chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Subsequent to the ZOSTAVAX inoculation, the pt was treated by a physician at a healthcare center; This initial spontaneous report was received from a lawyer regarding a case in litigation involving a female patient (pt) of unknown age. There was no information about the pt's concurrent conditions, concomitant therapies or medical history provided. On 09-DEC-2014, the pt was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, lot number and expiration date were not reported) at a pharmacy as prescribed and/or administered by a healthcare provider, for the long-term prevention of shingles and herpes Zoster related conditions. Subsequent to the zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a physician at a healthcare center. It was reported that the pt would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the adverse event was not reported.   The reporter considered the adverse event to be related to Zoster Vaccine Live (ZOSTAVAX).
Dizziness; hallucinations; nausea; disorientation; itching; photophobia; small, dry blisters on my back which caused skin to rub off and then left it sensitive and had a burning feeling when clothes touched the area.
Positive for COVID; This is a spontaneous report from a contactable consumer (Patients wife). A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on 15Apr2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced with COVID-19 on 22Apr2021. It was reported that both her husband and his mom have experienced side effects since getting vaccinated. Her mother in-law got her 2nd dose on April 19th and my husband got his 1st dose on 15Apr. She has not been vaccinated and started getting symptoms on 22Apr. Both my husband, me and one of our children have all tested POSITIVE for COVID. On 22Apr2021 the patient underwent lab tests SARS-CoV-2 test: Positive. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
patient came in  with arm redness, no itching no hotness,  looks like allergic reaction .  area a lot bigger than single injection site.  looks like allergic to dilluent maybe?  I called his primary doctor left message with details,  secretary said she would follow up with patient
ALL 12HRS FOLLOWING THE SHOT. LEFT SHOULDER VERY SORE - UNLIKE SHOT #1 OR #2 SHOOTING PAIN IN LEFT ELBOW JOINT COLD SWEAT HEADACHE BODY ACHES FATIGUE - FELT LIKE I WAS AT 50% DIARRHEA LASTED FOR 24HRS APPROX.
Had TRUMENBA and MENACTRA vaccines on 6/6/17. That evening he noted his arms were sore, testicles were tender. Rash noted at 6 am on 6/7/17 involving both arms. He had urticarial eruptions on both thighs. He was seen by PCP at 12:30 pm on 6/7/17. He was prescribed MEDROL and ZYRTEC.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "acid reflux" (unspecified if ongoing); "5 major joint replacements" (unspecified if ongoing); "numerous surgeries for various reasons" (unspecified if ongoing); "cervical cancer" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL, start date: 03Jan2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "not recovered" and all described as "COVID-19". The patient tested SARS-CoV-2 positive  in Feb2023. The patient started paxlovid on 23Feb2023 and took for 5 days. She tested on day six and was still positive. After 11 days she retested and was still positive but the line was barely visible. At this time she had no symptoms. She then waited and retested on 08Mar2023 when symptoms returned and was positive right away. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
ANOTHER SMALL VESSEL THAT MIGHT BE A PANCREATICODUODENAL ARTERY (PCD) HAD NARROWING FOLLOWED BY DILATION; 2 SPLENIC ANEURYSM/MULTIPLE SMALL ANEURYSMS NEAR THE ENTRY TO THE SPLEEN; MAJOR HEALTH ISSUES; GREATLY IMPACTED THE PATIENT'S EVERYDAY QUALITY OF LIFE; DID NOT FEEL WELL; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent condition included: non-smoker. The patient maintained a healthy weight. The patient never had high blood pressure and any sign of health issues like aneurysm prior to getting the vaccine. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21P, and expiry: unknown) dose was not reported, 1 total, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  From an unspecified date in APR-2021, the patient did not feel well, and this had greatly impacted the patient's everyday quality of life. From an unspecified date in MAY-2021, the patient had major health issues. On an unspecified date in AUG-2021, the patient was diagnosed with 2 splenic aneurysm. The patient visited physicians for splenic aneurysm and all the physicians (doctors) did not think that it was related. The patient had been trying to treat the biggest splenic aneurysm since an unspecified date in AUG-2021; however, the patient had been bounced back and forth between doctors and kept getting referred to different specialists. On an unspecified date, the patient had computerised tomogram (CT) scan; however, result was not reported.  On an unspecified date in OCT-2021 (reported as last week), the patient had another CT scan where CT abdomen angiogram showed multiple small aneurysms near the entry to the spleen, as well as a larger one that was approximately 2cm, and another one along the first part of the splenic artery. Also, another small vessel that might be a pancreaticoduodenal artery (PCD) has narrowing followed by dilation. The patient would have an appointment with an interventional radiologist on 19-OCT-2021.  The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from 2 splenic aneurysm/multiple small aneurysms near the entry to the spleen, and did not feel well, and the outcome of major health issues, another small vessel that might be a pancreaticoduodenal artery (PCD) had narrowing followed by dilation and greatly impacted patient's everyday quality of life was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20211020951- covid-19 vaccine ad26.cov2.s - 2 splenic aneurysm/multiple small aneurysms near the entry to the spleen, another small vessel that might be a pancreaticoduodenal artery (PCD) had narrowing followed by dilation . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Patient didn't have any side effects from his first dose. With his second, he felt fine for about 15 hours. Then his lips and eyes started to swell, his throat got itchy, & he started taking deep breaths. These are telltale signs of him starting to have an anaphylactic reaction. I gave him two Benadryl immediately, and monitored him.  His breathing improved and I didn't have to inject him with his Epipen or take him to the hospital. The swelling in his eyes and lips didn't subside, however, so I gave him routine doses of Benadryl for about 12 hours while monitoring him. He was fine again, for another 20 hours or so, and then his symptoms started to come back. Benadryl stopped it completely that time and I didn't have to give him anymore.
