chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site). On 11-Feb-2021, VACCINATION SITE PAIN (Pain at injection site) had resolved. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not reported by the reporter. Treatment medication was not reported by the reporter.
She has been having pain in the left upper arm since the vaccines were given, tender to touch, no redness, no swelling, no fever, no difficulty moving the arm, no weakness in the arm. She does report several of her friends punched her in the arm several times after she received the vaccines.  Mom waited two weeks to come in as she hoped that it would resolve.
I felt nausea as soon as I got the shot.  I felt a sense of weird calmness over my body. The second day I had a fever of 100.3, body aches, sore arm with slight redness, headache, dizziness, foggy brain and I slept all day. The third day (today) I have a foggy brain, a sore arm with a big red patch on it.  But starting to feel better.
After receiving vaccine, patient immediately started complaining of difficulty breathing and swallowing. Visually in distress and panicked. Epi via autoinjector administered at 0845 in left lateral thigh. 15L 02 initiated by non rebreather. Ambulance called. Benadryl 50 mg IM given in left deltoid. Client noticeably began breathing easier with less distress and reported less difficulty breathing. Transported via to local hospital.
This spontaneous report was received from a registered nurse refers to the multiple patients of unknown age and gender. On an unspecified date in 2015, starting from August 2015 and continued through October 2015, the nurse reported that unspecified number of patients were vaccinated with improperly stored PNEUMOVAX 23 (lot # K019561 and expiry date 22-APR-2016 and L011531; expiry: 07-JAN-2017). Concomitant medications were not reported. No symptoms were reported. No PQC were involved and no further information was provided. This is one of the several reports from the same source. Additional information has been requested.
Patient was given dose of expired vaccine. Vaccine was refrigerated.  Patient reported a headache a few hours later which resolved on it's own. No medications were taken.
received doses from an expire vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received doses from an expire vial) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054C21A and 054C21A) for COVID-19 vaccination.     Concurrent medical conditions included Anemia since 18-Mar-2021, Amenorrhea, Benign essential hypertension and Allergy to nuts (Walnut). Concomitant products included AMLODIPINE from 17-Jul-2020 to an unknown date and ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) from 12-Mar-2021 to an unknown date for an unknown indication.   On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received doses from an expire vial). On 24-Jun-2021, EXPIRED PRODUCT ADMINISTERED (received doses from an expire vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   the patient race was given as Black.  No concomitant medication information was provided.  No treatment medication information was given.
This spontaneous report as received from a registered medical assistant refers to 2 patients of unknown age and gender. On 22-JUN-2016, the patients were vaccinated with improperly stored doses of PNEUMOVAX23 (lot # L033707 and expiration date 18-MAY-2017), (route and dose were not provided). No adverse effect reported. The vaccines were exposed to 59.5F for 15 hours, 55 min (Data logger: yes). Additional information has been requested.
experienced 2 hive marks on her left upper arm at the injection site; 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 22 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Sep2021 (Batch/Lot number: unknown) at the age of 22 years 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: INJECTION SITE URTICARIA (non-serious) with onset 16Sep2021, outcome "unknown", described as "experienced 2 hive marks on her left upper arm at the injection site".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I began to notice a rash on my arm on 1/22/21, which grew into the size of an orange by 1/23/21 AM. The rash became very warm to the touch, tender, and itchy. I went to my local Urgent Care on 1/23/21. I treated it with cortisone cream for the itchiness and began taking Benadryl orally on PM of 1/23/21. There is minimal to no rash present as of 1/28/21, with no itchiness or warmness.
Menstrual cycle has changed from 4 weeks to 3 weeks; This is a spontaneous report received from a contactable consumer or other non hcp. A 45-years-old non pregnancy female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) dose number unknown via an unspecified route of administration on 15Mar2021 (age at vaccination 45years old) as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient medical history was not reported. Concomitant medication(s) included levothyroxine sodium (LEVOXYL) taken for an unspecified indication, start and stop date were not reported. Since the vaccination, the patient had not been tested positive for COVID-19. The patient previously took tapazole and experienced drug hypersensitivity, gluten, and experienced drug hypersensitivity. On 28Mar2021 the patient experienced menstrual cycle has changed from 4 weeks to 3 weeks. The patient did not receive any treatment for the adverse events. The clinical outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Information has been received from a physician concerning a female (age unknown), who on an unspecified date, was vaccinated with a first dose of Gardasil. Subsequently, the patient fainted after vaccine was administered. The patient was either sitting or standing when the vaccine was administered. The patient sought unspecified medical attention. The patient recovered on an unspecified date. No product quality complaint was involved. This is 2 of three reports from the same source. Additional information has been requested.
