chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced injection site pain, pain in arm, erythema of extremities, extremities hot feeling of and swelling arm. On an unknown date, the outcome of the injection site pain, pain in arm, erythema of extremities, extremities hot feeling of and swelling arm were recovered/resolved. It was unknown if the reporter considered the injection site pain, pain in arm, erythema of extremities, extremities hot feeling of and swelling arm to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported, but could be 86 or 87 years old. The patient developed pain at the injection site on the first day. The next morning (1 day after vaccination), the patient's arm was painful, red, swollen and hot. The events slowly resolved over the next several days. The reporter agreed to follow up.
from 4.30pm on day : dopey and dozey and went to bed at 8.30 p.m.  Tiredness, muscle pain, itching ankles, elbows, head, back;  muscle pain; headache; joint pain; all for one week or more.
The area where vaccine got administered swell  within about 2 inches of injection site was painful 1 day after vaccine was given.
This spontaneous report as received from a physician refers to a 26 week old female patient. No information regarding the patient's medical history and concurrent conditions was provided. On an unknown date, the patient was vaccinated with a dose of ROTATEQ, lot # M004508, orally, (dose and expiration date were not provided). There were no concomitant medications reported. The physician stated that the initial dose of ROTATEQ was administered when the child was 26 weeks old, that is later than the recommended start date for the vaccine. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information is not expected because the reporter did not wish to be contacted.
The very next day around 4:00 AM through 11:00 PM the next night, 9/17/2022. I had body aches, headache, I was a little dizzy when I stood up, fatigue. I took a couple of aspirins and slept as much as I could. I stayed home from work for one day.
This spontaneous report as received from a pharmacist refers to two unspecified patients of unknown age and gender. On 07-JUL-2014 the patients were vaccinated with improperly stored doses of ZOSTAVAX (0.65 ml, subcutaneous, lot# and strength were unspecified). No adverse events were reported. The outcome was unknown. Additional information has been requested.
I  got my second dose of Moderna vaccine on Wednesday. The day after the first dose, I was very shaky all day, had diarrhea, and ended up with hives on my arms, neck and face. The hives went away pretty quickly after taking Benedryl. This is now two days after my second dose. I've had intense body aches, fatigue, headaches, and today developed hives all over my chest and stomach. I have taken one Benedryl and the hives are still there.
Pt states having a red swollen arm with cellulitis (per md) going from injection site up and around to back of neck.  Md diagnosed as cellulitis and gave prescription of Septra DS twice daily for 7 days-
Soreness first few days.  Day 5 began swelling (6 inches in diameter and raised approximately 1/8 inch), redness, pain, allergic reaction at injection site.
administered 0.5 mL of the Moderna COVID-19 Vaccine for booster dose; This patient had the Jensen and ended up giving the 0.5ml of Moderna; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (administered 0.5 mL of the Moderna COVID-19 Vaccine for booster dose) and INTERCHANGE OF VACCINE PRODUCTS (This patient had the Jensen and ended up giving the 0.5ml of Moderna) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 for COVID-19 vaccination.    No Medical History information was reported.   On 17-Mar-2021, the patient received dose of COVID-19 VACCINE NRVV AD26 (unknown route) 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (administered 0.5 mL of the Moderna COVID-19 Vaccine for booster dose) and INTERCHANGE OF VACCINE PRODUCTS (This patient had the Jensen and ended up giving the 0.5ml of Moderna). At the time of the report, INCORRECT DOSE ADMINISTERED (administered 0.5 mL of the Moderna COVID-19 Vaccine for booster dose) and INTERCHANGE OF VACCINE PRODUCTS (This patient had the Jensen and ended up giving the 0.5ml of Moderna) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  The patient had the Jensen vaccine and it was more than 2 months. An unknown dose was received on 17-Mar-2021.  No treatment information was provided by the reporter.
