chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient and pharmacist suspect that some of the vaccine leaked out of the injection site after the vaccine was administered / Patient is concerned that she did not get the entire dose of the vaccine; Patient and pharmacist suspect that some of the vaccine leaked out of the injection site after the vaccine was administered / Patient is concerned that she did not get the entire dose of the vaccine; This spontaneous case was received on 20-Aug-2021 via Med Communications (reference number: SEQW21-01661) from a pharmacist and concerned a 70-year-old, female patient.   The patient's medical history was not reported. The patient was not taking any concomitant medications. The patient reported she normally had side effects after receiving a vaccine.  On 19-Aug-2021, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; route of administration: intramuscular, dose: 0.5 ml and anatomical location: left deltoid) for influenza prophylaxis. The batch number reported was 312842 and expiration date 19-May-2022. The vaccine was administered with no issues and the patient felt great after her vaccination.   On the same day, an unknown amount of time after receiving Fluad Quadrivalent, when the patient peeled back the band-aid that was placed on her arm after the injection she noticed that there was a lot of fluid in the cotton pad that was not blood or bodily fluid. The patient and pharmacist suspected that some of the vaccine leaked out of the injection site after the vaccine was administered and ended up on the cotton pad of the band-aid. The patient was concerned that she did not get the entire dose of the vaccine (explicitly coded as 'Incomplete dose administered').  Patient stated that she was due for her COVID-19 booster dose and would reach out to pharmacist in Oct-2021, well after her booster dose regarding revaccination.   The outcome of the event 'vaccination site extravasation' was not reported.   The reporter did not provide a causality assessment.   The reporter assessed the case as non-serious.  Company comment: On the same date after receiving Fluad Quadrivalent, the patient peeled back the band-aid that was placed on her arm after the injection and she noticed that there was a lot of fluid in the cotton pad. The patient and pharmacist suspected that some of the vaccine leaked out of the injection site after the vaccine was administered. Vaccination site extravasation is assessed as not related to the vaccine. Incorrect dose is assessed as not related, per company's conventions.; Sender's Comments: On the same date after receiving Fluad Quadrivalent, the patient peeled back the band-aid that was placed on her arm after the injection and she noticed that there was a lot of fluid in the cotton pad. The patient and pharmacist suspected that some of the vaccine leaked out of the injection site after the vaccine was administered. Vaccination site extravasation is assessed as not related to the vaccine. Incorrect dose is assessed as not related, per company's conventions.
Starting to feel the side effects of the shot with no adverse event reported; Initial information received on 14-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an adult patient with unknown age and gender who experienced starting to feel the side effects with no adverse event reported of the shot while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (Batch number, expiry date, frequency, formulation, strength was unknown) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date the patient developed a non-serious starting to feel the side effects of the shot with no adverse event reported (adverse drug reaction) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event starting to feel the side effects of the shot.
Pt's hospital immunization record and state registry not verified by administering nurse. State registry verified but did not include most recent vaccinations given (and charted in the pt's immunization record at the hospital). Colleague reported that registry showed no record of vaccinations (however there were, colleague may have entered incorrect search criteria).
Patient hade severe pain in back shoulder area that radiated to neck, head and upper arm.  Six hours later pain is persistent.
pt recvd vax; 3" diam red hard well circumscribed area on lt thigh at inject site; approx p/ pt returned home on previous day from vax;
Patient had a delayed large local reaction.  At 48 hours large and warm, now at approximately 14 days flat and approximately 3 by 8 inches.  No systemic symptoms.
