chrisvoncsefalvay/vaers-outcomes huggingface dataset:
constantly salivating, spitting; gagging; stomach pain; not able to function very well; headache; extreme nausea; This spontaneous case was reported by a physician assistant and describes the occurrence of SALIVARY HYPERSECRETION (constantly salivating, spitting), RETCHING (gagging), ABDOMINAL PAIN UPPER (stomach pain), MALAISE (not able to function very well) and HEADACHE (headache) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Depression and Anxiety. Concomitant products included DROSPIRENONE, ETHINYLESTRADIOL BETADEX (YAZ [DROSPIRENONE;ETHINYLESTRADIOL BETADEX]) for Birth control, ESCITALOPRAM OXALATE (LEXAPRO) for Depression and Anxiety.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced SALIVARY HYPERSECRETION (constantly salivating, spitting), RETCHING (gagging), ABDOMINAL PAIN UPPER (stomach pain), MALAISE (not able to function very well), HEADACHE (headache) and NAUSEA (extreme nausea). At the time of the report, SALIVARY HYPERSECRETION (constantly salivating, spitting), RETCHING (gagging), ABDOMINAL PAIN UPPER (stomach pain), MALAISE (not able to function very well), HEADACHE (headache) and NAUSEA (extreme nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.
MIGRAINE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 08-APR-2021, the subject experienced migraine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of migraine was not reported. This report was non-serious.
Information has been received from a consumer concerning a 9 yr old male who was vaccinated with a dose of varicella virus vaccine live. Subsequently the pt experienced a mild case of breakthrough chickenpox. It was reported that there had been an outbreak of chickenpox in the child's school. There was no product quality complaint involved. Additional information has been requested.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. Patient's medica history and concurrent condition was not reported. On 17-FEB-2015 the patient was vaccinated with a dose of improperly stored PROQUAD (0.5 ml, subcutaneously (lot # K008579, expiry date: 13-DEC-2015). No adverse effects reported. No product quality complaint (PQC) involved. This is one of several reports received from the same source. Additional information has been requested.
Large local reaction redness & swelling down into elbow. Clarinex 5 mg
PT EXPERIENCING LARGE, EXPANDING RED AREA  AT THE INJECTION SITE. WARM TO THE TOUCH.  PT REPORTS IT WAS PRESENT AT HER FIRST DOSE BUT NOT AS LARGE.   SHE REPORTED THAT IT WAS  ABOUT 5X4 INCHES ON 06/28 AND TODAY IT IS MUCH LARGER.  SHE CAME TO THE PHARMACY TO REPORT THE REACTION.  SHE HAS BEEN USING ICE AND BENEDRYL AS TREATMENT- SHE WAS ADVISED TO USE UP TO 300 MG PER DAY OF BENEDRYL.  SHE WAS ALSO ADVISED TO REPORT TO EMERGENCY DEPARTMENT IF EXPERIENCING ANY FEVER AND/OR BREATHING ISSUES.  SHE DECLINED TO SEEK MEDICAL TREATMENT AT THIS TIME.
Patient received the shot. Within a few minutes he became light headed, chest pain, and was hot. We gave him a cold pack and water to drink. We checked his BP which was elevated. We contacted EMS, they advised us to give him four 81mg ASA.  The EMS came and evaluated him and he was feeling much better.
This case was reported by a consumer via other manufacturer and described the occurrence of adverse reaction in a patient who received Seasonal Influenza vaccine. On an unknown date, the patient received Seasonal Influenza vaccine at an unknown dose. On an unknown date, an unknown time after receiving Seasonal Influenza vaccine, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to Seasonal Influenza vaccine. Additional details were provided as follows: The consent for contacting the reporter for further information was provided, but for the patient the consent was not provided.
After his 2 month shots, patient became lethargic and unarousable for 24 hours.  Self-resolved.  After the exact same vaccinations at 4 months, patient again became significantly lethargic immediately following vaccines.  No fevers.
Pt claims to have developed "Serum Sickness" from the vaccine. She says she has been in to the emergency room several times related to side effects.
Pt reported swollen lymph node above his R clavicle last November.  He had received his 1st COVID vax on 1/26/21 (MODERNA).   In February 2021 he developed a swollen/tender R axillary node.  Patient had undergone his 2nd COVID vax on 3/1/2021.    Diagnosis: Nodular sclerosing classical Hodgkin Lymphoma, Stage II Bulky (Unfavorable) ? 6/7/2021
Case number PHEH2014US021411 is an initial spontaneous report from the pharmacist on 23 Oct 2014. This report refers to a female adult patient who was in her 30s-40s age. She was vaccinated with FLUVIRIN, (batch number: not reported) via subcutaneous route from a nurse on an unknown date. On an unknown date, the patient experienced more sore in the arm compared to the intramuscular injections which she had received in the past. The outcome, seriousness and causality of the event were not reported.