The vial was initially stored in the refrigerator on 19JUL2022 and vaccine administered on 29AUG2022; No adverse event; Received expired 2nd Primary dose, after 30-day Use By Date Expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired 2nd Primary dose, after 30-day Use By Date Expiry), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 19JUL2022 and vaccine administered on 29AUG2022) and NO ADVERSE EVENT (No adverse event) in a 20-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 011B22A and 011B22A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Jul-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 29-Aug-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 29-Aug-2022,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired 2nd Primary dose, after 30-day Use By Date Expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 19JUL2022 and vaccine administered on 29AUG2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired 2nd Primary dose, after 30-day Use By Date Expiry), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 19JUL2022 and vaccine administered on 29AUG2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Received expired 2nd Primary dose, after 30-day Use By Date Expiry) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 19JUL2022 and vaccine administered on 29AUG2022).    No concomitant medications were reported. The vial size was reported as 5.5 mL. The vial was initially stored in the refrigerator on 19-Jul-2022. The vial did not undergo any temperature excursions. No treatment medications were reported.
dizziness; tongue and lip tingling; welt on bottom lip; chest tightness; SOB with activity for 2-4 hours; itching; burning; diarrhea; redness traveling up arm into chest; This is a spontaneous report from a contactable nurse reporting for herself.  A 47-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular in the right arm on 29Dec2020 03:30 at single dose for COVID-19 immunization. Medical history included breast cancer, allergy to peanuts, dogs, cats, the outdoors. Concomitant medication included tamoxifen (unknown manufacturer). On 29Dec2020 04:00 the patient experienced dizziness, tongue and lip tingling, welt on bottom lip, chest tightness, SOB with activity for 2-4 hours, itching immediately after injection (as reported), then burning, then redness traveling up arm into chest, and immediate onset of diarrhea. The outcome of the events was recovered. The patient received famotidine (PEPCID) and Cetirizine as treatment for the event. No other vaccine was administered in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19.  Information on the lot/batch number has been requested.
Got COVID-19; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Got COVID-19) and DRUG INEFFECTIVE (Lack of drug effect) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 021B21A) for COVID-19 vaccination.     Concurrent medical conditions included Sinus disorder. Concomitant products included CETIRIZINE for Sinus disorder.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2021, the patient experienced COVID-19 (Got COVID-19) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (Got COVID-19) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.      Company comment: This case concerns a 53-year-old, female patient with no relevant medical history, who experienced the unexpected non serious event of COVID 19. Drug ineffective was also captured as event. The event occurred approximately 7.5 months after the second dose of mRNA-1273. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.    No medical history information for patient was reported.   This case was linked to MOD-2022-461890 (Patient Link).; Sender's Comments: This case concerns a 53-year-old, female patient with no relevant medical history, who experienced the unexpected non serious event of COVID 19. Drug ineffective was also captured as event. The event occurred approximately 7.5 months after the second dose of mRNA-1273. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.
On 3/22/2023, I got up early in the morning, and I had scratchy throat, sinus congestion, fatigue, and body aches. I took a home antigen test on 3/23/2023 and got a positive result. I called the clinic and asked about getting PAXLOVID. I was then told that I needed to go there to be tested before I could get PAXLOVID. I was given a PCR test, and the result was positive. When I was prescribed the PAXLOVID, I was told to cease taking amlodipine and pravastatin while I took the PAXLOVID. I did this for five days, as prescribed. About three days in, I began to feel much better. On about 3/29/2023, I took another home antigen test and got a negative result. I took another on 3/30/2023, and it was also negative.
pt recvd vax;chills,fever,aching all over,some v;still cont as of 4may94;no local rxn;24may94 f/u:fever & aching lasted 8 days on & off;tx w/ apap,clear liquids;MD felt rxn due to vax,probably a viral illness that happend to coincide w/ vax
I went in to get my CBC done just because the last times I got my vaccines, my platelet counts really dropped. It?s like a protocol now to go before, after, and monitor for 6 weeks. Since I have ITT, I already have low platelet count anyway.   Got my CBC done yesterday and the platelet count was at 68,000 on Monday and it was at 30,000 yesterday after the vaccine. Now I will just be monitoring to see that it goes back up.   Still ongoing since 2nd vaccination and still being treated for the following: Bottoms of feet turn purple. Every test done and nothing in relation to circulation. Tests cannot determine the problem. There's just this sensation and I check my feet and they're purple. Noted with dermatologist. Thought that it would go away and it's been since the 2nd vaccine and that was back in April 2021. Around the same time where I began having shoulder issues. Seems to be frozen shoulder. Was going to PT and that never helped. Finally got a steroid injection in January 2022, but I still have limited mobility and going to PT again. They said it should be another year or so until I get some mobility.
