chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Symptoms Nausea, Migraine, Edema. Treatment - Antibiotic, Steroids.
This spontaneous report was received from a healthcare worker (also reported as other; details unspecified) referring to multiple unspecified patients. No information about patients' medical history, concurrent condition and concomitant medications were reported. On an unknown date, the patients were vaccinated with improperly stored doses of M-M-R II which had (lot # L012480, expiry date: 10-APR-2017; lot # L043702, expiry date: 03-NOV-2017 and lot # L035674, expiry date: 17-SEP-2017)(dose and route not provided). The vaccines were exposed to a minimum of 27 degree Fahrenheit and maximum of 57 degree Fahrenheit. The temperature excursions were detected by a data logger. No adverse effects were reported. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Tachycardia; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for herself that a 48-years-old female patient (non-pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Ew0175), via an unspecified route of administration administered at Arm left on 27Apr2021 16:15 at the age of 48 years as single dose for COVID-19 immunisation. The patient medical history and concurrent condition included Fibroids, PVCs (Premature ventricular contractions) and gerd (Gastrooesophageal reflux disease). The patient received Metoprolol tartrate, medroxyprogesterone 10 mg medications within 2 weeks of vaccination. Patient's past drug history included Latex, cipro and flagyl. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Apr2021, the patient had experienced tachycardia. The patient previously had first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Ew0150), via an unspecified route of administration administered at Arm left on 06Apr2021 04:15 PM, at single dose for COVID-19 immunisation. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient has not recovered from the event. Information on Lot/Batch number was available. Additional information has been requested.
Burning at injection site immediately upon administration Pain & swelling at injection site within an hour generalized myalgias & malaise 18-24 hours later
Patient syncope episode lasting 10 seconds. Patient history syncope post immunization. Patient evaluated for 30 minutes. Patient refusal fire department. Pt vs evaluation . WNL. Patient advised seek medical medical attention if condition worsens or reoccurs. Patient left AOX4 denies complaints. Last meal 04/05/21 at 800pm. Patient signed refusal and advised risks.
Initial and follow up information has been received from a licensed practical nurse and a nurse through the Pregnancy Registry for GARDASIL vaccine regarding a 24 year old female with von Willebrand's disease, seasonal allergies, hypertension, allergies to BENADRYL and aspirin and migraines who on 25-JUL-2007 was vaccinated intramuscularly with her first dose of GARDASIL (Lot # 658094/0524U). Concomitant therapy included OVCON 35, BENICAR and ALLEGRA. The OVCON 35 was discontinued on 24-AUG-2007. On 24-AUG-2007, the patient took a home pregnancy test (test not specified) which was positive (LMP = 20-JUL-2007). No symptoms have been reported. The patient was scheduled for an office visit on 26-SEP-2007. On 25-MAR-2008, the patient delivered a pre-term baby at 35 weeks gestation (not further specified). The baby had some respiratory difficulty at birth and was placed in the ICU, otherwise appeared healthy. No other details available at this time. Additional information is not available.
At 2am I woke up with a fever and severe headache. I went to the bathroom and then to the sink to get Tylenol. After opening the Tylenol, I could feel myself beginning to pass out so I laid on the floor where it went dark. I had faint breathing and was sweating. My arms began tingle. With assistance, I was able to return to bed with no further issues.
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 # 0975AA, expiry date unknown) (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 121 reports received from the same source. Additional information has been requested.
Fever; Headache- left side of my head; Generalised aching; Aching all over the body; soreness arm; A spontaneous report was received from a reporter like a consumer concerning a female patient  who received Moderna's COVID-19 vaccine (mRNA-1273) and reported events like soreness arm/pain in extremity, aching all over the body/pain, fever/pyrexia, headache-left side of her hand/headache. The patient's medical history was not provided. No concomitant medications were reported. On 12 Jan 2021, prior to the onset of the events, the patient received their first of the two planned doses of mRNA-1273(lot/batch: unknown) intramuscularly in the anatomical position for prophylaxis of COVID-19 infection. On 15 Jan 2021, she experienced soreness arm, aching all over the body on 16 Jan 2021,  she started having fever, headache- left side of my head and generalized aching on 17 Jan 2021. Laboratory details were not reported. Treatment information included advil and tylenol . The outcome of the event was unknown. Action taken with mRNA-1273 in response to the events was unknown. At the time of this report, the outcome of the event was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Body aches; 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 MYALGIA (Body aches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Body aches). At the time of the report, MYALGIA (Body aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Approximately 30-45 mins after vaccine injection, I began menstrual bleeding.  I suffered a miscarriage 3 weeks prior to the vaccination, and was not expecting to start my menstrual cycle.  Since the miscarriage and up to the day of vaccination, I had light and inconsistent spotting (brown in color).  However, after the vaccination I have had a light flow of blood, red/pink in color.  My best guess is that an anticoagulant in the vaccine caused my blood to thin to the point where I began bleeding again from the recent miscarriage.  The bleeding is ongoing as of the time of this report.
