chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient bled after the vaccine administration yet the shot was given within the IM region. There was a small knot after the bleeding stopped. However, today the patient returned at night to let me (the pharmacist) know that she developed a rash on her arm over 6 inches below the injection site (which I looked up and this is apparently a normal sign of a healthy immune response dubbed "covid arm" with soreness in her arm from inject site down to red hot rash and her lymph nodes were inflammed bilaterally on her neck. Patient also felt warm to the touch and she told me she had fever and soreness today. I told her to do cold compresses at the injection site, take tylenol/ibuprofen, use hydrocortisone cream otc if rash became itchy, switch to other arm for future injections, and to call me with any concerns and I will call her Friday to check up on her. Patient was ok otherwise.
Patient administered vaccine, then developed severe nausea and vomiting including "dry heaves" approximately 6 hours later, lasting for approximately 1 hour.  Patient felt ill the following day, and had vomiting x1 that morning.  Then patient fully recovered,
pt recv vax; severe local rxn; to avoid pertussis; fever, chills, redness, swelling around vax area;
3 minutes after shot began feeling "pin &needles"feeling in the face and upper and lower extremities
Began with "numbness" in L hand/leg. 8/15/11 c/o pain in chest, blurred vision.  Seen at ER 8/15 and Pediatric neurologist 8/17.  No treatment to date.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age (no details provided). Information regarding medical history was not provided. On 15-OCT-2012 the patient was vaccinated with ROTATEQ (lot number, dose number and route not provided). No other co-suspects were reported. No concomitant medications were reported. On 15-OCT-2012 the patient was administered an expired dose: the dose of ROTATEQ had expired on 03-OCT-2012. No treatment information was reported. Additional information has been requested.
COVID Positive; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (COVID Positive) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (COVID Positive). At the time of the report, SARS-COV-2 TEST POSITIVE (COVID Positive) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter.  Treatment information was not provided by the reporter.
severe headache; feel tired and lazy; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (severe headache) and FATIGUE (feel tired and lazy) in a female 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 HEADACHE (severe headache) and FATIGUE (feel tired and lazy). At the time of the report, HEADACHE (severe headache) and FATIGUE (feel tired and lazy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment was provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-022357 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-022357:same reporter, diff patient (male)
Swelling or welt under both eyes. Blister-like bumps on swelling when I 1st noticed it, but they have lessened. But the welt is still there, and I feel the swelling more so now than I did last night. It's now been about 38 hours since receiving vaccine. It doesn't seem to be getting worse, aside from now being able to feel the swelling. Also, like I said, the blister-like bumps, on the welt/swelled area, have dissipated, so that got better. My face is also breaking out with acne since the shot. I do occasionally get acne break outs tho.
Administered incomplete dose less than 0.3 mL of Pfizer. Dose repeated in opposite arm.
Symptoms: lasting mild fever (99F), rapid at rest heart beats (85 - 95 bpm), hand tremors Diagnostic: Hyperthyroidism (per lab results) with inflame thyroid (per Ultrasound)  Treatment: Referred to Endocrinologist.  Prescribed Methimazole 5mg twice daily Outcome (as of 6/24/2021): Condition improved.  Will continue Endocrinologist visit to monitor condition
After my second Pfizer vaccine, which I was out of sorts ford 1 week, then I developed mild gout symptoms in both big toes , left big toe cleared up within a few days , right foot was very inflamed, swollen  and Could not bed big toe, which forced me to go to my foot doctor wherein he described gout and rec'd an injection in my right foot.
Seasonal flu shot-right arm-was sore for a few days then started to get some numbness and tingling in right arm and some periodic weakness in right arm.
Woke up next morning after injection and above my knee on top of thigh is numb. I have no feeling on top if my leg. Called my family practitioner to let her know.  No action has been taken yet.
sore arm.  ongoing mild pain in the upper left arm since the vaccine was given 6 months ago.
Covid Arm - Raised Red area around injection site.  Slight itch early but has lessened over time.
Swollen hot red rash  on arm starting one inch from vaccine site, two inches wide, three inches long
my cycle was delayed; sharp pain in my stomach; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) at the age of 22 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MENSTRUATION DELAYED (non-serious) with onset 21Sep2021, outcome "not recovered", described as "my cycle was delayed"; ABDOMINAL PAIN UPPER (non-serious) with onset 21Sep2021, outcome "not recovered", described as "sharp pain in my stomach". The events "my cycle was delayed" and "sharp pain in my stomach" required physician office visit. Therapeutic measures were not taken as a result of menstruation delayed, abdominal pain upper.  Additional information: It was reported that, the patient used to have regular menstruation before the Pfizer vaccine and after the Pfizer vaccine her cycle was delayed for the first time in her life. She also experienced a sharp pain in her stomach after the vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive other vaccines within 4 weeks prior to the vaccination. The patient did not receive any other medications in 2 weeks. No known allergies were reported.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Nausea, vomiting, elevated heart rate, low grade fever, chills started next day. Weakness and mild nausea day two.
pt said she is uncomfortable seeing the needle and blood, so advised to look the other way while administration.,   She also said she was nervous, and had felt dizzy in the past while getting vaccination but never fainted or loss consciousness.  The vaccine is administered and she is doing fine.   she said she was feeling ok and walked to the chair.    after about  10 minutes I get called that she fell and hit her head on the floor.  I immediately go to her and ask how she was doing.  she wanted cold water, which was provided and she said she was ok .  advised to sit in the chair for 30 minutes and after she said she was feeling ok,   advised to hold husband hand while waking back to the car.
