chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient reported swelling, redness, and itching at and around the site of injection on left arm. She reported some improvement in symptoms on 9/28/2014, but still has some swelling, redness, and itching. She will report back to the pharmacy and her doctor if symptoms don't improve.
Developed rash on abdomen 1st day post vaccination. Not itchy. Then developed rash on trunk and legs. No injection site rash or reaction. Went to tanning bed day after vaccination.
Information has been received from a registered pharmacist concerning a patient with no drug reactions or allergies who on 17-MAR-2011 was vaccinated with a dose of 0.5 milliliters of MMR II intramuscularly (lot number not provided). The patient experienced pain at injection site. Laboratory diagnostics studies were not performed. No treatment for the adverse event was given. The patient did not seek medical attention. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
This spontaneous report as received from a currently 26-year-old female patient who was reporting on herself. The patient did not have any pertinent medical history, drug reactions or allergies and was not taking any concomitant medications. On an unknown date (reported as "maybe when she was 13 years old"), the patient was vaccinated with the first dose of either GARDASIL 9 or GARDASIL (could not be confirmed which one) in the right arm (dose, route of administration, lot number and expiration date not provided). On an unknown date, after receiving the first dose of the vaccine, the patient developed an allergic reaction, she experienced itchiness on her arm and then developed hives hours later. The patient recovered on an unknown date after the first dose. Then after receiving the second dose of the vaccine, on an unspecified date, the patient developed the same side effects but "only way worse". Her symptoms were so bad that she had to take "a ton of BENDARYL to recover". Her physician stated that it was not recommended to take the third dose of the vaccine. The outcome of the events was reported as recovered. The reporter considered the events to be related to suspect therapy. This is one of two reports referring to the same patient. Sender's Comments: US-009507513-1709USA011119.
Itchy, red, raised patch on arm around injection site.  Approx 3 inches x 2 inches.     Took one Benadryl after appearance, took two Benadryl the following evening.   Red area was also hot to he touch.
get pain when raising arm or squeezing hand; Fatigued; initial arm pain that went away/ arm pain that came on 4 or 5 days after injection and is persistent; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (initial arm pain that went away/ arm pain that came on 4 or 5 days after injection and is persistent), MYALGIA (get pain when raising arm or squeezing hand) and FATIGUE (Fatigued) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, the patient experienced PAIN IN EXTREMITY (initial arm pain that went away/ arm pain that came on 4 or 5 days after injection and is persistent). On 22-May-2021, the patient experienced MYALGIA (get pain when raising arm or squeezing hand) and FATIGUE (Fatigued). The patient was treated with IBUPROFEN at an unspecified dose and frequency and ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. On 19-May-2021, PAIN IN EXTREMITY (initial arm pain that went away/ arm pain that came on 4 or 5 days after injection and is persistent) had resolved. At the time of the report, MYALGIA (get pain when raising arm or squeezing hand) and FATIGUE (Fatigued) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.
Nothing could stay down (she was throwing up); 1st dose Date Received 07 Jan 2021 2nd dose Date Received: 29JAN2021; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Nothing could stay down (she was throwing up)) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose Date Received 07 Jan 2021 2nd dose Date Received: 29JAN2021) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 025L20A) for COVID-19 vaccination.     Concomitant products included TELMISARTAN (MICARDIS) for Blood pressure management.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose Date Received 07 Jan 2021 2nd dose Date Received: 29JAN2021). On an unknown date, the patient experienced VOMITING (Nothing could stay down (she was throwing up)). At the time of the report, VOMITING (Nothing could stay down (she was throwing up)) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose Date Received 07 Jan 2021 2nd dose Date Received: 29JAN2021) outcome was unknown.            Patient Current condition included Blood pressure, takes Micardis 80/20 but has not taken it for almost 2 months. No any treatment medications were reported.   This case was linked to MOD-2022-493750, MOD-2022-493510 (Patient Link).
Patient presented to the ED and was subsequently hospitalized within six weeks of receiving Covid-19 booster. Patient hospitalized for TIA.
