chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash on back with blisters, itching, Dr. diagnosed as shingles. MD - Dr. consulted. Will not take second shot-taking VALTREX.
This spontaneous report as received from a pharmacist refers to approximately seven patients with unknown demographics. Their pertinent medical history, drug reactions/allergies and concurrent conditions were not reported. On unknown dates since April 2016, the patients were vaccinated, subcutaneously, with 0.65 ml doses of improperly stored ZOSTAVAX (which had a lot # of L044529 and an expiration date of 09-FEB-2017; however, the dosage numbers and anatomical locations were unknown. No concomitant therapies were reported. Despite being vaccinated with such an improperly stored vaccine, no adverse events were reported. Notably, the vaccine underwent a temperature excursion on 21 F for a time of 11 hours and 30 minutes on an unspecified date in April 2016. Following this, the vaccine experienced another temperature excursion of 6.8 F for a time frame of 11 hours and 20 minutes as well, on the night of 20-JUN-2016. However, following this recent improper storage, it had not been administered to any patient. Additional information has been requested.
Redness and swelling on right thigh x 3 days. Has pruritis. No pain or fever. Applied ice to affected area. Skin: 5 x 8 cm patch with erythematous border and central clearing over right anterior thigh, no induration, no TTP.  Dr. prescribed DiphenhydrAMINE HCl 12.5 MG/5ML mL, Liquid  q6 hrs Sig:  Take 5 mL PO q6-8  hours prn swelling, pruritis, 30 days, 1 refills. Care Plan: Return to the clinic if condition worsens or new symptoms arise and/or signs/symptoms have not resolved- increased swelling, redness or fever.
After getting the first round of the Vaccine, I had the loss of smell and taste happen as if I had covid again, and it's lasted for a month now. It's affecting my appetite.
Patient's grand daughter states patient did not remember how she got home after the vaccination.  Grand daughter states patient concerning about  memory loss after the vaccine.
VACCINE WAS PAINFUL, GOT STUCK TWICE BECAUSE SHE WAS STARTLED AND JUMPED. NEXT MORNING WOKE UP WITH CHEST PAIN AND ARRYTHMIA, EXTREME FATIGUE--STILL HAVE; SNEEZING AND HEADACHE. DOING REST FOR THE TREATMENT. EAR ACHE STILL PRESENT RIGHT SIDE. PAIN IN ARM LASTED ABOUT 4 DAYS. ARRYTHMIA AND CHEST PAIN STOPPED 12/1/21. FATIGUE IS STILL PRESENT. OXYGEN LEVEL IS AT 95 PER OXIMETER.
Patient was fine after receiving the vaccine until he was put into his car seat approximately 10 minutes after getting the vaccine. At that time,  he threw up. According to his parents, it was the entire content of his stomach. They returned to the waiting area and requested to be seen by a nurse. I met them and assessed patient. His color was normal, breathing was normal, and was smiling. They waited an additional 20 minutes; I checked on them again and he was fine; normal color, breathing, and smiling.
Patient received COVID BIVALENT vaccine around 11:00am on 9/21. Patient showed no signs or symptoms of adverse reaction, but at 4:45pm, there was an immediate drop in patient's oxygen saturation, patient was pale with bilateral hands cyanotic and unresponsive. Patient showed no vital signs of life.
Pfizer lot #FJ6369 with temp excursion. Reported to Pfizer company and ok?d for use. Instructed by their staff to report each dose given in this system.?
Quick onset of fever (peaked at slight above 100 deg F), chest pains, shortness of breath, and severe chills about 11 hours after vaccine was taken. These symptoms were mild the next morning and afternoon and I was able to work fine from home. This evening, my fever once again flared up to 100 deg F.
2nd vaccine received at 0930 1/13  Around 1300: 1/13-1/14  Body aches, chills, headache, nausea/vomiting
Client was administered a dose Pfizer pediatric vaccine that was not diluted. Client is well when parents were contacted.
Arm is very sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is very sore) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included TOFACITINIB CITRATE (XELJANZ XR) for Arthritis, SITAGLIPTIN (JANUVIA [SITAGLIPTIN]) and EMPAGLIFLOZIN (JARDIANCE) for an unknown indication.    On 16-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm is very sore). At the time of the report, PAIN IN EXTREMITY (Arm is very sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided by reporter.
