chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt received vaccine next day pt called and said pt injection site was swollen to golf ball size pt had fever and was vomiting too pt ice area and took ibuprofen and after 2 days symptoms improved still a little swollen but much better
Volunteer inadvertently administered this vaccine to a 17yo (ineligible for Moderna).
Arm was red from shoulder to elbow. Was seen by physician on 09/28/17.
Generalized urticaria, post vax, (less than 24 hours later); resolved with Benadryl.
Fever of 99.8F; Chills; Sore at injection arm; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 99.8F), CHILLS (Chills) and INJECTION SITE PAIN (Sore at injection arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included AMOXYCILLIN [AMOXICILLIN] for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced INJECTION SITE PAIN (Sore at injection arm). On 20-Feb-2021, the patient experienced PYREXIA (Fever of 99.8F) and CHILLS (Chills). At the time of the report, PYREXIA (Fever of 99.8F), CHILLS (Chills) and INJECTION SITE PAIN (Sore at injection arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Feb-2021, Pyrexia: inconclusive (Inconclusive) 99.8F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatments were reported.
This was (is) modest but I was encouraged to report it: Itching at the site on the arm, reddening of the skin around it (about the size of a quarter). This has continued now for about 18 hours with varying intensity but nothing dramatic. I expect it to ease off over the next day or two.
Bell's Palsy, went to Emergency department in Feb 4th 20201, was monitored and given corticosteroids and I had a negative COVID test. I was also experiencing loss of taste, fever, muscle pain, join pain, chest pain, chills, drowsiness.
body aches, lethargy, earache:  within first 24 hours early onset of menstruation: 72 hours after injection
Information has been received from a health professional concerning a patient who on 19-OCT-2006 was vaccinated with a first dose of Rotateq. It was reported that on 12-FEB-2007 the patient would be coming into the office for a second dose of Rotateq. No symptoms had been reported. No product quality complaint was involved. No other information was provided. Additional information has been requested.
urinating constantly; up all night; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75 year-old female patient received bnt162b2 (BNT162B2), administration date 28Mar2021 (Lot number: ER2613) at the age of 75 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing); "Hot flashes" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Lot number: EN6199; in shoulder as dose 1, single), administration date: 05Mar2021, when the patient was 75 years old, for COVID-19 immunisation, reaction(s): "Diarrhea". The following information was reported: POLLAKIURIA (non-serious) with onset 28Mar2021, outcome "not recovered", described as "urinating constantly"; POOR QUALITY SLEEP (non-serious) with onset 28Mar2021, outcome "unknown", described as "up all night".  Additional information: Vaccine was administered in the shoulder (as reported). It was reported that the patient got her last shot on Sunday (28Mar2021) and has been urinating constantly, up all night, back and forth.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021369170 Same reporter, drug and event; different patient
Patient was menstruating regularly before vaccination. Not heavy flow.  No period for May and June 2021. July - period for about 3 weeks. Aug - period with huge  table tennis ball size clots. Clots at least 3 times a day. Flow become heavy. Pads would drip blood. Had to move from ultra thin to heavy pads. Don't remember menstruating this heavy even in my younger days.   Periods every 2 weeks. 2022 ? still having more blood loss compared to before vaccine but less than after vaccine.  Clot size now small. Maybe size of 3 cherries.   Still having to use medium size pads instead of ultra thin pads.
After receiving the vaccine . Patient complained of feeling dizziness and tingling in the body and mouth. Patients left palm also turned very red.
swelling in the injection arm, but felt normal; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling in the injection arm, but felt normal) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included METFORMIN and SITAGLIPTIN PHOSPHATE (JANUVIA [SITAGLIPTIN PHOSPHATE]) for Diabetes.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE SWELLING (swelling in the injection arm, but felt normal). At the time of the report, VACCINATION SITE SWELLING (swelling in the injection arm, but felt normal) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.
The pt experienced a swollen arm with 3 X 5 inch area of redness. The pt recovered within 48 hours. From follow up correspondence received on 4/16/01, it was reported that the adverse event occurred on 4/28/99. "Reviewed, no additional info at this time."