My COVID-19 symptoms started on 02/20/2023. I had sore throat, cough, body aches, and high fever.  On 02/22/2023 I did a COVID-19 test which was positive. I scheduled an appointment with my doctor but  I wasn't able to get in. So I went to the emergency room instead.  They prescribed Paxlovid for 5 days and cough pills as well.
This case was reported by a pharmacist and described the occurrence of anaphylactic reaction in a adult female patient who received BOOSTRIX. On an unknown date, the patient received the 1st dose of BOOSTRIX (unknown). On an unknown date, unknown after receiving BOOSTRIX, the patient experienced anaphylactic reaction (serious criteria GSK medically significant). On an unknown date, the outcome of the anaphylactic reaction was unknown. It was unknown if the reporter considered the anaphylactic reaction to be related to BOOSTRIX. Additional information received: The pharmacist reported the a physician in their clinic or hospital asked about cross-sensitivity between FLULAVAL QUADRIVALENT ingredients and Tdap vaccine (unsure if BOOSTRIX or ADACEL) because a while back the MD had an anaphylactic of anaphylactoid-like reaction to the Tdap she received. She had no other details and refused to provide all contact information when asked. She will check with MD about which product and call back to report any additional details.
Swelling on arm of injection site.  Started as 4 smaller bumps. The next day, one larger bump appeared.
-15 minutes after shot: Shortness of breath, Shooting pains down left arm. Warmth at injection site. Slight adrenaline response. Swelling in hands, had to remove my rings.  -2 hours after shot: I felt really light headed and tired. Broke out in chills and excessive sweating. Went to bed.  -4 hours after shot: I woke up to body aches and an extreme headache. Still excessively sweating. Took Tylenol as recommended by staff . Went back to bed.  - woke up next day. Extremely fatigued, still having chills. Whole left arm is hot to touch and I feel nauseous. Body still aches. I take more Tylenol and go back to bed.  -Wake up later afternoon. I feel much better.
WITHIN A LITTLE OVER 24 HOURS.  FIRST SIGNS, SEVERE SORE THROAT, NECK PAIN, ARM PAIN, STOMACH PAIN, A PINK EYE TYPE INFECTION. LETHARGIC.  AT FIRST THOUGHT IT WAS THE SHOTS, THEN THOUGHT MAYBE THE FLU.  NOW I GO BACK TO THE SHOTS!  I DID NOT HAVE HER SEEN FOR TREATMENT.  THIS LASTED A WEEK AND A HALF. HARD TIME BREATHING.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL, 1 DF. Other suspect therapies included RECOMBIVAX HB, VAQTA and ROTATEQ. No medical history was reported. No concomitant medication was reported. On an unknown date the patient experienced patient received dose of improperly stored vaccine and no adverse event. The outcome of no adverse event is unknown. No further information was provided. Additional information is not expected.
Fever, Chills, deltoid pain mild developed abruptly 20 hours after injection.
Caller states she has also had a pulling in her right leg.; Caller would like to know if the vaccine will cause you to have hot and cold flashes?; hot and cold flashes; 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 51 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date Apr2021 (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: MUSCLE STRAIN (non-serious), outcome "unknown", described as "Caller states she has also had a pulling in her right leg."; FEELING OF BODY TEMPERATURE CHANGE (non-serious), outcome "unknown", described as "Caller would like to know if the vaccine will cause you to have hot and cold flashes?"; FLUSHING (non-serious), outcome "unknown", described as "hot and cold flashes".  Additional information: patient received the first dose of the Pfizer COVID vaccine a week or two ago. She would like to know if the vaccine will cause to have hot and cold flashes. Patient has also had a pulling in her right leg, it is hard to describe the feeling in her leg but it happens on the right side where the shot was given.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Vaccine administration error: Technician administered Moderna COVID-19 vaccine to a patient using a prepackaged pre-assembled syringe.  At the time of immunization, the connection of the needle to the syringe was not tight and subsequently some vaccine escaped and ran down the patients arm. According to the technician, "a substantial amount of the vaccine ran down the arm and did not go into the muscle" After discussion with supervisor and chief physician, review of CDC guidelines and call to DHA Immunization healthcare branch, decision made in concert with patient to administer another dose of the vaccine as less than half dose was given.  Pt received a second dose of vaccine and event was explained in full.  Pt was contacted in the following days, denied adverse effects and was feeling healthy and well.
