chrisvoncsefalvay/vaers-outcomes huggingface dataset:
7/29/21 first dose of vaccination, 8/8/21 Diarrhea, fatigue, previous days exposure, 8/9/21- tested positive
Patient states she has redness/soreness/tenderness and warmth at the injection site since the day of the vaccine. It is now 6 days later and she reports the same symptoms. On 8/7/16 the patient reports having red spots develop and pain that woke her up in the night.
Vaccines administered. Seen 2 days later at 4th BAS with pain, swelling, erythema to right arm from shoulder to elbow. Vitals BP 192/86, P 104, R 16, T 99.1.RX- Ciproflaxin, Naproxan, Benadryl, Patient monitored-then dc'd.  Bedrestx24 hrs. Seen for f/u next day with decreased symptoms.
Felt faint over weekend, increased pulse when getting up, bright red rash all around the arm, lump at site on date of vaccine which is still t here and is size of egg yolk, VERY SORE. Patient called doctor and was told to take Benadryl.
Per mom; Redness cover upper Arm  the Night of shot & persists 2nd day to slowly  Reslove. Arm was tender on 1st day; less so the 2nd  day.
Noticed in area that vaccine was given that multiple red whelps in a circle developed.  C/o mild soreness, no pruritis.  The area started small but by the next day site reaction was a little larger than golf ball size.  Reports this morning that looks more like one whelp and still red in color.  No fever.
Pregnancy; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a 32-year-old female patient (para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025T20-2A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use in August 2020. Concurrent medical conditions included Asthma since 2002. Concomitant products included LORATADINE for Allergy, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-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 11-May-2021. On 31-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). The vaginal delivery occurred on 10-May-2021, which was reported as Full-term. For neonate 1, with an APGAR score of 8 and 9 at (1, 5 minutes). The outcome was reported as Delivered NOS. On 31-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided. Estimated date of conception- 4 Aug 2020 Patient delivered a female baby (weeks at gestation 39 weeks, weight (3.7 kgs), length (53.3 cms) and head circumference (33 cms).   Most recent FOLLOW-UP information incorporated above includes: On 01-Aug-2021: Significant follow up appended to AER-updated pregnancy information and outcome.; Sender's Comments: This is a case of product exposure during pregnancy with no associated adverse events for this 32-year-old female patient. Patient will continue to be contacted for further monitoring of adverse events during the pregnancy.
Initial and follow up information has been received from a Registered Nurse and physician's office concerning a 14 and 1/2 year old white female patient who on 10-JAN-2008 was vaccinated IM with a first dose of pneumococcal 23v polysaccharide vaccine lot # 659149/1383U. The reporter reported that the patient got injection site reaction of pain, swelling and redness. In follow up the reporter reported that the patient was febrile, nauseated, did not feel well and had warm tender arm for several days. Her arm was rechecked on 24-JAN-2008 in the doctor's office visit. She had no redness, warmth, tenderness and had full range of motion. She recovered after 24-JAN-2008. Additional information is not expected.
A few hours after vaccination the fever started and muscle aches/chills also began. Around 10:00 P.M., pain in the right calf started and light pain in the left side of the chest with shortness of breath. Patient went to the ER and was hospitalized for 1 day.
1) On 3/1/21, 3 days after first dose of Pfizer, started to get a cold sore on mouth. Self-treated with L-lysine for 2-3 days to keep it from breaking out. Disappeared after about 3-4 days.  2) On the night of 3/4/21, 6 days after vaccine, came down with achiness, chills, general malaise, a little nausea. Treated with rest. Lasted  18-24 hours.
Information has been received from a woman in a physician's office concerning an 8 year old male with a history of "SBE" who on 21-AUG-1998 was vaccinated SC in the right arm with a first dose of Varivax (lot # 625045/1573E). There was no illness at the time of vaccination. On 12-APR-2006, the patient developed chickenpox and was seen by the physician. No diagnostic laboratory tests were performed. Subsequently, the patient recovered from chickenpox on an unspecified date in April 2006. Additional information is not expected.
Patient was 16 when vaccine was administered. (authorized for 18 and older) No known adverse reactions.
