chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen and incredibly painful lymph node in the left arm pit; Swollen and incredibly painful lymph node in the left arm pit; Swollen and incredibly painful lymph node in the left arm pit; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Aug2021 13:00 (Batch/Lot number: unknown) at the age of 26 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Postural orthostatic tachycardia syndrome" (unspecified if ongoing). There were no concomitant medications. The following information was reported: PERIPHERAL SWELLING (non-serious), LYMPH NODE PAIN (non-serious), LYMPHADENOPATHY (non-serious) all with onset 17Aug2021, outcome "recovered" (Aug2021) and all described as "Swollen and incredibly painful lymph node in the left arm pit". Therapeutic measures were not taken as a result of peripheral swelling, lymph node pain, lymphadenopathy.  Additional information: Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No list of any other medications the patient received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. No known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Vaccines administered around 10:15 am; Mom went next door to WIC and returned at 10:30 AM. Child noted to have rash and hives to entire front of neck and chin. Rash to cheeks and chest. Child in no visible resp distress, awake and alert but fuzzy. Benadryl 0.25 PO given. EMS called.
Pt states right arm painful several hours after vaccine given.  Small knot, by the next day had a 25 cent size knot, red and hot to touch. Pt was out of town and came in 10 days later and advised us of reaction.  She had knot the size of nickel.  Pt advised if not better should make appt to have provider check.  Pt states she is in and out of town.
Fever/chills starting 8-9 hours post vaccine, sore arm, rash over trunk, neck, and face on day 2 post vaccine. All symptoms resolved by day 3.
One son had Moderna all the way; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BODY FLUID (One son had Moderna all the way) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPOSURE VIA BODY FLUID (One son had Moderna all the way) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPOSURE VIA BODY FLUID (One son had Moderna all the way) had resolved and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPOSURE VIA BODY FLUID (One son had Moderna all the way).    This case was considered for father of the 1st grandson.  No concomitant and treatment medications were reported.  He received Moderna all the way.  His partner (mother of the 1st grandson) received COVID-19 vaccinations, however it is not sure if she received Moderna.   This case was linked to US-MODERNATX, INC.-MOD-2023-722092 (Linked Report). This case was linked to MOD-2023-722087 (Parent-Child Link).   See case MOD-2023-722087 for details regarding the child case.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-722092:Case for Mother of 1st grandson
Pt fainted while sitting on the chair few seconds after the shot was administered. the fainting lasted few seconds then she came back fully aware of what just happened. she stayed in the room to be monitored then she vomited but felt better after. she was doing fine when she left. she was on the room a total of 40 minutes.
PATIENT STATES THAT SHE EXPERIENCED ARM NUMBNESS AND LOSS OF FINE MOTOR SKILL IN FINGERS.
This pt had an otic infection at the time of vax. She received vax on 08/20/99. Six days post vax the pt experienced cold sores in each corner of the mouth. The pt was not eating or sleeping well. The pts mother was exceptionally concerned that this may be secondary to varicella vaccine and that someone may catch it from her. It was also noted extremely concerned that it could be possible herpes and there could be significant consequences. It was also reported that the pts family had a history of immunodeficiency. Follow up was received from an LPN. On 08/30, four days post onset the pharynx was erythematous with come viral type vesicle on the soft palate. She had cracking and irritation in the corner of the mouth and was teething all four molars. This was felt to be possible viral pharyngitis. The physician felt the symptoms were unrelated to varicella virus vaccine live. No further information is available.
2 days after immunization child's arm had localized reaction with area measuring 4 3/4" in diameter with darker center of 1 1/4" of redness. Area warm to touch and he c/o itching. His father gave him PO BENADRYL night before and instructed him to give him some more. The following morning redness had subsided.
HEADACHE; This spontaneous report received from a parent concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 05-AUG-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 06-AUG-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache. This report was non-serious.