Client reported feeling "itchy"  approx. 15 after 1st Pfizer dose. V/S taken @ 10:56 am and WNL. RN on site assessed areas where client reported feeling itchy: lower back, scalp, and abdomen. No hives or visible signs of rash observed. Client reported having similar reactions with all vaccines and takes Atarax medication for relief. Client was offered and declined benadryl from lead RN due to she "hates drowsiness from Benadryl; prefer to take Atarax at home." Client was observed for 30 minutes and left unassisted with a family member, observed to have a steady gait. Denied SOB or and was A&Ox 4
Initial unsolicited report received from a nurse on 30-May-2018. This case involves an eight-year-old patient (gender not reported) who was vaccinated a dose of ADACEL) Batch number, expiration date, dose, route and site of administration was not reported for both vaccines) on an unspecified date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to inappropriate age at vaccine administration. It was reported that patient had received four doses of PENTACEL on board and did not received 5th DTaP and is now 8 years old and just received a QUADRACEL. No adverse event 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 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. List of documents held by sender: none.
Information has been received from a physician concerning a 15 year old female who in approximately May 2007, was vaccinated with 0.5 mL of the first dose of Gardasil. Subsequently the patient developed a subcutaneous pea size nodule at the injection site that can not be seen but can be felt. As of 20-JUL-2007, the patient had not recovered. Medical attention was sought. Additional information has been requested.
Fever of 102.1, muscle aches all over, stuffy nose, headache, nausea, chills, and dizziness.
Pt was given DTaP in right deltoid on 8/22/12. Within 24 hrs pt had 10 x 8 cm area of erythema and induration which was painful. This resolved over 3 days. Interestingly, since then pt will get recurrent swelling and erythema in same area about every 2-3 months. Was seen by Allergist who diagnosed pt with recall urticaria secondary to DTaP.
Mild fatigue; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the arm left on 04May2021 at 10:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. Concomitant medications were not reported. The patient had no known allergies. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the arm left on 13Apr2021 at 10:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 05May2021 at 11:00, the patient experienced mild fatigue relieved by rest. The clinical outcome of the event mild fatigue was recovered on an unknown date in May2021.  No follow-up attempts are needed. No further information is expected.
Papular vesicular lesions noted Day #4 after vaccina vaccination in right index finger, right wrist, right elbow, left prox thigh and on 4/13/06 noted 3 new lesions on face forehead. On 4/17/06 all lesions fading. No systemic symptoms.
This spontaneous report received from a consumer via a company representative via social media (JNJ Corporate) concerned a male 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 previously received with Covid-19 vaccine ad26. cov2.s (dose number in series 1) (unspecified manufacturer) (suspension for injection, route of admin and batch number were not reported) dose was not reported, 1 total administered for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of Covid-19 vaccine ad26. cov2.s (dose number in series 1). The patient received Covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient died due to unspecified cause of death (dose number in series 2). The reporter stated that, "My ex and his brother both died from getting the J&J booster". On an unspecified date, the patient died from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20220327356. Sender's Comments: V0: 20220327268-covid-19 vaccine ad26.cov2.s-death. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable. Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH.
Repeated vomiting the evening after vaccination and then diarrhea 2 days later. No fever.
Atypical measles rash, fever. Rash started on face and progressed throughout body. Still has some rash but is resolving.
Pt recvd vax & exp fever, chills, myalgia & diarrhea, next day exp diarrhea, incontinent & to weak to get out of bed; exp lt leg swelling, edema, cellulitis; pt was adm; MD felt poss GBS; also erythema, flu sx, gouty podagra; pt flushed;
Site: Pain at Injection Site-Severe, Systemic: Shakiness-Medium, Systemic: Weakness-Medium, Additional Details: Patient states cannot lift her right arm and it shakes when she lifts her arm.  There is constant pain at the injection site that is tender to touch and the pain is getting worse.  She has a hard time gripping with her hand when she lifts her arm. Her arm feels weak.