I have had COVID-19 about 2 months before I got the vaccine. There were some lingering effects like tiredness and loss of teste and smell that were improving. About a week and a half after getting the vaccine I noticed that items started to smell like fish or burned.  Symptoms described as parosmia. I can not be sure if this was caused by the vaccine, but it did start after I had the vaccine.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Apr2022 as dose number unknown, single (Lot number: FJ9943) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL, start date: Mar2021, stop date: Oct2022. Past drug history included: Gabapentin, reaction(s): "taking gabapentin for damaged femoral nerve", notes: taking gabapentin for damaged femoral nerve 600mg 3x daily(program would not allow more than one med) doubled vaxxed and double boosted; Tetanus toxoid, reaction(s): "Known allergies: Tetanus toxoid"; Gadolinium, reaction(s): "Known allergies: gadolinium". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Red, raised area about 4 or 5 cm at injection site. Itchy and painful for a week.
tonic/clonic sz lasting about 3 mins on 28MAR95 aobut 0630; seen in ofc @ 1030 where had a few maculopapular skin-lesion but otherwise nl exam, t102.6 R @ home; Had CBC, BC & Chem 7;
Patient received shot on 8/21/2019. She reported to pharmacy two days later with complaint of itchy/sore arm and evident erythema at injection site. Patient was instructed that this can be a normal, mild reaction to vaccination, but to inform the pharmacist if it worsens or changes in the next few days.  Reaction has since resolved since first report.
VAQTA adult dose administered post-expiry; This spontaneous report was received from a physician referring to an Adult female patient of unknown age. Information about medical history, concurrent conditions and concomitant therapies was not provided.       On 15-OCT-2020, the patient was vaccinated with post-expiry hepatitis a vaccine, inactivated (VAQTA) (1 dose, lot # S021449, expiration date 23-AUG-2020; strength and route were not reported) for prophylaxis (expired product administered).
Whole body itching; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 09Mar2021 09:00 (Lot Number: EN6198, Expiry date not reported) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included asthma, and contrast media allergy (known allergies: IVP dye). The patient was not pregnant at the time of vaccination. The patient was vaccinated at a public health clinic/veterans administration facility. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included montelukast sodium (SINGULAIR) taken for an unspecified indication, start and stop date were not reported; budesonide, formoterol fumarate (SYMBICORT) taken for an unspecified indication, start and stop date were not reported; fexofenadine hydrochloride (ALLEGRA) taken for an unspecified indication, start and stop date were not reported; buspirone taken for an unspecified indication, start and stop date were not reported; and zolpidem tartrate (AMBIEN) taken for an unspecified indication, start and stop date were not reported. The patient previously took iodine and experienced drug hypersensitivity. The patient experienced whole body itching on 11Mar2021 17:00 with outcome of not recovered. No therapeutic measures were taken as a result of the event. The event was reported as non-serious.  No follow-up attempts are possible. No further information is expected.
Pt given full Phizer vaccine series after completion of J&J in March 2021.
Chronic hives started 04/10/21 and still have them today; get new ones every day. Also now suffering from fatigue, shortness of breath, and back pain. Have tried treatment with oral steroids, topical steroids, generic Benadryl, generic Allegra, loratadine, generic Pepcid, generic Singulair, Xolair injections. Seeing primary care doctor and have also seen dermatologist, immunologist, rheumatologist.