none of the patients responded to PPV23; This literature marketed report has been received from the authors of a published literature article, titled as stated below and refers to a 68 years old male patient with chronic lymphocytic leukaemia. He received 4 courses of antibiotics in the year before enrollment. There was no therapy prior to ibrutinib.  Pre-vaccination, the number of Streptococcus pneumoniae serotypes with immunoglobulin G (IgG) titers greater than 1.3 microgram/milliliter was 10. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (lot #, expiration date, dose, route, and site of administration were not reported) for prophylaxis. Concomitant therapies included ibrutinib.  Post-vaccination, the number of Streptococcus pneumoniae serotypes with IgG titers greater than 1.3 microgram/milliliter was 9. The patient did not respond to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (vaccination failure). The outcome of event was unknown. The reporter considered vaccination failure to be related to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown).  A copy of the published article is attached as further documentation of the patient's experience.  This is one of ten reports derived from the same literature article (cross referenced with MARRS# US-009507513-2103USA003406).  Sender's Comments:  US-009507513-2103USA003406:
No adverse reaction. No side effect to note. This person was given a Pfizer vaccine, after already receiving the Johnson and Johnson vaccine. States that she was told she received the Pfizer vaccine the first time and after reviewing documentation, she received the Johnson and Johnson. The 2nd vaccine, Pfizer was not needed.
Approximately 1 1/2 hours after receiving Tdap hands started swelling, palmar surfaces turned bright orange and approximately another 20 minutes later started coughing and feeling throat closing.  Was given IV steroids, IV benadryl and sent home with oral steroid pack and epi-pen.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose 02/09/21Lot#EL9264 2nd dose 03/02/21 ,lot#EN6202 Diagnosed covid positive:08/11/21 Symptom onset:08/10/21 Exposure:Travel Symptoms:Runny nose ,headache
Information has been received from a physician concerning a 6 yr old an African American male pt with no pre-existing allergies or medical conditions who on 23Jun00 was vaccinated SC in the right thigh with a first dose of varicella virus vaccine live. The pt was not ill at the time of vaccination. The physician reported that on 26Mar05, the pt experienced a bad case of breakthrough varicella. It was described as a full blown clinical picture that was reported to have started with cold symptoms the day prior to the rash, a fever and 100 plus lesions on the arm and trunk. The pt was prophylactically treated for infection with cephalexin (Keflex). There were no second complications. There were no lab tests performed. Symptoms resolved within seven days and the pt recovered. No product quality complaint was reported. The pt sought unspecified medical attention. No additional information is expected.
Information has been received from a physician concerning a 12-year-old female patient who on an unknown date was vaccinated with the second dose of GARDASIL (lot number, route and injection site unknown). Concomitant vaccinations included the first dose of MENACTRA and HAVRIX. Subsequently, in October 2008 ("sometime last month"), the patient was experiencing hair loss. She didn't sought any medical attention and her outcome was not reported. Additional information has been requested.
9 days after 1st dose, I notice soreness on my arm near the injection site when I was lying in bed.  There appears to be a red spot that is itchy & warm to the touch. The area is to the right of the injection site
nose bleed/kind of "blew like a quarter size of blood clot"; congestion in her throat; headache; tired, very tired and just wanted to sleep; nausea, some nausea; feeling unwell; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL0140 and expiry date unknown) via unspecified route of administration on 14Jan2021 at single dose for Covid-19 immunization on her job (nursing home). Medical history included blood pressure high. Concomitant medications vitamins. The patient took that COVID-19 vaccine shot yesterday (later clarified the date as 14Jan2021) on her job. The patient informed that she was okay the first day, but yesterday (15Jan2021) last night she had some new problems and she wanted to talk about and see it's a clinical sign. The patient informed that it was headache, tired, very tired and just wanted to sleep. The patient had no swelling/no swelling in arm, nausea, some nausea and even she has been just feeling unwell. The patient informed that today (16Jan2021) this morning, she was having nosebleed until the last time she felt like congestion in her throat and she kind of "blew like a quarter size of blood clot". The patient blew her nose and it bled a while, but then a quarter size blood clot come out and since then it wasn't bleeding, her nose was not bleeding. The patient did not receive treatment due to the events. The patient underwent lab tests and procedures which included COVID testing; swab the nose: negative on 13th or maybe 14th (Jan2021). The outcome of the events headache, tired, very tired and just wanted to sleep, nausea, some nausea, feeling unwell, nose bleed/kind of "blew like a quarter size of blood clot", congestion in her throat was unknown.