pharmacist pulled back the label and noticed that the lyophilized tablet was not dissolved; the lyophilized tablet was not dissolved; the lyophilized tablet was not dissolved; Wrong technique in drug usage process; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 63-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 3EX93, expiry date 24-FEB-2025) for prophylaxis. This case was associated with a product complaint.   On 29-SEP-2023, the patient received Arexvy (injection, right arm). On 29-SEP-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: the lyophilized tablet was not dissolved), inappropriate dose of vaccine administered (Verbatim: the lyophilized tablet was not dissolved) and wrong technique in drug usage process (Verbatim: Wrong technique in drug usage process). On an unknown date, the patient experienced pharmaceutical product complaint (Verbatim: pharmacist pulled back the label and noticed that the lyophilized tablet was not dissolved).The outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered, wrong technique in drug usage process and pharmaceutical product complaint were unknown.   Additional Information: GSK Receipt Date: 02-OCT-2023 and 05-OCT-2023 The reporter reported that another pharmacist at facility gave an Arexvy injection to a patient.  After injecting the Arexvy into the patient's right arm, the pharmacist pulled back the label and noticed that the lyophilized tablet was not dissolved and administering pharmacist then called patient back, reconstituted the same undissolved antigen vial with another new adjuvant vial and re-administered the dose of Arexvy, which led to inappropriate preparation of medication, inappropriate dose of vaccine administered and wrong technique in drug usage process. Both injections were given in the same arm on the same day. The reporter reviewed video of administering pharmacist reconstituting Arexvy dose both times and stated that he prepared the dose correctly according to the PI instructions.  No harm to patient had been reported by facility staff at this time. The reported defect was classified as vaccine appearance.
This spontaneous report as received from a nurse refers to two patients of unknown age and gender. Medical history was not reported. The nurse informed that on an unknown date the patients were vaccinated with doses of improperly stored PNEUMOVAX23 (strength, dosage, route, lot number and expiration date were not reported). Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
hot, flushed face and cheeks, hands tingly, red rash on cheeks , 50 mg of liquid BENADRYL given and observed client and monitored vital signs for one and half hours and then she felt better and she went home from school with her mother.
Information has been received from a medical assistant concerning a 29-year-old female with an allergy to codeine and a medical history of sinus operation in December of 2007 and, who on 25-MAY-2007 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL. There was no concomitant medication. The medical assistant reported that "the patient had some tightness in her back when she received the first two doses, but they did resolve." On 23-JAN-2008 at 09:00 the patient was intramuscularly vaccinated with the third dose of GARDASIL (Lot # 655327/1287U). On 25-JAN-2008, also reported as "one week after" the patient received her third intramuscular dose of GARDASIL (Lot # 655327/1287U) on 23-Jan-2008, she experienced dizziness, nausea, blurred vision and tightness in her back. On 30-JAN-2008 one week after vaccination the patient experienced tightness in her back. "Today," 25-Feb-2008, in the office her heart rate and blood pressure had also elevated. At the time of this report the patient had not recovered from tightness in her back, elevated heart rate and elevated blood pressure and the outcome of the other events was unknown. No product quality complaint was involved. Additional information has been requested. Follow up information received from a nurse practitioner regarding this patient indicated that she has not heard from the patient. Additional information is not expected.
Patient observed having trouble breathing.  Patient had altered mental status.  Patient did not improve after epi-pen administration.
Admission Date: 1/25/2023 Discharge Date: 1/31/2023   DETAILS OF HOSPITAL STAY: Patient is a 75 y.o. female with past medical history of chronic respiratory failure on 2 L nasal cannula baseline, COPD, permament atrial fibrillation on Eliquis, recent ORIF (11/23/22) due to L distal femur and R tib-fib fracture with persistent surgical wounds, chronic deconditioning due to nonweightbearing status, chronic prosthetic joint infection of Left knee on Zosyn through PICC line (started 1/2/23, discontinue date: 2/13/23), chronic anemia, chronic diastolic heart failure, essential hypertension, OSA who presented to Hospital Emergency room on 1/25/23 with worsening shortness of breath x 2 days.              Patient was noted to be COVID positive and was started on Decadron and remdesivir.  She completed her course of remdesivir while in hospital.  She will need 4 more days of Decadron 6 mg daily.               She was continued on her IV antibiotics through PICC line for chronic prosthetic joint infection (end date 2/13/23). Suture removed on 1/31/2023 by me, wound healed almost completely, with very small superficial dehiscence in the middle (2 in long). Minimal wound drainage. Follow up with ortho as scheduled before.    Seen by Wound clinic for chronic left hip wound. They recommended NS damp to dry 1/2 inch plain packing strip. Change twice per day.   She was noted to have potential contribution of fluid overload to her shortness of breath and was aggressively diuresed with IV Lasix while inpatient.  She tolerated this well. Net IO Since Admission: -9,175 mL [01/31/23 1147]. Patient improved during her stay and was discharged on Lasix 40 mg po bid.  She was weaned back to her home O2 requirements at baseline 2 l/min O2 via NC.   PT and OT saw the patient recommended Home with HHC.
redness and swelling at the injection site bilateral arms, symptoms started next day after patient received vaccines. Pt's mother also report pt was complaining of fingers and toes "feeling  funny" for 3 days, now resolved.
