chrisvoncsefalvay/vaers-outcomes huggingface dataset:
TOOK TWO DOSES ON CONSECUTIVE DAYS; This spontaneous case (PVX2019-1076) was received from nurse on 01-May-2019. It describes a 24-year-old adult male consumer who "took two doses on consecutive days", while being on oral Vivotif (one capsule every other day) for typhoid prophylaxis.  Case report: The consumer took first two doses on consecutive days. The doses were taken on 30-Apr-2019 and 01-May-2019, respectively.  Action taken with Vivotif was not applicable.  The clinical outcome of the event "took two doses on consecutive days" was unknown.  Company's Comment: The causality of the event "took two doses on consecutive days" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took two doses on consecutive days" was considered as not applicable.
Information has been received from 2 healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 01-JUN-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K026385, exp date 15-DEC-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Ear ringing/sensitivity; Constipation; Ear ringing/sensitivity; Headache across forehead; Joint pain (especially knees); Fatigue; Muscle soreness; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot Number: EW0175) via an unspecified route of administration in the left arm on 30Apr2021 at 11:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient had history of known allergies to Shrimp. The patient did not take any concomitant medications. The patient previously received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot Number: ER8729) via an unspecified route of administration in the left arm on 09Apr2021 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Apr2021 at 22:00, the patient experienced ear ringing/sensitivity, constipation, headache across forehead, joint pain (especially knees). fatigue and muscle soreness. The clinical outcomes of ear ringing/sensitivity, constipation, headache across forehead, joint pain (especially knees), fatigue and muscle soreness were recovered on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
I broke out in a rash all over my body and itched like crazy. At the injection site my arm was bright red and had a fever for almost two weeks. I had a golf ball size lump when the injection site was for about two weeks as well. I went to the Dr. for the itching and rash, they put me on a 10 day prednisone. I still have a rash on my right calf the rest of my body has went away.
Dizziness, throat itching and starting to close up. Epipen was administered.
The decedent reportedly was vaccinated 3-4 days before 01/19/21. The decedent was admitted to Hospital on 01/19/21 for end of life care and passed on 01/21/2021.
Although vial checked by 2 medical assistants a Tdap was given in error instead of a DTaP. Call made to the immunization program. Reported to physician. Mother notified.
patient received a COVID vaccine on 4/24/21. the injection was given high on the arm, possibly in the inarticular space. Patient complains of pain across the chest and back.   Injection was given by a nursing student:
I did not have a reaction to the vaccine. On 11/23/2022, I began not feeling well with a sore throat and a runny nose. I tested positive for COVID-19 on 12/03/2022. I had a telehealth visit with a doctor and received the prescription for Paxlovid. I have had no complications taking the medication. As of today, I continue to have a cough with some fatigue.
week after second dose patient skin became pink, eyes swelled almost shut, feeling of picky feeling inside Patient currently taking Xyzal
Left arm red and swollen, temp 101, congestion   Tx: alternate ice/heat take claritin/zyrtec
Patient received first dose of Pfizer on 0729/21 and the second dose was received on 08/19/2021. This Registered nurse was giving patients booster shots per their request. I went through all the paper work and had separated the piles based on when they last received their dose. This patients paper work ended up in the pile with the patients who needed a booster. This patient received a 3rd shot on 11/18/2021 of a johnson and johnson vaccine. Prior to the shot this RN went over the fact sheet with this patient and he was unsure of when and what injection he received as it was at the hospital. No adverse reactions have been reported by this patient.
Unrelenting, simultaneous vomiting and diarrhea ~7 hours to the minute after receiving the shot. Symptoms included abdominal pain, severe nausea.  Resulted in dehydration leading to dizziness, sweating, shivering.
Very dizzy, increased heart rate, heavy breathing. Felt like I was going to pass out.
