chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effects reported. No additional AE/No PQC; HCP called to report a TE with GARDASIL 9. Stored out of range and administered; This spontaneous report was received from a physician referring to a male patient of an unknown age and race.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 24-MAR-2023, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, 0.5 mL (lot # W009829, expiration date: 19-OCT-2024), administered as prophylaxis (strength, anatomical location, and route of administration were not provided), and which had a temperature excursion as it was stored out of range (product storage error). Nonetheless, no adverse effects were reported (no adverse event).
Pain in left calf (August 7) after Janssen vaccine (July 19th). But, also in context of COVID-19 positive rapid test (August 8, 2021) with nasal congestion and family members with COVID-19.  DVT evidence: d-dimer > 4,000. Venous ultrasound left calf confirmed DVT.
Patient new to us-seen one before today. He had appointment this morning-given PNEUMOVAX -already had PREVNAR. He presented with severe right shoulder pain 10/10 and vomiting started 3 hours after inj. We ordered Prednisone, Tramadol, Phenergan.
2 weeks after Vaccine had a annoying pain behind the ear and took Excedrin for it. Contacted doctor's office and a week later was scheduled a telehealth appt. After the doctor talked with me, advised to wait and see if it got worse. Also, was advised to take OTC pain relief (Tylenol) A week after that it subsided and to this day did not return.
Patient stated that swelling (localized to the upper arm) and redness (localized to the upper arm) occurred starting the day after the administration of the vaccine and continued lasted 2 days. She took otc ibuprofen to help with the pain.
Moderate headache started 4 days after injection. Then I developed chills (no fever), body aches, fatigue, loss of appetite and I still don?t feel any better. It?s been a VERY difficult 12 days so far
Patient presented to the ED and was subsequently hospitalized for acute visual loss/retinal artery occlusion within 6 weeks of receiving covid vaccination.
This spontaneous case was reported by a consumer and describes the occurrence of MECHANICAL URTICARIA (Dermatographism) and URTICARIA (migratory hives) in a 20-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced MECHANICAL URTICARIA (Dermatographism) and URTICARIA (migratory hives). At the time of the report, MECHANICAL URTICARIA (Dermatographism) and URTICARIA (migratory hives) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No concomitant drug was reported. No Treatment medications were reported. It was reported that reporter read an article on the (National Center Information) website, where a young man in his 20s, experienced dermatographism and migratory hives, after receiving the Moderna vaccine. This case was linked to MOD-2022-593007, MOD-2022-593014 (Patient Link).
Rash to ER 5-5-07 AM, 5-5-07 PM and 5-6-07 AM itchy.
Rapid mole growth in what seemed like overnight. Shave biopsy done on 1/29/21, resulting in melanoma. Wide excision and lymph node removal to remove melanoma. No evidence of melanoma in lymph nodes.
Then why do I always get sick about 3-4 days later?; Initial information was received on 11-Nov-2020 regarding an unsolicited valid serious case received from a consumer or non-health care professional via social media.   This case involves a patient (unknown demographics) who always got sick (illness), after the patient received INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, about 3-4 days later, the patient always got sick (illness) after taking the INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There will be no information available on batch number for this case.
Within 1/2 hour after injection, c/o itching red bumps to left arm.  Within 5 mins after injection c/o inordinate amount of pain.  This site only.  Gave BENADRYL at 5 PM 1/2 dose.  Was gone in AM.  Some tenderness but no swelling or decreased ROM, and no rash.
Two days after receiving the vaccine she complained of swelling, heat, and pain in her left arm pit and side breast area.
Top half of right arm became swollen, red, warm and hard a few hours after pneumococcal injection.
"feeling liquid" at the injection site; This case was reported by a other health professional via sales rep and described the occurrence of injection site blisters in a female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced injection site blisters. On an unknown date, the outcome of the injection site blisters was unknown.   It was unknown if the reporter considered the injection site blisters to be related to Bexsero.  Additional details were reported as follows: The age at vaccination was not reported. Reporter started that the patient received the Bexsero vaccine and experienced feeling liquid at the injection site, which led to injection site blisters. The reporter consented to follow-up.