Outbreak of Shingles after receiving the first dose; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter consented to follow up.
Herpes zoster diagnosis in a two-dose varicella vaccine recipient. Unilateral, one dermatome: inner thigh, left leg. Painful rash, no antiviral treatment. Lasted <4 weeks. No history of varicella.
Swelling & erythema 4 3/4in x 4 3/4in to (L) upper arm/deltoid started 10/22/11, seen in office 10/24/11. Also with area 1 1/2 in x 1 3/4in to (R) upper arm/deltoid. Treatment: cool compresses, oral steroids, ATARAX, TYLENOL.
p/vax pt devel T102; severe diarrhea; red eyes (conjunctivitis symptoms); lasted approx 36hours; seen by MD
headache, flu like, red rash, hives, dizzy, very weak, itchy when the hives start to go away, NOT GOOD!!!
Patiet was given FLUZONE HD on the morning of October 30, 2018. She has gotten flu vaccine in the past with no reactions. This is the first time she has gotten the High Dose. She came back to the pharmacy at 6:15 PM on October 30, 2018 and said she had an allergic reaction. Her left was swollen and red rash about 5 inches down from where the vaccine was given on her left arm (deltoid). It was warm and itchy. I put cold pack on her arm and also gave her 1 dose of BENADRYL 25 mg tablet.
I got my first dose of Moderna at pharmacy just before 8pm last night. Within about 20 mins of getting it my lips, tongue, and nose started to tingle. I knew something was really wrong when we stopped for food and I couldn?t taste the onion ring. Shortly after, my lips and tongue just went numb and my face felt tight. I would get a flutter of my heart racing then a rush of dizziness and felt like I was going out pass out. It was really strange.   The only other time I had felt anything like that is when I was given Vancomycin (even though I have a penicillin allergy) for my leg infection and my throat closed up rapidly.   I had my husband take me to the ER. When I checked in, my blood pressure was high which was unusual. They gave me a Benadryl shot and ran an EKG. EKG showed my heart rate was low but the doctor said since my blood pressure was so high it was probably offsetting it.   Five hours later, a lot of the symptoms had mostly passed and I got to go home. It is the next day and my  tongue still feels a little bit like pins and needles but overall feeling better this morning.
Severe chills; shivering; body aches; headache; Weakness; fatigue; Nausea; This is a spontaneous report received from a non-contactable consumer, the patient. A 43-year-old non pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 25Mar2021 at 13:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included thalassemia. Concomitant medications included cetirizine hydrochloride (ZYRTEC) and ibuprofen (ADVIL); both from unknown date for unspecified indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 04Mar2021 at 13:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation and shrimp on unknown date and experienced an seafood allergy. 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 was not tested for COVID-19. On 26Mar2021 at 02:00, the patient experienced severe chills, shivering, body aches, headache, weakness, fatigue and nausea. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the severe chills, shivering, body aches, headache, weakness, fatigue and nausea was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a 74 year old female with sulfa allergy and allergic to an antibiotics (unspecified) who on 6-JAN-2009 was vaccinated with a dose of ZOSTAVAX (Oka/Merck). On approximately 8-JAN-2009, "about 48 hours" post vaccination, the patient experienced an injection site reaction which included itchiness, redness, swelling and warmth around injection site area which was about 3" x 1" in diameter. The patient did not seek medical attention. Additional information has requested.
