chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 04-May-2022/ Dose administered after 30-day Use By Date; Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 04-May-2022/ Dose administered after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 04-May-2022/ Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 04-May-2022/ Dose administered after 30-day Use By Date) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (Batch number: EN3207) on 25-Mar-2021. Past adverse reactions to the above products included No adverse event with Pfizer.    On 04-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 04-May-2022/ Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 04-May-2022/ Dose administered after 30-day Use By Date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 04-May-2022/ Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 04-May-2022/ Dose administered after 30-day Use By Date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Patient had received 1st booster dose on 04 May 2022.  It was reported by pharmacist, the vaccine coordinator in their health care facility, that they inadvertently administered an expired dose of the Moderna Covid-19. Post further investigation of the issue, pharmacist identified an additional issue that staff were not dating the boxes of vaccine when placing them in the fridge for storage. This lot number 084J21A was received and placed in the fridge initially on 11-Jan-2022, which means that all doses administered more than 30 days after 11-Jan-2022 were not in accordance with the EUA. The vial did not undergo any temperature excursions. The patient did not report any adverse reaction to the health care professional's knowledge.  Treatment information was not provided by the reporter.
Within 24 hours post vax, the pt complained of numbness and tingling of the left hand, left wrist pain and stiffness in the hand. On 3/16/00, the pt recovered from her experienced. No further information is available.
Very hard, swollen, hot, red lump around injection site. It is VERY painful and continues to grow. It is approximately 3 1/2 inches by 3 inches.  And about 1/2 inch out from my muscle.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe
Inj. site warm to palp. and with some redness, 4 cm in width edematous area starting at deltoid and down arm 6 cm. "started 7/18".
2 weeks after receive a sub-cutaneous MMR booster in the left lateral deltoid, Employee reported tingling parasthesia, lateral deltoid in an area now measuring 15 x 7 cm.  She notes the tingling when she reaches forward or engages her deltoid muscle.  She notes decreased sensation to light touch in this area at all times, but it did not start until 2 weeks after receiving the MMR on 02 AUG 2023.  No treatment is rendered at this time. It is not clear if these symptoms are related to the vaccination.  It is possible that a superior lateral brachial cutaneous nerve was irritated by the 02 AUG 2023 vaccine.
Pt was walking up a gentle hill, felt chest pain radiating to both shoulders, pt was driven to ER and diagnosed with a massive bilateral saddle pulmonary emboli with right heart strain.  No prior history of lower extremity DVT.  Inpatient admission.  Pt was discharged on 3/22/21 and follow up with PCP and ONC for blood thinner medications.
NOTICED RED, WARM RAISED AREA FROM SHOULDER AREA TO 3/4 DOWN ARM AND COVERED FROM FRONT BICEP AREA TO TRICEP AREA. DIDN'T USE ANY CREAMS ETC. DIDN'T WANT TO MAKE IT WORSE. MOM STATES MUCH IMPROVED TODAY ON LIGHT RED COLOR AND NOT WARM TO AFFECTED AREAS
pt recv vax 23AUG9612noon;around  330PM called & said pt woke up from nap crying, stiff neck, unable to straighten neck, red nose;instructed to go to ER;MD said anaphylactic rxn 1hr post vax;oral & eye swelling;
I never had psoriasis which I never had before. I started having trouble remembering things. I had foggy brain, could not remember names and I was a 911 dispatcher and I was just forgetting things. I also got rashes under my breasts and spotty ones in my stomach and arms. I could not get rid of them with any OTC medication. My doctor did not know what they were and I was referred me to a dermatologist. I was also having SOB. I also went to a neurologist. I was also referred to a rheumatologist and dermatologist. The doctor said I also had pleuritis in my eyes and I was given drops for my eyes. I went to an allergist after that and he wanted me to go to an eye doctor and the doctor said it was episcleritis both are some like to auto immune disease. I also saw a cardiologist with my SOB. The rash on my breasts looked weird and as put on intensive treatment and it was psoriasis. The cardiologist said I had coronary artery disease which was diagnosed this year. The psoriasis was diagnosed 6 months ago. I went to the eye doctor where they put little test strip to see how many tears I produced. My voice also has been hoarse sine the vaccine. I am not saying the covid vaccine caused this maybe it was due to a flareup or was triggered it. I also have been falling down unexpectedly and I do not know why I am having this symptoms. I am danger to myself, like I said I do not say that it is the vaccine, I feel more like it was trigger than a cause. Lot# was not provided.