A zone of papules and pruritis suggestive of shingles; A zone of papules and pruritis suggestive of shingles; A zone of papules and pruritis suggestive of shingles; This is a spontaneous report from a contactable Other HCP. A 72-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6208), via an unspecified route of administration on 13Mar2021 at 10:00 am (at the age of 72-years-old) into Arm Left as a single dose for COVID-19 immunization at clinic. The patient had received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9266), via an unspecified route of administration on 20Feb2021 at 10:00 am into left arm as a single dose for COVID-19 immunization at clinic. Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing Verbatim. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies. On 16Apr2021, the patient experienced A zone of papules and pruritis suggestive of shingles. No treatment was given for the events. The outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a registered nurse refers to a 20 year old female patient. The patient's concurrent condition included allergy to latex. The patient had no pertinent medical history and no concomitant medications. On an unknown date, (also reported as "kid", the patient was vaccinated with M-M-R II (dose, lot #, expiry date, route of administration were not reported). On 04-DEC-2008, the patient had a measles, mumps and rubella titer drawn which resulted "non immune". On 13-JUL-2009, the patient had a second measles, mumps, and rubella titer which results "equivocal". The patient had a third measles, mumps and rubella titer drawn on 21-DEC-2015 which resulted "negative for measles but not mumps and rubella". It was reported that the patient has not received any additional doses of M-M-R II after any of the three titers that were drawn. The outcome of measles antibody negative was reported as not recovered/not resolved. The outcome of rubella negative and mumps antibody tests negative was reported as recovered/resolved on 21-DEC-2015. The relatedness between the events and M-M-R II was not reported. Additional information has been requested.
p/pt recv vax rpt rash; rash on neck, arms, trunk, face; c/o severe itching;
significant hair loss; longer/heavier menstrual cycles; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received second dose of BNT162B2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient received two doses of vaccine and on an unspecified date, the patient experienced significant hair loss and longer/heavier menstrual cycles. The patient would like to know if this is just temporary. The outcome of events was unknown.  Information regarding the lot/batch number has been requested.
INJECTION SITE SORENESS; CHILLS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk and expiry: unknown) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers No concomitant medications were reported.  On 12-MAR-2021, the subject experienced injection site soreness. On 12-MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site soreness, and chills. This report was non-serious.
noticed  rash on entire body  3/22/2021 around 6pm , non pruritic, called pharmacist he recommend taking Benadryl 50mg every 6 hours as needed , rash has improved some , not completely gone away
Patient wrongly was administered the plain Pfizer Vaccine and NOT the bi-valent Pfizer vaccine. Bivalent dose was intended dose (NOT given).
Client presented to vaccination site on 12/05/21. The client reported she received a 1st dose of Pfizer COVID vaccine, LOT#: FF8841 on 11/14/21. Client reported numbness in left arm (same arm where vaccine was administered) 15 minutes after vaccination of 1st dose of Pfizer COVID vaccine. Sensation was intact to palpation. Client described her whole arm felt, ?Gumbyish?. Symptoms lasted 5 minutes and resolved on their own. Client denied any other signs and symptoms of anaphylaxis. Client denied taking any medications for adverse reaction. Client did not follow up with provider. Client has no chronic medical conditions. Client reported having a history of developing a rash after coming in contact with grass. RN submitted a medical consult via text message to clinical project coordinators requesting to proceed with Pfizer COVID vaccine. Per CDC guidance, approval to proceed with Pfizer COVID vaccine was obtained from medical consult team via text message from  clinical project coordinator. Client received Pfizer COVID vaccine, LOT #FF8841 on 12/05/21 at 1748 by the vaccinating nurse. The client did not report any signs or symptoms during 15-minute observation period.  RN educated client on possible adverse reactions and when to seek medical care. Client left vaccination site after 15-minute observation period unassisted and with a steady gait.
This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (PLAQUE PSORIASIS ON BACK, LEGS, ARM AND FOREHEAD AND HAD DARK SPOTS ON STOMACH AND THIGHS/ IT WAS STILL VISIBLE AFTER ONE YEAR OF SKYRIZI TREATMENT) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis. No Medical History information was reported. On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PSORIASIS (PLAQUE PSORIASIS ON BACK, LEGS, ARM AND FOREHEAD AND HAD DARK SPOTS ON STOMACH AND THIGHS/ IT WAS STILL VISIBLE AFTER ONE YEAR OF SKYRIZI TREATMENT). At the time of the report, PSORIASIS (PLAQUE PSORIASIS ON BACK, LEGS, ARM AND FOREHEAD AND HAD DARK SPOTS ON STOMACH AND THIGHS/ IT WAS STILL VISIBLE AFTER ONE YEAR OF SKYRIZI TREATMENT) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.- No concomitant medications information was reported. The patient had developed plaque psoriasis after receiving the Covid vaccine. She was still experiencing psoriasis on her back, legs, arm, and forehead and has dark spots on her stomach and thighs. Plaque psoriasis was 90 percent over the body and in 2022, it was 80 percent. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medications were provided.