Positive pregnancy test; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Positive pregnancy test) in a 33-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 030L20A) for COVID-19 vaccination.     The patient's past medical history included Hyperemesis in December 2020. Concomitant products included ONDANSETRON (ZOFRAN [ONDANSETRON]) for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 25-Aug-2021. On 17-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Positive pregnancy test). At the time of the report, EXPOSURE DURING PREGNANCY (Positive pregnancy test) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Dec-2021, Pregnancy test: positive (Inconclusive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Hives and difficulty breathing - took Benadryl to help with the reaction. Symptoms began approximately 20 minutes after shot and lasted for approximately 24 hours.
pt had sl twitching on lt side wk p/shot; called MD said due to prematurity it was nervous sys not fully devel twitching got worse; pt was not using lt hand any more; seen by MD to see neurologist; neurologist adm to hosp; hemiparesis & sz;
when the patient got the shot, it hurt a little bit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a sponsored program (174934). The reporter is the patient.  A 53 year-old male patient received pneumococcal 20-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 20) (Batch/Lot number: unknown) at the age of 53 years as a single dose for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "when the patient got the shot, it hurt a little bit".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received vaccination 1/20/02 at 12:00. By 17:00, patient had fever, chills, right arm was frozen to shoulder, welts, rash and difficulty sleeping. By 11/21/02, patient still achy, but better. Took some Benadryl. By 11/22/02 swelling and aching gone; still some welts present.
This spontaneous report as received from a registered nurse refers to a 9 week old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 18-OCT-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M020102, expiry date: 08-MAR-2019 for prophylaxis. Concomitant medications were not reported. The patient was vaccinated at a private healthcare center and the vaccine was purchased with Private pay/ Insurance. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.
Information has been received from a 58 year old female registered nurse with a history of chickenpox at the age of 5 years and shingles in 2005 who on 04-MAY-2007 at 12:15 PM administered a first dose SC on the left arm a dose of Zostavax (Lot # 656395/0290U) to a 60 year old female patient. There was no illness at the time of vaccination. On 06-MAY-2007 at 9:00 AM, two days after administrating vaccine, the nurse patient had a break out of shingles. IT was reported that nurse used hand washing before and after administrating vaccine but did not wear gloves or mask. On 09-MAY-2007, the nurse was seen by a physician and was diagnosed with shingles (right trigeminal lesions). Treatment included one week of valcyclovir hydrochloride (VALTREX0. At the time of report, the nurse had not recovered. Additional information has been requested.
Apnea; Underarm pain; Neck pain; This is a spontaneous report received from a contactable consumer (patient). A 38-year-old female patient received first dose of BNT162B2, via an unspecified route of administration, administered in Arm Right on 26Apr2021 around noon (Batch/Lot Number: ER8735) at age of 38-year-old as single dose for covid-19 immunisation. Patient's medical history was reported as none. Family medical history relevant to AEs was reported as none. The facility where patient received the COVID vaccine was vaccination facility type, other- community center, not administered at military facility. No additional vaccines administered on same date of the Pfizer suspect. No Prior Vaccinations within 4 weeks. The patient's concomitant medications were not reported. After the first dose, she had neck pain on 27Apr2021, underarm pain on 28Apr2021, apnea on 28Apr2021. Apnea at night time like someone was squeezing her throat or nose. It would wake her up and she immediately feels like she was choking. She would also have apnea in the afternoon while sleeping. Like if she took a nap, 30 minutes after sleeping she would have it, she also referred to as sleep apnea. It would be in the afternoon and nighttime. AEs requested emergency room.  Caller mentioned she had scheduled a check up with her ear doctor, and her regular physician. Neck Pain went away after 3-4 days. She did not know the exact date. Underarm pain went away after 2-3 days. She did not know the exact date. She noticed Apnea started the second day after the first dose. After the first dose it did not start to reduce a little, for a while she was able to sleep all day, but it was not completed gone. At end of call she commented she just wanted to sleep, but was scared due to the apnea. She was worried about her heart or something was going on with it. She felt it's odd and due to vaccine because she never had before. Before, she was healthy and this only started after the vaccine. The outcome of events neck pain and underarm pain was recovered in 2021, of event apnea was not recovered. Information on Lot/Batch number was available. Additional information has been requested.
Injection site reaction. A nsg reported that a child received Prevnar, TriHibit, hepatitis B and IPV vaccines on 4/30/01. The following day the child developed an injection site reaction characterized by redness, warmth, and swelling. The specific sites on vaccine administration were not reported. She was also fussy. The child was seen in an ER where they marked the area of reaction. On 5/2/01 she was seen by the physician because the redness had spread outside the markings. A copy of this report has been forwarded to Aventis Pasteur, manufacturer of TriHibit and IPV.