neuropathy; a burning sensation to the left lateral part of her thigh and the inner part of her left thigh.; nerve pain or neuropathy; dull pain to the back of her right thigh which radiated to her right foot.; general soreness to her left arm in the area of the injection; This spontaneous report as received from a 37 years old female patient who was also a physician referring to herself. Information about pertinent medical history and concomitant medication was unknown. The patient had no known drug allergy (NKDA). The patient was not pregnant.  On 26-JAN-2021, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, anatomical location, lot# and expiration date were not reported) intramuscularly for vaccination.       On the same day, after the administration the patient only felt some general soreness to her left arm in the area of the injection. On 05-FEB-2021, the patient began to experience dull pain to the back of her right thigh which radiated to her right foot. The patient felt this sensation more when sitting or driving but not as much while walking. On 10-FEB-2021, the patient was having a burning sensation to the left lateral part of her thigh and the inner part of her left thigh. The patient felt as if it was nerve pain or neuropathy. The patient had called her physician but had been unable to speak directly to the physician as of the time of reporting. No treatment was given for these events. The patient would seek further treatment if her condition worsens. The outcome of these events was not resolved.  The causality between these events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  Upon internal review, neuropathy was determined to be medically significant.
This spontaneous report as received from a pharmacist refers to a 46 year old female patient with high blood pressure and latex allergy. On 04-NOV-2013 the patient was vaccinated with PNEUMOVAX23 (lot number J004387, expiry date 04-JAN-2015) intramuscular in the left arm. On 04-NOV-2013, the patient experienced fever and erythema around the injection site. There were no lab diagnostic studies performed. It was reported that the patient sought medical attention and called a pharmacy. The outcome of fever was unknown (also reported as fever broke yesterday). It was reported that the erythema around injection site spread from half inch to 3 inches in diameter. The outcome of erythema around the injection site was reported as not recovered. Additional information has been requested.
Right thigh with 12 cm diameter area of erythema/induration/warmth.  No apparent tenderness from ER chart on 11/08/2003.  (day after DTAP given in that thigh).  Patient put on Keflex for possible infection.  Patient seen by me 11/10/2003; still redness 19 cmx 17 cm of thigh, some resolved, no tenderness.
4.5 x 2.5 area redness and induration (L) outer thigh. Reaction noted 8/15/14 after allergic reaction to walnut on 8/13/14. Immunization given 8/5/14.
Baby has digestion issues. Increased amount of hiccups, increased vomiting if not elevated after breastfeeding (vs. laying flat in bed with the night time feedings). Does not digest milk. First took yogurt snacks, threw it up. Months later when it is time to start cow milk, she vomits it all up.
Approx 3 days after shot pox marks and rashes appeared. All over the body but concentrated in the armpits and inner thighs. Prescribed topical steroids.