Got injection at pharmacy on 10/18.  Arouse with 102.1 fever after midnight (on 10/19).  Took Tylenol at about 0530 and later took Motrin 400 mg (two tabs 200mg ea) at about 0930 because I was still feverish and about to lecture.  This treatment helped till about 1300, then drove home with chills--had car heater on and was 85 degrees outside.  Took hot shower and went to bed.  Got up an 1820 and then went back to bed at 2200.  Woke up during night drenched in sweat--I think my fever broke.  On 10/20 I felt much better and worked all day--but when I got home from work and changed my shirt, notice a 2-3 inch rash in diameter around the injection site with itching.  No cough previous to injection , but now noticing a cough.  Never had a reaction with any other shot like this and am concerned.
Fine for 6 hours  Then got flu like symptoms  I was freezing cold for 24 hours with a 104 fever. Had body aches that caused me to scream. I had a head ache and stomach ache. The severe issues were better by Thursday morning but I still have upset stomach when anything is ingested and diarrhea. I am a healthy individual. With a high pain tolerance. This was the sickest I have been in 10+ years no exaggeration.
body ache; mild fever; This is a spontaneous report from a contactable other healthcare professional reported for himself. A 24-year-old male patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK9231), via an unspecified route of administration (Arm Left, dose number 1) on 29Dec2020 19:00 at single dose for COVID-19 immunization. Medical history included COVID-19 from an unknown date prior vaccination. The patient was vaccinated in hospital. No other vaccine in four weeks was received. There were no concomitant medications. The patient experienced body ache, and mild fever on 30Dec2020. Treatment was not received. The patient underwent lab tests and procedures which included Nasal Swab/PCR: negative on 07Jan2021. Outcome of the events was recovered.
Big bump in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Big bump in the injection site) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Vertigo. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder NOS, PANTOPRAZOLE, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), PROMETHAZINE, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), BISMUTH SUBSALICYLATE (PEPTOBISMOL), DICYCLOMINE HCL, VITAMIN D NOS and PARACETAMOL (TYLENOL) for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced VACCINATION SITE INDURATION (Big bump in the injection site). In March 2021, VACCINATION SITE INDURATION (Big bump in the injection site) had resolved. Not Provided      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.   Concomitant medication included lung pill (unspecified).  No treatment was provided.   This case was linked to MOD-2021-076407, MOD-2021-076388, MOD-2021-077328 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Contains no new information; Sender's Comments:  MOD-2021-076407:Same patient-second dose case MOD-2021-076388:Same reporter MOD-2021-077328:Same reporter
Next morning both lower legs (calves) were extremely achy. My walking was very difficult. Felt like I exercised my legs excessively. Did not hurt when sitting or lying down. Lasted 2 days.
inside of her mouth swelled up; advised not to receive second dose of vaccine; pressure behind the face; irritation of lips/rash over lips; lip began to swell; scratchy throat; anal pain; anal itching; anal swelling; rash around and inside her mouth; This spontaneous case was reported by a consumer and describes the occurrence of ORAL MUCOSAL ERUPTION (rash around and inside her mouth), MOUTH SWELLING, LIP SWELLING, OROPHARYNGEAL PAIN (scratchy throat), and PROCTALGIA (anal pain) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Irritable bowel syndrome and Clostridium difficile colitis. Concurrent medical conditions included Drug allergy (rash), Drug allergy (rash), Anaphylaxis (throat closes), Dust allergy, Pollen allergy, Adhesive tape allergy, Allergy to animals (dogs Sneezing, Hives, Asthma), and Asthma. Concomitant products included BENADRYL, IBUPROFEN, and ALBUTEROL for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced ORAL MUCOSAL ERUPTION (rash around and inside her mouth). On 27-Mar-2021, the patient experienced LIP SWELLING, OROPHARYNGEAL PAIN (scratchy throat), PROCTALGIA (anal pain), ANAL PRURITUS (anal itching) and SWELLING (anal swelling). On an unknown date, the patient experienced MOUTH SWELLING (inside of her mouth swelled up), PRODUCT DOSE OMISSION ISSUE (advised not to receive second dose of vaccine), DISCOMFORT (pressure behind the face) and CHEILITIS (irritation of lips/rash over lips). The patient was treated with ZYRTEC at a dose of 10 mg; CLOBETASOL PROPIONATE (topical) at a dose of 0.5% cream; PREDNISONE (topical) at an unspecified dose and frequency, and HYDROCORTISONE (topical) at a dose of 1%. At the time of the report, ORAL MUCOSAL ERUPTION (rash around and inside her mouth), MOUTH SWELLING, LIP SWELLING, OROPHARYNGEAL PAIN (scratchy throat), PROCTALGIA (anal pain), ANAL PRURITUS (anal itching), SWELLING (anal swelling) and DISCOMFORT (pressure behind the face) had not resolved and PRODUCT DOSE OMISSION ISSUE (advised not to receive second dose of vaccine) and CHEILITIS (rash over lips) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       concomitant medicine includes multivitamin and probiotic.    Most recent FOLLOW-UP information incorporated above included, on 13-Jun-2021 follow up received on 13-jun-21 includes patient demographics and medical history allergic conditions was updated vaccine facility information was updated.