Red faced, sensitive to sunlight/easily sunburned, reoccurring back and abdominal rashes - lasted for a day at a time and would reoccur over an ~ 3-day period.
itchy rash on fingers and hands for three days; color change after itching to a dark red/purple
This spontaneous report has been received from a medical assistant referring to a 75 year-old female patient. The patient was allergic to NEOSPORIN AF. Concomitant therapies included FLONASE. No pertinent medical history. On 12-SEP-2018, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # R006466 (expiration date 24-OCT-2019), intramuscularly for prophylaxis. On an unknown date in September 2018, the patient developed swollen arms and redness. No lab diagnostics were performed. The patient had sought medical attention and was seen in the office. Treatment was given for the events. At the time of the report, the outcome of the events was not recovered. No causality assessment was provided.
Very itchy; Rash at the injection site; Red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Very itchy), VACCINATION SITE RASH (Rash at the injection site) and VACCINATION SITE ERYTHEMA (Red) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included No adverse event (No reported medical history). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), ATENOLOL, CITALOPRAM, OMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]), AMITRIPTYLINE and OXYBUTYNIN for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Very itchy), VACCINATION SITE RASH (Rash at the injection site) and VACCINATION SITE ERYTHEMA (Red). At the time of the report, VACCINATION SITE PRURITUS (Very itchy), VACCINATION SITE RASH (Rash at the injection site) and VACCINATION SITE ERYTHEMA (Red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Feels quite depressed and wants to cry; Stomach is not yet recovered; Slight fever; Chills; It felt like poison was leaving her body; Woke up at night; Bed and hair soaking wet; sign of weakness; Felt so dizzy like she was going to go down; Neck, shoulder and down her back was so painful; Neck, shoulder and down her back was so painful; could not get comfortable; Lost all appetite; Neck, shoulder and down her back was so painful; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Felt so dizzy like she was going to go down), BACK PAIN (Neck, shoulder and down her back was so painful), NECK PAIN (Neck, shoulder and down her back was so painful), ILLNESS (could not get comfortable) and DECREASED APPETITE (Lost all appetite) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Suspected COVID-19 (Went to several nursing homes, and eye doctor with crowded people), Cold and Cough. Concomitant products included AMLODIPINE BESILATE (NORVASC) for an unknown indication.    On 15-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced DIZZINESS (Felt so dizzy like she was going to go down), BACK PAIN (Neck, shoulder and down her back was so painful), NECK PAIN (Neck, shoulder and down her back was so painful), ILLNESS (could not get comfortable), DECREASED APPETITE (Lost all appetite) and ARTHRALGIA (Neck, shoulder and down her back was so painful). On 16-Mar-2021, the patient experienced SLEEP DISORDER (Woke up at night), HYPERHIDROSIS (Bed and hair soaking wet), ASTHENIA (sign of weakness), UNEVALUABLE EVENT (It felt like poison was leaving her body), PYREXIA (Slight fever) and CHILLS (Chills). On 17-Mar-2021, the patient experienced DEPRESSED MOOD (Feels quite depressed and wants to cry) and ABDOMINAL DISCOMFORT (Stomach is not yet recovered). On 15-Mar-2021, DIZZINESS (Felt so dizzy like she was going to go down), BACK PAIN (Neck, shoulder and down her back was so painful), NECK PAIN (Neck, shoulder and down her back was so painful), ILLNESS (could not get comfortable) and ARTHRALGIA (Neck, shoulder and down her back was so painful) had resolved. On 16-Mar-2021, SLEEP DISORDER (Woke up at night), HYPERHIDROSIS (Bed and hair soaking wet), ASTHENIA (sign of weakness), UNEVALUABLE EVENT (It felt like poison was leaving her body), PYREXIA (Slight fever) and CHILLS (Chills) had resolved. At the time of the report, DECREASED APPETITE (Lost all appetite) and DEPRESSED MOOD (Feels quite depressed and wants to cry) outcome was unknown and ABDOMINAL DISCOMFORT (Stomach is not yet recovered) had not resolved.            Patient would like to know if she could take Tylenol, if she had COVID-19 before what happens, and are these side effects common. Action taken with mRNA-1273 in response to the event was not applicable   This case was linked to MOD-2021-047987, MOD-2021-047987 (Patient Link).
