chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a certified medical assistant (also reported as healthcare worker) refers to a patient of unknown age. The patient was vaccinated subcutaneously with a dose of 0.5 ml VARIVAX 1350 U (lot number not reported) that had been improperly stored on 24-AUG-2012. No other co-suspects or concomitant medications were reported. The dose of VARIVAX (Merck) had been exposed to unknown temperatures, possibly above 77 degrees F. due to shipping issue. When this shipment of VARIVAX (Merck) arrived, 4-5 days after the date it was shipped from Merck, the medical assistant stated that the "cold packs"' felt hot. No adverse effect reported. Additional information has been requested.
While asleep the night of 11/21/2021, I woke up with extreme itching on my torso.  Over the next 24-48 hours welts developed all over my abdomen/torso.  It took me a while to realize these were hives.  I thought it was due to the Aleve I had been taking for shoulder pain, so I stopped taking the Aleve.  I developed dermatographia.  After showering I would have red marks all over my back and torso.  After dish washing I would have large red areas on my forearms.  I took over-the-counter antihistamines.  On 11/30/2021 I had a visit with the PA at my PCP's office.  She confirmed that I had hives and prescribed a steroid pack and told me to continue with the OTC antihistamines.  She ordered a comprehensive metabolic panel, both of which came back normal.  I felt much better after taking the steroid pack.  The itching was less severe but I would still get dermatographia and it appeared on more parts of my body, including my neck, face, legs.  I later saw a dermatologist who diagnosed chronic urticaria after it lasted for 6 weeks.  She also did some lab work which came back negative.  The dermatologist prescribed Xyzal, and once I begain taking that, my symptoms were better controlled.  I took 5 mg Xyzal once daily and it controlled my symptoms for months.  I stopped taking the Xyzal periodically, and symptoms would resume within 48 hours.  I weaned myself off of Xyzal in Aug/Sept 2022 and have not experienced any additional urticaria.  Note that I did get a 4th Moderna vaccine in April 2022, and had no skin reaction.  I was taking daily Xyzal at the time of the 4th vaccine.
The next day after vaccine had a very bad pounding headache, which made her right eye start to twitch. She became very ill.
This spontaneous report was received from a medical assistant refers to a 17 year old male patient. No pertinent medical history of the patient was reported. On 16-APR-2014 the patient was vaccinated with GARDASIL, (dose number, dose, lot number and expiration dates were not reported) intramuscular. No concomitant medications were reported. On 16-APR-2014, the patient was inadvertently administered two doses of GARDASIL. There were no adverse effects reported. It was unspecified whether the patient had sought medical attention. There was no product quality complaint involved. Additional information has been requested.
infection; Caller was diagnosed with colitis and GI bleed; Rectal bleeding; Ileus; Colitis; This is a spontaneous report from a contactable nurse. A 74-year-old female patient received first dosr of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6198; Expiration Date: Jun2021),via an unspecified route of administration, administered on left arm on 24Feb2021 12:59 at the age of 74 years-old at single dose for COVID-19 immunisation.  Medical history included regurge, diverticulosis, haemochromatosis, gingivitis, eczema, asthma, allergy to latex, bone density, polyps and did have an ileus 12 or 13 years ago and this one is in the same place. Concomitant medications included methylcellulose (CITRUCEL) taken for polyps; aluminium hydroxide gel, dried, magnesium carbonate (PEPCID [ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM CARBONATE]) taken for regurgitation; calcium carbonate, colecalciferol, vitamin k nos (CITRACAL [CALCIUM CARBONATE;COLECALCIFEROL;VITAMIN K NOS]) taken for bone density.  The states she received the first dose of the Pfizer COVID vaccine on 24Feb2021, 24 hours later she experienced a GI bleed. Caller states she couldn't go to the bathroom at first and had dry heaves for two hours and then it resolved when she passed bright red blood and laid down. She then went to the emergency room and they did a CAT scan and diagnosed her with an ileus and colitis. She was also given two antibiotics and she is scheduled for a colonoscopy. By 1500 she started to have rectal bleeding; she saw the blood because it burst. She went to the emergency room that evening and they did a CAT scan that showed the ileus was swollen from infection so they put her on antibiotics. One of the doctors said something in her gut was out of balance. She chose not to be admitted to the hospital. She was treated with Cipro and Flagyl. Today she is still tender but she is passing soft stool and everything seems to be normal and she is eating low residue diet. She is scheduled to received the next dose of the vaccine on 17Mar2021. She is asking if the ileus is an effect of the shot and mentioned she did have an ileus 12 or 13 years ago and this one is in the same place. The outcome of events was unknown.; Sender's Comments: Based on the information provided, and on plausible temporal association,  the Company  assessed that a reasonable possibility could not be completely excluded that the reported events were related to the  PFIZER-BIONTECH COVID-19 VACCINE. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Headache; fatigue; joint pain; left supraclavicular lymphadenopathy; This is a spontaneous report from a non-contactable physician.  A 30-year-old female patient second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left arm, on an unspecified date at a SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The patient experienced Headache, fatigue, joint pain, and left supraclavicular lymphadenopathy on an unspecified date.  The outcome of events was recovering. Therapeutic measures were taken as a result of headache and joint pain included OTC pain relievers.  No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been requested.
