chrisvoncsefalvay/vaers-outcomes huggingface dataset:
"I" had COVID in late March and it felt like "I" had it again for 24 hours.; "I" had testicular pain that came in separate occasions. One the night of and the second the day after. "My" testes felt pressure and it caused pain.; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 07May2021 at 14:30 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and prior to the vaccination, the patient was diagnosed with COVID-19 in late Mar(unspecified year). The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included fexofenadine hydrochloride (ALLEGRA) for unknown indication from unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0153) via an unspecified route of administration in the left arm on 16Apr2021 at 17:30 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. The patient had COVID-19 in late Mar(unspecified year). On 07May2021 at 22:30, the patient felt like having COVID-19 again for 24 hours. The patient experienced one weird event, testicular pain that happened in separate occasions. One the night of and the second the day after. The patient felt pressure in the testes and it caused pain. It resolved on its own within 24 hours. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events felt like having COVID-19 again for 24 hours, testicular pain, felt pressure in the testes and it caused pain were resolved on 08May2021 at 22:30.  No follow-up attempts are needed. No further information is expected.
After injecting the second dose, on the 5th day I was getting to work, I went up some stairs and I noticed a mild pain in the middle of my chest and a bit of fatigue. After eight days the pain has decreased, although it goes from the right side to the left side and towards the middle of my back.  I am no longer tired but from time to time I feel a burning or discomfort in my chest and I have not gone to a doctor to examine it, since the pain is mild I would like you to tell me if this is a case of normal mild side effects or if I require urgent medical attention.
I spotted for my period more than 1 week early.  I bled for 12 days.   I normally have a 5-6 day period.  After the second shot I bled for 14 days.  Then I got bacterial vaginosis in June and given 10 days of Flagyl.  Not only are my periods more than double, I also spot between periods.  In July I got a sore throat.  I was diagnosed with strep throat for the first time in my entire life.  I was given 10 days of penicillin.  I'm spotting again right now.  I'm hoping to see my obgyn on Monday.
Hives on most of body; feet, legs, arms, hands.  Hives are widespread and itchy.  They continue to spread.  No welling in or around mouth and no difficulty breathing.  Only treatment so far has been with benadryl tablets.
SEROUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. A 36-year-old female patient with no known medical history had received a subcutaneous right arm injection of JE-Vax (lot number EJN236A, a left arm injection of Typhim (lot number Z0479), and a intramuscular left arm injection of Rabavert (lot number 412011A). On 07 May 2007 the patient received a dose of Typhim (she had received "one or two" previous doses). On 22 May 2007, she received her third dose of JE-Vax and first dose of Rabavert. On 29 May 2007 the patient received her fourth dose of JE-Vax and second dose of Rabavert. Approximately 72 hours later, on 01 June 2007, she developed acute generalized severe urticaria in addition to small and large joint swelling. The patient presented to the emergency department and was treated with intramuscular benadryl and steroids. No respiratory, gastrointestinal, oral, or neurologic symptoms were noted, and the patient was discharged to home and prescribed five days of oral steroids. After four days, the patient's symptoms were "less", but not completely resolved. A corrective version was created using the original receipt date for the sole purpose of entering the suspect product Typhim per standard data entry procedure. No other medically significant information was received.
Very Dizzy, odd pains in legs, feet, arms, neck. Feel odd, some times headache.
Patient received first dose of Pfizer vaccine, waited 30 minutes with EMTs and reported no adverse reaction. Patient left to car and noticed redness in face at 10:05 am. Patient returned back to EMT and assisted to anti-gravity chair. Patient given 25mg/10mL of oral Benadryl at 10:10 am. Vitals taken every 5 minutes for 30 minutes. Symptoms resolved at 10:20 am and patient drove herself home at 10:45 am.
Headache, Myalgia, Arthralgia, Fever, Chills, fatigue Narrative:
Patient returns to Covid Clinic 3 hours after injection with her husband. CC: Feeling Funny, Weakness, and Shuffling Gait. Denies Respiratory involvement. Vital Signs Stable  No Rash observed. Patient reports s/s started while shopping at shopping center three hours after injection. Reports history of Anxiety and reports taking Xanax the night before the Covid Appointment.
Area around admin site is red and inflamed with pain. Redness and swelling began about 27 hours after vaccine administration, and has increased over past 24 hours.
Ok the reason I ended up having to seek care from the DR is because the onset of a severe headache that I started to get about an hour after the 2nd dose of the vaccine and it would not go away on it's own. I also had body aches and a sore arm but those are not something that I got attention for. I believe I contacted the DR on the same day but I am not totally certain. The DR ended up giving me pain medication which ended up making the headache go away. The headaches lasted for six days before I was able to get medication and take care of it. I get migraines but this was very different, a different headache.