14 days p/MMR devel fever to 103; seen in office 1 1/2 hrs prior to sz; PE nl x/fever; generalized sz started @ home, ended in MD office; estimated duration <3 mins; fixed lt lateral age x 2 mins then galzed stare & hypotonic x 15-20mins;
Fever for 36 hours; Ache for 36 hours; Chills for 36 hours; Swollen Lymph nodes; Two fingers on left hand are stiff, you can close your hand but those 2 finger wont lift up; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Two fingers on left hand are stiff, you can close your hand but those 2 finger wont lift up), PYREXIA (Fever for 36 hours), PAIN (Ache for 36 hours), CHILLS (Chills for 36 hours) and LYMPHADENOPATHY (Swollen Lymph nodes) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event .     On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Two fingers on left hand are stiff, you can close your hand but those 2 finger wont lift up) and LYMPHADENOPATHY (Swollen Lymph nodes). On 27-Jan-2021, the patient experienced PYREXIA (Fever for 36 hours), PAIN (Ache for 36 hours) and CHILLS (Chills for 36 hours). On 29-Jan-2021, PYREXIA (Fever for 36 hours), PAIN (Ache for 36 hours) and CHILLS (Chills for 36 hours) had resolved. At the time of the report, MUSCULOSKELETAL STIFFNESS (Two fingers on left hand are stiff, you can close your hand but those 2 finger wont lift up) and LYMPHADENOPATHY (Swollen Lymph nodes) outcome was unknown.            No concomitant medications were provided No treatment information provided
warmth over the left arm injection site; redness over the left arm injection site; pain over the left arm injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (warmth over the left arm injection site), VACCINATION SITE ERYTHEMA (redness over the left arm injection site) and VACCINATION SITE PAIN (pain over the left arm injection site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21A and 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced VACCINATION SITE WARMTH (warmth over the left arm injection site), VACCINATION SITE ERYTHEMA (redness over the left arm injection site) and VACCINATION SITE PAIN (pain over the left arm injection site). At the time of the report, VACCINATION SITE WARMTH (warmth over the left arm injection site), VACCINATION SITE ERYTHEMA (redness over the left arm injection site) and VACCINATION SITE PAIN (pain over the left arm injection site) outcome was unknown.            The patient went to her doctor and got treated with an antibiotic (unspecified). No concomitant medications were reported   Reporter did not allow further contact
Information has been received from a physician's assistant concerning a female who on 11/2/98 and in May 2001, was vaccinated with the first and second doses of varicella virus vaccine live. A titer was drawn on 6/5/01 indicated that the patient failed to seroconvert. Unspecified medical attention was sought. There was no product quality complaint. The reporter also indicated that another patient failed to seroconvert (WAES0407USA01108). Additional information has been requested.
Temperature 103 unless within 3 hours of Tylenol. (i.e. temp would be 103, then Tylenol, fever would drop below 100 until about 4 hours after dose, then return). Near unconsolable irritability when not taking Tylenol. Has continued through time of reporting (6/17/12, 6:20pm).
I had a hot, itchy, vax administration site reaction that lasted for 4 days. It looked a lot like ringworm except it was hot and super itchy. It was ultimately relieved by an Epsom salt bath, I think.
employee received vaccine at 1525 1535 noted lightheadedness & shaky feeling. Hx of vasovagal responses to injections & blood draws. Denies SOB, difficulty swallowing, nausea (+) hand/fingers tingling - VS- tachycardia to 120, O2 sat 97% became syncopal to ED
Patient received Tdap, VVX, MCV4 and HPV vaccines.  Fainted soon after vaccines were given.
Site: Pain at Injection Site-Severe, Systemic: bursitis-Severe, Additional Details: Diagnosed with bursitis on 11/16/2021, 6 days after vaccination
Baseball sized lump on right thigh at immunization location site. Bright red, warm to touch.