After each vaccine I had a fever and felt very bad. On January 31, 2022 I had an extremely scratchy throat I could not swallow. I had an extremely high temperature. I felt as if I had, received the vaccines all over again. On February 1, 2022 I tested positive for COVID-19.
Pain in arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The patient arm often hurts for 2 week after getting the flu Shot. The reporter did not consent to follow-up. This case was linked to case US2019203765 same reporter same patient.
This spontaneous report was received from a pharmacist, concerning a 10 months old female patient. The patient did not have medical history, concurrent conditions, concomitant medications, drug reactions or allergies. On 27-SEP-2017, the patient was vaccinated with PNEUMOVAX 23 with lot # M042599 and expiration date on 17-JUN-2018 (strength and dose were no reported), administered intramuscularly in her left deltoid, to prevent pneumonia. On 28-SEP-2017, the patient developed a bump of 1 inch under the injection site; so on 29-SEP-2017, she returned to the pharmacy and her arm was warm, swollen, reddened and painful to touch with a raised area at the injection site. Then, the patient took diphenhydramine hydrochloride (BENADRYL) without relief but she did not seek medical attention. No laboratory diagnostics studies were performed. No product quality complaint (PQC) was involved. At the time of this report, the patient had not recovered yet from the injection site mass, skin warm, peripheral swelling, erythema, and pain in extremity. The causal relationship between the injection site mass, skin warm, peripheral swelling, erythema, and pain in extremity with PNEUMOVAX 23 was not provided.
Information has been received from a healthcare worker concerning an adult female pt who in Nov 2004, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649914/0578P). Approx two days post vaccination, the pt developed a cellulitis type reaction at injection site, warmth, redness and painful. It was also reported that the pt sought unspecified medical attention. There was no product quality complaint involved. It was also reported that 3 other adult female pt's experienced the same adverse event following administration of pneumococcal 23v polysaccharide vaccine (lot 649914/0578P) (WAES 0501USA00531, 0501USA00532, and 0501USA00533). Additional information has been requested.
Swelling at the site of the shot. Hard to wake up. Unable to walk for two days. Fever of 104. Suddenly scared of water and screamed every time it touched her skin. Held her hands suspended in the air. I called health dept. was told it was normal.
the next day all I felt was arm soreness and fatigue.; felt fatigued and still out of it.  the next day all I felt was arm soreness and fatigue.; felt a little odd; anxiety especially around needles/syringes; left arm turned a bluish pink color; I told the pharmacists and they took my heart rate which was over 100 but my breathing was fine and normal; hands were cold and clammy; Was wobbly; This is a spontaneous report from a contactable consumer, the patient. A 19-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA Vaccine; Lot Number: ER8737), via an unspecified route of administration in the left arm on 07Apr2021 at 14:45 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. Medical history included depression/anxiety. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN), clindamycin phosphate (MANUFACTURER UNKNOWN), tretinoin (MANUFACTURER UNKNOWN). The patient did not have any allergies to medications, food, or other products. Prior to vaccination, the patient was not tested for COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 07Apr2021 at 14:45, the patient experienced anxiety especially around needles/syringes so part of the reaction could have something to do with that and received vaccine and walked to the waiting area to wait 15 minutes to see if body would react. It did. The left (injected) arm turned a bluish pink color. The patient told the pharmacists and they recorded the heart rate which was over 100 but breathing was fine and normal but hands were cold and clammy. The patient was offered water and crackers that patient took and later stood up to see if the patient would get dizzy which the patient did, the patient was wobbly when stood up and stayed after 15 minutes to make sure the patient didn't have any more reactions which the patient did not and left, but still was not feeling 100%. The patient still felt a little odd, off balance, and slightly out of it. But nothing more severe than that. The throat did not close up, face did not swell up, never vomited, felt any itchiness, or get a hot flushed feeling. The next day after vaccination, the patient experienced arm soreness and fatigue. No therapeutic measures were taken for the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events left (injected) arm turned a bluish pink color, heart rate which was over 100 but breathing was fine and normal but hands were cold and clammy, was wobbly, felt a little odd, off balance, and slightly out of it when stood up, arm soreness and fatigue was recovered in Apr2021. No follow-up attempts are needed. No further information is expected.
fever 101 2hr relieved w/advil;h/a 30hr not well relieved w/advil;malaise;
a lot of pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (a lot of pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history reported.     On 15-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 15-Feb-2021, the patient experienced PAIN (a lot of pain). At the time of the report, PAIN (a lot of pain) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not applicable.