No additional AE; an expired dose of PROQUAD was inadvertently administered to a patient; Spontaneous information has been received from a nurse referring to patient of unknown age or gender. Information regarding the patient' medical history, concurrent conditions, concomitant therapies and drug allergies or reactions were not provided.   On 28-FEB-2022, the patient was inadvertently administered an expired dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (dose and route not reported; lot # T029102, expiration date: 23-FEB-2022). It was confirmed that the vaccine was not involved in any temperature excursion prior to the administration and had been stored in the recommended storage range until the administration. No additional adverse event was reported.
Unable to create wheel on first and second try, administered both times on left forearm. Administered a 3rd time on R forearm and wheel was successfully created. For the three attempts the same lot number was used of FDP00009 with exp: 05/24.
Upset stomac, chills, fevers, headache, sore arm. Lasting 2 weeks. Gradually lessening the end of the third week.
MODERNA COVID VACCINE #3 GIVEN 8/23/21, LOT #003B21A; 2/4 - 2/15/22 pt in hospital and treated for COVID pneumonia; dc'd home with 4L O2 via NC; 2/19/22 pt to ED; still positive for COVID; requiring 7L O2 via NC with O2 saturation 80%; eventually placed on Vapotherm; CXR showed multifocal pneumonia; ABX, Albuterol, Vitamins C & D, zinc, steroids; transferred to ICU; eventually requiring intubation; multiorganism pneumonia; ABX and antifungals given; developed shock, treated with vasopressors; renal function worsened requiring CRRT; condition worsened more; pt lost pulse; code called; CPR, shocks, medications with improvement; pt passed away in the hospital
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 78-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 9th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced pain in arm and incomplete course of vaccination. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the incomplete course of vaccination was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The reporter stated that, the patient experienced pain in her arm following the 1st dose (received in an unknown arm) and therefore put off getting the 2nd dose beyond 6 months. Till the time of reporting, the patient had not received the 2nd dose of SHINGRIX, which led to incomplete course of vaccination.
VACCINE IS  INDICATED FOR AGES 18 AND OLDER AND P T IS 17
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 04-MAY-2012, the patient was administered with a dose of VARIVAX (Merck) (Lot # 669646/1703Z, expiry date 09-DEC-2012) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Called to obs area due to complaint of right arm pain after injection, radiating down to right hand, specifically 5th finger, same side as injection. First injection, no history of adverse reactions to immunizations. No ShOB, CP, N/V, diaphoresis. AOx4, normal speech, HRRR no murmur, CTAB, RUE NVI. Spoke to patient and monitored for greater than 5 minutes, she states she feels like it is subsiding at this point. Recommend heat/ice to the area as preferred/tolerated. Patient observation time extended by 15 minutes in total and had no further issues.
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age. Concurrent conditions and medical history of the patient were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored doses of VAQTA (lot# K005958, expiry date 09-FEB-2017; lot# K007791, expiry date 22-AUG-2016; lot# K018181, expiry date 04-JUN-2017; lot# K018182, expiry date 12-FEB-2017; lot# K019560, expiry date 02-JUN-2017; lot# L002717, expiry date 02-JUN-2017; lot# L018499, expiry date 25-FEB-2017) (dose, route unspecified). Concomitant therapies were not reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
hyperthyroid; hair to fall out; This is a spontaneous report from a contactable consumer. This patient reported information for herself and another patient. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced hyperthyroid and hair to fall out on an unspecified date. The outcome of the events was unknown.  Information on lot/batch number has been requested.
cough; mild shortness of breath; Fever; Chills; Nausea; Fatigue/tiredness; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough), DYSPNOEA (mild shortness of breath), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included INSULIN and PANTOPRAZOLE for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced COUGH (cough), DYSPNOEA (mild shortness of breath), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea), FATIGUE (Fatigue/tiredness) and ARTHRALGIA (joint pain). At the time of the report, COUGH (cough), DYSPNOEA (mild shortness of breath), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea), FATIGUE (Fatigue/tiredness) and ARTHRALGIA (joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported.