About 8 hours after vaccine, I felt muscle and body aches all over similar to flu symptoms
rashes on different parts of the body; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RASH (rashes on different parts of the body) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (rashes on different parts of the body). The patient was treated with BETAMETHASONE DIPROPIONATE, CLOTRIMAZOLE (CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE) (topical) on 16-Mar-2021 for Adverse event, at an unspecified dose and frequency and BETAMETHASONE DIPROPIONATE (AUGMENTED BETAMETHASONE DIPROPIONATE) (topical) for Adverse event, at a dose of 0.05 %. At the time of the report, RASH (rashes on different parts of the body) outcome was unknown.            Concomitant medications were  not provided.  The patient's dermatologist  conducted biopsy but result was  pending.   Most recent FOLLOW-UP information incorporated above includes: On 23-Aug-2021: Non significant follow up: Contact information verified
1st dose of Gardasil received on 3/26/07. Patient experienced syncope after 10-15 minutes.
Started 2 days after 2nd vaccination: fever, joint aches, weakness, vomiting, headache, cough, chills/cold sweats Last about 7 days and resolved
Patient was given IM injection into left deltoid. Patient seemed to tolerate injection well, bandage placed on site. Within 2 minutes, bandage was saturated with blood, and soaked through patient's shirt. RN applied pressure as well as new bandage. It was then noted patient had 2 hives at injection site and redness. Patient also complained of pain. Patient had no respiratory distress. Patient observed, and when guardian felt comfortable took patient home. Guardian called 3 hours later to say patient was still complaining a lot of discomfort, site was swollen and red.
I felt fine immediately following my shot, as well as the rest of the day. Overnight I started developing a fever which I knew was normal. However at 3 am I got up to use the restroom. I was sitting on the toilet and then next thing I remember I was on the floor with my face down. I passed out, and I am unsure how long I was out for, before I realized what happened. I have never passed out before, and do not have a history of doing so, so it is unclear why I passed out randomly.
Menactra was exposed to 27 Farenheit for more than 3 hours and was administered to 11 year old male patient, no AE; Initial information received on 01-Jul-2020 regarding an unsolicited valid non-serious case from other health professional.  This case is linked to cases 2020SA172973, 2020SA172697, 2020SA174880, 2020SA174885, 2020SA174942, 2020SA174911, 2020SA174941, 2020SA174910, 2020SA174940, 2020SA174906 and 2020SA173110 (same reporter).  This case involves a 11 year old male patient who was vaccinated with the  MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA], that was exposed to 27 Fahrenheit for more than 3 hours and the excursion occurred due to temperature of the refrigerator was manually changed.  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medication was not reported.   On 14-May-2020, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6594AB and expiration: 21-May-2021) via an unknown route at an unknown administration site as prophylactic vaccination.  It was an actual medication error case due to Product storage error temperature too low.  At the time of report no adverse event was reported  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.
I have always had HYPOGLYCEMIA, went for my lab work in preparation for my yearly physical and found out i am unexplained diabetic. None of the medications so far, that they have tried has improved my blood sugar or HBA1C.
HEAVY MENSTRUATION; DELAYED MENSTRUATION; IRREGULAR MENSTRUATION; This spontaneous report received from a consumer concerned multiple patients. The batch number was not reported and has been requested. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced heavy menstruation, delayed menstruation, and irregular menstruation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heavy menstruation, delayed menstruation and irregular menstruation was not reported. This report was non-serious. This case, from the same reporter is linked to 20211261052.
Moderna COVID-19 Vaccine EUA Red rash developed 11 days after vaccination.  Sore arm with itch.
Hives developed down spine. Saw doctor on 08/06/2010. Placed on prednisone for 5 days. Returned to doctors on 08/17/2010. Hives started to ooze. Placed on Doxycycline Hyclate 100mg for 10 days.