Muscle aches in entire left arm from this date thru Sunday 3:45 PM, chills all day Sunday, Saturday morning hoarseness and wheezing. All day Sunday chills, body aches and basically feeling like crap.
Herpes zoster flare up in right eye 7 months/Flare ups then switched to left eye; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient (not pregnant) received BNT162b2 (BNT162B2), administered in arm left, administration date 21Apr2021 08:30 (Lot number: EW0158) at the age of 29 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient did not have covid before immunization. There were no concomitant medications. Vaccination history included: Bnt162b2 (dose 1, lot# EW0150, in left arm, at 08:30), administration date: 31Mar2021, for COVID-19 immunisation. The following information was reported: OPHTHALMIC HERPES ZOSTER (non-serious) with onset 05Nov2021 15:00, outcome "recovered with sequelae", described as "Herpes zoster flare up in right eye 7 months/Flare ups then switched to left eye". It was reported that Herpes zoster flare up in right eye 7 months after first two vaccines. Flare ups then switched to left eye before going to Hospital ER. Local eye doctor referred me to Eye Center for further review where shingles was diagnosed. The event "herpes zoster flare up in right eye 7 months/flare ups then switched to left eye" was evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of ophthalmic herpes zoster: the patient was put on prescription. The patient was not tested positive for covid after vaccination. The patient then received the third dose of BNT162b2 on 12Jan2022 at 06:30 in left arm (Lot number FE3594) with VALTREX and PREDNISOL as other medications in two weeks.
Severe muscle and joint pain, headache, nausea, stomach cramps, fatigue/weakness, fever
I started feeling numbness and tingling in my left leg occasionally. Then, the symptoms became more frequent. Then, I started feeling a sensation of coldness. It spread over the course of a few months. I contacted my Rheumatologist to see if it was an issue with her. She told me to call all my specialists and family doctor to see if it could be an issue with the medications they've given. It was not an issue with anybody else. I called the Rheumatologist back again. She said it sounded like neuropathy symptoms and told me to go see a Neuropathist. It took me month to get an appointment. On June 27, I had my appointment with my Neuropathist and, at current time, I am undergoing testing.
Approximately 8-10 days following first injection, developed hives over injection site.  Then to follow with severe redness, heat, itching  over the deltoid muscle measure approximately 4-6 inches with axillary tender lymph nodes.   Resolved within 48-72 hours.  No medications needed to treated.  I have pictures to document if you need them.   I did not seek out medical care.
Shortness of breath began 7/9/2021; went to urgent care center 7/11/2021, then hospital; CatScan diagnosis of multiple pulmonary embolisms in nearly every lobe of both lungs.  No leg pain typically associated with DVTs; ultrasound of both lower extremities negative for signs of DVT.  Patient noticed higher than normal use of albuterol inhaler 2-3 weeks prior to incident.  Physicians indicated that PEs likely accumulated over several days prior to incident.  No other signs, indications of origin of clots outside of lungs.  Because of tetralogy history, echocardiogram of heart performed; indication of additional stress on right ventricular wall; follow-up with patient's cardiologist, assessment that heart ===>
Inactivated Polio vaccine given on 4/2/2019 from an open multi-dose vial of vaccine that had been subject to temperatures out of range for 27 minutes.  Vaccine was above 46 deg F on 4/1/2019. Vaccinating nurse was unaware of the excursion at the time of administration.
I received my 1st dose of the vaccine on 3/19 which was also the same time I should have gotten my period. My period cycle ranges from 24-26 days on average, so it wasn't certain that I would get my period on 3/19. As on 4/10/2021 I discovered that I never got my period. There is no possible chance that I am pregnant because I am not sexually active and have never been. I haven't taken any form of contraceptive for about 2 years, maybe longer. The only factor, other than the vaccine, that might cause a missed period could be stress. The date of my vaccine shot was around the end of the school term which is a higher stress time period, but not much more than normal and I experience that level of stress about every 9-11 weeks. None of which did I miss or have a delayed period.   My 2nd dose is scheduled for 4/16/2021.
