chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DTaP given on 1/12/09 right arm, Had right arm swelling, redness, felt firm to touch, worsened over 2 days. Seen in clinic on 1/14/09, had indurated erythematous, warm swelling. Did ice compresses at home. Given Motrin and benadryl and asked to follow up.
Shaking, hives on neck and chest, tightness in chest and throat, pounding heart
P/receiving immun @ 2PM on 13MAY91; pt began running a t102.5 @ midnight; temp cont @ 102.5 through the next day then inc 103.4 w/vomiting & diarrhea; Seen by MD 15MAY91;
Redness, edema, rash and itchiness in nasal bridge and Eyelids; Redness, edema, rash and itchiness in nasal bridge and Eyelids; edema; rash and itchiness in nasal bridge and eyelids; Redness, edema, rash and itchiness in nasal bridge and eyelids; Redness, edema, rash and itchiness in nasal bridge and eyelids; Redness, edema, rash and itchiness in nasal bridge and eyelids; Redness, edema, rash and itchiness in nasal bridge and eyelids; This is a spontaneous report from a contactable consumer (patient). A 44-year old non-pregnant female patient (not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration administered in Arm Left on 10Apr2021 12:30 (44-year-old at the time of vaccination) as dose 2, single for covid-19 immunization. Medical history included hypothyroidism from an unknown date and unknown if ongoing. The patient had no allergies to medications, food, or other products. Concomitant medications included quetiapine, lithium, drospirenone, ethinylestradiol (YASMIN); levothyroxine sodium (EUTIROX) all for unknown indications from unknown dates and unknown if ongoing. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration administered in Arm Left on 20Mar2021 as dose 1, single for COVID-19 immunization. The patient had not received any vaccine within four weeks. The patient had no covid prior to vaccination. The patient was not tested since vaccination. On 12Apr2021 01:00, the patient experienced redness, edema, rash and itchiness in nasal bridge and eyelids. Therapeutic measures were taken as a result of the events using Cetirizine 10mg. Adverse event resulted in: Doctor or other healthcare professional office/clinic visit. The outcome of the events was recovering.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Had a rash develop about 3? long & 1 1/2  wide. It started going up my arm about an inch but the stopped progressing up my arm.  It itched.  Itching stopped but the skin is discolored a pale red.
Approximately 5 minutes after vaccination, patient complained of feeling hot, some fatigue.  Initial BP: 158/116.  O2Sat: 97%; P: 70.   BP rechecked at 10 minute intervals.  BP: 160/108; 172/ 118, 178/118.   BP remained high,  denied hx of HTN but reported feeling dizzy or lightheaded last week.   Recommended f/u at ER due to  elevated BP.   EMS activated, care transferred to ambulance crew at 10:55am.   Transported to Hospital.  Patient spoke another language; wife present to translate.
CDC reports: 2 mo infant experienced screaming episode for > 4 hrs following DTP/OPV immunization.
diarrhea at 0200 on 12/19 (~ 12 hours after vaccine), patient doing fine now ~ 22 hours after vaccine
a big lump under the arm; fever in the arm for 5 days; rash spreading down her arm; swelling in the arm; swelling; really bad itchiness; numbness in the arm; soreness; This spontaneous case was reported by a consumer and describes the occurrence of SKIN MASS (a big lump under the arm), FEELING HOT (fever in the arm for 5 days), RASH (rash spreading down her arm), PERIPHERAL SWELLING (swelling in the arm) and SWELLING (swelling) in a 31-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.     Concomitant products included TRAMADOL, PROGESTERONE, LORAZEPAM, IBUPROFEN, GABAPENTIN, FENOFIBRATE (ADIPEX [FENOFIBRATE]) and ESTRADIOL for an unknown indication.    On 03-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced SKIN MASS (a big lump under the arm), FEELING HOT (fever in the arm for 5 days), RASH (rash spreading down her arm), PERIPHERAL SWELLING (swelling in the arm), SWELLING (swelling), PRURITUS (really bad itchiness), HYPOAESTHESIA (numbness in the arm) and MYALGIA (soreness). In September 2021, SKIN MASS (a big lump under the arm), FEELING HOT (fever in the arm for 5 days), RASH (rash spreading down her arm), PERIPHERAL SWELLING (swelling in the arm), SWELLING (swelling), PRURITUS (really bad itchiness), HYPOAESTHESIA (numbness in the arm) and MYALGIA (soreness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication were reported.