-2010: RIGHT lateral thigh paresthesia and pain, extending toward the anterior side of the leg; had associated dysesthesias and intermittent aching of the RIGHT buttock; symptoms came on gradually and are exacerbated with prolonged standing -- > Saw a neurologist at PAMF for this symptom June 4, 2011 and was diagnosed with meralgia paresthetica -- > resolved after months and has not recurrent Came and went a lot, really pronounced as a resident standing in the OR all day; also bothered her during her first pregnancy in 2012   -August 26 2019: Sudden onset of vertigo and imbalance, causing her to fall; unable to walk due to dizziness; severe nausea and vomiting; photophobia and phonophobia; some blurry/double vision Had a pre-existing hx of migraines for years Grandmother died right before this episode -- > ENT (2 of her close friends, one at hospital and one at other hospital) thought this was a vestibular migraine -- > didn't go into ED -- > took ativan prescribed by one of the ENTs -- > went to work the next day and still felt that she wasn't seeing or walking straight -- > went to ED and met Dr. in neurology -- > MRI brain August 26 2019 showed several scattered T2 and flair hyperintense foci without associated enhancement -- > saw Dr. in neuro-otology -- > She was given a steroid dose for vestibular migraine and symptoms improved, though still felt a little off balance 2 weeks later   -- > MRI brain December 2019 stable   Received her second Pfizer Covid vaccine January 10, 2021 Daughter also had COVID19   -January 18 2021: Numbness and tingling in the bottom of the RIGHT foot, ascending up the leg, also with tingling in the LEFT leg; heaviness in the legs Saw a patient with MS 3 days into this and her sx sounded the same as the patient's -- > contacted her neurologist   -January 23 2021: RIGHT>LEFT finger tingling There was never a motor deficit   -- > MRI brain January 26, 2021 showed a new LEFT parietal lobe T2 lesion compared to December 2019 -- > MRI cervical spine January 25, 2021 showed a C5-C6 lesion -- > IV Solu-Medrol x3 days, then oral prednisone taper; patient's sx were 95% resolved after 1 1000-mg steroid dose on January 28 2021, then did 500 mg X 2 days, and on a taper right now Leg sx were already resolving before the steroids   When in the shower, she has a calloused type feeling in her fingers.  Otherwise, sx have resolved.
Pt recv vax on 10/29/98; on same day pt exp rash on torso, upper respiratory congestion, myalgia; tx=Epi injection & 2 meds
Expired  5 doses had been given at that point.; Dose 0.5 ml was admistered to the patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired  5 doses had been given at that point.) and ACCIDENTAL OVERDOSE (Dose 0.5 ml was admistered to the patient) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2022 at 2:30 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 21-Jan-2022 at 2:30 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired  5 doses had been given at that point.) and ACCIDENTAL OVERDOSE (Dose 0.5 ml was admistered to the patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired  5 doses had been given at that point.) and ACCIDENTAL OVERDOSE (Dose 0.5 ml was admistered to the patient) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  It was reported that the Moderna vaccine was pulled from freezer on 16-Dec-2021. The Beyond use date of 15-Jan-2022 was printed in red and taped to the top of the boxes.  On 26-Jan-2022, the staff brought it to attention that it was still in the fridge and expired-5 doses had been given at that point. Moderna contacted and report filed. The beyond use date added to the daily Covid usage and wastage report. On 27-Jan-2022, the reporter checked all the other agency sites. Every clinic had done the same, without noticing the beyond use date.  On 31-Jan-2022, Moderna responded- revaccination not required, but adverse event report needed to be completed.  It was also reported that the patient was notified of error and that a repeat vaccine was not required. The patient denied any adverse effects.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-Feb-2022: Follow up received with significant information - IRD was changed from 25-Feb-2022 to 24-Feb-2022.
Started to note then pain and swelling in the area at the area of the shot;  following day she noted increased swellingand pain, redness to about 15 cm diameter, and it has abated 3/31/2016 AM with less redness and swelling.  No fevers chills; no facial swelling, breathing issues or tongue and lip swelling.