Watery stool on 2/24/2021  about 2mins Diarrhea on 2/26/2021 once in the AM and again at 9pm.
pt recvd vax on 14FEB92 &  on 28FEB92 pt devel severe urticarial reaction; 3MAR92 presented to MD treated w/Pred; skin biopsy revealed chronic urticaria;
The patient tested positive for covid; The patient tested positive for covid; Sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 39 year-old male patient (reporter's brother in law) received bnt162b2 (BNT162B2), administered in arm, administration date Aug2021 (Batch/Lot number: unknown) as dose 2, single and administered in arm, administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2021, outcome "unknown" and all described as "The patient tested positive for covid"; ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "Sick". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Nov2021) positive. Clinical course: He was calling because he was pissed off because he got Covid from his brother in law who was vaccinated with our vaccine. His brother in law got sick so was not working and transmitted it to the caller and he was mad. Caller stated we have a product issue. His wife was out of work and his kids are out of school. Caller confirmed it was his brother in law who got the Pfizer Covid-19 Vaccine. He was calling to find out what we are going to do to help him out. People were trusting the vaccine and it's not working. The company has to take some kind of responsibility. The caller said it's not safe and effective. Caller explained the patient got sick last Wednesday; that's when he got tested for covid. He also got the results then too later that evening. The patient tested positive for covid. Caller stated he talked to the patient a few times. This was the only person outside of his family he was in contact with. The patient used the Abbott Test. Patient got the first dose Jun2021 or Jul2021. Patient got the second dose in Aug2021. Caller mentioned he did not know why we call it a vaccine. If get a vaccine it should be effective. How was it called a vaccine, that was like false advertisement. It should be more like "therapeutic."  The lot number for bnt162b2 was not provided and will be requested during follow up.
On June 7 and 8 I had a few feelings of being dizzy.  On June 10 in the afternoon I was hit with severe vertigo: I vomited many times, couldn't walk without help, couldn't do anything without help, even using the toilet.  I went to urgent care that after noon.  On Jun 14 because I had no relief and saw my practitioner.  On Jun 15 and 16 I saw a Physical Therapist. He looked at my eye movements with some sort of camera.  He put me through several Epley maneuvers which didn't help at all, then suggested some physical therapy movements to do.  I walked with help from my husband the first week, with a cane or walking sticks for the next 4 weeks, and finally now, at week 8, I am mostly free from dizziness, although not quite.  I have no idea if it was related to the vaccine.  I wish the next question (Item 20: Has the patient recovered from the adverse event) had a 4th selection of "mostly" or "partially."  I am choosing the word NO since I am not completely well yet.
vial put in refrigerator 11/01/2021. used after 31 days.
At breakfast around 7:00am noticed left eye droop and facial asymmetry. Kept asking what was wrong with her eyes. Finished breakfast and went to change her diaper. Bright red sun burn looking ovals around injection sites on both legs consuming most of her upper thigh. Kept her undressed and bright red sun burn spots quickly started showing hives clusters and consumed her entire legs within about an hour. Quickly got everyone ready to rush to urgent care. In the 20-30 minutes it took to get to urgent care the hives spread across her entire torso and some on her face. Oxygen level was checked upon arrival at urgent care and was ok. Urgent care doctor gave a dose of Benadryl and her hives completely went away within 30-40 minutes.  Left eye droop continued to persist weekly for the first few months, then seen only about once a month when she is fatigued and now only once every few months. Chiropractor has suggest a detox with a naturopath who specializes in vaccine injury but we have not done this yet.
WORRY; This spontaneous report was received from a patient and concerned a female of unspecified age, race and ethnicity. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested No concomitant medications were reported.  On an unspecified date, the patients "was so worry" because she heard on the news that people had Guillain Barre syndrome after they got their Janssen Covid 19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of worry was not reported. This report was non-serious.
2 patients were administered IPOL post excursion with no reported adverse event; temperature excursion of unknown cause; at a low of 1.6 C and out of range for 26 minutes with no reported adverse event; Initial information received on 13-Mar-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 10 years old female patient and it was reported temperature excursion of unknown cause; at a low of 1.6 C and out of range for 26 minutes and 2 patients were administered poliomyelitis vaccine (inactivated) (Ipol) post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitants and family history were not provided.   On 31-Jan-2023, it was reported temperature excursion of unknown cause; at a low of 1.6 c and out of range for 26 minutes with no reported adverse event (product storage error) (latency: unknown).  On 10-Feb-2023, 2 patients were administered 0.5 mL (dose 1) of poliomyelitis vaccine (inactivated) (Ipol) suspension for injection (once; batch/lot number: V1A121M and expiry date: 15-Feb-2024; strength: unknown) via intramuscular route in the left deltoid for immunization post excursion with no reported adverse event (poor quality product administered) (latency: same day).  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the events.    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.