Received H1N1 1-14-10, pt developed severe HA 1/15/10 which lasted over 4 days. Had to go to Emergency Room and clinic several times for pain relief.
the patient was given FLUBLOK  instead of Flucelvax, no AE; Flublok was administered to a 15-year-old patient, no AE; Initial information was received on 15-Oct-2020 regarding an unsolicited valid    This case involves a 15 year old male patient who was vaccinated with a 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot QFAA2010 and expiration date was not reported) via an intramuscular route in the right deltoid for prophylactic vaccination on 14-Oct-2020 instead of INFLUENZA VACCINE INACT SAG 3V [FLUCELVAX] (wrong product administered, Product administered to patient of inappropriate age).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  No concomitant medication was given.   This was an actual medication error case due to wrong vaccine administered and inappropriate age at vaccine administration (latency same day).  At the time of reporting, no adverse reaction reported (unknown to reporter).  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.
Presented to local emergency department with symptoms of shortness of breath, cough, loss of taste and smell. Symptoms had been present for approximately 1 week at time of presentation. She was transferred to unspecified medical facility for admission and eventually transferred to ICU.
Patient received 1st dose on 4/5/2021 and did not receive their 2nd dose until 5/16/2021. Patient got COVID after their 1st dose.
Mother had the tetanus shot due to laceration late October 1995, just before Halloween.  Became pregnant 8 weeks later on 18 December 1995.  Had undiagnosed placental abnormality resulting in vasa previa rupture at term and DEATH of normal 8 pound infant 36 hours after birth which took place 12 Sept 1996.
This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Malaise), DECREASED APPETITE (Decreased appetite,), SWELLING (Swelling on the left side), ABDOMINAL DISCOMFORT (Upset stomach) and PAIN IN EXTREMITY (thumb and wrist pian) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced MALAISE (Malaise), DECREASED APPETITE (Decreased appetite,), SWELLING (Swelling on the left side), ABDOMINAL DISCOMFORT (Upset stomach), PAIN IN EXTREMITY (thumb and wrist pian), IMPAIRED WORK ABILITY (Left knee pain, thumba nd wrist pain, hard to work), ARTHRALGIA (Left knee pain), MYALGIA (Muscle soreness,), HEADACHE (Headache) and PYREXIA (Low-grade fever). At the time of the report, MALAISE (Malaise), DECREASED APPETITE (Decreased appetite,), SWELLING (Swelling on the left side), ABDOMINAL DISCOMFORT (Upset stomach), ARTHRALGIA (Left knee pain), MYALGIA (Muscle soreness,), HEADACHE (Headache) and PYREXIA (Low-grade fever) outcome was unknown and PAIN IN EXTREMITY (thumb and wrist pian) and IMPAIRED WORK ABILITY (Left knee pain, thumba nd wrist pain, hard to work) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment included ibuprofen and acetaminophen.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: updated additional information- events (left knee pain, thumb and wrist pain upset stomach and hard to work)
1st day after vaccine - fever up to 100.4, chills and headache, 3rd day - 4 episodes of diarrhea and nausea and vomiting, headaches, fatigue and bodyache
every dose made her sick; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Celiac disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162B2 (DOSE 1, SINGLE), for COVID-19 Immunization, reaction(s): "every dose made her sick". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "every dose made her sick".  Additional information: The patient reported that every dose of the Pfizer COVID-19 vaccine (original primary series and two booster doses) made her sick. She suspected that this reaction was caused by gluten or an egg-derived ingredient. She took a third booster dose from Moderna and that vaccine didn't make her sick at all.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201206645 Same patient/drug/event, different dose;
Pt was given TDAP (Adacel) instead of DTAP to complete primary series accidentally. Will need to follow-up for DTAP. No adverse event. Pt given wrong vaccine and must return for correct one.
Woke up around 1:30am with extreme chills, shakes, tremors, teeth chattering, and could not stay still in bed. Took Tylenol in the evening and took another dose at 2am. It was about 78 degrees in our house that evening, and I had a comforter and another blanket on in bed.  The chills subsided by 7am, but then my body felt like it got hit by a truck and was hard to move or get out of bed. I had to stay home and attempt to work from home, although the body weakness and headache lasted until 8pm on 4/28.  Overall, it felt like flu condensed into a 24 hour period.
severe headache, body aches, lack of appetite tylenol and ibuprofen, plenty of fluids feeling much better after 36 hours
Per Department of Public Health recommendation and CDC guidelines: case offered reimmunization with Pfizer Vaccine for appropriate age in 8 weeks.