Rash appeared 4 days after immunication of varicella and PCV-7, no fever noted. Child had 5-6 vesicles clustered on L thigh with erythema.
Completed 2 doses of Moderna on March 5 and April 5, 2021. I developed hives, swelling in hands, tingling tongue, and tightness in throat at exposure to  person positive with COVID-19. Children living in home developed symptoms of COVID on Monday, July 26th. My hives developed at 3am, July 30, 2021. Currently still have hives, but they are being managed successfully with benadryl. Prednisone was prescribed at ER to take if Benadryl is ineffective.
No fever 2 days after vaccinations were given - pt developed erythema & swelling on (L) upper extremity (around where vaccination was given). Erythema began spreading down arm & was accompanied by pruritus. Pt presented to ER - was given Clindamycin x 14 days due to ? cellulitis? vs. allergic rxn? Recommended BENADRYL & TYLENOL prn for other sx. Sx have improved after 2 days.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurts, soreness in arm), ERYTHEMA (Redness size of two quarters), PYREXIA (A little fever) and VACCINATION SITE REACTION (Arm is leathered and sticky around the injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062G20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm hurts, soreness in arm), ERYTHEMA (Redness size of two quarters), PYREXIA (A little fever) and VACCINATION SITE REACTION (Arm is leathered and sticky around the injection site). At the time of the report, PAIN IN EXTREMITY (Arm hurts, soreness in arm), ERYTHEMA (Redness size of two quarters), PYREXIA (A little fever) and VACCINATION SITE REACTION (Arm is leathered and sticky around the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Feb-2021, Body temperature: inconclusive (Inconclusive) a little fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.
This spontaneous report was received from a registered nurse referring to two unspecified patients of unknown age and gender. On 14-AUG-2017, the patients were vaccinated with expired doses of GARDASIL 9, lot number L018351, expiration date 11-AUG-2017, for prophylaxis. No adverse effects were reported.
Information has been received from a consumer concerning his 16 month old daughter with no medical history and no drug allergies/reactions who on 26-MAY-2011 or 27-MAY-2011 was vaccinated with a dose of MMR II (lot # not reported). The reporter stated that his daughter received MMR II and later experienced high fevers to 105F. It was unknown if the child received additional vaccines when MMR II was administered. On 02-JUN-2011 she did not respond to APAP or ibuprofen with temperature fluctuating to 100F and then back up to 104F-105F. The next day, on 03-JUN-2011 the patient was in a weird state of mind, not cheerful like she usually was but lethargic. She had purple toned skin that looked black and blue. Later that day she was taken to hospital emergency room. She then had shivering which the doctor said was a probable febrile seizure with dehydration. She had one episode of vomiting during an exam of her mouth and throat. Her temperature was 104.5. She was admitted to the hospital. She was treated with intravenous fluids and intravenous ROCEPHIN. Fever decreased. No seizure activity. On 04-JUN-2011 the patient was discharged from the hospital. On 05-JUN-2011 the patient experienced a blotchy rash in chest, neck, cheeks for 24 hours and tired, lethargic, very weak, fever again to 101F. The patient was seen by pediatrician on 05-JUN-2011 with possible roseola. Today, on 07-JUN-2011 she was starting to eat and doing a little better. Also her sister had a history of epilepsy and her cousin had Guillain-Barre at age 2. Chest x ray, blood and urine tests were performed with no results provided. At the time of reporting, the patient was recovering. Additional information has been requested.
pt recvd 3 doses of Engerix-B of 24 individuals who recvd series p/3rd dose 13 h ad neg titer levels & failed to achieve protective titers;
Pt vaccinated with DTP/OPV developed local swelling to entire arm, hot, red & painful - Phoned MD advised to treat w/ice packs & tylenol.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 20-FEB-2019, the patient was vaccinated with one improperly stored dose of VARIVAX, lot # R023502, expiry date: 16-AUG-2020 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The administered dose of vaccine was reconstituted with improperly stored sterile diluent, lot # R034106, expiry date: 22-JUN-2021 (dose, route of administration, anatomical location and indication were not provided). The reporter did not know temperature and time frame of excursion. There was no previous temperature excursion. It was not reported if digital data logger was involved. No adverse effects were reported. This is one of 4 reports received from the same reporter. Sender's Comments: US-009507513-1903USA005457; US-009507513-1903USA005459; US-009507513-1902USA010800.