This spontaneous report as received from a healthcare worker refers to the patients of unknown age and gender with no medical history reported. On an unknown date in approximately 2015 (reported as since 12-MAY-2015), an unspecified number of patients had been vaccinated with doses of improperly stored ROTATEQ, orally, lot # K006458, expiry date: 24-FEB-2016 (dose was not reported). No concomitant medications were reported. No adverse events were reported. Product quality complaint (PQC) was not reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Narrative:  75 year old male admitted on 2/4/22 with SOB and treatment of COVID-19 infection. He had been vaccinated x 3 with Moderna (1st dose: 2/23/21, 2nd dose 3/23/21, 3rd dose 9/29/21). He received 3 days of remdesivir and 3 days of IV dexamethasone for treatment and was discharged on 2/7/22.
fever 105 tx w/Ibuprofen, APAP, cool bath resolved w/in 1hr;
Very painful arm red swollen circle that started size of a golf ball and on day 3 spread larger than softball to over top of shoulder and down toward elbow. Started antibiotics and day 4 is still about size of softball and still very painful into neck to under armpit and shoulder.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21May2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 57 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 21Jan2021 as dose 1, single (Lot number: 029L20A), in left arm, on 18Feb2021 as dose 2, single (Lot number: 031M20A), in left arm and on 06Dec2021 as dose 3 (booster), single (Lot number: 045J21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Crohn's Disease" (unspecified if ongoing); "hiatal hernia" (unspecified if ongoing); "mild asthma" (unspecified if ongoing); "scented soaps" (unspecified if ongoing); "milk fat" (unspecified if ongoing); "walnuts" (unspecified if ongoing); "tomatoes" (unspecified if ongoing). Concomitant medication(s) included: MESALAMINE, start date: Jan2013; OMEPRAZOL, start date: Jan2013. Past drug history included: Bacitracin, reaction(s): "Known allergies: bacitracin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Treatment of COVID-19; (08Jun2022) Positive, notes: On day 8 my antigen home covid-19 test showed as very faintly positive; (11Jun2022) Positive, notes: I took another home test on day 11 and it showed a very dark positive line. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: adverse event: On day 8 my antigen home covid-19 test showed as very faintly positive and I was feeling pretty good with only minor coughing and stuffy nose. By day 10, my cough got worse, I began sneezing more and the congestion got a lot worse. I took another home test on day 11 and it showed a very dark positive line. My fever did not return, but the congestion and coughing still continues through today, day 15.
This spontaneous report was received from a nurse, concerning a patient of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On 16-FEB-2017, the patient was vaccinated with an inappropriate storage dose of PROQUAD (dose, frequency and route not reported), lot # M033215 with expiration date of 09-JAN-2018; and with a properly stored dose of VARIVAX (dose, frequency, route, lot and expiration date not reported). No adverse effects were reported. The temperature excursion of the PROQUAD vaccine was greater than 14 °F but less than 46 °F, for a time frame of 2 months. No previous temperature incursion was reported. No product quality complaint was involved (PQC). Data logger was involved. Additional information has been requested.
THROWING UP; UNCONTROLLABLE SHAKES FROM HEAD TO TOE FEET WERE EXTREMELY COLD; FELT DISORIENTED; FELT LIKE GOING TO PASS OUT; SEVERE CHILLS; SHORT TERM HEARING LOSS; METALLIC TASTE; This spontaneous report received from a patient concerned a patient of unspecified age and sex and of unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: UNKNOWN) dose was not reported, 1 total administered on 19-JUN-2021 14:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 19-JUN-2021, within an hour after vaccination the patient had symptoms of short term hearing loss and a metallic taste. After that all was good no signs or symptoms from vaccine, the patient went to bed at 23:00. On 20-JUN-2021, at 1:05 the patient woke up with severe chills and uncontrollable shakes from head to toe feet were extremely cold. The patient was used to stay at -21 temperatures and currently living at place which was rarely ever cold. The patient went outside to warm up roughly for 10 minutes, later felt very disorientated and felt like going to pass out by 1:23 was throwing up two times. Shortly after expelling vomit the patient felt much better. All symptoms seemed to last around an hour or less. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from short term hearing loss, and metallic taste on 19-JUN-2021, and throwing up, uncontrollable shakes from head to toe feet were extremely cold, felt disoriented, felt like going to pass out, and severe chills on 20-JUN-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210645469-covid-19 vaccine ad26.cov2.s-Short term hearing loss.This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
30 minutes after shot administered in left arm, pain in left shoulder blade along with pain on left side of neck. After 2 days, pain in neck subsided as pain in left shoulder blade and left shoulder increased and after a week left index finger and thumb became numb. Pain remains in left shoulder, however pain in shoulder blade after 2 weeks moves from left should blade to neck and sometimes both. Loss of sleep due to pain and on a scale of 1-10 pain is an 8-9 constantly. Went to a Chiropractor on Monday, March 29, 2021 for an adjustment and assessment, nerve test reveled nerves in that area not firing properly. Followed with a massage with no avail or reduction in pain or numbness. Have an appointment with DO my doctor on Thursday, April 8, 2021 or if she can get me in sooner.