The evening of my injection I noticed a red spot on the arm of injection, by morning I had a trail of raised, itchy, patches. Right arm, forearm, right leg on lower thigh and top of knee.
I was doing the dishes at night as usual and all at once I felt off balance and the room started to spin...I had to sit down and it was still spinning...this went on for about 45 seconds. I have never had vertigo prior and don't even remember having dizziness ever in my life. I did have a cup of green tea just prior but I have had green tea before. Of course, I cannot say what caused this, but I can say that it was most unusual and frightening and given the close proximity in time to when I had my dose of Moderna it is possible that it was a side reaction of it. My Dr. said it was of a benign nature, sometimes an ear crystal dislodges and causes dizziness, but that it could have been from the vaccine.
Experience heart severe palpitations the day following the vaccination and extreme pain from shoulder to neck. Six days later I still experience heart palpitations randomly through the day.
Caller stated she had a red line going down from elbow to wrist on opposite arm than was vaccinated on Monday. She stated it is not painful or itchy but did take Benadryl yesterday. She denies any other symptoms. She got vaccine at a Center. No lot number was available at the time of this documentation.
17cm X 9cm area of erythema on left deltoid area. Treated with Tylenol and warm compresses q 3-4h X 2 days. Chief complaint: skin tenderness. Skin has redness, swelling and pain in left upper arm. Assessment: Allergic reaction, new. Treated with Benadryl 50mg, q6, 30 tablets and warm soaks tid
severe pain in her whole arm, where she have to pick up her arm to use it; arm "felt heavy"; This spontaneous report as received from a medical assistant refers to a 70-year-old female patient. The patient had no known allergies. No information regarding the patient's pertinent medical history and concomitant therapies was provided.  On 14-DEC-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) syringe, lot # U018309, expiry date 08-JAN-2023, 0.5 milliliter, intramuscularly in the left arm for prophylaxis (reported as immunization).  In the evening of 14-DEC-2021, after the administration of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), the patient started to experience severe pain in her whole arm, where she had to pick up her arm to use it (pain in extremity), and her arm also "felt heavy" (limb discomfort). No treatment was given for the adverse events. The patient did not seek a medical attention in regards to the events.  The outcome of pain in extremity and limb discomfort was unknown. The relatedness between the events of pain in extremity and limb discomfort and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2112USA010039: US-009507513-2112USA010305: US-009507513-2112USA010181:
8 days post shot - redness, swelling and arm soreness at the injection site. Headache, muscle ache.
Rash was red and spread on / arms and legs being / similar to a bad sunburn; This case was reported by a pharmacist via call center representative and described the occurrence of red rash in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number G4HX3, expiry date 13th May 2022) for prophylaxis.   On 3rd October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 5th October 2020, 2 days after receiving Shingrix, the patient experienced red rash. On 6th October 2020, the outcome of the red rash was recovered/resolved.   It was unknown if the reporter considered the red rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but could be 68 or 69 years. The patient received the 1st dose of Shingrix in left deltoid. The patient developed a rash on 5th October 2020. The rash was red and spread on patient's arms and legs being very similar to a bad sunburn (patient's description), the rash was not itchy and patient had no trouble breathing. The reporter on the day of reporting contacted patient and patient confirmed the rash had cleared. The reporter called to request information for an adverse event and safety of a second dose for the patient  The reporter consented to follow up..
Believes that the syringe was not filled with any solution at the time of administration; A Spontaneous report was received from a consumer concerning a female patient (age not provided) who received Moderna (mRNA-1273) vaccine and believed that the syringe was not filled with any solution at the time of administration (vaccine underdose)  The patient's medical history was not provided. No relevant concomitant medications was known.   On 26-Jan-2020, the patient received their second of two planned doses of mRNA-1273 (Batch number: unknown) via unknown route, for prophylaxis of Covid-19 infection.   The reporter stated that both of them have received the second dose and believed that his wife did not receive the full second dose ( believed that the syringe was not filled with any solution at the time of administration).  Lab data was not provided.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was unknown.  The outcome of event was unknown.; Reporter's Comments: This report refers to a case of underdose for mRNA-1273 with no associated AEs.
