chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AEs were reported; Medical assistant reported a temperature excursion for PROQUAD which was improperly stored and administered to a patient.; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications were not provided.   On 15-MAR-2021, the patient was vaccinated with a improperly stored of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), as prophylaxis (formulation, concentration, dose, vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported; lot number T027294, which has been verified to be valid, expiration date reported and validated as 08-FEB-2022). The vaccine administered experienced a temperature excursion of 20.04 degrees Fahrenheit (F), for a time frame of 40 minutes as recorded by a data logger (product storage error). There was no previous temperature excursion reported. No additional adverse events were reported.
Severe headache, vomiting and dry heaving, diarrhea, high fever, severe joint pain, painful to be touched anywhere. My lymph nodes swelled in my right armpit 2 days later.  My symptoms lasted  about 14 hours with exception of my swollen lymph nodes. They were swollen for about 10 days . I was prescribed Zofran by my PCP for the severe nausea and vomiting then took Tylenol and Motrin for fever and pain.
Unsure of onset of VZV rash, but first noticed it about a week after receiving first dose of COVID vax. Rash was under left armpit, was associated with mild pain/irritation. When rash did not resolve, ultimately saw dermatologist on 1/8/2021. PCR of scraping from rash confirmed VZV.  Was prescribed Valtrex for rash on 1/8/2021, but did not take it due to receipt of 2nd dose of covid vax on 1/8/2021 and wanted to avoid taking meds concomitantly.  Rash resolved slowly on its own.
Within a month of this vaccine my vision got kind of blurry within a few weeks. It would clear up but then it would go back to being blurry. It's a steady on/off routine of when it comes and goes. I called my doctor told me to drink plenty of fluids and take TYLENOL if I develop a fever.
Her arm started hurting the night of the shot. It was a little swollen the next day so she started using a hot wash cloth on it. It has been slowly getting worse and today (9/17) the site was swollen about 3-4 inches across, red, and painful. Advised patient to see MD.
About 1cm firm, mobile, non tender, non erythematous mass (likely scar tissue) at right and left anteriolateral thigh at injection sites.
patient with myelitis transverse received Pfizer Covid 19 vaccine; patient with myelitis transverse received Pfizer Covid 19 vaccine; Paresthesias to bilateral hands to elbows, right foot/leg; brain fog; fatigue; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; lot number: EK-5730; expiration date: unknown) at 39-year-old age of vaccination intramuscularly in the left arm on 26Dec2020 11:30 at a single dose for covid-19 immunization. Medical history included myelitis transverse from 2015 to an unknown date and depression. The patient has no known allergies. The patient was not diagnosed with covid-19 prior to vaccination. The patient did not receive other vaccine in four weeks but has other medications in two weeks. It was reported that the patient with myelitis transverse received Pfizer Covid 19 vaccine on 26Dec2020. On Dec2020, the patient had paresthesias to bilateral hands to elbows, right foot/leg with brain fog and fatigue. Symptoms appeared approximately 12-18hrs after injection. There was no treatment receive for the adverse events. The events resolved 48 hours after. The adverse events resulted in a doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient underwent lab tests and procedures which included nasal swab (sars-cov-2 test) with the result of negative on 22Jan2021. The outcome of the events was recovered on Dec2020.
Patient previously received vaccine series with COVID-19 Moderna vaccine (3/17/2021, 4/14/2021, 12/5/2021) and additional booster with Pfizer-BioNTech monovalent 5/23/2022.  Patient requested additional booster which should have been with the bivalent formulation. However instead the physician ordered for the patient to receive Pfizer-BioNTech monovalent vaccine on 10/4/2022. Dose administered and no harm occurred to patient. Ordering physician notified of error.
I started getting symptoms on 5/25/2022. I thought I had allergies but my husband tested positive for COVID-19. I did a home test of COVID-19 and the first one was negative. The next day, I went and had a PCR COVID-19 test on 5/26/2022. I did a telehealth visit. I had a runny nose and a headache and since my symptoms were mild I did not take Paxlovid. I had fatigue and a cough. My sense of taste was dulled but not lost which could be due to the postnasal drip. The headache lasted 2 days. I still have postnasal drip. I am still taking allergy medicines.
ecchymosis & induration 7cm x 3cm;reddened, warm, painful;warm compress & APAP for tx
About 24 hours after vaccination: patient experienced muscle aches and pain, achy feeling, fever, stomach ache, nausea, diarrhea,shivering. feeling warm
Vaccinated 12/20/2020.   On 12/21/2020  developed loss of taste/smell, nasal congestion, cough, and shortness of breath.  Positive COVID test.