white outline; arm is weak & heavy; skin felt really thick and hard; hot to touch; hurts; itchy around the area of shot; Big red circle on arm 1inch around shot/hot and red; felt worked out; nauseous for 2 hours; heavy head like having helmet on head; felt dizzy for little while; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (white outline), MUSCULAR WEAKNESS (arm is weak & heavy), INDURATION (skin felt really thick and hard), HEAD DISCOMFORT (heavy head like having helmet on head) and DIZZINESS (felt dizzy for little while) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O11L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]), OMEPRAZOLE and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced HEAD DISCOMFORT (heavy head like having helmet on head), DIZZINESS (felt dizzy for little while), NAUSEA (nauseous for 2 hours) and MYALGIA (felt worked out). On an unknown date, the patient experienced SKIN DISCOLOURATION (white outline), MUSCULAR WEAKNESS (arm is weak & heavy), INDURATION (skin felt really thick and hard), VACCINATION SITE WARMTH (hot to touch), PAIN (hurts), VACCINATION SITE PRURITUS (itchy around the area of shot) and VACCINATION SITE ERYTHEMA (Big red circle on arm 1inch around shot/hot and red). The patient was treated with CETIRIZINE HYDROCHLORIDE (BENADRYL ALLERGY [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at a dose of UNK, qd. At the time of the report, SKIN DISCOLOURATION (white outline), MUSCULAR WEAKNESS (arm is weak & heavy), INDURATION (skin felt really thick and hard), HEAD DISCOMFORT (heavy head like having helmet on head), DIZZINESS (felt dizzy for little while), VACCINATION SITE WARMTH (hot to touch), PAIN (hurts), VACCINATION SITE PRURITUS (itchy around the area of shot), NAUSEA (nauseous for 2 hours), VACCINATION SITE ERYTHEMA (Big red circle on arm 1inch around shot/hot and red) and MYALGIA (felt worked out) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 05-Jul-2021: Follow up received on 05-Jul-2021 contains significant information event outcome for all the reported side effects was updated as recovered/resolved, declined consent for further follow up and also concomitant medications were added from initial source document.
PATIENT IS HAVING BRUSES AROUND THE VACCINATION SITE WITH A SIZE OF A QUARTER AND EXPERIENCING FLU LIKE SYMPTOMS (FEEL BODY ACHES, FEEL TIRED, HEAVY ARMS); PATIENT TOOK ADVIL 2 TABLETS OF 200MG 4 TIMES TODAY, BUT FEEL SAME DEGREE OF SYMPSTOMS
Patient came for Dose #2 on 3/31/2021.Patient reports Moderna arm redness and swelling at first dose site after receiving first dose 3/3/2021. That dose was administered by RN PHN, another County employee. Patient reported reaction lasted 2-3 days and just faded. She described the area as "bite-like" with terrific itchiness. PHN providing second dose reviewed risk and benefits of vaccine. To date, literature associates this reaction with primarily first dose but there is a chance it could recur. Patient was willing to proceed. Patient vaccinated with dose # 2 3/31/2021 Lot 030B21A. She desired same arm for IM vaccination. PHNwill report in VAERS.
Rash below injection site. Currently lasting 2+ days. Slight growth in size. Red, warm to touch, itchy, swollen.
Circled area of redness, warmth and slight swelling,  measures 6.25cm x 9 cm.  onset 1/20/21.  Area less red on 1/22/21 and more yellow reddish on 1/22/21 remains about the same size over the three days.  Treated with ice packs TID
only had a sore arm for the following 2 days after the injection; This is a spontaneous report from a non-contactable other hcp (patient). A 23-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: ,EL3247 Expiration date was not reported), via an unspecified route of administration on 05Feb2021 (at the age of 23-years-old), as dose number unknown, single for COVID-19 immunisation. Patient has no relevant medical history. Concomitant medications included ascorbic acid (VIT C) and ergocalciferol (VIT D), both taken for an unspecified indication, start and stop date were not reported. Patient has no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced only had a sore arm for the following 2 days after the injection on 06Feb2021. It was also reported that patient had no other symptoms. Patient did not receive treatment for the event. The outcome of event was recovered on 08Feb2021.  No follow-up attempts are possible. No further information is expected.
several petit mal form seizures w/ER; seen by MD 20JUN92 following vax; on 16JUN92 pts mom states grand mal form seizures x 3 following wk though febrile and had tonsillitis;
Pediatric patient received MMRV vaccine on 1/4/07.  Presented on 1/8/07 to clinic w/  approximately 6 varicella lesions on trunk, otherwise well.  Presented 1/16/07 to clinic w/ rash c/w eczema herpeticum on trunk.
is a fever normal; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (is a fever normal) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (is a fever normal). At the time of the report, PYREXIA (is a fever normal) outcome was unknown.            No Relevant concomitant medications was reported.  Treatment information was not provided.  Action taken with mRNA-1273 Moderna COVID-19 Vaccine was not applicable
This spontaneous prospective pregnancy report as received from a medical assistant refers to a 24 year old healthy female patient. The patient had 1 living child. The patient had no concomitant medications or drug allergies/reactions. Para was 2, gravida was 1. At the time of the report, the patient's gestational age was 21 weeks and 4 days. The patient became pregnant with menstrual period (LMP) of 10-SEP-2015 and estimated delivery date (EDD) of 16-JUN-2016. On 09-FEB-2016, the patient was inadvertently vaccinated, while pregnant, with 0.5 ml dose of VARIVAX (Merck) lot # L034372, expiry date 08-SEP-2017, once, (route of administration was not reported). Initial exposure to VARIVAX (Merck) was at 21 week(s). The pregnancy outcome was outcome pending. No adverse effects were reported. No treatment was given for the event. No lab diagnostic studies were performed. Additional information has been requested.