The patient has a history of stage IV kidney disease and bladder cancer s/p cystectomy and urostomy. He was seen in the ED on 7/29/23. Per family, over the past 36 hours the patient has not been moving or talking as much as normal. The patient additionally reported weakness and productive cough. He was found to have a fever of 102.3. A COVID PCR test done in the ED resulted positive. Ultimately, he was admitted 7/29/23 - 8/3/23. Discharge diagnoses include generalized weakness and fever secondary to COVID infection, among other diagnoses. He did not require supplemental oxygen during his admission. Of note, the patient has received the primary COVID vaccine and three boosters.
3rd dose of Moderna given using expired Moderna Vaccine vial - Vial expired on 10/13/2021 given on 10/18/2021  Lot number 048C21A- manufacture expiration date 11/09/2021 - removed from freezer on 09/13/2021- expired 10/13/2021
pt recvd vax;mom described golf ball sized inflamed raised area around inject site;3 days later to ped;redness & swelling dec;lethargy cont;no meds prescribed;low grade fever;
Pt received a Hepatitis B vaccination instead of a Hepatitis A vaccines. He did not have any adverse reaction after vaccination. Is the 5th hepatitis vaccine he received.
Dose 1 given 2/10/2021 Moderna lot # 024M20A  Patient died at Medical Center on 1/3/2022 from brain bleed. This was not a covid related death.
Information has been received from a RN concerning a 7 yr old female with no medical history or allergies who on 25Feb99 was vaccinated with a 0.5mL dose of varicella virus vaccine live. There was no concomitant medication. On 25Dec05 the pt presented with breakthrough chickenpox with 30 lesions. Unspecified medical attention was sought. No lab diagnostic tests were performed. Subsequently, the pt recovered. There was no product quality complaint involved. Additional information has been requested.
3hrs p/vax pt stated that began w/coughing, sl diff breathing & then several hrs p/vax;low grade fever;took APAP did not call PMD: called on ofc next morning 31OCT95;
Information has been received from a registered nurse concerning a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with the second dose of GARDASIL 9 (dose, route, lot# and expiration date unknown) (inappropriate schedule of drug administration). And then on an unknown date, the third dose of GARDASIL 9 (dose, route, lot# and expiration date unknown) was administered only 6 and a half weeks after the second dose (inappropriate schedule of drug administration). No adverse effect was reported. Additional information has been requested.
Swelling and pain to (R) arm 2 x 3. Rx Pen VK 250mg QID x 10 days BENADRYL liq.
Pt had persistent crying for 2 hrs following immun on 27FEB91; OPV had just been given previously on same day;
Left arm from shoulder to fingertips feels numb and tingly and like a chill/coldness running all down my arm starting day after shot and still continuing as of today.
pt recv vax 23OCT97 & 23OCT97 & p/the 2nd vax pt devel a sore throat, blocked ears, nasal congestion & a diffused, red, raised rash on face, torso & extremities;the lesions were flat topped plaques w/sl scaling virulent to five pap lesions
Migraine headache; Migraine headache; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the right arm on 29Mar2021 at 15:45 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma and history of migraines. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received DEMEROL and CIPRO and experienced allergy. On 11Apr2021, the patient experienced migraine headache. The event resulted in emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the migraine headache which included treatment with meds and testing. The clinical outcome of the event migraine headache was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
FELT DIZZY AND LIGHTHEADED, FELT BETTER ONCE SHE LAID DOWN ON THE EXAM TABLE FOR ABOUT 20 MINS
Intense bone/joint pain that occurred ~8 hours after vaccine.  Started in hips/back, then moved to extremities. Patient unable to walk normally due to pain.  Took 500 mg of acetaminophen at bedtime.  Symptoms resolved the next morning except for slight right knee pain, which resolved by the afternoon.  Patient feels that joints "crack" more frequently after vaccine.
17Feb 2010 received call from SM stating that he had a reaction "to the Anthrax vaccine" on 11Sept 10 Anthrax given in (R) deltoid after member educated on Anthrax vaccine and possible side effects. Member signed Anthrax education 600 over print and questions answered. SM stated understanding. SM called 17 Sep at 1930 and stated that he started having burning in (R) arm and (R) hand "a few minutes after receiving vaccine. Lasted approx 1 hour and "then injection site was just sore." Sunday a.m awakened with joint pain, chest tightness, dyspnea and nausea, dizziness and malaise throughout the day. Did not go to work, but SM did not go to ED or physician. SM stated that, "On Tuesday, felt better in a hazy dream like state until late Thursday (L) forearm began swelling - palm increased inside of elbow 1 1/2" to outer forearm redness and raised area. SM c/o soreness - pulsing pain in arm with flu shot - not arm with anthrax injection. When SM called he stated that he was feeling better on this day until (L) side of scalp started hurting around 9-10 a.m. - at this time SM realized that he had solid black scab on (L) side of head - denied hitting head. Member also c/o intestinal burning that started on Sunday (day after shot) no vomiting, - 1 loose stool. SM stated that he has felt "bad - on and off since time he received shots". Also, stated that he had sharp "flash like" pains in his head that lasted 15-20 seconds that started on 17Sep 2010. Instructed member to go to ED if symptoms returned or worsened. Also, to have information emailed/sent ASAP and report on Oct drill to see physician.