Skin on her face and neck felt tight; Skin on her face and neck felt dry; Swollen eyes; Had a Rash; This spontaneous case was reported by a consumer and describes the occurrence of SKIN TIGHTNESS (Skin on her face and neck felt tight), DRY SKIN (Skin on her face and neck felt dry), EYE SWELLING (Swollen eyes) and RASH (Had a Rash) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy and Allergy (The patient has outdoor allergy and takes allergy shots).    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced SKIN TIGHTNESS (Skin on her face and neck felt tight), DRY SKIN (Skin on her face and neck felt dry), EYE SWELLING (Swollen eyes) and RASH (Had a Rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of UNK dosage form. At the time of the report, SKIN TIGHTNESS (Skin on her face and neck felt tight), DRY SKIN (Skin on her face and neck felt dry), EYE SWELLING (Swollen eyes) and RASH (Had a Rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information was not provided.  She took some Benadryl but it has not helped her symptoms much. She finds her symptoms more annoying than anything else.
Nausea, Dizziness, hyperventilation , elevated heart rate ,hypotension and anxiety
I had shortness of breath and flushing after the injection. I was monitored at the site for about 45 minutes by EMT's. I had a headache for several days following the injection with fatigue. Also, my menstrual cycle lasted for 3 weeks, it stopped for 4 or 5 days and the started again for another 10 days and I had to seek medical care.
OFF LABEL USE; VACCINE ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; This spontaneous report received from a health care professional concerned a 14 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 18-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-SEP-2021, the patient experienced off label use. On 18-SEP-2021, the patient experienced vaccine administered to patient of inappropriate age. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered to patient of inappropriate age and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211217833, 20211217956, 20211218297, 20211218548 and 20211218731.
Parent reports coffee cup sized red painful raised rash at site of varicella injection. Parent took child to urgent care where she was given a steroid injection and oral medication. Parent unsure of name of medication. Pain and rash decreased some after injection. Treated 7/20/12.
Information has been received from a registered nurse referring to a patient of unknown age and gender. On 12-JUN-2015 the patient received improperly stored PROQUAD (Merck) (lot # L005293, expiration date: 17-AUG-2016, 0.5 ml, once, subcutaneous) (incorrect product storage). No adverse effects were reported. Additional information has been requested.
Pt recieved a ppv-23 pneumovax on 10/18/06. On 10/20/06 pt returned to office with low grade fever, pain and swelling distally from injection site (SQ) in left upper extremity to the mid forearm.  Area warm to touch, erythematous and edematous.  Diagnosed as cellulitis, given Ciprofloxacin x 10 days.  To be seen for recheck in 2 weeks. Pt was co-administered Fluviron Flu Vaccine the same visit (10/18/06) in the Right upper extremity without adverse effect. The PPV-23 was  lot #0485F exp.5/5/07.
pt recv vax 1OCT97 & 8OCT97 pt exp hair loss;
Client received the COVID vaccine (Pfizer, lot # EW0182, expiration date 05/13/2021 at 0930) at 11:20AM. On 05.12.21, client was found by EMT sitting upright and complaining of chest tightness/sensation s/p vaccine administration approx. 30 mins later. Client is a 27 year old female, alert and tracking. Initial VS: BP 128/78, pulse 74, RR 12, O2 sat 99% and fully oriented. EMT advised client to remain additional 30 mins to monitor VS and symptoms to which she agreed. Client denies any pertinent medical history. She states has allergy to antibiotics but not specific to which. This is the client's first dose of the Pfizer vaccine. Assessment revealed no swelling, hives, discoloration, shortness of breath or other signs of anaphylaxis. Airway, breathing and circulation were intact. Her remaining vitals at 1210  - 124/72, pulse 72, O2 99% respirations 14. At 1215, BP 126/74, pulse 72, RR 14, sat 99%. At 1220, BP 128/76, pulse 72, RR 12, sat 99%. At 1225, BP 122/74, pulse 70, RR 14, sat 99%. Client reports resolution of chest tightness after initial set of vital signs and denies any other symptoms. At 1230, BP 126/76, pulse 72, RR 14, sat 99% and continues to be fully oriented.  Client was registered for V safe and provided with vaccine relevant information. Client was instructed to seek medical attention if a life-threatening reaction occurs later in the afternoon or evening. Client left facility ambulatory with steady gait. Client declined any further intervention or EMS activation.
