chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Started 1 minute after vaccination. Started with nausea and chest pain and tingling in vaccinated arm down to hands/fingers. Swelling at injection site. Then started to feel hot/sweaty. Swelling occurred in bilateral arms and fingers and weakness in the legs. No breathing issues but then reported swelling of lips and tongue. Gave 50mg Benadryl. Called EMS with consent
This spontaneous report as received from a pharmacist and a health care student refers to a 60 year old male patient with no drug allergies. Patient's pertinent medical history was none. On 04-OCT-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # J002865, expiry date was 07-JUN-2014) 0.65 milliliter (ml), subcutaneously. Approximately on an unknown date in 2013 (reported as in the last 4 weeks) the patient also received influenza virus vaccine (manufacturer unknown) (Lot number, expiry date, route and dose were not reported). No concomitant medications were reported. Approximately on an unknown date in October 2013, the patient's arm was red, swollen, had hyperthermia/heat and was tender. Patient sought medical attention (saw the pharmacist). No lab diagnostic studies were performed. Patient had received no treatment as yet. The pharmacist inquired regarding the route of vaccine administration that it was not correspondent with proper administration guidelines. The vaccine was directed to be given subcutaneous and the pharmacist asked if the shot should be given in the deltoid area where one would give an IM (intramuscular). The outcome of the event arm was red, swollen, had hyperthermia/heat and was tender was unknown. A similar reaction with ZOSTAVAX was reported for the same lot number (MARRS #1310USA003246). Additional information has been requested.
big red and hot welt at the injection site; big red and hot welt at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (big red and hot welt at the injection site) and VACCINATION SITE ERYTHEMA (big red and hot welt at the injection site) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Overweight.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, 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 experienced VACCINATION SITE WARMTH (big red and hot welt at the injection site) and VACCINATION SITE ERYTHEMA (big red and hot welt at the injection site). At the time of the report, VACCINATION SITE WARMTH (big red and hot welt at the injection site) and VACCINATION SITE ERYTHEMA (big red and hot welt at the injection site) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment medications were not provided by the reporter. Patient state that they have lupus but didn't mention which type of Lupus as current condition. Patient 1 is schedule to get a Moderna booster today and wonders if it authorized yet and whether it would be a full dose or half a dose   This case was linked to MOD-2021-358543 (Patient Link).
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 14-MAY-2012, the patient was inoculated with the ZOSTAVAX (lot number, dosage, and route of administration not provided), for routine adult health maintenance and the intended purpose of the long-term prevention of shingles and zoster-related injuries. The ZOSTAVAX did not prevent shingles or zoster-related injuries as intended. On or about 06-AUG-2015, the patient was treated for herpes zoster. The patient was prescribed gabapentin for management of her painful symptoms and chronic pain. On or about 16-JUL-2015, the patient was treated and was diagnosed with postherpetic neuralgia. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles and zoster-related injuries, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
This spontaneous report as received from a licensed practical nurse refers to a 12 year old patient. The patient's medical history, concurrent condition and concomitant medications were not reported. On an unknown recent date, the patient was vaccinated with a dose of PROQUAD (lot # and expiry date were not reported) for prophylaxis (drug administered to patient of inappropriate age). No adverse effects were reported in the patient. No other information was available.
not feeling well/general malaise/feeling sick; feeling really bad; a bad headache; feeling sick and nauseated/nausea; worried it will not go away; frustrated; This is a spontaneous report received from a contactable consumer (patient). A 76-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ELI283, expiry date unknown), via an unspecified route of administration in the right arm, on 11Jan2021, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported she had her first vaccine on 11Jan2021. On 19Jan2021, the patient was feeling really bad, had a bad headache, general malaise and was feeling sick and nauseated. She was not feeling well and has not been feeling well the last 3 days. She thought the side effect would be right after getting the vaccine however hers started on 19Jan2021 (2 days ago). She stated she had an awful headache which she still has and had nausea. She wanted to know if it was normal to have happened this far away from receiving the vaccine, this amount of time from the vaccine. The patient reported that she is not quite as bad now, but she still feels it. The patient was worried it will not go away (Jan2021). The patient became frustrated and stated that she was just trying to find out if what she was feeling was normal. The patient also thought she had COVID and took a test in Jan2021 but she did not have COVID (negative). The outcome of the events "not feeling well/general malaise/feeling sick", "feeling really bad", "a bad headache" and "feeling sick and nauseated/nausea" was recovering; and the outcome of "worried it will not go away" and "frustrated" was unknown.