2 days p/vax pt exp swollen, indurated erythematous area on left deltoid.
This spontaneous report as received from a nurse refers to a patient of unknown gender and age. No information regarding the patient's concurrent conditions, medical history or concomitant therapies was provided. On 08-AUG-2016, the patient was vaccinated with a dose of GARDASIL 9 (formulation, route of administration were not provided, lot # M003659, expiration date 20-SEP-2017) for prophylaxis. On 15-NOV-2016, the patient was vaccinated with a dose of GARDASIL (formulation, route of administration were not provided, lot # K011562, expiration date: 08-APR-2017) for prophylaxis. No adverse effects were reported. Additional information has been requested.
I had bad and swollen sore throat, sinus drainage, difficulty swallowing, and fever. I tested positive for COVID-19 at home. My doctor sent me to the ER for an infusion which they did not do anymore. So, they sent me home without doing anything. My doctor sent in a prescription for Paxlovid and my symptoms went away almost immediately.
Sore throat; Fever; 17-year-old received the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), PYREXIA (Fever) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old received the Moderna vaccine) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), PYREXIA (Fever) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old received the Moderna vaccine). On 07-Sep-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old received the Moderna vaccine) had resolved. At the time of the report, OROPHARYNGEAL PAIN (Sore throat) and PYREXIA (Fever) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: Follow up received on 10-SEP-2021 and does not contain any new information On 13-Sep-2021: Follow up received on 13-SEP-2021 and does not contain any new information
HCP reports no further AE's; inadvertent administration of PROQUAD to a 29 year old female instead of MMR II; This spontaneous report was received from a medical assistant referring to a 29-year-old female patient. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 24-FEB-2022, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) 0.5 milliliter, one time, lot number T032150, expiration date 20-MAR-2022 for prophylaxis (route of administration not provided), instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (wrong product administered). Measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) was diluted with 0.5 milliliters of sterile diluent(STERILE DILUENT) lot number S024969, expiration date 17-MAR-2022. No adverse event was reported.
Acute pericarditis, severe chest pain, colchicine 0.6 mg tablet 2 times per day for 10 days, asprin 81 mg
immed itching @ site progressed to 5cm sized red welt; by 2 1/2 hrs later red splotches on chest & reddened, burning eyes;welt @ site lasted 3-4 days;took one dose of DPH  30-45" p/inj;no resp signs/sxs devel
Vaginal Yeast Infection started 2 days after second Covid vaccine. Purchased cream but it is not helping. Going to Dr. tomorrow. I have never had a yeast infection in my life, so the Covid vaccine definitely caused this.
Patient got COVID after receiving vaccine; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Patient got COVID after receiving vaccine) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced COVID-19 (Patient got COVID after receiving vaccine). At the time of the report, COVID-19 (Patient got COVID after receiving vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment was provided.
Patient developed large hive, swollen/red/raised welt at site of immunization (the size of her entire upper arm). Recommended BENADRYL and hydrocortisone cream.
Member presented with a pruritic rash that had developed on his face approximately 12 hours after receiving his 5th Anthrax vaccination. The rash had spread to his torso and lower extremities. Findings of  punch biopsy felt to be consistent with an erythema multiform reaction. The patient was treated wtih a 2 week course of prednisone and intramuscular diphenhydramine(Benadryl), and clearing of symptoms was noted within 10 days.
This case was reported by a pharmacist and described the occurrence of raised liver function tests in a 30 year old male patient who received hepatitis B vaccine recombinant for prophylaxis. On an unspecified date, the subject received the second dose of Engerix B. On an unspecified date in 2004, the patient was exposed to Xylen, Formalin, and Acetone. The pharmacist reported that the exposure was primarily inhalation on repeated occasions, with limited skin exposure. At an unspecified time in 2004 following the second administration of Engerix B and following the exposure to xylen, formalin, and acetone, the patient experienced slightly elevated liver function tests, elevated bilirubin of 1.2 or 1.3, elevated monocytes (value not reported), and a headache. Concurrent medications and medical history were not reported. The outcome of the events was unknown at the time of initial reporting. Comment: Raised liver function tests and elevated bilirubin were assessed as medically serious (OMIC). 60 day follow-up report from GlaxoSmithKline (October 1, 2004 to October 21, 2004). As per third party events are unresolved symptoms continue.
