed an irritation that resulted in a crustiness and dryness around the eyelid, the latter which persist. Then, about two weeks following the shot, my left hand, near the thumb and wrist, developed a weakness and extreme pain that came for around 24 hours, departed, and came back a few days later. I had four episodes of this, though that also has not made an appearance since the last week of March.
11/04/16 patient came to clinic reported swelling and warmth and redness to injection site with "stinging". Vaccine was not administered here in clinic but at Dr.'s office at a different location.
SLIGHT LOSS OF HEARING IN RIGHT EAR; RINGING IN RIGHT EAR; LEFT LEG CRAMPING; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had 2 beers and pizza for dinner around 5 pm that evening of 20-Nov-2021. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 18-NOV-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 18-NOV-2021, the patient experienced left leg cramping. On 20-NOV-2021, the patient experienced slight loss of hearing in right ear. On 20-NOV-2021, the patient experienced ringing in right ear. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left leg cramping on 18-NOV-2021, and slight loss of hearing in right ear, and ringing in right ear on 20-NOV-2021. This report was non-serious.
Felt like acid coming out of the pores; very red and burning with spots; very red and burning with spots; sever face pain then a rash; sever face pain then a rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-healthcare professional). The reporter is the patient. A 55-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 28Oct2021 07:15 (Lot number: 2590) at the age of 55 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: FACIAL PAIN (non-serious), RASH (non-serious) all with onset 30Oct2021, outcome "recovered" (04Nov2021) and all described as "sever face pain then a rash", FEELING ABNORMAL (non-serious) with onset 31Oct2021, outcome "recovered" (06Nov2021), described as "Felt like acid coming out of the pores" RASH MACULAR (non-serious), BURNING SENSATION (non-serious) all with onset 30Oct2021, outcome "recovered" (04Nov2021) and all described as "very red and burning with spots". Therapeutic measures were not taken as a result of facial pain, rash, feeling abnormal, rash macular, burning sensation.  Additional information: The patient was no COVID, prior vaccination and not tested positive for COVID post vaccination. The patient had no known allergies. The patient stated that Extreme rash on face, very red and burning with spots. she could not go out in public. Why her face got wet i.e. show, it would significantly escalate the redness and pain. It felt like acid was coming out of her pores. Patient received vaccine Facility in Doctor's office/urgent care.  Follow-up attempts are completed. No further information is expected.
My dad reacted to moderna jab he now has tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (My dad reacted to moderna jab he now has tinnitus) in a male patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (My dad reacted to moderna jab he now has tinnitus). At the time of the report, TINNITUS (My dad reacted to moderna jab he now has tinnitus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment drugs were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Started itching on various parts of body.  Itching progressed and that evening the spots scratched were red, raised, and bumpy.  Hives???  This lasted several days and was helped by taking Benedryl or Allegra.  10 days later, still itchy.  On 10/31/2011 patient also started feeling very nauseous, and that has lasted until today, 11/3/2011.
After 2nd dose, patient experienced arm pain, fever, and flu-like symptoms for 24 hours after administration.
Fever, headache, body aches, nausea started in the first 24 hours.  Took OTC meds, plenty of fluids and rest. Over the next few days fatigue, muscle weakness and body aches.  At day 8 I woke up with a red, swollen, hot, itchy knot in my left arm at the injection site.  Treating with cool compresses and Benadryl cream.
Started with body aches, fever, lethargy, exhaustion developed cough lasted for 5 days.  Cough still lingers now on day 6.  Haven?t felt this bad in a very long time.  Felt it important to report this.  2nd dose.  No real reaction after first except a little soreness. Crazy. Why this reaction?
Full body pain ..weakness fatigue soreness stiffness. Chest and shoulder joint arm pain. Cant walk some days neck and back pain buttocks hip pain sensitive to touch.hard to lift legs to walk
redness on arm from shoulder to elbow; This case was reported by a pharmacist via sales rep and described the occurrence of erythema of extremities in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number 4M2C7, expiry date 19th December 2021) for prophylaxis.   On 17th November 2019, the patient received Shingrix (intramuscular) .5 ml. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced erythema of extremities. On an unknown date, the outcome of the erythema of extremities was recovered/resolved.   It was unknown if the reporter considered the erythema of extremities to be related to Shingrix.  Additional details were provided as follows: After the Shingrix shot received on left arm, the patient had redness on arm from shoulder to elbow and went away after 3 weeks. The patient did not hurt or itch just red. The reporter agree to follow up from GSK
Right arm swelling (present but improved at time of presentation), right arm itching (no longer present at time of presentation), right arm erythematous rash (no longer present at time of presentation), face & eyelid swelling (present but improved at time of presentation), fever for 2 days (had resolved as of presentation), ear pain (bilateral, present at time of presentation), itchy eyes (resolved at time of presentation)
A report received from a health care professional on 10/29/2002, concerning a 25 year old female vaccinee who experienced an injection site reaction after receiving Fluvirin on 10/23/2002. On 10/24/2002, the vaccinee developed a 3" X 3" area of redness, swelling, tenderness and itching near the injection site. The vaccinee has not yet recovered. There was insufficient information to determine the reporter's causality assessment. Update 1, 12/11/2002,  A follow-up report received from a health care professional indicated that other symptoms of the event included swelling and ecchymosis superior to the injection site. The vaccinee recovered after 3 days.
Woke up with acute stomach pain, fever, tremor, reported to have ?tingly? feet when he walked. Stomach pain not experienced before in the past in this manner. Got treated at urgent care and received an x-ray, which showed constipation and trapped gas. Negative COVID PCR. Treated with Motrin and Miralax. Stomach pain subsided 12 hours late, fever subsided 24 hours later.
Pt c/o pain and some swelling and reddness at injection site on Sat 10/12/2002: it continued to get worse with the swelling going from shoulder to elbow, pain got worse- went to ER- Dx with cellulitis and put on Cipro (cellulitis of left arm)
About 4 hours after shot, fatigue. Then, nausea about 6 hours after. In the middle of the night progressed to throbbing headache, chills, nausea, fever. Chills and fever has lowered, but severe headache still remains at 6:00pm.