No additional AE's/PQC's reported; products experienced an excursion; This spontaneous report has been received from a medical assistant referring to a 4 year old patient with unknown gender. The patient's medical history, concurrent condition and concomitant medication were not reported.   On 07-SEP-2021 during transport varicella virus vaccine live (oka/merck) (VARIVAX) experienced temperature excursion of -10 Degrees Celsius to 8 Degrees Celsius (4C) for 20 minutes and on 09-SEP-2021 -10 Degrees Celsius to 8 Degrees Celsius (4C) for 20 minutes. Previous temperature excursion included -10 Degrees Celsius to 8 Degrees Celsius (4C) for 7 hours and 30 minutes.  On 09-SEP-2021 the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (1 dosage form; lot # U002394, expiration date 22-JAN-2023; route and strength were unknown) for prophylaxis (Product storage error).  No additional adverse event was reported (No adverse event).      This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA005628: US-009507513-2109USA005648: US-009507513-2109USA005662: US-009507513-2109USA005618: US-009507513-2109USA005639: US-009507513-2109USA005632: US-009507513-2109USA005910: US-009507513-2109USA005742: US-009507513-2109USA005891: US-009507513-2109USA005964: US-009507513-2109USA005651: US-009507513-2109USA005918: US-009507513-2109USA005758: US-009507513-2109USA005760: US-009507513-2109USA005705: US-009507513-2109USA005776: US-009507513-2109USA005901: US-009507513-2109USA005752: US-009507513-2109USA005641: US-009507513-2109USA005945: US-009507513-2109USA005881: US-009507513-2109USA005902: US-009507513-2109USA005701: US-009507513-2109USA005795: US-009507513-2109USA005730: US-009507513-2109USA006765:
I first had itchy hands and then it spread to my scalp, chest, forearms, back, stomach, chest, and inner ears. It started 10 days after my third moderns booster. I took Benadryl but symptoms returned after 4 hours of the Benadryl treatment. Every time the symptoms returned it had spread to more parts of my body. Itchiness was accompanied by hives.  I went to minute clinic and was prescribed triamcinilone ointment.
pt recv vax & 21MAR97 pt devel chickenpox which consisted of approx 10 to 15 lesions & accompanied by a fever;pt was uncomfortable from itching;sx were verified to be varicella by a MD;
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date approximately in February 2013 the patient was vaccinated with PNEUMOVAX23 dose 1 at the dose of 0.5 milliliter (ml), intramuscular. The patient was inadvertently administered a second dose of PNEUMOVAX23 in December 2013. No adverse effects reported. No further information provided. Additional information is not expected.
It was reported that several pt recv MMR vax & poss rubella vax; two children recv rubella & 1 child recv MMR the clinic did not know which child got which vaccine & they wanted all children to recv MMR vax;
Mild headache; Mild fatigue; Mild injection site pain; This is a spontaneous report from a non-contactable consumer, the patient. A 14-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 13May2021 at 15:15 (at the age of 14-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications were not reported. On 13May2021 at 15:15, the patient experienced mild injection site pain. On 14May2021, the patient experienced mild headache and mild fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event mild injection site pain, mild headache, and mild fatigue were recovered on an unknown date in May2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sore Arm (After First Vaccine); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm (After First Vaccine)) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm (After First Vaccine)). On 25-Mar-2021, PAIN IN EXTREMITY (Sore Arm (After First Vaccine)) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications provided. No treatment information provided.   This case was linked to MOD-2021-083716 (Patient Link).
Severe leg cramping the 3rd and 4th night following vaccination. Headache the 3rd day following vaccination which lasted for about 3 days. Fatigue, malaise, generally feeling unwell. Sore arm with bruising for one week.
Symptoms included HA, malaise, low grade fever, chills and body aches.  Took acetaminophen.  Lasted 24 hours.  Reaction to 2nd shot was only malaise that lasted 24 hours.
Has 10 skin lesions that appeared two days ago. Afebrile. Complained of itching.
vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.   This case was linked to MOD-2021-395985 (Patient Link).
Had fatigue and generalized body aches.  Developed an itchy rash that started on her face and spread to her scalp chest, trunk and bilateral arms. She was off of work for one week and was treated with Cephalexin to prevent any secondary infection.  Was given a mask to wear during contagious period.
Adverse event; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Adverse event) 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 ADVERSE EVENT (Adverse event). At the time of the report, ADVERSE EVENT (Adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was not provided by the reporter.
Individual is a foreign exchange student  who presented with his guardian. This nurse questioned the patient's age. Age at date of vaccine is 16. The guardian stated that she had spoke to the Health Department and they told her it was okay for the individual to receive the vaccine at 16 years old.  Patient was able to self register and book appointment through the VRAS system for this clinic that had Moderna only vaccine.  This nurse administered vaccine.
Imm. following vaccination, ran a high fever for 2 days then started requiring more supplemental home O2 (2L-4L). Progressively developed worse SOB w/exertion. Was seen in clinic 4/20/21. Sent to ER for hypoxemia on 4L O2 @ dx w/pneumonitis on x-ray. Sent home on steroids.
Moderna  1st shot (3/5/21) had chills and headache for about 6 hrs,    With the 2nd shot chills, severe headache to the point that I was in bed all day.  Symptoms lasted about 15 hrs.
Patient received pfizer covid-19 vaccine ~4:00pm, patient advised to have a seat for 15 minutes, but patient tried to leave without waiting, and ended up fainting within 2 minutes of leaving, I advised him to have a seat and provided him a cold water bottle, within another 2 to 3 minutes, patient vomitted. After using the restroom, patient reported to feel better but I still advised him to sit for 15 more minutes where I continued to monitor him while firefighters also came to do quick tests and reporting as well.
Accidental third dose given due to facility having lost records; as of now the patient is currently doing fine.  Was told the third dose still needed to be reported