PATIENT CAME TO OUR HEALTH DEPT TO REPORT THAT SHE HAS HAD CHRONIC PAIN IN HER UPPER LEFT ARM SINCE RECEIVING THE  JANSSEN VACCINE IN JULY OF 2021.  SHE SAID THAT SHE HAD BEEN TO A COUPLE OF CLINICS AND THEY HAVE NOT BEEN ABLE TO FIND ANYTHING WRONG WITH THE ARM.  SHE IS CURRENTLY WEARING A PAIN PATCH ON THE DELTOID AREA OF THAT ARM.  HER LAST PROVIDER TOLD HER TO REPORT HER SYMPTOMS TO THE HEALTH DEPT.  SHE ALSO REPORTS OCCASIONAL ITCHING, BUT NO RASH OR REDNESS AT THE INJECTION SITE.
Patient in observation area post vaccination - was sitting in chair and observed by EMS to stiffen and fall from chair to floor. Patient aroused quickly. Scalp wound on forehead - bleeding controlled and stopped quickly. Per EMS vital signs all within normal limits and blood glucose was 88. No known history of fainting or seizures. After discussion and assessment with EMS patient declined EMS transport.
The patient experienced typical arm sorenesss the evening of her vaccine. The next day (August 13th, 2022), she reports limited mobility in her left arm. She also began experiencing severe pain in her arm through her elbow, including her shoulder, back, and under her breast area. She tried icing the area and icyhot, and neither helped her pain. As of August 29th, she continues to experience severe pain. She cannot sleep on her left side.
Pt has history of anaphylactic allergic reaction (not to vaccine or contraindicated material), made aware of risk (was told she would have to stay 30 minutes) and decided to be vaccinated. Approximately 20-25 minutes after her vaccination, she mentioned to the living facility manager that she wasn't feeling well. I checked her blood pressure (142/111) and pulse (82) at 8:27am. She said that was elevated for her and she felt as though she was having difficulty breathing. I had the living facility staff member call 911. At 8:29, I proceeded to help the patient self inject in her right upper leg with a generic epipen (this was her preference since she has used before) - I added with counting to 10. I then gave her 50mg diphenhydramine IM in her left upper arm (Moderna injection was in right upper arm). Within 1-2 minutes, she said that she could tell the epipen was working and helping her to breathe more easily. At 8:34am, I took her blood pressure (148/111) and pulse (90). By 8:38am, she said she was starting to struggle to breath again. Per the pharmacy emergencey protocol, epipen can be given again in 10-20 minutes. At 10 minutes, since she still said her breathing was getting more difficult and the EMS had not arrived, she was given a second dose of a generic epipen in the left upper leg. EMS arrived 2-3 minutes later and was provided with all above information. Follow up phone call with doctor at the emergency department, said that she was monitored for an hour and then sent home. He advised that she not get the second Moderna shot or if determined necessary by her PCP to get it in a doctor's office setting.
Excessive tiredness.  Slept 16 hours straight for a couple of days.  I talked to 2 different on people 3/20/21 on the phone and don't remember talking to them.  After sleeping 16 hours I got up and fixed me dinner (which took about 1 hr).  I sat down and ate my dinner and the next thing I knew I woke up with my empty plate in front of me.  I had fallen asleep again and had slept sitting at the table for another 3 hrs.  I was extremely sleepy for about 2 days and them I was fine.   Other than being out of it for a couple of days  I had no other adverse reactions.
Fever, skin hurt to touch, nausea, sore muscles, swollen lymph nodes.
Information has been received from a 92 year old female consumer who on 06-DEC-2007 was vaccinated with a single dose of zoster vaccine live (Oka/Merck). Subsequently, in early January 2008 the patient developed an area of intense itching and "pimples" on her left upper thigh. Medical attention was sought, the patient was examined in the office. In early February 2008, her primary physician referred her to a dermatologist for consultation. the dermatologist prescribed betamethasone topical cream. The symptoms resolved initially with use of the cream. At the time of the report the patient had not recovered. She was continuing to experience intermittent episodes of intense itching in the affected area. There was no product quality complaint involved. Additional information has been requested.