pt c/o unable to walk d/t swelling & arthralgias in knees;saw MD for tx was better 2 days later
1140 Medical Technologist from HCF calling to report that a patient who received the J&J covid vaccine in March now tests positive for Covid 19.  Patient started having a cough and shortness of breath on June 1st.  Arrived at the hospital June 4th.  Diagnosis : Covid pneumonia.  Patient is improving on 3 liters of oxygen via nasal cannula.  Meds:  albuteral,  decadron, apap , zofran, Remdesivir .   Patient has history of being  overweight ,  diabetic , and hypertensive.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  ACUTE NON ST ELEVATION MI  9/30/2022 &  12/3/2022 --  RECURRENCE OF SAME SYMPTOMS
Body aches, headaches, chest/stomach aches, tiredness. Lasted 2-3 days after the shot.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 14-DEC-2018, the patient was vaccinated with improperly stored VAQTA (lot # R013859, expiration date 14-JUN-2019) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Tingling in hands and arm soreness, feeling like they are asleep 1 hour after injection. No treatment. Symptoms eventually resolved.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 2:13 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 2:13 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 46.87 for dose administered on 3-Apr-2021 No concomitant medications were reported. Batch number 030B21A underwent temperature excursion on 3-Apr-2021 with temperature 34 degrees Fahrenheit from 09:00 AM. This vial was moved to fridge on 30-Mar-2021 and beyond use date for the vial was reported as 29-Apr-2021. Product moved to clinic on 3-Apr-2021. Vial was stored in cooler 1, on 03-APR-2021, Excursion duration at 8 am 38, at 9 am 34, at 10 am 38, at 11 am 42, at 12 pm 41, at 1 pm 41, at 2 pm 41, at 3 pm 40 and at 4 pm 40 and 5 pm 41 taken using a Fisherbrand traceable temperature monitor in F. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. No treatment medications were reported.
Skin infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SKIN INFECTION (non-serious), outcome "unknown", described as "Skin infection". Therapeutic measures were taken as a result of skin infection.  Additional information: Patient (Pt) wants to know if he chooses to postpone his second dose of the Pfizer COVID-19 vaccine due to his skin infection and being on antibiotics how long can he wait to receive the second dose after receiving the first dose beyond the recommend 3 week interval. Pt states that he has a skin infection and that his doctor (HCP) has prescribed antibiotics for him to take. Pt was concerned that currently taking these antibiotics at the same time that he is scheduled to receive his second dose may cause the Pfizer COVID-19 vaccine to be less effective or produce less antibodies. He would like to know if taking an antibiotic would cause any interactions with the vaccine. Pt states that he did not have any side effects after receiving his first dose of the Pfizer COVID-19 vaccine, however, he would like to know if he can take Tylenol in the event that he does have side effects after his second dose. He also states that he heard people should not take Tylenol prior to receiving the vaccine. Pt states that at the location where he received his first dose of the Pfizer COVID-19 vaccine the vaccination providers were administering Pfizer and Johnson and Johnson covid vaccines. He asks if he needs to verify that he receives the Pfizer COVID-19 vaccine for his second dose. Pt when received his first dose of the Pfizer COVID-19 vaccine he noticed that there were different colored caps on the vials and he states that with the new authorization of 12 years old and older being able to receive the Pfizer COVID-19 vaccine he is asking if there is any different in the doses for children versus adults (do the different color caps mean different dose strengths). What was the weight range in the group of 12 to 15 year olds in the Phase 3 study. Pt would like to know if the Pfizer COVID-19 vaccine is just as effective when the second dose is given at 6 weeks versus the recommended 3 weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
One week after receiving first vaccine developed red rash on left arm around injection site. Up until this point only experienced soreness in my left arm for approximately 2 days after injection.
COVID vaccine breakthrough case. Moderna 3/20/21 045A21A, 4/17/21 016B21A and boosted 1/19/22 013H21B
Pain in arm; Armpit tender; couldn't eat; headache; shivering; sweating; heat; muscle tightness; This case was reported by a consumer via call center representative and described the occurrence of feeling hot in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Concurrent medical conditions included back disorder.   On 31st December 2019 14:00, the patient received the 1st dose of Shingrix. On 31st December 2019, less than a day after receiving Shingrix, the patient experienced feeling hot, muscle tightness, shivering and sweating. On 31st December 2019 19:00, the patient experienced headache. On 1st January 2020, the patient experienced bedridden and unable to eat. On an unknown date, the patient experienced pain in arm and axillary pain. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the feeling hot, muscle tightness, shivering, sweating, bedridden, unable to eat and axillary pain were unknown and the outcome of the headache was resolved with sequelae and the outcome of the pain in arm was recovering/resolving.   It was unknown if the reporter considered the feeling hot, muscle tightness, headache, shivering, sweating, bedridden, unable to eat, pain in arm and axillary pain to be related to Shingrix.  Additional details were received as follows: The patient stated that after vaccination she felt heat running through her veins. The patient started feeling muscle tightness that got worse and worse until she could not even sit on the couch. The patient had a bad headache that progressed to the worst headache she had ever had. The patient stated that the head was in a vice with constant pressure. The patient also had some shivering and sweating, but the headache was the part that was very bad. The patient lay in bed all day because she could not do much and could not eat. The patient arm was little sore and her armpit was very tender. The patient does not want to get the 2nd dose. The patient stated that would rather have shingles again. The patient did not consent to follow up.