Patient brought to ED 6/8 am with substernal chest pain onset 6/7 pm. Tests include EKG, chest xray, serial troponin, Chest CT, BNP, d dimer, labs. Patient admitted for further work up which ruled out PE, aortic dissection, pneumothorax. Initial EKG showed ST changes in inferior lead and repeat EKG consistent with pericarditis. CXR showed pulmonary vascular congestion and prominent interstitial markings. WBC showed leukocytosis. Elevated CRP. Patient started on aspirin and colchicine with improvement and discharged home.
Within 24 hours of receiving vaccines child developed redness and swelling from (R) trochanteric region to distal tibia.
This is a spontaneous report received from a contactable consumer or other non-healthcare professional. A female patient, of an unspecified age, received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# unknown), via an unspecified route of administration, on Feb 7, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Husband reported on behalf of his wife. Feb 7, 2021 was the first dose of the COVID-19 vaccine. On Feb 12, 2021 patient had a rash and wanted to know if this was a side effect. The outcome of the event: unknown. Follow-up attempts completed. No further information expected.
the vial was initially stored in the refrigerator on 19-May-2022 after expiration date 24-Apr-2022; No adverse event; Dose administered after manufacturer date of expiry to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry to patient), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 19-May-2022 after expiration date 24-Apr-2022) and NO ADVERSE EVENT (No adverse event) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry to patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 19-May-2022 after expiration date 24-Apr-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry to patient), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 19-May-2022 after expiration date 24-Apr-2022) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry to patient) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 19-May-2022 after expiration date 24-Apr-2022).    No concomitant medications were reported. Number of doses/vials were reported as 200 doses 20 vials. Date the vial was initially stored in the refrigerator were reported as 05-May-2022, 06-May-2022,19-May-2022, 02-Jun-2022, 09-Jun-2022 and 23-Jun-2022. Office manager explained that vaccines were removed from the freezer on date of appointments to be used, and any unused portion was put in refrigerator. Date(s) of administration of vaccine was reported as 05-May-2022, 06-May-2022,19-May-2022, 02-Jun-2022, 09-Jun-2022 and 23-Jun-2022 to12 patients. The vial did not undergo any temperature excursions.  No treatment medications were reported.
Ped pfizer dose was given without diluting the vaccine. Followed up with patient no side effects so far.
This spontaneous report was received from a 61 years old female patient with unspecified allergies. The patient was vaccinated with one shot 0.65 ml ZOSTAVAX on 11-OCT-2012. Lot# was unspecified. Concomitant medications included: AMITIZA. The patient reported that, on 11-OCT-2012, the ZOSTAVAX was given to her in her muscle, not subcutaneously. She had been back to the office 3 times and each time the office had repeatedly told her that the vaccine was given in her muscle. Her arm at the injection site on the right arm was sore from Thursday (11-OCT-2012) to Saturday (13-OCT-2012) and currently it was just sore when touched. No treatment was given for the event. No lab diagnostic study performed. The patient was not recovered. The patient was seen at the office to seek medical attention. Additional information has been requested.
Hives on arms and back x2wks worse after vaccine Benadryl 50mg po
First shot: mild fever diarrhea, arm pain, headache, fatigue, lethargy Anaphylaxis- swelling of lips, mouth, tongue, face, coughing, wheezing, closed airway, dry heaving, increased heart rate
This spontaneous report was received from a Registered Nurse and refers to an 8 year old male child. On 18-SEP-2007 the patient ws vaccinated with (Oka/Merck) VARIVAX. On 07-JUL-2014, the patient was diagnosed with Contact Dermatitis and given Triamcinolone. On 08-JUL-2014 the patient developed "red streaking and swelling on the left mid back", AUGMENTION was started on 08-JUL-2014, "a PCR test was performed which was Negative for VZV". On 09-JUL-2014, vesicles developed on the left mid back. On 15-JUL-2014, the patient ws seen by an unspecified Dermatologist who diagnosed the patient with Shingles. Acyclovir was started on 16-JULY-2014. The patient has not recovered. All listed data confirmed by the reporter, no further information was provided. Outcome is patient has not recovered. Additional information is not expected.