Reaction after Janssen vaccine (1805031), in right arm, at 1:20pm 3-16-2021: - Within 15 minutes: nothing - Within an hour or two after: itchy right hand, pulsing in right side of head behind eye, dizziness - About 8pm, onset like a wall: severe anxiety/impending feeling of doom, shortness of breath slightly, increased heart rate, tiredness, muscle aches, sore skin, feeling of sharp pains in ?blood stream?, chills, nausea - 12pm after sleeping for about half an hour: flushing of face, slight shortness of breath, facial swelling and blotchiness, swollen lips, fast heart rate, feeling of impending doom, nausea, tongue swelling, slight difficulty swallowing, nasal congestion, groggy voice, sinuses full of moving fluid, ear pressure, hot with chills, eye redness, achy body and sore skin, feeling of sharp pains ?in blood stream?  - 1am, in addition to previous symptoms (peak of symptoms): Fever 101.4 F, puffy feet that hurt, dizziness  - 1:30am, after eating a little: temp 100.8 F, puffiness went down slightly and severe symptoms improved a bit. Still chills  - 2:45am woke up drenched in sweat and hot, 100.7 F. Chills mostly gone. Nose very stuffy. Eye pressure/pain. Feel improved. Chest feels exhausted. Still body aches but improved. Ear pressure. - 8am: 99.4 F. Feel better mostly overall. Head feels like a cinder block. Eyes and ears hurt. Body aches mostly gone. Pain at injection site. Chills gone. Sweats gone. Skin still sore. - 1pm: 98.3 F. - Only remaining symptom for next couple days is tenderness at the injection site.  -Following a few days: completely recovered. no symptoms, back to 100%
rashes improved; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Rash" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "recovered", described as "rashes improved".  Additional information: Consumer called in saying that he wants to report good news that he was miraculously healed by our vaccine. He confirmed that he received the 1st and 2nd dose of our COVID-19 vaccine. has rashes on his back for 4 and a half years but after receiving the 1st dose of our vaccine, his rashes improved. After the 2nd dose, rashes were gone. Patient is asking if this is the 1st time that someone reported a miraculously healing side effect of our vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Severe swelling and redness of rear right arm from top of arm to elbow. Reported to MD and MD recommended warm compress and IBU.
Fever, malaise, fussy. Patient inadvertently given Zostavax instead of Varivax.
Information has been received from a 77 year old female consumer with no allergies and with medical history of asthma, depression and gastrointestinal problems who on 17-JUN-2008 was vaccinated subcutaneously with 0.65 ml dose of ZOSTAVAX (Oka/Merck) (Lot # 658395/0966U) in the left thigh. Concomitant therapy included NEXIUM, albuterol, ibuprofen, PROZAC, trazodone HCl, carbidopa/levodopa and MIRAPEX. The patient stated that shortly after received ZOSTAVAX (Oka/Merck) (Lot # 0966U), she developed redness, heat, bump and rash 3 inches in diameter at injection site on her left thigh. The patient had not reported this to physician, thus far. At the time of the report, the patient had not recovered from the AEs. There was no product quality complaint. Follow-up information was received concerning a 77 year old male with 122 pounds of weight and 5' tall, who on 17-JUN-2008 at 9:00 am was vaccinated with ZOSTAVAX (Oka/Merck) (Lot # 658395/0966U) in the left leg. On 19-JUN-2008 at 10:00 am, the patient experienced local erythema without sequelae. At the time of reporting the patient recovered. No further information is available.
(R) deltoid 5x2cms of cellulitis & erythema after the MENVEO injection, placed on AUGMENTIN/placed on - warm compress, patient did well.
Potential Adverse Event because she got COVID-19 5 days after getting the Moderna COVID-19; Stuffy nose; Chilled; Headache; Fever; Started feeling bad; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Potential Adverse Event because she got COVID-19 5 days after getting the Moderna COVID-19), NASAL CONGESTION (Stuffy nose), FEELING ABNORMAL (Started feeling bad), CHILLS (Chilled) and HEADACHE (Headache) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy.    On 20-Jan-2021 at 12:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021 at 8:00 AM, the patient experienced FEELING ABNORMAL (Started feeling bad). On an unknown date, the patient experienced COVID-19 (Potential Adverse Event because she got COVID-19 5 days after getting the Moderna COVID-19), NASAL CONGESTION (Stuffy nose), CHILLS (Chilled), HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, COVID-19 (Potential Adverse Event because she got COVID-19 5 days after getting the Moderna COVID-19) and CHILLS (Chilled) outcome was unknown and NASAL CONGESTION (Stuffy nose), FEELING ABNORMAL (Started feeling bad), HEADACHE (Headache) and PYREXIA (Fever) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, SARS-CoV-2 test: positive (Positive) positive COVID-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up document was received on 14-07-2021 and it included patient details(age, weight, height, email), allergic drug and batch number of dose 1 COVID-19 vaccine new events and outcome were added.
I have diarrhea. I started experiencing this symptom the day after I got the vaccine.
This spontaneous prospective pregnancy report as received from a consumer refers to her 25 years old daughter. On an unknown date the patient was vaccinated with dose 3 of GARDASIL (Lot# and route not reported). The consumer stated that the patient had suffered (2) ectopic pregnancies after receiving the GARDASIL dosages (3). The first ectopic pregnancy occurred approximately eight months ago (approximately in June 2012) where she stayed at hospital for two days and had had one of her fallopian tubes removed due to a rupture. The LMP and EDD were not known. The pregnancy outcomes were ectopic termination. At the time of reporting, the patient's outcome was unknown. Upon internal review, the second episode of ectopic pregnancy was considered to be an event of medically significant. Additional information has been requested. The patient was hospitalized.