Body ache; fatigue; Weakness; Abdominal noises; Sick to her stomach/super sick stomach; Not feeling good; awful stomach ache; could not eat/she can't eat; This is a spontaneous report from a contactable consumer reporting for herself. A 49-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EL1284), via an unspecified route of administration, on 30Dec2020, at single dose, for COVID-19 immunisation. Medical history included ongoing overweight. Concomitant medications were not reported. The patient experienced sick to her stomach/super sick stomach on 03Jan2021 with outcome of unknown, not feeling good on 03Jan2021 with outcome of unknown, awful stomach ache on 03Jan2021 with outcome of unknown, could not eat/she can't eat on 03Jan2021 with outcome of unknown, body ache on 07Jan2021 with outcome of unknown, fatigue on 07Jan2021 with outcome of unknown, weakness on 07Jan2021 with outcome of unknown, abdominal noises on 07Jan2021 with outcome of unknown. The patient underwent lab tests and procedures which included COVID-19 virus test: unknown on 05Jan2021. Therapeutic measures were taken as a result of sick to her stomach/super sick stomach (nausea) and included treatment with Pepto-Bismol.
This medically confirmed spontaneous report (initial receipt: 26-Feb-2016) concerns a 34 year-old male patient. On 22-Sep-2015, the patient received AFLURIA (batch number U55406: expiry date: 30-Jun-2016 yet reported as 12-Jun-2016) 0.5 mL via the intramuscular route. The AFLURIA vaccine was stored at 0.6 to 1.1 degrees Celsius (reported as 33-34 degrees Fahrenheit) multiple times. The last excursion was 0 degrees Celsius (reported as 32 degrees Fahrenheit) for no more than 24 hours. The outcome was not reported.
temp elevation up to 102.7R which came down w/APAP but then re-elevated-lasted approx x 24hr;induration size quarter then devel & pt to MD 13MAY97;essentially but lump size pea persists;
5:15 @ emergency BP high;6:00 given cortisone & sudafed;rt arm swelling & unmovable;throat swelling & tight;eye dilated;
Cellulitis; Upset stomach; Mild muscle aches; Fatigue; A spontaneous report was received from a consumer concerning a male patient, who was also the patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced mild muscle aches, fatigue, cellulitis, and upset stomach.  The patient's medical history was not provided.  Concomitant medications were not reported.  On 26 Dec 2020, the patient received their first of two planned doses of mRNA-1273 for the prophylaxis of COVID-19 infection.  On 27 Dec 2020, the patient experienced mild muscle aches felt fatigued for a few days.  One week later, the injection site was red, swollen, hot to the touch and looked like cellulitis.  The redness grew significantly, and he also had an upset stomach.  The symptoms resolved.  Treatment information was not provided.  Action taken for the event was not reported.  The events, mild muscle aches, fatigue, cellulitis, and upset stomach, were considered recovered/resolved on an unknown date.; Reporter's Comments: This case concerns a male patient, who experienced the serious unexpected events of cellulitis, a non-serious unexpected event of abdominal discomfort and non-serious expected event of myalgia and fatigue. The event of myalgia and fatigue occurred after 2 days after the first dose of mRNA-1273 (Lot# unknown). The date of onset for cellulitis and abdominal discomfort was not provided. The treatment details were not provided. Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Vaccine stored incorrectly at -20 Celsius. No valid vaccine administered-no adverse effects
Case number PHEH2016US023776, is an initial spontaneous report received from a medical assistant on 14 Sep 2016. This report refers to a 61 years old male patient. Past medical history and concomitant medications were not reported. He was vaccinated with one single dose of FLUVIRIN (batch number: 1514801 and expiry date; May 2016) at a dose of 0.5 ml, intramuscularly on 14 Sep 2016. On 14 Sep 2016, 8 patients have received expired FLUVIRIN vaccine from last year over several days. No adverse event was reported following this medication error (expired product administered). The case was assessed as non-serious by the medical assistant.