Unusually heavy menstrual bleeding with thinner consistency that started a few days earlier than expected and just two days after receiving the vaccination. Injection site still painful and swollen today. If it is relevant, I also experienced more common effects like severe body body pain and hot flashes beginning several hours after receiving the vaccine, lasting 48 hrs.
flat red rash on lower jaw and cheeks of face; today spread to back, bil arms, hands, abd, neck, starting on bil legs (new tonight); hives covered
This spontaneous report was received from a registered nurse regarding an unspecified patients of unknown age. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored RECOMBIVAX HB, lot # K012874, expiration date 09-JUN-2016. No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. Temperature/Time: 9.5C for 2 hours and 30 minutes, Data Logger: yes, yes it was administered. There was a previous temperature excursion 1.5 C for 1 hour, 10.5C for 1 hour and 30 minutes. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Developed bruising around left eye at around 10 PM and n date of injection that continued through today March 8, 2021. Also developed a vertical grey stripe in left eye near pupil of left eye. No pain & no vision loss. Bruising improved overnight but worsened each day as the day went on.
This is a spontaneous report from a contactable physician. This physician reported similar events for 2 patients. This is the first of two reports. A 17-year-old male patient of an unspecified ethnicity received TRUMENBA, via an unspecified route of administration on 01Nov2016 at single dose for meningitis immunisation. The patient medical history and concomitant medications were not reported. Within 15 minutes of getting the injection; the patient had migraine and stiffness of both hands. This lasted for about half an hour. The outcome was recovered. Sender's Comments: Linked Report(s) : US-PFIZER INC-2017056141 same reporter/drug, different patient US-PFIZER INC-2017056141.
Left arm pain around the site of injection - first few days.  Headache, low grade but constant - 3+ weeks (Possible) low grade fever - in the first week. Body aches - first week. Nerve pain, tenderness to the touch - torso, left side - front, side, and back L - lasted 3+ weeks. Sometimes severe, with stabbing pain. Extreme tiredness, napping. Sometimes insomnia - this lasted about 4 weeks. Stomach pain - 3+ weeks
Administered Fluvirin vaccine, patient collapsed and passed out. He came to and was sweating blood pressure 70/40, pulse 58, blood pressure 109/68, pulse 68, blood pressure 110/71, pulse 71.  Sat down and drank H20.  Felt better after 15 minutes.  Refused to emergency room.  Vasovagal, syncope.
Throbbing headache, chills, stabbing lower back pain, hot flashes, dizziness, lightheaded when standing, syncope when standing
Patient states on Saturday morning her left arm pit was sore and itching, it was like her lymph nodes were swollen (patient's words). By the end of Saturday night both armpits (L and R) were swollen/itchy/painful. Her injection site was warm to the touch. Sunday the 10th it was very painful and she took BENADRYL and TYLENOL. Monday she called her doctor but at this point she was starting to get better. Doctor advised her to tell the pharmacy. She came in on the 22nd to tell the pharmacy. At this time she is doing better.