Dizziness; Weakness; Mild headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), ASTHENIA (Weakness), HEADACHE (Mild headache) and FATIGUE (Fatigue) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced DIZZINESS (Dizziness), ASTHENIA (Weakness), HEADACHE (Mild headache) and FATIGUE (Fatigue). At the time of the report, DIZZINESS (Dizziness), ASTHENIA (Weakness), HEADACHE (Mild headache) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
stated that PENTACEL was mixed with the solution part of the ACT-HIB and was administered incorrectly with no reported adverse event; stated that PENTACEL was mixed with the solution part of the ACT-HIB and was administered incorrectly with no reported adverse event; Initial information received on 19-Oct-2023 regarding an unsolicited valid non-serious case received via nurse.  This case involves a 1-year-old female patient and the reporter stated that diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] was mixed with the solution part of the act-hib and was administered incorrectly with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (Daptacel) for Prophylactic vaccination.  On 19-Oct-2023, the patient received a 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection (strength: unknown) (lot: UJ859AA, 02-Apr-2024) via intramuscular route in the right thigh for Immunization and reporter stated that pentacel was mixed with the solution part of the act-hib and was administered incorrectly with no reported adverse event (product preparation error and poor quality product administered) (latency: same day)  It was reported, preparation and administration of PENTACEL that was mixed with a saline diluent of ACT-HIB.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
After this patient received his vaccine, the RN who administered the shot discovered that there was a small dark speck in the vial. After the speck was discovered, the vial was immediately set aside and not used for any further vaccinations. As of 48 hours post vaccine administration, the patient is doing well and per his report to me today has not had any acute symptoms. He was informed of the presence of the speck in the vial and this was reported to manufacturer as well.
Sunday night started feeling the effects of the intramuscular shot. Skin only felt a little warm to the touch. Pain across the shoulder radiating toward the collarbone. Using the arm exacerbated the shoulder/collarbone pain. Pt did not notice any rash until Monday 9/17 in the evening. Pt has a six inch rash that is radiating from the deltoid toward the inside of the elbow. Marked the area the rash has appeared and advised the pt to keep an eye on the area if it goes outside the marking lines to contact her pcp.
flu-like symptoms; injection site pain; redness; pain/soreness; itchiness; This is a spontaneous report from a contactable consumer. This (Age: 77; Unit: Unknown) old female consumer (patient) reported that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration from 20Jan2021 to 30Jan2021 at single dose for covid-19 immunization. Patient's medical history and concomitant medication were not reported. Caller called to report her adverse reactions to the vaccine. She received the 1st dose of the vaccine on 30Jan2021 which was a Saturday. The day after on 31Jan2021, she experienced flu-like symptoms and injection site pain, redness, and pain/soreness. The flu-like symptoms were resolved, the injection site pain, redness, and pain lasted until Thursday and has turned into an itchiness on an unknown date in 2021 as of calling. She is asking if she can take the 2nd shot. Outcome of event pruritus was unknown while for other events was recovered on an unknown date in 2021.   Information about Lot/Batch number is requested.
pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in the arm) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in the arm). At the time of the report, PAIN IN EXTREMITY (pain in the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications reported.  No treatment medications were provided
After all patients were checked in, this patient came in to be vaccinated. Staff had given RN the face sheet for a different patient. RN then gave face sheet and card to LVN. The LVN administered both Bivalent Moderna and Flu to patient. During QA, it was discovered that it was the wrong patient that was vaccinated and documented on. Patient was informed and she was okay with receiving Moderna, however she was already up do date with FLU vaccine in January 2023. Patient informed she received another FLU vaccine in the same flu season. Patient did not report any adverse reactions.
Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Fever). On 24-Mar-2021, PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, Body temperature: 100 (High) 100 F.         Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medications information was reported. No treatment medications were provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-030563 (Patient Link).
Pt had severe rash and itching, spread over body w/i minutes. Treated w/BENADRYL & contacted physician. EMS took her away. Called back later, pt is ok.
Left testicle swollen and sore for a few days after first dose; Left testicle swollen and sore for a few days after first dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Mar2021 09:00 (Lot number: ER 2613) at the age of 46 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: TESTICULAR SWELLING (non-serious), TESTICULAR PAIN (non-serious) all with onset 21Mar2021, outcome "recovered" (2021) and all described as "Left testicle swollen and sore for a few days after first dose". Therapeutic measures were not taken as a result of testicular swelling, testicular pain.  Additional information: The patient has no known allergies to medications, food, or other products. The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not been diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care.   No follow-up attempts are possible. No further information is expected.
pt recv vax 14NOV96 & devel a diffuse rash from elbow to shoulder 2-3 days p/inj;tx w/topical DPH & the sx resolved w/in 1wk;
By the time 24 hours passed, I felt fine.  Around 1:00 the following day I began to feel generally sick.  I felt tired, headachy, nauseous.  I rested and felt worse and worse.  I soon began chilling -- couldn't get warm.  After a couple hours, I took my temp and it registered 101.1.  I went to bed feeling quite unwell.  When I awoke the next morning, I felt pretty good and felt fine all the next day.