patient is a 55 year old female who has completed a 30-minute observation period with the following signs and symptoms of an adverse reaction: sensation of throat swelling or throat closure and other - hoarseness of air, gasping air, shortness of breathz, chest tightness. Endorsed that symptoms started 5 mins after vaccination. Had a hx of airway problem before and gets allergy.   PMHx:  hypersensitive Airway syndrome Gastric bypass  hypertensive with consistent SOB and chest tightness with mild respiratory distress. Called 911 to transfer patient to Emergency Department for higher level of care.
Initial information received on 06-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 2 years old male patient who had male child only received one dose of 0.25 ml FLUZONE QUAD and not the second dose, while he received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a 0.25 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route. It was a case of actual medication error due to missed dose. Final diagnosis was male child only received one dose of 0.25 ml FLUZONE QUAD and not the second dose. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Not Applicable for male child only received one dose of 0.25 ml FLUZONE QUAD and not the second dose. 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.
Per received vaccine on 4/30/21 patient called pharmacy 2 days later on 5/2/21 after receiving shot, stated he has a golf ball size red itchy skin on left palm and also rash inner side of forearm. Patient only feeling itchiness, but otherwise stated feeling OK. We sent a fax to PCP on 5/3/21 @10am and are waiting for a response. Patient will also contact PCP for next steps.
Immediately after admin of PNEUMOVAX and FLUVIRIN pt grabbed chest and said it felt like air went out and felt funny like she can't breathe. Grabbed EPI-PEN pt said wait I think I'll be OK son in room said she was nervous at that moment. After about 17 min pt color and skin temp returned. 911 was called immediately when pt stated chest felt tight and no air. F/U at 5:30 pm pt was at home and resting. 10/22 Pt c/o has 100 degrees fever and arm swollen. 10/22 - Pt says honestly she feels as though she has the flu w/ temp of 100. Pt also states she has gingivitis and runs low grade fevers off and on for the past few years. Pt has called the MD who told her this was not serious and not to worry.
Bruising, discoloration (purple/blue) under skin, doesn't hurt approximately 1 inch above elbow (3 inches long x 2 inches wide).
bone loss; had covid-pfizer booster 12/2; fever 100.9; chills; neck/shoulder pain; neck/shoulder pain; aching; clenching of teeth/bruxism; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP). A 68 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administration date 02Dec2021 (Batch/Lot number: unknown) at the age of 68 years as dose 3 (booster), single for covid-19 immunisation; palbociclib (IBRANCE), first regimen from 06Dec2019 (Batch/Lot number: unknown) to 01Nov2021 at 125 mg and second regimen since 01Dec2021 (Batch/Lot number: unknown) at 125 mg; denosumab (PROLIA) (Batch/Lot number: unknown) at single (unk, single). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose1, MANUFACTURER UNKNOWN); Covid-19 vaccine (Dose2, MANUFACTURER UNKNOWN). The following information was reported: IMMUNISATION (non-serious) with onset 02Dec2021, outcome "unknown", described as "had covid-pfizer booster 12/2"; PYREXIA (non-serious) with onset 02Dec2021, outcome "recovered", described as "fever 100.9"; CHILLS (non-serious) with onset 02Dec2021, outcome "unknown", described as "chills"; NECK PAIN (non-serious) with onset 02Dec2021, outcome "not recovered", ARTHRALGIA (non-serious) with onset 02Dec2021, outcome "not recovered" and all described as "neck/shoulder pain"; PAIN (non-serious) with onset 02Dec2021, outcome "unknown", described as "aching"; BRUXISM (non-serious) with onset 02Dec2021, outcome "not recovered", described as "clenching of teeth/bruxism"; BONE LOSS (non-serious), outcome "unknown", described as "bone loss". The clinical course is as follows: the patient had prolia shot, started palbociclib on 01Dec2021, had covid-Pfizer booster bnt162b2 on 02Dec2021, the patient had fever 100.9, chills, neck/shoulder pain, aching, clenching on 02Dec2021. Fever resolved. Has ongoing clenching of teeth/bruxism, TMS, requiring crowns with bone loss. The action taken for palbociclib was unknown and for denosumab was not applicable. Therapeutic measures were taken as a result of bruxism, bone loss and included TMS and crowns.