Patient received vaccine 4/12/17. Over 2 days, patient developed swelling, irritation to pain greater than silver dollar size swelling w/warmth to touch and pain.
the next day pt daughter called & said mom was having swelling & redness & fever from tetanus;had to go to ER;MD dx cellulitis rt arm;tx w/ATB;better 12JUN97;
Hives, itching the evening of receiving the vaccine. Given 40mg Solumedrol and sent home on Prednisone taper.
Had Td booster 8/5/04 about 1PM. Went home, had a nap, ate lunch then about 4PM her tongue, chin, and lips became numb. She called here. I advised to watch for improvement or worsening of symptoms and call or go to ER as appropriate. Says she went to bed with a HA that night which she does not normally have. Awoke at 4 AM and was very dizzy, went back to bed and when she got up at 7AM took allergy/sinus rx as her head was still still throbbing. Says she feels better since getting up but was not completely gone. She is able to function normally. She will be returning to work next week. PC to work she is in a meeting and will call me back. PC to work-she is working and cannot come to the phone, will call me back. I will not try to call again.
a delay of over 5 weeks from the first dose, with no ae; Initial information received on 23-Dec-2020 regarding an unsolicited valid non-serious case received from a pharmacist .  This case involves a 54 years old male patient who experienced a delay of over 5 weeks from the first dose (inappropriate schedule of product administration), while he received vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  The patients medical history, concomitant medication, medical treatment(s), vaccination(s) and family history were not provided.   On 14-Nov-2020, the patient was vaccinated of suspect RABIES (HDC) VACCINE (lot unknown and expiration date: unknown) via unknown route in unknown administration site for immunization.  On 23-Dec-2020, 1 month 9 days after initiation of suspect, a delay of over 5 weeks from the first dose (inappropriate schedule of product administration).   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.
Initial report received from a Healthcare professional on 10 December 2014. This case is a part of 3 cluster cases and this case is linked to case 2014SA172329 and 2014SA172324. A patient, whose medical history and concomitant medications was not reported, had received a intramuscular dose of FLUZONE QIV (Batch number UI245AB, expiry date 30 Jun 2014) in the deltoid, on an unspecified date. On an unspecified date after vaccination the patient had experienced fever. The patient's illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions were reported as unknown. The patient required ER visit. At the time of this report, the patient was recovered within 8 hours of onset of event. List of documents held by sender: none. Follow-up information received from nurse on 07 April 2015. A 35-year-old female patient, whose medical history was reported as an egg allergy, had received a dose of FLUZONE QIV on 27 November 2014. On 28 November 2014, one day after vaccination patient had experienced high fever (104 degree celsius), swollen arm pit glands, vomiting and loose stools. It was reported that, patient was healthy at the time of vaccination but patient's children was sick at home and patient's sister had a site reaction to injection. Patient had no vaccine within 4 weeks prior to vaccination, laboratory data and other medications. Patient was vaccinated at hospital and vaccine purchased from hospital funds. It was reported that, patient did not required emergency room. The patient had recovered from all events on an unspecified date. List of documents held by sender: none.
Vaccines administered on 9-27-11. Patient seen again on 10/4/11 with c/o polydipsia & polyuria. Serum glucose 451.
No adverse events occurred.  Patient was 16 at time of vaccination.  Pfizer was not available for Booster and Moderna was given.
Day after vaccine unrelenting fsevere headache, jaw pain, charlie horses. Day 2 after vaccine arm swelling, HOT, spreading getting larger during the day along with headache. Day 3 after vaccine arm still red, geographic pattern on arm in different location, never localized and very irregular in shape- tingly feeling started in pinky and ring finger of left arm where vaccine was given. Day 4 after vaccine RIGHT had not associated with vaccine has tingly feeling. - like hit funny bone. No numbness, just tingly
I?ve had post menopausal bleeding since 12/12/21 through now. I haven?t had a period  in 3 years
first dose given on May 13th 2019/ is still valid in order to continue with SHingrix second dose.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 13th May 2019, batch number -9277N, expiry date 27th June 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter asked if Shingrix first dose given on 13th May 2019 to a female patient was still valid in order to continue with shingrix second dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
After dose 2, I had my menstrual cycle start one day later, which was one week earlier than it should have come.  Separately, I had a sharp pain for 24 hours in my left breast.  It has been reported that I have intramammary lymph nodes, and may have been associated with that.
Fever of 103F; whole body ache with stiff legs; severe headache. Fever decreased with Advil and Extra Strength Tylenol. Fever reoccurred a few hours later. Tx'd with Advil also headache.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown dates, an unspecified number of patients were administered with improperly stored doses of PROQUAD (Merck) (doses, routes of administration, lot numbers and expiration dates were not provided). No adverse effects were reported. Additional information has been requested.