This case was reported by a physician, also the consumer, via sales representative and described the occurrence of inadvertent exposure to vaccine in an adult female subject who was vaccinated with ROTARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of ROTARIX (unknown) and experienced inadvertent exposure to vaccine and pharmaceutical product complaint. The physician reported to the representative that when she "attached the transfer valve and then attempted to inject the diluent into the vial through the valve, everything exploded and the liquid went all over". The vial containing the vaccine nor the vial containing the diluent broke, it just sprayed backwards and got all over the physician. Follow-up received on 06 May 2010: Safety statement reported no safety concern identified in association with the batch and the complaint.
Complained of soreness and large reddened area left arm(sq). State had rapid heartbeat and low blood pressure Saturday 11-16-02. State arm looks much better Monday 11-18-02 but still hurts some and patient feels like she getting chills. Encouraged to see MD. Saw Dr. and he said it look like an infection and gave Augmentin 1000mg po BID v 6 days.
8 x 8 cm red, swollen area to left arm where VARIVAX was given.
Flu Shot Fridays my arm was sore for two days; Initial information was received on 13-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional (patient) via social media.  This case involves adult patient (unknown gender) who experienced "flu shot fridays my arm was sore for two days" (pain in extremity), after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious flu shot fridays my arm was sore for two days (pain in extremity) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the event.  It was reported "flu Shot Fridays my arm was sore for two days".  At time of reporting, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Patient passed out.  Patient regained consciousness felt sweaty fatigued light headed.  Patient remained seated and started to feel better after about 30 minutes.
fever; dizziness; aching joints; headache; shortness of breath; swollen and painful lymph nodes in left armpit only; swollen and painful lymph nodes in left armpit only; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 39-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247, expiration date: unknown), intramuscular on the left arm on 30Dec2020 at 15:00 at a single dose for COVID-19 immunization. Medical history included gastroparesis, low thyroid, iron anemia, and known allergies: latex, apples, kiwi and avocado. Concomitant medications included bifidobacterium infantis (ALIGN), colecalciferol (VITAMIN D [COLECALCIFEROL]), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), duloxetine hydrochloride (CYMBALTA), ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE), folic acid (FOLIC ACID), levothyroxine (LEVOTHYROXINE), omeprazole (OMEPRAZOLE), and pantoprazole (PANTOPRAZOLE). The patient had no other vaccine in four weeks. On 30Dec2020, the patient experienced (first shot) fever, dizziness, aching joints, headache, shortness of breath, swollen and painful lymph nodes in left armpit only, 24 hours after the shot and lasted for two weeks. The patient had no COVID prior vaccination and tested negative post-vaccination through nasal swab on 13Jan2021, which resulted negative. No treatment was administered for the events. The event swollen and painful lymph nodes in left armpit only resolved on 14Jan2021 while the rest of the events had not resolved.   Information on the lot/batch number has been requested.
Staring spell shortly after vaccine when mom had reached her car and placed pt in car seat. She remained very tired, sleepy, and developed a fever (101.5) within 1/2 hr, persisting x ____.
Client is a 7 year old boy who received his first dose of Ped Pfizer.  A few minutes after receiving the vaccine, while waiting in the paking lot, client began to develop a rash on his face, and upper chest area.  At 1624 Patient was treated with 25 mg of diphenhydramine, vitals: BP - 116/86, HR - 87, O2 - 100, R - 18.  Mom was advised to consult with pediatrician before giving second pfizer dose, and if symptoms worsen to take child to emergency room.  Both, RN & EMT waited for 25 minutes with patient which by then his rash had mostly cleared up.
For several days, the usual arm soreness.  Approx. 7 days following, a large red area with intense itching which continues today.  Photos are available.  No other symptoms (fatigue, fever, body aches, etc.) -- just the injection site area is now extremely itchy and still tender to the touch.  To treatment.
Prior to vaccine being given my blood pressure was 120/80, when they checked it again to give my second dose it was 170/101, I was then given a 5 day hypertension evaluation and put on blood pressure medicine and given the 2nd shot. I received my 3rd AVA abroad and 3 days later my BP was 90/60. At that point they told me to stop taking any blood pressure meds.  Now my BP is unstable and I am back to taking Zestoretic and due for my 4th AVA. The doctor at the site says this is a very common occurence and I shouldn't worry about it. I happen to think that doctor needs retraining.
He says he got his second COVID shot (Moderna) on Saturday and says his lymph nodes in his neck and armpits got swollen and sore which was similar to when he once got bit by a black widow. His energy has been low, and he has been feeling dizzy with a fever on Sunday and Monday. He has not been able to go back to work since the shot. He says that on Sunday he wasn't able to get out of bed. He got the shot because his mother's nursing home required it in order for him to see his mother.