This is a spontaneous report from a non-contactable consumer. A 47-years-old female patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on Feb2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. Not known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included sertraline (SERTRALINE) taken for an unspecified indication, start and stop date were not reported. On an unspecified date of Apr2021 patient experienced new onset alopecia areata. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event was not recovered. No follow-up attempts are possible information about lot/batch number cannot be obtained. No further information is expected.
one papulomacular lesion @ site of inj appeared 11 days p/vax;
got shingles 90 days after 2nd dose of vaccine on right side of face; Tingling; Itching; Pain on forehead- right side of the face; mild rash, skin rash; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (got shingles 90 days after 2nd dose of vaccine on right side of face), PARAESTHESIA (Tingling), PRURITUS (Itching), FACIAL PAIN (Pain on forehead- right side of the face) and RASH (mild rash, skin rash) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M2072 and 004M2a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hyperthyroidism (Hyperthyroidism in the beginning now Hashimotos.) and Fever blister (FEVER BLISTERS OCCASIONALLY AND ALWAYS ON THE LEFT SIDE OF MY FACE). Previously administered products included for an unreported indication: TETANUS VACCINE (FROM 1981-1982 RECATION DUE TO THE VACCINE- FEVER  AND STOMACH UPSET.  PATIENT NOW BELIEVES THAT IT WASNT DUE TO THE VACCINE  AS DID NOT GET ANY EACTIONS LAST YEAR). Concurrent medical conditions included Sulfonamide allergy (RASH, FEVER AND TEMPERATURE), Perfume sensitivity (LARYNGITIS ,HARD TO BREATHE), Allergy (LARYNGITIS ,HARD TO BREATHE), Allergy to chemicals (RASH), Hashimoto's thyroiditis, Epstein-Barr virus infection, Sjogren's disease and Thyroid disorder (Hyperthyroid in beginning, now Hashimotos) since 1988. Concomitant products included L-LYSINE [LYSINE], CALCIUM and COLECALCIFEROL, FISH OIL (OMEGA 3 + VITAMIN D) for Supplementation therapy, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder, ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-May-2021, the patient experienced HERPES ZOSTER (got shingles 90 days after 2nd dose of vaccine on right side of face), PARAESTHESIA (Tingling), PRURITUS (Itching), FACIAL PAIN (Pain on forehead- right side of the face), RASH (mild rash, skin rash) and HEADACHE (Headaches). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) at a dose of 2 gram three times a day. At the time of the report, HERPES ZOSTER (got shingles 90 days after 2nd dose of vaccine on right side of face), PARAESTHESIA (Tingling), PRURITUS (Itching), FACIAL PAIN (Pain on forehead- right side of the face), RASH (mild rash, skin rash) and HEADACHE (Headaches) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient reported that she got shingles exactly 90 days after her second dose. The patient said that it was mild case and lasted only for about 3 weeks.   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Follow-up received. Added patient  history, allergy, historical vaccine and historical conditions. Updated patient information-height,weight, race. updated patient initials.
fainted; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SYNCOPE (fainted) 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 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced SYNCOPE (fainted) (seriousness criterion medically significant). At the time of the report, SYNCOPE (fainted) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. The reporter stated that patient fainted and was taken to the hospital emergency room. No treatment information was provided  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-089124, MOD-2021-089511 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. MOD-2021-089124:Reporter's husband MOD-2021-089511:Same Reporter_Invalid Case_No patient identifier
Patient remarked several hours post vaccination arm uncomfortable, inflamed and redness began later. Patient went to urgent care and received antibiotics for infection ( injection site reaction)
mom first noticed red spot on shoulder on 16JUL97 & in 3 days 19JUL97 pt had water blisters & spreading into neck;didn't have fever or didn't seem to feel bad;took to local MD & sent to dermatologist;prescribed med;
fever; swelling at the injection site; arm pain; bright red arm; This spontaneous report was received from a 69 year old female patient. The patient did not have any known pertinent medical history, allergies, drug reactions nor concomitant medications. On 06-MAR-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) dose reported as "single injection" for prevent infection(lot # and expiration date were not reported). On the same date, the patient experienced a "fever, swelling at the injection site and a bright red arm." The patient stated that she was also experiencing "arm pain that had not gone away for three months" since receiving the vaccination.   The patient visited the physician, however no treatment was administered for the adverse events. At the reporting time, the patient did not recovered from the aforementioned events. Causality assessment was not provided.