Patient awoke approximately a week after receiving the Prevnar 13 vaccine with initial wrist pain. He stated that over time the pain began to radiate up his arm to his shoulder. He sought medical treatment and was given an X-ray, with no musculoskeletal abnormalities found. Patient has since been prescribed a muscle relaxer (Metaxalone), opioid analgesic (Norco) and NSAID (Naproxen) to alleviate his pain.
the patient received the first dose of GARDASIL 9 on 6MAY2021 and was inadvertently adminitered the second dose of GARDASIL 9 on 20MAY2021; was inadvertently administered the second dose of GARDASIL 9 on 20MAY2021; weird behavior; panic attacks; the patient has not had a menstrual cycle since she was vaccinated; constant drooling; spacing out; fatigue; This spontaneous report was received from a physician referring to an 11-year-old female patient. The patient had none pertinent medical history or concomitant medication. She had no known drug allergies.  On 06-MAY-2021 the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot number 1659422 has been verified to be valid, expiration date reported and validated as 04-SEP-2022), and on 20-MAY-2021, she was inadvertently administered with the second dose (product administration error and inappropriate schedule of product administration). Both doses were administered at a dose of 0.5 milliliter, via intramuscular for prophylaxis (anatomical location of administration was not reported).    Since an unknown date in 2021, the patient had been experiencing some weird behavior, along with panic attacks, constant drooling, fatigue, and she appeared to be "spacing out" (feeling abnormal). The patient's last menstrual cycle was right before she had her first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), and she had not had a menstrual cycle since then (amenorrhoea). The patient started with all these symptoms after her first dose with of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). The patient did not seek for medical attention, neither underwent any diagnostic laboratory diagnostics or studies. By the time of the report, the patient had not recovered from the events.   The reporter did not provide a causal relationship between of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the events.
30 hours after injection: chills, headache, muscle aches, body rash, diarrhea, tiredness
Grandmother complains that patient has had fatigue beginning 1 month after vaccination and is not improving. Patient was energic and never still and now grandmother states he mostly sits. Also complains of being cold all the time. Wears multiple layers of clothing and sleeps with 6 blankets. Grandmother states this began after vaccination.
Tamar's monthly cycle began on January 21, 2022. She received the second vaccine shot on January 25, 2022 and as of today, March 13, 2022 her cycle has not stopped. She is a VERY healthy child and she has been bleeding for almost two (2) months none stop and the longer the bleeding, the heavier it becomes.
other zoster related injuries; shingles; Information has been received from a lawyer and refers to a female patient of unknown age. On or about 04-FEB-2008, the patient was administered with zoster vaccine live (ZOSTAVAX) (dose, unit, route of administration, lot # and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions by a healthcare provider at a pharmacy. Subsequently, the patient was treated by a physician for the following injuries resulting from patients's zoster vaccine live (ZOSTAVAX) use: shingles and other zoster related injuries. The outcome of the events was not reported. The events were considered to be related to zoster vaccine live (ZOSTAVAX).
Headache, nausea, stomach pain, loss of appetite, sore throat, runny nose, joint pain, pain and numbness in entire arm that the injection was put in.
This case was reported by a nurse and described a 44-year-old female subject who was vaccinated with Engerix-B. The subject's medical history included renal failure (cause not specified) requiring hemodialysis, diabetes, and hypertension. Concurrent medications included Venofer, Epoetin alfa (Epogen), Etofenamate (Fenax), Nifedipine (Procardia), Hydralazine (Hydralazine), Human Insulin (Novolin), Atorvastatin calcium (Lipitor), Thyroxine sodium (Synthyroid), Calcium salt (Calcium) and Ramipril (Altace). On 23 March 2006 the subject received 1st dose of Engerix-B (Lot AHBVB171AA). On an unspecified date on or after 23 March 2006 and on or before 30 March 2006, less than one week after vaccination with Engerix-B, the subject "tested positive for hepatitis B". The nurse reported that the subject "tested negative for hepatitis B on December 2005, January 2006 and February 2006". At the time of initial reporting, 30 March 2006, the event was ongoing.
screaming for 1 1/2-2 hrs inconsolably 4 hrs p/vax;
Rash between fingers, inside arms, behind legs, around arm pit region and around hip bones. Rash hot to touch. Still spreading to other regions as of 1/3/2011.