Tenderness & soreness at injection site within a couple of hours dissipating by 04/30/2018. Flu like symptoms (chills & mild sweating) during very early AM on 04/27/2018- self limiting. Redness noted at injection site with a 2 inch diameter approximately 10 PM on 04/27/218, dissipating by AM on 05/01/2018. At no time did I run a fever or need to take Tylenol or ibuprofen. No impact on diet. Had full range or motion with left arm and shoulder.
Itching at the injection site; Redness at the injection site, Redness about 3x4 inches; Warm at the injection site; Little pain at the injection site; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE PAIN (Little pain at the injection site), VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site, Redness about 3x4 inches) and VACCINATION SITE WARMTH (Warm at the injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011V201A) for COVID-19 vaccination.     No medical history was provided by reporter.     On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION SITE PAIN (Little pain at the injection site). On 18-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site, Redness about 3x4 inches) and VACCINATION SITE WARMTH (Warm at the injection site). The patient was treated with OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) ongoing from 18-Jan-2021 at a dose of 1 dosage form. On 11-Jan-2021, VACCINATION SITE PAIN (Little pain at the injection site) had resolved. On 21-Jan-2021, VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site, Redness about 3x4 inches) and VACCINATION SITE WARMTH (Warm at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment and concomitant medications were not provided by reporter.
Symptoms: no appetite, tired, dizzy, aches, feverish, arm hot and swollen (left). Patient took TYLENOL, BENADRYL.
I am reporting a breakthrough Covid19 infection.  I woke up and my body felt very sore and muscles were very achy and I was congested.  Since I had plans to visit family I wanted to ensure I was ok.  I did the at home nasal swab test and it was positive.   My symptoms persisted and then I got a slight headache.  I reached out to my doctor and she prescribed the Paxolovid.
Rebound infection; This spontaneous case was reported by a non-health professional and describes the occurrence of COVID-19 (Rebound infection) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Psoriatic arthritis and Drug allergy. Concomitant products included LEVONORGESTREL (MIRENA) and SECUKINUMAB (COSENTYX) for an unknown indication.   On 03-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 29-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Rebound infection). At the time of the report, COVID-19 (Rebound infection) had not resolved.            Treatment information was not provided.  Company Comment: This spontaneous case reported by non-health professional concerns a patient of unknown age and gender, with relevant medical history of psoriatic arthritis, who experienced unexpected, non-serious AESI Covid19, approximately 8 ½ months after receiving a third dose of mRNA-1273.  The patient was treated with a 5-day course of Nirmatrelvir/Ritonavir (Paxlovid) for Covid19, then reported a rebound infection 5 days later.  Information about the first 2 doses of Covid19 vaccination were not available.  The ongoing Covid19 pandemic could be contributory factor.  The patient's medical history of psoriatic arthritis could also be a confounder.  The benefit risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case reported by non-health professional concerns a patient of unknown age and gender, with relevant medical history of psoriatic arthritis, who experienced unexpected, non-serious AESI Covid19, approximately 8 ½ months after receiving a third dose of mRNA-1273.  The patient was treated with a 5-day course of Nirmatrelvir/Ritonavir (Paxlovid) for Covid19, then reported a rebound infection 5 days later.  Information about the first 2 doses of Covid19 vaccination were not available.  The ongoing Covid19 pandemic could be contributory factor.  The patient's medical history of psoriatic arthritis could also be a confounder.  The benefit risk relationship of mRNA-1273 is not affected by this report.
Information has been received from a certified medical assistant concerning an 84 year old female with no allergies, a cognitive impairment, and a history of colon cancer who on 09 Nov 2006 was vaccinated SC with a 0.65 mL dose of Zostavax (lot # 652965/0632F). Concomitant therapy included Coumadin, Aricept, Namenda, Zoloft, and Temazepam. Sometime after vaccination, in approximately, November 2006, the patient's mental status began deteriorating. She became more lethargic and forgetful since the injections. According to the patients husband, she is no longer able to read and sits for hours staring into space. She became more dependent on others to do a common task, such as personal hygiene. Unspecifeid medical attention was sought. No diagnostic laboratory tests were performed. At the time of the report, the patient had not recovered. A product quality complaint was not involved. Additional information has been requested.
Pt received vax 8/23/95. Developed chickenpox 1/20/00.
Initially, headache, body aches, fatigue. After 6 days, profound fatigue still present
Bruising at the injection site, redness with heat, and red circle about the size of a fried egg.
Scattered erythematous pap. pus, lesions on trunk (5 or 6), neck (1), legs and arms (1 or 2).