Information has been received from a pharmacist referring to 3 newborns (numbered 210, 211 and 212). Background: Since June 2015, there had been 1645 times (30 minutes each time = 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time =72 hours) that temperature was 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 21-SEP-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
12 hours after receiving the flu injection, I got up, had a very heavy feeling in my head and fainted twice.
Received shot around 2:10 pm. Experienced some stinging at injection site within a few seconds that became uncomfortable for several minutes then disappeared.  At 2:40 texted spouse that my face was tingling.  Started in cheeks and upper lip and spread to nose. A few minutes after that I started having hot flashes and my face was flushed.  Hot flashes lasted for an hour and subsided, tingling has mostly subsided except for area of cheek closest to my nose (it is 6 pm now).  Did not formally check into the urgent care facility but did contact them to see if this was normal.  Was advised to take antihistamine and, and if symptoms worsened to go to ER.  Symptoms did not get worse.
The client stated about one hour after receiving the 2nd COVID vaccine Monderna, he developed "feeling warm and a headache." The client stated these symptoms lasted less than 2 hours. The client did not verify his temperature with a thermometer. The client stated he developed body aches the day after receiving the second dose of COVID vaccine Moderna. The client denied any dizziness, shortness of breath, or other symptoms of anaphylaxis. The client took Tylenol which helped his symptoms.
Swelling started on Sun, 11/13 in the area of the injection. 2-3" diameter of redness, with swelling, itchiness; burning and pain when scratched area.
pt followed for metastatic melanoma recv flu vax & apparently had sudden death approx 45min later;no prev rxn to flu vax;
2 inch by 2 inch rash that has developed on day 7 after the vaccination date at the site of the injection.
expired Daptacel administered to 10 years old patient; expired Daptacel administered to 10 years old patient; Initial information received on 10-Jun-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 10 years old female patient who administered expired 0.5ml dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] lot C5180BA, expiry date: 06-Apr-2019 via intramuscular route in the right deltoid on 07-Jun-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included was POLIO VACCINE INACT 3V (VERO) (IPOL POLIO VACCINE) and HEPATITIS B VACCINE (HEPATITIS B VACCINE).  It was an actual medication error due to expired vaccine used and inappropriate age at vaccine administration.  At the time of reporting, adverse event was not reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
received his primary smallpox vaccination on Sunday, February 8, 2004, 3 jabs, left arm. Eight days later, he reports that he played basketball for approximately three hours. He went home and took a shower, after which he noticed red splotches on his chest, back, thighs, and cheeks. The next morning his chest had cleared up but the rash remained on his back, thighs, and cheeks. He reports that he waited a couple of days because at the time he did not think the rash was that "big of a deal". Several of the lesions were pimple-like in appearance. He denies any fever, myalgias, or other symptoms. Two days later, his fiancée called the hospital to explain his rash and she was told that he needed to have someone evaluate the rash. At that time he went to the clinic. He was referred to the medical center. There he saw a doctor. There were no cultures performed, no pictures taken of the rash and no medication was provided.  The doctor told the patient that he had erythema multiforme and that it would clear up without treatment.
Ischemic occipital stroke affected me by blocking right eye peripheral vision and balance . I was dizzy and nauseous for about 20 hours.  Treatment and 6 day rehab mitigated most of it though loss of peripheral is ongoing after 3 months.  My Doctor and Opthamologist  are treating .  The first indication/sign was immediately prior with heavy dizziness causing a fall.
This is one case out of a cumulative total of 220 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 19 December 2013. These 220 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial report received on 19 December 2013 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 28-month-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 4 doses of PENTACEL; lot number C3879AA received on 01 September 2011, lot number C3980AB received on 01 November 2011, lot number C4045AA on 04 Jan 2012 and lot number C4374AA on 23 March 2013 (routes and sites of administration not reported). On 13 November 2013, the subject developed a cough and paroxysmal cough on 13 November 2013 without a whoop. The subject also experienced sleep disturbance and vomiting. Laboratory testing included positive PCR on 14 November 2013. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 14 November 2013 for 5 days. The subject was not hospitalized. At the time of final contact on 27 November 2013, the subject's cough was still persisting. The duration of the cough was reported at that time as 14 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Patient said she developed a headache about 4 days after the vaccine and she still has the headache today, 28 days later