the patient on the like 3rd day was knocked out a few seconds and almost brought her to the emergency room; This is a spontaneous report from a contactable consumer (caller is the husband of the patient). This is the second of 2 reports.  A 27-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the beginning of May2021 (Batch/Lot number was not reported) as single dose (at the age of 27) for covid-19 immunisation. Medical history included ongoing genital herpes (reporter does not know when she was diagnosed with genital herpes but states it was many years ago and was before the Pfizer Covid vaccine), caesarean section (she had their 2nd son and had C-sections with both children). There were no concomitant medications. The patient experienced the patient on the like 3rd day was knocked out a few seconds and almost brought her to the emergency room  in May2021. It was reported 'she does take anything like one Tylenol in her case she would be fine but she cannot handle strong doses of any medication and had an epidural shot and can't handle over doses of any medication and states that he has no lots, expiry dates, medication names for medications that she cannot handle the doses of including Tylenol to provide'. The outcome was unknown.    The lot number for BNT162b2 was not provided and will be requested during follow up
anti-inflammatory response to the vaccine; feel weird; tested positive for covid-19; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for covid-19), FEELING ABNORMAL (feel weird) and VACCINATION COMPLICATION (anti-inflammatory response to the vaccine) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jul-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for covid-19). On 31-Jul-2021, the patient experienced FEELING ABNORMAL (feel weird). On 02-Aug-2021, the patient experienced VACCINATION COMPLICATION (anti-inflammatory response to the vaccine). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. On 06-Aug-2021, SARS-COV-2 TEST POSITIVE (tested positive for covid-19) had resolved. At the time of the report, FEELING ABNORMAL (feel weird) and VACCINATION COMPLICATION (anti-inflammatory response to the vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jul-2021, SARS-CoV-2 test: positive (Positive) Positive. On 31-Jul-2021, Heart rate: 118 (High) Elevated at 118.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported. On 06Aug2021 patient finished the quarantine, and was negative for covid-19.They went to the pharmacy to get their second dose of the Moderna vaccine and were advice not to take it and to wait for 30 days.
PATIENT DEVELOPED NAUSEA AND VOMITING, HA AND VISUAL CHANGES. REPORTED "I FELT LIKE I WAS DYING". SITE WITH 4X6 CM RED HARD AREA.
Severe stomach pain and irritability. Change in sleep schedule. Change in mood. This is still ongoing.
Started developing dizziness and exhaustion that was diagnosed after significant decrease in Hemoglobin detected in blood panel.
pt recv vax 11FEB98 930AM on 11FEB98 by 430PM had fever of 103;fever peaked Friday evening @ 104.5;mom medicated w/alternating doses of infant APAP;fever did not drop below 100;mom gave tepid bath;fever from 100-104 until Sunday
ACUTE NON ST ELEVATION MI ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 8/30/2022 &  9/16/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
VERTIGO; MUSCLE PAINS; NAUSEA; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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, start therapy date were not reported 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 MAR-2021, the subject experienced vertigo. On MAR-2021, the subject experienced muscle pains. On MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle pains, nausea and vertigo was not reported. This report was non-serious. This case, from the same reporter is linked to 20210355508.
tired; shivering; Extremely itchy/ Still very itchy; large red area where the shot was given/ red, but less red than days before.; temperature was 100F-101.9F; This is a spontaneous report from a non-contactable consumer (patient). A 95-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9262), via an unspecified route of administration on 25Feb2021 (at the age of 95-years-old) as dose number unknown, single for COVID-19 immunization. Medical history included transient ischaemic attack which started 16 months ago. The patient had no known allergies. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. No other vaccine was given in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. The patient was extremely itchy and had a large red area where the shot was given on 26Feb2021. The patient was still very itchy, red, but less red than days before at the time of report. The patient temperature was 100F-101.9F on 26Feb2021 19:30. The patient called 911 and took acetaminophen, liquids, cool compress, get rid of electric blanket, and used wool and/or cotton blankets as treatment. The patient was shivering like she was all day on 26Feb2021. On 27Feb2021, morning, the temperature was 99 F, felt better and was very tired. On 28Feb2021 patient requested going out for a joyride. The outcome of event pyrexia was recovered on an unspecified date. The outcome of all other events was recovering.  No follow-up attempts are possible. No further information is expected.
Moderate soreness at injection site that started 10 1/2 hours or so after I received the 1st shot. The soreness lasted about a day and a half.
Clients reports noting 1 inch line of small fluid filled blisters on Rt arm where MMR was given yesterday, also note Lt arm had 1 inch C shaped reddened area where Varicella was placed. No other symptoms.
Grand Mal seizure resulting in hospitalization. Immediately proceeding the seizure, patient experienced rash and itching on upper arms. No previous history of seizures.
Systemic muscle aches Systemic joint pain Fever 99.4 degrees  Mild headache Fatigue  Elevated blood pressure 145/85 Injection site soreness Symptoms began within 24 hours and peaked at 30 hours.  Muscle and joint pain continues at 40 hours.