received the first and second dose of the Pfizer covid 19 vaccine and then had an as ischemic stroke; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP) from medical information team.  An 85-year-old female patient received BNT162b2 (COMIRNATY), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "auto immune disease" (unspecified if ongoing), notes: Caller stated that there were persons with auto immune disease and still took the shot. The patient's concomitant medications were not reported.  The following information was reported: ISCHAEMIC STROKE (medically significant), outcome "unknown", described as "received the first and second dose of the Pfizer covid 19 vaccine and then had an as ischemic stroke".  Clinical course: Reporter Subtype: Caregiver. Caller stated that she read that the second dose of the Pfizer covid 19 vaccine was stronger, and this could be why the patient had the stroke. Caller stated that she heard that Pfizer and Moderna stopped doing trials on persons in their seventies. Caller asked if there were any specific trials for persons in their eighties. Caller stated she called a year ago. Caller would not provide any demographics. Caller wanted to speak with someone in the lab. Caller wanted to know the data regarding a person in their early eighties that received the first and second dose of the Pfizer covid 19 vaccine and then had an as ischemic stroke and then got the booster. Caller wanted to know if there was any data on a person that had an ischemic stroke and got the booster and got sick, asking what the adverse reaction was. Caller wanted to know if the vaccine was contraindicated in this person. Caller refused to be sent to RA because she said it would not help and she was not here to help the company. Caller stated the patient would only agree to report to RA if the patient got the information about persons having an ischemic stroke and then getting the booster. Caller stated that it is too bad that Pfizer does not have information about persons that are 65,75 or 85 because they are the ones in danger noting it is too bad that the trials were not done on the age group 80 and older. Caller stated this age group was the age group that needs the vaccine the most. Caller stated that there were persons with auto immune disease and still took the shot. Caller stated she was at ground zero because Pfizer did not have any specific information. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "She got a Booster Vaccine yesterday and she is having fever up to 103.9 and it is 103.5 right now after taking Tylenol". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The reporter was Consumer or other non health professional. Dates for She got a Booster Vaccine yesterday and she is having fever up to 103.9 and it is 103.5 right now after taking Tylenol: (From: Unspecified To: Unspecified).The reporter had COVID-19 Vaccine a Pfizer product. The COVID-19 Vaccine and Tylenol a Pfizer product manufacturer , NDC , UPC number and Expiry date were unknown. The reporter was asked When probed for the concern, reporter stated, "So, my "cousin" (further not clarified), she (consumer) got a Booster (Pfizer, COVID-19 Vaccine) yesterday and she has been having fever of up to 103.9. When paraphrased to confirm the concern, reporter stated, "Yes, so she is having fever and the fever is up to 103.9 and it's 103.5 right now after taking Tylenol (Tylenol captured as suspect conservatively)". (Tylenol Manufacturer further not clarified hence left unchecked in the tab). The Reporter was informed about Pfizer Medical Information Department and provided contact. The Reporter stated, "Are they (MI Department) still open right now. The Reporter was provided with the number of Pfizer Medical Information and was requested to select option 3 and timings as 8 am to 9 pm from Monday to Friday as per (EST). In response to MI timing, reporter stated, "Then what can I do now and Reporter was informed to contact nearest Emergency care and did not meet only had Healthcare card. The reporter asked Reporter type was not available over the call, hence reporter type was captured as consumer or non-healthcare professional by default. Follow-up (15Mar2022): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
2 inch x 1.5 inch erythematous, mildly tender papule, (L) anterior thigh. BENADRYL given in office. No urticaria. No anaphylactoid rxn. Mom reports area worsened 1/25/14, taken to urgent care center, given 3 day supply KEFLEX -> much improved. Mom still giving BENADRYL.
Vaccinated Spikevax- MOD 100mcg 11/22/2021, 02/22/2021, 01/25/2021. Asymptomatic positive for COVID-19. Hospitalization 2/22/22.
This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. This pharmacist reported similar events for 2 patients. This is the 1st of 2 reports. An over 65 years old male patient of unspecified race/ethnicity received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at 0.5 ml single, for immunisation. The patient's medical history and concomitant medications were not reported. A couple weeks later the patient came into the store and said that experienced arm soreness around injection site on an unspecified date with outcome of recovered. Sender's Comments: Linked Report(s) : US-PFIZER INC-2017052155 Same reporter/drug/event different patient.
Pneumonia vaccine and arm swollen and red at the site , warm to the touch and distant red spots by the site as well. Soreness at site I have pics of my arm , this site will not let me upload them
At midnight I began feeling like something was wrong but wasn't sure what. Checked blood which was 444. I tried to write a note at 0057 and was unable to. Went to ER and was worked up for a stroke.
