chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a healthcare worker regarding unspecified number of patients of unknown age and gender. There was no information on patients pertinent medical history and drug reactions or allergies. The healthcare worker reported that an unspecified number of patients received unspecified doses of improperly stored COMVAX, product batch/lot# reported as J009691, expiry date reported as 29-DEC-2015. No adverse effects were reported. There was no product qualtity complaint involved. The outcome of the events were unknown. This is one of the several reports from the same source.
patient developed hives under one eye in the immediate hours after vaccine.  His symptoms resolved with one dose of zyrtec.
Redness, warm to touch, slight edema. Ice packs, ibuprofen, RTO in 2 wks per dr.
Red spots/patches on my legs, face, head, arms and hand including  knots all over my face, head,  neck, front,  back, top and both sides.  These knots average from small to large and are very uncomfortable.  My bottom lip is severely swollen.  Headaches.  Please help!!!!
PNEUMOVAX administered at 2:00 p.m. by 4:15 p.m. same date, pulse dropped from 80 to 48 and SpO2/pulse ox dropped from 100% to 86%. Non-productive cough and crackles lung sounds were noted. Resident c/o, "just not feeling well". Squad to Emergency Room immediately.
Hives and jitteriness reported that evening after receiving vaccine (4-5 hours later).
afternoon 5JAN94 pt very irritable, fever 102 x 2 R, thigh swollen inc fifty cent piece, mom called MD on call, gave pt warm bath resulting in dec swelling & dec irritability, APAP given q 4 hrs;
This case was reported in a literature article and described the occurrence of anaphylaxis in a 36-year-old female subject who received Flu seasonal TIV Dresden. This case refers to patient 10 in the literature article. Historical conditions included contact dermatitis and allergic rhinitis. On an unknown date, 3 hrs after receiving Flu seasonal TIV Dresden and dTpa vaccine, the subject developed anaphylaxis. Serious criteria included GSK medically significant and life threatening. Additional event(s) included angioedema with serious criteria of GSK medically significant, choking with serious criteria of GSK medically significant, cough and nausea. The subject was treated with antihistamine and Steroid (Unspecified). The outcome of anaphylaxis was recovered/resolved. The outcome(s) of the additional event(s) included angioedema (recovered/resolved), choking (recovered/resolved), cough (recovered/resolved) and nausea (recovered/resolved). The investigator considered that there was a reasonable possibility that the anaphylaxis, angioedema, choking, cough and nausea may have been caused by Flu seasonal TIV Dresden and dTpa vaccine. Relevant Tests: Lab test performed on unknown date Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Heart rate result was increased unknown. Additional information was provided: This case was reported in a literature article and it described the occurrence of a vaccine-triggered anaphylaxis in a 36-year-old female patient who had received an unspecified Tdap vaccine (manufacturer unknown) and an unspecified trivalent influenza vaccine (manufacturer unknown). The patient was a female. The subject's medical history included atopic disease with contact dermatitis and allergic rhinitis. No further information on the patient's concurrent medical conditions, medical or family history, or concomitant medication was provided. On an unspecified date, between the 1st of January 2009 and the 31st of December 2011, the patient received an unspecified dose of an unspecified Tdap and an unspecified trivalent influenza vaccine (dosages unknown; administration routes and sites unspecified; batch numbers not provided). On an unspecified date, 3 hours after the vaccination, the patient developed angioedema, "choking" cough, heart rate increased and nausea. This was classified as anaphylaxis by the urgent care doctor. According to the authors the case was considered as Brighton level 2 and setting of initial evaluation was clinic. The patient was treated by oral antihistamine, oral steroid and cool compress. At the time of reporting the outcome of the events was recovered. This event was classified as vaccine related according to the authors. The authors concluded that "Anaphylaxis after vaccination is rare in all age groups. Despite its rarity, anaphylaxis is a potentially life-threatening medical emergency that vaccine providers need to be prepared to treat. This case is 1 of the 28 valid cases reported in the same literature article.
Per mom sore arm x 2 days - had flu vaccine 10/6/15 - started running low grade fever 10/11/15, vomited, headache, dizzy, disoriented. On the 13th breathing fast and heavy - called 911. EMS came, checked her out and appeared to be ok. Still running low grade fever. Seems to be feeling better. Mom just wanted us to know - states was wondering if anyone else called with those complaints - states she may just have virus. Advised to see PMD for further eval.