Patient reports approximately 1 week +/1 day after receiving her first Moderna COVID-19 vaccination she began to feel a tingling/numb sensation on her tongue. The following day when she awoke she had complete paralysis of one half of her face. Patient then went to see PCP where she was informed she had developed Bells Palsy. Patient is currently being treated with high dose steroids as well as valacyclovir.
Sore muscles in the left arm were severe that day. Over a few days the muscle pain was less, but has never gone away. I am still experiencing muscle pain in my upper left arm to such a degree that I don't have full use of that arm.
patient states his hand started to swell up on same side he got vaccination about 10 minutes after getting the shot.  Patient states that it got worse over 24 hours and then he was having trouble grasping objects with the swollen hand.
Initial and follow-up reports were received from a nurse on 13 September 2010 and 15 September 2010, respectively. A 71-year-old female patient had received an intramuscular left deltoid injection of FLUZONE High-Dose (lot number U3600AA) on 10 September 2010 as part of her well visit. When the patient returned home, an 8 mile ride from the office, she felt like her throat was closing off, but her airway was not obstructed. She could not catch her breath and was nauseated and shaky and vomited one time. The patient did not want to go to the hospital and self-mediated with BENADRYL. Fifteen minutes after taking the BENADRYL, the patient felt better and all her symptoms resolved within one hour. It was noted the patient had medical conditions of asthma that was being treated with albuterol and QVAR and hypertension that was treated with an unspecified medication. The patient receives yearly flu vaccines. It was reported the patient has a history of local reactions to prior vaccines (reactions and vaccines not identified), and was not pre-medicated prior to receiving the FLUZONE HD; and did not stay at the office for observation after the vaccination. Per the reporter, the events was considered to be an anaphylactic reaction, but did not know if she would call it severe or not, but if the patient had been in the office when it happened she would have given EPI. The reporter has since followed up with the patient and reported that the patient had not experienced any other symptoms and has not needed any other follow-up or care. Documents held by sender: None.
Pt developed hives and mild angio edema of hard areas, face, lower extremities. H/o fever 102 24 hrs after vaccination.
Three days after second Pfizer shot, extreme chest pain, tightness.  PCP Seen and PCP sent to cardiologist for full workup.  EKG normal.  Patient sent for urgent  CAT scan with contrast to check for pulmonary emboli.  None found.  Results normal, but patient on day 10 of severe chest pain and tightness.  Doctor suggested it is inflammation brought on by vaccine.
A report was received from a healthcare professional on 15/Nov/2006 concerning a  unidentified vaccinee.  No other details were provided at this time.  Further information was received on 28/Nov/2006 from the same healthcare professional concerning a 69-year-old female vaccinee. The vaccinee has a history of diabetes, no details concerning concomitant medications were provided.  On 03/Nov/2006 the vaccinee received Fluvirin in the left deltoid.  Eight days later she awoke in the night with severe left arm pain which did not resolve. The following day 11/Nov/2006, the vaccinee attended the emergency room where investigations were carried out to elicit the cause of the pain, a treadmill stress test, cardiac enzymes, glucose reading, X-ray of the C-spine and CT scan were performed and were all reported with TYLENOL #3 with codeine which had no effect, and Morphine which resulted in an itchy rash, but no pain relief.  TORADOL was then administered with pain relief 1 hour, and was repeated a number of times.  On 13/Nov/2006 the vaccinee pain resolved, the itching and rash had also resolved, and she was discharged from hospital.  No cause was found for the left arm pain, and the vaccinee has had no recurrence.  A copy of the hospital discharge summary has been requested.
Redness, itching and swelling occurred within a day on the upper arm about 15 mm from spot where vaccine was given (the area is about 10 x 15 cm).
Rash around injection site. Small red, chicken pox like areas scattered on left arm, left side of neck, and breast. Some complaints of itching. Hydrocortisone cream was ordered. Resident states it is no longer itching. Area seems to be resolving.