benign growth on my left nipple; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 59 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date May2021 (Lot number: EW0177) 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: NIPPLE DISORDER (non-serious), outcome "unknown", described as "benign growth on my left nipple". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Patient was also Reporter. COVID-19 Vaccine is a Pfizer product. About Height and weight of Pharmacist, Pharmacist stated that her height is 5 (feet) 3 (inches) or 5 (feet) 4 (inches) and her weight is, Patient do not dare to weight herself, she is so fat, she think she is in like 170 or 173 (pounds)." Pharmacist stated, "No, the card does not provide that page and she is a pharmacist, nobody is writing and she also participated on vaccination, that information is not given on the patient card and the Pfizer does not provide that information. Pharmacist stated that she was not sure that the registry to the CDC might give that information but not at the level of patient on the vaccination card that information is not there". Pharmacist stated, "No, they did not put that. They are only putting the name and the LOT number using the CDC card and just the day it was administered, there is no information of the vaccine expiration date or what so ever. The CDC card does not annotate that". Pharmacist stated, "In her case, she got it on the left arm and actually two days after he got a reaction on her nipple and we do not know, she got black a reaction and had to have a biopsy on her nipple and that came two days after she got her first vaccine, it came out as benign growth, but it was very interesting that she got that immediately two days after the vaccination and my son, she think he also because we are right handed so got vaccinated on the left hand, on the left arm." She got a growth a benign growth on her left nipple which was not there it's invisible and she got a biopsy done." Patient got the same EW0177 for the first dose.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101870644 similar report from same reporter
Vaccine administration error.  The Moderna Lot# 048F21A shipment expired on 01/22/22.  The vaccine was administered to the patient on 01/24/22.
This case was reported by a other health professional via call center representative and described the occurrence of injection site swelling in a 75-year-old female patient who received SHINGRIX (batch number 3AF9E, expiry date 2nd February 2021) for prophylaxis. On 25th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced injection site swelling and injection site itching. On an unknown date, the outcome of the injection site swelling and injection site itching were recovering/resolving. The reporter considered the injection site swelling and injection site itching to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left deltoid. The patient experienced swelling and itching at the injection site the next day after receiving the SHINGRIX vaccination.
This case was reported by a nurse via call center representative and described the occurrence of syncope in a 56-year-old female patient who received FLUARIX QUADRIVALENT (batch number 4LX29, expiry date 30th June 2016). Concomitant products included PAXIL and Low Dose Aspirin. On 8th October 2015, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On 9th October 2015, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced syncope, fall and bruise of head. On an unknown date, the patient experienced leg cramps. On an unknown date, the outcome of the syncope and leg cramps were recovered/resolved and the outcome of the fall and bruise of head were recovering/resolving. The reporter considered the syncope, fall and bruise of head to be possibly related to FLUARIX QUADRIVALENT. The reporter considered the leg cramps to be unrelated to FLUARIX QUADRIVALENT. Additional details provided were as follows: This case was reported by a nurse who herself was the patient. On 8th October 2015, at 16:30, the patient received a dose of FLUARIX QUADRIVALENT. On 9th October 2015, at around 4am (approximately 12 hours after vaccination), the patient woke up with leg cramps. She began walking around and experienced syncope. Due to syncope, the patient experienced a fall and hit her head, which resulted in head contusion. The patient went to emergency room, no overnight hospitalization was required.