Information has been received from a RN concerning a 48yr old female who on 07Sep05 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (0.5ml) (IM) (lot 550453/0791P). Subsequently, within two days, the pt experienced injection site redness, mild swelling and arthralgia. The pt was treated with ice, ibuprofen (Tylenol) and ibuprofen, as needed. No product quality complaint involved. It was also reported that another pt had an adverse reaction following vaccination with pneumococcal 23v polysaccharide vaccine (WAES0509USA02437). Additional information has been requested.
changes in the menstrual cycle of premenopausal women; This spontaneous case was reported by a patient and describes the occurrence of MENSTRUAL DISORDER (changes in the menstrual cycle of premenopausal women) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced MENSTRUAL DISORDER (changes in the menstrual cycle of premenopausal women). At the time of the report, MENSTRUAL DISORDER (changes in the menstrual cycle of premenopausal women) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood oestrogen: higher estrogen levels in body.         Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.
March 7, 2021 at about 6:30 p.m. I had two spells where I had no control over my body.  I fell and could not get up.  I had no strength and was unable to get up.  Each time it only lasted a few seconds or minutes.  It was sort of like I fainted but stronger.  I had spent most of the day resting as I had a very bad headache but that was about gone when I had the two spells.  I had also had a small patch of hives (fever and swelling) about the size of my hand at the site of the shot.  That lasted about a week after each shot.   I thought this was something I should report.  Thanks.
Pt stated she developed itchy red rash on right and left arm and all over her waist area.
On May 11 2021, I went to the gym to workout my back muscles in after work (around 3pm). After completing a heavy set of rack pulls I got light headed. After removing the weight to put it away, I accidentally dropped 25 pounds weight which was abnormal because I lost grip while light headed. I tried to walk off the pain by walking to the other side of the gym and within the next 10 minutes my face started turning pale and my lips dark blue/purple. I was sitting down as I progressively grew more light headed and started blacking out. My brother called over several people to help me maintain consciousness and an employee noted my lip and face color, low pulse and high rate of breathing. I fainted for a couple minutes then took a sip of gatorade and bounced back. I felt like that was a near death experience. Possibly related to some heart issue. A few weeks after I got a physical checkup at my doctor's office and the bloodwork came back clean. I have nothing to show why this episode occurred and feel like I should have some heart tests as a follow up.  Before this incident I have been going to the gym without ever having experienced this kind of issue. What was notably odd though is I started having some chest pains not too long after my 2nd vaccination that I originally attributed to a bad sleeping position (I sleep on my side). I would have tightness that at times were consistent. Overtime the pain got weaker as I stopped doing intensive workouts. I thought it could've been a muscle tear but a tear would've healed by now. I still experience a bit of tightness when I do heavy chest exercise or if I compress my chest muscles and squeeze in the middle.  I'm submitting this report because its been recently identified myocarditis is a possible side affect of the vaccine.
Guillain Barre syndrome; He reports that he started to experience tingling of his feet and hands about 6-7 days ago. He came to ED at that time and was given pain medication for his back pain and muscle relaxants, which has since resolved but he feels stiffness in his lower back since then. At that time he was also noted to have low potassium and sodium, reports that he was given IVF and potassium repleted. He notes that walks everyday but noticed that for the first time his legs began to give out even when he was walking short distances within his house about 6 days ago. 2 days ago he was unable to walk short distance in his house at all and began to use a rolling chair. At that time he was still able to transfer from chair to the toilet seat. On the day of presentation he started to use a wheelchair around the house (unclear where ti was obtained, no assistance at baseline). He no longer is able to transfer himself from the chair to the bed or toilet seat. Feels that his hands are beginning to feel weak as well. He cannot tell if he is at the peak of his weakness yet. Denies difficulty with swallowing, breathing or speech. No shooting pains down his legs, no change in sensation in saddle area, no loss of control of bowel or urinary movements.