Pt developed severe pain in left shoulder. Went to Dr who felt it was arthritis after X-ray. She followed up with another Dr who felt pt had developed shingles and ordered prednisone and valacyclovir.
Large lump, red, warm and pain. 10 cm area of redness w/a 1 cm lump. Mild rash on torso. The patient received KEFLEX and prednisone. Also tried BENADRYL.
had covid after his first dose; had covid after his first dose; headaches; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect from a contactable Physician. A male patient of an unspecified age received his first single dose of BNT162B2 (Pfizer/ BioNTech Covid-19 vaccine) on an unspecified date in Dec2020 for Covid-19 immunization. The patient previously had Covid in Apr2020. Concomitant medications were not reported. After his first dose of vaccine, in Dec2020, the patient had Covid and headaches. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The reported "had Covid" after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported event and BNT162B2 administration.
Next day: Fatigue 2 days after: Joint & muscle pain, chills, fever (101.3?), nausea, head and nasal congestion 3 days after: Joint & muscle pain, chills, fever (102.6?), nausea, head and nasal congestion 4 days after: Joint & muscle pain, chills, fever (102.0?), nausea, bad headache
Client reports taking 1st capsule of oral typhoid on 04/04/05 in evening, Wednesday 04/06/05 late morning developed rash, welts on inside of thighs. Rash gone by 2:30 PM on 04/06/05. Took 2nd capsule Wednesday 04/06/05 night. Developed rash, welts on 04/07/05 and 04/08/2005 intermittently. Client applied hydrocortisone cream for itchyness. Client called Health Dept, was instructed no to take rest of capsules. On 04/11/05 client reports rash resolved on 04/08/05 and has had no more symptoms since.
8/8/21: Right sided unilateral hearing loss started around 12pm  8/9/21-current (8/15/21): unilateral hearing loss, tinnitus, vertigo and intermittent vomiting  8/11/21: seen by PCP and audiogram was done. (results below). Seen by ENT and diagnosed with Meniere's disease.  8/13/21: second opinion ENT appt and repeat audiogram was done (results below). Intratympanic steroid injection was given in my right ear.  Vaccine received at 23 wks 6 days gestation  EDD: 11/27/21
Patient was mistakenly given Moderna vaccine and was under the age of 18.  At the time of his monitoring pt had no adverse effect of the vaccine.
Left upper arm swollen and sore.  Diffuse red firm area.  Denied numbness, tingling, loss of sensation.  Not warm to touch.  No SOB or difficulty breathing.
Developed numbness in her feet, right more than left. No weakness of the muscle. Developed sometime in October 2007. Mother reports patient did develop a viral syndrome about a month before the onset of the numbness. She was not seen by any Doctors for that. I saw her on November 11,07 and sent her to see the pediatric neurologist on 11-27-07 . Nerve conduction study showed mild polyneuropathy and diagnosis of Guillain-Barre syndrome was made. No treatment was given.  01/10/2008 MR received for OVs 7/26/07 to 11/20/07 and Neuro report dated 11/27/07.  WCC on 7/26/07 with normal exam. Next visit 11/20/07 with c/o "feet falling asleep x 3-4 weeks".  PE (+) for decreased sensation R foot, DTRs decreased.  Referred to Neuro.  Neuro visit 11/27/07 with c/o numbness and foot pain when walking.  Reduced sensation upper and lower extremities. OV 12/13/07 with PE (+) for areflexia and distal decreased appreciation of touch and temp. DX:  Guillain-Barre Syndrome 9/04/2008 MR received from Neuro including EMG/NCS as reported above.  F/U 12/13/07 with numbness ongoing. Seen again 1/03/2008. Pt had some resolution, but numbness returned, most pronounced in R leg and now hands.  Unable to elicit DTRs in upper extremities. F/U 8/21/08 with increased pain in feet. DTRs absent in upper and lower extremities with normal sensation. (+) Pes planus.
Fluzone Highdose was administered on august 27th 2019 to patient, however doctor realize the dose was expired/No AE; Initial information received on 28-Aug-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an 82 years old female patient who received an expired dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (pre-filled syringe).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Patient was not on any concomitant medication.  On 27-Aug-2019, the patient received a single 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ036AB (expiry date: 09-May-2019) via intramuscular route in the left deltoid.  It was a case of actual medication error due to expired vaccine used.  It was reported that no adverse event was experienced.  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 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.
Allergic reaction to SHINGRIX 2 - 3 days after his shot on 07-26-2018 at pharmacy. Rash vesicular and ulcerative rash on his neck (mimicking chickenpox) head and face. DEPO MEDROL 40 mg and BENADRYL 50 mg IM; (Given) patient is doing well but is advised to go to ER if feels bad, (i.e., SOB, difficulty breathing, etc.).