Fever-like symptoms over night the same day as vaccination including hot flashes and cold sweats. Pain and swelling in the receiving arm as well as minor swelling of the lymph node on the same side.
lightheaded/dizziness; vertigo; nauseated; he had a sore arm; 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 39 year-old male patient received bnt162b2 (BNT162B2), administration date 08Apr2021 (Lot number: EW0153) 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: DIZZINESS (non-serious) with onset Apr2021, outcome "unknown", described as "lightheaded/dizziness"; VERTIGO (non-serious) with onset Apr2021, outcome "unknown", described as "vertigo"; NAUSEA (non-serious) with onset Apr2021, outcome "unknown", described as "nauseated"; PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "unknown", described as "he had a sore arm".  Additional information: NDC number, Expiry Date of COVID 19 vaccine were Unknown. The patient stated that he received the first dose of the Pfizer-BioNTech COVID-19 vaccine 6 days ago. He explained for the first 3 days he didn't experience side effects, then for the last 3 days "all of a sudden" he was "lightheaded", had "vertigo" and felt "nauseated". He asked if this delayed onset of symptoms was seen in the report of similar side effects for the vaccine, he had a sore arm the first three days and then he read that it seemed dizziness and lightheadedness can be part of it and he started having that after 3 days and now has had it 2 days in row but did not feel any of that the first 3 days. he knew dizziness could be caused by something separate like an ear infection and wanted to know if it was normal to experience this after the vaccine. Investigation Assessment was not provided.  No follow-up attempts are possible. No further information is expected.
2 days after COVID-19 vaccine noted painful bump above clavicle . Eval 8/13/21 in office less than or equal to 2-3 mm  tender L supraclavicular node and 3/4 mm tender L axillary node; CBC/LDH/ESR Normal
Approx 4 hours after receiving HIGH DOSE flu vaccine; patient started vomiting and having shakes. BS was low. Ate and came back to normal. Took 20 min nap and woke weak, shaky, not feeling well, chills, rigors, and vomiting again. Taken to ER by family.
blind in one eye for almost 2 weeks; Initial information was received on 16-Oct-2021 regarding an unsolicited valid serious case received from a consumer/non-health care professional under (reference US-SA-SAC20211021000134).  This case involves a female patient (unknown age) who experienced blind in one eye for almost 2 weeks (blindness unilateral) after received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a serious blind in one eye for almost 2 weeks (blindness unilateral) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Social media, reporter's sister-in-law was blind in one eye for almost 2 weeks after the jab.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment for the event.  On an unknown date, the patient recovered from the event (blindness unilateral).  There will be no information available on the batch number for this case.; Sender's Comments: This case concerns a female patient of (unknown age) who experienced blindness unilateral (unknown latency) after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. There is no further information regarding patient's medical condition at the time of vaccination and laboratory tests ruling out other alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
6/4/15 9:30AM - Patient called clinic stating awoke around 3-3:30AM with burning/hurting at base of skull in back of head. Unable to lie head back on pillow due to pain. States pain worsened and spread to both ears, especially left ear; hurt to turn head side-to-side, esp. to left side; having some lightheadedness and balance issues. No fever. I contacted Sanofi Pasteur and spoke with medical rep - advised patient to go to Emergency Room for evaluation. Spoke with patient 6/5 - she states did not go to ER - took TYLENOL and "head eased off". Today has "general headache."
Within 3-4 hours of MMR vaccine administration pt seemed dizzy, increased fussy and refused to walk. He began crawling instead of walking. By the next morning he seemed better. Had normal physical exam 07/13/04 AM before vaccine. Later in afternoon pt refused to walk on exam, but non tender with from passively.
p/vax pt exp a gradually increasing fever;pt devel a varicella-like rash w/about 20-24 raised bumps on face, back, chest, arm, & leg;
Patient states arm is swollen, red, and warm to the touch.  Painful when moving/lifiting arm. Started about one hour prior to reporting. No reported difficulties breathing.   Recommended cold/ice pack on arm and taking APAP/Ibuprofen prn to relieve pain and inflammation.  Consulted to seek urgent care if no improvement or worsening symptoms.
pt says the day after he got the vax he woke up with a rapid heartbeat with some chest pressure.  He took his BP reading and it read 154/94 and pulse rate 121.  He says his heart is racing, he has slight chills and has soreness in the right shoulder. Pt will contact his PCP.