In early April of 2007 I was given the Pneumovax vaccine because I had contracted pneumonia earlier in the year. As you know, starting in the latter part of April, I began to have various symptoms (tingling and numbness which started in the extremities and then moved on to include the torso and head, weakness - especially in the knees and general fatigue). You are also aware that we did do numerous tests including MRI scan and bloodwork, all of which came back negative. These symptoms persisted from the end of April until the present time, gradually diminishing. (I think the symptoms are diminishing because I have implemented a wellness program of more exercise, acupuncture treatments and a detox program) I am feeling MUCH better since I began this regimen, although the symptoms are not yet completely gone, I believe I will return to my former excellent health. I truly believe these symptoms were connected to the Pneumovax shot. I went online and found two web sites which deal with the Pneumovax vaccine. Both of these websites begin by saying there is little risk with this vaccine, HOWEVER, if your scroll down to the "Adverse Reactions" there is a list of reactions recorded in clinical test. Four of those symptoms exactly coincide with mine! I have attached the printout for your information. I am basically writing this letter just to make you aware of the possible risks of this vaccine. I never had a reaction like this to any other immunization in my life. Perhaps you can contact the manufacturer of the vaccine and report my experience, or at least forward this letter to them. I also feel that the manufacturer should reimburse me for the cost of the immunization because I have incurred great medical testing costs in trying to diagnose these symptoms. I hope that you will take the time to consider this information.
her arm is still sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (her arm is still sore) 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 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (her arm is still sore). At the time of the report, PAIN IN EXTREMITY (her arm is still sore) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Injection site swollen baseball size.  Site became red and hot.  Symptoms lasted about 1.5 weeks after onset.
Post vax, the pt experienced left leg pain, weakness in the toes, and numbness above the knee.
Day after vaccine, left deltoid became red and swollen.  Tender and warm to touch.  Over the next several days signs and symptoms progressively worsened down arm to elbow area.  On 1/14/09, client saw PMD.  Signs and symptoms continued through 1/15/09.  C/O slight itching of arm, denies numbness.  C/O lymph nodes in groin tender.  Dr. prescribed prednisone 5 mg X 4 days, cipro 500 mg bid X 4 days, cool/warm compresses.
Arm was very sore for about five days, started itching around day 3; noticed redness day 5; day 8 felt that it was raised and "hard"; day 10 looked in mirror and saw the defined circle, applied steroidal ointment for itchiness; looked on internet for Moderna vaccine reactions, read article that led me here. I'm not freaked out, but will get second injection in other arm; decided to make a report.
This case was reported by a consumer via call center representative and described the occurrence of ophthalmic herpes zoster in a female patient who received SHINGRIX for prophylaxis. On 30th August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, less than a day after receiving SHINGRIX, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant), herpes dermatitis, tingling and headache. On an unknown date, the outcome of the ophthalmic herpes zoster, herpes dermatitis, tingling and headache were unknown. It was unknown if the reporter considered the ophthalmic herpes zoster, herpes dermatitis, tingling and headache to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had shingles on the right side of her face, eye, forehead, with pain in her head also. Approximately 12 to 14 hours after the vaccination, the patient began having the same pain, tingling that had back then. On the date of reporting, the patient still had the tingling. The patient was aksing whether this was normal.
No symptoms at time of shot A week later started to feel a lump and itchy and felt and looked like mosquito bite. Next day the redness and circle is getting larger and heat coming from it.
Around 7pm - coughing started; 9-9:30p pain in BLE; 10/16/12 1-2am pain in BUE, chest tightness, headache, and dizziness; 3:30am went to adult emergency dept (blood work, EKG/heart monitoring, urine and ultrasound of BLE completed).
With 12 hours I began running a low grade fever.  Sore arm.  Swelling of lymoh node under keft arm and keft side of neck.  I ran a fever from about 24 hours post vaccination for 48 (102.4).  Continued with swollen and painful lymph nodes, nausea, and muscle aches.  Muscle aches were not quite as bad as those with influenza.  Tiredness-slept about 18-20 hours each of the first two days.  At 48 hours or a bit later, fever dropped to 101.4 and finally stopped at about 72 hours.  I did not return to work until I had been w/o fever for 12+ hours.  Still neefed extra sleep but a 2 hour nap sufficed on day three.  The worst of it was the swollen gland in armpit and the fever.