I passed out or fainted; I passed out or fainted; Hand and feet were extremely cold; This is a spontaneous report from a contactable consumer. A 52-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Right arm on 04May2021 (Batch/Lot Number: EW0164; Expiration Date: Aug2021) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 05May2021, 1 day after the administration of vaccine the patient experienced I passed out or fainted and Hand and feet were extremely cold. Clinical course reported as I passed out or fainted and my hand and feet were extremely cold before fainting. Patient stated, that he had been trying to report an adverse reaction to the Pfizer COVID 19 Vaccine, the second shot through the 'portfolio' on the website and he tried 3 times and for whatever reasons it just won't transmit the information. So he was wondering, it is possible to report that with a live agent today. The outcome was not recovered for Hand and feet were extremely cold and unknown for rest of the events.
This retrospective pregnancy case was reported in a literature article and described the occurrence of stillbirth in a female subject of unspecified age who was vaccinated with H1N1 (manufacturer unspecified). On an unspecified date, the subject received unspecified dose of H1N1 (unknown route, site of injection and batch number). Her last menstrual period was on an unspecified date and estimated date of delivery was not provided. The subject was exposed to the vaccine during the first trimester. At an unspecified time after vaccination with H1N1 and after an unspecified number of weeks of gestation, the subject experienced stillbirth. This case was assessed as medically serious by GSK. This case is linked to 27 other cases (related by publication). Summary of the article: The potential serious consequences of maternal influenza infection in pregnancy have long been recognized; pregnant women are at increased risk for influenza-associated morbidity and mortality. As reviewed recently, there are limited data on the safety of influenza vaccine in pregnancy; however, to date, there has been no indication that seasonal influenza vaccines containing inactivated virus pose a risk to the mother or the foetus. This has led to the current recommendation that all pregnant women be vaccinated with the seasonal influenza vaccine regardless of trimester. Despite these recommendations, vaccination rates remain less than optimal. Surveys have demonstrated that mother's concerns about safety contribute to poor compliance with vaccine recommendations. This situation was escalated during the 2009-10 H1N1 season, when lack of safety data about the H1N1 was coupled with intensive public health messaging that emphasized the need for all pregnant women to be vaccinated. Additional safety information on H1N1-containing vaccines when used in pregnancy was therefore needed. The purpose of this study was to evaluate the foetal risk and relative safety of the H1N1. To assess risks and relative safety of the H1N1-containing vaccines, the author conducted a prospective cohort study of H1N1-vaccine-exposed and unexposed comparison women who were recruited during pregnancy and followed to outcome between October 2009 and August 2012. There were 1032 subjects available for analysis; 841 women were exposed to a H1N1-containing vaccine in pregnancy, and 191 women were unexposed to any influenza vaccine in pregnancy. Nine of 328 (2.7%) first-trimester-exposed pregnancies resulted in an infant with a major birth defect compared to 6/188 (3.2%) in the unexposed. The hazard ratio (HR) for spontaneous abortion was not elevated. Adjusted HRs for preterm delivery were elevated for exposure anytime in pregnancy, specifically with exposure in the 1st or 2nd trimester. However, the mean decrease in gestational age in the exposed pregnancies was approximately three days. In conclusions, no meaningful evidence of increased relative risk or HR for major birth defects, spontaneous abortion, or small for gestational age infants was demonstrated.
Large local reaction to smallpox site with lateral/medial redness extending down deltoid spreading anteriorly into bicep (4x2inches).  Site pale red and warm to touch with no spreading vesicles.  + left axillary lymphadenopathy, Full ROM left arm with good grip and no paresthesia.
I was given Gardasil first dose on 8/23 and started to experience intermittent twitches, spasms and muscle weakness in my back, behind my armpit. Symptoms went on for 3 more days, sometimes twitches to where the shoulder moves along
pt devel pruritic rash on chest & abd 3 days p/vax;pt also exp flu-like sx for a few days;pt recovered as of the date of this report;this is one of 4 pt from this site to have an adverse exp p/flu vax;
patient recieved an expired vaccine, no AE; Initial information received on 17-Jun-2020 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional.  This case involves male patient (age not reported) who received a dose of vaccine IPV (VERO) [IPOL], which was expired on 02-May-2020, (lot number not reported) via unknown route in unknown administration site as prophylactic vaccination on an unspecified date.  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to expired vaccine used.  No adverse event was reported at the time of reporting.  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.  There will  be no information on the batch number for this case.
On 1/20/09 after clinic visit, and @ 7:30p felt dizzy, faint, sensitive to light and mom states pt. got really pale. Mom gave tylenol and went to sleep. When getting up this am, feels dizzy, faint when standing up headache enc to seek pmd care. Saw Dr. P/c attempted 4x's. No answer.  2/3/09 MR received from PCP for OV 1/21/09 for c/o dizziness, H/A and weakness x 1 day since receiving shots. Took first OCP that day as well. Reports light sensitivity, spinning sensation. PE WNL.  Impression:  Dizziness/ Vertigo.  Suspected adverse reaction to either HPV or OCP. Tx:  Meclizine