Right deltoid with redness, warm to touch-size of an orange, not crossing the joint space. Treat with cool compresses, MOTRIN, and BENADRYL.
Administered MenCYW-135 liquid conjugate without reconstituting with MenA Lyophilized conjugate.
Tinitus in left ear as of 4/13/21.  And disgnosed with a blod clot in right calf symptom of clot felt on 4/17/21
Got barachial neurities; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 13-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: Unknown), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE, Batch/Lot No: Unknown), for COVID-19 immunization. The following information was reported: RADICULITIS BRACHIAL (non-serious) with onset 2022, outcome "unknown", described as "Got barachial neurities". The event "got barachial neurities" required physician office visit. Therapeutic measures were taken as a result of radiculitis brachial.  Additional information: The patient didn't taken any other vaccine in four weeks. Other medications in two weeks was unknown. Adverse event was treated with Steroids. No COVID prior to vaccination. No Known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Rapid heart rate, heart palpitations, stomach pain?started 12 hours after vaccine.
Area on right arm about 4x8in. red, elevated and itching.  No fever or other symptoms. Client saw MD who diagnosed cellulitis and prescribed Sulfameth TMPDS 800-160 mg BID for 14 days.
Patient 4 years/old with hx of lumbar myeolominingocele, hrocephalus, s/p shunt, neurogenic bladder. Patient also with hx of brain surgery about a month ago due to shunt revision. Patient came for his annual well check (4 y/o), and received ProQuad and Quadracel vaccines. Reported allergies by mom were iodine and latex. Approximately 30 min after patient left the clinic, mother called to report that patient rolled his eyes up and passed out. She called 911, and was taken to ER for evaluation and management.
Breakthrough case admission after three vaccines Moderna 2/17/21 Lot# 015M20A;  Moderna 3/17/21 Lot# 002b21a;  mODERNA 11/3/21 lOT# 077c21b
Patient complains of feeling hot and feverish but chilled.  Pt states she has some mild tightness in her right chest and feels dizzy.  She is diaphoretic.  BP 136/88; HR 81; RR 15; Oxygen 100%; Temp 99.2 F
Body aches, low grade fever, stomach ache, headache, sore throat which began soon after shot. Asthma attack began 11/21/03 (10 days after flu shot). (1st asthma hospitalization for this patient in 6 years.) Failed to clear after 4 days home management and oral steroid. The follow up received on 12/24/03 states URI and pharyngitis were not evident on date of vaccination. Symptoms began within 24 hrs after vaccination. Tx PCN. Later erythromycin and Solu-Medrol. VAccine provider-pcp does not expect a discharge summary will be available-overnight hospitalization.
Patients right arm became inflamed, red and swollen. Pt went to clinic - diagnosed w/cellulitis. Given CIPRO.
Given Td on 8/28/09 along with PPD. Came into office 8/31 for reading PPD. C/o area of Td: (+) red (+) hot (+) hard area extending from deltoid to back of arm. Tenderness in lymph nodes (L) axillary only.
he felt a little sore; tired for the a day; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (he felt a little sore) and FATIGUE (tired for the a day) in a 56-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 from April 2020 to May 2020. Concurrent medical conditions included Sleep disorder, Herpes zoster and Memory impairment. Concomitant products included VALACICLOVIR HYDROCHLORIDE (VALTREX) for Herpes zoster, MULTIVITAMINS [VITAMINS NOS] for Memory disturbance, GINKGO BILOBA (GINGKO BILOBA) for Memory impairment, CLONAZEPAM (KLONOPIN) for Sleep disorder.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (he felt a little sore) and FATIGUE (tired for the a day). At the time of the report, MYALGIA (he felt a little sore) and FATIGUE (tired for the a day) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The gender of the patient was non-binary. No treatment medication was provided. They had an organ transplant and is immunocompromised.   This case was linked to MOD-2021-306223, MOD-2021-306228 (Patient Link).