Mental cloudiness; Moderate body aches; Persistent headache; Low grade fever (99-100F); Chills; Significant pain/discomfortant at the injection site; Slight pain/discomfort at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Mental cloudiness), PAIN (Moderate body aches), HEADACHE (Persistent headache), PYREXIA (Low grade fever (99-100F)) and CHILLS (Chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Dec-2020, the patient experienced VACCINATION SITE PAIN (Slight pain/discomfort at the injection site). On 19-Jan-2021, the patient experienced FEELING ABNORMAL (Mental cloudiness), PAIN (Moderate body aches), HEADACHE (Persistent headache), PYREXIA (Low grade fever (99-100F)), CHILLS (Chills) and VACCINATION SITE PAIN (Significant pain/discomfortant at the injection site). On 25-Dec-2020, VACCINATION SITE PAIN (Slight pain/discomfort at the injection site) had resolved. On 21-Jan-2021, FEELING ABNORMAL (Mental cloudiness), PAIN (Moderate body aches), HEADACHE (Persistent headache), PYREXIA (Low grade fever (99-100F)), CHILLS (Chills) and VACCINATION SITE PAIN (Significant pain/discomfortant at the injection site) had resolved.            Concomitant product use was not provided. Treatment information was not provided.
I had vaccination on 10/18/2022. On 10/18/2022 my arm started to swell up and I had a fever for 3-5 days.  I reached out to the nurse advice line on 10/18/2022 and was not given a course of treatment. After 5 days I felt better.
This case was reported by a consumer via call center representative and described the occurrence of shingles in a adult patient who received SHINGRIX for prophylaxis. On 8th December 2018, the patient received the 1st dose of SHINGRIX. On 19th December 2018, 11 days 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 details were reported as follows: The age at vaccination was not reported. The patient had a Shingles eruption on the day before reporting on 19th December 2018. The patient was asking was this a common occurrence, could they expect more outbreaks before or after they get there 2nd shot in two months.
Nausea, she is afraid because she had contact with someone that tested positive, Headache and body aches. Loss of taste, congested.
Patient claims when she woke up the next day, she had broke out on her arms/shoulder around the injection site and a spot below her left eye.  Over the next 2 days, the rash lessened and then went away.
Approximately four hours post vax, pt developed elbow pain and swelling and pain of entire left arm from the shoulder down to the hand.  Pts arm was also hot.
PATIENT WAS FEELING ITCHY AT /AROUND SITE OF INJECTION AND IN THE EVENING HAD LABORED BREATHING .  SHE SAID SHE TOOK  BENADRYL THAT SHE HAD ON HAND AND ALSO SHE  USED ALBUTEROL INHALER - 2 PUFFS AND THAT HELPED HER.
Patient called pharmacy on 9/13/10 and said her arm hurt and painful and she have not seen by Dr.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 06-MAY-2013 the patient was vaccinated with an expired dose of GARDASIL, 0.5 ml, intramuscular (lot # 668261/1397AA, Exp 09-APR-2013). No adverse effect reported. This is one of several reports from the same reporter. Additional information has been requested.
rec'd at 1716, monitored per protocol, discharged at 1731. called vaccination center at 1750 c/o dizziness, possible increased HR. advised to monitor self and report to ED if symptoms continued. verbalized understanding.
pt recvd vax & exp miscarriage sometime p/2nd dose of vax; pt was seen by a MD; no further details are available @ this time;
Severe arm pain, feeling of strong bruising, sensitive to the touch, and interfering with sleep, for 2.5 days. Then general soreness for 2 more days. Feeling as though I had too strong a dose.
Shingles outbreak; This case was reported by a consumer and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 5 days after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   The reporter considered the shingles to be unrelated to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination were not reported. The patient reported a shingles outbreak five days after getting the vaccine for the same.  The patient's MD (physician), believed it was unrelated and patient's friends who had MD's said the same, along with nurses. But the patient thought it was curious and wanted to report it. The reporter also asked to advise of the proper agency. Consent to follow up granted.
COVID 19 Treatment; COVID 19 Treatment; Moderna Feb2023; Pfizer Jul2022; Jansen Jul2020; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Nov2021 as dose 2, single (Batch/Lot number: unknown), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and in Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), in Feb2023 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (COVID-19 VACCINE JANSSEN), in Jul2020 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "penicillin" (unspecified if ongoing), notes: Known allergies: penicillin. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset Nov2021, outcome "unknown", described as "Moderna Feb2023; Pfizer Jul2022; Jansen Jul2020"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (11Mar2023) Negative; (15Mar2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient was treated with Paxlovid for covid-19 from 04Mar2023 to 09Mar2023. Became very ill Friday 03Mar2023, got Paxlovid on 4th - started p.m. Finished 9th in a.m. Tested negative the 11th Felt ill 14th p.m. tested positive for Covid a.m. 15Mar2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Skin rash with bubbles (looks like eczema) on left arm, left chest, and left back
7 days after the first dose, I developed hives around the vaccination site. It was erythematous and tender to palpation. 24 hours later, the hives had resolved, but the erythema and tenderness persisted. By 48 hours, there were petechiae that had developed as well, but the erythema did not progress beyond the marked border from the previous days. Symptoms slowly resolved over the next 5 days (total 7 days).