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician concerning a 17 year old female patient who had genital warts prior to vaccination, at an unspecified date was vaccinated with the first dose of Gardasil (lot# 658558/1061U).  Concomitant therapy included ORTHO 0.5/35 and CONDYLOX.  The patient was treated for genital warts.  After the second dose of Gardasil (lot# 658488/1264U) the patient's genital warts came back and same thing happened after the third dose of Gardasil (lot# 659182/1757U).  One of the nurses mentioned that it was a "very severe case of genital warts".  The patient also developed shingles after the third vaccination.  Unknown medical attention was sought.  At the time of reporting the patient was not recovered.  Additional information has been requested.
9 Days after the first dose of moderna, I developed a substernal chest pressure that would not go away and the inablility to take a deep breath. I went to an ED where they did a covid test that was negative and was sent home.
Patient came into office on 03/22/2019 with redness and swelling up upper left arm. Patient states she had been running low grade fever but was not at time in office. Provider ordered BACTRIM DS 800-160mg tablet twice daily for 7 days as well as ice and compression. Patient was instructed to come back to clinic on 03/25/2019 if no symptom improvement or to seek emergency medical care if worsening reaction arises.
Bilateral leg pain shooting down legs mainly at night 9/10 in severity lasting for 3 weeks followed by progressive bilateral lower extremity weakness that resulted in paralysis of both legs.
Infant was immunized 1/19/11 DTaP, Hib, IPV, HepB, PCV13, Rotavirus. Infant died ? SIDS.
On 2-6-14 shingles vaccine given. On 2-7-14 pt. at clinic left 9 PM. Showed redness, soreness, swelling and itching to area.
Patient states about an hour after receiving the vaccine, she became lightheaded, dizzy, extreme headache, and had joint pain in her shoulders and knees. Per patient the symptoms lasted 5/29/15, 5/30/15, and 5/31/15. Patient reports headache, joint aches, dizziness resolved today 6/1/15. Patient reports she is still having injection site tenderness in the left deltoid. No redness, swelling.
Approximately 30 hours after receiving second vaccination I got a fever of 103 that was sustained for several hours. The next day well my fever had dropped it lasted until early evening.
No adverse event; HCP stated they had 12 patients from 6 months to 5 years not previously vaccinated, and accidentally they administered 2 doses 1 month apart (0.25 mL); This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (HCP stated they had 12 patients from 6 months to 5 years not previously vaccinated, and accidentally they administered 2 doses 1 month apart (0.25 mL)) and NO ADVERSE EVENT (No adverse event) in a 12-month-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     It was unknown if patient had any relevant medical history conditions, allergy, concomitant diseases and risk factor. Patient didn't receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.    On 29-Jun-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 27-Jul-2023, received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to .25 milliliter. On 27-Jul-2023, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (HCP stated they had 12 patients from 6 months to 5 years not previously vaccinated, and accidentally they administered 2 doses 1 month apart (0.25 mL)). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (HCP stated they had 12 patients from 6 months to 5 years not previously vaccinated, and accidentally they administered 2 doses 1 month apart (0.25 mL)) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (HCP stated they had 12 patients from 6 months to 5 years not previously vaccinated, and accidentally they administered 2 doses 1 month apart (0.25 mL)).    No concomitant medication was reported.  It was reported that patient 5 didn't report any adverse events. No treatment medication was reported. This case is reported for patient 5 out of 12 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-737216 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-737216:master case
fatigue, nasal congestion, sore throat, tested positive for covid on 7/30/22