4 or 5 days p/vax pt devel hives on buttocks, lateral thighs & knees;also devel erythematous, maculopapular rash on face, torso & lower legs;3 days p/onset of hives pt had bruising where hives had been;devel fever of 102;poss viral infect
Tdap vac. 8-25 - L deltoid now red swollen area 8 cm x 8 cm. TTP and warm. Afeb. Tx-ADVIL; ZYRTEC; Cold comp
Vaccination site swelling; Headache; Fever; Swollen Glands in Throat; Achiness; Fatigue; Elevated Heart Rate; Shortness of Breath; Hardness; Injection site Hot Sensation; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PYREXIA (Fever), LYMPHADENOPATHY (Swollen Glands in Throat), PAIN (Achiness) and FATIGUE (Fatigue) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026LZOA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included Blood Thinner for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced HEADACHE (Headache), PYREXIA (Fever), LYMPHADENOPATHY (Swollen Glands in Throat), PAIN (Achiness), FATIGUE (Fatigue), HEART RATE INCREASED (Elevated Heart Rate), DYSPNOEA (Shortness of Breath), VACCINATION SITE INDURATION (Hardness) and VACCINATION SITE WARMTH (Injection site Hot Sensation). On an unknown date, the patient experienced VACCINATION SITE SWELLING (Vaccination site swelling). At the time of the report, HEADACHE (Headache), PYREXIA (Fever), LYMPHADENOPATHY (Swollen Glands in Throat), PAIN (Achiness), FATIGUE (Fatigue), HEART RATE INCREASED (Elevated Heart Rate), DYSPNOEA (Shortness of Breath), VACCINATION SITE INDURATION (Hardness), VACCINATION SITE WARMTH (Injection site Hot Sensation) and VACCINATION SITE SWELLING (Vaccination site swelling) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
STILL ITCHING Days after receiving the shot my arm was swollen and red and itched. similar to my other Moderna shots on 12-10-21.  I have had previous surgeries.  ALL my previous incisions itch. Back surgery from over 6-7 years ago itches Tummy tuck scar end points itch. Previous hip surgery - right leg Itches. Female surgery points (laparoscopy) itch.  It almost seems like my body is rejecting all the stitches from previous surgeries.  ALL my previous surgery sites itch and are still itching today.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 at 12:00 as dose 5 (booster), single (Lot number: GH9694) at the age of 68 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 09Feb2021 as dose 1, single (Lot number: EL9269), in left arm, on 02Mar2021 as dose 2, single (Lot number: FL9267), in left arm, on 28Sep2021 as dose 3 (booster), single (Lot number: B01558A), in left arm and on 05Apr2022 at 16:30 as dose 4 (booster), single (Lot number: FM0698), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergies" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2022) Negative, notes: Two mornings later I tested negative and felt fine; (Nov2022) positive, notes: Two mornings after that I tested positive again. Therapeutic measures were taken as a result of vaccination failure, covid-19 (PAXLOVID treatment). No follow-up attempts are possible. No further information is expected.
Pt had a typhoid injection in left deltoid at 1300 on 08/01/22.  At 0500 on 08/02/22, pt woke up c/o lump on left side of throat and difficulty swallowing her medication.  Pt came back to the clinic at 0800 to report the symptom and states it feels better.  Pt c/o tenderness with palpation on left side cervical lymph node.  Pt recently returned from out of the country evening of 07/29/22.  Pt had Covid one month ago.  Pt has no known allergies.  Pt ate chicken and rice for dinner with a glass of wine for dinner on 08/01/22 which is normal for her.
severe stomach pain and lower abdominal pain that felt like an appendicitis and is continuing as a constant "slow pain".; severe stomach pain and lower abdominal pain that felt like an appendicitis and is continuing as a constant "slow pain".; severe stomach pain and lower abdominal pain that felt like an appendicitis and is continuing as a constant "slow pain".; felt miserable; bad headache; felt short of breath; dizzy; Sick; She can't even remember how old she is.; This is a spontaneous report from a contactable consumer (patient) via Medical Information team. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 02Apr2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, patient experienced severe stomach pain and lower abdominal pain that felt like an appendicitis and was continuing as a constant "slow pain". It was also reported that on an unspecified date after receiving the vaccine, patient has felt miserable, had a bad headache, felt short of breath, dizzy, sick and she can't even remember how old she was. Outcome of events "felt miserable", "felt short of breath", "dizzy", "sick" and "she can't even remember how old she was" was unknown while for all other events was not recovered.   No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Consistently hearing a light ringing tone that sounds like the phone is off the hook in my left ear.
Patient is a resident at a facility .  Pharmacy went to their facility to do three off site COVID vaccine clinics that were spaced at least 21 days apart per our CDC contract. Patient received 3 doses total of Pfizer. They were vaccinated on 1/08/21, 1/29/21, and 2/19/21. The facility has been notified of this incident. At this time, no adverse affects have been reported.
Breakthrough COVID-19 infection. Pt received Moderna on 1/2/2021, 1/30/2021, and 11/9/2021.
Pt first reported sx on Oct 15, 2019. Pt reported lingering pain in arm and tingling sensation in hand since receiving vaccinations. Pt also had raised bump at site of Shingles injection. Discussed OTC options and following up with PCP, but to my knowledge pt has not attempted to seek medical attention or treat symptoms. Pt returned approx 2 weeks later to pharmacy on Oct 28, 2019 to report that sx still persist, although have gotten better with time. Pt's suspected PCP contacted on 11/1/19 to report adverse event.
Three hours following the COVID19 Vaccination with Pfizer BioNTech, the patient began experiencing severe chest pains. No d-dimer or triopion tests were done. However, the patient and guardian suspects myocarditas seen by the chest pain and a mild fever were both attributed as a side effect of the vaccine.
Petechia rash all over legs and body, spontaneous bruising with very little contact before our eyes.  Eye rub gave him black eyes.
immed redness & swelling @ DTAP inj site-also redness on other leg w/HIB;DPH given immed-good response;
I was extremely fatigue and achy. Had a fever that exceeded 102. No previous complications with pregnancy.