Fever 100.5; chills; joint pain; nausea; headache; tachycardia; shortness of breath; dizziness; pain & swelling at injection site and up my neck; pain & swelling at injection site and up my neck; worst patient have ever felt, felt like body had been poisoned; This is a spontaneous report from a contactable nurse (patient). A 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1686 and expiry date: unknown), via an unspecified route of administration on the left arm on 09Jan2021 at a single dose for COVID-19 immunization. Medical history included heart disease, diabetes and allergies to sulfa antibiotics. Patient's concomitant medications were not reported. The patient received the first dose on 21Dec2020 (lot number: EH9899) on the left arm. The patient experienced fever 100.5, chills, joint pain, nausea, headache, tachycardia, shortness of breath, dizziness, chills, pain & swelling at injection site and up my neck, inability to lift even a water bottle without having pain on 10Jan2021. In summary it was the worst patient have ever felt, felt like body had been poisoned. Outcome of the events was recovering. No treatment was given for the events. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.  No follow up attempts are possible. No further information is expected.
tested positive; tested positive; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 01Dec2021 as dose 3 (booster), single (Lot number: 33030BD) at the age of 52 years, in left arm for covid-19 immunisation; COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Overweight" (unspecified if ongoing). There were no concomitant medications. The following information was reported: COVID-19 (medically significant) with onset 27Apr2022, outcome "not recovered", DRUG INEFFECTIVE (medically significant) with onset 27Apr2022, outcome "unknown" and all described as "tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Apr2022) positive; (02May2022) negative, notes: a rapid in home test; (06May2022) negative, notes: a rapid in home test; (07May2022) positive. Therapeutic measures were taken as a result of covid-19. COVID 19 Treatment included Paxlovid from 27Apr2022 to 02May2022.  Clinical course: No known allergies reported. The patient received no other medications in 2 weeks. Patient had tested positive on 27Apr and took the 5 days of Paxlovid and felt no symptoms upon completion. On his last day of taking Paxlovid 02May, he was tested negative with a rapid in home test. 3 days later on 05May he began experiencing minor symptoms (cough, runny nose). On 06May the symptoms worsened and he took a rapid in home test which was negative. On 07May the cough was much worse and he tested positive.  No follow-up attempts are possible. No further information is expected.
Patient had an inflamed and painful lymph node on the left side on the neck the day after the vaccine.
The pharmacist pulled the box of vials out of a styrofoam cooler on the counter; This non-serious case was reported by a consumer and described the occurrence of incorrect storage of drug in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced incorrect storage of drug (Verbatim: The pharmacist pulled the box of vials out of a styrofoam cooler on the counter). The outcome of the incorrect storage of drug was unknown.  Additional Information: GSK Receipt Date: 16-OCT-2023 The reporter went on Sunday to inquire about GSK RSV vaccine. The reporter wanted to make sure they had GSK's and not Pfizer's. The pharmacist pulled the box of vials out of a styrofoam cooler on the counter, which led to incorrect storage of drug. The reporter asked, shouldn't it be stored in a freezer or refrigerator. They were not actively unpacking it.  The reporter just wanted to let GSK know.
Pt had a syncopal event. Vitals:123/82,92,16, O2 Sat 100% When sitting, pt denies dizziness. 14:05 108/68,78,18,100% no unusual symptoms or sensation. 14:10 c/o of having slight dizziness.  Pt remains sitting in bed 123/72,106,18,100% 14:17 122/74,99,18, 100%.  Claims HA is almost gone. Pt stable and released from vaccination site to home w/ husband
Wrong Dose - Pediatric Dose Administered to 12 year old - No adverse reaction
Vaccine administered was given 4 day beyond use date. Contacted patient to inform her and see if she had any adverse reaction. Patient reports having no issues or concerns.
Information has been received from an 84 year old male with allergies to penicillin and kidney dye and a history of Shingles about 6 months ago who on approximately 22-JUL-2008 (a week ago) was vaccinated with a dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included vitamins and eye drops. A couple days ago, the patient experienced bleeding from his rectum. Subsequently, the patient recovered. The patient did not seek medical attention. Additional information has been requested.