This spontaneous report as received from a doctor of pharmacy refers to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 12-JUN-2013, the patient was vaccinated with ZOSTAVAX (lot # J000443 and expiry date 11-APR-2014) (dose and route were not reported). No concomitant medication was reported. The call was reported originally on 04-NOV-2013 in which the reporter requested the stability for an improperly stored ZOSTAVAX. At the time of the call it was reported that the ZOSTAVAX was exposed to 15F for an unspecified amount of hours but reported that no doses of ZOSTAVAX were administered. The reporter called back again on 05-NOV-2013, and stated that he thought the ZOSTAVAX might have been stored improperly since May 2013 and that the temperature of the ZOSTAVAX had ranged between 15F and 20F for an unspecified amount of hours. At that time the reporter was unsure if the ZOSTAVAX was administered but stated that he thought the ZOSTAVAX would had been administered. On further investigation, the pharmacist reported that ZOSTAVAX had been improperly stored since about 10-OCT-2013 reaching a highest of 20F for a total time of 600 hours. It was reported that the patient had no adverse effect. Further investigation stated that the pharmacist had determined that this case might involve approximately 5 different lots of ZOSTAVAX (details unspecified) stored improperly at temperatures up to 21F. He stated the time frame for the excursions would be as of the day each of the ZOSTAVAX lots was received at his facility through the date of patient administration, which he believed might had been months, dating back to on an unknown date in May 2013. These involved approximately 40 patients. He had no specific breakdown of time frame as his records indicate when he received each lot but he was calling further for the data. He also could not identify, at this time, which lot # was administered on which date. Pharmacist would call back after he had complied all of the necessary information and would like revaccination recommendations for any excursion that could not be supported. Pharmacist stated there had been no adverse effects noted by any of the patients. The pharmacist faxed a spreadsheet which included the 38 patients names, the dates of administration as well as the lot and expiration dates of ZOSTAVAX which was supported an administrated. This is one of several reports from the same source. Additional information has been requested.
Just wants to sleep/Eyes just want to close; Redness in throat; Limbs heavy; Can fall asleep in any position; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), SOMNOLENCE (Just wants to sleep/Eyes just want to close), PHARYNGEAL ERYTHEMA (Redness in throat), LIMB DISCOMFORT (Limbs heavy) and POSTURE ABNORMAL (Can fall asleep in any position) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced DIARRHOEA (Diarrhea). On 18-Apr-2021, the patient experienced SOMNOLENCE (Just wants to sleep/Eyes just want to close), PHARYNGEAL ERYTHEMA (Redness in throat), LIMB DISCOMFORT (Limbs heavy) and POSTURE ABNORMAL (Can fall asleep in any position). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea), SOMNOLENCE (Just wants to sleep/Eyes just want to close), PHARYNGEAL ERYTHEMA (Redness in throat), LIMB DISCOMFORT (Limbs heavy) and POSTURE ABNORMAL (Can fall asleep in any position) outcome was unknown. Not Related    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Apr-2021, Influenza: negative (Negative) Negative. On 20-Apr-2021, SARS-CoV-2 test: negative (Negative) Negative. On 20-Apr-2021, Streptococcus test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
I lost my vision for about three days. Half my body went numb. I was dizzy, was cold. My heart raced.  I had 5 kids with no issues prior to the vaccine. Now after the vaccine I have had two second trimester miscarriages with no explanation, just that the baby?s heart stopped beating each time.
Arm Swollen, red, and hot started 08/24/2005 6" area Omnicef and Benadryl
Fever (102-103.8), chills, headache, joint pain starting 6 hours after vaccine and continuing until early afternoon the next day. After that, weakness and low fever until the following day. The next day muscle pain in shoulder around vaccination area.
Experienced chills, fever, severe headache, bodyaches, night sweats day After vaccination. Continue to have headaches and brain fog for 4 to 5 days after vaccination. Have continued to have moderate headaches almost daily and frontal and parietal regions, sometimes in temporal region.
Patient had a reaction 8 hours following administration of this vaccine.  She had rash, nausea and vomiting blood, headache and chills.
Complaints of nausea, vomiting and chills. In the Emergency room. Had to have IV Zofran, promethazine, and Normal Saline Bolus.
About 6 hours after first dose my heart started racing. Then on and off for 3 weeks my heart would sporadically pound or race and other times it would flutter. My chest felt tired, like my heart was beating super hard.