Late day 4 into Day 5, severe underarm pain with visibly and tender to the touch lymph nodes, making it hard to lift arm. No treatment. Went away 1.5 wk later  2 to 3 wks extreme vertigo with nausea and, less hearing in right ear ? out of work 1.5 wks, rest, prescribed 6 day methylpredisolone pack and Meclizine
Fine rash around sit ot tight deltoid. Pt reported short loss of breath all day attended school didn't visit school nurse. Called health department at 1500, referred for shortness of breath. Possibly allergic reaction. Treated 10/23/2001 with Decadrom IM and Preventil. Nebulizer treatment. Sent home with Prednisane pack and Proventil Inhaler.
affected my hair/it lost a huge bunch of the hair/ doctor is stating alopecia, 1% of hair left, completely lost her hair within three weeks; everything is gone, like 99.9% including eyebrows, bold; CRP that was elevated; Body aches; Fever 99.4F; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ALOPECIA (affected my hair/it lost a huge bunch of the hair/ doctor is stating alopecia, 1% of hair left, completely lost her hair within three weeks), MADAROSIS (everything is gone, like 99.9% including eyebrows, bold), C-REACTIVE PROTEIN INCREASED (CRP that was elevated), MYALGIA (Body aches) and PYREXIA (Fever 99.4F) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unavailable at the time) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On an unknown date, the patient experienced ALOPECIA (affected my hair/it lost a huge bunch of the hair/ doctor is stating alopecia, 1% of hair left, completely lost her hair within three weeks), MADAROSIS (everything is gone, like 99.9% including eyebrows, bold), C-REACTIVE PROTEIN INCREASED (CRP that was elevated), MYALGIA (Body aches) and PYREXIA (Fever 99.4F). At the time of the report, ALOPECIA (affected my hair/it lost a huge bunch of the hair/ doctor is stating alopecia, 1% of hair left, completely lost her hair within three weeks), MADAROSIS (everything is gone, like 99.9% including eyebrows, bold), C-REACTIVE PROTEIN INCREASED (CRP that was elevated), MYALGIA (Body aches) and PYREXIA (Fever 99.4F) had not resolved.            no concomitant medications and treatment details reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-100832 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Significant follow up, new ADR and reporter email address were updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-100832:First Dose Case
This spontaneous report was received from a physician refers to a 20 year old female patient. On 07-JUL-2011 the patient was vaccinated with dose 1, standard 0.5 milliliter (ml) GARDASIL (lot# 1561z, expiration date 23-MAR-2013). On 02-APR-2013, the patient was vaccinated with dose 2 0.5 milliliters (ml) GARDASIL (lot# H015555, 13-APR-2015) intramuscular. No adverse effects reported. Additional information has been requested.
Eyes were like bananas; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EYE DISORDER (Eyes were like bananas) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) and AMLODIPINE for an unknown indication.   On 29-Apr-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EYE DISORDER (Eyes were like bananas). On 02-May-2021, EYE DISORDER (Eyes were like bananas) had resolved.            Treatment information use unknown
injection site was sore; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th November 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left arm. After the first dose of the Shingrix vaccine the injection site was sore. The reporter did not consent to follow up. For tolerance of 2nd dose refer case US2020053227.
My COVID-19 symptoms started on 01/02/2023 at noon. I had a high fever of 103.00, chills, body aches, loss of appetite, head congestions, weakness and fatigue. I tested positive with a home COVID-19 test on 01/04/2023. I called my doctor's office on 01/04/2023 she prescribed me with PAXLOVID for 5 days. I started taking the medication on 01/05/2023. I still have lingering fatigue.
Information has been received from a registered nurse concerning a patient of unknown age and gender. Patient's pertinent medical history, drug reactions or allergies were not reported. On 07-JAN-2016, the patient received an improperly stored dose of PROQUAD (Merck) with the lot # L032761, expiration date 24-FEB-2017 and albumin status therapy type as rHA (dose, route and anatomical location of administration were not reported). The condition storage was 7F for 10 minutes. There was previous temperature excursion with 8F for 40 minutes and 18.2 F for 5 minutes. No concomitant therapy was provided. No adverse effects or reactions to this vaccine were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.