swollen lymph node under the left armpit; the lymph node used to hurt a lot but now it is just really big; This is a spontaneous report from a contactable consumer (Patient) via Medical Information Team. A 17-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: ER8733) on 02Apr2021 at Noon (age the age of 17-years-old) and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EW0170), on 26Apr2021, both doses via an unspecified route of administration, administered in left arm as single dose for COVID-19 immunization. Patient medical history included no other illness except that he usually gets fever after vaccines, no vaccine in particular, just after most vaccines, he gets a fever. There was no history of any previous immunization with Pfizer Vaccine and no additional vaccines administered on same date of vaccination. The patient concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 03Apr2021 (next day after first dose), when woke up, patient experienced swollen lymph node under the left armpit (the same arm he got vaccine), and lymph node used to hurt a lot but now it was just really big. It was still there a month later when he was getting his second dose. The patient mother stated that they wanted to see the doctor to see how bad her son symptoms were and because of pain but the doctor told them to call Pfizer and stated that family doctor does not want to see them because there is nothing that they can do. The events not required any visit to emergency room or physician office. No relevant tests were done. There was no investigation assessment. Reporter stated that he was wondering if this is still normal to be there. The patient did not receive any treatment for the events. The outcome of the event swollen lymph node under the left armpit was not resolved, while outcome of the event lymph node used to hurt a lot but now it was just really big was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Presented with GLF related to "10 days of illness with minimal PO intake". Extreme weakness. Positive for Covid.
Case number PHEH2012US018215 is an initial spontaneous report received from a nurse on 13 Sep 2012. This report refers to an 11-years-old male patient whose medical history and concomitant medications were not reported. It was reported that he only received the MenCYW-135 liquid conjugate vaccine component of MENVEO (batch number X110077) intramuscularly and did not receive Men A lyophilized conjugate vaccine component on 13 Sep 2012. No adverse reaction was reported.
(R) arm at vaccine site red, swollen, warm to touch. Cold pack applied to site.
6 1/2 mo pt devel isolated lt VIth nerve palsy 2nd day p/DTP/OPV/HIB; throught to be secondary to DTP; No tx;
MMR given 11/12/02. Flu sx 11/22/02. Dizziness 11/23/02. Red rash 11/24/02. Swollen L knee 11/25/02-swollen R knee and hands. Rx Aleve and Benadryl.
Marble size cyst under right collar bone, the same arm as the vaccine was administered. Doctor suggested surgery to remove.
Patient came in and has black, warm to touch, spot around the injection site and down arm to elbow.  It is darkened in color and warm to the touch.
itching @ 8 hrs, fever of 101.4 @ 8 hrs, skin redness @ 8 hrs; hives covering entire body; eyes sensitive to light; pt given Calamine, DPH, Pred;
Pt was given Pfizer vaccine 2 weeks earlier and failed to let us or his facility know. After his Moderna vaccine we were notified of his Pfizer vaccine 2 weeks earlier. No adverse sx. We contacted State Immunization Program and reviewed situation with them. They advised to fill out VAERS form. Pt doing well yesterday and today 1-28-21. No concerns noted per his staff.
Information has been received from a physician assistant concerning a 21 year old female with no medical history or drug allergies who was vaccinated with the first (661044/0548X) and the second (659655/0940X) dose of GARDASIL IM, 0.5 ml, on 27-JAN-2009 and 08-APR-2009 respectively. Concomitant therapy included unspecified birth control pills. "a couple of days ago" the patient experienced numbness on the felt side of the nose to upper left lip. The second dose was given IM in the left deltoid. The patient did not have any problems after the first dose. No adverse effect reported. The patient did not have any lab diagnostics studies performed. At the time of the report the patient was not recovered. The patient sought medical attention by phone. Follow-up information has been received from a physician assistant who did not know the onset date as the patient did not mention it to her. Additional information has been requested.
Pt developed palpitations and left arm pain several hours after receiving vaccination.  Developed subjective fever as well.
Vasovagal syncope. I awoke at around 2:00 AM to use the bathroom and to get some Tylenol for left arm pain. As I was walking back to my bed I was seeing dark spots in my vision. I was able to reach my couch to lay down before falling to the ground. I have just read the reportable events table and see now that I am able to report this event; I would have reported it sooner if I was aware; also reporting it as my job; as a registered nurse, is in jeopardy. My doctor will not write me an exempt form for the second dose because I am well at this time. I do not feel safe getting the second dose and hope you may help me come to a conclusion or some documentation where I can be exempt from the second dose and keep caring for patients in the hospital. I was caring for patients throughout the COVID-19 pandemic and was safe enough to never get it prior to getting vaccinated as I did not have any antibodies for Covid-19. You may reach me. I look forward to speaking to someone about this if possible. Thank you.
Reactivation of  alteration of taste similar to that which happened during Covid infection 8 mos earlier